ACS Surgery News

HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.

That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.

Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.

“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.

Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.

They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.

Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).

Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).

Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.

As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.

There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.

Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.

The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.

HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.

That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.

Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.

“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.

Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.

They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.

Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).

Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).

Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.

As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.

There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.

Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.

The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.

HOUSTON – Patients who achieve complete clinical responses after neoadjuvant therapy for locally advanced rectal cancer may, in many cases, be safely spared the trauma and morbidity of total mesorectal excision.

That’s the opinion of investigators at Memorial Sloan Kettering Cancer Center, New York, who found that nearly two-thirds of patients followed with nonoperative management (NOM) had durable complete clinical remissions (cCR) for at least 4 years.

Disease-specific survival and overall survival rates among patients who had nonoperative management were similar to those seen in patients with pathologic complete responses (pCR), defined as no viable tumor cells in the resected specimen.

“We know that there is a very good overall and disease-free survival associated with a [pCR]. Clinical complete response is also associated with pathologic complete response. In that regard, this brings up the question: Is an operation always necessary in these patients?” Dr. Jesse Joshua Smith of the cancer center said at the annual Society of Surgical Oncology Cancer Symposium.

Dr. Smith and colleagues conducted a review of their center’s experience to date with NOM for patients with locally advanced rectal cancer, asking whether the data support the approach as oncologically safe and effective for organ preservation.

They identified 442 patients with rectal cancer treated with neoadjuvant chemotherapy from 2006 through 2014 and compared results for 73 who achieved a cCR and were followed with nonoperative management with those of 72 patients who had a pCR following total mesorectal excision.

Demographic and clinical characteristics between the groups were generally similar, although patients in the pCR group were significantly younger (58 years vs. 65 years, P = .01), had a greater tumor distance from the anal verge (median of 6 cm vs. 5.25 cm, P = .02), and higher proportions of clinical stage II (32% vs. 24%) and III (66% vs. 62%, P = .02).

Among the 73 patients managed with NOM, 54 had durable cCR at 4 years. Of the remaining 19 with local tumor regrowth, 2 had local excisions with no further recurrence and 17 went on to have rectal resections. The total number of patients with rectal preservation in this group was 56 (77%).

Of the 19 patients in the conservatively managed group who had local regrowths, all but three of the recurrences were detected within 13 months.

As noted before, neither disease-specific survival nor overall survival were significantly different between patients managed with NOM or with total mesorectal excision.

There were numerically more distant recurrences at both 1 and 4 years among patients treated with NOM compared with total mesorectal excision (7% vs. 2%, and 17% vs. 9%, respectively), but the differences were not statistically significant, the authors found.

Dr. Smith noted that patients who are offered the option of NOM have a discussion with the surgeon emphasizing that the practice is nonstandard management, carries about a 25% risk of local regrowth, and requires increased endoscopic and radiographic surveillance. Patients also are informed about the risks of salvage abdominoperineal resection or extended resections, and about the potential risk of compromising cure.

The study was supported in part by the Berezuk Colorectal Cancer Fund. Dr. Smith reported having no disclosures.

Despite being billed as a permanent solution to the annual threat of Medicare payment cuts to physicians, a bill repealing the Sustainable Growth Rate formula will not ensure adequate physician payments in the long term, according to actuaries at the Centers for Medicare & Medicaid Services.

In an April 9 report outlining the effect of the Medicare Access and CHIP Reauthorization Act (H.R. 2), the CMS Office of the Actuary said it anticipates “that physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter.

thinkstockphotos.com

“Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2,” the report’s authors noted.

The actuarial report attributes the long-term issues to a number of the bill’s provisions. First, it notes the expiration in 2025 of updates totaling $500 million per year and a 5% annual bonus, which will result in a payment reduction for most physicians.

Second, “this bill specifies the physician payment update amounts for all years in the future, and these amounts do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases,” the report warned. That will result in payments that will be inadequate when rates of inflation are higher or when price updates are not enough to cover cost increases.

Compared with costs under current law, the CMS actuaries estimated the legislation’s net cost to the federal government from 2015 through 2025 would be $102.8 billion.

The SGR repeal bill, which also reauthorizes the Children’s Health Insurance Program for 2 more years, passed in the House March 26 with overwhelming bipartisan support. The bill is expected to pass the Senate after members return April 13 from their spring recess.

[email protected]

Despite being billed as a permanent solution to the annual threat of Medicare payment cuts to physicians, a bill repealing the Sustainable Growth Rate formula will not ensure adequate physician payments in the long term, according to actuaries at the Centers for Medicare & Medicaid Services.

In an April 9 report outlining the effect of the Medicare Access and CHIP Reauthorization Act (H.R. 2), the CMS Office of the Actuary said it anticipates “that physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter.

thinkstockphotos.com

“Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2,” the report’s authors noted.

The actuarial report attributes the long-term issues to a number of the bill’s provisions. First, it notes the expiration in 2025 of updates totaling $500 million per year and a 5% annual bonus, which will result in a payment reduction for most physicians.

Second, “this bill specifies the physician payment update amounts for all years in the future, and these amounts do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases,” the report warned. That will result in payments that will be inadequate when rates of inflation are higher or when price updates are not enough to cover cost increases.

Compared with costs under current law, the CMS actuaries estimated the legislation’s net cost to the federal government from 2015 through 2025 would be $102.8 billion.

The SGR repeal bill, which also reauthorizes the Children’s Health Insurance Program for 2 more years, passed in the House March 26 with overwhelming bipartisan support. The bill is expected to pass the Senate after members return April 13 from their spring recess.

[email protected]

Despite being billed as a permanent solution to the annual threat of Medicare payment cuts to physicians, a bill repealing the Sustainable Growth Rate formula will not ensure adequate physician payments in the long term, according to actuaries at the Centers for Medicare & Medicaid Services.

In an April 9 report outlining the effect of the Medicare Access and CHIP Reauthorization Act (H.R. 2), the CMS Office of the Actuary said it anticipates “that physician payment rates under H.R. 2 would be lower than scheduled under the current SGR formula by 2048 and would continue to worsen thereafter.

thinkstockphotos.com

“Absent a change in the method or level of update by subsequent legislation, we expect access to Medicare-participating physicians to become a significant issue in the long term under H.R. 2,” the report’s authors noted.

The actuarial report attributes the long-term issues to a number of the bill’s provisions. First, it notes the expiration in 2025 of updates totaling $500 million per year and a 5% annual bonus, which will result in a payment reduction for most physicians.

Second, “this bill specifies the physician payment update amounts for all years in the future, and these amounts do not vary based on underlying economic conditions, nor are they expected to keep pace with the average rate of physician cost increases,” the report warned. That will result in payments that will be inadequate when rates of inflation are higher or when price updates are not enough to cover cost increases.

Compared with costs under current law, the CMS actuaries estimated the legislation’s net cost to the federal government from 2015 through 2025 would be $102.8 billion.

The SGR repeal bill, which also reauthorizes the Children’s Health Insurance Program for 2 more years, passed in the House March 26 with overwhelming bipartisan support. The bill is expected to pass the Senate after members return April 13 from their spring recess.

[email protected]

HOUSTON – For some women with breast cancer, neoadjuvant therapy can increase the likelihood of breast-conserving treatment and may limit the extent of axillary dissection, a breast cancer researcher says.

“Neoadjuvant chemotherapy has long been used in the management of inflammatory breast cancer, in patients with locally advanced, or inoperable disease, and it’s increasingly being used in patients who have operable breast cancer,” said Dr. Elizabeth A. Mittendorf of the University of Texas MD Anderson Cancer Center, Houston.

