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Biomarkers come up empty for ribociclib targeting
BRUSSELS – The inability of researchers to find a biomarker that could flag a subgroup of breast cancer patients with increased responsiveness to ribociclib plus an aromatase inhibitor was “somewhat disappointing,” Philippe Bedard, MD, said at a breast cancer conference sponsored by the European Society for Medical Oncology.
Many patients who are candidates for this combination treatment, approved by the Food and Drug Administration in March 2017 for postmenopausal women with advanced breast cancer that is hormone receptor positive and HER2 negative, could also do just as well on an aromatase inhibitor alone, said Dr. Bedard, of the Princess Margaret Cancer Centre in Toronto.
“The only validated marker for response to a cyclin-dependent kinase 4/6 inhibitor [such as ribociclib] is hormone receptor positivity. The bottom line is that you can’t target to a more specific subgroup with a biomarker,” Dr. Bedard said in an interview.
The researchers who ran the study collected tumor specimens at baseline from all participants, and Fabrice André, MD reported results from analyses run for seven different biomarkers. The analysis looked at protein levels for three biomarkers – Rb, Ki67, and p16 – in 479, 463, and 405 patients respectively; messenger RNA levels for CCND1, CDKN2A, and ESR1 in 386 patients; and DNA mutational status for the PIKC3A gene in 573 patients. In all seven cases, responsiveness to ribociclib was roughly similar regardless of protein or RNA expression levels or the type of PIKC3A (wild or mutated) the tumor carried, reported Dr. André of the Gustave Roussy Cancer Institute in Villejuif, France. Additional biomarker studies on the MONALEESA-2 specimens are ongoing, he said.
[email protected]
On Twitter @mitchelzoler
Correction, 5/6/17: An earlier version of this article misstated the citation.
BRUSSELS – The inability of researchers to find a biomarker that could flag a subgroup of breast cancer patients with increased responsiveness to ribociclib plus an aromatase inhibitor was “somewhat disappointing,” Philippe Bedard, MD, said at a breast cancer conference sponsored by the European Society for Medical Oncology.
Many patients who are candidates for this combination treatment, approved by the Food and Drug Administration in March 2017 for postmenopausal women with advanced breast cancer that is hormone receptor positive and HER2 negative, could also do just as well on an aromatase inhibitor alone, said Dr. Bedard, of the Princess Margaret Cancer Centre in Toronto.
“The only validated marker for response to a cyclin-dependent kinase 4/6 inhibitor [such as ribociclib] is hormone receptor positivity. The bottom line is that you can’t target to a more specific subgroup with a biomarker,” Dr. Bedard said in an interview.
The researchers who ran the study collected tumor specimens at baseline from all participants, and Fabrice André, MD reported results from analyses run for seven different biomarkers. The analysis looked at protein levels for three biomarkers – Rb, Ki67, and p16 – in 479, 463, and 405 patients respectively; messenger RNA levels for CCND1, CDKN2A, and ESR1 in 386 patients; and DNA mutational status for the PIKC3A gene in 573 patients. In all seven cases, responsiveness to ribociclib was roughly similar regardless of protein or RNA expression levels or the type of PIKC3A (wild or mutated) the tumor carried, reported Dr. André of the Gustave Roussy Cancer Institute in Villejuif, France. Additional biomarker studies on the MONALEESA-2 specimens are ongoing, he said.
[email protected]
On Twitter @mitchelzoler
Correction, 5/6/17: An earlier version of this article misstated the citation.
BRUSSELS – The inability of researchers to find a biomarker that could flag a subgroup of breast cancer patients with increased responsiveness to ribociclib plus an aromatase inhibitor was “somewhat disappointing,” Philippe Bedard, MD, said at a breast cancer conference sponsored by the European Society for Medical Oncology.
Many patients who are candidates for this combination treatment, approved by the Food and Drug Administration in March 2017 for postmenopausal women with advanced breast cancer that is hormone receptor positive and HER2 negative, could also do just as well on an aromatase inhibitor alone, said Dr. Bedard, of the Princess Margaret Cancer Centre in Toronto.
“The only validated marker for response to a cyclin-dependent kinase 4/6 inhibitor [such as ribociclib] is hormone receptor positivity. The bottom line is that you can’t target to a more specific subgroup with a biomarker,” Dr. Bedard said in an interview.
The researchers who ran the study collected tumor specimens at baseline from all participants, and Fabrice André, MD reported results from analyses run for seven different biomarkers. The analysis looked at protein levels for three biomarkers – Rb, Ki67, and p16 – in 479, 463, and 405 patients respectively; messenger RNA levels for CCND1, CDKN2A, and ESR1 in 386 patients; and DNA mutational status for the PIKC3A gene in 573 patients. In all seven cases, responsiveness to ribociclib was roughly similar regardless of protein or RNA expression levels or the type of PIKC3A (wild or mutated) the tumor carried, reported Dr. André of the Gustave Roussy Cancer Institute in Villejuif, France. Additional biomarker studies on the MONALEESA-2 specimens are ongoing, he said.
[email protected]
On Twitter @mitchelzoler
Correction, 5/6/17: An earlier version of this article misstated the citation.
EXPERT ANALYSIS FROM IMPAKT 2017 BREAST CANCER CONFERENCE
Key clinical point:
Major finding: Hazard ratio benefits from ribociclib plus letrozole, compared with letrozole alone, were similar regardless of the levels of seven biomarkers.
Data source: Exploratory analysis of tumor specimens collected from 668 patients with breast cancer enrolled in the MONALEESA-2 study.
