A prospective study of XELIRI plus bevacizumab as a first-line therapy in Japanese patients with unresectable or recurrent colorectal cancer (KSCC1101) |
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Authors: | Koji?Ando Yasunori?Emi Toyokuni?Suenaga Masahiro?Hamanoue Soichiro?Maekawa Yasuo?Sakamoto Seiichiro?Kai Hironaga?Satake Takayuki?Shimose Mototsugu?Shimokawa Hiroshi?Saeki Eiji?Oki Kenji?Sakai Yoshito?Akagi Hideo?Baba Yoshihiko?Maehara Kyushu Study Group of Clinical Cancer |
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Affiliation: | 1.Department of Surgery and Science, Graduate School of Medical Sciences,Kyushu University,Fukuoka,Japan;2.Department of Surgery,Saiseikai Fukuoka General Hospital,Fukuoka,Japan;3.Surgery/Gastrointestinal Surgery, Public Interest Incorporated Association, Kagoshima,Nanpuh Hospital,Kagoshima,Japan;4.Department of Surgery,Imakiire General Hospital,Kagoshima,Japan;5.Department of Surgery,Munakata Medical Association Hospital,Fukuoka,Japan;6.Department of Gastroenterological Surgery,Kumamoto University Hospital,Kumamoto,Japan;7.Department of Surgery,Nakatsu Municipal Hospital,Oita,Japan;8.Department of Medical Oncology,Kobe City Medical Center General Hospital,Kobe,Japan;9.Clinical Research Support Center Kyushu,Fukuoka,Japan;10.Department of Cancer Information Research,National Hospital Organization Kyushu Cancer Center,Fukuoka,Japan;11.Department of Medical Oncology,National Hospital Organization Kumamoto Medical Center,Kumamoto,Japan;12.Department of Surgery, School of Medicine,Kurume University,Fukuoka,Japan;13.Department of Gastroenterological Surgery, Graduate School of Medical Sciences,Kumamoto University,Kumamoto,Japan |
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Abstract: | BackgroundThis study was designed to evaluate the efficacy and toxicity of XELIRI plus bevacizumab for the treatment of Japanese patients with unresectable or recurrent colorectal cancer (CRC).MethodsThis was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated unresectable or recurrent CRC, presence of measurable lesions, ≥20 years of age, Eastern Cooperative Oncology Group performance status 0 or 1, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELIRI (irinotecan 200 mg/m2 on day 1 plus capecitabine 800 mg/m2 b.i.d. on days 1–14) every 3 weeks. The primary endpoint was the objective tumor response rate.ResultsA total of 36 patients were enrolled in this study from July 2011 to September 2012. One patient did not fulfill the eligibility criteria and one patient withdrew their consent before the start of the treatment protocol. The confirmed objective response rate was 58.8% (95% CI 35.1–70.2%). The median progression-free survival was 9.6 months (95% CI 5.1–11.1 months) and the median overall survival was 23.1 months (95% CI 11.3–36.7 months). The grade ≥3 adverse events that were frequently encountered in this study were neutropenia (31.4%), leukopenia (22.9%), diarrhea (22.9%), anemia (20.0%), anorexia (20.0%) and febrile neutropenia (17.2%). The frequency of grade 3/4 adverse events, such as neutropenia and leukopenia, was much higher in patients with a UGT1A1 polymorphism.ConclusionsA first-line therapy comprising XELIRI plus bevacizumab yielded a promising response rate. However, careful attention should be given to adverse clinical events in Japanese patients receiving treatment with unresectable or recurrent CRC. |
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