A meta-analysis published in 2007 suggested that neoadjuvant therapy in patients with operable breast cancer reduced the mastectomy rate by 17%, a figure that Dr. Mittendorf said likely underestimates the benefit, because many of the trials included in the analysis did not require patients to be considered for breast conservation at presentation.

The meta-analysis also showed that local recurrence rates did not differ from those seen with mastectomy when patients treated with neoadjuvant therapy were downstaged to breast-conserving therapy, and that there were no differences in local recurrence rates for neoadjuvant vs. adjuvant chemotherapy stratified by type of surgery, Dr. Mittendorf said at the annual Society of Surgical Oncology Cancer Symposium.

Key clinical trials, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and B-27 trials, showed that neoadjuvant chemotherapy did not have an effect on either disease-free or overall survival compared with adjuvant chemotherapy, Dr. Mittendorf noted.

Response to neoadjuvant chemotherapy is also a good predictor of prognosis, she said, pointing to a pooled analysis of 12 studies published in 2014 in The Lancet. The authors of the analysis reported that patients with a pathologic complete response (pCR; no invasive disease in either the breast or axilla) after neoadjuvant chemotherapy had significantly improved survival, with the greatest prognostic values seen in patients with aggressive tumor subtypes.

Factors to consider when selecting neoadjuvant chemotherapy include:

• Tumor size.

• Lymph node status.

• Estrogen, progesterone, and/or HER2 status.

• Treatment sensitivity (as measured by Ki-67 or other markers).

• Pathologic complete response rates.

Chemo for HR-positive?

“With respect to hormone receptor–positive breast cancer, I think the most important question for these patients is do they even need chemotherapy?” Dr. Mittendorf said.

Hormone receptor–positive (HR-positive) breast cancers have been shown to be less responsive to neoadjuvant chemotherapy, and pCR is less prognostic of outcome in this tumor subtype. Older patients with HR-positive cancers who are borderline candidates for breast-conserving therapy might benefit from neoadjuvant therapy with an aromatase inhibitor, she noted.

HER2-positive disease

For patients with HER2-positive breast cancers, it may be possible to tailor neoadjuvant therapy, so that patients who achieve a pCR with neoadjuvant trastuzumab (Herceptin) might be spared an additional 6 months of adjuvant therapy. Dr. Mittendorf’s group published a recent study

Combination anti-HER2 therapies (trastuzumab and pertuzumab [Perjeta] as used in the NeoSphere Trial may help to improve pCR rates and outcomes in patients with HER2-positive tumors, Dr. Mittendorf said.

Triple negative disease

Among patients with triple-negative breast cancer (tumors lacking hormonal receptors and HER2), those who have residual cancer after neoadjuvant chemotherapy have a poor prognosis. At MD Anderson, patients with localized triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy first have a biopsy with molecular profiling, and are immediately started on an anthracycline-based regimen.

Patients who have a response to the chemotherapy proceed to receive a taxane, while nonresponders will be triaged onto phase II studies based on the subtype of triple-negative breast cancer. Patients who are positive for BRCA mutations will be started on a carboplatin/paclitaxel regimen, while those with mesenchymal tumor subtypes will be started on a phosphoinositide 3-kinase (PI3K) inhibitor, and those with basal-like tumors will be started on an immunotherapy protocol.Better understanding of the biology of different tumor subtypes may also help to reduce the extent of axillary surgery, by helping clinicians to identify those patients who are likely to have a nodal pCR, Dr. Mittendorf said.

HOUSTON – For some women with breast cancer, neoadjuvant therapy can increase the likelihood of breast-conserving treatment and may limit the extent of axillary dissection, a breast cancer researcher says.

“Neoadjuvant chemotherapy has long been used in the management of inflammatory breast cancer, in patients with locally advanced, or inoperable disease, and it’s increasingly being used in patients who have operable breast cancer,” said Dr. Elizabeth A. Mittendorf of the University of Texas MD Anderson Cancer Center, Houston.

A meta-analysis published in 2007 suggested that neoadjuvant therapy in patients with operable breast cancer reduced the mastectomy rate by 17%, a figure that Dr. Mittendorf said likely underestimates the benefit, because many of the trials included in the analysis did not require patients to be considered for breast conservation at presentation.

The meta-analysis also showed that local recurrence rates did not differ from those seen with mastectomy when patients treated with neoadjuvant therapy were downstaged to breast-conserving therapy, and that there were no differences in local recurrence rates for neoadjuvant vs. adjuvant chemotherapy stratified by type of surgery, Dr. Mittendorf said at the annual Society of Surgical Oncology Cancer Symposium.

Key clinical trials, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and B-27 trials, showed that neoadjuvant chemotherapy did not have an effect on either disease-free or overall survival compared with adjuvant chemotherapy, Dr. Mittendorf noted.

Response to neoadjuvant chemotherapy is also a good predictor of prognosis, she said, pointing to a pooled analysis of 12 studies published in 2014 in The Lancet. The authors of the analysis reported that patients with a pathologic complete response (pCR; no invasive disease in either the breast or axilla) after neoadjuvant chemotherapy had significantly improved survival, with the greatest prognostic values seen in patients with aggressive tumor subtypes.

Factors to consider when selecting neoadjuvant chemotherapy include:

• Tumor size.

• Lymph node status.

• Estrogen, progesterone, and/or HER2 status.

• Treatment sensitivity (as measured by Ki-67 or other markers).

• Pathologic complete response rates.

Chemo for HR-positive?

“With respect to hormone receptor–positive breast cancer, I think the most important question for these patients is do they even need chemotherapy?” Dr. Mittendorf said.

Hormone receptor–positive (HR-positive) breast cancers have been shown to be less responsive to neoadjuvant chemotherapy, and pCR is less prognostic of outcome in this tumor subtype. Older patients with HR-positive cancers who are borderline candidates for breast-conserving therapy might benefit from neoadjuvant therapy with an aromatase inhibitor, she noted.

HER2-positive disease

For patients with HER2-positive breast cancers, it may be possible to tailor neoadjuvant therapy, so that patients who achieve a pCR with neoadjuvant trastuzumab (Herceptin) might be spared an additional 6 months of adjuvant therapy. Dr. Mittendorf’s group published a recent study

Combination anti-HER2 therapies (trastuzumab and pertuzumab [Perjeta] as used in the NeoSphere Trial may help to improve pCR rates and outcomes in patients with HER2-positive tumors, Dr. Mittendorf said.

Triple negative disease

Among patients with triple-negative breast cancer (tumors lacking hormonal receptors and HER2), those who have residual cancer after neoadjuvant chemotherapy have a poor prognosis. At MD Anderson, patients with localized triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy first have a biopsy with molecular profiling, and are immediately started on an anthracycline-based regimen.

Patients who have a response to the chemotherapy proceed to receive a taxane, while nonresponders will be triaged onto phase II studies based on the subtype of triple-negative breast cancer. Patients who are positive for BRCA mutations will be started on a carboplatin/paclitaxel regimen, while those with mesenchymal tumor subtypes will be started on a phosphoinositide 3-kinase (PI3K) inhibitor, and those with basal-like tumors will be started on an immunotherapy protocol.Better understanding of the biology of different tumor subtypes may also help to reduce the extent of axillary surgery, by helping clinicians to identify those patients who are likely to have a nodal pCR, Dr. Mittendorf said.

HOUSTON – For some women with breast cancer, neoadjuvant therapy can increase the likelihood of breast-conserving treatment and may limit the extent of axillary dissection, a breast cancer researcher says.

“Neoadjuvant chemotherapy has long been used in the management of inflammatory breast cancer, in patients with locally advanced, or inoperable disease, and it’s increasingly being used in patients who have operable breast cancer,” said Dr. Elizabeth A. Mittendorf of the University of Texas MD Anderson Cancer Center, Houston.