Disclosures: MONALEESA-2 was sponsored by Novartis, the company that markets ribociclib (Kisqali). Dr. Bedard has received honoraria from Novartis, Pfizer, Roche, and Sanofi, and he has received research funding from Novartis and several other companies. Dr. André has received research funding from Novartis, AstraZeneca, Lilly, and Pfizer.
Breast density is no reason to perform MRI
LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.
Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.
“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.
The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).
Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).
In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.
HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).
Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).
Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).
“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.
The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.
The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.
The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”
LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.
Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.
“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.
The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).
Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).
In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.
HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).
Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).
Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).
“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.
The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.
The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.
The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”
LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.
Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.
“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.
The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).
Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).
In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.
HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).
Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).
Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).
“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.
The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.
The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.
The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”
AT ASBS 2017
Key clinical point: High breast density is probably not cause enough to order preoperative MRI.
Major finding: Freedom from recurrence rates were 90% in high density and 91% in low.
Data source: Retrospective analysis of 683 women at a single institution.
Disclosures: The study was funded internally. Dr. McLaughlin and Dr. Boughey reported having no relevant financial relationships.
Radiation bests mastectomy for occult breast cancer
LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.
Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.
ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.
Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.
Occult breast cancer – axillary lymph node metastases without clinical or radiologic evidence of a primary breast tumor – is rare and accounted for less than 0.1% of the 2.03 million breast cancer cases in the database. It’s been unclear how best to treat it; most of the previous investigations were small single-center series and case reports.
The only other significant review was smaller, with 750 women in the Surveillance, Epidemiology, and End Results database treated from 1983 to 2006, the “vast majority” before routine use of breast MRI. It showed that “definitive locoregional treatment with either mastectomy or [radiation therapy] improves [overall survival] in patients with occult breast cancer and axillary metastasis who undergo ALND,” but it didn’t suggest which option is best. The National Comprehensive Cancer Network recommends either approach (Cancer. 2010 Sep 1;116[17]:4000-6).
The new University of Maryland findings “confirm that women do not need to have a mastectomy if you can’t find the cancer in their breast. Women do better if you radiate the breast instead of removing it. A lot of academic centers are doing this now, but some people don’t know about it. This needs to be implemented in a more widespread fashion,” said Shelley Hwang, MD, a surgical oncologist at Duke University, Durham, N.C., who moderated Dr. Hessler’s presentation.
Indeed, patients were most likely to be treated with radiation and ALND at an academic center (OR 2.03, 95% CI 1.5-2.74, P less than .001), the only factor on multivariate analysis related to treatment choice.
The review excluded women with only internal mammary lymph node involvement, those with lumpectomies, and women who had less than four nodes recovered on ALND. Mastectomy and radiation patients were similar in nodal stage, race, income, insurance, estrogen receptor status, comorbidities, and year of diagnosis. On pathology, a tumor was found in about a third of the patients who had mastectomies. MRI use and recurrence rates were unavailable in the National Cancer Database.
The findings are subject to all the limits of database reviews, including the possible confounder that women treated at university hospitals might also have had more optimal systemic therapy, as an audience member noted.
The investigators said they had no financial disclosures.
LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.
Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.
ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.
Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.
Occult breast cancer – axillary lymph node metastases without clinical or radiologic evidence of a primary breast tumor – is rare and accounted for less than 0.1% of the 2.03 million breast cancer cases in the database. It’s been unclear how best to treat it; most of the previous investigations were small single-center series and case reports.
The only other significant review was smaller, with 750 women in the Surveillance, Epidemiology, and End Results database treated from 1983 to 2006, the “vast majority” before routine use of breast MRI. It showed that “definitive locoregional treatment with either mastectomy or [radiation therapy] improves [overall survival] in patients with occult breast cancer and axillary metastasis who undergo ALND,” but it didn’t suggest which option is best. The National Comprehensive Cancer Network recommends either approach (Cancer. 2010 Sep 1;116[17]:4000-6).
The new University of Maryland findings “confirm that women do not need to have a mastectomy if you can’t find the cancer in their breast. Women do better if you radiate the breast instead of removing it. A lot of academic centers are doing this now, but some people don’t know about it. This needs to be implemented in a more widespread fashion,” said Shelley Hwang, MD, a surgical oncologist at Duke University, Durham, N.C., who moderated Dr. Hessler’s presentation.
Indeed, patients were most likely to be treated with radiation and ALND at an academic center (OR 2.03, 95% CI 1.5-2.74, P less than .001), the only factor on multivariate analysis related to treatment choice.
The review excluded women with only internal mammary lymph node involvement, those with lumpectomies, and women who had less than four nodes recovered on ALND. Mastectomy and radiation patients were similar in nodal stage, race, income, insurance, estrogen receptor status, comorbidities, and year of diagnosis. On pathology, a tumor was found in about a third of the patients who had mastectomies. MRI use and recurrence rates were unavailable in the National Cancer Database.
The findings are subject to all the limits of database reviews, including the possible confounder that women treated at university hospitals might also have had more optimal systemic therapy, as an audience member noted.
The investigators said they had no financial disclosures.
LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.
Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.
ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.
Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.
Occult breast cancer – axillary lymph node metastases without clinical or radiologic evidence of a primary breast tumor – is rare and accounted for less than 0.1% of the 2.03 million breast cancer cases in the database. It’s been unclear how best to treat it; most of the previous investigations were small single-center series and case reports.
