膵がんにおいて術前化学放射線療法は有益である(Abstract LBA4002)

PREOPANC:術前の放射線療法を併用した化学療法は膵がん患者の生存率を改善する可能性がある
PREOPANC: Pre-operative chemotherapy with radiation may improve survival for people with pancreatic cancer
2018 ASCO Annual Meeting で取り上げられた第III相試験の結果、膵がんの術前に化学放射線療法を施行された患者は、治療を手術から開始する現在の標準治療を施行された患者に比べ無病生存期間が優れていたことが明らかにされた。このPREOPANC試験における全生存期間中央値は、術前化学放射線療法群で17.1か月であったのに対し、すぐに手術を施行された患者群では13.7か月であった(P=0.074)。膵がん再発までの期間もまた、術前治療群の方が長かった(9.9か月対7.9か月、P=0.023)。2年生存率についてもまた、術前化学放射線療法施行群において高かった(42% vs. 30%)。
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A randomized, phase III trial found that people who received chemoradiotherapy before pancreatic cancer surgery had better disease-free survival than those who started their treatment with surgery, which is the current standard of care. In addition, the two-year survival rate was higher for those who received chemoradiotherapy before surgery (42% vs. 30%). The preliminary findings of this trial show that chemoradiotherapy before surgery may be beneficial for patients with pancreatic cancer.

The study was presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.

"This is the first randomized clinical trial to show that pre-operative treatment improves outcomes for people with early stages of pancreatic cancer who can have surgery," said principal investigator Geertjan Van Tienhoven, MD, PhD, radiation oncologist at the Department of Radiation Oncology, Academic Medical Center in Amsterdam, the Netherlands. "We believe that this may be a practice-changing trial."

The PREOPANC-1 trial enrolled 246 patients with pancreatic cancer that can be surgically removed. The patients were randomly assigned to receive immediate surgery or chemoradiotherapy for 10 weeks, followed by surgery. Both treatment groups also received chemotherapy after surgery, and the total amount of chemotherapy given was equal in both groups. (The chemoradiotherapy group received part of the chemotherapy before surgery and the rest after.)

The median overall survival was 17.1 months with preoperative chemoradiotherapy compared to 13.7 months (p=0.074) with immediate surgery. The time until pancreatic cancer recurrence was longer with preoperative therapy, as well (9.9 months vs. 7.9 months, p=0.023). The chance of surviving longer than two years was also higher with pre-operative treatment than with immediate surgery (42% vs. 30%). In the subset of patients in which the tumor was surgically removed successfully, the difference in median survival was even greater: 42.1 months with preoperative treatment vs. 16.8 months with immediate surgery.

Resection was performed in 72% of patients in the immediate surgery group and 62% in the chemoradiotherapy group. Among the patients who had a resection, the tumor was microscopically completely removed in a greater proportion of patients who received preoperative treatment (63% vs. 31%).

"This study is an example of how treatments can be refined in an attempt to work better for patients. It's also a step in the right direction for people with pancreatic cancer, a disease that has proved extremely difficult to cure," said ASCO Expert Andrew Epstein, MD.

According to the authors, after the final analysis and publication of this trial, the next step is to attempt to find even more effective preoperative treatments. FOLFIRINOX chemotherapy or FOLFIRINOX combined with stereotactic body radiation therapy appear promising from other studies and should be tested against pre- operative gemcitabine and radiation in a randomized clinical trial.

This study received funding from the Dutch Cancer Society KWF.