A meta-analysis published in 2007 suggested that neoadjuvant therapy in patients with operable breast cancer reduced the mastectomy rate by 17%, a figure that Dr. Mittendorf said likely underestimates the benefit, because many of the trials included in the analysis did not require patients to be considered for breast conservation at presentation.

The meta-analysis also showed that local recurrence rates did not differ from those seen with mastectomy when patients treated with neoadjuvant therapy were downstaged to breast-conserving therapy, and that there were no differences in local recurrence rates for neoadjuvant vs. adjuvant chemotherapy stratified by type of surgery, Dr. Mittendorf said at the annual Society of Surgical Oncology Cancer Symposium.

Key clinical trials, including the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 and B-27 trials, showed that neoadjuvant chemotherapy did not have an effect on either disease-free or overall survival compared with adjuvant chemotherapy, Dr. Mittendorf noted.

Response to neoadjuvant chemotherapy is also a good predictor of prognosis, she said, pointing to a pooled analysis of 12 studies published in 2014 in The Lancet. The authors of the analysis reported that patients with a pathologic complete response (pCR; no invasive disease in either the breast or axilla) after neoadjuvant chemotherapy had significantly improved survival, with the greatest prognostic values seen in patients with aggressive tumor subtypes.

Factors to consider when selecting neoadjuvant chemotherapy include:

• Tumor size.

• Lymph node status.

• Estrogen, progesterone, and/or HER2 status.

• Treatment sensitivity (as measured by Ki-67 or other markers).

• Pathologic complete response rates.

Chemo for HR-positive?

“With respect to hormone receptor–positive breast cancer, I think the most important question for these patients is do they even need chemotherapy?” Dr. Mittendorf said.

Hormone receptor–positive (HR-positive) breast cancers have been shown to be less responsive to neoadjuvant chemotherapy, and pCR is less prognostic of outcome in this tumor subtype. Older patients with HR-positive cancers who are borderline candidates for breast-conserving therapy might benefit from neoadjuvant therapy with an aromatase inhibitor, she noted.

HER2-positive disease

For patients with HER2-positive breast cancers, it may be possible to tailor neoadjuvant therapy, so that patients who achieve a pCR with neoadjuvant trastuzumab (Herceptin) might be spared an additional 6 months of adjuvant therapy. Dr. Mittendorf’s group published a recent study

Combination anti-HER2 therapies (trastuzumab and pertuzumab [Perjeta] as used in the NeoSphere Trial may help to improve pCR rates and outcomes in patients with HER2-positive tumors, Dr. Mittendorf said.

Triple negative disease

Among patients with triple-negative breast cancer (tumors lacking hormonal receptors and HER2), those who have residual cancer after neoadjuvant chemotherapy have a poor prognosis. At MD Anderson, patients with localized triple-negative breast cancer who are scheduled to receive neoadjuvant chemotherapy first have a biopsy with molecular profiling, and are immediately started on an anthracycline-based regimen.

Patients who have a response to the chemotherapy proceed to receive a taxane, while nonresponders will be triaged onto phase II studies based on the subtype of triple-negative breast cancer. Patients who are positive for BRCA mutations will be started on a carboplatin/paclitaxel regimen, while those with mesenchymal tumor subtypes will be started on a phosphoinositide 3-kinase (PI3K) inhibitor, and those with basal-like tumors will be started on an immunotherapy protocol.Better understanding of the biology of different tumor subtypes may also help to reduce the extent of axillary surgery, by helping clinicians to identify those patients who are likely to have a nodal pCR, Dr. Mittendorf said.

CHICAGO – Sentinel lymph node mapping alone may suffice for initial staging in women with clinical high-risk endometrial cancer, according to a prospective cohort study reported at the annual meeting of the Society of Gynecologic Oncology.

“While the majority of women with endometrial cancer do not have nodal involvement, positive nodes are an important prognostic factor and often guide postoperative adjuvant therapy. The use of SLN [sentinel lymph node] mapping could potentially maximize the identification of positive nodes while minimizing the risk of full lymphadenectomy,” noted Dr. Pamela T. Soliman, Center Medical Director of the Gynecologic Medical Center at The University of Texas MD Anderson Cancer Center, Houston.

Susan London/Frontline Medical News

Dr. Pamela Soliman

She and her colleagues studied 60 women who had clinical stage II disease with high-risk features on preoperative biopsy. All women underwent preoperative PET-CT, then SLN mapping, and finally a full surgical staging with pelvic and para-aortic lymphadenectomy to the renal vessels.

Results showed that 92% of women had at least one SLN detected and 61% had SLNs detected bilaterally. “These findings are consistent with others reported in the literature suggesting that this technique is reproducible,” Dr. Soliman maintained.

Importantly, she said, all of the patients ultimately found to have stage IIIc disease had at least one positive SLN identified, translating to a sensitivity of SLN mapping of 100% and a false-negative rate of zero.

“While we do not expect that the true false-negative rate is zero in this patient population, our results are very promising, and we are hopeful that with our study and other studies presented here, we can potentially change the way we manage patients with high-risk endometrial cancer,” she said.

“If we continue to successfully identify the women with positive lymph nodes using the mapping technique, potentially an SLN biopsy alone could be considered for women with high-risk endometrial cancer. It’s unclear, however, how this change in practice will affect our postoperative management as well as our long-term survival,” Dr. Soliman added.

The SLN mapping in the study was done with a cervical injection of dye, both superficial and deep, at the 3 and 9 o’clock positions, with the surgical approach (laparotomy, laparoscopy, robot-assisted, or a combination) and type of dye used for mapping left up to the surgeon. Indocyanine green was used in about two-thirds of cases.

The high SLN detection rate was consistent across different surgical approaches and types of dye used, reported Dr. Soliman, who disclosed that she had no relevant conflicts of interest.

A total of 146 SLNs were identified in 56 women. Seventeen of these SLNs – all external iliac or obturator nodes – in 10 patients were positive; in half of these patients, the SLNs were the only histologically positive nodes found.

One woman had a negative SLN on the right, although the non-SLNs on that side were positive. “She was not considered a false-negative because her SLN biopsy on the other side was positive,” Dr. Soliman explained.

CHICAGO – Sentinel lymph node mapping alone may suffice for initial staging in women with clinical high-risk endometrial cancer, according to a prospective cohort study reported at the annual meeting of the Society of Gynecologic Oncology.

“While the majority of women with endometrial cancer do not have nodal involvement, positive nodes are an important prognostic factor and often guide postoperative adjuvant therapy. The use of SLN [sentinel lymph node] mapping could potentially maximize the identification of positive nodes while minimizing the risk of full lymphadenectomy,” noted Dr. Pamela T. Soliman, Center Medical Director of the Gynecologic Medical Center at The University of Texas MD Anderson Cancer Center, Houston.

Susan London/Frontline Medical News

Dr. Pamela Soliman

She and her colleagues studied 60 women who had clinical stage II disease with high-risk features on preoperative biopsy. All women underwent preoperative PET-CT, then SLN mapping, and finally a full surgical staging with pelvic and para-aortic lymphadenectomy to the renal vessels.

Results showed that 92% of women had at least one SLN detected and 61% had SLNs detected bilaterally. “These findings are consistent with others reported in the literature suggesting that this technique is reproducible,” Dr. Soliman maintained.

Importantly, she said, all of the patients ultimately found to have stage IIIc disease had at least one positive SLN identified, translating to a sensitivity of SLN mapping of 100% and a false-negative rate of zero.

“While we do not expect that the true false-negative rate is zero in this patient population, our results are very promising, and we are hopeful that with our study and other studies presented here, we can potentially change the way we manage patients with high-risk endometrial cancer,” she said.

