Andrew X. Zhu, MD, PhD

ANDREW X. ZHU, MD, PhD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, noted that Prep-02/ JSAP-05 is the first study to show the value of neoadjuvant chemotherapy in patients with resectable pancreatic adenocarcinoma. However, the findings are applicable only to Asian populations for whom the oral fluoropyrimidine has been shown to be beneficial, he maintained, and he would not extrapolate them to U.S. or European patients.

“I’m very data-driven,” he told The ASCO Post. “Right now, in the States, we have FOLFIRINOX (fluorouracil infusion, irinotecan, oxaliplatin) and gemcitabine/nab-paclitaxel, and these regimens are robust, with data to support their use.”

That said, Dr. Zhu does see potential advantages for neoadjuvant chemotherapy in resectable disease. He noted it can target the potential of metastatic disease that may already be present, ensure the delivery of active chemotherapy upfront, and spare patients with aggressive disease from proceeding to surgery.

For Prep-02/JSAP-05, he would like to see some clarification as to the dose intensity of S-1 in both arms, the margin positivity rate, the disease-free survival rate, and the use of additional systemic therapy at the time of recurrence. However, he said he “concurred with the authors” that based on the data, neoadjuvant gemcitabine/S-1 plus adjuvant S-1 improved the median overall survival in Japanese patients with resectable disease.

Use of Asian Regimen in United States: Words of Caution

“THE RESULT definitely provides another viable option in Japanese patients with pancreatic cancer, although the results should be interpreted cautiously, as this regimen is only used in Asia,” he said. “I think in the United States and Europe, it is unlikely to change how we treat resectable pancreatic cancer.” The question, he said, centers on what the neoadjuvant therapy was really able to accomplish. What was the impact of R1 resection on survival? Is neoadjuvant chemotherapy truly delaying relapse or just improving overall survival in general?

Still to be determined are the optimal neoadjuvant regimen, the treatment duration, and the role of radiotherapy in the neoadjuvant setting. These and other questions are being addressed in phase III trials. Meanwhile, Dr. Zhu noted that at Massachusetts General, neoadjuvant therapy is being used “aggressively” but within the confines of clinical trials. ■

DISCLOSURE: Dr. Zhu has served as a consultant/advisor to AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Exelixis, Lilly, Merck, Novartis, and Roche/Genentech and has received institutional research funding from Bayer, Bristol-Myers Squibb, Lilly, Merck, and Novartis