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- Title
A prospective study of XELOX plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer (KSCC 0902).
- Authors
Ogata, Yutaka; Shimokawa, Mototsugu; Tanaka, Takaho; Emi, Yasunori; Oki, Eiji; Saeki, Hiroshi; Sadanaga, Noriaki; Kusumoto, Tetsuya; Touyama, Tetsuo; Kimura, Masami; Baba, Hideo; Akagi, Yoshito; Shirouzu, Kazuo; Maehara, Yoshihiko
- Abstract
Background: This study was designed to evaluate the efficacy and safety of XELOX plus bevacizumab in a Japanese metastatic colorectal cancer population that included elderly patients. Methods: This was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated metastatic colorectal cancer, presence of measurable lesions, age ≥20 years; Eastern Cooperative Oncology Group performance status of 0-2, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELOX (130 mg/m oxaliplatin on day 1 plus 1,000 mg/m capecitabine b.i.d. on days 1-14) every 3 weeks. The primary endpoint was confirmed objective response rate. Results: The study included 47 patients (male/female 30/17; median age 69 years; age range 38-81 years with 10 patients ≥75 years; PS 0/1/2, 40/5/2) enrolled between May 2010 and March 2011. Responses were assessed in 46 eligible patients. The objective response rate was 52.2 % (95 % confidence interval [CI] 37.0-67.1). The median progression-free survival and overall survival were 10.0 months (95 % CI 7.8-12.3) and 34.6 months (95 % CI 19.9-not estimable), respectively. Frequently encountered grade 3 and 4 adverse events in this study were aspartate aminotransferase elevation (23.4 %), alanine aminotransferase elevation (21.3 %), anorexia (12.8 %), neutropenia (10.6 %), fatigue (8.5 %) and anemia (6.4 %). Grade 3 or 4 peripheral neuropathy was not observed. Conclusion: First-line treatment with XELOX plus bevacizumab showed a promising response rate and an acceptable tolerability profile in the clinical practice of Japanese metastatic colorectal cancer patients that included elderly patients. Registry: UMIN-CTR, ID number: UMIN000003915, URL:https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004706&language=E
- Subjects
COLON cancer patients; COLON cancer treatment; BEVACIZUMAB; COMBINATION drug therapy; JAPANESE people; LONGITUDINAL method; DISEASES
- Publication
International Journal of Clinical Oncology, 2016, Vol 21, Issue 2, p335
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-015-0895-3