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New vulvar cancer guidelines stress regional disease control
HOLLYWOOD, FLA. – The National Comprehensive Cancer Network has issued new guidelines for the diagnosis and management of vulvar cancer.
Vulvar cancers are rare neoplasms, with an estimated U.S. annual incidence of 5,950 cases, and 1,110 deaths. The majority of cases (about 90%) are of squamous cell histology.
Treatment of vulvar cancer has evolved from en bloc resections used throughout most of the 20th century, to more refined techniques, said Dr. Benjamin E. Greer, professor of gynecological oncology at the University of Washington in Seattle.
“In the 1980s, we started to modify treatment to reduce morbidity,” he said at the annual conference of the National Comprehensive Cancer Network.
With older, more radical techniques, groin breakdown, leg edema, and impaired sexual function were common post-surgery consequences. Current practice, however, is to perform regional lymph node management for unilateral cancers, radical local excision rather than en bloc resections, separate groin incisions, lymphatic mapping, radiation, chemotherapy, and, if necessary, exenteration, Dr. Greer noted.
The guidelines note that adequate surgical margins – 1 to 2 cm – at the time of primary surgery appear to be essential for reducing risk of local recurrence, and that if margins are within 8 mm of tumor, the surgeon should consider re-excision or adjuvant radiation.
Lymph node status is the most important determinant of survival, with historical reports showing overall survival following surgery of 70% to 80% among patients with negative nodes, compared with 30% to 40% of those with positive nodes, he said.
Evaluation of bilateral inguinofemoral groin nodes should be performed in patients with lesions in the vulvar midline, and ipsilateral groin node evaluation should be performed for those with lateral lesions lying more than 2 cm from the vulvar midline. Additionally, select patients may require sentinel lymph node biopsy, the guidelines state.
Unilateral carcinomas of the vulva can be treated with limited radical vulvectomy and ipsilateral inguinal femoral node dissection. Lymph node dissection can be performed through a separate incision. For patients with positive nodes, adjuvant radiation may aid in disease control. Patients with inoperable carcinomas are recommended to receive radiation and chemotherapy.
Radiation for vulvar cancer
“For early stage tumors, adjuvant radiotherapy is an effective treatment modality that significantly decreases recurrence, especially in surgically resected groins, and it leads to improvement in relapse-free and overall survival,” said Dr. Wui-Jin Koh, medical director for radiation oncology at the Fred Hutchinson Cancer Research Center in Seattle.
Concurrent chemotherapy and radiation may provide additional therapeutic benefit, especially for patients with advanced, unresectable tumors, and it may help to address systemic risk in patients with multiple positive lymph nodes, Dr. Koh said.
The guidelines state that radiation can be given with external beam radiation delivered via a 3D-conformal or intensity modulated (IMRT) technique, with brachytherapy boost for some tumors where the anatomy permits.
“Careful attention should be taken to ensure adequate tumor coverage by combining clinical examination, imaging findings, and appropriate nodal volumes at risk to define the target volume,” the guideline states.
For adjuvant therapy, doses of 50.4 Gy divided in 1.8 Gy fractions should be delivered once daily 5 days per week, with minimal treatment breaks.
For treatment of unresectable tumors, doses range from 59.4 Gy to 64.8 Gy in 1.8 Gy fractions, with a boost dose to approximately 70 Gy for large lymph nodes in select cases.
Residual disease
The decision to provide additional treatment following surgery is based on whether the patient is clinically negative for residual tumor at the primary site and nodes.
“If one has negative margins and negative nodes? Observation, absolutely,” Dr. Koh said. “If one has positive margins for invasive disease, our recommendation is to re-excise and not go straight to radiation, and if one can do it and get negative margins, again observe the majority of them.”
“Use radiation very judiciously,” he added. “Only if patients have positive margins or have unresectable primary disease do we routinely recommend radiation.”
Locally advanced disease
For patients who cannot be treated with conventional or sphincter-sparing, organ preserving surgery upfront, the recommendation is to provide chemoradiation, with initial radiation to the primary site, groins, and pelvis, and concurrent week cisplatin at a dose of 30-40 mg/m2 per week. The recommended radiation doses are 45 Gy to at-risk, microscopic clinical tumor volume, and 57.6 to 60 Gy to gross tumor volume (primary site and nodes).
“If one uses IMRT, you need to be very generous with the volumes,” Dr. Koh said.
The panelists also recommend re-imaging and re-evaluating patients 6 to 8 weeks after the completion of chemoradiation, with possible resection or biopsy of the primary tumor site, and limited groin resection of imaged residual disease.
For patients with clearly node-positive disease, “my general preference is to give upfront chemoradiation therapy to avoid delay of primary therapy, and then resect residual nodes after the chemoradiation is done,” he said.
HOLLYWOOD, FLA. – The National Comprehensive Cancer Network has issued new guidelines for the diagnosis and management of vulvar cancer.
Vulvar cancers are rare neoplasms, with an estimated U.S. annual incidence of 5,950 cases, and 1,110 deaths. The majority of cases (about 90%) are of squamous cell histology.
Treatment of vulvar cancer has evolved from en bloc resections used throughout most of the 20th century, to more refined techniques, said Dr. Benjamin E. Greer, professor of gynecological oncology at the University of Washington in Seattle.
“In the 1980s, we started to modify treatment to reduce morbidity,” he said at the annual conference of the National Comprehensive Cancer Network.
With older, more radical techniques, groin breakdown, leg edema, and impaired sexual function were common post-surgery consequences. Current practice, however, is to perform regional lymph node management for unilateral cancers, radical local excision rather than en bloc resections, separate groin incisions, lymphatic mapping, radiation, chemotherapy, and, if necessary, exenteration, Dr. Greer noted.
The guidelines note that adequate surgical margins – 1 to 2 cm – at the time of primary surgery appear to be essential for reducing risk of local recurrence, and that if margins are within 8 mm of tumor, the surgeon should consider re-excision or adjuvant radiation.
Lymph node status is the most important determinant of survival, with historical reports showing overall survival following surgery of 70% to 80% among patients with negative nodes, compared with 30% to 40% of those with positive nodes, he said.
Evaluation of bilateral inguinofemoral groin nodes should be performed in patients with lesions in the vulvar midline, and ipsilateral groin node evaluation should be performed for those with lateral lesions lying more than 2 cm from the vulvar midline. Additionally, select patients may require sentinel lymph node biopsy, the guidelines state.
Unilateral carcinomas of the vulva can be treated with limited radical vulvectomy and ipsilateral inguinal femoral node dissection. Lymph node dissection can be performed through a separate incision. For patients with positive nodes, adjuvant radiation may aid in disease control. Patients with inoperable carcinomas are recommended to receive radiation and chemotherapy.
Radiation for vulvar cancer
“For early stage tumors, adjuvant radiotherapy is an effective treatment modality that significantly decreases recurrence, especially in surgically resected groins, and it leads to improvement in relapse-free and overall survival,” said Dr. Wui-Jin Koh, medical director for radiation oncology at the Fred Hutchinson Cancer Research Center in Seattle.
Concurrent chemotherapy and radiation may provide additional therapeutic benefit, especially for patients with advanced, unresectable tumors, and it may help to address systemic risk in patients with multiple positive lymph nodes, Dr. Koh said.
The guidelines state that radiation can be given with external beam radiation delivered via a 3D-conformal or intensity modulated (IMRT) technique, with brachytherapy boost for some tumors where the anatomy permits.
“Careful attention should be taken to ensure adequate tumor coverage by combining clinical examination, imaging findings, and appropriate nodal volumes at risk to define the target volume,” the guideline states.
For adjuvant therapy, doses of 50.4 Gy divided in 1.8 Gy fractions should be delivered once daily 5 days per week, with minimal treatment breaks.
For treatment of unresectable tumors, doses range from 59.4 Gy to 64.8 Gy in 1.8 Gy fractions, with a boost dose to approximately 70 Gy for large lymph nodes in select cases.
Residual disease
The decision to provide additional treatment following surgery is based on whether the patient is clinically negative for residual tumor at the primary site and nodes.
“If one has negative margins and negative nodes? Observation, absolutely,” Dr. Koh said. “If one has positive margins for invasive disease, our recommendation is to re-excise and not go straight to radiation, and if one can do it and get negative margins, again observe the majority of them.”
“Use radiation very judiciously,” he added. “Only if patients have positive margins or have unresectable primary disease do we routinely recommend radiation.”
Locally advanced disease
For patients who cannot be treated with conventional or sphincter-sparing, organ preserving surgery upfront, the recommendation is to provide chemoradiation, with initial radiation to the primary site, groins, and pelvis, and concurrent week cisplatin at a dose of 30-40 mg/m2 per week. The recommended radiation doses are 45 Gy to at-risk, microscopic clinical tumor volume, and 57.6 to 60 Gy to gross tumor volume (primary site and nodes).
“If one uses IMRT, you need to be very generous with the volumes,” Dr. Koh said.
The panelists also recommend re-imaging and re-evaluating patients 6 to 8 weeks after the completion of chemoradiation, with possible resection or biopsy of the primary tumor site, and limited groin resection of imaged residual disease.
For patients with clearly node-positive disease, “my general preference is to give upfront chemoradiation therapy to avoid delay of primary therapy, and then resect residual nodes after the chemoradiation is done,” he said.
HOLLYWOOD, FLA. – The National Comprehensive Cancer Network has issued new guidelines for the diagnosis and management of vulvar cancer.
Vulvar cancers are rare neoplasms, with an estimated U.S. annual incidence of 5,950 cases, and 1,110 deaths. The majority of cases (about 90%) are of squamous cell histology.
Treatment of vulvar cancer has evolved from en bloc resections used throughout most of the 20th century, to more refined techniques, said Dr. Benjamin E. Greer, professor of gynecological oncology at the University of Washington in Seattle.
“In the 1980s, we started to modify treatment to reduce morbidity,” he said at the annual conference of the National Comprehensive Cancer Network.
With older, more radical techniques, groin breakdown, leg edema, and impaired sexual function were common post-surgery consequences. Current practice, however, is to perform regional lymph node management for unilateral cancers, radical local excision rather than en bloc resections, separate groin incisions, lymphatic mapping, radiation, chemotherapy, and, if necessary, exenteration, Dr. Greer noted.
The guidelines note that adequate surgical margins – 1 to 2 cm – at the time of primary surgery appear to be essential for reducing risk of local recurrence, and that if margins are within 8 mm of tumor, the surgeon should consider re-excision or adjuvant radiation.
Lymph node status is the most important determinant of survival, with historical reports showing overall survival following surgery of 70% to 80% among patients with negative nodes, compared with 30% to 40% of those with positive nodes, he said.
Evaluation of bilateral inguinofemoral groin nodes should be performed in patients with lesions in the vulvar midline, and ipsilateral groin node evaluation should be performed for those with lateral lesions lying more than 2 cm from the vulvar midline. Additionally, select patients may require sentinel lymph node biopsy, the guidelines state.
Unilateral carcinomas of the vulva can be treated with limited radical vulvectomy and ipsilateral inguinal femoral node dissection. Lymph node dissection can be performed through a separate incision. For patients with positive nodes, adjuvant radiation may aid in disease control. Patients with inoperable carcinomas are recommended to receive radiation and chemotherapy.
Radiation for vulvar cancer
“For early stage tumors, adjuvant radiotherapy is an effective treatment modality that significantly decreases recurrence, especially in surgically resected groins, and it leads to improvement in relapse-free and overall survival,” said Dr. Wui-Jin Koh, medical director for radiation oncology at the Fred Hutchinson Cancer Research Center in Seattle.
Concurrent chemotherapy and radiation may provide additional therapeutic benefit, especially for patients with advanced, unresectable tumors, and it may help to address systemic risk in patients with multiple positive lymph nodes, Dr. Koh said.
The guidelines state that radiation can be given with external beam radiation delivered via a 3D-conformal or intensity modulated (IMRT) technique, with brachytherapy boost for some tumors where the anatomy permits.
“Careful attention should be taken to ensure adequate tumor coverage by combining clinical examination, imaging findings, and appropriate nodal volumes at risk to define the target volume,” the guideline states.
For adjuvant therapy, doses of 50.4 Gy divided in 1.8 Gy fractions should be delivered once daily 5 days per week, with minimal treatment breaks.
For treatment of unresectable tumors, doses range from 59.4 Gy to 64.8 Gy in 1.8 Gy fractions, with a boost dose to approximately 70 Gy for large lymph nodes in select cases.
Residual disease
The decision to provide additional treatment following surgery is based on whether the patient is clinically negative for residual tumor at the primary site and nodes.
“If one has negative margins and negative nodes? Observation, absolutely,” Dr. Koh said. “If one has positive margins for invasive disease, our recommendation is to re-excise and not go straight to radiation, and if one can do it and get negative margins, again observe the majority of them.”
“Use radiation very judiciously,” he added. “Only if patients have positive margins or have unresectable primary disease do we routinely recommend radiation.”
Locally advanced disease
For patients who cannot be treated with conventional or sphincter-sparing, organ preserving surgery upfront, the recommendation is to provide chemoradiation, with initial radiation to the primary site, groins, and pelvis, and concurrent week cisplatin at a dose of 30-40 mg/m2 per week. The recommended radiation doses are 45 Gy to at-risk, microscopic clinical tumor volume, and 57.6 to 60 Gy to gross tumor volume (primary site and nodes).
“If one uses IMRT, you need to be very generous with the volumes,” Dr. Koh said.
The panelists also recommend re-imaging and re-evaluating patients 6 to 8 weeks after the completion of chemoradiation, with possible resection or biopsy of the primary tumor site, and limited groin resection of imaged residual disease.
For patients with clearly node-positive disease, “my general preference is to give upfront chemoradiation therapy to avoid delay of primary therapy, and then resect residual nodes after the chemoradiation is done,” he said.
AT THE NCCN ANNUAL CONFERENCE
Key clinical point: Nodal status is an important determinant of survival of patients with vulvar carcinomas.
Major finding: Historically, reported overall survival following surgery is 70% to 80% among patients with negative nodes, compared with 30% to 40% of those with positive nodes.
Data source: Review of new clinical guidelines for the management of patients with vulvar cancer.
Disclosures: Dr. Greer and Dr. Koh reported having no relevant clinical disclosures.
Skip lymphadenectomy if SLN mapping finds low-grade endometrial cancer
SAN DIEGO – Lymphadenectomy is unnecessary if sentinel lymph node mapping successfully stages low-grade endometrial cancer, according to researchers from Johns Hopkins University in Baltimore.
