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BOSTON – The real challenge for a new technology is not the good idea. It comes after FDA approval when a company must figure out how to get its device or procedure paid for, said Dr. Steven Schwaitzberg, professor and chief of the department of surgery at the University of Buffalo, speaking at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Physicians want to provide cutting-edge tools to their patients, but they need to be reimbursed, and getting payers, like hospitals or government payers, to pay for the new procedure or device is the challenge. The AGA center facilitates this process by running observational research device registries to collect the data that show patient need, document value, and provide proof of efficacy.

BOSTON – The real challenge for a new technology is not the good idea. It comes after FDA approval when a company must figure out how to get its device or procedure paid for, said Dr. Steven Schwaitzberg, professor and chief of the department of surgery at the University of Buffalo, speaking at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Physicians want to provide cutting-edge tools to their patients, but they need to be reimbursed, and getting payers, like hospitals or government payers, to pay for the new procedure or device is the challenge. The AGA center facilitates this process by running observational research device registries to collect the data that show patient need, document value, and provide proof of efficacy.

BOSTON – The real challenge for a new technology is not the good idea. It comes after FDA approval when a company must figure out how to get its device or procedure paid for, said Dr. Steven Schwaitzberg, professor and chief of the department of surgery at the University of Buffalo, speaking at the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology. Physicians want to provide cutting-edge tools to their patients, but they need to be reimbursed, and getting payers, like hospitals or government payers, to pay for the new procedure or device is the challenge. The AGA center facilitates this process by running observational research device registries to collect the data that show patient need, document value, and provide proof of efficacy.

BOSTON – Innovation, incoming AGA Institute President Timothy Wang explained at the AGA Tech Summit, is how AGA members will improve patient care and move the specialty forward. The AGA supports innovation through the work of the Center for GI Innovation and Technology, which sponsored the 2016 AGA Tech Summit, and by providing grants to young researchers through the AGA Research Foundation, such as the AGA–Boston Scientific and AGA–Covidien innovation awards, as well as many others.

BOSTON – Innovation, incoming AGA Institute President Timothy Wang explained at the AGA Tech Summit, is how AGA members will improve patient care and move the specialty forward. The AGA supports innovation through the work of the Center for GI Innovation and Technology, which sponsored the 2016 AGA Tech Summit, and by providing grants to young researchers through the AGA Research Foundation, such as the AGA–Boston Scientific and AGA–Covidien innovation awards, as well as many others.

BOSTON – Innovation, incoming AGA Institute President Timothy Wang explained at the AGA Tech Summit, is how AGA members will improve patient care and move the specialty forward. The AGA supports innovation through the work of the Center for GI Innovation and Technology, which sponsored the 2016 AGA Tech Summit, and by providing grants to young researchers through the AGA Research Foundation, such as the AGA–Boston Scientific and AGA–Covidien innovation awards, as well as many others.

AUSTIN, TEX. – The shift from fee-for-service to value-based health care raises important questions about determining a physician practice’s fair market value, according to financial analyst Albert “Chip” D. Hutzler.

How will the new systems impact valuation? What about commercial reasonableness of arrangements? In a video interview at an American Health Lawyers Association meeting, Mr. Hutzler of HealthCare Appraisers, Delray, Fla., discussed the intersection of fair market value and value-based care, and he offered guidance on how to prepare for the changes.

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – The shift from fee-for-service to value-based health care raises important questions about determining a physician practice’s fair market value, according to financial analyst Albert “Chip” D. Hutzler.

How will the new systems impact valuation? What about commercial reasonableness of arrangements? In a video interview at an American Health Lawyers Association meeting, Mr. Hutzler of HealthCare Appraisers, Delray, Fla., discussed the intersection of fair market value and value-based care, and he offered guidance on how to prepare for the changes.

[email protected]

On Twitter @legal_med

AUSTIN, TEX. – The shift from fee-for-service to value-based health care raises important questions about determining a physician practice’s fair market value, according to financial analyst Albert “Chip” D. Hutzler.

How will the new systems impact valuation? What about commercial reasonableness of arrangements? In a video interview at an American Health Lawyers Association meeting, Mr. Hutzler of HealthCare Appraisers, Delray, Fla., discussed the intersection of fair market value and value-based care, and he offered guidance on how to prepare for the changes.