“If we continue to successfully identify the women with positive lymph nodes using the mapping technique, potentially an SLN biopsy alone could be considered for women with high-risk endometrial cancer. It’s unclear, however, how this change in practice will affect our postoperative management as well as our long-term survival,” Dr. Soliman added.

The SLN mapping in the study was done with a cervical injection of dye, both superficial and deep, at the 3 and 9 o’clock positions, with the surgical approach (laparotomy, laparoscopy, robot-assisted, or a combination) and type of dye used for mapping left up to the surgeon. Indocyanine green was used in about two-thirds of cases.

The high SLN detection rate was consistent across different surgical approaches and types of dye used, reported Dr. Soliman, who disclosed that she had no relevant conflicts of interest.

A total of 146 SLNs were identified in 56 women. Seventeen of these SLNs – all external iliac or obturator nodes – in 10 patients were positive; in half of these patients, the SLNs were the only histologically positive nodes found.

One woman had a negative SLN on the right, although the non-SLNs on that side were positive. “She was not considered a false-negative because her SLN biopsy on the other side was positive,” Dr. Soliman explained.

CHICAGO – Sentinel lymph node mapping alone may suffice for initial staging in women with clinical high-risk endometrial cancer, according to a prospective cohort study reported at the annual meeting of the Society of Gynecologic Oncology.

“While the majority of women with endometrial cancer do not have nodal involvement, positive nodes are an important prognostic factor and often guide postoperative adjuvant therapy. The use of SLN [sentinel lymph node] mapping could potentially maximize the identification of positive nodes while minimizing the risk of full lymphadenectomy,” noted Dr. Pamela T. Soliman, Center Medical Director of the Gynecologic Medical Center at The University of Texas MD Anderson Cancer Center, Houston.

Susan London/Frontline Medical News

Dr. Pamela Soliman

She and her colleagues studied 60 women who had clinical stage II disease with high-risk features on preoperative biopsy. All women underwent preoperative PET-CT, then SLN mapping, and finally a full surgical staging with pelvic and para-aortic lymphadenectomy to the renal vessels.

Results showed that 92% of women had at least one SLN detected and 61% had SLNs detected bilaterally. “These findings are consistent with others reported in the literature suggesting that this technique is reproducible,” Dr. Soliman maintained.

Importantly, she said, all of the patients ultimately found to have stage IIIc disease had at least one positive SLN identified, translating to a sensitivity of SLN mapping of 100% and a false-negative rate of zero.

“While we do not expect that the true false-negative rate is zero in this patient population, our results are very promising, and we are hopeful that with our study and other studies presented here, we can potentially change the way we manage patients with high-risk endometrial cancer,” she said.

“If we continue to successfully identify the women with positive lymph nodes using the mapping technique, potentially an SLN biopsy alone could be considered for women with high-risk endometrial cancer. It’s unclear, however, how this change in practice will affect our postoperative management as well as our long-term survival,” Dr. Soliman added.

The SLN mapping in the study was done with a cervical injection of dye, both superficial and deep, at the 3 and 9 o’clock positions, with the surgical approach (laparotomy, laparoscopy, robot-assisted, or a combination) and type of dye used for mapping left up to the surgeon. Indocyanine green was used in about two-thirds of cases.

The high SLN detection rate was consistent across different surgical approaches and types of dye used, reported Dr. Soliman, who disclosed that she had no relevant conflicts of interest.

A total of 146 SLNs were identified in 56 women. Seventeen of these SLNs – all external iliac or obturator nodes – in 10 patients were positive; in half of these patients, the SLNs were the only histologically positive nodes found.

One woman had a negative SLN on the right, although the non-SLNs on that side were positive. “She was not considered a false-negative because her SLN biopsy on the other side was positive,” Dr. Soliman explained.

SAN DIEGO – The days when cardiologists could look down their noses at cardiac surgeons as primitive when it comes to conducting high-quality clinical research have come and gone.

“Cardiologists have been much more sophisticated than we have in doing randomized controlled trials. But cardiac surgeons are finally making strong progress in conducting randomized clinical trials, an area we’re not typically known for,” Dr. Vinod H. Thourani asserted at the annual meeting of the American College of Cardiology.

Much of this progress can be credited to the relatively recent creation of the Cardiothoracic Surgical Trials Network (CSTN), funded by the U.S. National Institutions of Health and the Canadian Institutes of Health Research. This surgical network is carrying out cutting-edge RCTs that will change the practice of cardiology as well as heart surgery, said Dr. Thourani, professor of surgery and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

To illustrate the breadth of current research in cardiothoracic surgery, he presented thumbnail sketches of RCTs due to report findings as early as this spring and no later than the latter part of next year or early 2017. The trials he selected, some conducted by the CSTN and others with industry sponsorship, address the aortic valve, the mitral valve, postoperative atrial fibrillation, revascularization in patients with unprotected left main coronary artery disease, and advanced heart failure.

• Heart failure: Outcomes of the ENDURANCE destination trial are due to be presented this spring at the annual meeting of the International Society for Heart and Lung Transplantation in Nice, France. This study will compare 12-month outcomes of continuous-flow ventricular assist devices as destination therapy in advanced heart failure. In this HeartWare-sponsored study, 310 patients received the investigational HeartWare ventricular assist system and 155 controls were implanted with the FDA-approved HeartMate II device marketed by Thoratec.

• Atrial fibrillation: The Rate Control Versus Rhythm Control for Postoperative Atrial Fibrillation trial compares the two management strategies in patients with new-onset AF following cardiac surgery. This CSTN-conducted study, to be presented next year, looks at which treatment approach results in fewer days in the hospital, as well as heart rhythm at discharge and through 60 days of follow-up, economic costs, and the incidence of postoperative clinical events.

• Coronary artery disease: The EXCEL trial has randomized 2,600 patients with unprotected left main coronary artery disease to coronary artery bypass surgery or percutaneous intervention with a XIENCE everolimus-eluting stent. The primary outcome is the composite of all-cause mortality, acute MI, or stroke. First results of this Abbott Vascular–sponsored trial are due to be reported next year.“This is a study that will clearly be impactful for you,” Dr. Thourani observed.

• Aortic valve disease: Two major RCTs are looking at the impact of extending transcatheter aortic valve replacement (TAVR) to an intermediate-surgical-risk population of patients with symptomatic severe aortic stenosis. The PARTNER II trial compares transfemoral or transapical/transaortic TAVR with a SAPIEN XT valve to surgical aortic valve replacement in patients with a Society of Thoracic Surgeons mortality risk score of 4%-8%. The primary endpoint is all-cause mortality and disabling stroke at 2 years. Results of this Edwards Lifesciences–sponsored trial will be presented by early 2016.

The Medtronic-sponsored SURTAVI trial compares TAVR using the company’s CoreValve alone or with PCI if revascularization is indicated versus surgical aortic valve replacement alone or with coronary artery bypass grafting if revascularization is indicated. This is a randomized trial involving 2,500 intermediate-risk patients. Of note, the SURTAVI investigators have revised the study protocol to open the trial to patients who are age 75 years or older or have an STS score of 2%-10%, which really redefines the concept of intermediate risk, Dr. Thourani said. Results will be presented by early 2017.

• Mitral valve disease: The Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation trial, carried out by the CSTN, will present 2-year outcome data later this year or in early 2016. The 1-year results caused major consternation in the surgical world. The eye opener was that 33% of patients in the repair group had moderate or severe mitral regurgitation at 12 months, compared with just 2% in the replacement group (N. Engl. J. Med. 2014;370:23-32). Mitral valve repair has traditionally been by far the more popular strategy. If the 2-year results show a growing disparity in terms of rates of severe mitral regurgitation, that may change.