Lymphadenectomy guided by frozen section remains common in the United States. But the Johns Hopkins research team found that using sentinel lymph node (SLN) mapping and biopsy instead cuts the rate of lymphadenectomy by 76%, without reducing the detection of lymphatic metastases.
It’s an important finding for cancer patients likely to survive their diagnosis. “We see low-grade patients in the clinic” who’ve had unnecessary lymphadenectomies, “and they are in terrible shape,” said investigator Dr. Abdulrahman Sinno, a gynecologic oncology fellow at Johns Hopkins. Up to half “have horrible side effects,” including crippling lymphedema and pain.
SLN mapping is “an alternative that gives us the information we need for nodal assessment without putting patients at risk. You’ll know if patients have metastases or not. If they fail to map, you do a frozen section, and if you have high-risk features, a lymphadenectomy only on [the side] that didn’t map,” Dr. Sinno said at the annual meeting of the Society of Gynecologic Oncology.
For the past several years, physicians at Johns Hopkins has been doing both SLN mapping for low-grade endometrial cancer as well as frozen sections to decide the need for lymphadenectomy. Using both approaches allowed the investigators to review how patients would have fared if they had gotten only one.
“[We could] safely study the utility of SLN mapping while maintaining the historical standard of using frozen sections to direct the need for lymphadenectomy,” Dr. Sinno said.
SLN mapping outperformed frozen section. Among 114 women, most with grade 1 disease but some with grade 2 or complex atypical hyperplasia, 8 had lymph node metastases. Mapping identified every one, five by standard hematoxylin-eosin staining, and three by ultrastaging. Frozen-section guided lymphadenectomy missed three.
Eighty four (37%) of the 224 hemi-pelvises in the study had lymphadenectomies based on worrisome frozen-section findings. If SLN mapping had been relied on to make the call, lymphadenectomies would have been performed in 20 (9%), a statistically significant difference (P = 0.004).
“Strategies that rely exclusively on uterine frozen section result in significant overtreatment. In the absence of a therapeutic benefit to lymphadenectomy, we believe” this is “unjustifiable when an alternative exists.” At Johns Hopkins these days, “if you map, you’re done,” Dr. Sinno said.
Almost two-thirds of the women had grade 1 endometrial cancer on preoperative histopathology, and about the same number on final pathology. Bilateral SLN mapping was successful in 71 cases (62%) and unilateral mapping in 27 cases (24%). At least one SLN was detected in 98 women (86%).
There were six recurrences after a median follow-up of 15 months. Four were in women who had full pelvic and periaortic lymphadenectomies that were negative. There was also a port site recurrence and a recurrence in an outlying patient with advanced disease. Overall, “recurrence was independent of whether sentinel nodes were applied,” Dr. Sinno said.
Women in the study were a median of 60 years old, with a median body mass index of 33.3 kg/m2.
Dr. Sinno reported having no relevant financial disclosures.
SAN DIEGO – Lymphadenectomy is unnecessary if sentinel lymph node mapping successfully stages low-grade endometrial cancer, according to researchers from Johns Hopkins University in Baltimore.
Lymphadenectomy guided by frozen section remains common in the United States. But the Johns Hopkins research team found that using sentinel lymph node (SLN) mapping and biopsy instead cuts the rate of lymphadenectomy by 76%, without reducing the detection of lymphatic metastases.
It’s an important finding for cancer patients likely to survive their diagnosis. “We see low-grade patients in the clinic” who’ve had unnecessary lymphadenectomies, “and they are in terrible shape,” said investigator Dr. Abdulrahman Sinno, a gynecologic oncology fellow at Johns Hopkins. Up to half “have horrible side effects,” including crippling lymphedema and pain.
SLN mapping is “an alternative that gives us the information we need for nodal assessment without putting patients at risk. You’ll know if patients have metastases or not. If they fail to map, you do a frozen section, and if you have high-risk features, a lymphadenectomy only on [the side] that didn’t map,” Dr. Sinno said at the annual meeting of the Society of Gynecologic Oncology.
For the past several years, physicians at Johns Hopkins has been doing both SLN mapping for low-grade endometrial cancer as well as frozen sections to decide the need for lymphadenectomy. Using both approaches allowed the investigators to review how patients would have fared if they had gotten only one.
“[We could] safely study the utility of SLN mapping while maintaining the historical standard of using frozen sections to direct the need for lymphadenectomy,” Dr. Sinno said.
SLN mapping outperformed frozen section. Among 114 women, most with grade 1 disease but some with grade 2 or complex atypical hyperplasia, 8 had lymph node metastases. Mapping identified every one, five by standard hematoxylin-eosin staining, and three by ultrastaging. Frozen-section guided lymphadenectomy missed three.
Eighty four (37%) of the 224 hemi-pelvises in the study had lymphadenectomies based on worrisome frozen-section findings. If SLN mapping had been relied on to make the call, lymphadenectomies would have been performed in 20 (9%), a statistically significant difference (P = 0.004).
“Strategies that rely exclusively on uterine frozen section result in significant overtreatment. In the absence of a therapeutic benefit to lymphadenectomy, we believe” this is “unjustifiable when an alternative exists.” At Johns Hopkins these days, “if you map, you’re done,” Dr. Sinno said.
Almost two-thirds of the women had grade 1 endometrial cancer on preoperative histopathology, and about the same number on final pathology. Bilateral SLN mapping was successful in 71 cases (62%) and unilateral mapping in 27 cases (24%). At least one SLN was detected in 98 women (86%).
There were six recurrences after a median follow-up of 15 months. Four were in women who had full pelvic and periaortic lymphadenectomies that were negative. There was also a port site recurrence and a recurrence in an outlying patient with advanced disease. Overall, “recurrence was independent of whether sentinel nodes were applied,” Dr. Sinno said.
Women in the study were a median of 60 years old, with a median body mass index of 33.3 kg/m2.
Dr. Sinno reported having no relevant financial disclosures.
SAN DIEGO – Lymphadenectomy is unnecessary if sentinel lymph node mapping successfully stages low-grade endometrial cancer, according to researchers from Johns Hopkins University in Baltimore.
Lymphadenectomy guided by frozen section remains common in the United States. But the Johns Hopkins research team found that using sentinel lymph node (SLN) mapping and biopsy instead cuts the rate of lymphadenectomy by 76%, without reducing the detection of lymphatic metastases.
It’s an important finding for cancer patients likely to survive their diagnosis. “We see low-grade patients in the clinic” who’ve had unnecessary lymphadenectomies, “and they are in terrible shape,” said investigator Dr. Abdulrahman Sinno, a gynecologic oncology fellow at Johns Hopkins. Up to half “have horrible side effects,” including crippling lymphedema and pain.
SLN mapping is “an alternative that gives us the information we need for nodal assessment without putting patients at risk. You’ll know if patients have metastases or not. If they fail to map, you do a frozen section, and if you have high-risk features, a lymphadenectomy only on [the side] that didn’t map,” Dr. Sinno said at the annual meeting of the Society of Gynecologic Oncology.
For the past several years, physicians at Johns Hopkins has been doing both SLN mapping for low-grade endometrial cancer as well as frozen sections to decide the need for lymphadenectomy. Using both approaches allowed the investigators to review how patients would have fared if they had gotten only one.
“[We could] safely study the utility of SLN mapping while maintaining the historical standard of using frozen sections to direct the need for lymphadenectomy,” Dr. Sinno said.
SLN mapping outperformed frozen section. Among 114 women, most with grade 1 disease but some with grade 2 or complex atypical hyperplasia, 8 had lymph node metastases. Mapping identified every one, five by standard hematoxylin-eosin staining, and three by ultrastaging. Frozen-section guided lymphadenectomy missed three.
Eighty four (37%) of the 224 hemi-pelvises in the study had lymphadenectomies based on worrisome frozen-section findings. If SLN mapping had been relied on to make the call, lymphadenectomies would have been performed in 20 (9%), a statistically significant difference (P = 0.004).
“Strategies that rely exclusively on uterine frozen section result in significant overtreatment. In the absence of a therapeutic benefit to lymphadenectomy, we believe” this is “unjustifiable when an alternative exists.” At Johns Hopkins these days, “if you map, you’re done,” Dr. Sinno said.
Almost two-thirds of the women had grade 1 endometrial cancer on preoperative histopathology, and about the same number on final pathology. Bilateral SLN mapping was successful in 71 cases (62%) and unilateral mapping in 27 cases (24%). At least one SLN was detected in 98 women (86%).
There were six recurrences after a median follow-up of 15 months. Four were in women who had full pelvic and periaortic lymphadenectomies that were negative. There was also a port site recurrence and a recurrence in an outlying patient with advanced disease. Overall, “recurrence was independent of whether sentinel nodes were applied,” Dr. Sinno said.
Women in the study were a median of 60 years old, with a median body mass index of 33.3 kg/m2.
Dr. Sinno reported having no relevant financial disclosures.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: Successful sentinel lymph node mapping gives all the information needed for nodal assessment.
Major finding: Sentinel lymph node mapping identified all eight nodal metastases; frozen-section guided lymphadenectomy missed three.
Data source: A review of 114 cases at Johns Hopkins University.
Disclosures: Dr. Sinno reported having no relevant financial disclosures.
Inking bests suturing to mark breast tumor margins
BOSTON – With art supplies and “mystery” sutures, a team of investigators has determined that immediate intraoperative inking of lumpectomy specimens appears to be a better method than suture placement for orienting specimens for pathology, a finding that could reduce re-excisions.
“Intraoperative specimen suturing appears to be inaccurate for margin identification, and additional means by the surgeon to improve the accuracy are needed. This could be either immediate inking or routine excision of shave margins, either at the original surgery or when you go back for re-excision, to take all the margins instead of one specific margin,” Dr. Angel Arnaout, a breast surgeon at the University of Ottawa, Ont., said at the annual Society of Surgical Oncology Cancer Symposium.
She presented results of the randomized, blinded SMART (Specimen Margin Assessment Technique) trial comparing suture placement with intraoperative inking within the same surgical specimen.
Positive resection margins during breast-conserving surgery are associated with a twofold increase in the risk of ipsilateral tumor recurrence, and require re-excision or conversion to mastectomy. Re-excisions rates range from 25% to 45%, but in the majority of cases – 53% to 65% – no additional disease is found, Dr. Arnaout said.
In addition to adding to patient distress, re-excisions diminish cosmetic results because they take additional tissue, and delay the start of adjuvant breast cancer therapy, she noted.
Surgeons typically orient specimens for pathologists by placing two or three sutures in the center of the margin surfaces or, less frequently, by intraoperative marking of the margins with ink. But in transit from the OR to the pathology lab, specimens often flatten or “pancake” under their own weight, making it challenging for the pathologist to identify the originally marked margins.
To test whether suturing or inking is better at identifying the extent of tumors during breast-conserving surgery, the investigators devised a strategy using benign breast tissue removed during prophylactic mastectomy or reduction mammoplasty.
The surgeons first performed a sham lumpectomy within the tissue. They then painted the specimen margins in the OR using a phospholuminescent paint obtained from an art supply store. The paint dries clear and colorless, but glows in different colors under black light. By using the paint, carefully selected so as not to interfere with pathology staining, the investigators were able to blind the pathologists to the actual orientation of the margins.
While the tissue was still in the OR, the surgeons then placed two or three orienting sutures in customary locations, plus a third, “mystery” suture at a location known only to the surgeon.
In the pathology lab, the assistant was asked to look at the sutures and outline in black ink the edges of the margins using the sutures for guidance.
The specimen was then examined under black light to determine the degree of discordance between surgeons and pathologist for identification of margins using the suture and painting methods (primary outcome), and to evaluate the discrepancy in the extent of margin surface areas as identified by the surgeons and the pathologists (secondary outcome).
“We asked breast surgeons ‘what would be a clinically significant discordance rate for you?’ and most of them said between 10% and 20%, so we looked for a 15% discordance rate as being clinically significant between the two margin assessment techniques,” Dr. Arnaout said.
They found that the overall discordance in the location of the mystery suture between surgeons and pathologists was similar whether the samples contained two or three location sutures, with discordance rates of 46% (34 of 75 samples) for two sutures, and 47% (41 of 88 samples) for three sutures.
For the secondary outcome of discordance in the extent of margins, they found that pathologists tended to estimate the mean surface of the anterior and posterior margins to be significantly larger than the surgeons did (P less than .01), while significantly underestimating the superior, inferior, and lateral margins (P less than .01 for superior and inferior, and P = .04 for lateral margins).
Examination under black light showed that often two or three additional margins would be included by the surgeon within what the pathologist had identified as the anterior margin.
“This has implications for the surgeon and for the patient,” Dr. Arnaout said. “For most of us that do lumpectomies that go from skin down to chest wall, if an anterior margin or posterior margin is positive, a lot of times we would fight not to go back because we would say there is no further room for re-excision.”
But if the tumor is within what is actually the superior margin but labeled by the pathologist as an anterior margin, the patient may miss an opportunity for successful re-excision, she explained.
The study was limited by the fact that the sham lumpectomy specimens did not contain skin or muscle, which would have allowed for more accurate margin orientation in an actual operative setting; by lack of compression of specimens with small nonpalpable lesions in containers, which further distorts specimens; and by the use of smaller lumpectomy specimens than normally obtained during cancer surgery, which could have resulted in overestimation of the discordance that might occur when larger specimens are taken, Dr. Arnaout said.
“The conclusion of our study is that specimen margin orientation really should be defined by the surgeon who knows the original shape and orientation of the tissue during surgery, and not to rely on the pathology to reorient based on some sutures placed in the centers of the specimens without defining the extent of the surface area of each of the margins,” she said.
The Canadian Cancer Society Research Institute and the Canadian Surgical Research Fund supported the study. Dr. Arnaout and coauthors reported no conflicts of interest.
BOSTON – With art supplies and “mystery” sutures, a team of investigators has determined that immediate intraoperative inking of lumpectomy specimens appears to be a better method than suture placement for orienting specimens for pathology, a finding that could reduce re-excisions.
“Intraoperative specimen suturing appears to be inaccurate for margin identification, and additional means by the surgeon to improve the accuracy are needed. This could be either immediate inking or routine excision of shave margins, either at the original surgery or when you go back for re-excision, to take all the margins instead of one specific margin,” Dr. Angel Arnaout, a breast surgeon at the University of Ottawa, Ont., said at the annual Society of Surgical Oncology Cancer Symposium.
She presented results of the randomized, blinded SMART (Specimen Margin Assessment Technique) trial comparing suture placement with intraoperative inking within the same surgical specimen.
