Masato Ozaka1, Hiroshi Ishii2, Tosiya Sato3, Makoto Ueno4, Masafumi Ikeda5, Kazuhiro Uesugi2, Naohiro Sata6, Kouichirou Miyashita7, Nobumasa Mizuno8, Kunihiro Tsuji9, Takuji Okusaka10, Junji Furuse11. 1. Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. masato.ozaka@jfcr.or.jp. 2. National Hospital Organization Shikoku Cancer Center, 160 Kou, Minami Umemoto, Matsuyama, 791-0280, Japan. 3. Department of Biostatistics, Kyoto University School of Public Health, Yoshida-honmachi, Sakyo-ku, Kyoto, 606-8501, Japan. 4. Division of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan. 5. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. 6. Department of Surgery, Jichi Medical University School of Medicine, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. 7. Internal Medicine of Gastroenterology, Showa University Northern Yokohama Hospital, Tsudukiku, Chigasakityuo 35-1, Yokohama, Kanagawa, 224-8503, Japan. 8. Department of Gastroenterology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. 9. Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kuratsukihigashi 2-1, Kanazawa, Ishikawa, 920-8530, Japan. 10. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 11. Department of Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan.
Abstract
BACKGROUND: We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer. METHODS: Patients with untreated metastatic pancreatic cancer (MPC) received modified FOLFIRINOX (intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2400 mg/m2 over 46 h, no bolus 5-FU). The primary endpoints were overall survival and the incidence of grade 3 or higher neutropenia. No patients received prophylactic pegfilgrastim. RESULTS: Sixty-nine pts. were enrolled from 39 institutions in Japan. The median overall survival was 11.2 months [95% confidence interval (CI) 9.0-]. The median progression-free survival was 5.5 months (95% CI 4.1-6.7). The response rate was 37.7% (95% CI 26.3-50.2), and the disease control rate was 78.3% (95% CI 66.7-87.3). The incidence of grade 3 or higher neutropenia was 47.8%. Serious adverse events occurred in six patients (8.7%). All AE proportions were less than those in the previous Japanese full-dose phase II study. One patient died due to interstitial pneumonia related to treatment. CONCLUSION: This is the first prospective study of modified FOLFIRINOX in Asia. Modified FOLFIRINOX in this study has an improved safety profile with maintained efficacy in MPC without prophylactic pegfilgrastim.
BACKGROUND: We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer. METHODS:Patients with untreated metastatic pancreatic cancer (MPC) received modified FOLFIRINOX (intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2400 mg/m2 over 46 h, no bolus 5-FU). The primary endpoints were overall survival and the incidence of grade 3 or higher neutropenia. No patients received prophylactic pegfilgrastim. RESULTS: Sixty-nine pts. were enrolled from 39 institutions in Japan. The median overall survival was 11.2 months [95% confidence interval (CI) 9.0-]. The median progression-free survival was 5.5 months (95% CI 4.1-6.7). The response rate was 37.7% (95% CI 26.3-50.2), and the disease control rate was 78.3% (95% CI 66.7-87.3). The incidence of grade 3 or higher neutropenia was 47.8%. Serious adverse events occurred in six patients (8.7%). All AE proportions were less than those in the previous Japanese full-dose phase II study. One patient died due to interstitial pneumonia related to treatment. CONCLUSION: This is the first prospective study of modified FOLFIRINOX in Asia. Modified FOLFIRINOX in this study has an improved safety profile with maintained efficacy in MPC without prophylactic pegfilgrastim.
Entities:
Keywords:
Chemotherapy; FOLFIRINOX; Metastatic; Modified FOLFIRINOX; Pancreatic cancer
Authors: Ramesh K Ramanathan; Shannon L McDonough; Philip A Philip; Sunil R Hingorani; Jill Lacy; Jeremy S Kortmansky; Jaykumar Thumar; E Gabriela Chiorean; Anthony F Shields; Deepti Behl; Paul T Mehan; Rakesh Gaur; Tara Seery; Katherine A Guthrie; Howard S Hochster Journal: J Clin Oncol Date: 2019-02-28 Impact factor: 50.717
Authors: Antonin Vary; Loïc Lebellec; Frédéric Di Fiore; Nicolas Penel; Claire Cheymol; Emilia Rad; Farid El Hajbi; Astrid Lièvre; Julien Edeline; André Michel Bimbai; Marie-Cécile Le Deley; Anthony Turpin Journal: Ther Adv Med Oncol Date: 2021-07-16 Impact factor: 8.168