Another CSTN study, the Surgical Intervention in Moderate Ischemic Mitral Regurgitation trial, found no demonstrable clinical benefit in adding a mitral valve repair operation to CABG surgery at 1 year of follow-up. The incidence of moderate or severe mitral regurgitation was lower at 1 year with concomitant valve repair and CABG, but this was offset by more neurologic events, longer ICU and total hospital stays, and no differences in the degree of reverse remodeling, mortality, or quality of life (N. Engl. J. Med. 2014;371:2178-88).

“Two-year follow-up is ongoing. It really becomes very important that later this year or next year we’re going to have the results available for you to determine if the lower incidence of moderate or severe mitral regurgitation at 1 year translates into a net clinical benefit for patients undergoing CABG and mitral repair. This study has big implications for the practice of thoracic surgery and for how cardiologists refer patients,” according to Dr. Thourani.

The COAPT trial is randomizing patients with symptomatic functional mitral regurgitation and very high surgical risk to percutaneous catheter-based treatment with the MitraClip or to a standard-care control group. One-year outcomes will be presented in 2016, and follow-up out to 5 years is planned.

“You can see now that in cardiac surgery there’s a lot going on,” Dr. Thourani concluded. “It’s not only good for us, but it’s good for you. As a cardiovascular community, we need to work together more.”

He reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott Medical, Boston Scientific, Medtronic, and Sorin.

[email protected]

SAN DIEGO – The days when cardiologists could look down their noses at cardiac surgeons as primitive when it comes to conducting high-quality clinical research have come and gone.

“Cardiologists have been much more sophisticated than we have in doing randomized controlled trials. But cardiac surgeons are finally making strong progress in conducting randomized clinical trials, an area we’re not typically known for,” Dr. Vinod H. Thourani asserted at the annual meeting of the American College of Cardiology.

Much of this progress can be credited to the relatively recent creation of the Cardiothoracic Surgical Trials Network (CSTN), funded by the U.S. National Institutions of Health and the Canadian Institutes of Health Research. This surgical network is carrying out cutting-edge RCTs that will change the practice of cardiology as well as heart surgery, said Dr. Thourani, professor of surgery and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

To illustrate the breadth of current research in cardiothoracic surgery, he presented thumbnail sketches of RCTs due to report findings as early as this spring and no later than the latter part of next year or early 2017. The trials he selected, some conducted by the CSTN and others with industry sponsorship, address the aortic valve, the mitral valve, postoperative atrial fibrillation, revascularization in patients with unprotected left main coronary artery disease, and advanced heart failure.

• Heart failure: Outcomes of the ENDURANCE destination trial are due to be presented this spring at the annual meeting of the International Society for Heart and Lung Transplantation in Nice, France. This study will compare 12-month outcomes of continuous-flow ventricular assist devices as destination therapy in advanced heart failure. In this HeartWare-sponsored study, 310 patients received the investigational HeartWare ventricular assist system and 155 controls were implanted with the FDA-approved HeartMate II device marketed by Thoratec.

• Atrial fibrillation: The Rate Control Versus Rhythm Control for Postoperative Atrial Fibrillation trial compares the two management strategies in patients with new-onset AF following cardiac surgery. This CSTN-conducted study, to be presented next year, looks at which treatment approach results in fewer days in the hospital, as well as heart rhythm at discharge and through 60 days of follow-up, economic costs, and the incidence of postoperative clinical events.

• Coronary artery disease: The EXCEL trial has randomized 2,600 patients with unprotected left main coronary artery disease to coronary artery bypass surgery or percutaneous intervention with a XIENCE everolimus-eluting stent. The primary outcome is the composite of all-cause mortality, acute MI, or stroke. First results of this Abbott Vascular–sponsored trial are due to be reported next year.“This is a study that will clearly be impactful for you,” Dr. Thourani observed.

• Aortic valve disease: Two major RCTs are looking at the impact of extending transcatheter aortic valve replacement (TAVR) to an intermediate-surgical-risk population of patients with symptomatic severe aortic stenosis. The PARTNER II trial compares transfemoral or transapical/transaortic TAVR with a SAPIEN XT valve to surgical aortic valve replacement in patients with a Society of Thoracic Surgeons mortality risk score of 4%-8%. The primary endpoint is all-cause mortality and disabling stroke at 2 years. Results of this Edwards Lifesciences–sponsored trial will be presented by early 2016.

The Medtronic-sponsored SURTAVI trial compares TAVR using the company’s CoreValve alone or with PCI if revascularization is indicated versus surgical aortic valve replacement alone or with coronary artery bypass grafting if revascularization is indicated. This is a randomized trial involving 2,500 intermediate-risk patients. Of note, the SURTAVI investigators have revised the study protocol to open the trial to patients who are age 75 years or older or have an STS score of 2%-10%, which really redefines the concept of intermediate risk, Dr. Thourani said. Results will be presented by early 2017.

• Mitral valve disease: The Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation trial, carried out by the CSTN, will present 2-year outcome data later this year or in early 2016. The 1-year results caused major consternation in the surgical world. The eye opener was that 33% of patients in the repair group had moderate or severe mitral regurgitation at 12 months, compared with just 2% in the replacement group (N. Engl. J. Med. 2014;370:23-32). Mitral valve repair has traditionally been by far the more popular strategy. If the 2-year results show a growing disparity in terms of rates of severe mitral regurgitation, that may change.

Another CSTN study, the Surgical Intervention in Moderate Ischemic Mitral Regurgitation trial, found no demonstrable clinical benefit in adding a mitral valve repair operation to CABG surgery at 1 year of follow-up. The incidence of moderate or severe mitral regurgitation was lower at 1 year with concomitant valve repair and CABG, but this was offset by more neurologic events, longer ICU and total hospital stays, and no differences in the degree of reverse remodeling, mortality, or quality of life (N. Engl. J. Med. 2014;371:2178-88).

“Two-year follow-up is ongoing. It really becomes very important that later this year or next year we’re going to have the results available for you to determine if the lower incidence of moderate or severe mitral regurgitation at 1 year translates into a net clinical benefit for patients undergoing CABG and mitral repair. This study has big implications for the practice of thoracic surgery and for how cardiologists refer patients,” according to Dr. Thourani.

The COAPT trial is randomizing patients with symptomatic functional mitral regurgitation and very high surgical risk to percutaneous catheter-based treatment with the MitraClip or to a standard-care control group. One-year outcomes will be presented in 2016, and follow-up out to 5 years is planned.

“You can see now that in cardiac surgery there’s a lot going on,” Dr. Thourani concluded. “It’s not only good for us, but it’s good for you. As a cardiovascular community, we need to work together more.”

He reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott Medical, Boston Scientific, Medtronic, and Sorin.

[email protected]

SAN DIEGO – The days when cardiologists could look down their noses at cardiac surgeons as primitive when it comes to conducting high-quality clinical research have come and gone.

“Cardiologists have been much more sophisticated than we have in doing randomized controlled trials. But cardiac surgeons are finally making strong progress in conducting randomized clinical trials, an area we’re not typically known for,” Dr. Vinod H. Thourani asserted at the annual meeting of the American College of Cardiology.

Much of this progress can be credited to the relatively recent creation of the Cardiothoracic Surgical Trials Network (CSTN), funded by the U.S. National Institutions of Health and the Canadian Institutes of Health Research. This surgical network is carrying out cutting-edge RCTs that will change the practice of cardiology as well as heart surgery, said Dr. Thourani, professor of surgery and codirector of the Structural Heart and Valve Center at Emory University, Atlanta.

