Surgical Oncology

WASHINGTON (IMNG) – A British study suggests that it is experience, not specialty, that makes the endoscopist.

The review of more than 2,000 colonoscopies performed in 1 year determined that gastroenterologists and surgeons had identical colonoscopy completion and adverse-event outcomes, Dr. Camille Yvon reported at the annual congress of the American College of Surgeons.

Dr. Yvon, of the Medway Maritime NHS Hospital in Gillingham, England, reported the results of an audit conducted at the Kent facility from March 2011 to March 2012. It was based on prospectively collected data and was designed to compare clinical outcomes among a group of 10 physicians who were performing endoscopies during that time. Included were five consultant colorectal surgeons, one senior trust grade surgeon, and four consultant gastroenterologists.

All of the clinicians were certified by the U.K. Joint Advisory Group on Endoscopy (JAG). The group requires clinicians to complete a mentored training period and to meet specific safety and quality standards, including the following:

• 90% completion rate for colonoscopies (entering the cecum).

• Adenoma detection rate more than 10%.

• Polyp recovery more than 90%.

• Good-quality bowel prep more than 90%.

• Colonoscopy perforation rate less than 1/1,000.

• Postpolypectomy bleeding requiring transfusion less than 1/100.

• Postpolypectomy perforation rate less than 1/500.

• Flexible sigmoidoscopy perforation rate less than 1/5,000.

To become JAG accredited, physicians must be supervised by an accredited physician while performing at least 200 procedures, 100 of which were in the past year; 75% must have been colonoscopies. Certification assessment is done by two different people on two different occasions.

The audit comprised 2,058 colonoscopies. The measured outcomes were number of colonoscopies per clinician, cecal intubation rate of at least 90%, perforation rate of less than 1/1,000, and a less than 1/100 rate of postpolypectomy bleeding requiring a transfusion.

Of the total number of colonoscopies, 1,237 were done by the surgeons and the rest by the gastroenterologists. Clinicians performed an average of 205 procedures per year (range, 105-448 per year). Gastroenterologists performed an average of 205 per year, while surgeons performed an average of 206.

The overall cecal intubation rate was 94%. The average rate for both surgeons and gastroenterologists was also 94%.

There were no perforations during the study period. There were two instances of severe postpolypectomy bleeding (0.09%). However, Dr. Yvon reported, the number was too small for any meaningful statistical analysis.

Dr. Yvon had no financial disclosures.

[email protected]

WASHINGTON (IMNG) – A British study suggests that it is experience, not specialty, that makes the endoscopist.

The review of more than 2,000 colonoscopies performed in 1 year determined that gastroenterologists and surgeons had identical colonoscopy completion and adverse-event outcomes, Dr. Camille Yvon reported at the annual congress of the American College of Surgeons.

Dr. Yvon, of the Medway Maritime NHS Hospital in Gillingham, England, reported the results of an audit conducted at the Kent facility from March 2011 to March 2012. It was based on prospectively collected data and was designed to compare clinical outcomes among a group of 10 physicians who were performing endoscopies during that time. Included were five consultant colorectal surgeons, one senior trust grade surgeon, and four consultant gastroenterologists.

All of the clinicians were certified by the U.K. Joint Advisory Group on Endoscopy (JAG). The group requires clinicians to complete a mentored training period and to meet specific safety and quality standards, including the following:

• 90% completion rate for colonoscopies (entering the cecum).

• Adenoma detection rate more than 10%.

• Polyp recovery more than 90%.

• Good-quality bowel prep more than 90%.

• Colonoscopy perforation rate less than 1/1,000.

• Postpolypectomy bleeding requiring transfusion less than 1/100.

• Postpolypectomy perforation rate less than 1/500.

• Flexible sigmoidoscopy perforation rate less than 1/5,000.

To become JAG accredited, physicians must be supervised by an accredited physician while performing at least 200 procedures, 100 of which were in the past year; 75% must have been colonoscopies. Certification assessment is done by two different people on two different occasions.

The audit comprised 2,058 colonoscopies. The measured outcomes were number of colonoscopies per clinician, cecal intubation rate of at least 90%, perforation rate of less than 1/1,000, and a less than 1/100 rate of postpolypectomy bleeding requiring a transfusion.

Of the total number of colonoscopies, 1,237 were done by the surgeons and the rest by the gastroenterologists. Clinicians performed an average of 205 procedures per year (range, 105-448 per year). Gastroenterologists performed an average of 205 per year, while surgeons performed an average of 206.

The overall cecal intubation rate was 94%. The average rate for both surgeons and gastroenterologists was also 94%.

There were no perforations during the study period. There were two instances of severe postpolypectomy bleeding (0.09%). However, Dr. Yvon reported, the number was too small for any meaningful statistical analysis.

Dr. Yvon had no financial disclosures.

[email protected]

WASHINGTON (IMNG) – A British study suggests that it is experience, not specialty, that makes the endoscopist.

The review of more than 2,000 colonoscopies performed in 1 year determined that gastroenterologists and surgeons had identical colonoscopy completion and adverse-event outcomes, Dr. Camille Yvon reported at the annual congress of the American College of Surgeons.

Dr. Yvon, of the Medway Maritime NHS Hospital in Gillingham, England, reported the results of an audit conducted at the Kent facility from March 2011 to March 2012. It was based on prospectively collected data and was designed to compare clinical outcomes among a group of 10 physicians who were performing endoscopies during that time. Included were five consultant colorectal surgeons, one senior trust grade surgeon, and four consultant gastroenterologists.

All of the clinicians were certified by the U.K. Joint Advisory Group on Endoscopy (JAG). The group requires clinicians to complete a mentored training period and to meet specific safety and quality standards, including the following:

• 90% completion rate for colonoscopies (entering the cecum).

• Adenoma detection rate more than 10%.

• Polyp recovery more than 90%.

• Good-quality bowel prep more than 90%.

• Colonoscopy perforation rate less than 1/1,000.

• Postpolypectomy bleeding requiring transfusion less than 1/100.

• Postpolypectomy perforation rate less than 1/500.

• Flexible sigmoidoscopy perforation rate less than 1/5,000.

To become JAG accredited, physicians must be supervised by an accredited physician while performing at least 200 procedures, 100 of which were in the past year; 75% must have been colonoscopies. Certification assessment is done by two different people on two different occasions.

The audit comprised 2,058 colonoscopies. The measured outcomes were number of colonoscopies per clinician, cecal intubation rate of at least 90%, perforation rate of less than 1/1,000, and a less than 1/100 rate of postpolypectomy bleeding requiring a transfusion.

Of the total number of colonoscopies, 1,237 were done by the surgeons and the rest by the gastroenterologists. Clinicians performed an average of 205 procedures per year (range, 105-448 per year). Gastroenterologists performed an average of 205 per year, while surgeons performed an average of 206.

The overall cecal intubation rate was 94%. The average rate for both surgeons and gastroenterologists was also 94%.

There were no perforations during the study period. There were two instances of severe postpolypectomy bleeding (0.09%). However, Dr. Yvon reported, the number was too small for any meaningful statistical analysis.

Dr. Yvon had no financial disclosures.

[email protected]

Rates of contralateral prophylactic mastectomy in breast cancer are on the rise, but are clinical indications always present to justify the procedure? Dr. Todd Tuttle discusses the trend and cautions physicians to provide patients with accurate assessments of cancer risk and the procedure's actual effects on life expectancy..

Rates of contralateral prophylactic mastectomy in breast cancer are on the rise, but are clinical indications always present to justify the procedure? Dr. Todd Tuttle discusses the trend and cautions physicians to provide patients with accurate assessments of cancer risk and the procedure's actual effects on life expectancy..

Rates of contralateral prophylactic mastectomy in breast cancer are on the rise, but are clinical indications always present to justify the procedure? Dr. Todd Tuttle discusses the trend and cautions physicians to provide patients with accurate assessments of cancer risk and the procedure's actual effects on life expectancy..

SAN FRANCISCO – Dermatologists and dermatologic surgeons risk a decreased reimbursement value for Mohs surgery if they don’t review the published criteria on its appropriate use, according to Dr. Sumaira Aasi.

Although it can be difficult, it is worth the effort to convince some patients that electrodessication, a curettage procedure, or some other management strategy is appropriate for their skin lesions, she said at the annual meeting of the Pacific Dermatologic Association.

"The reason is, at the end of the day, we might be killing the goose that laid the golden egg ourselves" if too many Mohs surgeries are done for inappropriate reasons, said Dr. Aasi of Stanford (Calif.) University.

SDr. Aasi urged the audience at the meeting to study criteria published in 2012 for the appropriate use of Mohs surgery, and to pay particular attention to scenarios deemed inappropriate for the procedure (J. Am. Acad. Dermatol. 2012;67:531-50).

There are an estimated 4 million nonmelanoma skin cancers in the United States each year, and the use of Mohs surgery increased by 400% from 1995 to 2009, Dr. Aasi said (Dermatol. Clin. 2012;30:167-75).

Some experts argue that the increase is a response to the increase in skin cancer cases, and others say the increasing number of Mohs surgeons is driving the rising rate of the procedure. "Regardless, it’s a problem," Dr. Aasi said.

Federal reimbursement programs don’t care if there is an epidemic of skin cancer, she said. If a surgery is being "overused," it is considered overvalued, and reimbursement rates are subject to change, she explained.

The top two CPT codes flagged by the federal government as potentially misvalued in the July 19, 2013, Federal Register were codes 17311 for Mohs surgery on the face, head, and neck and 17313 for Mohs surgery on the trunk and extremities, Dr. Aasi noted.

The 2012 appropriate-use criteria were created to help maintain the value of Mohs surgery in Medicare reimbursements, Dr. Aasi said. The American Academy of Dermatology, the American Society of Dermatologic Surgery, the American College of Mohs Surgery, and the American Society of Mohs Surgery convened a consensus panel of eight Mohs surgeons and nine non-Mohs surgeons. The panel considered 270 clinical scenarios and rated 74% appropriate for Mohs surgery, 17% inappropriate, and 9% uncertain, meaning there were conflicting data in the literature or not enough information to make a determination of the appropriateness of Mohs surgery in that scenario.

"I still think that Mohs surgeons in this panel were a little highly represented," Dr. Aasi said. Overall, the indications the panel deemed appropriate for Mohs surgery were "pretty generous," she added.

The consensus panel was asked to implicitly consider cost in deciding on the appropriateness of Mohs surgery for each scenario. "It’s an implicit consideration but a very important consideration," said Dr. Aasi.

Invasive melanoma was not included in the scenarios because if its complexity, but some scenarios did include melanoma in situ or lentigo maligna melanoma. The scenarios included different body areas, aggressive or nonaggressive skin cancers, tumor size, and the patient’s immune status. Agreement by at least 12 panel members was considered a consensus on the use of Mohs surgery.

Examples of scenarios that were considered inappropriate for Mohs surgery included nonaggressive basal cell or squamous cell carcinomas smaller than 2 cm on the trunk or extremities. Other lesions deemed inappropriate for Mohs included primary actinic keratosis (AK) with focal squamous cell cancer in situ, bowenoid AK, or squamous cell carcinoma in situ AK-type, labels that Dr. Aasi found "worrisome" because their definitions are unclear.

"As a Mohs surgeon, I found it a little surprising that they had to consider scenarios where actinic keratoses were being considered a possibility for Mohs surgery," she said.