Positive resection margins during breast-conserving surgery are associated with a twofold increase in the risk of ipsilateral tumor recurrence, and require re-excision or conversion to mastectomy. Re-excisions rates range from 25% to 45%, but in the majority of cases – 53% to 65% – no additional disease is found, Dr. Arnaout said.
In addition to adding to patient distress, re-excisions diminish cosmetic results because they take additional tissue, and delay the start of adjuvant breast cancer therapy, she noted.
Surgeons typically orient specimens for pathologists by placing two or three sutures in the center of the margin surfaces or, less frequently, by intraoperative marking of the margins with ink. But in transit from the OR to the pathology lab, specimens often flatten or “pancake” under their own weight, making it challenging for the pathologist to identify the originally marked margins.
To test whether suturing or inking is better at identifying the extent of tumors during breast-conserving surgery, the investigators devised a strategy using benign breast tissue removed during prophylactic mastectomy or reduction mammoplasty.
The surgeons first performed a sham lumpectomy within the tissue. They then painted the specimen margins in the OR using a phospholuminescent paint obtained from an art supply store. The paint dries clear and colorless, but glows in different colors under black light. By using the paint, carefully selected so as not to interfere with pathology staining, the investigators were able to blind the pathologists to the actual orientation of the margins.
While the tissue was still in the OR, the surgeons then placed two or three orienting sutures in customary locations, plus a third, “mystery” suture at a location known only to the surgeon.
In the pathology lab, the assistant was asked to look at the sutures and outline in black ink the edges of the margins using the sutures for guidance.
The specimen was then examined under black light to determine the degree of discordance between surgeons and pathologist for identification of margins using the suture and painting methods (primary outcome), and to evaluate the discrepancy in the extent of margin surface areas as identified by the surgeons and the pathologists (secondary outcome).
“We asked breast surgeons ‘what would be a clinically significant discordance rate for you?’ and most of them said between 10% and 20%, so we looked for a 15% discordance rate as being clinically significant between the two margin assessment techniques,” Dr. Arnaout said.
They found that the overall discordance in the location of the mystery suture between surgeons and pathologists was similar whether the samples contained two or three location sutures, with discordance rates of 46% (34 of 75 samples) for two sutures, and 47% (41 of 88 samples) for three sutures.
For the secondary outcome of discordance in the extent of margins, they found that pathologists tended to estimate the mean surface of the anterior and posterior margins to be significantly larger than the surgeons did (P less than .01), while significantly underestimating the superior, inferior, and lateral margins (P less than .01 for superior and inferior, and P = .04 for lateral margins).
Examination under black light showed that often two or three additional margins would be included by the surgeon within what the pathologist had identified as the anterior margin.
“This has implications for the surgeon and for the patient,” Dr. Arnaout said. “For most of us that do lumpectomies that go from skin down to chest wall, if an anterior margin or posterior margin is positive, a lot of times we would fight not to go back because we would say there is no further room for re-excision.”
But if the tumor is within what is actually the superior margin but labeled by the pathologist as an anterior margin, the patient may miss an opportunity for successful re-excision, she explained.
The study was limited by the fact that the sham lumpectomy specimens did not contain skin or muscle, which would have allowed for more accurate margin orientation in an actual operative setting; by lack of compression of specimens with small nonpalpable lesions in containers, which further distorts specimens; and by the use of smaller lumpectomy specimens than normally obtained during cancer surgery, which could have resulted in overestimation of the discordance that might occur when larger specimens are taken, Dr. Arnaout said.
“The conclusion of our study is that specimen margin orientation really should be defined by the surgeon who knows the original shape and orientation of the tissue during surgery, and not to rely on the pathology to reorient based on some sutures placed in the centers of the specimens without defining the extent of the surface area of each of the margins,” she said.
The Canadian Cancer Society Research Institute and the Canadian Surgical Research Fund supported the study. Dr. Arnaout and coauthors reported no conflicts of interest.
BOSTON – With art supplies and “mystery” sutures, a team of investigators has determined that immediate intraoperative inking of lumpectomy specimens appears to be a better method than suture placement for orienting specimens for pathology, a finding that could reduce re-excisions.
“Intraoperative specimen suturing appears to be inaccurate for margin identification, and additional means by the surgeon to improve the accuracy are needed. This could be either immediate inking or routine excision of shave margins, either at the original surgery or when you go back for re-excision, to take all the margins instead of one specific margin,” Dr. Angel Arnaout, a breast surgeon at the University of Ottawa, Ont., said at the annual Society of Surgical Oncology Cancer Symposium.
She presented results of the randomized, blinded SMART (Specimen Margin Assessment Technique) trial comparing suture placement with intraoperative inking within the same surgical specimen.
Positive resection margins during breast-conserving surgery are associated with a twofold increase in the risk of ipsilateral tumor recurrence, and require re-excision or conversion to mastectomy. Re-excisions rates range from 25% to 45%, but in the majority of cases – 53% to 65% – no additional disease is found, Dr. Arnaout said.
In addition to adding to patient distress, re-excisions diminish cosmetic results because they take additional tissue, and delay the start of adjuvant breast cancer therapy, she noted.
Surgeons typically orient specimens for pathologists by placing two or three sutures in the center of the margin surfaces or, less frequently, by intraoperative marking of the margins with ink. But in transit from the OR to the pathology lab, specimens often flatten or “pancake” under their own weight, making it challenging for the pathologist to identify the originally marked margins.
To test whether suturing or inking is better at identifying the extent of tumors during breast-conserving surgery, the investigators devised a strategy using benign breast tissue removed during prophylactic mastectomy or reduction mammoplasty.
The surgeons first performed a sham lumpectomy within the tissue. They then painted the specimen margins in the OR using a phospholuminescent paint obtained from an art supply store. The paint dries clear and colorless, but glows in different colors under black light. By using the paint, carefully selected so as not to interfere with pathology staining, the investigators were able to blind the pathologists to the actual orientation of the margins.
While the tissue was still in the OR, the surgeons then placed two or three orienting sutures in customary locations, plus a third, “mystery” suture at a location known only to the surgeon.
In the pathology lab, the assistant was asked to look at the sutures and outline in black ink the edges of the margins using the sutures for guidance.
The specimen was then examined under black light to determine the degree of discordance between surgeons and pathologist for identification of margins using the suture and painting methods (primary outcome), and to evaluate the discrepancy in the extent of margin surface areas as identified by the surgeons and the pathologists (secondary outcome).
“We asked breast surgeons ‘what would be a clinically significant discordance rate for you?’ and most of them said between 10% and 20%, so we looked for a 15% discordance rate as being clinically significant between the two margin assessment techniques,” Dr. Arnaout said.
They found that the overall discordance in the location of the mystery suture between surgeons and pathologists was similar whether the samples contained two or three location sutures, with discordance rates of 46% (34 of 75 samples) for two sutures, and 47% (41 of 88 samples) for three sutures.
For the secondary outcome of discordance in the extent of margins, they found that pathologists tended to estimate the mean surface of the anterior and posterior margins to be significantly larger than the surgeons did (P less than .01), while significantly underestimating the superior, inferior, and lateral margins (P less than .01 for superior and inferior, and P = .04 for lateral margins).
Examination under black light showed that often two or three additional margins would be included by the surgeon within what the pathologist had identified as the anterior margin.
“This has implications for the surgeon and for the patient,” Dr. Arnaout said. “For most of us that do lumpectomies that go from skin down to chest wall, if an anterior margin or posterior margin is positive, a lot of times we would fight not to go back because we would say there is no further room for re-excision.”
But if the tumor is within what is actually the superior margin but labeled by the pathologist as an anterior margin, the patient may miss an opportunity for successful re-excision, she explained.
The study was limited by the fact that the sham lumpectomy specimens did not contain skin or muscle, which would have allowed for more accurate margin orientation in an actual operative setting; by lack of compression of specimens with small nonpalpable lesions in containers, which further distorts specimens; and by the use of smaller lumpectomy specimens than normally obtained during cancer surgery, which could have resulted in overestimation of the discordance that might occur when larger specimens are taken, Dr. Arnaout said.
“The conclusion of our study is that specimen margin orientation really should be defined by the surgeon who knows the original shape and orientation of the tissue during surgery, and not to rely on the pathology to reorient based on some sutures placed in the centers of the specimens without defining the extent of the surface area of each of the margins,” she said.
The Canadian Cancer Society Research Institute and the Canadian Surgical Research Fund supported the study. Dr. Arnaout and coauthors reported no conflicts of interest.
FROM SSO 2016
Key clinical point: Intraoperative suture placement is an inaccurate method for orienting breast tumor specimens for pathology.
Major finding: Discordance in identifying tumor margin surface between surgeons and pathologists was similar whether the samples contained two or three location sutures, with discordance rates of 46% (34 of 75 samples) for two sutures, and 47% (41 of 88 samples) for three sutures.
Data source: Randomized clinical trial of 163 specimens obtained from 49 patients.
Disclosures: The Canadian Cancer Society Research Institute and the Canadian Surgical Research Fund supported the study. Dr. Arnaout and coauthors reported no conflicts of interest.
Better sarcoma outcomes at high-volume centers
BOSTON – In sarcoma as in other cancers, experience counts.
That’s the conclusion of investigators who found that patients with extra-abdominal sarcomas who were treated in high-volume hospitals had half the 30-day mortality rate, higher likelihood of negative surgical margins, and better overall survival, compared with patients treated in low-volume hospitals.
“It appears there is a direct association between hospital volume and short-term as well as long-term outcomes for soft-tissue sarcomas outside the abdomen,” said Dr. Sanjay P. Bagaria of the Mayo Clinic in Jacksonville, Fla.
The findings support centralization of services at the national level in centers specializing in the management of sarcomas, he said at the annual Society of Surgical Oncology Cancer Symposium.
Previous studies have shown that patients treated in high-volume centers for cancers of the esophagus, pancreas, and lung have better outcomes than patients treated in low-volume centers, he noted.
Given the rarity of sarcomas, with an incidence of approximately 12,000 in the U.S. annually, their complexity, with more than 60 histologic subtypes, and the multimodality approach required for them, it seemed likely that a positive association between volume and outcomes could be found, Dr. Bagaria said.
He and colleagues queried the U.S. National Cancer Database, a hospital registry of data from more than 1,500 facilities accredited by the Commission on Cancer.
They drew records on all patients diagnosed with extra-abdominal sarcomas from 2003 through 2007 who underwent surgery at the reporting hospitals, and divided the cases into terciles as either low volume (3 or fewer surgical cases per year), medium volume (3.2-11.6 per year), or high volume (12 or more cases per year).
One third (33%) of all cases were concentrated in just 44 high-volume hospitals, which comprised just 4% of the total hospital sample of 1,163. An additional third (34%) of cases were managed among 196 medium-volume hospitals (17% of the hospital sample), and the remaining third (33%) were spread among 923 low-volume hospitals (79%).
The 30-day mortality rates for low-, medium-, and high-volume hospitals, respectively, were 1.7%, 1.1%, and 0.6% (P less than .0001).
Similarly, the rates of negative margins (R0 resections) were 73.%, 78.2%, and 84.2% (P less than .0001).
Five-year overall survival was identical for low- and medium-volume centers (65% each), but was significantly better for patients treated at high-volume centers (69%, P less than .001)
Compared with low-volume centers, patients treated at high-volume centers had an adjusted odds ratio (OR) for 30-day mortality of 0.46 (P = .01), an adjusted OR for R0 margins of 1.87 (P less than .001), and OR for overall mortality of 0.92 (P = .04).
Dr. Bagaria noted that the study was limited by missing data about disease-specific survival and by possible selection bias associated with the choice of Commission on Cancer-accredited institutions, which account for 70% of cancer cases nationwide but comprise one-third of all hospitals.
BOSTON – In sarcoma as in other cancers, experience counts.
That’s the conclusion of investigators who found that patients with extra-abdominal sarcomas who were treated in high-volume hospitals had half the 30-day mortality rate, higher likelihood of negative surgical margins, and better overall survival, compared with patients treated in low-volume hospitals.
“It appears there is a direct association between hospital volume and short-term as well as long-term outcomes for soft-tissue sarcomas outside the abdomen,” said Dr. Sanjay P. Bagaria of the Mayo Clinic in Jacksonville, Fla.
The findings support centralization of services at the national level in centers specializing in the management of sarcomas, he said at the annual Society of Surgical Oncology Cancer Symposium.
Previous studies have shown that patients treated in high-volume centers for cancers of the esophagus, pancreas, and lung have better outcomes than patients treated in low-volume centers, he noted.
Given the rarity of sarcomas, with an incidence of approximately 12,000 in the U.S. annually, their complexity, with more than 60 histologic subtypes, and the multimodality approach required for them, it seemed likely that a positive association between volume and outcomes could be found, Dr. Bagaria said.
He and colleagues queried the U.S. National Cancer Database, a hospital registry of data from more than 1,500 facilities accredited by the Commission on Cancer.
They drew records on all patients diagnosed with extra-abdominal sarcomas from 2003 through 2007 who underwent surgery at the reporting hospitals, and divided the cases into terciles as either low volume (3 or fewer surgical cases per year), medium volume (3.2-11.6 per year), or high volume (12 or more cases per year).
One third (33%) of all cases were concentrated in just 44 high-volume hospitals, which comprised just 4% of the total hospital sample of 1,163. An additional third (34%) of cases were managed among 196 medium-volume hospitals (17% of the hospital sample), and the remaining third (33%) were spread among 923 low-volume hospitals (79%).
The 30-day mortality rates for low-, medium-, and high-volume hospitals, respectively, were 1.7%, 1.1%, and 0.6% (P less than .0001).
Similarly, the rates of negative margins (R0 resections) were 73.%, 78.2%, and 84.2% (P less than .0001).
Five-year overall survival was identical for low- and medium-volume centers (65% each), but was significantly better for patients treated at high-volume centers (69%, P less than .001)
Compared with low-volume centers, patients treated at high-volume centers had an adjusted odds ratio (OR) for 30-day mortality of 0.46 (P = .01), an adjusted OR for R0 margins of 1.87 (P less than .001), and OR for overall mortality of 0.92 (P = .04).
Dr. Bagaria noted that the study was limited by missing data about disease-specific survival and by possible selection bias associated with the choice of Commission on Cancer-accredited institutions, which account for 70% of cancer cases nationwide but comprise one-third of all hospitals.
BOSTON – In sarcoma as in other cancers, experience counts.