To illustrate the breadth of current research in cardiothoracic surgery, he presented thumbnail sketches of RCTs due to report findings as early as this spring and no later than the latter part of next year or early 2017. The trials he selected, some conducted by the CSTN and others with industry sponsorship, address the aortic valve, the mitral valve, postoperative atrial fibrillation, revascularization in patients with unprotected left main coronary artery disease, and advanced heart failure.

• Heart failure: Outcomes of the ENDURANCE destination trial are due to be presented this spring at the annual meeting of the International Society for Heart and Lung Transplantation in Nice, France. This study will compare 12-month outcomes of continuous-flow ventricular assist devices as destination therapy in advanced heart failure. In this HeartWare-sponsored study, 310 patients received the investigational HeartWare ventricular assist system and 155 controls were implanted with the FDA-approved HeartMate II device marketed by Thoratec.

• Atrial fibrillation: The Rate Control Versus Rhythm Control for Postoperative Atrial Fibrillation trial compares the two management strategies in patients with new-onset AF following cardiac surgery. This CSTN-conducted study, to be presented next year, looks at which treatment approach results in fewer days in the hospital, as well as heart rhythm at discharge and through 60 days of follow-up, economic costs, and the incidence of postoperative clinical events.

• Coronary artery disease: The EXCEL trial has randomized 2,600 patients with unprotected left main coronary artery disease to coronary artery bypass surgery or percutaneous intervention with a XIENCE everolimus-eluting stent. The primary outcome is the composite of all-cause mortality, acute MI, or stroke. First results of this Abbott Vascular–sponsored trial are due to be reported next year.“This is a study that will clearly be impactful for you,” Dr. Thourani observed.

• Aortic valve disease: Two major RCTs are looking at the impact of extending transcatheter aortic valve replacement (TAVR) to an intermediate-surgical-risk population of patients with symptomatic severe aortic stenosis. The PARTNER II trial compares transfemoral or transapical/transaortic TAVR with a SAPIEN XT valve to surgical aortic valve replacement in patients with a Society of Thoracic Surgeons mortality risk score of 4%-8%. The primary endpoint is all-cause mortality and disabling stroke at 2 years. Results of this Edwards Lifesciences–sponsored trial will be presented by early 2016.

The Medtronic-sponsored SURTAVI trial compares TAVR using the company’s CoreValve alone or with PCI if revascularization is indicated versus surgical aortic valve replacement alone or with coronary artery bypass grafting if revascularization is indicated. This is a randomized trial involving 2,500 intermediate-risk patients. Of note, the SURTAVI investigators have revised the study protocol to open the trial to patients who are age 75 years or older or have an STS score of 2%-10%, which really redefines the concept of intermediate risk, Dr. Thourani said. Results will be presented by early 2017.

• Mitral valve disease: The Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation trial, carried out by the CSTN, will present 2-year outcome data later this year or in early 2016. The 1-year results caused major consternation in the surgical world. The eye opener was that 33% of patients in the repair group had moderate or severe mitral regurgitation at 12 months, compared with just 2% in the replacement group (N. Engl. J. Med. 2014;370:23-32). Mitral valve repair has traditionally been by far the more popular strategy. If the 2-year results show a growing disparity in terms of rates of severe mitral regurgitation, that may change.

Another CSTN study, the Surgical Intervention in Moderate Ischemic Mitral Regurgitation trial, found no demonstrable clinical benefit in adding a mitral valve repair operation to CABG surgery at 1 year of follow-up. The incidence of moderate or severe mitral regurgitation was lower at 1 year with concomitant valve repair and CABG, but this was offset by more neurologic events, longer ICU and total hospital stays, and no differences in the degree of reverse remodeling, mortality, or quality of life (N. Engl. J. Med. 2014;371:2178-88).

“Two-year follow-up is ongoing. It really becomes very important that later this year or next year we’re going to have the results available for you to determine if the lower incidence of moderate or severe mitral regurgitation at 1 year translates into a net clinical benefit for patients undergoing CABG and mitral repair. This study has big implications for the practice of thoracic surgery and for how cardiologists refer patients,” according to Dr. Thourani.

The COAPT trial is randomizing patients with symptomatic functional mitral regurgitation and very high surgical risk to percutaneous catheter-based treatment with the MitraClip or to a standard-care control group. One-year outcomes will be presented in 2016, and follow-up out to 5 years is planned.

“You can see now that in cardiac surgery there’s a lot going on,” Dr. Thourani concluded. “It’s not only good for us, but it’s good for you. As a cardiovascular community, we need to work together more.”

He reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott Medical, Boston Scientific, Medtronic, and Sorin.

[email protected]

HOUSTON – Newer systemic therapies for metastatic malignant melanoma have resulted in significant gains in survival, but at a cost that may be unsustainable in the near future, according to Dr. Jeffrey E. Gershenwald.

Up to one-half of all expenses related to the treatment of malignant melanoma are accounted for by the care of patients with advanced disease, yet patients with distant metastases (stage IV disease) account for only about 2% of all patients, said Dr. Gershenwald, professor of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston.

“How best can we achieve the right therapy for the right patient at the right time, and as we learn more and more about some of the therapies, particularly in melanoma, for the right length of time? We can’t really afford to give treatments in perpetuity, so we need to know how long they actually need to be delivered in order to have optimal value for the patient,” he said at the annual Society of Surgical Oncology Cancer Symposium.

Over the last 3 decades, and particularly over the last 5 years, there have been tremendous forward strides in therapy. In 1975, when dacarbazine became the standard of care for metastatic melanoma, it was associated with response rates of only about 6%-15%, durable responses in only 5%-15% of patients, and a median overall survival of about 6-9 months, Dr. Gershenwald reported.

Treatment toxicities, but not response rates, increased with the introduction of interleukin-2 in 1998, which for want of a better drug became the new preferred treatment.

But with the introduction of new systemic therapies, such as immune checkpoint inhibitors (ipilimumab [Yervoy], nivolumab [Opdivo], and pembrolizumab [Keytruda]) and targeted agents (vemurafenib [Zelboraf], dabrafenib [Tafinlar], and trametinib [Mekinist]), response rates have soared, resulting in an improvement in 1-year survival rates from about 30% to 35% in 1970 to as high as 80% in clinical trials in 2014.

Increased survival, higher costs

Dr. Gershenwald pointed to a recently published cost-effectiveness analysis of treatment strategies for BRAF-mutated metastatic melanoma. In it, the authors noted that vemurafenib costs $13,000 per month, translating into $207,000 for a patient with median survival. Patients for whom vemurafenib fails are often put on ipilimumab, at $150,000 per course.

The authors calculated that the incremental cost-effectiveness ratio (ICER) for vemurafenib compared with dacarbazine was nearly $354,993 per quality-adjusted life-year (QALY) gained, a figure that is more than threefold higher than widely accepted thresholds for cost-effective treatment ($50,000-$100,000 per QALY gained).

The ICER for firstline vemurafenib followed by ipilimumab was $158,139, still well above the accepted limits.

The authors of the cost analysis noted that the treatments could become cost effective if drug prices were to drop significantly, or if clinical trials could establish whether it was possible to achieve a durable response without continued therapy.

Going forward, clinicians will need to consider disease burden, including both the extent and growth rate of the disease, as well as the risk of recurrence, in deciding whether to use adjuvant therapies, Dr. Gershenwald said.

In addition, clinical choices will be based on disease biology, predictors of response (although few such predictors currently exist), the likelihood of resistance, and drug toxicities, quality of life, and ease of administration, he said.

Dr. Gershenwald disclosed serving on a Merck advisory board.

HOUSTON – Newer systemic therapies for metastatic malignant melanoma have resulted in significant gains in survival, but at a cost that may be unsustainable in the near future, according to Dr. Jeffrey E. Gershenwald.