Physicians can use the appropriate-use criteria to talk with other health care providers, third-party payers, and patients, said Dr. Aasi. Talking with patients can be most difficult, because if they’ve heard of Mohs surgery, they often want "the technique where I [the patient] know right away that I’m going to be clear," she said.

When Mohs surgery is inappropriate, "I try to convince them that, no, you don’t need it. It’s like an atomic bomb being used to kill a flea," she said.

The appropriate-use criteria do not compare different treatment modalities with Mohs surgery, Dr. Aasi emphasized, but they aim to state simply whether or not Mohs surgery would be appropriate in selected scenarios.

"I urge everyone to read" the criteria, she said.

Dr. Aasi reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Dermatologists and dermatologic surgeons risk a decreased reimbursement value for Mohs surgery if they don’t review the published criteria on its appropriate use, according to Dr. Sumaira Aasi.

Although it can be difficult, it is worth the effort to convince some patients that electrodessication, a curettage procedure, or some other management strategy is appropriate for their skin lesions, she said at the annual meeting of the Pacific Dermatologic Association.

"The reason is, at the end of the day, we might be killing the goose that laid the golden egg ourselves" if too many Mohs surgeries are done for inappropriate reasons, said Dr. Aasi of Stanford (Calif.) University.

SDr. Aasi urged the audience at the meeting to study criteria published in 2012 for the appropriate use of Mohs surgery, and to pay particular attention to scenarios deemed inappropriate for the procedure (J. Am. Acad. Dermatol. 2012;67:531-50).

There are an estimated 4 million nonmelanoma skin cancers in the United States each year, and the use of Mohs surgery increased by 400% from 1995 to 2009, Dr. Aasi said (Dermatol. Clin. 2012;30:167-75).

Some experts argue that the increase is a response to the increase in skin cancer cases, and others say the increasing number of Mohs surgeons is driving the rising rate of the procedure. "Regardless, it’s a problem," Dr. Aasi said.

Federal reimbursement programs don’t care if there is an epidemic of skin cancer, she said. If a surgery is being "overused," it is considered overvalued, and reimbursement rates are subject to change, she explained.

The top two CPT codes flagged by the federal government as potentially misvalued in the July 19, 2013, Federal Register were codes 17311 for Mohs surgery on the face, head, and neck and 17313 for Mohs surgery on the trunk and extremities, Dr. Aasi noted.

The 2012 appropriate-use criteria were created to help maintain the value of Mohs surgery in Medicare reimbursements, Dr. Aasi said. The American Academy of Dermatology, the American Society of Dermatologic Surgery, the American College of Mohs Surgery, and the American Society of Mohs Surgery convened a consensus panel of eight Mohs surgeons and nine non-Mohs surgeons. The panel considered 270 clinical scenarios and rated 74% appropriate for Mohs surgery, 17% inappropriate, and 9% uncertain, meaning there were conflicting data in the literature or not enough information to make a determination of the appropriateness of Mohs surgery in that scenario.

"I still think that Mohs surgeons in this panel were a little highly represented," Dr. Aasi said. Overall, the indications the panel deemed appropriate for Mohs surgery were "pretty generous," she added.

The consensus panel was asked to implicitly consider cost in deciding on the appropriateness of Mohs surgery for each scenario. "It’s an implicit consideration but a very important consideration," said Dr. Aasi.

Invasive melanoma was not included in the scenarios because if its complexity, but some scenarios did include melanoma in situ or lentigo maligna melanoma. The scenarios included different body areas, aggressive or nonaggressive skin cancers, tumor size, and the patient’s immune status. Agreement by at least 12 panel members was considered a consensus on the use of Mohs surgery.

Examples of scenarios that were considered inappropriate for Mohs surgery included nonaggressive basal cell or squamous cell carcinomas smaller than 2 cm on the trunk or extremities. Other lesions deemed inappropriate for Mohs included primary actinic keratosis (AK) with focal squamous cell cancer in situ, bowenoid AK, or squamous cell carcinoma in situ AK-type, labels that Dr. Aasi found "worrisome" because their definitions are unclear.

"As a Mohs surgeon, I found it a little surprising that they had to consider scenarios where actinic keratoses were being considered a possibility for Mohs surgery," she said.

Physicians can use the appropriate-use criteria to talk with other health care providers, third-party payers, and patients, said Dr. Aasi. Talking with patients can be most difficult, because if they’ve heard of Mohs surgery, they often want "the technique where I [the patient] know right away that I’m going to be clear," she said.

When Mohs surgery is inappropriate, "I try to convince them that, no, you don’t need it. It’s like an atomic bomb being used to kill a flea," she said.

The appropriate-use criteria do not compare different treatment modalities with Mohs surgery, Dr. Aasi emphasized, but they aim to state simply whether or not Mohs surgery would be appropriate in selected scenarios.

"I urge everyone to read" the criteria, she said.

Dr. Aasi reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Dermatologists and dermatologic surgeons risk a decreased reimbursement value for Mohs surgery if they don’t review the published criteria on its appropriate use, according to Dr. Sumaira Aasi.

Although it can be difficult, it is worth the effort to convince some patients that electrodessication, a curettage procedure, or some other management strategy is appropriate for their skin lesions, she said at the annual meeting of the Pacific Dermatologic Association.

"The reason is, at the end of the day, we might be killing the goose that laid the golden egg ourselves" if too many Mohs surgeries are done for inappropriate reasons, said Dr. Aasi of Stanford (Calif.) University.

SDr. Aasi urged the audience at the meeting to study criteria published in 2012 for the appropriate use of Mohs surgery, and to pay particular attention to scenarios deemed inappropriate for the procedure (J. Am. Acad. Dermatol. 2012;67:531-50).

There are an estimated 4 million nonmelanoma skin cancers in the United States each year, and the use of Mohs surgery increased by 400% from 1995 to 2009, Dr. Aasi said (Dermatol. Clin. 2012;30:167-75).

Some experts argue that the increase is a response to the increase in skin cancer cases, and others say the increasing number of Mohs surgeons is driving the rising rate of the procedure. "Regardless, it’s a problem," Dr. Aasi said.

Federal reimbursement programs don’t care if there is an epidemic of skin cancer, she said. If a surgery is being "overused," it is considered overvalued, and reimbursement rates are subject to change, she explained.

The top two CPT codes flagged by the federal government as potentially misvalued in the July 19, 2013, Federal Register were codes 17311 for Mohs surgery on the face, head, and neck and 17313 for Mohs surgery on the trunk and extremities, Dr. Aasi noted.

The 2012 appropriate-use criteria were created to help maintain the value of Mohs surgery in Medicare reimbursements, Dr. Aasi said. The American Academy of Dermatology, the American Society of Dermatologic Surgery, the American College of Mohs Surgery, and the American Society of Mohs Surgery convened a consensus panel of eight Mohs surgeons and nine non-Mohs surgeons. The panel considered 270 clinical scenarios and rated 74% appropriate for Mohs surgery, 17% inappropriate, and 9% uncertain, meaning there were conflicting data in the literature or not enough information to make a determination of the appropriateness of Mohs surgery in that scenario.

"I still think that Mohs surgeons in this panel were a little highly represented," Dr. Aasi said. Overall, the indications the panel deemed appropriate for Mohs surgery were "pretty generous," she added.

The consensus panel was asked to implicitly consider cost in deciding on the appropriateness of Mohs surgery for each scenario. "It’s an implicit consideration but a very important consideration," said Dr. Aasi.

Invasive melanoma was not included in the scenarios because if its complexity, but some scenarios did include melanoma in situ or lentigo maligna melanoma. The scenarios included different body areas, aggressive or nonaggressive skin cancers, tumor size, and the patient’s immune status. Agreement by at least 12 panel members was considered a consensus on the use of Mohs surgery.

Examples of scenarios that were considered inappropriate for Mohs surgery included nonaggressive basal cell or squamous cell carcinomas smaller than 2 cm on the trunk or extremities. Other lesions deemed inappropriate for Mohs included primary actinic keratosis (AK) with focal squamous cell cancer in situ, bowenoid AK, or squamous cell carcinoma in situ AK-type, labels that Dr. Aasi found "worrisome" because their definitions are unclear.

"As a Mohs surgeon, I found it a little surprising that they had to consider scenarios where actinic keratoses were being considered a possibility for Mohs surgery," she said.

Physicians can use the appropriate-use criteria to talk with other health care providers, third-party payers, and patients, said Dr. Aasi. Talking with patients can be most difficult, because if they’ve heard of Mohs surgery, they often want "the technique where I [the patient] know right away that I’m going to be clear," she said.

When Mohs surgery is inappropriate, "I try to convince them that, no, you don’t need it. It’s like an atomic bomb being used to kill a flea," she said.

The appropriate-use criteria do not compare different treatment modalities with Mohs surgery, Dr. Aasi emphasized, but they aim to state simply whether or not Mohs surgery would be appropriate in selected scenarios.

"I urge everyone to read" the criteria, she said.

Dr. Aasi reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

The false-negative rate of sentinel lymph node results was almost 13% after neoadjuvant chemotherapy, in a study of women initially presenting with biopsy-proven node-positive breast cancer, which is above the acceptable threshold, a study has shown.

Considering the threshold for a false-negative rate is 10%, "changes in approach and patient selection that result in greater sensitivity would be necessary" to support the use of sentinel lymph node (SLN) surgery "as an alternative" to axillary lymph node dissection in this population of patients with breast cancer, concluded Dr. Judy Boughey of the department of surgery, Mayo Clinic, Rochester, Minn., and her associates in the Alliance for Clinical Trials in Oncology.

The investigators also found that false-negative SLN biopsy results were significantly lower when two mapping agents were used; the false-negative rate was also significantly lower when at least three sentinel lymph nodes were sampled. The results of the study were presented at the annual clinical congress of the American Congress of Surgeons and simultaneously published online on Oct. 7, 2013, in JAMA (doi:10.1001/jama.2013.278932).

The phase II study addressed the false-negative rate of SLN biopsy after neoadjuvant chemotherapy, in women who initially presented with pathologically confirmed node-positive disease. The study enrolled 701 women from July 2009 to June 2011, at 136 institutions. The women had clinical stage T0 through T4, N1 through N2, M0 breast cancer; most (663) had cN1 disease (disease in movable axillary lymph nodes) and 38 had cN2 disease (disease in fixed or matted axillary lymph nodes). After chemotherapy was completed, the patients had surgery, involving SLN biopsy and axillary lymph node dissection.

Of the 701 women, 687 underwent both SLN biopsy and axillary lymph node dissection, 2 had only SLN biopsy, and 12 had axillary lymph node dissection only. Most of the 689 women who underwent SLN biopsy had the procedure performed with blue dye and radiolabeled colloid (79%), 116 (16.8%) had radiolabeled colloid only, and 28 (4.1%) had blue dye only.

Of the 689 women who had SLN biopsy, at least one SLN was detected in 639 (almost 93%). Among the 651 women with cN1 disease, at least one SLN was detected in 605 women (93%); and among the 38 women with cN2 disease, at least one SNL was detected in 34 (89.5%).

In 525 of the patients with cN1 disease, at least two SLNs were excised and axillary lymph node dissection was completed. There was no residual node disease found in 215 of these patients, for a nodal pathologic complete response rate of 41%.

Of the remaining 310 patients, nodal disease was found in the sentinel lymph nodes in 108 patients (20.6%), and in both axillary and sentinel nodes in 163 patients (31.1%).

