Abstract CT124: A phase II study of bevacizumab and irinotecan as second-line therapy for patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab

Abstract

Abstract Background: FOLFIRI plus bevacizumab (BV) is widely used as second-line chemotherapy for patients with metastatic colorectal cancer (mCRC) previously treated with FOLFOX/XELOX plus bevacizumab. However, there is insufficient data characterizing the effectiveness of administration of fluoropyrimidine beyond first disease progression. FOLFIRI requires using a CV catheter. Oral fluoropyrimidine may cause severe diarrhea when administered with irinotecan (CPT-11). CPT-11+BV may overcome those problems. Methods: Patients with mCRC previously treated with at least four courses of fluoropyrimidine, oxaliplatin, and bevacizumab were designated to receive 150 mg/m2 of CPT-11 and 10 mg/kg of BV, every 2 weeks as second-line therapy. The primary endpoint was progression-free survival (PFS), and secondary endpoints included response rate (RR), overall survival (OS), and adverse events. Results: Thirty patients from six institutes were enrolled from March 2011 to January 2014. Twenty-five (83.3%) patients were refractory to first-line therapy and eight patients (16.6%) were unable to tolerate first-line therapy. The median PFS was 5.7 months (95% CI; 4.2-7.3 months) and the RR was 6.7% (range, 0.8-22.1%. Grades 3-4 adverse events included leucopenia (36.7%), neutropenia (50%), thrombocytopenia (26.7%), anemia (30%), diarrhea (3.3%), anorexia (6.7%), and hypertension (3.3%). Relative dose intensities were 94.5% and 96.3% for CPT-11 and BV, respectively. Median OS was 11.8 months (6.3 months-not reached). Conclusions: Administration of CPT-11 plus BV to patients with mCRC achieved comparable efficacy with relatively lower toxicities compared with the results of previous studies using FOLFIRI plus BV as second-line therapy. The dose intensity of CPT-11 was judged satisfactory. Clinical trial information: UMIN000005228 Citation Format: Go Nakajima, Hidekazu Kuramochi, Masayuki Ando, Michio Itabashi, Kazuyuki Kawakami, Mie Hamano, Eiichi Hirai, Takayuki Iino, Hajime Yokomizo, Ryuji Okuyama, Tatsuo Araida, Kazuhiko Yoshimatsu, Shingo Kameoka, Kazuhiko Hayashi. A phase II study of bevacizumab and irinotecan as second-line therapy for patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT124.