Phase II clinical trial of gemcitabine plus oxaliplatin in patients with metastatic pancreatic adenocarcinoma with a fam
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ORIGINAL ARTICLE
Phase II clinical trial of gemcitabine plus oxaliplatin in patients with metastatic pancreatic adenocarcinoma with a family history of pancreatic/breast/ovarian/prostate cancer or personal history of breast/ovarian/prostate cancer (FABRIC study) Naohiro Okano1 · Chigusa Morizane2 · Shogo Nomura3 · Hideaki Takahashi4 · Hidetaka Tsumura5 · Hironaga Satake6 · Nobumasa Mizuno7 · Kunihiro Tsuji8 · Kazuhiko Shioji9 · Akinori Asagi10 · Kohichiroh Yasui11 · Sho Kitagawa12 · Tomomi Kashiwada13 · Atsushi Ishiguro14 · Masashi Kanai15 · Makoto Ueno16 · Takashi Ogura17 · Satoshi Shimizu18 · Kazutoshi Tobimatsu19 · Masayo Motoya20 · Koji Nakashima21 · Masafumi Ikeda4 · Takuji Okusaka2 · Junji Furuse1 Received: 11 April 2020 / Accepted: 2 June 2020 © Japan Society of Clinical Oncology 2020
Abstract Background A family/personal history of breast, ovarian, or pancreatic cancer is a useful predictive marker for response to platinum-based chemotherapy in treating patients with pancreatic cancer. These cancers, and prostate cancer, are known as BRCA-related malignancies. We evaluated the efficacy of gemcitabine plus oxaliplatin (GEMOX) in patients with metastatic pancreatic cancer with a family/personal history of these cancers. Methods Chemotherapy-naïve patients with metastatic pancreatic cancer with a family history of pancreatic/breast/ovarian/prostate cancer or a personal history of breast/ovarian/prostate cancer were included. Patients received fixed dose-rate gemcitabine (1000 mg/m2) and oxaliplatin (100 mg/m2) every 2 weeks. The primary endpoint was 1-year survival, and the threshold and expected values were set at 30 and 50%, respectively. The target sample size was determined to be 43, with a one-sided alpha value of 5% and power of 80%. A total of 45 patients were enrolled. Results Among the first 43 enrolled patients, the 1-year survival rate was 27.9% [90% confidence interval (CI) 17.0–41.3], which did not meet the primary endpoint. Median overall survival, progression-free survival, and response rates were 7.6 months (95% CI 6.0–10.7), 4.0 months (95% CI 2.0–4.6), and 26.7% (95% CI 14.6–41.9), respectively, in all registered patients. The GEMOX regimen was generally tolerated; the most common grade three or higher adverse events were hematological toxicities. Conclusion GEMOX did not show the expected efficacy in patients with metastatic pancreatic cancer with a family or personal history of pancreatic/breast/ovarian/prostate cancer. Selection of GEMOX based on family/personal history is not recommended. Trial registration number UMIN000017894. Keywords BRCA · Pancreatic cancer · Gemcitabine · Oxaliplatin · Platinum compounds
Introduction Familial pancreatic cancer is defined as having two or more first-degree relatives (FDRs) with pancreatic cancer and accounts for 4–10% of all pancreatic cancer cases [1]. A * Naohiro Okano naohiro‑[email protected]‑u.ac.jp Extended author information available on the last page of the article
family history of pancreatic cancer increases the risk of developin
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