Dr Epstein: This is an important trial looking at a subset of patients with pancreas cancer that has not metastasized. It looked at patients with either resectable pancreas tumors or borderline resectable tumors. Particularly with the borderline resectable patients， we need more studies like this to see if preoperative therapies are going to be of additional benefit. While we are awaiting final results from the final events this study was powered for， it is suggested that there might be benefit for the randomization towards chemoradiotherapy in addition to surgery. We need more information from this trial， but it is an important next step in this difficult-to-treat disease.

 

Dr Epstein: It is possible， but I do think we need more research before we call this first-line evidence. We not only need the final results of the trial showing statistical significance to show any merit at all， but we also need to see what the contributors are from the different populations in the trial， specifically the resectable patients and the borderline resectable patients. With the resectable patients， as we also saw with Conroy et al， if the tumor can be surgically removed， then FOLFIRINOX gives much more overall survival benefit compared to the previous standard of gemcitabine alone. So it still remains to be seen what can be done with resectable patients. But for borderline resectable patients， we would need more data that is statistically significant from this trial， as well as the role of chemotherapy alone without radiation. With a systemic disease like pancreas cancer， chemotherapy alone may have just as much， if not more， merit and less burden than radiation therapy adds.

 

 

Dr Epstein: I agree that it is an excellent example of “less is more”. It is a very important trial in the randomized setting evaluating the merits of something that has been done in the United States and elsewhere without any high level evidence outlining what is helpful and what is not. Patients with colorectal cancer who had a spread of their cancer to the peritoneum (which makes up a small subset of colorectal cancer) were randomized to receive surgery alone or surgery with the addition of HIPEC (heated intraperitoneal chemotherapy). The use of heated chemotherapy is based on non-randomized small series data that seems to indicate there might be benefit. This trial answered that question with a resounding no. It does not add additional benefit. In fact， it adds harm. We saw at 60 days there was a higher post-operative complication rate in the patients who received the additional chemotherapy. We no longer need to do heated intraperitoneal chemotherapy， or any intraperitoneal chemotherapy for colorectal cancer patients in the context of this clinical trial， because without this clinical trial data， we are not putting our best treatment strategies forward for patients and their families.

 

 

Dr Epstein: There have been many findings at this year’s ASCO. Another couple in the theme of “less is more” were presented at the Plenary Session yesterday. The TAILORx study showed that we can spare thousands of women the detriments of cytotoxic chemotherapy in those patients with intermediate risk recurrence score resected early stage breast cancer. Additionally， in the age of modern therapy with TKIs， in renal cell cancer we have now changed the standard of practice for metastatic renal cell cancer. Previously， the standard was to surgically remove the kidney cancer in the metastatic setting， but now we can spare patients the morbidity and risks associated with nephrectomy. So there are a lot of interesting things being done. More needs to be done. But the “less is more” findings are sobering and helpful.