Residual node disease was found in the axillary lymph nodes of only 39 (7.4%) of the patients. Therefore, the results of the SLN biopsy results were false negative in 39 of the 310 patients, for a false negative rate of 12.6%.

While the study results "suggest that surgeons cannot reliably detect all axillary lymph node metastases in patients with cN1 breast cancer following chemotherapy" with SLN procedures, "we did identify important factors influencing the likelihood of a false-negative SLN," the authors said. The false-negative rate for the SLN biopsy results was significantly decreased when both blue dye and radiolabeled colloid were used as mapping agents, and when at least three sentinel lymph nodes were biopsied.

When both blue dye and radiolabeled colloid were used, the false-negative rate was 10.8%, compared with 20.3% when only one agent was used. "Using two mapping agents with different molecule sizes and transit times is an important surgical standard that should be adhered to for SLN surgery after chemotherapy," they said, noting that after chemotherapy, "the axilla often has more fibrosis, making evaluation of lymphatic drainage and surgical dissection more challenging."

And when at least three SLNs were examined, the false negative rate was 9.1%, compared with 21.1% when two were sampled. "As the accuracy of any sampling test is dependent on the amount of material sampled, these results are not surprising," they said, noting that this has been found in other studies.

SLN is less invasive than axillary dissection and is considered a reliable way to check for axillary nodal disease in women who present with node-negative disease, but the use of SLN biopsy after neoadjuvant chemotherapy in women with cN1 disease "has been questioned," because the false-negative rate for this approach in this population has ranged from 7% to 25% in small studies, the only data available on this approach, according to the authors.

The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group (ACOSOG). The patients were in the ACOSOG Z1071 trial. Four of the authors reported having grants from the National Institutes of Health or Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures from LifeCell. The remaining 17 authors said they had no relevant financial disclosures.

[email protected]

The false-negative rate of sentinel lymph node results was almost 13% after neoadjuvant chemotherapy, in a study of women initially presenting with biopsy-proven node-positive breast cancer, which is above the acceptable threshold, a study has shown.

Considering the threshold for a false-negative rate is 10%, "changes in approach and patient selection that result in greater sensitivity would be necessary" to support the use of sentinel lymph node (SLN) surgery "as an alternative" to axillary lymph node dissection in this population of patients with breast cancer, concluded Dr. Judy Boughey of the department of surgery, Mayo Clinic, Rochester, Minn., and her associates in the Alliance for Clinical Trials in Oncology.

The investigators also found that false-negative SLN biopsy results were significantly lower when two mapping agents were used; the false-negative rate was also significantly lower when at least three sentinel lymph nodes were sampled. The results of the study were presented at the annual clinical congress of the American Congress of Surgeons and simultaneously published online on Oct. 7, 2013, in JAMA (doi:10.1001/jama.2013.278932).

The phase II study addressed the false-negative rate of SLN biopsy after neoadjuvant chemotherapy, in women who initially presented with pathologically confirmed node-positive disease. The study enrolled 701 women from July 2009 to June 2011, at 136 institutions. The women had clinical stage T0 through T4, N1 through N2, M0 breast cancer; most (663) had cN1 disease (disease in movable axillary lymph nodes) and 38 had cN2 disease (disease in fixed or matted axillary lymph nodes). After chemotherapy was completed, the patients had surgery, involving SLN biopsy and axillary lymph node dissection.

Of the 701 women, 687 underwent both SLN biopsy and axillary lymph node dissection, 2 had only SLN biopsy, and 12 had axillary lymph node dissection only. Most of the 689 women who underwent SLN biopsy had the procedure performed with blue dye and radiolabeled colloid (79%), 116 (16.8%) had radiolabeled colloid only, and 28 (4.1%) had blue dye only.

Of the 689 women who had SLN biopsy, at least one SLN was detected in 639 (almost 93%). Among the 651 women with cN1 disease, at least one SLN was detected in 605 women (93%); and among the 38 women with cN2 disease, at least one SNL was detected in 34 (89.5%).

In 525 of the patients with cN1 disease, at least two SLNs were excised and axillary lymph node dissection was completed. There was no residual node disease found in 215 of these patients, for a nodal pathologic complete response rate of 41%.

Of the remaining 310 patients, nodal disease was found in the sentinel lymph nodes in 108 patients (20.6%), and in both axillary and sentinel nodes in 163 patients (31.1%).

Residual node disease was found in the axillary lymph nodes of only 39 (7.4%) of the patients. Therefore, the results of the SLN biopsy results were false negative in 39 of the 310 patients, for a false negative rate of 12.6%.

While the study results "suggest that surgeons cannot reliably detect all axillary lymph node metastases in patients with cN1 breast cancer following chemotherapy" with SLN procedures, "we did identify important factors influencing the likelihood of a false-negative SLN," the authors said. The false-negative rate for the SLN biopsy results was significantly decreased when both blue dye and radiolabeled colloid were used as mapping agents, and when at least three sentinel lymph nodes were biopsied.

When both blue dye and radiolabeled colloid were used, the false-negative rate was 10.8%, compared with 20.3% when only one agent was used. "Using two mapping agents with different molecule sizes and transit times is an important surgical standard that should be adhered to for SLN surgery after chemotherapy," they said, noting that after chemotherapy, "the axilla often has more fibrosis, making evaluation of lymphatic drainage and surgical dissection more challenging."

And when at least three SLNs were examined, the false negative rate was 9.1%, compared with 21.1% when two were sampled. "As the accuracy of any sampling test is dependent on the amount of material sampled, these results are not surprising," they said, noting that this has been found in other studies.

SLN is less invasive than axillary dissection and is considered a reliable way to check for axillary nodal disease in women who present with node-negative disease, but the use of SLN biopsy after neoadjuvant chemotherapy in women with cN1 disease "has been questioned," because the false-negative rate for this approach in this population has ranged from 7% to 25% in small studies, the only data available on this approach, according to the authors.

The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group (ACOSOG). The patients were in the ACOSOG Z1071 trial. Four of the authors reported having grants from the National Institutes of Health or Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures from LifeCell. The remaining 17 authors said they had no relevant financial disclosures.

[email protected]

The false-negative rate of sentinel lymph node results was almost 13% after neoadjuvant chemotherapy, in a study of women initially presenting with biopsy-proven node-positive breast cancer, which is above the acceptable threshold, a study has shown.

Considering the threshold for a false-negative rate is 10%, "changes in approach and patient selection that result in greater sensitivity would be necessary" to support the use of sentinel lymph node (SLN) surgery "as an alternative" to axillary lymph node dissection in this population of patients with breast cancer, concluded Dr. Judy Boughey of the department of surgery, Mayo Clinic, Rochester, Minn., and her associates in the Alliance for Clinical Trials in Oncology.

The investigators also found that false-negative SLN biopsy results were significantly lower when two mapping agents were used; the false-negative rate was also significantly lower when at least three sentinel lymph nodes were sampled. The results of the study were presented at the annual clinical congress of the American Congress of Surgeons and simultaneously published online on Oct. 7, 2013, in JAMA (doi:10.1001/jama.2013.278932).

The phase II study addressed the false-negative rate of SLN biopsy after neoadjuvant chemotherapy, in women who initially presented with pathologically confirmed node-positive disease. The study enrolled 701 women from July 2009 to June 2011, at 136 institutions. The women had clinical stage T0 through T4, N1 through N2, M0 breast cancer; most (663) had cN1 disease (disease in movable axillary lymph nodes) and 38 had cN2 disease (disease in fixed or matted axillary lymph nodes). After chemotherapy was completed, the patients had surgery, involving SLN biopsy and axillary lymph node dissection.

Of the 701 women, 687 underwent both SLN biopsy and axillary lymph node dissection, 2 had only SLN biopsy, and 12 had axillary lymph node dissection only. Most of the 689 women who underwent SLN biopsy had the procedure performed with blue dye and radiolabeled colloid (79%), 116 (16.8%) had radiolabeled colloid only, and 28 (4.1%) had blue dye only.

Of the 689 women who had SLN biopsy, at least one SLN was detected in 639 (almost 93%). Among the 651 women with cN1 disease, at least one SLN was detected in 605 women (93%); and among the 38 women with cN2 disease, at least one SNL was detected in 34 (89.5%).

In 525 of the patients with cN1 disease, at least two SLNs were excised and axillary lymph node dissection was completed. There was no residual node disease found in 215 of these patients, for a nodal pathologic complete response rate of 41%.

Of the remaining 310 patients, nodal disease was found in the sentinel lymph nodes in 108 patients (20.6%), and in both axillary and sentinel nodes in 163 patients (31.1%).

Residual node disease was found in the axillary lymph nodes of only 39 (7.4%) of the patients. Therefore, the results of the SLN biopsy results were false negative in 39 of the 310 patients, for a false negative rate of 12.6%.

While the study results "suggest that surgeons cannot reliably detect all axillary lymph node metastases in patients with cN1 breast cancer following chemotherapy" with SLN procedures, "we did identify important factors influencing the likelihood of a false-negative SLN," the authors said. The false-negative rate for the SLN biopsy results was significantly decreased when both blue dye and radiolabeled colloid were used as mapping agents, and when at least three sentinel lymph nodes were biopsied.

When both blue dye and radiolabeled colloid were used, the false-negative rate was 10.8%, compared with 20.3% when only one agent was used. "Using two mapping agents with different molecule sizes and transit times is an important surgical standard that should be adhered to for SLN surgery after chemotherapy," they said, noting that after chemotherapy, "the axilla often has more fibrosis, making evaluation of lymphatic drainage and surgical dissection more challenging."

And when at least three SLNs were examined, the false negative rate was 9.1%, compared with 21.1% when two were sampled. "As the accuracy of any sampling test is dependent on the amount of material sampled, these results are not surprising," they said, noting that this has been found in other studies.

SLN is less invasive than axillary dissection and is considered a reliable way to check for axillary nodal disease in women who present with node-negative disease, but the use of SLN biopsy after neoadjuvant chemotherapy in women with cN1 disease "has been questioned," because the false-negative rate for this approach in this population has ranged from 7% to 25% in small studies, the only data available on this approach, according to the authors.

The study was supported by a grant from the National Cancer Institute to the American College of Surgeons Oncology Group (ACOSOG). The patients were in the ACOSOG Z1071 trial. Four of the authors reported having grants from the National Institutes of Health or Komen Foundation, having contracts with Galena BioPharma, or having been paid for lectures from LifeCell. The remaining 17 authors said they had no relevant financial disclosures.

[email protected]

SAN FRANCISCO – The distance of a breast cancer from a woman’s nipple added to the ability of nomograms to predict sentinel lymph node positivity, based on a study of data from 401 breast cancers.

The data came from 395 patients who had clinical stage T1 (85% of the cohort) or T2 tumors and underwent prebiopsy ultrasounds at the Mayo Clinic, Rochester, Minn. The investigators performed a second review of the images to measure the tumors’ distance from the nipple.

Nomograms published online by the Memorial Sloan-Kettering Cancer Center and by the University of Texas M.D. Anderson Cancer Center do a reasonably good job of discriminating which newly diagnosed breast cancer patients who have not undergone neoadjuvant therapy are likely to have positive and negative sentinel nodes. Using those two nomograms alone on the patients in the study produced an area under the curve (AUC) of 0.71 for the Memorial Sloan-Kettering nomogram and 0.74 for the M.D. Anderson nomogram. Adding a tumor-to-nipple distance of 2 cm or less improved the AUCs to 0.73 and 0.76, respectively, Dr. Miraj Shah-Khan and her coinvestigators reported.