Up to one-half of all expenses related to the treatment of malignant melanoma are accounted for by the care of patients with advanced disease, yet patients with distant metastases (stage IV disease) account for only about 2% of all patients, said Dr. Gershenwald, professor of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston.

“How best can we achieve the right therapy for the right patient at the right time, and as we learn more and more about some of the therapies, particularly in melanoma, for the right length of time? We can’t really afford to give treatments in perpetuity, so we need to know how long they actually need to be delivered in order to have optimal value for the patient,” he said at the annual Society of Surgical Oncology Cancer Symposium.

Over the last 3 decades, and particularly over the last 5 years, there have been tremendous forward strides in therapy. In 1975, when dacarbazine became the standard of care for metastatic melanoma, it was associated with response rates of only about 6%-15%, durable responses in only 5%-15% of patients, and a median overall survival of about 6-9 months, Dr. Gershenwald reported.

Treatment toxicities, but not response rates, increased with the introduction of interleukin-2 in 1998, which for want of a better drug became the new preferred treatment.

But with the introduction of new systemic therapies, such as immune checkpoint inhibitors (ipilimumab [Yervoy], nivolumab [Opdivo], and pembrolizumab [Keytruda]) and targeted agents (vemurafenib [Zelboraf], dabrafenib [Tafinlar], and trametinib [Mekinist]), response rates have soared, resulting in an improvement in 1-year survival rates from about 30% to 35% in 1970 to as high as 80% in clinical trials in 2014.

Increased survival, higher costs

Dr. Gershenwald pointed to a recently published cost-effectiveness analysis of treatment strategies for BRAF-mutated metastatic melanoma. In it, the authors noted that vemurafenib costs $13,000 per month, translating into $207,000 for a patient with median survival. Patients for whom vemurafenib fails are often put on ipilimumab, at $150,000 per course.

The authors calculated that the incremental cost-effectiveness ratio (ICER) for vemurafenib compared with dacarbazine was nearly $354,993 per quality-adjusted life-year (QALY) gained, a figure that is more than threefold higher than widely accepted thresholds for cost-effective treatment ($50,000-$100,000 per QALY gained).

The ICER for firstline vemurafenib followed by ipilimumab was $158,139, still well above the accepted limits.

The authors of the cost analysis noted that the treatments could become cost effective if drug prices were to drop significantly, or if clinical trials could establish whether it was possible to achieve a durable response without continued therapy.

Going forward, clinicians will need to consider disease burden, including both the extent and growth rate of the disease, as well as the risk of recurrence, in deciding whether to use adjuvant therapies, Dr. Gershenwald said.

In addition, clinical choices will be based on disease biology, predictors of response (although few such predictors currently exist), the likelihood of resistance, and drug toxicities, quality of life, and ease of administration, he said.

Dr. Gershenwald disclosed serving on a Merck advisory board.

HOUSTON – Newer systemic therapies for metastatic malignant melanoma have resulted in significant gains in survival, but at a cost that may be unsustainable in the near future, according to Dr. Jeffrey E. Gershenwald.

Up to one-half of all expenses related to the treatment of malignant melanoma are accounted for by the care of patients with advanced disease, yet patients with distant metastases (stage IV disease) account for only about 2% of all patients, said Dr. Gershenwald, professor of surgical oncology at the University of Texas M.D. Anderson Cancer Center, Houston.

“How best can we achieve the right therapy for the right patient at the right time, and as we learn more and more about some of the therapies, particularly in melanoma, for the right length of time? We can’t really afford to give treatments in perpetuity, so we need to know how long they actually need to be delivered in order to have optimal value for the patient,” he said at the annual Society of Surgical Oncology Cancer Symposium.

Over the last 3 decades, and particularly over the last 5 years, there have been tremendous forward strides in therapy. In 1975, when dacarbazine became the standard of care for metastatic melanoma, it was associated with response rates of only about 6%-15%, durable responses in only 5%-15% of patients, and a median overall survival of about 6-9 months, Dr. Gershenwald reported.

Treatment toxicities, but not response rates, increased with the introduction of interleukin-2 in 1998, which for want of a better drug became the new preferred treatment.

But with the introduction of new systemic therapies, such as immune checkpoint inhibitors (ipilimumab [Yervoy], nivolumab [Opdivo], and pembrolizumab [Keytruda]) and targeted agents (vemurafenib [Zelboraf], dabrafenib [Tafinlar], and trametinib [Mekinist]), response rates have soared, resulting in an improvement in 1-year survival rates from about 30% to 35% in 1970 to as high as 80% in clinical trials in 2014.

Increased survival, higher costs

Dr. Gershenwald pointed to a recently published cost-effectiveness analysis of treatment strategies for BRAF-mutated metastatic melanoma. In it, the authors noted that vemurafenib costs $13,000 per month, translating into $207,000 for a patient with median survival. Patients for whom vemurafenib fails are often put on ipilimumab, at $150,000 per course.

The authors calculated that the incremental cost-effectiveness ratio (ICER) for vemurafenib compared with dacarbazine was nearly $354,993 per quality-adjusted life-year (QALY) gained, a figure that is more than threefold higher than widely accepted thresholds for cost-effective treatment ($50,000-$100,000 per QALY gained).

The ICER for firstline vemurafenib followed by ipilimumab was $158,139, still well above the accepted limits.

The authors of the cost analysis noted that the treatments could become cost effective if drug prices were to drop significantly, or if clinical trials could establish whether it was possible to achieve a durable response without continued therapy.

Going forward, clinicians will need to consider disease burden, including both the extent and growth rate of the disease, as well as the risk of recurrence, in deciding whether to use adjuvant therapies, Dr. Gershenwald said.

In addition, clinical choices will be based on disease biology, predictors of response (although few such predictors currently exist), the likelihood of resistance, and drug toxicities, quality of life, and ease of administration, he said.

Dr. Gershenwald disclosed serving on a Merck advisory board.

CHICAGO – Placement of a U-tube drain provides enhanced percutaneous drainage and minimizes catheter-related complications in patients with complicated or infected necrotizing pancreatitis, new research suggests.

The U-tube method uses a large, 20-French Silastic tube with numerous large holes in the middle. One exit must be anterior through the peritoneal cavity and the other can be posterior in the retroperitoneum, Dr. Daniel E. Abbott said at the annual meeting of the Central Surgical Association.

Patrice Wendling/Frontline Medical News

The novel drainage system allows bidirectional flushing, greater interface with large fluid collections leading to more rapid resolution of retroperitoneal necrosis, and less risk of dislodgement resulting in fewer catheter exchanges or replacements. The system also creates a large-bore fistula tract to fall back on should subsequent fistulojejunostomy be needed, said Dr. Abbott of the University of Cincinnati Medical Center.

He reported on the largest clinical experience with primary U-tube drainage to date, involving 22 patients with necrotizing pancreatitis (NP) treated from 2011 to 2014. In 7 patients, (32%) no surgical procedure was ultimately required.

Of the others, 13 required further surgical intervention for a disrupted duct, and (59%) 2 patients died (9.1% ), Dr. Abbott said. Among eight patients who underwent fistulojejunostomy and five who underwent distal pancreatectomy and/or splenectomy, NP resolved in all but one patient with a recurrent amylase-rich fluid leak.

This compares favorably with a 20% mortality rate and 80% NP resolution among five institutional controls treated with open necrosectomy, he said.

Dr. Abbott acknowledged that the study was limited by small numbers and an insufficient control group for direct comparison.

Other studies have shown mortality rates in NP ranging from 39% with open necrosectomy to 4.5% with focused open necrosectomy, but their median length of stays were 54.5 days and 57 days, respectively. LOS was trimmed to just 19 days in one open necrosectomy study (Ann. Surg. 2008;247:294-9), but mortality was 11.4%, Dr. Abbott observed.