[email protected]

On Twitter @legal_med

AMSTERDAM – An unexpectedly dramatic benefit from combining trastuzumab and lapatinib when briefly treating women scheduled for breast cancer surgery has researchers focused on the best follow-up study to this promising but preliminary finding from 66 patients.

Among 66 patients with newly diagnosed HER2-positive breast cancer and scheduled for surgery, an average 11 days of treatment with a combination of trastuzumab (Herceptin) and lapatinib (Tykerb) during the period before surgery resulted in a pathologic complete response (pCR) in seven patients (11%) and 11 patients (17%) with minimal residual disease (MRD), Dr. Nigel Bundred reported at the European Breast Cancer Conference.

Mitchel L. Zoler/Frontline Medical News

These patients had breast cancer tumors at baseline with a median diameter of 2 cm that with treatment for not quite 2 weeks resulted in either complete tumor disappearance or shrinkage to less than 5 mm in diameter in 18 (27%) of the patients on dual therapy, said Dr. Bundred, a professor of surgical oncology at the University Hospital of South Manchester (England).

“No cancer has ever disappeared that fast. It was flabbergasting,” Dr. Bundred said in an interview. “We need to confirm the results, and get larger numbers of patients.”

“This was a really surprising finding,” said Judith M. Bliss, professor and director of the Clinical Trials & Statistics unit of the Institute of Cancer Research in London and a co-investigator. “We knew that trastuzumab and lapatinib are effective treatments, but we had not expected to see such a dramatic effect on the structure and size of the tumor in such a short period of time,” Prof. Bliss said in a video interview.

The finding came as part of the Effect of Perioperative Anti-HER2 Therapy on Overall Survival–Biologic Phase (EPHOS-B) trial, designed to assess changes in a marker of cell proliferation (Ki67) and in a marker of cell apoptosis in relation to treatment with trastuzumab, lapatinib, or both when administered during the 10-12 days from the time patients entered the study until their scheduled surgery.

During the first phase of EPHOS-B, when 130 patients received trastuzumab monotherapy, lapatinib monotherapy, or neither, one of the 57 patients on trastuzumab (2%) had a pathologic complete response and one patient (2%) had minimal residual disease. No patients on lapatinib alone or in the control arm with no anti-HER2 drug had this sort of response.

During the second phase, 127 patients received trastuzumab alone, trastuzumab plus lapatinib in combination, or controls who received no anti-HER2 treatment. The substantial number of complete or partial responders in the 66 patients who received combined treatment with trastuzumab and lapatinib contrasted with one minimal residual disease among 32 patients (3%) who received trastuzumab alone and no responders among the 29 controls.

Patients receiving trastuzumab, alone or in the combined regimen, received a standard intravenous loading dosage of 6 mg/kg on days 1 and 8 after entry into the protocol, followed by a third dose after surgery on days 15-19; those also receiving lapatinib received 1 g/day orally for 28 days starting on entry.

“A quarter of the patients seem exquisitely sensitive to the combination of trastuzumab and lapatinib,” said Dr. David Cameron, another collaborator on the EPHOS-B study. “It’s pretty unusual to treat for 10-12 days and have 10% of the tumors disappear.”

Follow-up studies will be needed to determine whether patients with a pathologic complete response or minimal residual disease can forgo some or all of the chemotherapy that would usually follow surgery and still have good long-term disease-free survival. “We will focus on optimizing the short-term effect, and then modulate subsequent treatments,” said Dr. Cameron, professor and clinical director of oncology at the University of Edinburgh.

“We think these are patients who don’t need chemotherapy and are particularly sensitive to anti-HER2 drugs,” but so far that hasn’t been proven, cautioned Ms. Bliss.

The striking efficacy of trastuzumab combined with lapatinib in these 66 patients contrasts with the previously reported results from the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) study, which failed to show an advantage in disease-free survival with trastuzumab plus lapatinib, compared with either of these two agents used individually during 1 year of adjuvant treatment in more than 8,000 randomized patients (J Clin Oncol. 2015 Nov 23. doi: 10.1200/JCO.2015.62.1797), But the EPHOS-B results did agree with results from the much smaller NeoALTTO study, which showed in a randomized, multicenter, phase III study with 455 patients a significant incremental increase in pathologic complete response rate in patients on combined trastuzumab plus lapatinib, compared with patients on either drug alone (Lancet. 2012;379 [9816]:633-40).