The only other significant review was smaller, with 750 women in the Surveillance, Epidemiology, and End Results database treated from 1983 to 2006, the “vast majority” before routine use of breast MRI. It showed that “definitive locoregional treatment with either mastectomy or [radiation therapy] improves [overall survival] in patients with occult breast cancer and axillary metastasis who undergo ALND,” but it didn’t suggest which option is best. The National Comprehensive Cancer Network recommends either approach (Cancer. 2010 Sep 1;116[17]:4000-6).
The new University of Maryland findings “confirm that women do not need to have a mastectomy if you can’t find the cancer in their breast. Women do better if you radiate the breast instead of removing it. A lot of academic centers are doing this now, but some people don’t know about it. This needs to be implemented in a more widespread fashion,” said Shelley Hwang, MD, a surgical oncologist at Duke University, Durham, N.C., who moderated Dr. Hessler’s presentation.
Indeed, patients were most likely to be treated with radiation and ALND at an academic center (OR 2.03, 95% CI 1.5-2.74, P less than .001), the only factor on multivariate analysis related to treatment choice.
The review excluded women with only internal mammary lymph node involvement, those with lumpectomies, and women who had less than four nodes recovered on ALND. Mastectomy and radiation patients were similar in nodal stage, race, income, insurance, estrogen receptor status, comorbidities, and year of diagnosis. On pathology, a tumor was found in about a third of the patients who had mastectomies. MRI use and recurrence rates were unavailable in the National Cancer Database.
The findings are subject to all the limits of database reviews, including the possible confounder that women treated at university hospitals might also have had more optimal systemic therapy, as an audience member noted.
The investigators said they had no financial disclosures.
AT ASBS 2017
Key clinical point:
Major finding: Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation.
Data source: Review of 934 cases in the National Cancer Database.
Disclosures: The investigators said they had no financial disclosures.
Mastectomy unnecessary for some breast cancer recurrences
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
LAS VEGAS – Although mastectomy is the standard of care for tumor recurrence following lumpectomy and whole breast irradiation, a second lumpectomy with partial breast irradiation is a sound alternative under certain circumstances, according to Manjeet Chadha, MD, professor of radiation oncology and director of the department of radiation oncology at Icahn School of Medicine at Mount Sinai, New York.
It depends on whether the new lesion is a true recurrence, or simply another primary tumor. In the absence of a genetic footprint to compare the two, Dr. Chadha and her colleagues use several of what she called “soft criteria” to make the call and counsel women.
True ipsilateral recurrence of an aggressive tumor tends to happen early, and in the same quadrant. However, if breast cancer recurs more than 3 years after treatment of the primary tumor and in a different quadrant, and if the patient is negative for BRCA mutation, and if the new growth is small, localized on MRI, histologically different from the primary tumor, and likely to be resected with clean margins, Dr. Chadha said she is comfortable offering a second lumpectomy and partial breast radiation – usually multicatheter brachytherapy – to women who do not want a mastectomy.
“Second cancer in a previously irradiated breast is not an uncommon clinical entity. Based on patient preference, the option of repeat breast conservation and reirradiation may be offered selectively as an alternative to mastectomy,” followed by systemic therapy, she said at the annual meeting of the American Society of Breast Surgeons.
“I think all of us across the country are discussing presentations like this in tumor boards,” but it’s not always offered as an option. Sometimes, “the mindset of the treating surgeon is ‘oh, this breast has had radiation; I can’t give radiation again.’ Clearly, whole breast reirradiation is not recommended,” but it seems possible based on a growing body of literature to differentiate new primaries with new biology from true recurrences, and to treat them safely with breast conserving surgery and partial irradiation, she said.
The largest series to date of salvage lumpectomy with multicatheter brachytherapy followed 217 women for a median of 3.9 years. Median tumor size was 1.2 cm. The 5-year local control rate – effectively, the mastectomy-free survival – was 94.4%, and the overall survival was 88.7%, which mirrors the success of first-time lumpectomy with whole breast irradiation, and lends support to the notion that some recurrences are, in fact, entirely new disease. The European team reported excellent or good cosmetic results in 85% of women (Radiother Oncol. 2013 Aug;108[2]:226-31).
The series used high-dose radiation. Dr. Chadha said she and her colleagues have had similar success with low-dose multicatheter brachytherapy, with similarly good aesthetic results. To avoid cosmetic impact, however, she noted it’s important to work with radiation oncologists “mindful of the nuances of what’s needed,” including how far to separate the skin from the radiation.
Brachytherapy has the most support in the literature, but external beam therapy is also an option. “Whatever technique you use, the delineation of the target and the geometric coverage of the lumpectomy cavity [must be] complete in all cases,” she said.
Dr. Chadha had no financial conflicts of interest.
EXPERT ANALYSIS FROM ASBS 2017
Sutureless, guided lumpectomy produced clean margins in majority
LAS VEGAS – An automated, minimally invasive, stereotactic-guided lumpectomy performed well in an outpatient setting, with no sutures required, potentially decreasing patient morbidity, according to Pat Whitworth, MD.
Pain scores were low, and all high-risk lesions were successfully removed.
The new technology is part of the natural progression of cancer resection, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, at the annual meeting of the American Society of Breast Surgeons.
“We went from radical mastectomy, to modified radical mastectomy, to lumpectomy. This is just part of that progression where we match what we do to what the patient really needs,” he said.
Dr. Whitworth said he believes that radiologists will soon be using such technology to treat breast cancer, which puts the onus on breast cancer surgeons to adopt it themselves. “I think it’s important for breast surgeons to acquire the necessary skill and techniques to use the same tools and work collaboratively with radiologists, because this is coming,” he said.