That’s the conclusion of investigators who found that patients with extra-abdominal sarcomas who were treated in high-volume hospitals had half the 30-day mortality rate, higher likelihood of negative surgical margins, and better overall survival, compared with patients treated in low-volume hospitals.
“It appears there is a direct association between hospital volume and short-term as well as long-term outcomes for soft-tissue sarcomas outside the abdomen,” said Dr. Sanjay P. Bagaria of the Mayo Clinic in Jacksonville, Fla.
The findings support centralization of services at the national level in centers specializing in the management of sarcomas, he said at the annual Society of Surgical Oncology Cancer Symposium.
Previous studies have shown that patients treated in high-volume centers for cancers of the esophagus, pancreas, and lung have better outcomes than patients treated in low-volume centers, he noted.
Given the rarity of sarcomas, with an incidence of approximately 12,000 in the U.S. annually, their complexity, with more than 60 histologic subtypes, and the multimodality approach required for them, it seemed likely that a positive association between volume and outcomes could be found, Dr. Bagaria said.
He and colleagues queried the U.S. National Cancer Database, a hospital registry of data from more than 1,500 facilities accredited by the Commission on Cancer.
They drew records on all patients diagnosed with extra-abdominal sarcomas from 2003 through 2007 who underwent surgery at the reporting hospitals, and divided the cases into terciles as either low volume (3 or fewer surgical cases per year), medium volume (3.2-11.6 per year), or high volume (12 or more cases per year).
One third (33%) of all cases were concentrated in just 44 high-volume hospitals, which comprised just 4% of the total hospital sample of 1,163. An additional third (34%) of cases were managed among 196 medium-volume hospitals (17% of the hospital sample), and the remaining third (33%) were spread among 923 low-volume hospitals (79%).
The 30-day mortality rates for low-, medium-, and high-volume hospitals, respectively, were 1.7%, 1.1%, and 0.6% (P less than .0001).
Similarly, the rates of negative margins (R0 resections) were 73.%, 78.2%, and 84.2% (P less than .0001).
Five-year overall survival was identical for low- and medium-volume centers (65% each), but was significantly better for patients treated at high-volume centers (69%, P less than .001)
Compared with low-volume centers, patients treated at high-volume centers had an adjusted odds ratio (OR) for 30-day mortality of 0.46 (P = .01), an adjusted OR for R0 margins of 1.87 (P less than .001), and OR for overall mortality of 0.92 (P = .04).
Dr. Bagaria noted that the study was limited by missing data about disease-specific survival and by possible selection bias associated with the choice of Commission on Cancer-accredited institutions, which account for 70% of cancer cases nationwide but comprise one-third of all hospitals.
Key clinical point: Surgical volume, a surrogate for experience, has been shown to have a direct correlation with patient outcomes for cancers of the esophagus, lung, and pancreas, and this appears to be true for sarcomas as well.
Major finding: Patients treated for sarcoma at high-volume centers had lower 30-day and overall mortality and a higher probability of negative margins than those treated at low-volume centers.
Data source: Retrospective review of data on 14,634 patients treated at 1,163 U.S. hospitals.
Disclosures: The authors reported no relevant disclosures.
CT of chest, extremity effective for sarcoma follow-up
BOSTON – CT scans appear to be effective for detecting local recurrences and pulmonary metastases in patients treated for soft-tissue sarcomas of the extremities, for about a third less than the cost of follow-up with MRI.
In a retrospective study by Dr. Allison Maciver and her colleagues, among 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 patients had a total of 14 local recurrences detected on CT, and 11 of the recurrences were in patients who were clinically asymptomatic.
Surveillance CT also identified 15 cases of pulmonary metastases, and 4 incidental second primary malignancies, Dr. Maciver of the Roswell Park Cancer Institute in Buffalo, N.Y., and her coinvestigators found, and there was only one false-positive recurrence.
The benefits of CT over extremity MRI in this population include decreased imaging time, lower cost, and a larger field of view, allowing for detection of second primary malignancies, she noted in a poster session at the annual Society of Surgical Oncology Cancer Symposium.
Many sarcomas of the extremities are highly aggressive, and timely detection of local recurrences could improve chances for limb-sparing salvage therapies. Although MRI has typically been used to follow patients with sarcomas, it is expensive and has a limited field of view, Dr. Maciver said.
In addition, the risk of pulmonary metastases with some soft-tissue sarcomas is high, necessitating the use of chest CT as a surveillance tool.
To see whether CT scans of the chest and extremities could be a cost-effective surveillance strategy for both local recurrences and pulmonary metastases, the investigators did a retrospective study of a prospective database of patients who underwent surgical resection for soft-tissue sarcomas of the extremities from 2001 through 2014 and who had CT as the primary follow-up imaging modality.
They identified a total of 91 high-risk patients followed for a median of 50.5 months. The patients had an estimated 5-year freedom from local recurrence of 82%, and from distant recurrence of 80%. Five-year overall survival was 76%.
Of the 15 patients found on CT to have pulmonary metastases, there were 4 incidentally discovered second primary cancers, including 1 each of non–small cell lung cancer, pancreatic adenocarcinoma, Merkel cell carcinomatosis, and myxofibrosarcoma. There were no false-positive pulmonary metastases.
The estimated cost of 10 years of surveillance, based on 2014 gross technical costs, was $64,969 per patient for chest CT and extremity MRI, compared with $41,595 per patient for chest and extremity CT surveillance, a potential cost savings with the CT-only strategy of $23,374 per patient.
The investigators said that the overall benefits of CT, including the cost savings in an accountable care organization model, “appear to outweigh the slightly increased radiation exposure.”
The study was internally funded. The authors reported having no relevant financial disclosures.
BOSTON – CT scans appear to be effective for detecting local recurrences and pulmonary metastases in patients treated for soft-tissue sarcomas of the extremities, for about a third less than the cost of follow-up with MRI.
In a retrospective study by Dr. Allison Maciver and her colleagues, among 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 patients had a total of 14 local recurrences detected on CT, and 11 of the recurrences were in patients who were clinically asymptomatic.
Surveillance CT also identified 15 cases of pulmonary metastases, and 4 incidental second primary malignancies, Dr. Maciver of the Roswell Park Cancer Institute in Buffalo, N.Y., and her coinvestigators found, and there was only one false-positive recurrence.
The benefits of CT over extremity MRI in this population include decreased imaging time, lower cost, and a larger field of view, allowing for detection of second primary malignancies, she noted in a poster session at the annual Society of Surgical Oncology Cancer Symposium.
Many sarcomas of the extremities are highly aggressive, and timely detection of local recurrences could improve chances for limb-sparing salvage therapies. Although MRI has typically been used to follow patients with sarcomas, it is expensive and has a limited field of view, Dr. Maciver said.
In addition, the risk of pulmonary metastases with some soft-tissue sarcomas is high, necessitating the use of chest CT as a surveillance tool.
To see whether CT scans of the chest and extremities could be a cost-effective surveillance strategy for both local recurrences and pulmonary metastases, the investigators did a retrospective study of a prospective database of patients who underwent surgical resection for soft-tissue sarcomas of the extremities from 2001 through 2014 and who had CT as the primary follow-up imaging modality.
They identified a total of 91 high-risk patients followed for a median of 50.5 months. The patients had an estimated 5-year freedom from local recurrence of 82%, and from distant recurrence of 80%. Five-year overall survival was 76%.
Of the 15 patients found on CT to have pulmonary metastases, there were 4 incidentally discovered second primary cancers, including 1 each of non–small cell lung cancer, pancreatic adenocarcinoma, Merkel cell carcinomatosis, and myxofibrosarcoma. There were no false-positive pulmonary metastases.
The estimated cost of 10 years of surveillance, based on 2014 gross technical costs, was $64,969 per patient for chest CT and extremity MRI, compared with $41,595 per patient for chest and extremity CT surveillance, a potential cost savings with the CT-only strategy of $23,374 per patient.
The investigators said that the overall benefits of CT, including the cost savings in an accountable care organization model, “appear to outweigh the slightly increased radiation exposure.”
The study was internally funded. The authors reported having no relevant financial disclosures.
BOSTON – CT scans appear to be effective for detecting local recurrences and pulmonary metastases in patients treated for soft-tissue sarcomas of the extremities, for about a third less than the cost of follow-up with MRI.
In a retrospective study by Dr. Allison Maciver and her colleagues, among 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 patients had a total of 14 local recurrences detected on CT, and 11 of the recurrences were in patients who were clinically asymptomatic.
Surveillance CT also identified 15 cases of pulmonary metastases, and 4 incidental second primary malignancies, Dr. Maciver of the Roswell Park Cancer Institute in Buffalo, N.Y., and her coinvestigators found, and there was only one false-positive recurrence.
The benefits of CT over extremity MRI in this population include decreased imaging time, lower cost, and a larger field of view, allowing for detection of second primary malignancies, she noted in a poster session at the annual Society of Surgical Oncology Cancer Symposium.
Many sarcomas of the extremities are highly aggressive, and timely detection of local recurrences could improve chances for limb-sparing salvage therapies. Although MRI has typically been used to follow patients with sarcomas, it is expensive and has a limited field of view, Dr. Maciver said.
In addition, the risk of pulmonary metastases with some soft-tissue sarcomas is high, necessitating the use of chest CT as a surveillance tool.
To see whether CT scans of the chest and extremities could be a cost-effective surveillance strategy for both local recurrences and pulmonary metastases, the investigators did a retrospective study of a prospective database of patients who underwent surgical resection for soft-tissue sarcomas of the extremities from 2001 through 2014 and who had CT as the primary follow-up imaging modality.
They identified a total of 91 high-risk patients followed for a median of 50.5 months. The patients had an estimated 5-year freedom from local recurrence of 82%, and from distant recurrence of 80%. Five-year overall survival was 76%.
Of the 15 patients found on CT to have pulmonary metastases, there were 4 incidentally discovered second primary cancers, including 1 each of non–small cell lung cancer, pancreatic adenocarcinoma, Merkel cell carcinomatosis, and myxofibrosarcoma. There were no false-positive pulmonary metastases.
The estimated cost of 10 years of surveillance, based on 2014 gross technical costs, was $64,969 per patient for chest CT and extremity MRI, compared with $41,595 per patient for chest and extremity CT surveillance, a potential cost savings with the CT-only strategy of $23,374 per patient.
The investigators said that the overall benefits of CT, including the cost savings in an accountable care organization model, “appear to outweigh the slightly increased radiation exposure.”
The study was internally funded. The authors reported having no relevant financial disclosures.
Key clinical point: Lower-cost CT scans of the extremity and chest appear to be effective for surveillance of patients following resection of soft-tissue sarcomas.
Major finding: Of 91 patients with soft-tissue sarcomas of the extremity followed with CT, 11 had a total of 14 local recurrences detected. Of the recurrences, 11 were clinically asymptomatic.
Data source: A retrospective study of a prospectively maintained surgical database.
Disclosures: The study was internally funded. The authors reported having no relevant financial disclosures.
Should esophageal cancer follow-up ever end?
About one third of patients who have esophagectomy for locally advanced esophageal cancer can survive disease-free for 5 years or longer, and once they reach that milestone, they have a good chance of living another 5 years, but previous studies have not explored if these patients continue disease-free or determined any independent predictors for long-term survival.
To get answers, investigators at Cornell University, New York conducted a retrospective review of a prospective database of 355 patients who underwent esophagectomy for cT2N0M0 or higher disease between 1988 and 2009, 126 of whom were alive and disease-free after 5 years.
The actuarial overall survival of this group was 94% at 7 years and 80% at 10 years, according to results published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016 Mar;151:726-32). The findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available at the AATS website (www.aats.org).
The 33% disease-free survival rate of these patients is “promising,” Dr. Galal Ghaly and colleagues said. “These excellent results are likely the result of accurate preoperative staging, standardization of surgical and perioperative management, and the use of multimodality treatment strategies,” they said.
But even after 5 years without disease, these patients were at risk of recurrence or other problems. Twenty-three patients (18%) experienced a second primary cancer elsewhere and eight (6.3%) had recurrence of esophageal cancer. Pulmonary-related deaths accounted for 10 (7.9%) of 22 (17.5%) non-cancer deaths after 5 years. “Careful follow-up is necessary for these patients, even after the 5-year mark,” Dr. Ghaly and colleagues said.
The study identified en bloc resection as the sole independent predictor of disease-free survival in these patients, a finding the investigators called “surprising,” but one with an explanation: “It is possible that patients undergoing en bloc resection were selected for that surgical procedure because of better performance status, fewer comorbidities or less frail appearance,” Dr. Ghaly and colleagues said. “Such a group might be expected to have a longer [overall survival] on the basis of those differences alone.”
Dr. Ghaly and coauthors acknowledged that over the 20-year term of the study changes in treatment approaches could have influenced patient outcomes, but a multivariable analysis accounted for that. They did find variability in preoperative staging, however. “Another limitation is the lack of a consistent method of preoperative staging, with 55% to 63% of patients staged by endoscopic ultrasonography and PET scanning,” Dr. Ghaly and coauthors said. However, that only resulted in 13 patients (10%) eventually found to have pT1N0 disease, and the results remained the same after those patients were excluded from the analysis.
Coauthor Dr. Paul J. Christos disclosed he had received a grant from the Clinical and Translational Science Center at Cornell University, New York. The other coauthors had no financial relationships to disclose.
The study by Dr. Ghaly and colleagues “provides some much-needed good news in esophageal cancer,” Dr. Gail Darling of the University of Toronto said in her invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:733-4). She noted that 5-year survival after esophagectomy was once considered a cure, but increased survival after 5 years thanks to the use of neoadjuvant therapy raises the question: Has it simply delayed recurrence?
Dr. Gail Darling |
The study has shown that not all patients are cured even if they’re disease-free after 5 years, Dr. Darling said, making the case for follow-up beyond 5 years. Besides the risk of recurrence of esophageal cancer, a second reason for longer-term follow-up is the risk of second cancers. “This paper reminds us that we should not give up on our patients,” Dr. Darling said. “What a terrible thing it would be to be cured of one of the deadliest cancers, only to die from one that is more often curable.”
The role of pulmonary disease as a leading cause of death in these patients after 5 years cannot be ignored either, she said. People who have had esophagectomy often have chronic cough and reflux, and 25% of 5-year survivors had preexisting pulmonary disease. “Did patients die of their preexisting pulmonary disease, or did chronic reflux and aspiration contribute to their deaths?” she asked. “Perhaps chronic reflux is more than a quality-of-life issue.”