Another promising finding from EPHOS-B was that among the 64 patients who had their left ventricular ejection fraction assessed prior to the second phase, none of 32 patients on the combined regimen showed signs of cardiotoxicity with a reduced ejection fraction following treatment, Dr. Bundred reported.

Until now, not much was known about the beneficial mechanisms of anti-HER2 drugs, he noted. The results from EPHOS-B “tell us that combined treatment does more than just shut down cell replication. It might be that trastuzumab induces an immune response.” The former tumor beds of patients with pathologic complete response as well as regions with minimal residual disease showed large numbers of tumor infiltrating lymphocytes, a sign of a robust immune response.

Trastuzumab and lapatinib work by different mechanisms, Dr. Bundred stressed. “The only way you can combine drugs is by understanding their mechanisms. We’re still looking for the mechanisms of the anti-HER2 drugs.”

[email protected]

On Twitter @mitchelzoler

AMSTERDAM – An unexpectedly dramatic benefit from combining trastuzumab and lapatinib when briefly treating women scheduled for breast cancer surgery has researchers focused on the best follow-up study to this promising but preliminary finding from 66 patients.

Among 66 patients with newly diagnosed HER2-positive breast cancer and scheduled for surgery, an average 11 days of treatment with a combination of trastuzumab (Herceptin) and lapatinib (Tykerb) during the period before surgery resulted in a pathologic complete response (pCR) in seven patients (11%) and 11 patients (17%) with minimal residual disease (MRD), Dr. Nigel Bundred reported at the European Breast Cancer Conference.

Mitchel L. Zoler/Frontline Medical News

These patients had breast cancer tumors at baseline with a median diameter of 2 cm that with treatment for not quite 2 weeks resulted in either complete tumor disappearance or shrinkage to less than 5 mm in diameter in 18 (27%) of the patients on dual therapy, said Dr. Bundred, a professor of surgical oncology at the University Hospital of South Manchester (England).

“No cancer has ever disappeared that fast. It was flabbergasting,” Dr. Bundred said in an interview. “We need to confirm the results, and get larger numbers of patients.”

“This was a really surprising finding,” said Judith M. Bliss, professor and director of the Clinical Trials & Statistics unit of the Institute of Cancer Research in London and a co-investigator. “We knew that trastuzumab and lapatinib are effective treatments, but we had not expected to see such a dramatic effect on the structure and size of the tumor in such a short period of time,” Prof. Bliss said in a video interview.

The finding came as part of the Effect of Perioperative Anti-HER2 Therapy on Overall Survival–Biologic Phase (EPHOS-B) trial, designed to assess changes in a marker of cell proliferation (Ki67) and in a marker of cell apoptosis in relation to treatment with trastuzumab, lapatinib, or both when administered during the 10-12 days from the time patients entered the study until their scheduled surgery.

During the first phase of EPHOS-B, when 130 patients received trastuzumab monotherapy, lapatinib monotherapy, or neither, one of the 57 patients on trastuzumab (2%) had a pathologic complete response and one patient (2%) had minimal residual disease. No patients on lapatinib alone or in the control arm with no anti-HER2 drug had this sort of response.

During the second phase, 127 patients received trastuzumab alone, trastuzumab plus lapatinib in combination, or controls who received no anti-HER2 treatment. The substantial number of complete or partial responders in the 66 patients who received combined treatment with trastuzumab and lapatinib contrasted with one minimal residual disease among 32 patients (3%) who received trastuzumab alone and no responders among the 29 controls.

Patients receiving trastuzumab, alone or in the combined regimen, received a standard intravenous loading dosage of 6 mg/kg on days 1 and 8 after entry into the protocol, followed by a third dose after surgery on days 15-19; those also receiving lapatinib received 1 g/day orally for 28 days starting on entry.

“A quarter of the patients seem exquisitely sensitive to the combination of trastuzumab and lapatinib,” said Dr. David Cameron, another collaborator on the EPHOS-B study. “It’s pretty unusual to treat for 10-12 days and have 10% of the tumors disappear.”

Follow-up studies will be needed to determine whether patients with a pathologic complete response or minimal residual disease can forgo some or all of the chemotherapy that would usually follow surgery and still have good long-term disease-free survival. “We will focus on optimizing the short-term effect, and then modulate subsequent treatments,” said Dr. Cameron, professor and clinical director of oncology at the University of Edinburgh.

