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- Title
Bevacizumab + Capecitabine as Maintenance Therapy after Initial Bevacizumab + XELOX Treatment in Previously Untreated Patients with Metastatic Colorectal Cancer: Phase III 'Stop and Go' Study Results - A Turkish Oncology Group Trial.
- Authors
Yalcin, Suayib; Uslu, Ruchan; Dane, Faysal; Yilmaz, Ugur; Zengin, Nurullah; Buyukunal, Evin; Buyukberber, Suleyman; Camci, Celalettin; Sencan, Orhan; Kilickap, Sadettin; Ozdener, Fatih; Cevik, Duygu
- Abstract
Objective: It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin (XELOX) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer (mCRC). Methods: Patients received either bevacizumab (7.5 mg/kg) + XELOX (capecitabine 1,000 mg/m2 twice daily on days 1-14 + oxaliplatin 130 mg/m2 on day 1 every 3 weeks) until disease progression (arm A) or the same doses of bevacizumab + XELOX for 6 cycles followed by bevacizumab + capecitabine until disease progression (arm B). The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR) and safety. Results: One hundred and twenty-three patients were randomized. Treatment compliance was similar in both groups. Median PFS was significantly longer for arm B than for arm A (11.0 vs. 8.3 months; p = 0.002). There was no significant difference between the two arms for ORR (66.7 vs. 59.0%; p = 0.861) or median OS (23.8 vs. 20.2 months; p = 0.100). Tolerability was acceptable in both treatment arms; the most frequent grade 3/4 treatment-related adverse events (arm B vs. arm A) were fatigue (6.6 vs. 16.1%), diarrhoea (3.3 vs. 11.3%), anorexia (3.3 vs. 11.3%), and neuropathy (1.6 vs. 8.1%). Conclusions: Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizumab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX. © 2013 S. Karger AG, Basel
- Subjects
TURKEY; ANTINEOPLASTIC agents; BEVACIZUMAB; OXALIPLATIN; THERAPEUTIC use of antimetabolites; ACADEMIC medical centers; BLOOD testing; COMBINATION drug therapy; COLON tumors; CONFIDENCE intervals; METASTASIS; HEALTH outcome assessment; RESEARCH funding; SURVIVAL; TREATMENT effectiveness; DESCRIPTIVE statistics; KAPLAN-Meier estimator; LOG-rank test; THERAPEUTICS
- Publication
Oncology, 2013, Vol 85, Issue 6, p328
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000355914