Dr. Darling acknowledged the study delivers “some much needed good news in esophageal cancer.” At the same time, “much work needs to be done.” That work includes addressing surgical quality. “We count lymph nodes and measure margins,” she said. “Is this enough? Is en bloc esophagectomy the answer?” The infrequency of esophageal cancer probably obviates a randomized trial, but the capabilities for collaborating on data collection and analysis provide an opportunity to determine the best surgical approach, she said. “At that point, the task of delivering high-quality surgery will rest with us.”
Dr. Darling had no financial relationships to disclose.
The study by Dr. Ghaly and colleagues “provides some much-needed good news in esophageal cancer,” Dr. Gail Darling of the University of Toronto said in her invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:733-4). She noted that 5-year survival after esophagectomy was once considered a cure, but increased survival after 5 years thanks to the use of neoadjuvant therapy raises the question: Has it simply delayed recurrence?
Dr. Gail Darling |
The study has shown that not all patients are cured even if they’re disease-free after 5 years, Dr. Darling said, making the case for follow-up beyond 5 years. Besides the risk of recurrence of esophageal cancer, a second reason for longer-term follow-up is the risk of second cancers. “This paper reminds us that we should not give up on our patients,” Dr. Darling said. “What a terrible thing it would be to be cured of one of the deadliest cancers, only to die from one that is more often curable.”
The role of pulmonary disease as a leading cause of death in these patients after 5 years cannot be ignored either, she said. People who have had esophagectomy often have chronic cough and reflux, and 25% of 5-year survivors had preexisting pulmonary disease. “Did patients die of their preexisting pulmonary disease, or did chronic reflux and aspiration contribute to their deaths?” she asked. “Perhaps chronic reflux is more than a quality-of-life issue.”
Dr. Darling acknowledged the study delivers “some much needed good news in esophageal cancer.” At the same time, “much work needs to be done.” That work includes addressing surgical quality. “We count lymph nodes and measure margins,” she said. “Is this enough? Is en bloc esophagectomy the answer?” The infrequency of esophageal cancer probably obviates a randomized trial, but the capabilities for collaborating on data collection and analysis provide an opportunity to determine the best surgical approach, she said. “At that point, the task of delivering high-quality surgery will rest with us.”
Dr. Darling had no financial relationships to disclose.
The study by Dr. Ghaly and colleagues “provides some much-needed good news in esophageal cancer,” Dr. Gail Darling of the University of Toronto said in her invited commentary (J Thorac Cardiovasc Surg. 2016 Mar;151:733-4). She noted that 5-year survival after esophagectomy was once considered a cure, but increased survival after 5 years thanks to the use of neoadjuvant therapy raises the question: Has it simply delayed recurrence?
Dr. Gail Darling |
The study has shown that not all patients are cured even if they’re disease-free after 5 years, Dr. Darling said, making the case for follow-up beyond 5 years. Besides the risk of recurrence of esophageal cancer, a second reason for longer-term follow-up is the risk of second cancers. “This paper reminds us that we should not give up on our patients,” Dr. Darling said. “What a terrible thing it would be to be cured of one of the deadliest cancers, only to die from one that is more often curable.”
The role of pulmonary disease as a leading cause of death in these patients after 5 years cannot be ignored either, she said. People who have had esophagectomy often have chronic cough and reflux, and 25% of 5-year survivors had preexisting pulmonary disease. “Did patients die of their preexisting pulmonary disease, or did chronic reflux and aspiration contribute to their deaths?” she asked. “Perhaps chronic reflux is more than a quality-of-life issue.”
Dr. Darling acknowledged the study delivers “some much needed good news in esophageal cancer.” At the same time, “much work needs to be done.” That work includes addressing surgical quality. “We count lymph nodes and measure margins,” she said. “Is this enough? Is en bloc esophagectomy the answer?” The infrequency of esophageal cancer probably obviates a randomized trial, but the capabilities for collaborating on data collection and analysis provide an opportunity to determine the best surgical approach, she said. “At that point, the task of delivering high-quality surgery will rest with us.”
Dr. Darling had no financial relationships to disclose.
About one third of patients who have esophagectomy for locally advanced esophageal cancer can survive disease-free for 5 years or longer, and once they reach that milestone, they have a good chance of living another 5 years, but previous studies have not explored if these patients continue disease-free or determined any independent predictors for long-term survival.
To get answers, investigators at Cornell University, New York conducted a retrospective review of a prospective database of 355 patients who underwent esophagectomy for cT2N0M0 or higher disease between 1988 and 2009, 126 of whom were alive and disease-free after 5 years.
The actuarial overall survival of this group was 94% at 7 years and 80% at 10 years, according to results published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016 Mar;151:726-32). The findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available at the AATS website (www.aats.org).
The 33% disease-free survival rate of these patients is “promising,” Dr. Galal Ghaly and colleagues said. “These excellent results are likely the result of accurate preoperative staging, standardization of surgical and perioperative management, and the use of multimodality treatment strategies,” they said.
But even after 5 years without disease, these patients were at risk of recurrence or other problems. Twenty-three patients (18%) experienced a second primary cancer elsewhere and eight (6.3%) had recurrence of esophageal cancer. Pulmonary-related deaths accounted for 10 (7.9%) of 22 (17.5%) non-cancer deaths after 5 years. “Careful follow-up is necessary for these patients, even after the 5-year mark,” Dr. Ghaly and colleagues said.
The study identified en bloc resection as the sole independent predictor of disease-free survival in these patients, a finding the investigators called “surprising,” but one with an explanation: “It is possible that patients undergoing en bloc resection were selected for that surgical procedure because of better performance status, fewer comorbidities or less frail appearance,” Dr. Ghaly and colleagues said. “Such a group might be expected to have a longer [overall survival] on the basis of those differences alone.”
Dr. Ghaly and coauthors acknowledged that over the 20-year term of the study changes in treatment approaches could have influenced patient outcomes, but a multivariable analysis accounted for that. They did find variability in preoperative staging, however. “Another limitation is the lack of a consistent method of preoperative staging, with 55% to 63% of patients staged by endoscopic ultrasonography and PET scanning,” Dr. Ghaly and coauthors said. However, that only resulted in 13 patients (10%) eventually found to have pT1N0 disease, and the results remained the same after those patients were excluded from the analysis.
Coauthor Dr. Paul J. Christos disclosed he had received a grant from the Clinical and Translational Science Center at Cornell University, New York. The other coauthors had no financial relationships to disclose.
About one third of patients who have esophagectomy for locally advanced esophageal cancer can survive disease-free for 5 years or longer, and once they reach that milestone, they have a good chance of living another 5 years, but previous studies have not explored if these patients continue disease-free or determined any independent predictors for long-term survival.
To get answers, investigators at Cornell University, New York conducted a retrospective review of a prospective database of 355 patients who underwent esophagectomy for cT2N0M0 or higher disease between 1988 and 2009, 126 of whom were alive and disease-free after 5 years.
The actuarial overall survival of this group was 94% at 7 years and 80% at 10 years, according to results published in the March issue of the Journal of Thoracic and Cardiovascular Surgery (2016 Mar;151:726-32). The findings were first presented at the 95th annual meeting of the American Association for Thoracic Surgery in April 2015 in Seattle. A video of the presentation is available at the AATS website (www.aats.org).
The 33% disease-free survival rate of these patients is “promising,” Dr. Galal Ghaly and colleagues said. “These excellent results are likely the result of accurate preoperative staging, standardization of surgical and perioperative management, and the use of multimodality treatment strategies,” they said.
But even after 5 years without disease, these patients were at risk of recurrence or other problems. Twenty-three patients (18%) experienced a second primary cancer elsewhere and eight (6.3%) had recurrence of esophageal cancer. Pulmonary-related deaths accounted for 10 (7.9%) of 22 (17.5%) non-cancer deaths after 5 years. “Careful follow-up is necessary for these patients, even after the 5-year mark,” Dr. Ghaly and colleagues said.
The study identified en bloc resection as the sole independent predictor of disease-free survival in these patients, a finding the investigators called “surprising,” but one with an explanation: “It is possible that patients undergoing en bloc resection were selected for that surgical procedure because of better performance status, fewer comorbidities or less frail appearance,” Dr. Ghaly and colleagues said. “Such a group might be expected to have a longer [overall survival] on the basis of those differences alone.”
Dr. Ghaly and coauthors acknowledged that over the 20-year term of the study changes in treatment approaches could have influenced patient outcomes, but a multivariable analysis accounted for that. They did find variability in preoperative staging, however. “Another limitation is the lack of a consistent method of preoperative staging, with 55% to 63% of patients staged by endoscopic ultrasonography and PET scanning,” Dr. Ghaly and coauthors said. However, that only resulted in 13 patients (10%) eventually found to have pT1N0 disease, and the results remained the same after those patients were excluded from the analysis.
Coauthor Dr. Paul J. Christos disclosed he had received a grant from the Clinical and Translational Science Center at Cornell University, New York. The other coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Patients who achieve 5-year disease-free survival after esophagectomy for cancer should continue on follow-up beyond 5 years.
Major finding: After 5 years of disease-free survival, 6.3% of patients had recurrence of esophageal cancer, 18% had a second cancer elsewhere, and 7.9% died of pulmonary-related problems.
Data source: Retrospective review of a prospectively assembled thoracic surgery database of 355 patients who had esophagectomy for cT2N0M0 esophageal cancer from 1988 to 2009.
Disclosures: Coauthor Dr. Paul J. Christos disclosed partial support of a grant from Cornell University, New York. The other authors had no relationships to disclose.
Bilateral sentinel lymph node biopsy safe alternative for assessing early cervical cancer
SAN DIEGO – Bilateral sentinel lymph node biopsy alone is a safe alternative to bilateral pelvic lymphadenectomy for stage I cervical cancer and might reduce morbidity, results from an observational study suggest.
“Prior studies have shown detection rates for sentinel lymph nodes and sensitivity for metastases of approximately 95% for cervical tumors less than 2 cm,” Dr. Genevieve K. Lennox said at the annual meeting of the Society of Gynecologic Oncology. “To our knowledge, ours is the first study specifically investigating the long-term outcomes for patients who have had bilateral sentinel lymph node biopsy alone for lymph node assessment in stage I cervical cancer.”
Dr. Lennox, a gynecologic oncology fellow in the department of ob.gyn. at the University of Toronto, and her associates used the university’s prospective cervical cancer database to identify 1,188 patients with stage IA/IB cervical cancer with negative lymph nodes on pathology after primary surgery with either bilateral pelvic lymphadenectomy (BPLND) or bilateral sentinel lymph node biopsy (BSLNB). They used Wilcoxon rank sum, chi square, and Fisher’s exact tests to compare the two groups, and a Cox proportional hazards model to identify predictors of recurrence-free survival.
The researchers observed no differences in recurrence-free survival between BPLND and BSLNB at 2 years (95% vs. 97%, respectively) or at 5 years (92% vs. 93%), nor in tumor size, histology, depth of invasion, intra-operative complications, or short-term morbidity. BPLND was, however, associated with increased surgical time (2.8 vs. 2 hours for BSLNB; P less than .001), blood loss (500 mL vs. 100 mL; P less than .001), transfusion (23% vs. 0%; P less than .001), and postoperative infection (11% vs. 0%; P = .001). Age, surgical date, stage, lymphovascular space invasion, and radicality of surgery differed between groups, she reported.
After controlling for confounders on multivariable cox regression analysis, only tumor size, lymphovascular space invasion, and histology were prognostic for recurrence-free survival, but mode of lymph node assessment was not.
“Seeing the data, it struck me how much less invasive the treatment of early cervical cancer has become over the past 20 years,” Dr. Lennox said. “Based on our data, it appears that bilateral sentinel lymph node biopsy alone is a safe alternative to bilateral pelvic lymphadenectomy for stage I cervical cancer and might reduce morbidity.”
She acknowledged certain limitations of the study, including its observational design and low recurrence rate. “However, to conduct a noninferiority trial with a 3% margin, assuming a 5-year recurrence rate of 7% in the pelvic lymphadenectomy group and 10% in the sentinel lymph node biopsy group, would require approximately 1,400 patients,” Dr. Lennox noted. “Since such a study is not feasible, we will have to continue accumulating data from prospective observational studies to inform decision making about the use of the sentinel lymph node strategy in cervical cancer.”
SAN DIEGO – Bilateral sentinel lymph node biopsy alone is a safe alternative to bilateral pelvic lymphadenectomy for stage I cervical cancer and might reduce morbidity, results from an observational study suggest.
“Prior studies have shown detection rates for sentinel lymph nodes and sensitivity for metastases of approximately 95% for cervical tumors less than 2 cm,” Dr. Genevieve K. Lennox said at the annual meeting of the Society of Gynecologic Oncology. “To our knowledge, ours is the first study specifically investigating the long-term outcomes for patients who have had bilateral sentinel lymph node biopsy alone for lymph node assessment in stage I cervical cancer.”
Dr. Lennox, a gynecologic oncology fellow in the department of ob.gyn. at the University of Toronto, and her associates used the university’s prospective cervical cancer database to identify 1,188 patients with stage IA/IB cervical cancer with negative lymph nodes on pathology after primary surgery with either bilateral pelvic lymphadenectomy (BPLND) or bilateral sentinel lymph node biopsy (BSLNB). They used Wilcoxon rank sum, chi square, and Fisher’s exact tests to compare the two groups, and a Cox proportional hazards model to identify predictors of recurrence-free survival.
The researchers observed no differences in recurrence-free survival between BPLND and BSLNB at 2 years (95% vs. 97%, respectively) or at 5 years (92% vs. 93%), nor in tumor size, histology, depth of invasion, intra-operative complications, or short-term morbidity. BPLND was, however, associated with increased surgical time (2.8 vs. 2 hours for BSLNB; P less than .001), blood loss (500 mL vs. 100 mL; P less than .001), transfusion (23% vs. 0%; P less than .001), and postoperative infection (11% vs. 0%; P = .001). Age, surgical date, stage, lymphovascular space invasion, and radicality of surgery differed between groups, she reported.
After controlling for confounders on multivariable cox regression analysis, only tumor size, lymphovascular space invasion, and histology were prognostic for recurrence-free survival, but mode of lymph node assessment was not.
“Seeing the data, it struck me how much less invasive the treatment of early cervical cancer has become over the past 20 years,” Dr. Lennox said. “Based on our data, it appears that bilateral sentinel lymph node biopsy alone is a safe alternative to bilateral pelvic lymphadenectomy for stage I cervical cancer and might reduce morbidity.”