Sentinel lymph nodes were positive in 20% of the 401 tumors; 17 of 33 tumors within 2 cm of the nipple had positive sentinel lymph nodes (52%), compared with 17% of 368 tumors farther than 2 cm from the nipple, Dr. Shah-Khan, of the Medical College of Wisconsin, Milwaukee, and her associates reported in a poster presented at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In each subgroup of probability predicted by the nomograms, tumor-to-nipple distance helped to refine the probability of a positive node.

When the Memorial Sloan-Kettering nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 35%, compared with 11% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 62% if a tumor was within 2 cm of the nipple or 29% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 32% if it was farther away.

When the M.D. Anderson nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 42%, compared with 14% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 83% if a tumor was within 2 cm of the nipple or 40% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 67% if it was farther away, she reported.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Shah-Khan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The distance of a breast cancer from a woman’s nipple added to the ability of nomograms to predict sentinel lymph node positivity, based on a study of data from 401 breast cancers.

The data came from 395 patients who had clinical stage T1 (85% of the cohort) or T2 tumors and underwent prebiopsy ultrasounds at the Mayo Clinic, Rochester, Minn. The investigators performed a second review of the images to measure the tumors’ distance from the nipple.

Nomograms published online by the Memorial Sloan-Kettering Cancer Center and by the University of Texas M.D. Anderson Cancer Center do a reasonably good job of discriminating which newly diagnosed breast cancer patients who have not undergone neoadjuvant therapy are likely to have positive and negative sentinel nodes. Using those two nomograms alone on the patients in the study produced an area under the curve (AUC) of 0.71 for the Memorial Sloan-Kettering nomogram and 0.74 for the M.D. Anderson nomogram. Adding a tumor-to-nipple distance of 2 cm or less improved the AUCs to 0.73 and 0.76, respectively, Dr. Miraj Shah-Khan and her coinvestigators reported.

Sentinel lymph nodes were positive in 20% of the 401 tumors; 17 of 33 tumors within 2 cm of the nipple had positive sentinel lymph nodes (52%), compared with 17% of 368 tumors farther than 2 cm from the nipple, Dr. Shah-Khan, of the Medical College of Wisconsin, Milwaukee, and her associates reported in a poster presented at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In each subgroup of probability predicted by the nomograms, tumor-to-nipple distance helped to refine the probability of a positive node.

When the Memorial Sloan-Kettering nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 35%, compared with 11% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 62% if a tumor was within 2 cm of the nipple or 29% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 32% if it was farther away.

When the M.D. Anderson nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 42%, compared with 14% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 83% if a tumor was within 2 cm of the nipple or 40% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 67% if it was farther away, she reported.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Shah-Khan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The distance of a breast cancer from a woman’s nipple added to the ability of nomograms to predict sentinel lymph node positivity, based on a study of data from 401 breast cancers.

The data came from 395 patients who had clinical stage T1 (85% of the cohort) or T2 tumors and underwent prebiopsy ultrasounds at the Mayo Clinic, Rochester, Minn. The investigators performed a second review of the images to measure the tumors’ distance from the nipple.

Nomograms published online by the Memorial Sloan-Kettering Cancer Center and by the University of Texas M.D. Anderson Cancer Center do a reasonably good job of discriminating which newly diagnosed breast cancer patients who have not undergone neoadjuvant therapy are likely to have positive and negative sentinel nodes. Using those two nomograms alone on the patients in the study produced an area under the curve (AUC) of 0.71 for the Memorial Sloan-Kettering nomogram and 0.74 for the M.D. Anderson nomogram. Adding a tumor-to-nipple distance of 2 cm or less improved the AUCs to 0.73 and 0.76, respectively, Dr. Miraj Shah-Khan and her coinvestigators reported.

Sentinel lymph nodes were positive in 20% of the 401 tumors; 17 of 33 tumors within 2 cm of the nipple had positive sentinel lymph nodes (52%), compared with 17% of 368 tumors farther than 2 cm from the nipple, Dr. Shah-Khan, of the Medical College of Wisconsin, Milwaukee, and her associates reported in a poster presented at a breast cancer symposium sponsored by the American Society of Clinical Oncology.

In each subgroup of probability predicted by the nomograms, tumor-to-nipple distance helped to refine the probability of a positive node.

When the Memorial Sloan-Kettering nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 35%, compared with 11% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 62% if a tumor was within 2 cm of the nipple or 29% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 32% if it was farther away.

When the M.D. Anderson nomogram predicted less than a 25% chance of node positivity, adding a tumor-to-nipple distance of 2 cm or less changed the probability to 42%, compared with 14% if the distance was greater than 2 cm. A probability of 25%-49% from the same nomogram changed to 83% if a tumor was within 2 cm of the nipple or 40% for tumors farther from the nipple. A probability of 50% or greater from the nomogram changed to 100% if a tumor was within 2 cm of the nipple or 67% if it was farther away, she reported.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Shah-Khan reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

ATLANTA – Five common radiation therapy practices are not adequately supported by evidence and may not be the best choice for many patients, radiation oncology experts said at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The evidence-based recommendations on radiation therapy for breast cancer, prostate cancer, and bone metastases are part of the national "Choosing Wisely" campaign, which is aimed at improving the quality of care by reducing or eliminating overuse of tests and procedures. This campaign is about "removal of waste to improve quality and safety, and doing no harm to patients," said Daniel Wolfson, executive vice president and chief operating officer of the American Board of Internal Medicine (ABIM) Foundation, which is leading the Choosing Wisely campaign.

Medical societies in various disciplines have released recommendations geared toward individual clinical disciplines, and now it’s ASTRO’s turn, said Dr. Michael L. Steinberg, chairman of ASTRO’s board of directors, in a briefing announcing the guidelines. "The list serves only as a starting point for a detailed conversation between a patient and physician, and to ensure patient-centered care, which is a core principle of ASTRO."

The five recommendations are:

• Don’t initiate whole-breast radiotherapy as a part of breast conservation therapy in women aged 50 years and older with early-stage invasive breast cancer without considering shorter treatment schedules.

"We’ve known for years that whole-breast radiation improves local control and improves survival, and has cosmetic advantages over mastectomy," Dr. Steinberg said. In recent years, however, randomized clinical trials have demonstrated that shorter courses of therapy – less than 4 weeks, compared with 5 weeks for conventionally fractionated radiation – produce equivalent tumor control and cosmetic outcomes.

• Don’t initiate management of patients who have low-risk prostate cancer without discussing active surveillance.

Patients with low-risk prostate cancer should discuss "reasonable management options" with their physicians, including active surveillance. With this recommendation, ASTRO is "reinforcing the shared decision-making model," Dr. Steinberg said.

• Don’t routinely use extended fractionation schemes (more than 10 fractions) for palliation of bone metastases.

Patients with bone metastases may derive equivalent pain relief from 30 Gy in 10 fractions, 20 Gy over 5 fractions, or even a single 8-Gy fraction, studies suggest. The single-fraction option is more convenient for patients, but it may be associated with a marginally higher need for retreatment of the same site. Patients who are not ambulatory, have transportation problems, or a limited prognosis may be good candidates for the single-fraction option, the guidelines say.

• Don’t routinely recommend proton-beam therapy for prostate cancer outside of a prospective clinical trial or registry.

"There is no clear evidence that proton-beam therapy for prostate cancer offers any clinical advantage over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive therapy," the Choosing Wisely guidelines state.

At ASTRO 2012, investigators reported that men who receive proton-beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient. In addition, proton-beam therapy is estimated to cost about 70% more than external-beam radiotherapy for the treatment of prostate cancer.

• Don’t routinely use intensity-modulated radiation therapy (IMRT) to deliver whole-breast radiotherapy as part of breast conservation therapy.

"Clinical trials have suggested lower rates of skin toxicity after using modern 3D conformal techniques relative to older methods of 2D planning. In these trials, the term ‘IMRT’ has generally been applied to describe methods that are more accurately defined as field-in-field 3D conformal radiotherapy. While IMRT may be of benefit in select cases where the anatomy is unusual, its routine use has not been demonstrated to provide significant clinical advantage," the guidelines note.

The cost difference between 3D conformal radiotherapy and IMRT for whole-breast radiotherapy is approximately $7,000, according to Dr. Steinberg.

"These are not ‘never do this’ recommendations, these are ‘engage the patient in the shared-decision paradigm’ guidelines, because there may be patients that are better treated with, let’s say, IMRT [for whole-breast radiotherapy]," he said.

Asked whether the Choosing Wisely guidelines in radiation oncology and other disciplines might be used by insurers to justify denying reimbursement for certain procedures, Mr. Wolfson said that "we haven’t seen that, and whether it comes to be will be the question, but we would sharply criticize that [approach]."

ATLANTA – Five common radiation therapy practices are not adequately supported by evidence and may not be the best choice for many patients, radiation oncology experts said at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The evidence-based recommendations on radiation therapy for breast cancer, prostate cancer, and bone metastases are part of the national "Choosing Wisely" campaign, which is aimed at improving the quality of care by reducing or eliminating overuse of tests and procedures. This campaign is about "removal of waste to improve quality and safety, and doing no harm to patients," said Daniel Wolfson, executive vice president and chief operating officer of the American Board of Internal Medicine (ABIM) Foundation, which is leading the Choosing Wisely campaign.

Medical societies in various disciplines have released recommendations geared toward individual clinical disciplines, and now it’s ASTRO’s turn, said Dr. Michael L. Steinberg, chairman of ASTRO’s board of directors, in a briefing announcing the guidelines. "The list serves only as a starting point for a detailed conversation between a patient and physician, and to ensure patient-centered care, which is a core principle of ASTRO."

The five recommendations are:

• Don’t initiate whole-breast radiotherapy as a part of breast conservation therapy in women aged 50 years and older with early-stage invasive breast cancer without considering shorter treatment schedules.

"We’ve known for years that whole-breast radiation improves local control and improves survival, and has cosmetic advantages over mastectomy," Dr. Steinberg said. In recent years, however, randomized clinical trials have demonstrated that shorter courses of therapy – less than 4 weeks, compared with 5 weeks for conventionally fractionated radiation – produce equivalent tumor control and cosmetic outcomes.

• Don’t initiate management of patients who have low-risk prostate cancer without discussing active surveillance.

Patients with low-risk prostate cancer should discuss "reasonable management options" with their physicians, including active surveillance. With this recommendation, ASTRO is "reinforcing the shared decision-making model," Dr. Steinberg said.

• Don’t routinely use extended fractionation schemes (more than 10 fractions) for palliation of bone metastases.

Patients with bone metastases may derive equivalent pain relief from 30 Gy in 10 fractions, 20 Gy over 5 fractions, or even a single 8-Gy fraction, studies suggest. The single-fraction option is more convenient for patients, but it may be associated with a marginally higher need for retreatment of the same site. Patients who are not ambulatory, have transportation problems, or a limited prognosis may be good candidates for the single-fraction option, the guidelines say.

• Don’t routinely recommend proton-beam therapy for prostate cancer outside of a prospective clinical trial or registry.

"There is no clear evidence that proton-beam therapy for prostate cancer offers any clinical advantage over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive therapy," the Choosing Wisely guidelines state.