To see if it were possible to achieve results similar to those with lumpectomy, Dr. Whitworth analyzed data from 279 women who had a small ductal carcinoma in situ (DCIS), invasive carcinoma, or high-risk lesion removed using a 15- or 20-mm radiofrequency basket capture with imaging guidance (lumpectomy). Patients who received a cancer diagnosis underwent a second, 20-mm basket capture to obtain shaved margins.
The procedure was conducted under local anesthesia and sedation, and the incisions were closed using Steri-Strip skin closures. The average pain score was 1.55 out of 10 (range, 0-7).
Of 125 patients found to have DCIS (n = 52) and invasive lesions (n = 73), the first capture achieved clear margins in 69 cases, and the shaved margin capture achieved clean margins in another 33 cases.
The remaining 23 patients (18%) had a positive margin by histologic standards following lumpectomy and shaved margin. Of the 22 with reported results, 17 (77%) had no residual lesion following open surgery.
The results convinced Dr. Wentworth of the technique’s utility, particularly in patients who may have a heightened surgical risk, he said. “We think this can replace open lumpectomy in selected patients, with favorable margin clearance.”
The approach is fairly simple, but Dr. Wentworth recommended beginning with stereotactic-guided technology before attempting the ultrasound-guided version, which requires a little more skill. “The biggest challenge is learning that you have to use a lot more local anesthetic. When this technology first came out, people tried to use the same amount of local anesthetic that they used for standard vacuum-assisted core biopsy, and it’s very painful unless you put 30 or 40 cc of dilute anesthetic in there,” said Dr. Wentworth.
The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
LAS VEGAS – An automated, minimally invasive, stereotactic-guided lumpectomy performed well in an outpatient setting, with no sutures required, potentially decreasing patient morbidity, according to Pat Whitworth, MD.
Pain scores were low, and all high-risk lesions were successfully removed.
The new technology is part of the natural progression of cancer resection, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, at the annual meeting of the American Society of Breast Surgeons.
“We went from radical mastectomy, to modified radical mastectomy, to lumpectomy. This is just part of that progression where we match what we do to what the patient really needs,” he said.
Dr. Whitworth said he believes that radiologists will soon be using such technology to treat breast cancer, which puts the onus on breast cancer surgeons to adopt it themselves. “I think it’s important for breast surgeons to acquire the necessary skill and techniques to use the same tools and work collaboratively with radiologists, because this is coming,” he said.
To see if it were possible to achieve results similar to those with lumpectomy, Dr. Whitworth analyzed data from 279 women who had a small ductal carcinoma in situ (DCIS), invasive carcinoma, or high-risk lesion removed using a 15- or 20-mm radiofrequency basket capture with imaging guidance (lumpectomy). Patients who received a cancer diagnosis underwent a second, 20-mm basket capture to obtain shaved margins.
The procedure was conducted under local anesthesia and sedation, and the incisions were closed using Steri-Strip skin closures. The average pain score was 1.55 out of 10 (range, 0-7).
Of 125 patients found to have DCIS (n = 52) and invasive lesions (n = 73), the first capture achieved clear margins in 69 cases, and the shaved margin capture achieved clean margins in another 33 cases.
The remaining 23 patients (18%) had a positive margin by histologic standards following lumpectomy and shaved margin. Of the 22 with reported results, 17 (77%) had no residual lesion following open surgery.
The results convinced Dr. Wentworth of the technique’s utility, particularly in patients who may have a heightened surgical risk, he said. “We think this can replace open lumpectomy in selected patients, with favorable margin clearance.”
The approach is fairly simple, but Dr. Wentworth recommended beginning with stereotactic-guided technology before attempting the ultrasound-guided version, which requires a little more skill. “The biggest challenge is learning that you have to use a lot more local anesthetic. When this technology first came out, people tried to use the same amount of local anesthetic that they used for standard vacuum-assisted core biopsy, and it’s very painful unless you put 30 or 40 cc of dilute anesthetic in there,” said Dr. Wentworth.
The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
LAS VEGAS – An automated, minimally invasive, stereotactic-guided lumpectomy performed well in an outpatient setting, with no sutures required, potentially decreasing patient morbidity, according to Pat Whitworth, MD.
Pain scores were low, and all high-risk lesions were successfully removed.
The new technology is part of the natural progression of cancer resection, said Dr. Whitworth, director of the Nashville (Tenn.) Breast Center, at the annual meeting of the American Society of Breast Surgeons.
“We went from radical mastectomy, to modified radical mastectomy, to lumpectomy. This is just part of that progression where we match what we do to what the patient really needs,” he said.
Dr. Whitworth said he believes that radiologists will soon be using such technology to treat breast cancer, which puts the onus on breast cancer surgeons to adopt it themselves. “I think it’s important for breast surgeons to acquire the necessary skill and techniques to use the same tools and work collaboratively with radiologists, because this is coming,” he said.
To see if it were possible to achieve results similar to those with lumpectomy, Dr. Whitworth analyzed data from 279 women who had a small ductal carcinoma in situ (DCIS), invasive carcinoma, or high-risk lesion removed using a 15- or 20-mm radiofrequency basket capture with imaging guidance (lumpectomy). Patients who received a cancer diagnosis underwent a second, 20-mm basket capture to obtain shaved margins.
The procedure was conducted under local anesthesia and sedation, and the incisions were closed using Steri-Strip skin closures. The average pain score was 1.55 out of 10 (range, 0-7).