She acknowledged certain limitations of the study, including its observational design and low recurrence rate. “However, to conduct a noninferiority trial with a 3% margin, assuming a 5-year recurrence rate of 7% in the pelvic lymphadenectomy group and 10% in the sentinel lymph node biopsy group, would require approximately 1,400 patients,” Dr. Lennox noted. “Since such a study is not feasible, we will have to continue accumulating data from prospective observational studies to inform decision making about the use of the sentinel lymph node strategy in cervical cancer.”
SAN DIEGO – Bilateral sentinel lymph node biopsy alone is a safe alternative to bilateral pelvic lymphadenectomy for stage I cervical cancer and might reduce morbidity, results from an observational study suggest.
“Prior studies have shown detection rates for sentinel lymph nodes and sensitivity for metastases of approximately 95% for cervical tumors less than 2 cm,” Dr. Genevieve K. Lennox said at the annual meeting of the Society of Gynecologic Oncology. “To our knowledge, ours is the first study specifically investigating the long-term outcomes for patients who have had bilateral sentinel lymph node biopsy alone for lymph node assessment in stage I cervical cancer.”
Dr. Lennox, a gynecologic oncology fellow in the department of ob.gyn. at the University of Toronto, and her associates used the university’s prospective cervical cancer database to identify 1,188 patients with stage IA/IB cervical cancer with negative lymph nodes on pathology after primary surgery with either bilateral pelvic lymphadenectomy (BPLND) or bilateral sentinel lymph node biopsy (BSLNB). They used Wilcoxon rank sum, chi square, and Fisher’s exact tests to compare the two groups, and a Cox proportional hazards model to identify predictors of recurrence-free survival.
The researchers observed no differences in recurrence-free survival between BPLND and BSLNB at 2 years (95% vs. 97%, respectively) or at 5 years (92% vs. 93%), nor in tumor size, histology, depth of invasion, intra-operative complications, or short-term morbidity. BPLND was, however, associated with increased surgical time (2.8 vs. 2 hours for BSLNB; P less than .001), blood loss (500 mL vs. 100 mL; P less than .001), transfusion (23% vs. 0%; P less than .001), and postoperative infection (11% vs. 0%; P = .001). Age, surgical date, stage, lymphovascular space invasion, and radicality of surgery differed between groups, she reported.
After controlling for confounders on multivariable cox regression analysis, only tumor size, lymphovascular space invasion, and histology were prognostic for recurrence-free survival, but mode of lymph node assessment was not.
“Seeing the data, it struck me how much less invasive the treatment of early cervical cancer has become over the past 20 years,” Dr. Lennox said. “Based on our data, it appears that bilateral sentinel lymph node biopsy alone is a safe alternative to bilateral pelvic lymphadenectomy for stage I cervical cancer and might reduce morbidity.”
She acknowledged certain limitations of the study, including its observational design and low recurrence rate. “However, to conduct a noninferiority trial with a 3% margin, assuming a 5-year recurrence rate of 7% in the pelvic lymphadenectomy group and 10% in the sentinel lymph node biopsy group, would require approximately 1,400 patients,” Dr. Lennox noted. “Since such a study is not feasible, we will have to continue accumulating data from prospective observational studies to inform decision making about the use of the sentinel lymph node strategy in cervical cancer.”
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: Bilateral sentinel lymph node biopsy (BSLNB) alone is a safe alternative to bilateral pelvic lymphadenectomy (BPLND) for stage I cervical cancer and might reduce morbidity.
Major finding: No differences in recurrence-free survival were observed between BPLND and BSLNB at 2 years (95% vs. 97%, respectively) or at 5 years (92% vs. 93%), but BPLND was associated with increased surgical time (2.8 vs. 2 hours; P less than .001), blood loss (500 mL vs. 100 mL; P less than .001), transfusion (23% vs. 0%; P less than .001), and postoperative infection (11% vs. 0%; P = .001).
Data source: Observational study of 1,188 patients with stage IA/IB cervical cancer who had negative lymph nodes on pathology after primary surgery with either BPLND or BSLNB.
Disclosures: Dr. Lennox reported having no financial disclosures.
10-year DCIS recurrence risk dwindles with age
BOSTON – Recurrence rates of cancer following breast-conserving surgery for ductal carcinoma in situ differ significantly with patient age, with younger women having a three-fold higher 10-year recurrence rate than older women.
The lower risk for 10-year recurrence among older women was independent of whether they had received adjuvant radiation therapy, reported Dr. Patricia A. Cronin, a surgical fellow at Memorial Sloan Kettering Cancer Center in New York City.
“Women over 80 are at low risk of recurrence, even in the absence of adjuvant therapies, whilst young age is a highly significant risk factor for any recurrence, in particular invasive recurrence, and therefore age is an important factor that should be weighed when considering other treatment options, including surgical options and adjuvant therapy,” she said at the annual Society of Surgical Oncology Cancer Symposium.
Ductal carcinoma in situ (DCIS) now accounts for more than 20% of all breast cancers. It can be treated with breast conserving surgery (BCS) alone or in conjunction with adjuvant therapy, radiation, and endocrine therapy, or by mastectomy.
“All treatment options have excellent survival but there can be markedly different recurrence rates,” Dr. Cronin said.
She noted that age is recognized as a risk factor for recurrence after BCS for DCIS, an observation confirmed in radiotherapy trials, but added that “the full nature of the relationship between age and recurrence and its interaction with other factors is not clear.”
DCIS through the ages
To get a better handle on the effect of age on recurrence, the investigators looked at data on patients who underwent breast-conserving surgery from 1978 through 2010. The women were stratified by age into six categories, beginning with those under age 40 and continuing at 10-year increments to age 80 and older.
Clinical, pathological, and treatment factors included in the analysis were family history, clinical vs. radiologic presentation, nuclear grade, necrosis, number of excision, margin status, radiotherapy, endocrine therapy, and treatment period.
Outcomes included ipsilateral DCIS recurrence, ipsilateral invasive breast cancer, ipsilateral axillary node recurrence, and distant recurrence in the absence of both ipsilateral recurrence and contralateral breast cancer.
A total of 2,996 women were identified, 363 of whom (12%) had local recurrences, either as DCIS in 192 patients, invasive disease in 160, of unknown status in 11.
An analysis of recurrence rates by age showed decreasing risk with each advance in age category, compared with women under age 40, with women aged 40-49 having a hazard ratio (HR) of 0.68 (P = .05), and women age 80 and over having an HR of 0.34 (P = .01), with 10-year recurrence rates ranging from 27% in the youngest cohort to about 8% in the oldest (log rank P less than .0001 for the overall effect of age on recurrence).
Looking at the individual factors associated with age, women under age 40 had a significantly higher proportion of clinical vs. radiologic presentation, with either a mass, nipple discharge, or Paget disease. Younger women also had less endocrine therapy.
Older women less frequently underwent multiple excisions, and more frequently had close or positive surgical margins, as well as lower rates of adjuvant therapy, and less endocrine therapy than women in the middle-age categories.
In a multivariable analysis for recurrence risk by age controlling for presentation, family history, necrosis, excision number, margin status, adjuvant radiation, endocrine therapy, and treatment period, the association between age and risk remained significant beginning in patients aged 50-59 (HR, 0.46; P = .0005) and continuing to dwindle through the decades to those age 80 and older (HR, 0.21; P = .001).
Age was also significantly associated with recurrence both among who received radiation and those who did not.
Women under age 40 were also found to be at greater risk for invasive recurrences, with 15.8% of all patients in this age group having invasive recurrences, and 11.5% having recurrent DCIS. In contrast, among all women aged 80 and older, 3.2% had invasive recurrences, and 3.4% had recurrent DCIS.
Question of mammography
Following Dr. Cronin’s presentation, Dr. Nicholas Tranakas from Broward Health Medical Center in Fort Lauderdale, Fla., asked whether, since the evidence shows that the majority of younger patients do not have indolent disease, they should be screened with mammography at earlier age than current guidelines recommend.
Dr. Cronin noted that although women under 40 don’t routinely undergo screening, “you can see that most patients under 40 present clinically, and therefore it’s hard in this study to make any recommendations in regards to screening.”
Asked how she counsels younger patients, she noted that although the data on recurrence risk in younger women are provocative, overall survival rates are excellent for both breast-conserving procedures and mastectomy, and the decision about which procedure to choose may rely on the patient’s degree of aversion to risk.
“We don’t automatically recommend mastectomy under 40, but I think this data does make us very concerned about recurrence, and particularly invasive recurrence and its potential influence then on distant disease,” she said.
The study funding source was not reported. The authors reported having no disclosures. Dr. Tranakas reported no disclosures.
BOSTON – Recurrence rates of cancer following breast-conserving surgery for ductal carcinoma in situ differ significantly with patient age, with younger women having a three-fold higher 10-year recurrence rate than older women.
The lower risk for 10-year recurrence among older women was independent of whether they had received adjuvant radiation therapy, reported Dr. Patricia A. Cronin, a surgical fellow at Memorial Sloan Kettering Cancer Center in New York City.
“Women over 80 are at low risk of recurrence, even in the absence of adjuvant therapies, whilst young age is a highly significant risk factor for any recurrence, in particular invasive recurrence, and therefore age is an important factor that should be weighed when considering other treatment options, including surgical options and adjuvant therapy,” she said at the annual Society of Surgical Oncology Cancer Symposium.
Ductal carcinoma in situ (DCIS) now accounts for more than 20% of all breast cancers. It can be treated with breast conserving surgery (BCS) alone or in conjunction with adjuvant therapy, radiation, and endocrine therapy, or by mastectomy.
“All treatment options have excellent survival but there can be markedly different recurrence rates,” Dr. Cronin said.
She noted that age is recognized as a risk factor for recurrence after BCS for DCIS, an observation confirmed in radiotherapy trials, but added that “the full nature of the relationship between age and recurrence and its interaction with other factors is not clear.”
DCIS through the ages
To get a better handle on the effect of age on recurrence, the investigators looked at data on patients who underwent breast-conserving surgery from 1978 through 2010. The women were stratified by age into six categories, beginning with those under age 40 and continuing at 10-year increments to age 80 and older.
Clinical, pathological, and treatment factors included in the analysis were family history, clinical vs. radiologic presentation, nuclear grade, necrosis, number of excision, margin status, radiotherapy, endocrine therapy, and treatment period.
Outcomes included ipsilateral DCIS recurrence, ipsilateral invasive breast cancer, ipsilateral axillary node recurrence, and distant recurrence in the absence of both ipsilateral recurrence and contralateral breast cancer.
A total of 2,996 women were identified, 363 of whom (12%) had local recurrences, either as DCIS in 192 patients, invasive disease in 160, of unknown status in 11.
An analysis of recurrence rates by age showed decreasing risk with each advance in age category, compared with women under age 40, with women aged 40-49 having a hazard ratio (HR) of 0.68 (P = .05), and women age 80 and over having an HR of 0.34 (P = .01), with 10-year recurrence rates ranging from 27% in the youngest cohort to about 8% in the oldest (log rank P less than .0001 for the overall effect of age on recurrence).
Looking at the individual factors associated with age, women under age 40 had a significantly higher proportion of clinical vs. radiologic presentation, with either a mass, nipple discharge, or Paget disease. Younger women also had less endocrine therapy.
Older women less frequently underwent multiple excisions, and more frequently had close or positive surgical margins, as well as lower rates of adjuvant therapy, and less endocrine therapy than women in the middle-age categories.
In a multivariable analysis for recurrence risk by age controlling for presentation, family history, necrosis, excision number, margin status, adjuvant radiation, endocrine therapy, and treatment period, the association between age and risk remained significant beginning in patients aged 50-59 (HR, 0.46; P = .0005) and continuing to dwindle through the decades to those age 80 and older (HR, 0.21; P = .001).
Age was also significantly associated with recurrence both among who received radiation and those who did not.
Women under age 40 were also found to be at greater risk for invasive recurrences, with 15.8% of all patients in this age group having invasive recurrences, and 11.5% having recurrent DCIS. In contrast, among all women aged 80 and older, 3.2% had invasive recurrences, and 3.4% had recurrent DCIS.
Question of mammography
Following Dr. Cronin’s presentation, Dr. Nicholas Tranakas from Broward Health Medical Center in Fort Lauderdale, Fla., asked whether, since the evidence shows that the majority of younger patients do not have indolent disease, they should be screened with mammography at earlier age than current guidelines recommend.
Dr. Cronin noted that although women under 40 don’t routinely undergo screening, “you can see that most patients under 40 present clinically, and therefore it’s hard in this study to make any recommendations in regards to screening.”
Asked how she counsels younger patients, she noted that although the data on recurrence risk in younger women are provocative, overall survival rates are excellent for both breast-conserving procedures and mastectomy, and the decision about which procedure to choose may rely on the patient’s degree of aversion to risk.
“We don’t automatically recommend mastectomy under 40, but I think this data does make us very concerned about recurrence, and particularly invasive recurrence and its potential influence then on distant disease,” she said.
The study funding source was not reported. The authors reported having no disclosures. Dr. Tranakas reported no disclosures.
BOSTON – Recurrence rates of cancer following breast-conserving surgery for ductal carcinoma in situ differ significantly with patient age, with younger women having a three-fold higher 10-year recurrence rate than older women.
The lower risk for 10-year recurrence among older women was independent of whether they had received adjuvant radiation therapy, reported Dr. Patricia A. Cronin, a surgical fellow at Memorial Sloan Kettering Cancer Center in New York City.
“Women over 80 are at low risk of recurrence, even in the absence of adjuvant therapies, whilst young age is a highly significant risk factor for any recurrence, in particular invasive recurrence, and therefore age is an important factor that should be weighed when considering other treatment options, including surgical options and adjuvant therapy,” she said at the annual Society of Surgical Oncology Cancer Symposium.
Ductal carcinoma in situ (DCIS) now accounts for more than 20% of all breast cancers. It can be treated with breast conserving surgery (BCS) alone or in conjunction with adjuvant therapy, radiation, and endocrine therapy, or by mastectomy.
“All treatment options have excellent survival but there can be markedly different recurrence rates,” Dr. Cronin said.
She noted that age is recognized as a risk factor for recurrence after BCS for DCIS, an observation confirmed in radiotherapy trials, but added that “the full nature of the relationship between age and recurrence and its interaction with other factors is not clear.”
DCIS through the ages
To get a better handle on the effect of age on recurrence, the investigators looked at data on patients who underwent breast-conserving surgery from 1978 through 2010. The women were stratified by age into six categories, beginning with those under age 40 and continuing at 10-year increments to age 80 and older.