At ASTRO 2012, investigators reported that men who receive proton-beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient. In addition, proton-beam therapy is estimated to cost about 70% more than external-beam radiotherapy for the treatment of prostate cancer.

• Don’t routinely use intensity-modulated radiation therapy (IMRT) to deliver whole-breast radiotherapy as part of breast conservation therapy.

"Clinical trials have suggested lower rates of skin toxicity after using modern 3D conformal techniques relative to older methods of 2D planning. In these trials, the term ‘IMRT’ has generally been applied to describe methods that are more accurately defined as field-in-field 3D conformal radiotherapy. While IMRT may be of benefit in select cases where the anatomy is unusual, its routine use has not been demonstrated to provide significant clinical advantage," the guidelines note.

The cost difference between 3D conformal radiotherapy and IMRT for whole-breast radiotherapy is approximately $7,000, according to Dr. Steinberg.

"These are not ‘never do this’ recommendations, these are ‘engage the patient in the shared-decision paradigm’ guidelines, because there may be patients that are better treated with, let’s say, IMRT [for whole-breast radiotherapy]," he said.

Asked whether the Choosing Wisely guidelines in radiation oncology and other disciplines might be used by insurers to justify denying reimbursement for certain procedures, Mr. Wolfson said that "we haven’t seen that, and whether it comes to be will be the question, but we would sharply criticize that [approach]."

ATLANTA – Five common radiation therapy practices are not adequately supported by evidence and may not be the best choice for many patients, radiation oncology experts said at the annual meeting of the American Society for Radiation Oncology (ASTRO).

The evidence-based recommendations on radiation therapy for breast cancer, prostate cancer, and bone metastases are part of the national "Choosing Wisely" campaign, which is aimed at improving the quality of care by reducing or eliminating overuse of tests and procedures. This campaign is about "removal of waste to improve quality and safety, and doing no harm to patients," said Daniel Wolfson, executive vice president and chief operating officer of the American Board of Internal Medicine (ABIM) Foundation, which is leading the Choosing Wisely campaign.

Medical societies in various disciplines have released recommendations geared toward individual clinical disciplines, and now it’s ASTRO’s turn, said Dr. Michael L. Steinberg, chairman of ASTRO’s board of directors, in a briefing announcing the guidelines. "The list serves only as a starting point for a detailed conversation between a patient and physician, and to ensure patient-centered care, which is a core principle of ASTRO."

The five recommendations are:

• Don’t initiate whole-breast radiotherapy as a part of breast conservation therapy in women aged 50 years and older with early-stage invasive breast cancer without considering shorter treatment schedules.

"We’ve known for years that whole-breast radiation improves local control and improves survival, and has cosmetic advantages over mastectomy," Dr. Steinberg said. In recent years, however, randomized clinical trials have demonstrated that shorter courses of therapy – less than 4 weeks, compared with 5 weeks for conventionally fractionated radiation – produce equivalent tumor control and cosmetic outcomes.

• Don’t initiate management of patients who have low-risk prostate cancer without discussing active surveillance.

Patients with low-risk prostate cancer should discuss "reasonable management options" with their physicians, including active surveillance. With this recommendation, ASTRO is "reinforcing the shared decision-making model," Dr. Steinberg said.

• Don’t routinely use extended fractionation schemes (more than 10 fractions) for palliation of bone metastases.

Patients with bone metastases may derive equivalent pain relief from 30 Gy in 10 fractions, 20 Gy over 5 fractions, or even a single 8-Gy fraction, studies suggest. The single-fraction option is more convenient for patients, but it may be associated with a marginally higher need for retreatment of the same site. Patients who are not ambulatory, have transportation problems, or a limited prognosis may be good candidates for the single-fraction option, the guidelines say.

• Don’t routinely recommend proton-beam therapy for prostate cancer outside of a prospective clinical trial or registry.

"There is no clear evidence that proton-beam therapy for prostate cancer offers any clinical advantage over other forms of definitive radiation therapy. Clinical trials are necessary to establish a possible advantage of this expensive therapy," the Choosing Wisely guidelines state.

At ASTRO 2012, investigators reported that men who receive proton-beam radiotherapy for prostate cancer have modestly better bowel function in the short term than do those who receive conformal or intensity-modulated radiation, but the effect is transient. In addition, proton-beam therapy is estimated to cost about 70% more than external-beam radiotherapy for the treatment of prostate cancer.

• Don’t routinely use intensity-modulated radiation therapy (IMRT) to deliver whole-breast radiotherapy as part of breast conservation therapy.

"Clinical trials have suggested lower rates of skin toxicity after using modern 3D conformal techniques relative to older methods of 2D planning. In these trials, the term ‘IMRT’ has generally been applied to describe methods that are more accurately defined as field-in-field 3D conformal radiotherapy. While IMRT may be of benefit in select cases where the anatomy is unusual, its routine use has not been demonstrated to provide significant clinical advantage," the guidelines note.

The cost difference between 3D conformal radiotherapy and IMRT for whole-breast radiotherapy is approximately $7,000, according to Dr. Steinberg.

"These are not ‘never do this’ recommendations, these are ‘engage the patient in the shared-decision paradigm’ guidelines, because there may be patients that are better treated with, let’s say, IMRT [for whole-breast radiotherapy]," he said.

Asked whether the Choosing Wisely guidelines in radiation oncology and other disciplines might be used by insurers to justify denying reimbursement for certain procedures, Mr. Wolfson said that "we haven’t seen that, and whether it comes to be will be the question, but we would sharply criticize that [approach]."

SAN FRANCISCO – A change in the status of any breast cancer tumor biomarker after neoadjuvant therapy was independently associated with a 37% decreased likelihood of recurrence in 5 years, a multivariate analysis showed.

The subtyping of breast cancer by receptor status changed in 41% of 398 samples between the initial tumor and residual disease after neoadjuvant chemotherapy.

In patients with any change in the status of estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), after neoadjuvant chemotherapy, 63% were relapse free 5 years later as compared with 48% of patients with no receptor change, a significant difference.

Overall survival at 5 years, however, did not differ significantly based on receptor status change, Dr. Napa Parinyanitikul and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology. At 5 years, 73% of patients with a receptor status change and 63% with no change were alive.

The study analyzed data on patients treated at her institution in 1992-2012 who had tumor biomarker results from pretreatment biopsies and from samples of residual disease after neoadjuvant chemotherapy. Most patients in the study were white, with clinical stage II or III disease.

Of the tumors, 49% were hormone receptor–positive and HER2 negative; 18% were HER2 positive, and 33% were negative for all three receptors (triple-negative breast cancer). Neoadjuvant chemotherapy consisted of a taxane-based regimen in 10%, an anthracycline-based regimen in 19%, an anthracycline/taxane-based regimen in 71%, and trastuzumab-based chemotherapy in 49%. The 88% of patients with hormone receptor-positive disease received adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor.

After a median of 40 months of follow-up, 32% of women had died and 42% had a recurrence of breast cancer, reported Dr. Parinyanitikul, a fellow at the University of Texas MD Anderson Cancer Center, Houston.

The likelihood of receptor status changes differed significantly by the subtype of breast cancer. Of hormone receptor–positive cancers, 51% had a change in receptor status, compared with 27% of HER2-positive cancers and 22% of triple-negative breast cancers.

Other factors did not significantly affect the likelihood of receptor status change, including patient age or race, histology, tumor stage or grade, the presence of lymphovascular invasion, or the class of neoadjuvant chemotherapeutic agents.

Of ER-positive tumors, 11% changed to ER negative after neoadjuvant chemotherapy; of ER-negative tumors, 21% changed to ER positive. Of the PR-positive tumors, 35% changed to PR-negative; of PR-negative tumors, 12% changed to PR positive. Of HER2-positive tumors, 40% changed to HER2 negative; of HER2-negative tumors, 3% changed to HER2 positive. Among 35 patients treated with trastuzumab, the HER2 status changed in 16 (46%).

Patients who had tumors with an ER-negative status that did not change had the worst 5-year rates for overall survival (47%) and relapse-free survival (40%), compared with patients whose tumors had an ER-positive status did not change (81% overall survival and 63% relapse-free survival), patients whose ER status changed from positive to negative (67% and 66% survival rates, respectively), and patients whose ER status changed from negative to positive (75% and 59%, respectively).

Similarly, patients who had PR-negative tumors whose status did not change had significantly lower rates of overall survival (51%) and relapse-free survival (41%), compared with patients whose PR-positive tumor status did not change (87% and 67%, respectively), those who changed from PR positive to PR negative (78% and 73%, respectively), and patients whose PR-negative status changed to PR positive (69% and 55%, respectively).

Changes or lack of change in HER2 subgroups were not significantly associated with varying outcomes.

The investigators also looked at the absolute percent changes in ER or PR status using cutoffs in 10% increments from 10% to 50%. The 5-year overall survival rate was significantly greater in ER-positive patients who had at least a 20% change in ER status, compared with those with less than a 20% change (87% vs. 73%, respectively). The 5-year relapse-free survival rate also was significantly greater if the ER status changed by at least 20% (71%), compared with smaller ER changes (59%).

Of cancers that were hormone receptor–positive and HER2 negative before neoadjuvant chemotherapy, 20% changed to HER2-positive or triple-negative breast cancer after treatment, 12% of tumors that had been HER2 positive changed to triple negative tumors, and 2% of triple negative breast cancers changed to HER2-positive after treatment. These changes produced only one significant effect on outcomes: 5-year overall survival rates were significantly lower in patients who changed from HER2-positive to triple-negative breast cancer (23%), compared with those whose HER2-positive cancer did not change to triple negative (71%).

Larger prospective studies are needed to confirm the findings and to determine any impact of biomarker changes on long-term survival, she said.

Previous studies have reported discordance in hormone receptor status in up to 51% of breast cancers between the primary tumor and residual disease and changes in HER2 status in up to 43% of cases. Conclusions about associations between changes in receptor status and clinical outcomes have been inconsistent.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Parinyanitikul reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A change in the status of any breast cancer tumor biomarker after neoadjuvant therapy was independently associated with a 37% decreased likelihood of recurrence in 5 years, a multivariate analysis showed.

The subtyping of breast cancer by receptor status changed in 41% of 398 samples between the initial tumor and residual disease after neoadjuvant chemotherapy.

In patients with any change in the status of estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), after neoadjuvant chemotherapy, 63% were relapse free 5 years later as compared with 48% of patients with no receptor change, a significant difference.

Overall survival at 5 years, however, did not differ significantly based on receptor status change, Dr. Napa Parinyanitikul and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology. At 5 years, 73% of patients with a receptor status change and 63% with no change were alive.

The study analyzed data on patients treated at her institution in 1992-2012 who had tumor biomarker results from pretreatment biopsies and from samples of residual disease after neoadjuvant chemotherapy. Most patients in the study were white, with clinical stage II or III disease.

Of the tumors, 49% were hormone receptor–positive and HER2 negative; 18% were HER2 positive, and 33% were negative for all three receptors (triple-negative breast cancer). Neoadjuvant chemotherapy consisted of a taxane-based regimen in 10%, an anthracycline-based regimen in 19%, an anthracycline/taxane-based regimen in 71%, and trastuzumab-based chemotherapy in 49%. The 88% of patients with hormone receptor-positive disease received adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor.

After a median of 40 months of follow-up, 32% of women had died and 42% had a recurrence of breast cancer, reported Dr. Parinyanitikul, a fellow at the University of Texas MD Anderson Cancer Center, Houston.