Of 125 patients found to have DCIS (n = 52) and invasive lesions (n = 73), the first capture achieved clear margins in 69 cases, and the shaved margin capture achieved clean margins in another 33 cases.
The remaining 23 patients (18%) had a positive margin by histologic standards following lumpectomy and shaved margin. Of the 22 with reported results, 17 (77%) had no residual lesion following open surgery.
The results convinced Dr. Wentworth of the technique’s utility, particularly in patients who may have a heightened surgical risk, he said. “We think this can replace open lumpectomy in selected patients, with favorable margin clearance.”
The approach is fairly simple, but Dr. Wentworth recommended beginning with stereotactic-guided technology before attempting the ultrasound-guided version, which requires a little more skill. “The biggest challenge is learning that you have to use a lot more local anesthetic. When this technology first came out, people tried to use the same amount of local anesthetic that they used for standard vacuum-assisted core biopsy, and it’s very painful unless you put 30 or 40 cc of dilute anesthetic in there,” said Dr. Wentworth.
The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
AT ASBS 2017
Key clinical point: The technique could replace standard lumpectomy in patients at high surgical risk.
Major finding: Clean margins were obtained in 102 of 125 women with diagnosed cancer.
Data source: A retrospective analysis of 279 patients.
Disclosures: The study was funded by Medtronic, which markets the technology. Dr. Whitworth is a principal at Targeted Medical Education, which receives funding from Medtronic.
VIDEO: Dr. Lisa Newman on triple negative breast cancer in African American women
LAS VEGAS – The heavy burden of triple negative and other aggressive breast cancers among African American women cannot be simplified to socioeconomic factors alone.
International investigations by Lisa Newman, MD, director of the Breast Oncology Program at the Henry Ford Health System, Detroit, and other researchers are making it clear that genetic factors play a significant role.
She explained the latest findings and what they mean for screening, genetic referral, and treatment in an interview at the American Society of Breast Surgeons annual meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – The heavy burden of triple negative and other aggressive breast cancers among African American women cannot be simplified to socioeconomic factors alone.
International investigations by Lisa Newman, MD, director of the Breast Oncology Program at the Henry Ford Health System, Detroit, and other researchers are making it clear that genetic factors play a significant role.
She explained the latest findings and what they mean for screening, genetic referral, and treatment in an interview at the American Society of Breast Surgeons annual meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – The heavy burden of triple negative and other aggressive breast cancers among African American women cannot be simplified to socioeconomic factors alone.
International investigations by Lisa Newman, MD, director of the Breast Oncology Program at the Henry Ford Health System, Detroit, and other researchers are making it clear that genetic factors play a significant role.
She explained the latest findings and what they mean for screening, genetic referral, and treatment in an interview at the American Society of Breast Surgeons annual meeting.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ASBS 2017
DCIS tool IDs axillary node biopsy candidates
LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.
“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.
The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).
They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.
This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.
The team is working on posting the nomogram online for widespread use.
It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.
“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.
LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.
“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.
The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).
They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.
This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.
The team is working on posting the nomogram online for widespread use.
It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.
“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.
LAS VEGAS – A new tool identifies patients with ductal carcinoma in situ (DCIS) who are at high risk for being upstaged as a result of the pathology report. The screen could encourage patients to undergo axillary nodal staging during the core needle biopsy (CNB), thus avoiding a second procedure.
“The risk factors have been well described, but they haven’t helped give individual risk or individual percentages. Our goal was to try to individualize that risk so that we could counsel patients,” said lead researcher James Jakub, MD, chair of the division of breast endocrine and metabolic surgery at Mayo Clinic Rochester, at the annual meeting of the American Society of Breast Surgeons.
The researchers found that grade on CNB, mass lesion on imaging, multifocal/centric disease, and linear dimension combined to predict the likelihood of being upstaged to invasive disease (C statistic, 0.71; 95% confidence interval, 0.66-0.77).
They then combined those characteristics to create a nomogram and tested it against the validation set. In that group, 11% of patients were upstaged to invasive disease. The nomogram performed almost identically in the external validation set (C statistic, 0.71; 95% CI, 0.63-0.79). The model predicted 56 upstages, and 46 occurred.
This wasn’t the first attempt to create a nomogram to predict upstaging in DCIS patients, but others were not tested against external datasets. “That’s a weakness with other studies. Unless it’s validated externally, you don’t really know if you can apply it to your population. That was a very large plus: having colleagues who were willing to collaborate to validate it,” said Dr. Jakub.
The team is working on posting the nomogram online for widespread use.
It remains to be seen whether the availability of the nomogram will, in fact, change patients’ decision-making and result in more axillary nodal biopsies during CNB procedures in high risk patients.
“We haven’t looked into that. It will be interesting to see how it influences [sentinel lymph node] biopsy rate at our institution, and we’d love to hear from institutions who apply it. My sense is that patients who are at high risk are going to be interested in doing that. I think it will definitely change their management,” said Dr. Jakub.
AT ASBS 2017
Key clinical point: High risk patients who choose axillary biopsy could avoid a second procedure.
Major finding: The 4-item nomogram predicted upstaging with a C statistic of 0.71.
Data source: A retrospective sample (n = 827) and validation study (n = 579).
Disclosures: The source of funding was not disclosed. Dr. Jakub reported having no financial disclosures.