Dr. Abbott’s center is currently placing one to two U-tubes per month in patients with symptomatic NP (nausea, vomiting, weight loss, or infection on radiographic imaging) amenable to drainage and plans to update the analysis with prospectively collected data, including costs, in 2-3 years, he said.

“The U-tube obviously seems to work very well, but ... our radiologists sometimes have a hard time placing just one single tube. That [U-]tube, in particular, has to come anterior and out posterior and other organs can potentially get in the way,” said Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore University Health System, Evanston, Ill.

The morbidity and mortality rates are certainly better, but the improvements could be the result of improved ICU care or getting away from antibiotics, said Dr. Ujiki, a discussant at the meeting.

Dr. Abbott noted that “we are operating on people when they’re generally well instead of operating when they’re generally sick. When you’re doing an open necrosectomy, not only might there be multisystem organ failure, but [patients’] nutritional status is undoubtedly poor as well.”

Radiologists have yet to be unable to place a U-tube, but have delayed placement in stable, normotensive patients until fluid collections get larger to provide a better target, he said. The U-tube also can be placed at separate interventions. The two things patients complain most about are the size of the large tubes and when enzymatic fluid leaks onto their skin if the tube become clogged.

[email protected]

CHICAGO – Placement of a U-tube drain provides enhanced percutaneous drainage and minimizes catheter-related complications in patients with complicated or infected necrotizing pancreatitis, new research suggests.

The U-tube method uses a large, 20-French Silastic tube with numerous large holes in the middle. One exit must be anterior through the peritoneal cavity and the other can be posterior in the retroperitoneum, Dr. Daniel E. Abbott said at the annual meeting of the Central Surgical Association.

Patrice Wendling/Frontline Medical News

The novel drainage system allows bidirectional flushing, greater interface with large fluid collections leading to more rapid resolution of retroperitoneal necrosis, and less risk of dislodgement resulting in fewer catheter exchanges or replacements. The system also creates a large-bore fistula tract to fall back on should subsequent fistulojejunostomy be needed, said Dr. Abbott of the University of Cincinnati Medical Center.

He reported on the largest clinical experience with primary U-tube drainage to date, involving 22 patients with necrotizing pancreatitis (NP) treated from 2011 to 2014. In 7 patients, (32%) no surgical procedure was ultimately required.

Of the others, 13 required further surgical intervention for a disrupted duct, and (59%) 2 patients died (9.1% ), Dr. Abbott said. Among eight patients who underwent fistulojejunostomy and five who underwent distal pancreatectomy and/or splenectomy, NP resolved in all but one patient with a recurrent amylase-rich fluid leak.

This compares favorably with a 20% mortality rate and 80% NP resolution among five institutional controls treated with open necrosectomy, he said.

Dr. Abbott acknowledged that the study was limited by small numbers and an insufficient control group for direct comparison.

Other studies have shown mortality rates in NP ranging from 39% with open necrosectomy to 4.5% with focused open necrosectomy, but their median length of stays were 54.5 days and 57 days, respectively. LOS was trimmed to just 19 days in one open necrosectomy study (Ann. Surg. 2008;247:294-9), but mortality was 11.4%, Dr. Abbott observed.

Dr. Abbott’s center is currently placing one to two U-tubes per month in patients with symptomatic NP (nausea, vomiting, weight loss, or infection on radiographic imaging) amenable to drainage and plans to update the analysis with prospectively collected data, including costs, in 2-3 years, he said.

“The U-tube obviously seems to work very well, but ... our radiologists sometimes have a hard time placing just one single tube. That [U-]tube, in particular, has to come anterior and out posterior and other organs can potentially get in the way,” said Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore University Health System, Evanston, Ill.

The morbidity and mortality rates are certainly better, but the improvements could be the result of improved ICU care or getting away from antibiotics, said Dr. Ujiki, a discussant at the meeting.

Dr. Abbott noted that “we are operating on people when they’re generally well instead of operating when they’re generally sick. When you’re doing an open necrosectomy, not only might there be multisystem organ failure, but [patients’] nutritional status is undoubtedly poor as well.”

Radiologists have yet to be unable to place a U-tube, but have delayed placement in stable, normotensive patients until fluid collections get larger to provide a better target, he said. The U-tube also can be placed at separate interventions. The two things patients complain most about are the size of the large tubes and when enzymatic fluid leaks onto their skin if the tube become clogged.

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CHICAGO – Placement of a U-tube drain provides enhanced percutaneous drainage and minimizes catheter-related complications in patients with complicated or infected necrotizing pancreatitis, new research suggests.

The U-tube method uses a large, 20-French Silastic tube with numerous large holes in the middle. One exit must be anterior through the peritoneal cavity and the other can be posterior in the retroperitoneum, Dr. Daniel E. Abbott said at the annual meeting of the Central Surgical Association.

Patrice Wendling/Frontline Medical News

The novel drainage system allows bidirectional flushing, greater interface with large fluid collections leading to more rapid resolution of retroperitoneal necrosis, and less risk of dislodgement resulting in fewer catheter exchanges or replacements. The system also creates a large-bore fistula tract to fall back on should subsequent fistulojejunostomy be needed, said Dr. Abbott of the University of Cincinnati Medical Center.

He reported on the largest clinical experience with primary U-tube drainage to date, involving 22 patients with necrotizing pancreatitis (NP) treated from 2011 to 2014. In 7 patients, (32%) no surgical procedure was ultimately required.

Of the others, 13 required further surgical intervention for a disrupted duct, and (59%) 2 patients died (9.1% ), Dr. Abbott said. Among eight patients who underwent fistulojejunostomy and five who underwent distal pancreatectomy and/or splenectomy, NP resolved in all but one patient with a recurrent amylase-rich fluid leak.

This compares favorably with a 20% mortality rate and 80% NP resolution among five institutional controls treated with open necrosectomy, he said.

Dr. Abbott acknowledged that the study was limited by small numbers and an insufficient control group for direct comparison.

Other studies have shown mortality rates in NP ranging from 39% with open necrosectomy to 4.5% with focused open necrosectomy, but their median length of stays were 54.5 days and 57 days, respectively. LOS was trimmed to just 19 days in one open necrosectomy study (Ann. Surg. 2008;247:294-9), but mortality was 11.4%, Dr. Abbott observed.

Dr. Abbott’s center is currently placing one to two U-tubes per month in patients with symptomatic NP (nausea, vomiting, weight loss, or infection on radiographic imaging) amenable to drainage and plans to update the analysis with prospectively collected data, including costs, in 2-3 years, he said.

“The U-tube obviously seems to work very well, but ... our radiologists sometimes have a hard time placing just one single tube. That [U-]tube, in particular, has to come anterior and out posterior and other organs can potentially get in the way,” said Dr. Michael Ujiki, director of minimally invasive surgery at NorthShore University Health System, Evanston, Ill.

The morbidity and mortality rates are certainly better, but the improvements could be the result of improved ICU care or getting away from antibiotics, said Dr. Ujiki, a discussant at the meeting.

Dr. Abbott noted that “we are operating on people when they’re generally well instead of operating when they’re generally sick. When you’re doing an open necrosectomy, not only might there be multisystem organ failure, but [patients’] nutritional status is undoubtedly poor as well.”

Radiologists have yet to be unable to place a U-tube, but have delayed placement in stable, normotensive patients until fluid collections get larger to provide a better target, he said. The U-tube also can be placed at separate interventions. The two things patients complain most about are the size of the large tubes and when enzymatic fluid leaks onto their skin if the tube become clogged.

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