The likelihood of receptor status changes differed significantly by the subtype of breast cancer. Of hormone receptor–positive cancers, 51% had a change in receptor status, compared with 27% of HER2-positive cancers and 22% of triple-negative breast cancers.

Other factors did not significantly affect the likelihood of receptor status change, including patient age or race, histology, tumor stage or grade, the presence of lymphovascular invasion, or the class of neoadjuvant chemotherapeutic agents.

Of ER-positive tumors, 11% changed to ER negative after neoadjuvant chemotherapy; of ER-negative tumors, 21% changed to ER positive. Of the PR-positive tumors, 35% changed to PR-negative; of PR-negative tumors, 12% changed to PR positive. Of HER2-positive tumors, 40% changed to HER2 negative; of HER2-negative tumors, 3% changed to HER2 positive. Among 35 patients treated with trastuzumab, the HER2 status changed in 16 (46%).

Patients who had tumors with an ER-negative status that did not change had the worst 5-year rates for overall survival (47%) and relapse-free survival (40%), compared with patients whose tumors had an ER-positive status did not change (81% overall survival and 63% relapse-free survival), patients whose ER status changed from positive to negative (67% and 66% survival rates, respectively), and patients whose ER status changed from negative to positive (75% and 59%, respectively).

Similarly, patients who had PR-negative tumors whose status did not change had significantly lower rates of overall survival (51%) and relapse-free survival (41%), compared with patients whose PR-positive tumor status did not change (87% and 67%, respectively), those who changed from PR positive to PR negative (78% and 73%, respectively), and patients whose PR-negative status changed to PR positive (69% and 55%, respectively).

Changes or lack of change in HER2 subgroups were not significantly associated with varying outcomes.

The investigators also looked at the absolute percent changes in ER or PR status using cutoffs in 10% increments from 10% to 50%. The 5-year overall survival rate was significantly greater in ER-positive patients who had at least a 20% change in ER status, compared with those with less than a 20% change (87% vs. 73%, respectively). The 5-year relapse-free survival rate also was significantly greater if the ER status changed by at least 20% (71%), compared with smaller ER changes (59%).

Of cancers that were hormone receptor–positive and HER2 negative before neoadjuvant chemotherapy, 20% changed to HER2-positive or triple-negative breast cancer after treatment, 12% of tumors that had been HER2 positive changed to triple negative tumors, and 2% of triple negative breast cancers changed to HER2-positive after treatment. These changes produced only one significant effect on outcomes: 5-year overall survival rates were significantly lower in patients who changed from HER2-positive to triple-negative breast cancer (23%), compared with those whose HER2-positive cancer did not change to triple negative (71%).

Larger prospective studies are needed to confirm the findings and to determine any impact of biomarker changes on long-term survival, she said.

Previous studies have reported discordance in hormone receptor status in up to 51% of breast cancers between the primary tumor and residual disease and changes in HER2 status in up to 43% of cases. Conclusions about associations between changes in receptor status and clinical outcomes have been inconsistent.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Parinyanitikul reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A change in the status of any breast cancer tumor biomarker after neoadjuvant therapy was independently associated with a 37% decreased likelihood of recurrence in 5 years, a multivariate analysis showed.

The subtyping of breast cancer by receptor status changed in 41% of 398 samples between the initial tumor and residual disease after neoadjuvant chemotherapy.

In patients with any change in the status of estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), after neoadjuvant chemotherapy, 63% were relapse free 5 years later as compared with 48% of patients with no receptor change, a significant difference.

Overall survival at 5 years, however, did not differ significantly based on receptor status change, Dr. Napa Parinyanitikul and her associates reported at a breast cancer symposium sponsored by the American Society of Clinical Oncology. At 5 years, 73% of patients with a receptor status change and 63% with no change were alive.

The study analyzed data on patients treated at her institution in 1992-2012 who had tumor biomarker results from pretreatment biopsies and from samples of residual disease after neoadjuvant chemotherapy. Most patients in the study were white, with clinical stage II or III disease.

Of the tumors, 49% were hormone receptor–positive and HER2 negative; 18% were HER2 positive, and 33% were negative for all three receptors (triple-negative breast cancer). Neoadjuvant chemotherapy consisted of a taxane-based regimen in 10%, an anthracycline-based regimen in 19%, an anthracycline/taxane-based regimen in 71%, and trastuzumab-based chemotherapy in 49%. The 88% of patients with hormone receptor-positive disease received adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor.

After a median of 40 months of follow-up, 32% of women had died and 42% had a recurrence of breast cancer, reported Dr. Parinyanitikul, a fellow at the University of Texas MD Anderson Cancer Center, Houston.

The likelihood of receptor status changes differed significantly by the subtype of breast cancer. Of hormone receptor–positive cancers, 51% had a change in receptor status, compared with 27% of HER2-positive cancers and 22% of triple-negative breast cancers.

Other factors did not significantly affect the likelihood of receptor status change, including patient age or race, histology, tumor stage or grade, the presence of lymphovascular invasion, or the class of neoadjuvant chemotherapeutic agents.

Of ER-positive tumors, 11% changed to ER negative after neoadjuvant chemotherapy; of ER-negative tumors, 21% changed to ER positive. Of the PR-positive tumors, 35% changed to PR-negative; of PR-negative tumors, 12% changed to PR positive. Of HER2-positive tumors, 40% changed to HER2 negative; of HER2-negative tumors, 3% changed to HER2 positive. Among 35 patients treated with trastuzumab, the HER2 status changed in 16 (46%).

Patients who had tumors with an ER-negative status that did not change had the worst 5-year rates for overall survival (47%) and relapse-free survival (40%), compared with patients whose tumors had an ER-positive status did not change (81% overall survival and 63% relapse-free survival), patients whose ER status changed from positive to negative (67% and 66% survival rates, respectively), and patients whose ER status changed from negative to positive (75% and 59%, respectively).

Similarly, patients who had PR-negative tumors whose status did not change had significantly lower rates of overall survival (51%) and relapse-free survival (41%), compared with patients whose PR-positive tumor status did not change (87% and 67%, respectively), those who changed from PR positive to PR negative (78% and 73%, respectively), and patients whose PR-negative status changed to PR positive (69% and 55%, respectively).

Changes or lack of change in HER2 subgroups were not significantly associated with varying outcomes.

The investigators also looked at the absolute percent changes in ER or PR status using cutoffs in 10% increments from 10% to 50%. The 5-year overall survival rate was significantly greater in ER-positive patients who had at least a 20% change in ER status, compared with those with less than a 20% change (87% vs. 73%, respectively). The 5-year relapse-free survival rate also was significantly greater if the ER status changed by at least 20% (71%), compared with smaller ER changes (59%).

Of cancers that were hormone receptor–positive and HER2 negative before neoadjuvant chemotherapy, 20% changed to HER2-positive or triple-negative breast cancer after treatment, 12% of tumors that had been HER2 positive changed to triple negative tumors, and 2% of triple negative breast cancers changed to HER2-positive after treatment. These changes produced only one significant effect on outcomes: 5-year overall survival rates were significantly lower in patients who changed from HER2-positive to triple-negative breast cancer (23%), compared with those whose HER2-positive cancer did not change to triple negative (71%).

Larger prospective studies are needed to confirm the findings and to determine any impact of biomarker changes on long-term survival, she said.

Previous studies have reported discordance in hormone receptor status in up to 51% of breast cancers between the primary tumor and residual disease and changes in HER2 status in up to 43% of cases. Conclusions about associations between changes in receptor status and clinical outcomes have been inconsistent.

The symposium was cosponsored by the American Society of Breast Disease, the American Society of Breast Surgeons, the National Consortium of Breast Centers, the Society of Surgical Oncology, and the American Society for Radiation Oncology.

Dr. Parinyanitikul reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

LEBANON, N.H. – Medicare patients with advanced cancer are more likely to receive hospice care than in previous years, although it is still too late in their treatment to deliver the full benefits of palliative care, according to a report issued by the Dartmouth Institute for Health Policy and Clinical Practice.

The report also states that geography and the treatment styles favored by individual health systems, rather than patient preferences, drive the level of intensive, end-of-life treatments used.

The findings are part of the Dartmouth Atlas Project, which uses Medicare data to examine how health care resources are allocated nationally. The report is the institute’s first longitudinal analysis of trends in end-of-life care for advanced cancer patients across regions, academic medical centers, and National Cancer Institute–designated cancer centers.

Controlling for patient age, sex, race, tumor type, and non–cancer-related comorbidities, the investigators found that, when compared with similar data collected from 2003 to 2007 and published by the institute in 2010, the number of advanced cancer patients on Medicare dying in the hospital decreased by an average of 28.8% during 2003-2007 to 24.7% in 2010. An increase from 54.6% to 61.3% in the number of patients who were enrolled in hospice in the last month of life was also found. The number of patients for whom hospice was initiated during the last 3 days of life increased from 8.3% during 2003-2007 to 10.9% in 2010.

When asked in an interview about the importance of starting hospice sooner in terminal care, Dr. Lorenzo Norris, director of psycho-oncology services at George Washington University Medical Center in Washington, said, "The biggest misconception is that hospice is strictly for end of life. Palliative care is just good medicine. If you limit the hospice care to the last 3 days, you’ve already limited the options a patient has. If you offer palliative care 5 or 6 months out, you can start reducing symptom burdens and increase a patient’s quality of life, which is very important because during that last year to 6 months is when patients are finishing unresolved financial and relationship issues. Palliative care allows them to more fully engage in their life."

When viewed according to the medical center delivering the care, between 13% and 50% of Medicare patients with advanced cancer died in a hospital in 2010, rather than in a hospice setting – typically the patient’s home. These figures include data from NCI-designated cancer centers. Hospice treatment in the last month of life for patients treated in mid- and northwestern states such as Oregon and Iowa trended as much as nearly 50% higher than in places such as Alaska and New York City.

Addressing the reasons for regional variations in care, Dr. Ira Byock, director of palliative medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., wrote in an accompanying editorial that, "Previous research has also shown that regional supply of health care resources, such as hospital and intensive care beds and imaging equipment, is one driver of the intensity of care, irrespective of the patient’s particular condition or illness level."

The analysts found the overall rate of ICU admissions for treatments such as intubation, a feeding tube, or cardiopulmonary resuscitation during the last month of life increased from 23.7% in the period between 2003 and 2007 to 28.8% in 2010. The number of days patients spent in the ICU in the last month of life varied more than fivefold across all centers, the analysts wrote.

"Our research continues to find that patients with advanced cancer are often receiving aggressive care until their final days, when we know that most patients would prefer care directed toward a better quality of life through hospice and palliative services. The increase in patients admitted to hospice care only days before death suggests that hospice services are often provided too late to provide much benefit," Dr. David C. Goodman, coprincipal investigator for the Dartmouth Atlas Project, said in a statement.

When asked why some oncologists are not referring their patients to hospice sooner, Dr. Clifford Hudis, president of the American Society of Clinical Oncology said, "There are many circumstances, based on culture, family dynamics, and patient’s wishes, where it is hard to communicate the value of hospice services. Some patients remain fearful of the very word and, in some situations, there is an unwillingness to acknowledge the severity of illnesses. These barriers can often be overcome through an increase in communication between doctors and patients about care goals and wishes."