FDA boxed warning leads to drop off in use of ESAs
The Food and Drug Administration’s 2007 “boxed warning” about serious adverse events associated with the use of erythropoietin-stimulating agents (ESAs) was followed by a substantial reduction in their use among patients recovering from colorectal, breast, or lung cancer, according to a new report.
Boxed warnings are considered one of the strongest mechanisms with which the FDA can communicate concerns about drug safety to the public. However, some critics have questioned the effectiveness of these warnings, and the available evidence “remains inconclusive, largely because almost all of [the data] were drawn from observational studies using pre-post designs without control groups,” said John Bian, PhD, of the University of South Carolina College of Pharmacy and Hollings Cancer Center, Columbia, and his associates.
The investigators analyzed data in the SEER cancer registry for the period immediately before and immediately after the 2007 boxed warning was issued. Their sample comprised 45,319 patients aged 66 years and older who were treated either in the “pre” warning period (January 2004-September 2006) or the “post” period (April 2007-September 2009). This included a control group of 3,375 patients with myelodysplastic syndromes. Use of ESAs in these patients was off-label and was not targeted by the boxed warning (J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2017.72.6273).The use of ESAs declined sharply after the boxed warning was issued, except in the control group. The proportion of breast cancer patients receiving ESAs dropped from 49%-55% before 2007 to 30% in 2007, 16% in 2008, and 9% in 2009.
Similarly, the proportion of colorectal cancer patients receiving ESAs declined from about 35%-40% before 2007 to 18% in 2007, 11% in 2008, and 9% in 2009. The proportion of lung cancer patients receiving ESAs decreased from 56%-58% before 2007 to 40% in 2007, 29% in 2008, and 24% in 2009. In contrast, the proportion of patients with myelodysplastic syndromes receiving ESAs – the control group – remained relatively stable at 39%-42% before 2007, 35% in 2007, and 32% in 2008 and 2009.
This represents a reduction of approximately 40% overall in the use of ESAs among targeted patients after the warning was issued. However, this decrease appeared to have little effect on the incidence of hospitalization for venous thromboembolism in this patient population, Dr. Bian and his associates noted.
The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
The Food and Drug Administration’s 2007 “boxed warning” about serious adverse events associated with the use of erythropoietin-stimulating agents (ESAs) was followed by a substantial reduction in their use among patients recovering from colorectal, breast, or lung cancer, according to a new report.
Boxed warnings are considered one of the strongest mechanisms with which the FDA can communicate concerns about drug safety to the public. However, some critics have questioned the effectiveness of these warnings, and the available evidence “remains inconclusive, largely because almost all of [the data] were drawn from observational studies using pre-post designs without control groups,” said John Bian, PhD, of the University of South Carolina College of Pharmacy and Hollings Cancer Center, Columbia, and his associates.
The investigators analyzed data in the SEER cancer registry for the period immediately before and immediately after the 2007 boxed warning was issued. Their sample comprised 45,319 patients aged 66 years and older who were treated either in the “pre” warning period (January 2004-September 2006) or the “post” period (April 2007-September 2009). This included a control group of 3,375 patients with myelodysplastic syndromes. Use of ESAs in these patients was off-label and was not targeted by the boxed warning (J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2017.72.6273).The use of ESAs declined sharply after the boxed warning was issued, except in the control group. The proportion of breast cancer patients receiving ESAs dropped from 49%-55% before 2007 to 30% in 2007, 16% in 2008, and 9% in 2009.
Similarly, the proportion of colorectal cancer patients receiving ESAs declined from about 35%-40% before 2007 to 18% in 2007, 11% in 2008, and 9% in 2009. The proportion of lung cancer patients receiving ESAs decreased from 56%-58% before 2007 to 40% in 2007, 29% in 2008, and 24% in 2009. In contrast, the proportion of patients with myelodysplastic syndromes receiving ESAs – the control group – remained relatively stable at 39%-42% before 2007, 35% in 2007, and 32% in 2008 and 2009.
This represents a reduction of approximately 40% overall in the use of ESAs among targeted patients after the warning was issued. However, this decrease appeared to have little effect on the incidence of hospitalization for venous thromboembolism in this patient population, Dr. Bian and his associates noted.
The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
The Food and Drug Administration’s 2007 “boxed warning” about serious adverse events associated with the use of erythropoietin-stimulating agents (ESAs) was followed by a substantial reduction in their use among patients recovering from colorectal, breast, or lung cancer, according to a new report.
Boxed warnings are considered one of the strongest mechanisms with which the FDA can communicate concerns about drug safety to the public. However, some critics have questioned the effectiveness of these warnings, and the available evidence “remains inconclusive, largely because almost all of [the data] were drawn from observational studies using pre-post designs without control groups,” said John Bian, PhD, of the University of South Carolina College of Pharmacy and Hollings Cancer Center, Columbia, and his associates.
The investigators analyzed data in the SEER cancer registry for the period immediately before and immediately after the 2007 boxed warning was issued. Their sample comprised 45,319 patients aged 66 years and older who were treated either in the “pre” warning period (January 2004-September 2006) or the “post” period (April 2007-September 2009). This included a control group of 3,375 patients with myelodysplastic syndromes. Use of ESAs in these patients was off-label and was not targeted by the boxed warning (J Clin Oncol. 2017 Apr 25. doi: 10.1200/JCO.2017.72.6273).The use of ESAs declined sharply after the boxed warning was issued, except in the control group. The proportion of breast cancer patients receiving ESAs dropped from 49%-55% before 2007 to 30% in 2007, 16% in 2008, and 9% in 2009.
