Phase I study of primary treatment with 5-FU,oxaliplatin, irinotecan,levofolinate, and panitumumab combination chemotherapy in patients with advanced/recurrent colorectal cancer involving the wild-type RAS gene: the JACCRO CC-14 study |
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Authors: | Hironaga Satake author-information" >,Akihito Tsuji,Masato Nakamura,Masaaki Ogawa,Takeshi Kotake,Yukimasa Hatachi,Hisateru Yasui,Akinori Takagane,Yoshihiro Okita,Kumi Nakamura,Toshihide Onikubo,Masahiro Takeuchi,Masashi Fujii |
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Affiliation: | 1.Department of Medical Oncology,Kobe City Medical Center General Hospital,Kobe,Japan;2.Department of Clinical Oncology,Kagawa University Faculty of Medicine–Kagawa University Hospital,Kita-gun,Japan;3.Aizawa Comprehensive Cancer Center,Aizawa Hospital,Matsumoto,Japan;4.Department of Surgery,Kazuno Kosei Hospital,Kazuno,Japan;5.Department of Surgery,Hakodate Goryoukaku Hospital,Hakodate,Japan;6.Department of Clinical Medicine (Biostatistics),Kitasato University School of Pharmacy,Tokyo,Japan;7.Japan Clinical Cancer Research Organization,Tokyo,Japan |
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Abstract: | BackgroundFOLFOXIRI is now regarded as the chemotherapy regimen that offers the best platform for the treatment of colorectal cancer. However, the safety and efficacy of FOLFOXIRI + panitumumab has not been demonstrated. We conducted a phase I study to determine the recommended dose of FOLFOXIRI + panitumumab as first-line treatment for RAS wild-type metastatic colorectal cancer (mCRC).MethodsPatients received combination therapy consisting of panitumumab (6 mg/kg on day 1) + FOLFOXIRI [irinotecan (CPT-11), oxaliplatin (L-OHP) 85 mg/m2, and folinate (LV) 200 mg/m2] on day 1, followed by fluorouracil (5-FU) 3200 mg/m2 infused as a 46-h continuous infusion starting on day 1) repeated every 2 weeks as first-line treatment of RAS wild-type mCRC patients. A decrease in CPT-11 dose was planned (started at level 1: CPT-11 165 mg/m2).ResultsSeven patients were enrolled, and six were assessed for safety and efficacy. Maximum tolerated dose was not reached at level 1; all patients were treated at these levels. The common Grade 3 or 4 relevant toxicities were diarrhea (50%), hypokalemia (33%) and stomatitis (33%). No treatment-related deaths occurred. Of the six patients assessed four had partial response and the two others had stable disease; hence, the response rate was 66.7% (95% confidence interval 28.9–100%) and the disease control rate was 100%. Time to protocol treatment failure was 7.2 (1.4–7.3) months.ConclusionThe FOLFOXIRI + panitumumab chemotherapy regimen was well tolerated by our patients with mCRC and showed promising anti-tumor activity. The recommended phase II dose was determined to be the same as the standard doses of this regimen used worldwide. |
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