Taiga Otsuka1,2, Tsuyoshi Shirakawa3,4, Mototsugu Shimokawa5,6, Futa Koga7, Yasunori Kawaguchi7,8, Yujiro Ueda9, Junichi Nakazawa10, Azusa Komori11, Satoshi Otsu11, Shiho Arima12, Masaru Fukahori13, Yoshinobu Okabe13, Akitaka Makiyama14,15, Hiroki Taguchi16,17, Takuya Honda18, Taro Shibuki19,20, Kenta Nio21, Yasushi Ide22, Toshihiko Mizuta19,23, Kenji Mitsugi24, Norio Ureshino1,25. 1. Department of Medical Oncology, Saga Medical Center Koseikan, 400 Kase-machi, Saga-shi, Saga, 840-8571, Japan. 2. Department of Internal Medicine, Minato Medical Clinic, 3-11-3 Nagahama, Chuo-ku,, Fukuoka-shi, Fukuoka, 810-0072, Japan. 3. Department of Medical Oncology, Fukuoka Wajiro Hospital, 2-2-75 Wajirogaoka, Higashi-ku, Fukuoka-shi, Fukuoka, 811-0213, Japan. twriver1979@gmail.com. 4. Karatsu Higashi-Matsuura Medical Association Center, 2566-11 Chiyoda-machi, Karatsu-shi, Saga, 847-0041, Japan. twriver1979@gmail.com. 5. Clinical Research Institute, National Kyushu Cancer Center, 3-1-1 Notame, Minami-ku, Fukuoka-shi, Fukuoka, 811-1395, Japan. 6. Department of Biostatistics, Yamaguchi University Graduate School of Medicine, 1-1-1 Minamikogushi, Ube-shi, Yamaguchi, 755-8505, Japan. 7. Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, 400 Kase-machi, Saga-shi, Saga, 840-8571, Japan. 8. Department of Gastroenterology, Asakura Medical Association Hospital, 422-1 Raiha, Asakura-shi, Fukuoka, 838-0069, Japan. 9. Department of Hematology and Oncology, Japanese Red Cross Kumamoto Hospital, 2-1-1 Nagamine Minami, Higashi-ku, Kumamoto-shi, Kumamoto, 861-8520, Japan. 10. Department of Medical Oncology, Kagoshima City Hospital, 37-1 Uearata-cho, Kagoshima-shi, Kagoshima, 890-8760, Japan. 11. Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita, 879-5593, Japan. 12. Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan. 13. Department of Internal Medicine, Division of Gastroenterology, Kurume University Hospital, 67 Asahi-machi, Kurume-shi, Fukuoka, 830-0011, Japan. 14. Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, 806-8501, Japan. 15. Cancer Center, Gifu University Hospital, 1-1 Yanagido, Gifu-shi, Gifu, 501-1194, Japan. 16. Department of Gastroenterology, Saiseikai Sendai Hospital, 2-46 Harada-cho, Satsumasendai-shi, Kagoshima, 895-0074, Japan. 17. Department of Gastroenterology, Izumi General Medical Center, 520 Myojin-cho, Izumi-shi, Kagoshima, 899-0131, Japan. 18. Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki-shi, Nagasaki, 852-8501, Japan. 19. Department of Internal Medicine, Imari Arita Kyoritsu Hospital, Saga, 860 Ninose-ko, Arita-cho, Nishi-matsuura-gun, Saga, 849-4193, Japan. 20. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan. 21. Department of Medical Oncology, Sasebo Kyosai Hospital, 10-17 Shimanji-cho, Sasebo-shi, Nagasaki, 857-8575, Japan. 22. Department of Internal Medicine, Karatsu Red Cross Hospital, 2430 Watada, Karatsu-shi, Saga, 847-8588, Japan. 23. Department of Internal Medicine, Fujikawa Hospital, 1-2-6 Matsubara, Saga-shi, Saga, 840-0831, Japan. 24. Department of Medical Oncology, Hamanomachi Hospital, 3-3-1 Nagahama, Chuo-ku, Fukuoka-shi, Fukuoka, 810-8539, Japan. 25. Department of Medical Oncology, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu-shi, Chiba, 292-8535, Japan.
Abstract
PURPOSE: Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX, FFX) and gemcitabine plus nab-paclitaxel (GnP) are considered standard treatments for patients with metastatic pancreatic cancer. Direct comparisons are not available that establish which is optimal. METHODS: We conducted a propensity score-adjusted analysis of patients with metastatic pancreatic cancer to identify the therapeutic advantages of these standard therapies. We used clinical data as part of a multicenter retrospective study of patients with unresectable or recurrent pancreatic cancer treated with FFX or GnP (NAPOLEON study). RESULTS: FFX and GnP were initially administered to 102 and 153 patients, respectively. The GnP group comprised more patients of advanced age, worse performance status, lower body mass index, recurrence, and lower albumin concentrations. Median overall survival (OS) and progression-free survival (PFS) were 11.5 months and 5.8 months in the FFX group and 11.1 months and 5.9 months in the GnP group, respectively. Propensity score-adjusted analysis indicated that the administration of FFX or GnP was not independently associated with OS (adjusted hazard ratio [HR] 1.06; 95% confidence interval [CI] 0.76-1.47; P = 0.73). Similarly, the difference in PFS was not significant between groups (adjusted HR 0.93; 95% CI 0.68-1.26; P = 0.62). Gastrointestinal disorders were more common in the FFX group, whereas the frequencies of hematological, nervous system, and skin disorders were higher in the GnP group. CONCLUSION: The efficacies of FFX and GnP were comparable, although safety profiles differed and should be considered in selecting treatment.
PURPOSE:Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX, FFX) and gemcitabine plus nab-paclitaxel (GnP) are considered standard treatments for patients with metastatic pancreatic cancer. Direct comparisons are not available that establish which is optimal. METHODS: We conducted a propensity score-adjusted analysis of patients with metastatic pancreatic cancer to identify the therapeutic advantages of these standard therapies. We used clinical data as part of a multicenter retrospective study of patients with unresectable or recurrent pancreatic cancer treated with FFX or GnP (NAPOLEON study). RESULTS:FFX and GnP were initially administered to 102 and 153 patients, respectively. The GnP group comprised more patients of advanced age, worse performance status, lower body mass index, recurrence, and lower albumin concentrations. Median overall survival (OS) and progression-free survival (PFS) were 11.5 months and 5.8 months in the FFX group and 11.1 months and 5.9 months in the GnP group, respectively. Propensity score-adjusted analysis indicated that the administration of FFX or GnP was not independently associated with OS (adjusted hazard ratio [HR] 1.06; 95% confidence interval [CI] 0.76-1.47; P = 0.73). Similarly, the difference in PFS was not significant between groups (adjusted HR 0.93; 95% CI 0.68-1.26; P = 0.62). Gastrointestinal disorders were more common in the FFX group, whereas the frequencies of hematological, nervous system, and skin disorders were higher in the GnP group. CONCLUSION: The efficacies of FFX and GnP were comparable, although safety profiles differed and should be considered in selecting treatment.
Authors: M Ducreux; A Sa Cuhna; C Caramella; A Hollebecque; P Burtin; D Goéré; T Seufferlein; K Haustermans; J L Van Laethem; T Conroy; D Arnold Journal: Ann Oncol Date: 2015-09 Impact factor: 32.976
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