Similarly, the proportion of colorectal cancer patients receiving ESAs declined from about 35%-40% before 2007 to 18% in 2007, 11% in 2008, and 9% in 2009. The proportion of lung cancer patients receiving ESAs decreased from 56%-58% before 2007 to 40% in 2007, 29% in 2008, and 24% in 2009. In contrast, the proportion of patients with myelodysplastic syndromes receiving ESAs – the control group – remained relatively stable at 39%-42% before 2007, 35% in 2007, and 32% in 2008 and 2009.
This represents a reduction of approximately 40% overall in the use of ESAs among targeted patients after the warning was issued. However, this decrease appeared to have little effect on the incidence of hospitalization for venous thromboembolism in this patient population, Dr. Bian and his associates noted.
The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
Key clinical point:
Major finding: The use of ESAs among cancer patients that were targeted by the boxed warning dropped by about 40% after the warning was issued.
Data source: A retrospective cohort study involving 45,319 cancer patients enrolled in the SEER data registry during 2004-2009.
Disclosures: The study was supported by the National Institutes of Health. Dr. Bian reported having no relevant financial disclosures. His associates reported ties to Quincy Bioscience, Bristol-Myers Squibb, Taiho Pharmaceutical, Mylan, Eli Lilly, Merck, Amgen, and BDI Pharma.
VIDEO: How to pick surgical margins with mixed breast lesions
LAS VEGAS – According to recent guidelines, no ink on tumor is the right surgical margin for early stage invasive breast cancer and 2 mm is the right lumpectomy margin for ductal carcinoma in situ (DCIS) treated with whole breast radiation. But, what do you do when invasive carcinoma is associated with DCIS?
It’s a common question for breast surgeons. Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York City, explained how to handle the situation in a video interview at the annual meeting of the American Society of Breast Surgeons.
She was the senior author on the 2014 invasive breast cancer guidelines and the lead author on the 2016 DCIS guidelines, both of which were consensus statements on surgical margins from the Society of Surgical Oncology and other groups (Ann Surg Oncol. 2014 Mar;21[3]:704-16; Ann Surg Oncol. 2016 Nov;23[12]:3801-10).
Dr. Morrow explained the thinking behind the guidelines and how to apply them to mixed lesions and other clinical scenarios, as well as their limitations and what remains to be determined. A key point is that a margin less than 2 mm is not by itself an indication for mastectomy in DCIS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – According to recent guidelines, no ink on tumor is the right surgical margin for early stage invasive breast cancer and 2 mm is the right lumpectomy margin for ductal carcinoma in situ (DCIS) treated with whole breast radiation. But, what do you do when invasive carcinoma is associated with DCIS?
It’s a common question for breast surgeons. Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York City, explained how to handle the situation in a video interview at the annual meeting of the American Society of Breast Surgeons.
She was the senior author on the 2014 invasive breast cancer guidelines and the lead author on the 2016 DCIS guidelines, both of which were consensus statements on surgical margins from the Society of Surgical Oncology and other groups (Ann Surg Oncol. 2014 Mar;21[3]:704-16; Ann Surg Oncol. 2016 Nov;23[12]:3801-10).
Dr. Morrow explained the thinking behind the guidelines and how to apply them to mixed lesions and other clinical scenarios, as well as their limitations and what remains to be determined. A key point is that a margin less than 2 mm is not by itself an indication for mastectomy in DCIS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
LAS VEGAS – According to recent guidelines, no ink on tumor is the right surgical margin for early stage invasive breast cancer and 2 mm is the right lumpectomy margin for ductal carcinoma in situ (DCIS) treated with whole breast radiation. But, what do you do when invasive carcinoma is associated with DCIS?
It’s a common question for breast surgeons. Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York City, explained how to handle the situation in a video interview at the annual meeting of the American Society of Breast Surgeons.
She was the senior author on the 2014 invasive breast cancer guidelines and the lead author on the 2016 DCIS guidelines, both of which were consensus statements on surgical margins from the Society of Surgical Oncology and other groups (Ann Surg Oncol. 2014 Mar;21[3]:704-16; Ann Surg Oncol. 2016 Nov;23[12]:3801-10).
Dr. Morrow explained the thinking behind the guidelines and how to apply them to mixed lesions and other clinical scenarios, as well as their limitations and what remains to be determined. A key point is that a margin less than 2 mm is not by itself an indication for mastectomy in DCIS.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
From ASBS 2017
Resection reduces inflammatory breast cancer lesion recurrence
LAS VEGAS – In patients with nonmetastatic inflammatory breast cancer (IBC), aggressive surgical resection can reduce local/regional recurrence rates to levels comparable to those seen in patients with noninflammatory breast cancer.
The key to the improved outcome is the presence of a plastic surgeon who can help close a tricky incision. “We have a multidisciplinary team that allows us to call upon the plastic surgeons if we can’t control the incision, and they help us with a flap closure,” said Kelly Rosso, MD, a breast surgical oncology fellow at the MD Anderson Cancer Center, Houston, who presented the study results at the annual meeting of the American Society of Breast Surgeons.
To see if their surgical interventions were producing better outcomes, the team analyzed data from 114 patients with nonmetastatic inflammatory breast cancer who had received trimodality therapy (neoadjuvant chemotherapy, surgery, and radiation therapy) from 2007 to 2015.
The median patient age was 52 years, and the median follow-up period was 3.6 years. In total, 55% of patients had N2 IBC, and 45% had N3 disease.
