Abstract
Background: Anti-Epidermal growth factor receptor (EGFR) antibody therapy showed to be effective in treatment for metastatic colorectal cancer (mCRC) with wild KRAS. Especially in BOND-1 trial, combination chemotherapy with anti-EGFR antibody plus irinotecan(IRI) was expected more effective than anti-EGFR antibody alone, resistant to IRI.There were no report of randomized trial to clarify the difference of efficacy between panitumumab(Pmab) plus IRI and Pmab alone, and no report for Pmab plus IRI in Japanese. We conducted a phase II study to evaluate the efficacy and safetyfor Pmab plus IRI.Methods: Subjects were mCRC patients with wild KRAS, who showed resistance to fluoropyrimidine, oxaliplatin(L-OHP) and IRI, and had measurable disease, ECOG PS 0-2. Pmab(6 mg/kg) plus IRI was administered every two weeks. The primary endpoint was response rate(RR). Secondary endpoints were disease control rate (DCR), progression free survival (PFS), overall survival (OS), response duration, and adverse event (AE).Results: A total of 31 subjects were enrolled between July 2010 and July 2012. Median age was 64 years old (range 42-74). Nineteen patients had liver metastasis, 11 had lungmetastasis and 3 had lymph nodemetastasis. An independent review committee evaluated for efficacy in eligible 31 subjects in accordance with the RECIST ver. 1.1. The RR was29.0% (95%CI,14.2-48.0 %). DCR was 74.2% (95%CI,55.4-88.1%), median PFS was 5.6 months(95%CI: 3.4-8.1) and median OS was 10.6 months(95%CI: 6.9-15.8). In 31 subjects, the incidence of any Grade 3 or greater adverse events was 58.1%. Major adverse events of Grade 3 were diarrhea (19.4%), rash acneiform (12.9%), fatigue (9.7%), anorexia (9.7%). A sudden death and an infusion related reaction were occurred.Conclusion: Combination chemotherapy with Pmab plus IRI was demonstaratedto be safe and more effective than Japanese single arm phase II of Pmab alone. This resultis equal to efficacy and safety of other reports for Pmab plus IRI.
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