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- Title
First-Line XELOX Plus Bevacizumab Followed by XELOX Plus Bevacizumab or Single-Agent Bevacizumab as Maintenance Therapy in Patients with Metastatic Colorectal Cancer: The Phase III MACRO TTD Study.
- Authors
DÖAZ-RUBIO, EDUARDO; GàMEZ-ESPA¥A, AUXILIADORA; MASSUTÖ, BARTOMEU; SASTRE, JAVIER; ABAD, ALBERT; VALLADARES, MANUEL; RIVERA, FERNANDO; SAFONT, MARIA J.; DE PRADO, PURIFICACIàN MARTÖNEZ; GALLN, MANUEL; GONZµLEZ, ENCARNACIàN; MARCUELLO, EUGENIO; BENAVIDES, MANUEL; FERNµNDEZ-MARTOS, CARLOS; LOSA, FERRµN; ESCUDERO, PILAR; ARRIVI, ANTONIO; CERVANTES, ANDRS; DUE¥AS, ROSARIO; LàPEZ-LADRàN, AMELIA
- Abstract
Purpose. The aim of this phase III trial was to compare the efficacy and safety of bevacizumab alone with those of bevacizumab and capecitabine plus oxaliplatin (XELOX) as maintenance treatment following induction chemotherapy with XELOX plus bevacizumab in the first-line treatment of patients with metastatic colorectal cancer (mCRC). Patients and Methods. Patients were randomly assigned to receive six cycles of bevacizumab, capecitabine, and oxaliplatin every 3 weeks followed by XELOX plus bevacizumab or bevacizumab alone until progression. The primary endpoint was the progression-free survival (PFS) interval; secondary endpoints were the overall survival (OS) time, objective response rate (RR), time to response, duration of response, and safety. Results. The intent-to-treat population comprised 480 patients (XELOX plus bevacizumab, n 239; bevacizumab, n 241); there were no significant differences in baseline characteristics. The median follow-up was 29.0 months (range, 0-53.2 months). There were no statistically significant differences in the median PFS or OS times or in the RR between the two arms. The most common grade 3 or 4 toxicities in the XELOX plus bevacizumab versus bevacizumab arms were diarrhea, hand-foot syndrome, and neuropathy. Conclusion. Although the non-inferiority of bevacizumab versus XELOX plus bevacizumab cannot be confirmed, we can reliably exclude a median PFS detriment >3 weeks. This study suggests that maintenance therapy with single-agent bevacizumab may be an appropriate option following induction XELOX plus bevacizumab in mCRC patients.
- Subjects
BLOOD testing; ANTINEOPLASTIC agents; COMBINATION drug therapy; COLON tumors; COMBINED modality therapy; CONFIDENCE intervals; LONGITUDINAL method; METASTASIS; HEALTH outcome assessment; PHYSICAL diagnosis; RECTUM tumors; REGRESSION analysis; RESEARCH funding; STATISTICAL sampling; SURVIVAL analysis (Biometry); RANDOMIZED controlled trials; TREATMENT effectiveness; DISEASE progression
- Publication
Oncologist, 2012, Vol 17, Issue 1, p15
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2011-0249