Satoshi Nagayama1, Suguru Hasegawa2, Koya Hida2, Kenji Kawada2, Etsuro Hatano2, Kojiro Nakamura2, Satoru Seo2, Kojiro Taura2, Kentaro Yasuchika2, Takashi Matsuo3, Masazumi Zaima3, Akiyoshi Kanazawa4, Hiroaki Terajima5, Masaharu Tada5, Yukihito Adachi6, Ryuta Nishitai7, Dai Manaka7, Tsunehiro Yoshimura8, Koji Doi9, Takahiro Horimatsu10, Akira Mitsuyoshi11, Kenichi Yoshimura12, Miyuki Niimi12, Shigemi Matsumoto10, Yoshiharu Sakai2, Shinji Uemoto2. 1. Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan. nagayama@kuhp.kyoto-u.ac.jp. 2. Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan. 3. Department of Surgery, Shiga Medical Center for Adults, 5-4-30 Moriyama, Moriyama City, Shiga, Japan. 4. Department of Surgery, Osaka Red Cross Hospital, 5-30 Fudegasaki-cho, Ten-noji-ku, Osaka, Japan. 5. Department of Surgery, Kitano Hospital, 2-4-20 Oogimachi, Kita-ku, Osaka, Japan. 6. Department of Surgery, Saiseikai Noe Hospital, 1-3-25 Furuichi, Joto-ku, Osaka, Japan. 7. Department of Surgery, Kyoto Katsura Hospital, 17 Hirao-cho, Yamada, Nishikyo-ku, Kyoto, Japan. 8. Department of Surgery, Tenri Yorozu Hospital, 200 Mishima-cho, Tenri, Nara, Japan. 9. Department of Surgery, Fukui Red Cross Hospital, 2-4-1 Tsukimi, Fukui, Japan. 10. Department of Medical Oncology, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan. 11. Department of Surgery, Mitsubishi Kyoto Hospital, 1 Gosho-cho, Katsura, Sakyo-ku, Kyoto, Japan. 12. Translational Research Center, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan.
Abstract
BACKGROUND: Although liver resection combined with preoperative chemotherapy is expected to improve outcomes of patients with resectable colorectal liver metastasis (CRLM), there is as yet insufficient clinical evidence supporting the efficacy of preoperative systemic chemotherapy. The aim of this phase II study was to assess the feasibility and efficacy of preoperative FOLFOX systemic chemotherapy for patients with initially resectable CRLM. METHODS: A prospective multi-institutional phase II study was conducted to evaluate the feasibility and efficacy of preoperative chemotherapy for resectable CRLM (ClinicalTrials.gov identifier number NCT00594529). Patients were scheduled to receive 6 cycles of mFOLFOX6 therapy before liver surgery. The primary endpoint was the macroscopic curative resection rate. RESULTS: A total of 30 patients were included in this study. Two patients who were diagnosed with hepatocellular and intrahepatic cholangiocellular carcinoma based on pathology were excluded from the analysis. More than half of the patients (57 %) had solitary liver metastasis. The completion rate of preoperative chemotherapy was 64.3 % and the response rate was 53.6 %. Two patients were unable to proceed to liver resections due to disease progression and severe postoperative complications following primary tumor resection. Macroscopic curative resection was obtained in 89.3 % of eligible patients. Postoperative mortality and severe complication (≥Gr. 3) rates were 0 and 11 %, respectively. The 3-year overall and progression-free survival rates were 81.9 and 47.4 %, respectively. CONCLUSION: Our phase II study demonstrated the feasibility of liver resection combined with preoperative mFOLFOX6 therapy in patients with initially resectable CRLM. Further study is warranted to address the oncological effects of preoperative chemotherapy.
BACKGROUND: Although liver resection combined with preoperative chemotherapy is expected to improve outcomes of patients with resectable colorectal liver metastasis (CRLM), there is as yet insufficient clinical evidence supporting the efficacy of preoperative systemic chemotherapy. The aim of this phase II study was to assess the feasibility and efficacy of preoperative FOLFOX systemic chemotherapy for patients with initially resectable CRLM. METHODS: A prospective multi-institutional phase II study was conducted to evaluate the feasibility and efficacy of preoperative chemotherapy for resectable CRLM (ClinicalTrials.gov identifier number NCT00594529). Patients were scheduled to receive 6 cycles of mFOLFOX6 therapy before liver surgery. The primary endpoint was the macroscopic curative resection rate. RESULTS: A total of 30 patients were included in this study. Two patients who were diagnosed with hepatocellular and intrahepatic cholangiocellular carcinoma based on pathology were excluded from the analysis. More than half of the patients (57 %) had solitary liver metastasis. The completion rate of preoperative chemotherapy was 64.3 % and the response rate was 53.6 %. Two patients were unable to proceed to liver resections due to disease progression and severe postoperative complications following primary tumor resection. Macroscopic curative resection was obtained in 89.3 % of eligible patients. Postoperative mortality and severe complication (≥Gr. 3) rates were 0 and 11 %, respectively. The 3-year overall and progression-free survival rates were 81.9 and 47.4 %, respectively. CONCLUSION: Our phase II study demonstrated the feasibility of liver resection combined with preoperative mFOLFOX6 therapy in patients with initially resectable CRLM. Further study is warranted to address the oncological effects of preoperative chemotherapy.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: Bernard Nordlinger; Halfdan Sorbye; Bengt Glimelius; Graeme J Poston; Peter M Schlag; Philippe Rougier; Wolf O Bechstein; John N Primrose; Euan T Walpole; Meg Finch-Jones; Daniel Jaeck; Darius Mirza; Rowan W Parks; Murielle Mauer; Erik Tanis; Eric Van Cutsem; Werner Scheithauer; Thomas Gruenberger Journal: Lancet Oncol Date: 2013-10-11 Impact factor: 41.316
Authors: Y Fong; A M Cohen; J G Fortner; W E Enker; A D Turnbull; D G Coit; A M Marrero; M Prasad; L H Blumgart; M F Brennan Journal: J Clin Oncol Date: 1997-03 Impact factor: 44.544
Authors: Thomas Aloia; Mylène Sebagh; Marylène Plasse; Vincent Karam; Francis Lévi; Sylvie Giacchetti; Daniel Azoulay; Henri Bismuth; Denis Castaing; René Adam Journal: J Clin Oncol Date: 2006-11-01 Impact factor: 44.544