When asked about the potential economic implications of the data, Dr. Goodman said, "The goal of better end-of-life care is to improve patient well-being. Often, it is less expensive to provide good care that patients want, [rather] than the usual care that patients receive."

The report also indicated that the number of patients who saw 10 or more different physicians during the last six months of their lives rose from 46.2% to 58.5%. The analysts interpreted this to mean "more patients may have experienced fragmented care."

In a statement Dr. Hudis encouraged the oncology community to "keep striving to deliver the right care at the right time." In an e-mail interview, Dr. Hudis wrote that, "The overall trend is a good one because it is concordant with the overall goals of ASCO: to make sure that every patient has access to the highest quality care throughout their disease experience."

Dr. Goodman and Dr. Byock report no relevant disclosures. The report was principally funded by the Robert Wood Johnson Foundation, with support from a consortium of funders including the WellPoint Foundation, the United Health Foundation, and the California HealthCare Foundation.

[email protected]

LEBANON, N.H. – Medicare patients with advanced cancer are more likely to receive hospice care than in previous years, although it is still too late in their treatment to deliver the full benefits of palliative care, according to a report issued by the Dartmouth Institute for Health Policy and Clinical Practice.

The report also states that geography and the treatment styles favored by individual health systems, rather than patient preferences, drive the level of intensive, end-of-life treatments used.

The findings are part of the Dartmouth Atlas Project, which uses Medicare data to examine how health care resources are allocated nationally. The report is the institute’s first longitudinal analysis of trends in end-of-life care for advanced cancer patients across regions, academic medical centers, and National Cancer Institute–designated cancer centers.

Controlling for patient age, sex, race, tumor type, and non–cancer-related comorbidities, the investigators found that, when compared with similar data collected from 2003 to 2007 and published by the institute in 2010, the number of advanced cancer patients on Medicare dying in the hospital decreased by an average of 28.8% during 2003-2007 to 24.7% in 2010. An increase from 54.6% to 61.3% in the number of patients who were enrolled in hospice in the last month of life was also found. The number of patients for whom hospice was initiated during the last 3 days of life increased from 8.3% during 2003-2007 to 10.9% in 2010.

When asked in an interview about the importance of starting hospice sooner in terminal care, Dr. Lorenzo Norris, director of psycho-oncology services at George Washington University Medical Center in Washington, said, "The biggest misconception is that hospice is strictly for end of life. Palliative care is just good medicine. If you limit the hospice care to the last 3 days, you’ve already limited the options a patient has. If you offer palliative care 5 or 6 months out, you can start reducing symptom burdens and increase a patient’s quality of life, which is very important because during that last year to 6 months is when patients are finishing unresolved financial and relationship issues. Palliative care allows them to more fully engage in their life."

When viewed according to the medical center delivering the care, between 13% and 50% of Medicare patients with advanced cancer died in a hospital in 2010, rather than in a hospice setting – typically the patient’s home. These figures include data from NCI-designated cancer centers. Hospice treatment in the last month of life for patients treated in mid- and northwestern states such as Oregon and Iowa trended as much as nearly 50% higher than in places such as Alaska and New York City.

Addressing the reasons for regional variations in care, Dr. Ira Byock, director of palliative medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., wrote in an accompanying editorial that, "Previous research has also shown that regional supply of health care resources, such as hospital and intensive care beds and imaging equipment, is one driver of the intensity of care, irrespective of the patient’s particular condition or illness level."

The analysts found the overall rate of ICU admissions for treatments such as intubation, a feeding tube, or cardiopulmonary resuscitation during the last month of life increased from 23.7% in the period between 2003 and 2007 to 28.8% in 2010. The number of days patients spent in the ICU in the last month of life varied more than fivefold across all centers, the analysts wrote.

"Our research continues to find that patients with advanced cancer are often receiving aggressive care until their final days, when we know that most patients would prefer care directed toward a better quality of life through hospice and palliative services. The increase in patients admitted to hospice care only days before death suggests that hospice services are often provided too late to provide much benefit," Dr. David C. Goodman, coprincipal investigator for the Dartmouth Atlas Project, said in a statement.

When asked why some oncologists are not referring their patients to hospice sooner, Dr. Clifford Hudis, president of the American Society of Clinical Oncology said, "There are many circumstances, based on culture, family dynamics, and patient’s wishes, where it is hard to communicate the value of hospice services. Some patients remain fearful of the very word and, in some situations, there is an unwillingness to acknowledge the severity of illnesses. These barriers can often be overcome through an increase in communication between doctors and patients about care goals and wishes."

When asked about the potential economic implications of the data, Dr. Goodman said, "The goal of better end-of-life care is to improve patient well-being. Often, it is less expensive to provide good care that patients want, [rather] than the usual care that patients receive."

The report also indicated that the number of patients who saw 10 or more different physicians during the last six months of their lives rose from 46.2% to 58.5%. The analysts interpreted this to mean "more patients may have experienced fragmented care."

In a statement Dr. Hudis encouraged the oncology community to "keep striving to deliver the right care at the right time." In an e-mail interview, Dr. Hudis wrote that, "The overall trend is a good one because it is concordant with the overall goals of ASCO: to make sure that every patient has access to the highest quality care throughout their disease experience."

Dr. Goodman and Dr. Byock report no relevant disclosures. The report was principally funded by the Robert Wood Johnson Foundation, with support from a consortium of funders including the WellPoint Foundation, the United Health Foundation, and the California HealthCare Foundation.

[email protected]

LEBANON, N.H. – Medicare patients with advanced cancer are more likely to receive hospice care than in previous years, although it is still too late in their treatment to deliver the full benefits of palliative care, according to a report issued by the Dartmouth Institute for Health Policy and Clinical Practice.

The report also states that geography and the treatment styles favored by individual health systems, rather than patient preferences, drive the level of intensive, end-of-life treatments used.

The findings are part of the Dartmouth Atlas Project, which uses Medicare data to examine how health care resources are allocated nationally. The report is the institute’s first longitudinal analysis of trends in end-of-life care for advanced cancer patients across regions, academic medical centers, and National Cancer Institute–designated cancer centers.

Controlling for patient age, sex, race, tumor type, and non–cancer-related comorbidities, the investigators found that, when compared with similar data collected from 2003 to 2007 and published by the institute in 2010, the number of advanced cancer patients on Medicare dying in the hospital decreased by an average of 28.8% during 2003-2007 to 24.7% in 2010. An increase from 54.6% to 61.3% in the number of patients who were enrolled in hospice in the last month of life was also found. The number of patients for whom hospice was initiated during the last 3 days of life increased from 8.3% during 2003-2007 to 10.9% in 2010.

When asked in an interview about the importance of starting hospice sooner in terminal care, Dr. Lorenzo Norris, director of psycho-oncology services at George Washington University Medical Center in Washington, said, "The biggest misconception is that hospice is strictly for end of life. Palliative care is just good medicine. If you limit the hospice care to the last 3 days, you’ve already limited the options a patient has. If you offer palliative care 5 or 6 months out, you can start reducing symptom burdens and increase a patient’s quality of life, which is very important because during that last year to 6 months is when patients are finishing unresolved financial and relationship issues. Palliative care allows them to more fully engage in their life."

When viewed according to the medical center delivering the care, between 13% and 50% of Medicare patients with advanced cancer died in a hospital in 2010, rather than in a hospice setting – typically the patient’s home. These figures include data from NCI-designated cancer centers. Hospice treatment in the last month of life for patients treated in mid- and northwestern states such as Oregon and Iowa trended as much as nearly 50% higher than in places such as Alaska and New York City.

Addressing the reasons for regional variations in care, Dr. Ira Byock, director of palliative medicine at Dartmouth-Hitchcock Medical Center, Lebanon, N.H., wrote in an accompanying editorial that, "Previous research has also shown that regional supply of health care resources, such as hospital and intensive care beds and imaging equipment, is one driver of the intensity of care, irrespective of the patient’s particular condition or illness level."

The analysts found the overall rate of ICU admissions for treatments such as intubation, a feeding tube, or cardiopulmonary resuscitation during the last month of life increased from 23.7% in the period between 2003 and 2007 to 28.8% in 2010. The number of days patients spent in the ICU in the last month of life varied more than fivefold across all centers, the analysts wrote.

"Our research continues to find that patients with advanced cancer are often receiving aggressive care until their final days, when we know that most patients would prefer care directed toward a better quality of life through hospice and palliative services. The increase in patients admitted to hospice care only days before death suggests that hospice services are often provided too late to provide much benefit," Dr. David C. Goodman, coprincipal investigator for the Dartmouth Atlas Project, said in a statement.

When asked why some oncologists are not referring their patients to hospice sooner, Dr. Clifford Hudis, president of the American Society of Clinical Oncology said, "There are many circumstances, based on culture, family dynamics, and patient’s wishes, where it is hard to communicate the value of hospice services. Some patients remain fearful of the very word and, in some situations, there is an unwillingness to acknowledge the severity of illnesses. These barriers can often be overcome through an increase in communication between doctors and patients about care goals and wishes."

When asked about the potential economic implications of the data, Dr. Goodman said, "The goal of better end-of-life care is to improve patient well-being. Often, it is less expensive to provide good care that patients want, [rather] than the usual care that patients receive."

The report also indicated that the number of patients who saw 10 or more different physicians during the last six months of their lives rose from 46.2% to 58.5%. The analysts interpreted this to mean "more patients may have experienced fragmented care."

In a statement Dr. Hudis encouraged the oncology community to "keep striving to deliver the right care at the right time." In an e-mail interview, Dr. Hudis wrote that, "The overall trend is a good one because it is concordant with the overall goals of ASCO: to make sure that every patient has access to the highest quality care throughout their disease experience."

Dr. Goodman and Dr. Byock report no relevant disclosures. The report was principally funded by the Robert Wood Johnson Foundation, with support from a consortium of funders including the WellPoint Foundation, the United Health Foundation, and the California HealthCare Foundation.

[email protected]

Young women who elect contralateral prophylactic mastectomy do so, in part, because they want to improve their chances for survival, even though they realize there is no convincing evidence of a survival benefit, based on results from a survey.

Moreover, many women, particularly those without a known BRCA mutation, substantially overestimate their risk of developing cancer in the unaffected breast, Shoshana M. Rosenberg, Sc.D., of the Dana-Farber Cancer Institute and the Harvard School of Public Health, both in Boston, and her colleagues reported in the Sept. 17 issue of Annals of Internal Medicine.

The findings suggest "some degree of cognitive dissonance," since almost all respondents cited both the desire to improve survival or extend life and a desire to prevent metastatic disease as extremely or very important reasons for choosing contralateral prophylactic mastectomy, while also demonstrating awareness that bilateral mastectomy would not extend survival, the researchers said. Anxiety and fear of recurrence likely influenced the decision-making process and led women to identify their desire to extend life and prevent metastatic disease as among the most important reasons for having contralateral prophylactic mastectomy.

Of 550 women diagnosed at age 40 years or younger with breast cancer in one breast, 123 (22%) who underwent bilateral mastectomy were included in the analysis. Of those women, 94% said the desire to improve survival was an extremely or very important factor in their decision to undergo contralateral prophylactic mastectomy. Yet 74% of mutation carriers and 84% of noncarriers acknowledged that most women who are diagnosed with early-stage breast cancer and undergo treatment will ultimately die of something other than breast cancer.

Also, 98% cited a desire to decrease their risk of contralateral breast cancer and 95% cited a desire for peace of mind as extremely or very important factors in their decision (Ann. Intern. Med. 2013;17:373-81).