Clinical, pathological, and treatment factors included in the analysis were family history, clinical vs. radiologic presentation, nuclear grade, necrosis, number of excision, margin status, radiotherapy, endocrine therapy, and treatment period.
Outcomes included ipsilateral DCIS recurrence, ipsilateral invasive breast cancer, ipsilateral axillary node recurrence, and distant recurrence in the absence of both ipsilateral recurrence and contralateral breast cancer.
A total of 2,996 women were identified, 363 of whom (12%) had local recurrences, either as DCIS in 192 patients, invasive disease in 160, of unknown status in 11.
An analysis of recurrence rates by age showed decreasing risk with each advance in age category, compared with women under age 40, with women aged 40-49 having a hazard ratio (HR) of 0.68 (P = .05), and women age 80 and over having an HR of 0.34 (P = .01), with 10-year recurrence rates ranging from 27% in the youngest cohort to about 8% in the oldest (log rank P less than .0001 for the overall effect of age on recurrence).
Looking at the individual factors associated with age, women under age 40 had a significantly higher proportion of clinical vs. radiologic presentation, with either a mass, nipple discharge, or Paget disease. Younger women also had less endocrine therapy.
Older women less frequently underwent multiple excisions, and more frequently had close or positive surgical margins, as well as lower rates of adjuvant therapy, and less endocrine therapy than women in the middle-age categories.
In a multivariable analysis for recurrence risk by age controlling for presentation, family history, necrosis, excision number, margin status, adjuvant radiation, endocrine therapy, and treatment period, the association between age and risk remained significant beginning in patients aged 50-59 (HR, 0.46; P = .0005) and continuing to dwindle through the decades to those age 80 and older (HR, 0.21; P = .001).
Age was also significantly associated with recurrence both among who received radiation and those who did not.
Women under age 40 were also found to be at greater risk for invasive recurrences, with 15.8% of all patients in this age group having invasive recurrences, and 11.5% having recurrent DCIS. In contrast, among all women aged 80 and older, 3.2% had invasive recurrences, and 3.4% had recurrent DCIS.
Question of mammography
Following Dr. Cronin’s presentation, Dr. Nicholas Tranakas from Broward Health Medical Center in Fort Lauderdale, Fla., asked whether, since the evidence shows that the majority of younger patients do not have indolent disease, they should be screened with mammography at earlier age than current guidelines recommend.
Dr. Cronin noted that although women under 40 don’t routinely undergo screening, “you can see that most patients under 40 present clinically, and therefore it’s hard in this study to make any recommendations in regards to screening.”
Asked how she counsels younger patients, she noted that although the data on recurrence risk in younger women are provocative, overall survival rates are excellent for both breast-conserving procedures and mastectomy, and the decision about which procedure to choose may rely on the patient’s degree of aversion to risk.
“We don’t automatically recommend mastectomy under 40, but I think this data does make us very concerned about recurrence, and particularly invasive recurrence and its potential influence then on distant disease,” she said.
The study funding source was not reported. The authors reported having no disclosures. Dr. Tranakas reported no disclosures.
Key clinical point: The risk of 10-year recurrence of ductal carcinoma in situ diminishes significantly with age.
Major finding: The risk for recurrence within 10 years among women younger than age 40 was 27%, compared with approximately 8% for women age 80 and older.
Data source: Retrospective study of 2,996 treated for DCIS from 1978 through 2010.
Disclosures: The study funding source was not reported. The authors reported having no disclosures. Dr. Tranakas reported no disclosures.
Debulking advanced ovarian cancer to low volume linked with better survival
SAN DIEGO – There is a survival benefit to debulking stage IIIC ovarian, fallopian tube, and peritoneal tumors down to 10mm or smaller in size, a single-center retrospective study demonstrated.
“You shouldn’t just relegate those patients [in whom] you can’t get a complete gross resection to neoadjuvant chemotherapy, because their median survival is going to generally be around 30-36 months,” Dr. Dennis S. Chi said in an interview in advance of the annual meeting of Society of Gynecologic Oncology. “But if you do a primary debulking and you get the volume of residual disease down to 10 mm or smaller in maximal diameter, the median survivals can be in the mid-40s to over 80 months.”
Dr. Chi, head of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center, New York, said that the current findings come at a time when the initial management of advanced ovarian cancer is in flux and is controversial. “For decades it used to be that the initial step was to do an operation and to do a primary debulking surgery,” he said. “But studies in the 1980s and 1990s showed that if you did primary debulking surgery and you did the standard surgery that gynecologic oncologists did at that time, greater than 50% of the time you would not do an operation that would result in an optimal debulking, where you get all or almost all of the visible cancer out.”
Two camps formed, he continued, one consisting of clinicians who believe “we need to do better surgery, or more comprehensive surgery,” and another group of clinicians who say, “Why don’t we treat with chemotherapy first for three treatments, and then do surgery? Maybe this will shrink the cancer and consequently improve the surgical outcome.’ Both camps agree that if you cannot get all the cancer out or almost all the cancer out, then you should start with chemotherapy first. The question then lies, what is the cut-off?”
In a study led by Dr. Chi and Dr. Vasileios Sioulas, the Senior International Gynecologic Oncology Fellow at Memorial Sloan Kettering Cancer Center, the authors set out to explore the effect of primary cytoreduction to minimal but gross residual disease in women with bulky stage IIIC ovarian/fallopian tube/primary peritoneal cancer. They retrospectively evaluated the records of 496 women who underwent primary debulking surgery at the cancer center between 2001 and 2010. Their median age was 62 years, the median operative time was 265 minutes, and 46% of the patients received at least one cycle of primary or consolidation intraperitoneal chemotherapy.
The researchers assigned patients to one of four groups based on reported gross residual disease. More than one-third (37%) had no gross residual disease (group 1); 26% had residual disease of 1-5 mm in diameter (group 2); 11% had residual disease of 6-10 mm in diameter (group 3), and 26% had residual disease that exceeded 10 mm in diameter (group 4). The median follow-up in the entire cohort was 53 months, the median progression-free survival was 18.6 months, and the median overall survival was 54.7 months. However, median progression-free survival and median overall survival varied significantly among the four assigned groups. It was 26.7 months for group 1, 20.7 months for group 2, 16.2 months for group 3, and 13.6 months for group 4 (P less than .001). At the same time, median overall survival was 83.4 months for group 1, 54.5 months for 2, 43.8 months for group 3, and 38.9 months for group 4 (P less than .001).
To be consistent with the vast majority of the existing literature, which used the cut-off of 10 mm to define optimal residual disease, Dr. Sioulas and his associates merged patients with residual disease 1-5 mm and 6-10 mm into one group and found that its median overall survival was 52.6 months. Patients with residual disease of 1-10 mm had significantly better overall survival, as compared to those with residual disease greater than 10 mm (P less than .001). Importantly, among the patients with residual disease of 1-10 mm, the administration of at least one cycle of primary intraperitoneal chemotherapy was associated with significantly prolonged overall survival, as compared to the sole use of intravenous chemotherapy. The median overall survival for those groups was 65.1 and 40.6 months, respectively (P = .002).
“I certainly believe neoadjuvant chemotherapy is the best approach in certain situations, but I don’t think it should be the knee-jerk reflex for all patients with advanced ovarian cancer,” Dr. Chi said. “I think that may be doing a disservice to many patients who could get a distinct prolongation of life and overall survival, or even cure, with a primary debulking surgery approach.”
He noted that ovarian cancer “goes where it wants to go. It doesn’t care what the training or surgical capabilities of the surgeon are. It’s going to go where it wants to go, so you can’t make the patient and the disease fit into your training skill set. You have to adapt your training skill set to the disease.”
The ideal study of this issue, Dr. Chi said, would “compare 400 or 500 patients with primary debulking and 400 or 500 patients who receive neoadjuvant chemotherapy to see which approach is better. There are two trials that have been done in Europe and have shown that it doesn’t matter, that the outcomes are the same whether you do primary debulking first or neoadjuvant chemotherapy first [see N. Engl. J. Med. 2010;363;943-53 and Lancet 2015;386:249-57]. Unfortunately, the survival outcomes in their primary debulking surgery arm were much lower as compared to other studies, especially those conducted in the United States. This highlights the importance of homogeneity in advanced surgical skills as a prerequisite before we draw definite conclusions about the survival outcomes after primary debulking surgery in patients with advanced disease.”
Dr. Chi acknowledged certain limitations of the study, including its retrospective design and the fact that surgeons at Memorial Sloan Kettering “are more willing, and have more support staff available, to perform comprehensive surgeries than at other centers.”
SAN DIEGO – There is a survival benefit to debulking stage IIIC ovarian, fallopian tube, and peritoneal tumors down to 10mm or smaller in size, a single-center retrospective study demonstrated.
“You shouldn’t just relegate those patients [in whom] you can’t get a complete gross resection to neoadjuvant chemotherapy, because their median survival is going to generally be around 30-36 months,” Dr. Dennis S. Chi said in an interview in advance of the annual meeting of Society of Gynecologic Oncology. “But if you do a primary debulking and you get the volume of residual disease down to 10 mm or smaller in maximal diameter, the median survivals can be in the mid-40s to over 80 months.”
Dr. Chi, head of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center, New York, said that the current findings come at a time when the initial management of advanced ovarian cancer is in flux and is controversial. “For decades it used to be that the initial step was to do an operation and to do a primary debulking surgery,” he said. “But studies in the 1980s and 1990s showed that if you did primary debulking surgery and you did the standard surgery that gynecologic oncologists did at that time, greater than 50% of the time you would not do an operation that would result in an optimal debulking, where you get all or almost all of the visible cancer out.”
Two camps formed, he continued, one consisting of clinicians who believe “we need to do better surgery, or more comprehensive surgery,” and another group of clinicians who say, “Why don’t we treat with chemotherapy first for three treatments, and then do surgery? Maybe this will shrink the cancer and consequently improve the surgical outcome.’ Both camps agree that if you cannot get all the cancer out or almost all the cancer out, then you should start with chemotherapy first. The question then lies, what is the cut-off?”
In a study led by Dr. Chi and Dr. Vasileios Sioulas, the Senior International Gynecologic Oncology Fellow at Memorial Sloan Kettering Cancer Center, the authors set out to explore the effect of primary cytoreduction to minimal but gross residual disease in women with bulky stage IIIC ovarian/fallopian tube/primary peritoneal cancer. They retrospectively evaluated the records of 496 women who underwent primary debulking surgery at the cancer center between 2001 and 2010. Their median age was 62 years, the median operative time was 265 minutes, and 46% of the patients received at least one cycle of primary or consolidation intraperitoneal chemotherapy.
The researchers assigned patients to one of four groups based on reported gross residual disease. More than one-third (37%) had no gross residual disease (group 1); 26% had residual disease of 1-5 mm in diameter (group 2); 11% had residual disease of 6-10 mm in diameter (group 3), and 26% had residual disease that exceeded 10 mm in diameter (group 4). The median follow-up in the entire cohort was 53 months, the median progression-free survival was 18.6 months, and the median overall survival was 54.7 months. However, median progression-free survival and median overall survival varied significantly among the four assigned groups. It was 26.7 months for group 1, 20.7 months for group 2, 16.2 months for group 3, and 13.6 months for group 4 (P less than .001). At the same time, median overall survival was 83.4 months for group 1, 54.5 months for 2, 43.8 months for group 3, and 38.9 months for group 4 (P less than .001).
To be consistent with the vast majority of the existing literature, which used the cut-off of 10 mm to define optimal residual disease, Dr. Sioulas and his associates merged patients with residual disease 1-5 mm and 6-10 mm into one group and found that its median overall survival was 52.6 months. Patients with residual disease of 1-10 mm had significantly better overall survival, as compared to those with residual disease greater than 10 mm (P less than .001). Importantly, among the patients with residual disease of 1-10 mm, the administration of at least one cycle of primary intraperitoneal chemotherapy was associated with significantly prolonged overall survival, as compared to the sole use of intravenous chemotherapy. The median overall survival for those groups was 65.1 and 40.6 months, respectively (P = .002).
“I certainly believe neoadjuvant chemotherapy is the best approach in certain situations, but I don’t think it should be the knee-jerk reflex for all patients with advanced ovarian cancer,” Dr. Chi said. “I think that may be doing a disservice to many patients who could get a distinct prolongation of life and overall survival, or even cure, with a primary debulking surgery approach.”
He noted that ovarian cancer “goes where it wants to go. It doesn’t care what the training or surgical capabilities of the surgeon are. It’s going to go where it wants to go, so you can’t make the patient and the disease fit into your training skill set. You have to adapt your training skill set to the disease.”
The ideal study of this issue, Dr. Chi said, would “compare 400 or 500 patients with primary debulking and 400 or 500 patients who receive neoadjuvant chemotherapy to see which approach is better. There are two trials that have been done in Europe and have shown that it doesn’t matter, that the outcomes are the same whether you do primary debulking first or neoadjuvant chemotherapy first [see N. Engl. J. Med. 2010;363;943-53 and Lancet 2015;386:249-57]. Unfortunately, the survival outcomes in their primary debulking surgery arm were much lower as compared to other studies, especially those conducted in the United States. This highlights the importance of homogeneity in advanced surgical skills as a prerequisite before we draw definite conclusions about the survival outcomes after primary debulking surgery in patients with advanced disease.”
Dr. Chi acknowledged certain limitations of the study, including its retrospective design and the fact that surgeons at Memorial Sloan Kettering “are more willing, and have more support staff available, to perform comprehensive surgeries than at other centers.”
SAN DIEGO – There is a survival benefit to debulking stage IIIC ovarian, fallopian tube, and peritoneal tumors down to 10mm or smaller in size, a single-center retrospective study demonstrated.
“You shouldn’t just relegate those patients [in whom] you can’t get a complete gross resection to neoadjuvant chemotherapy, because their median survival is going to generally be around 30-36 months,” Dr. Dennis S. Chi said in an interview in advance of the annual meeting of Society of Gynecologic Oncology. “But if you do a primary debulking and you get the volume of residual disease down to 10 mm or smaller in maximal diameter, the median survivals can be in the mid-40s to over 80 months.”
Dr. Chi, head of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center, New York, said that the current findings come at a time when the initial management of advanced ovarian cancer is in flux and is controversial. “For decades it used to be that the initial step was to do an operation and to do a primary debulking surgery,” he said. “But studies in the 1980s and 1990s showed that if you did primary debulking surgery and you did the standard surgery that gynecologic oncologists did at that time, greater than 50% of the time you would not do an operation that would result in an optimal debulking, where you get all or almost all of the visible cancer out.”
