XELOX with bevacizumab in elderly patients age 75 or older with metastatic colorectal cancer: Results of a planned interim analysis for multicenter phase II ASCA study.

Authors

null

Keiichiro Ishibashi

Saitama Medical Center, Saitama Medical University

Keiichiro Ishibashi , Yoshinori Munemoto , Masaki Matsuoka , Taishi Hata , Michiya Kobayashi , Junichi Hasegawa , Mutsumi Fukunaga , Akinori Takagane , Toshio Otsuji , Yasuhiro Miyake , Michitaka Nagase , Junichi Sakamoto , Hideyuki Mishima , Koji Oba

Organizations

Saitama Medical Center, Saitama Medical University, Fukuiken Saiseikai Hospital, Dongo Hospital, Osaka University, Kochi Medical School, Department of Surgery, Osaka Rosai Hospital, Sakai City Hospital, Hakodate Goryokaku Hospital, Minoh City Hospital, Jichi Medical University, Nagoya University Graduate School of Medicine, Unit of Cancer Center, Aichi Medical University, Translational Research and Clinical Trial Center,

Research Funding

Other Foundation

Background: Combination chemotherapy of capecitabine plus oxaliplatin (XELOX) with bevacizumab is commonly used as standard chemotherapy for metastatic colorectal cancer (mCRC). A previous meta-analysis showed that there was no difference between two age groups of <65 years and ≥65 years on overall survival (OS) after treatment with chemotherapy with bevacizumab. However, the safety and efficacy of XELOX with bevacizumab in elderly patients (pts) ≥75 years with mCRC remain unclear. Methods: This study was an open-label multicentre phase II study to evaluate the efficacy and safety of XELOX with bevacizumab in pts ≥75 years with metastatic CRC. The primary objective was to assess progression-free survival (PFS). The secondary endpoints were the safety, response rate (RR), time to treatment-failure (TTF) and OS. Results: 36 pts were enrolled. Pts characteristics were; median age 78 (range 75-86); male/female, 21/15; ECOG performance status 0/1, 30/6; colon/rectum 24/12, creatinine clearance (CCr) 60.2 ml/min (range 32.6-84.6). Median follow-up period was 220 days. RR was 55.6% and median TTF was 209 days. The median PFS and median OS are not reached. Grade 3 or 4 adverse events (AEs) were reported in 22 pts (62.8%). Common grade 3 or 4 AEs were hypertension (11.4%), leukopenia (20.0%), peripheral sensory neuropathy (14.3%), hand foot syndrome (8.6%), and fatigue (8.6%). Examining the relationship between renal function (CCr) and AEs, the incidence of Grade 3 or 4 AEs in the lower CCr group was significantly higher than that in the higher CCr group (61.6% vs. 47.8%; p=0.013); hematological toxicities (87.5% vs. 14.8%; p=0.0003) and non-hematological toxicities (61.5% vs. 11.1%; p=0.018). Conclusions: XELOX with bevacizumab is safely administered in elderly patients ≥75 years. Renal function (CCr) could be a good predictive marker for grade 3 or 4 AEs. Clinical trial information: UMIN000003500.

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Abstract Details

Meeting

2013 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon and Rectum

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

UMIN000003500

Citation

J Clin Oncol 31, 2013 (suppl 4; abstr502)

DOI

10.1200/jco.2013.31.4_suppl.502

Abstract #

502

Poster Bd #

D2

Abstract Disclosures