“We think these are patients who don’t need chemotherapy and are particularly sensitive to anti-HER2 drugs,” but so far that hasn’t been proven, cautioned Ms. Bliss.

The striking efficacy of trastuzumab combined with lapatinib in these 66 patients contrasts with the previously reported results from the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) study, which failed to show an advantage in disease-free survival with trastuzumab plus lapatinib, compared with either of these two agents used individually during 1 year of adjuvant treatment in more than 8,000 randomized patients (J Clin Oncol. 2015 Nov 23. doi: 10.1200/JCO.2015.62.1797), But the EPHOS-B results did agree with results from the much smaller NeoALTTO study, which showed in a randomized, multicenter, phase III study with 455 patients a significant incremental increase in pathologic complete response rate in patients on combined trastuzumab plus lapatinib, compared with patients on either drug alone (Lancet. 2012;379 [9816]:633-40).

Another promising finding from EPHOS-B was that among the 64 patients who had their left ventricular ejection fraction assessed prior to the second phase, none of 32 patients on the combined regimen showed signs of cardiotoxicity with a reduced ejection fraction following treatment, Dr. Bundred reported.

Until now, not much was known about the beneficial mechanisms of anti-HER2 drugs, he noted. The results from EPHOS-B “tell us that combined treatment does more than just shut down cell replication. It might be that trastuzumab induces an immune response.” The former tumor beds of patients with pathologic complete response as well as regions with minimal residual disease showed large numbers of tumor infiltrating lymphocytes, a sign of a robust immune response.

Trastuzumab and lapatinib work by different mechanisms, Dr. Bundred stressed. “The only way you can combine drugs is by understanding their mechanisms. We’re still looking for the mechanisms of the anti-HER2 drugs.”

[email protected]

On Twitter @mitchelzoler

AMSTERDAM – An unexpectedly dramatic benefit from combining trastuzumab and lapatinib when briefly treating women scheduled for breast cancer surgery has researchers focused on the best follow-up study to this promising but preliminary finding from 66 patients.

Among 66 patients with newly diagnosed HER2-positive breast cancer and scheduled for surgery, an average 11 days of treatment with a combination of trastuzumab (Herceptin) and lapatinib (Tykerb) during the period before surgery resulted in a pathologic complete response (pCR) in seven patients (11%) and 11 patients (17%) with minimal residual disease (MRD), Dr. Nigel Bundred reported at the European Breast Cancer Conference.

Mitchel L. Zoler/Frontline Medical News

These patients had breast cancer tumors at baseline with a median diameter of 2 cm that with treatment for not quite 2 weeks resulted in either complete tumor disappearance or shrinkage to less than 5 mm in diameter in 18 (27%) of the patients on dual therapy, said Dr. Bundred, a professor of surgical oncology at the University Hospital of South Manchester (England).

“No cancer has ever disappeared that fast. It was flabbergasting,” Dr. Bundred said in an interview. “We need to confirm the results, and get larger numbers of patients.”

“This was a really surprising finding,” said Judith M. Bliss, professor and director of the Clinical Trials & Statistics unit of the Institute of Cancer Research in London and a co-investigator. “We knew that trastuzumab and lapatinib are effective treatments, but we had not expected to see such a dramatic effect on the structure and size of the tumor in such a short period of time,” Prof. Bliss said in a video interview.

The finding came as part of the Effect of Perioperative Anti-HER2 Therapy on Overall Survival–Biologic Phase (EPHOS-B) trial, designed to assess changes in a marker of cell proliferation (Ki67) and in a marker of cell apoptosis in relation to treatment with trastuzumab, lapatinib, or both when administered during the 10-12 days from the time patients entered the study until their scheduled surgery.

During the first phase of EPHOS-B, when 130 patients received trastuzumab monotherapy, lapatinib monotherapy, or neither, one of the 57 patients on trastuzumab (2%) had a pathologic complete response and one patient (2%) had minimal residual disease. No patients on lapatinib alone or in the control arm with no anti-HER2 drug had this sort of response.

During the second phase, 127 patients received trastuzumab alone, trastuzumab plus lapatinib in combination, or controls who received no anti-HER2 treatment. The substantial number of complete or partial responders in the 66 patients who received combined treatment with trastuzumab and lapatinib contrasted with one minimal residual disease among 32 patients (3%) who received trastuzumab alone and no responders among the 29 controls.