Nearly all (113 of 114) patients had negative surgical margins. A total of 29 patients died during the follow-up period, and the 5-year survival rate was 69%. The odds of a local/regional recurrence over 2 years was 3% (95% confidence interval, 1%-10%). The 2-year odds of recurrence or distant metastasis was 23% (95% CI, 16%-32%).
Dr. Lucci said that he suspects that many surgeons avoid resection of inflammatory breast cancer lesions under the assumption that the disease is metastatic in nature and fear that an attempt at local control would put the patient through unnecessary surgery with little benefit.
The new study challenges that belief. “I think this is a changing paradigm. We have to consider that those patients need to be thought of as still resectable and think about getting rid of that local disease, at the very least to improve their quality of life and hopefully to improve their overall outcome,” Dr. Lucci said.
The results should be readily achievable in other centers, he added. “If they have a plastic surgeon who’s willing to help them, they can resect to negative margins just as well [as in noninflammatory patients]. And, if they have a radiation therapist who’s dedicated to doing a more aggressive course, they can achieve the same results.”
Dr. Rosso and Dr. Lucci reported having no financial disclosures.
LAS VEGAS – In patients with nonmetastatic inflammatory breast cancer (IBC), aggressive surgical resection can reduce local/regional recurrence rates to levels comparable to those seen in patients with noninflammatory breast cancer.
The key to the improved outcome is the presence of a plastic surgeon who can help close a tricky incision. “We have a multidisciplinary team that allows us to call upon the plastic surgeons if we can’t control the incision, and they help us with a flap closure,” said Kelly Rosso, MD, a breast surgical oncology fellow at the MD Anderson Cancer Center, Houston, who presented the study results at the annual meeting of the American Society of Breast Surgeons.
To see if their surgical interventions were producing better outcomes, the team analyzed data from 114 patients with nonmetastatic inflammatory breast cancer who had received trimodality therapy (neoadjuvant chemotherapy, surgery, and radiation therapy) from 2007 to 2015.
The median patient age was 52 years, and the median follow-up period was 3.6 years. In total, 55% of patients had N2 IBC, and 45% had N3 disease.
Nearly all (113 of 114) patients had negative surgical margins. A total of 29 patients died during the follow-up period, and the 5-year survival rate was 69%. The odds of a local/regional recurrence over 2 years was 3% (95% confidence interval, 1%-10%). The 2-year odds of recurrence or distant metastasis was 23% (95% CI, 16%-32%).
Dr. Lucci said that he suspects that many surgeons avoid resection of inflammatory breast cancer lesions under the assumption that the disease is metastatic in nature and fear that an attempt at local control would put the patient through unnecessary surgery with little benefit.
The new study challenges that belief. “I think this is a changing paradigm. We have to consider that those patients need to be thought of as still resectable and think about getting rid of that local disease, at the very least to improve their quality of life and hopefully to improve their overall outcome,” Dr. Lucci said.
The results should be readily achievable in other centers, he added. “If they have a plastic surgeon who’s willing to help them, they can resect to negative margins just as well [as in noninflammatory patients]. And, if they have a radiation therapist who’s dedicated to doing a more aggressive course, they can achieve the same results.”
Dr. Rosso and Dr. Lucci reported having no financial disclosures.
LAS VEGAS – In patients with nonmetastatic inflammatory breast cancer (IBC), aggressive surgical resection can reduce local/regional recurrence rates to levels comparable to those seen in patients with noninflammatory breast cancer.
The key to the improved outcome is the presence of a plastic surgeon who can help close a tricky incision. “We have a multidisciplinary team that allows us to call upon the plastic surgeons if we can’t control the incision, and they help us with a flap closure,” said Kelly Rosso, MD, a breast surgical oncology fellow at the MD Anderson Cancer Center, Houston, who presented the study results at the annual meeting of the American Society of Breast Surgeons.
To see if their surgical interventions were producing better outcomes, the team analyzed data from 114 patients with nonmetastatic inflammatory breast cancer who had received trimodality therapy (neoadjuvant chemotherapy, surgery, and radiation therapy) from 2007 to 2015.
The median patient age was 52 years, and the median follow-up period was 3.6 years. In total, 55% of patients had N2 IBC, and 45% had N3 disease.
Nearly all (113 of 114) patients had negative surgical margins. A total of 29 patients died during the follow-up period, and the 5-year survival rate was 69%. The odds of a local/regional recurrence over 2 years was 3% (95% confidence interval, 1%-10%). The 2-year odds of recurrence or distant metastasis was 23% (95% CI, 16%-32%).
Dr. Lucci said that he suspects that many surgeons avoid resection of inflammatory breast cancer lesions under the assumption that the disease is metastatic in nature and fear that an attempt at local control would put the patient through unnecessary surgery with little benefit.
The new study challenges that belief. “I think this is a changing paradigm. We have to consider that those patients need to be thought of as still resectable and think about getting rid of that local disease, at the very least to improve their quality of life and hopefully to improve their overall outcome,” Dr. Lucci said.
The results should be readily achievable in other centers, he added. “If they have a plastic surgeon who’s willing to help them, they can resect to negative margins just as well [as in noninflammatory patients]. And, if they have a radiation therapist who’s dedicated to doing a more aggressive course, they can achieve the same results.”
Dr. Rosso and Dr. Lucci reported having no financial disclosures.
At ASBS 2017
Key clinical point:
Major finding: The odds of a local/regional recurrence over 2 years were 3%.
Data source: A retrospective analysis of 114 patients.
Disclosures: Dr. Rosso and Dr. Lucci reported having no financial disclosures.