Mutation carriers estimated their risk of developing cancer in the contralateral breast in the 5 years after unilateral treatment at 20%, noncarriers estimated that risk at 10%. The risk for women with BRCA mutations is estimated to be 24%-31%. The group without mutations overestimated their risk, which is actually about 2%-4% over 5 years. Women in both groups estimated the risk of chest wall recurrence after bilateral mastectomy at 5%, which is actually estimated at less than 1%, the researchers noted.

Survey participants were women whose median age was 37 years at cancer diagnosis and who were recruited from four academic and five community hospitals in Massachusetts, and from one academic site in Toronto between November 2006 and November 2010. The participants were recruited as part of the Helping Ourselves, Helping Others: Young Women’s Breast Cancer Study. Most had stage I or stage II breast cancer, and all were believed to have breast cancer only in one breast. About 60% of tumors were estrogen receptor–positive, and about 25% of the women were BRCAmutation carriers.

The survey was a one-time supplement to the ongoing prospective cohort study. It is one of the largest surveys to date to examine decision-making, risk perceptions, and psychosocial aspects of contralateral prophylactic mastectomy among young women with breast cancer, the investigators said. The survey findings are important, given that the rates of contralateral prophylactic mastectomy have increased dramatically in recent years, from 4%-6% in the late 1990s to 11%-25% in more recent reports, even though "the value of the procedure for most women with unilateral early-stage breast cancer is unclear," the researchers said.

The study was limited by the lack of validation of the survey, the possibility of recall bias (since the women were surveyed an average of 2 years following surgery), and the possibility of limited generalizability of the findings because the study population was primarily white, non-Hispanic, and college educated. Yet, the findings highlight a need for improved communication with patients, they said.

Although 96%-97% of participants believed they were clear about benefits and risks, and which mattered most, many women reported that several outcomes associated with surgery were worse than they had expected. For example, 33% reported needing a higher-than-expected number of operations or procedures, and 28% said that numbness or tingling in the chest was worse than expected.

"With respect to QOL outcomes, 42% reported that their sense of sexuality was worse than they expected after surgery, and nearly one-third indicated that self-consciousness about appearance was also worse than expected," the researchers reported.

Only about half of the participants indicated that their physicians had talked at least to some degree about reasons not to have contralateral prophylactic mastectomy, suggesting a potential role for "interventions that ensure women are sufficiently informed and the actual risk for contralateral disease is effectively communicated," the investigators said.

Additional clarification of these conflicting responses would be helpful, they said, suggesting that future investigation "might include focus groups or collection of qualitative data with the goal of elucidating the role of cognitive biases in making treatment decisions."

This study was primarily funded by Susan G. Komen for the Cure. Dr. Rosenberg reported receiving support from the National Cancer Institute.

Young women who elect contralateral prophylactic mastectomy do so, in part, because they want to improve their chances for survival, even though they realize there is no convincing evidence of a survival benefit, based on results from a survey.

Moreover, many women, particularly those without a known BRCA mutation, substantially overestimate their risk of developing cancer in the unaffected breast, Shoshana M. Rosenberg, Sc.D., of the Dana-Farber Cancer Institute and the Harvard School of Public Health, both in Boston, and her colleagues reported in the Sept. 17 issue of Annals of Internal Medicine.

The findings suggest "some degree of cognitive dissonance," since almost all respondents cited both the desire to improve survival or extend life and a desire to prevent metastatic disease as extremely or very important reasons for choosing contralateral prophylactic mastectomy, while also demonstrating awareness that bilateral mastectomy would not extend survival, the researchers said. Anxiety and fear of recurrence likely influenced the decision-making process and led women to identify their desire to extend life and prevent metastatic disease as among the most important reasons for having contralateral prophylactic mastectomy.

Of 550 women diagnosed at age 40 years or younger with breast cancer in one breast, 123 (22%) who underwent bilateral mastectomy were included in the analysis. Of those women, 94% said the desire to improve survival was an extremely or very important factor in their decision to undergo contralateral prophylactic mastectomy. Yet 74% of mutation carriers and 84% of noncarriers acknowledged that most women who are diagnosed with early-stage breast cancer and undergo treatment will ultimately die of something other than breast cancer.

Also, 98% cited a desire to decrease their risk of contralateral breast cancer and 95% cited a desire for peace of mind as extremely or very important factors in their decision (Ann. Intern. Med. 2013;17:373-81).

Mutation carriers estimated their risk of developing cancer in the contralateral breast in the 5 years after unilateral treatment at 20%, noncarriers estimated that risk at 10%. The risk for women with BRCA mutations is estimated to be 24%-31%. The group without mutations overestimated their risk, which is actually about 2%-4% over 5 years. Women in both groups estimated the risk of chest wall recurrence after bilateral mastectomy at 5%, which is actually estimated at less than 1%, the researchers noted.

Survey participants were women whose median age was 37 years at cancer diagnosis and who were recruited from four academic and five community hospitals in Massachusetts, and from one academic site in Toronto between November 2006 and November 2010. The participants were recruited as part of the Helping Ourselves, Helping Others: Young Women’s Breast Cancer Study. Most had stage I or stage II breast cancer, and all were believed to have breast cancer only in one breast. About 60% of tumors were estrogen receptor–positive, and about 25% of the women were BRCAmutation carriers.

The survey was a one-time supplement to the ongoing prospective cohort study. It is one of the largest surveys to date to examine decision-making, risk perceptions, and psychosocial aspects of contralateral prophylactic mastectomy among young women with breast cancer, the investigators said. The survey findings are important, given that the rates of contralateral prophylactic mastectomy have increased dramatically in recent years, from 4%-6% in the late 1990s to 11%-25% in more recent reports, even though "the value of the procedure for most women with unilateral early-stage breast cancer is unclear," the researchers said.

The study was limited by the lack of validation of the survey, the possibility of recall bias (since the women were surveyed an average of 2 years following surgery), and the possibility of limited generalizability of the findings because the study population was primarily white, non-Hispanic, and college educated. Yet, the findings highlight a need for improved communication with patients, they said.

Although 96%-97% of participants believed they were clear about benefits and risks, and which mattered most, many women reported that several outcomes associated with surgery were worse than they had expected. For example, 33% reported needing a higher-than-expected number of operations or procedures, and 28% said that numbness or tingling in the chest was worse than expected.

"With respect to QOL outcomes, 42% reported that their sense of sexuality was worse than they expected after surgery, and nearly one-third indicated that self-consciousness about appearance was also worse than expected," the researchers reported.

Only about half of the participants indicated that their physicians had talked at least to some degree about reasons not to have contralateral prophylactic mastectomy, suggesting a potential role for "interventions that ensure women are sufficiently informed and the actual risk for contralateral disease is effectively communicated," the investigators said.

Additional clarification of these conflicting responses would be helpful, they said, suggesting that future investigation "might include focus groups or collection of qualitative data with the goal of elucidating the role of cognitive biases in making treatment decisions."

This study was primarily funded by Susan G. Komen for the Cure. Dr. Rosenberg reported receiving support from the National Cancer Institute.

Young women who elect contralateral prophylactic mastectomy do so, in part, because they want to improve their chances for survival, even though they realize there is no convincing evidence of a survival benefit, based on results from a survey.

Moreover, many women, particularly those without a known BRCA mutation, substantially overestimate their risk of developing cancer in the unaffected breast, Shoshana M. Rosenberg, Sc.D., of the Dana-Farber Cancer Institute and the Harvard School of Public Health, both in Boston, and her colleagues reported in the Sept. 17 issue of Annals of Internal Medicine.

The findings suggest "some degree of cognitive dissonance," since almost all respondents cited both the desire to improve survival or extend life and a desire to prevent metastatic disease as extremely or very important reasons for choosing contralateral prophylactic mastectomy, while also demonstrating awareness that bilateral mastectomy would not extend survival, the researchers said. Anxiety and fear of recurrence likely influenced the decision-making process and led women to identify their desire to extend life and prevent metastatic disease as among the most important reasons for having contralateral prophylactic mastectomy.

Of 550 women diagnosed at age 40 years or younger with breast cancer in one breast, 123 (22%) who underwent bilateral mastectomy were included in the analysis. Of those women, 94% said the desire to improve survival was an extremely or very important factor in their decision to undergo contralateral prophylactic mastectomy. Yet 74% of mutation carriers and 84% of noncarriers acknowledged that most women who are diagnosed with early-stage breast cancer and undergo treatment will ultimately die of something other than breast cancer.

Also, 98% cited a desire to decrease their risk of contralateral breast cancer and 95% cited a desire for peace of mind as extremely or very important factors in their decision (Ann. Intern. Med. 2013;17:373-81).

Mutation carriers estimated their risk of developing cancer in the contralateral breast in the 5 years after unilateral treatment at 20%, noncarriers estimated that risk at 10%. The risk for women with BRCA mutations is estimated to be 24%-31%. The group without mutations overestimated their risk, which is actually about 2%-4% over 5 years. Women in both groups estimated the risk of chest wall recurrence after bilateral mastectomy at 5%, which is actually estimated at less than 1%, the researchers noted.

Survey participants were women whose median age was 37 years at cancer diagnosis and who were recruited from four academic and five community hospitals in Massachusetts, and from one academic site in Toronto between November 2006 and November 2010. The participants were recruited as part of the Helping Ourselves, Helping Others: Young Women’s Breast Cancer Study. Most had stage I or stage II breast cancer, and all were believed to have breast cancer only in one breast. About 60% of tumors were estrogen receptor–positive, and about 25% of the women were BRCAmutation carriers.

The survey was a one-time supplement to the ongoing prospective cohort study. It is one of the largest surveys to date to examine decision-making, risk perceptions, and psychosocial aspects of contralateral prophylactic mastectomy among young women with breast cancer, the investigators said. The survey findings are important, given that the rates of contralateral prophylactic mastectomy have increased dramatically in recent years, from 4%-6% in the late 1990s to 11%-25% in more recent reports, even though "the value of the procedure for most women with unilateral early-stage breast cancer is unclear," the researchers said.

The study was limited by the lack of validation of the survey, the possibility of recall bias (since the women were surveyed an average of 2 years following surgery), and the possibility of limited generalizability of the findings because the study population was primarily white, non-Hispanic, and college educated. Yet, the findings highlight a need for improved communication with patients, they said.

Although 96%-97% of participants believed they were clear about benefits and risks, and which mattered most, many women reported that several outcomes associated with surgery were worse than they had expected. For example, 33% reported needing a higher-than-expected number of operations or procedures, and 28% said that numbness or tingling in the chest was worse than expected.

"With respect to QOL outcomes, 42% reported that their sense of sexuality was worse than they expected after surgery, and nearly one-third indicated that self-consciousness about appearance was also worse than expected," the researchers reported.

Only about half of the participants indicated that their physicians had talked at least to some degree about reasons not to have contralateral prophylactic mastectomy, suggesting a potential role for "interventions that ensure women are sufficiently informed and the actual risk for contralateral disease is effectively communicated," the investigators said.

Additional clarification of these conflicting responses would be helpful, they said, suggesting that future investigation "might include focus groups or collection of qualitative data with the goal of elucidating the role of cognitive biases in making treatment decisions."

This study was primarily funded by Susan G. Komen for the Cure. Dr. Rosenberg reported receiving support from the National Cancer Institute.