Patients receiving trastuzumab, alone or in the combined regimen, received a standard intravenous loading dosage of 6 mg/kg on days 1 and 8 after entry into the protocol, followed by a third dose after surgery on days 15-19; those also receiving lapatinib received 1 g/day orally for 28 days starting on entry.

“A quarter of the patients seem exquisitely sensitive to the combination of trastuzumab and lapatinib,” said Dr. David Cameron, another collaborator on the EPHOS-B study. “It’s pretty unusual to treat for 10-12 days and have 10% of the tumors disappear.”

Follow-up studies will be needed to determine whether patients with a pathologic complete response or minimal residual disease can forgo some or all of the chemotherapy that would usually follow surgery and still have good long-term disease-free survival. “We will focus on optimizing the short-term effect, and then modulate subsequent treatments,” said Dr. Cameron, professor and clinical director of oncology at the University of Edinburgh.

“We think these are patients who don’t need chemotherapy and are particularly sensitive to anti-HER2 drugs,” but so far that hasn’t been proven, cautioned Ms. Bliss.

The striking efficacy of trastuzumab combined with lapatinib in these 66 patients contrasts with the previously reported results from the ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization) study, which failed to show an advantage in disease-free survival with trastuzumab plus lapatinib, compared with either of these two agents used individually during 1 year of adjuvant treatment in more than 8,000 randomized patients (J Clin Oncol. 2015 Nov 23. doi: 10.1200/JCO.2015.62.1797), But the EPHOS-B results did agree with results from the much smaller NeoALTTO study, which showed in a randomized, multicenter, phase III study with 455 patients a significant incremental increase in pathologic complete response rate in patients on combined trastuzumab plus lapatinib, compared with patients on either drug alone (Lancet. 2012;379 [9816]:633-40).

Another promising finding from EPHOS-B was that among the 64 patients who had their left ventricular ejection fraction assessed prior to the second phase, none of 32 patients on the combined regimen showed signs of cardiotoxicity with a reduced ejection fraction following treatment, Dr. Bundred reported.

Until now, not much was known about the beneficial mechanisms of anti-HER2 drugs, he noted. The results from EPHOS-B “tell us that combined treatment does more than just shut down cell replication. It might be that trastuzumab induces an immune response.” The former tumor beds of patients with pathologic complete response as well as regions with minimal residual disease showed large numbers of tumor infiltrating lymphocytes, a sign of a robust immune response.

Trastuzumab and lapatinib work by different mechanisms, Dr. Bundred stressed. “The only way you can combine drugs is by understanding their mechanisms. We’re still looking for the mechanisms of the anti-HER2 drugs.”

[email protected]

On Twitter @mitchelzoler

Patient interest in over-the-counter (OTC) antiaging products is increasing; however, the number of products to choose from can be overwhelming and patients may end up spending a lot of money on products that do not work. Dr. Anthony Rossi provides an overview of the latest trends in OTC antiaging products, including antioxidant-containing sunscreens, growth factors, and topical hyaluronic acid. Dr. Rossi notes that patients often call on dermatologists to offer product recommendations. Therefore, it is important for dermatologists to be familiar with product ingredients and counsel patients accordingly in order to maximize their effects on the skin.

Patient interest in over-the-counter (OTC) antiaging products is increasing; however, the number of products to choose from can be overwhelming and patients may end up spending a lot of money on products that do not work. Dr. Anthony Rossi provides an overview of the latest trends in OTC antiaging products, including antioxidant-containing sunscreens, growth factors, and topical hyaluronic acid. Dr. Rossi notes that patients often call on dermatologists to offer product recommendations. Therefore, it is important for dermatologists to be familiar with product ingredients and counsel patients accordingly in order to maximize their effects on the skin.

Patient interest in over-the-counter (OTC) antiaging products is increasing; however, the number of products to choose from can be overwhelming and patients may end up spending a lot of money on products that do not work. Dr. Anthony Rossi provides an overview of the latest trends in OTC antiaging products, including antioxidant-containing sunscreens, growth factors, and topical hyaluronic acid. Dr. Rossi notes that patients often call on dermatologists to offer product recommendations. Therefore, it is important for dermatologists to be familiar with product ingredients and counsel patients accordingly in order to maximize their effects on the skin.