Two camps formed, he continued, one consisting of clinicians who believe “we need to do better surgery, or more comprehensive surgery,” and another group of clinicians who say, “Why don’t we treat with chemotherapy first for three treatments, and then do surgery? Maybe this will shrink the cancer and consequently improve the surgical outcome.’ Both camps agree that if you cannot get all the cancer out or almost all the cancer out, then you should start with chemotherapy first. The question then lies, what is the cut-off?”
In a study led by Dr. Chi and Dr. Vasileios Sioulas, the Senior International Gynecologic Oncology Fellow at Memorial Sloan Kettering Cancer Center, the authors set out to explore the effect of primary cytoreduction to minimal but gross residual disease in women with bulky stage IIIC ovarian/fallopian tube/primary peritoneal cancer. They retrospectively evaluated the records of 496 women who underwent primary debulking surgery at the cancer center between 2001 and 2010. Their median age was 62 years, the median operative time was 265 minutes, and 46% of the patients received at least one cycle of primary or consolidation intraperitoneal chemotherapy.
The researchers assigned patients to one of four groups based on reported gross residual disease. More than one-third (37%) had no gross residual disease (group 1); 26% had residual disease of 1-5 mm in diameter (group 2); 11% had residual disease of 6-10 mm in diameter (group 3), and 26% had residual disease that exceeded 10 mm in diameter (group 4). The median follow-up in the entire cohort was 53 months, the median progression-free survival was 18.6 months, and the median overall survival was 54.7 months. However, median progression-free survival and median overall survival varied significantly among the four assigned groups. It was 26.7 months for group 1, 20.7 months for group 2, 16.2 months for group 3, and 13.6 months for group 4 (P less than .001). At the same time, median overall survival was 83.4 months for group 1, 54.5 months for 2, 43.8 months for group 3, and 38.9 months for group 4 (P less than .001).
To be consistent with the vast majority of the existing literature, which used the cut-off of 10 mm to define optimal residual disease, Dr. Sioulas and his associates merged patients with residual disease 1-5 mm and 6-10 mm into one group and found that its median overall survival was 52.6 months. Patients with residual disease of 1-10 mm had significantly better overall survival, as compared to those with residual disease greater than 10 mm (P less than .001). Importantly, among the patients with residual disease of 1-10 mm, the administration of at least one cycle of primary intraperitoneal chemotherapy was associated with significantly prolonged overall survival, as compared to the sole use of intravenous chemotherapy. The median overall survival for those groups was 65.1 and 40.6 months, respectively (P = .002).
“I certainly believe neoadjuvant chemotherapy is the best approach in certain situations, but I don’t think it should be the knee-jerk reflex for all patients with advanced ovarian cancer,” Dr. Chi said. “I think that may be doing a disservice to many patients who could get a distinct prolongation of life and overall survival, or even cure, with a primary debulking surgery approach.”
He noted that ovarian cancer “goes where it wants to go. It doesn’t care what the training or surgical capabilities of the surgeon are. It’s going to go where it wants to go, so you can’t make the patient and the disease fit into your training skill set. You have to adapt your training skill set to the disease.”
The ideal study of this issue, Dr. Chi said, would “compare 400 or 500 patients with primary debulking and 400 or 500 patients who receive neoadjuvant chemotherapy to see which approach is better. There are two trials that have been done in Europe and have shown that it doesn’t matter, that the outcomes are the same whether you do primary debulking first or neoadjuvant chemotherapy first [see N. Engl. J. Med. 2010;363;943-53 and Lancet 2015;386:249-57]. Unfortunately, the survival outcomes in their primary debulking surgery arm were much lower as compared to other studies, especially those conducted in the United States. This highlights the importance of homogeneity in advanced surgical skills as a prerequisite before we draw definite conclusions about the survival outcomes after primary debulking surgery in patients with advanced disease.”
Dr. Chi acknowledged certain limitations of the study, including its retrospective design and the fact that surgeons at Memorial Sloan Kettering “are more willing, and have more support staff available, to perform comprehensive surgeries than at other centers.”
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: A survival benefit was seen after debulking stage III ovarian/fallopian tube/primary peritoneal tumors down to 10 mm or smaller in diameter.
Major finding: Patients with residual disease of 1-10 mm had significantly better overall survival, as compared to those with residual disease greater than 10 mm (P less than .001).
Data source: A retrospective evaluation of 496 women who underwent primary debulking surgery at the Memorial Sloan Kettering Cancer Center between 2001 and 2010.
Disclosures: The researchers reported having no financial disclosures.
Low phosphate linked to postop infection risk
BOSTON – Phosphate levels following colorectal surgery are predictive of risk for intra-abdominal infections, and can be helpful in identifying low-risk patients who may be suitable for early discharge after surgery, investigators say.
“The association between hypophosphatemia and intra-abdominal infections after colorectal resection is a novel finding,” said Dr. Eran Sadot, a visiting surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York City.
He described an intra-abdominal infection (IAI) risk-prediction tool at the annual Society of Surgical Oncology Cancer Symposium.
An estimated 5%-15% of patients who undergo colorectal surgery develop an IAI, largely from anastomotic leak, fistula, or intra-abdominal abscess. IAIs are associated with prolonged length of stay and higher costs, as well as an estimated 20% increase in short-term mortality, and reduced long-term survival, he said.
“These complications typically become clinically evident beyond postop day 5, and early identification of intra-abdominal infections can potentially lead to early intervention and limit sepsis, “ he said.
Several studies have shown that hypophosphatemia is associated with poor outcomes in various clinical settings – among hospitalized patients in general, in surgical and cardiac intensive care units, following open heart surgery, and after hepatic resections, he noted.
The investigators hypothesized that patients who develop IAIs have an intense acute-phase response accompanied by hypophosphatemia, and that early measurement of postoperative phosphate levels could serve as a marker for systemic response and early IAI. They conducted a retrospective study of data on patients who underwent first colorectal resection at their center from 2005 through 2015. They looked at postoperative hypophosphatemia, defined as serum levels less than 2.5 mg/dL, and they used logistic regression to create a risk model.
The sample included 7,423 patients with a median age of 61 years, including 42% who underwent resection for colon cancer, 26% for rectal cancer, and the remainder for various diagnoses.
In all, 399 patients (5%) developed IAIs, and two of these patients (0.5%) died.
The authors looked at the course of perioperative serum phosphate levels and saw that all patients had a slight rise in phosphate levels on the day of surgery, which then dropped rapidly to a nadir on postoperative day, and began to recover on day 3. They found that patients who did not have IAIs had more rapid recovery of phosphate levels than did patients who developed infections. In addition, they found that hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI (P = .001).
In a multivariable model of the cohort characteristics stratified by IAI, the researchers saw that risk factors independently associated with IAI included body mass index greater than 30 kg.m2 (odds ratio [OR] 1.4, P = .04), combined liver resection (OR 1.9, P less than .001), estimated blood loss greater than 400 mL (OR 1.7, P = .01), hypophosphatemia on postoperative day 3 (OR 1.4, P = .03), and abnormal white blood cell count on postoperative day 3 (OR 1.9, P less than .001).
They then created an IAI risk score assigning 1 point each to the risk factors just mentioned and tested it as a risk prediction tool. A score of 0 or 1 was associated with a low, 5% predicted risk of IAI, giving the score a negative predictive value of 95%. Scores of 2-3 were associated with moderate risk of IAI (9%-15%), and scores of 4 or 5 were associated with high risk (17%-21%) of infection.
The area under the receiver operating characteristic curve was 0.66 (95% confidence interval 0.61-0.7), indicating a test with a good mix of sensitivity and specificity.
“This model may be used in conjunction with the recently developed enhanced recovery or ERAS pathways to safely reduce the hospital stay,” Dr. Sadot concluded.
The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.
BOSTON – Phosphate levels following colorectal surgery are predictive of risk for intra-abdominal infections, and can be helpful in identifying low-risk patients who may be suitable for early discharge after surgery, investigators say.
“The association between hypophosphatemia and intra-abdominal infections after colorectal resection is a novel finding,” said Dr. Eran Sadot, a visiting surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York City.
He described an intra-abdominal infection (IAI) risk-prediction tool at the annual Society of Surgical Oncology Cancer Symposium.
An estimated 5%-15% of patients who undergo colorectal surgery develop an IAI, largely from anastomotic leak, fistula, or intra-abdominal abscess. IAIs are associated with prolonged length of stay and higher costs, as well as an estimated 20% increase in short-term mortality, and reduced long-term survival, he said.
“These complications typically become clinically evident beyond postop day 5, and early identification of intra-abdominal infections can potentially lead to early intervention and limit sepsis, “ he said.
Several studies have shown that hypophosphatemia is associated with poor outcomes in various clinical settings – among hospitalized patients in general, in surgical and cardiac intensive care units, following open heart surgery, and after hepatic resections, he noted.
The investigators hypothesized that patients who develop IAIs have an intense acute-phase response accompanied by hypophosphatemia, and that early measurement of postoperative phosphate levels could serve as a marker for systemic response and early IAI. They conducted a retrospective study of data on patients who underwent first colorectal resection at their center from 2005 through 2015. They looked at postoperative hypophosphatemia, defined as serum levels less than 2.5 mg/dL, and they used logistic regression to create a risk model.
The sample included 7,423 patients with a median age of 61 years, including 42% who underwent resection for colon cancer, 26% for rectal cancer, and the remainder for various diagnoses.
In all, 399 patients (5%) developed IAIs, and two of these patients (0.5%) died.
The authors looked at the course of perioperative serum phosphate levels and saw that all patients had a slight rise in phosphate levels on the day of surgery, which then dropped rapidly to a nadir on postoperative day, and began to recover on day 3. They found that patients who did not have IAIs had more rapid recovery of phosphate levels than did patients who developed infections. In addition, they found that hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI (P = .001).
In a multivariable model of the cohort characteristics stratified by IAI, the researchers saw that risk factors independently associated with IAI included body mass index greater than 30 kg.m2 (odds ratio [OR] 1.4, P = .04), combined liver resection (OR 1.9, P less than .001), estimated blood loss greater than 400 mL (OR 1.7, P = .01), hypophosphatemia on postoperative day 3 (OR 1.4, P = .03), and abnormal white blood cell count on postoperative day 3 (OR 1.9, P less than .001).
They then created an IAI risk score assigning 1 point each to the risk factors just mentioned and tested it as a risk prediction tool. A score of 0 or 1 was associated with a low, 5% predicted risk of IAI, giving the score a negative predictive value of 95%. Scores of 2-3 were associated with moderate risk of IAI (9%-15%), and scores of 4 or 5 were associated with high risk (17%-21%) of infection.
The area under the receiver operating characteristic curve was 0.66 (95% confidence interval 0.61-0.7), indicating a test with a good mix of sensitivity and specificity.
“This model may be used in conjunction with the recently developed enhanced recovery or ERAS pathways to safely reduce the hospital stay,” Dr. Sadot concluded.
The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.
BOSTON – Phosphate levels following colorectal surgery are predictive of risk for intra-abdominal infections, and can be helpful in identifying low-risk patients who may be suitable for early discharge after surgery, investigators say.
“The association between hypophosphatemia and intra-abdominal infections after colorectal resection is a novel finding,” said Dr. Eran Sadot, a visiting surgical oncology fellow at Memorial Sloan Kettering Cancer Center in New York City.
He described an intra-abdominal infection (IAI) risk-prediction tool at the annual Society of Surgical Oncology Cancer Symposium.
An estimated 5%-15% of patients who undergo colorectal surgery develop an IAI, largely from anastomotic leak, fistula, or intra-abdominal abscess. IAIs are associated with prolonged length of stay and higher costs, as well as an estimated 20% increase in short-term mortality, and reduced long-term survival, he said.
“These complications typically become clinically evident beyond postop day 5, and early identification of intra-abdominal infections can potentially lead to early intervention and limit sepsis, “ he said.
Several studies have shown that hypophosphatemia is associated with poor outcomes in various clinical settings – among hospitalized patients in general, in surgical and cardiac intensive care units, following open heart surgery, and after hepatic resections, he noted.
The investigators hypothesized that patients who develop IAIs have an intense acute-phase response accompanied by hypophosphatemia, and that early measurement of postoperative phosphate levels could serve as a marker for systemic response and early IAI. They conducted a retrospective study of data on patients who underwent first colorectal resection at their center from 2005 through 2015. They looked at postoperative hypophosphatemia, defined as serum levels less than 2.5 mg/dL, and they used logistic regression to create a risk model.
The sample included 7,423 patients with a median age of 61 years, including 42% who underwent resection for colon cancer, 26% for rectal cancer, and the remainder for various diagnoses.
In all, 399 patients (5%) developed IAIs, and two of these patients (0.5%) died.
The authors looked at the course of perioperative serum phosphate levels and saw that all patients had a slight rise in phosphate levels on the day of surgery, which then dropped rapidly to a nadir on postoperative day, and began to recover on day 3. They found that patients who did not have IAIs had more rapid recovery of phosphate levels than did patients who developed infections. In addition, they found that hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI (P = .001).
In a multivariable model of the cohort characteristics stratified by IAI, the researchers saw that risk factors independently associated with IAI included body mass index greater than 30 kg.m2 (odds ratio [OR] 1.4, P = .04), combined liver resection (OR 1.9, P less than .001), estimated blood loss greater than 400 mL (OR 1.7, P = .01), hypophosphatemia on postoperative day 3 (OR 1.4, P = .03), and abnormal white blood cell count on postoperative day 3 (OR 1.9, P less than .001).
They then created an IAI risk score assigning 1 point each to the risk factors just mentioned and tested it as a risk prediction tool. A score of 0 or 1 was associated with a low, 5% predicted risk of IAI, giving the score a negative predictive value of 95%. Scores of 2-3 were associated with moderate risk of IAI (9%-15%), and scores of 4 or 5 were associated with high risk (17%-21%) of infection.
The area under the receiver operating characteristic curve was 0.66 (95% confidence interval 0.61-0.7), indicating a test with a good mix of sensitivity and specificity.
“This model may be used in conjunction with the recently developed enhanced recovery or ERAS pathways to safely reduce the hospital stay,” Dr. Sadot concluded.
The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.
Key clinical point: Hypophosphatemia may be a risk marker for intra-abdominal infections (IAI) following colorectal surgery.
Major finding: Hypophosphatemia on postoperative day 3 was associated with a 50% increased risk of IAI.
Data source: Retrospective review of data on 7,423 consecutive colorectal surgery patients.
Disclosures: The study was internally supported. Dr. Sadot and colleagues reported no conflicts of interest.