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Adjuvant Therapy in Locally Advanced Pancreatic Cancer

Insights From:Philip A. Philip, MD, Karmanos Cancer Center; Tanios Bekaii-Saab, MD, Mayo Clinic
Published: Thursday, Aug 04, 2016


Transcript:

Tanios Bekaii-Saab, MD:
For patients with localized pancreas cancer who actually undergo surgery, Whipple or pancreatectomy, once they come out of surgery, we have had had data for 2 to 3 decades actually that suggest that giving those patients or exposing them to adjuvant therapy makes a difference. So, we know that those patients would benefit from treatment. And, the next question was, what kind of treatment? The first consideration is chemotherapy versus chemotherapy and radiation. We have one study from the early 2000s that suggested that chemotherapy helps, whereby chemotherapy and radiation may be detrimental—although, that study had significant limitations.

Historically, though, when we look at the value of adding radiation to chemotherapy in pancreas cancer, it just does not seem to add value versus chemotherapy alone. At least at this point of time, outside of a clinical trial, it makes more sense to apply chemotherapy only for 6 months, and leave radiation as an experimental question—meaning in the confines of a clinical trial. This is being done by NRG/RTOG, looking at the question of whether we give chemotherapy for 5 months, and then apply radiation with chemotherapy for patients who do not progress. That question is still being asked in the experimental setting.

Outside of experimental setting, I believe that patients, regardless of resection margin or lymph node status, should receive adjuvant chemotherapy, no radiation. The next question is, which chemotherapy regimen? There’s gemcitabine alone and 5-FU. Gemcitabine alone seems to have activity; 5-FU seems to have very similar activity, although, because the study included only bolus 5-FU, there seems to be added toxicity compared to gemcitabine. So, right now the preferred regimen would be gemcitabine alone.

The next question, of course, is, can we do better than what we have right now? Right now, we doubled the disease-free survival of patients. We improved the overall survival a little bit with giving chemotherapy. And the question that remains is, can we do this better? So, there are three strategies that are asking the question. One unfortunately seems to have failed, in that, adding an immune therapy, the hyper acute vaccine algenpantucel-L, to chemotherapy or chemotherapy and radiation. We heard, at least from the press release, the study called IMPRESS was negative. So, it failed. The second strategy is actually to add nab-paclitaxel to gemcitabine versus gemcitabine alone, so try to simulate the improvements we’ve seen in the metastatic setting, and see if we can bring those to the localized setting. This study has completed and we’re waiting for the final results. We’ve heard that in ESPAC-4, which is a study that was conducted in Europe, looking at gemcitabine versus gemcitabine plus capecitabine is actually positive, at least statistically positive. We haven’t seen the results yet to make our minds up on whether it’s clinically meaningful or not. But, at least statistically, there has been an improvement. So, it seems a strategy of building up on gemcitabine or other cytotoxic agents may actually improve outcome in that disease. And finally, there’s a study with FOLFIRINOX, which may provide us some answers about whether a triplet would add more value. That study’s results are far from being obtained at this point of time. We have a number of strategies that are being looked at in the localized setting.

Transcript Edited for Clarity
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Transcript:

Tanios Bekaii-Saab, MD:
For patients with localized pancreas cancer who actually undergo surgery, Whipple or pancreatectomy, once they come out of surgery, we have had had data for 2 to 3 decades actually that suggest that giving those patients or exposing them to adjuvant therapy makes a difference. So, we know that those patients would benefit from treatment. And, the next question was, what kind of treatment? The first consideration is chemotherapy versus chemotherapy and radiation. We have one study from the early 2000s that suggested that chemotherapy helps, whereby chemotherapy and radiation may be detrimental—although, that study had significant limitations.

Historically, though, when we look at the value of adding radiation to chemotherapy in pancreas cancer, it just does not seem to add value versus chemotherapy alone. At least at this point of time, outside of a clinical trial, it makes more sense to apply chemotherapy only for 6 months, and leave radiation as an experimental question—meaning in the confines of a clinical trial. This is being done by NRG/RTOG, looking at the question of whether we give chemotherapy for 5 months, and then apply radiation with chemotherapy for patients who do not progress. That question is still being asked in the experimental setting.

Outside of experimental setting, I believe that patients, regardless of resection margin or lymph node status, should receive adjuvant chemotherapy, no radiation. The next question is, which chemotherapy regimen? There’s gemcitabine alone and 5-FU. Gemcitabine alone seems to have activity; 5-FU seems to have very similar activity, although, because the study included only bolus 5-FU, there seems to be added toxicity compared to gemcitabine. So, right now the preferred regimen would be gemcitabine alone.

The next question, of course, is, can we do better than what we have right now? Right now, we doubled the disease-free survival of patients. We improved the overall survival a little bit with giving chemotherapy. And the question that remains is, can we do this better? So, there are three strategies that are asking the question. One unfortunately seems to have failed, in that, adding an immune therapy, the hyper acute vaccine algenpantucel-L, to chemotherapy or chemotherapy and radiation. We heard, at least from the press release, the study called IMPRESS was negative. So, it failed. The second strategy is actually to add nab-paclitaxel to gemcitabine versus gemcitabine alone, so try to simulate the improvements we’ve seen in the metastatic setting, and see if we can bring those to the localized setting. This study has completed and we’re waiting for the final results. We’ve heard that in ESPAC-4, which is a study that was conducted in Europe, looking at gemcitabine versus gemcitabine plus capecitabine is actually positive, at least statistically positive. We haven’t seen the results yet to make our minds up on whether it’s clinically meaningful or not. But, at least statistically, there has been an improvement. So, it seems a strategy of building up on gemcitabine or other cytotoxic agents may actually improve outcome in that disease. And finally, there’s a study with FOLFIRINOX, which may provide us some answers about whether a triplet would add more value. That study’s results are far from being obtained at this point of time. We have a number of strategies that are being looked at in the localized setting.

Transcript Edited for Clarity
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