Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles followed by XELOX plus BEV or single agent (s/a) BEV as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC) the MACRO trial J. Tabernero E. Aranda, A. Gomez, B. Massutí, J. Sastre, A. Abad, M. Valladares, F. Rivera, Mª J. Safont, E. Diaz-Rubio On behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)
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J. Tabernero E. Aranda , A. Gomez, B. Massutí , J. Sastre, A. Abad,
Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles followed by XELOX plus BEV or single agent (s/a) BEV as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC) the MACRO trial. J. Tabernero E. Aranda , A. Gomez, B. Massutí , J. Sastre, A. Abad, - PowerPoint PPT Presentation
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Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles
followed by XELOX plus BEV or single agent (s/a) BEV as maintenance therapy in patients (pts) with
metastatic colorectal cancer (mCRC) the MACRO trial
J. TaberneroE. Aranda, A. Gomez, B. Massutí, J. Sastre, A. Abad, M. Valladares, F. Rivera, Mª J. Safont, E. Diaz-Rubio
On behalf of the Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)
Disclosures for J. Tabernero
• Advisory Board member and lecturer for:– Sanofi-Aventis and Roche; – Merck-Serono; Amgen; Imclone; MSD;
Bayer; Onyx; BMS; Boehringer; Celgene; Johnson & Johnson; Novartis; Pfizer
Study Design
ProgressionRCapecitabineOxaliplatin
Bevacizumabx6 cycles q3w
Bevacizumabuntil progression
N=480
N=239
N=241
CapecitabineOxaliplatin
Bevacizumabx6 cycles q3w
CapecitabineOxaliplatin
Bevacizumabuntil progression
Statistical analysis• Sample Size: 470 patients; 235 per arm
– Non-inferiority design – Assuming 10 months as median PFS – Non-inferiority limit of 7.6 m (HR=1.32)– Alpha error = 0.025, one side– Power = 80%– Randomization 1:1
• Efficacy analysis populations:– ITT population: All randomized patients
• Safety population: All patients with, at least, one dose of treatment
• Statistical Analysis:– Kaplan-Meier curves– Cox model hazard ratio (if proportional
assumptions are met)
Study Objectives• Primary endpoint
– Progression free survival* (PFS)
• Secondary endpoints– Overall survival (OS)– Objective tumor response by RECIST – Time to response (TTR)– Response duration– Number of treatment cycles– Safety
* Time from randomization to progression or death
Inclusion Criteria• Age ≥ 18 years • Histologically confirmed metastatic
colorectal adenocarcinoma• Measurable disease (RECIST)• ECOG ≤ 2 • No previous exposure to bevacizumab• No previous chemotherapy for metastatic
or advanced colorectal cancer• No adjuvant chemotherapy within 6
months before randomization• No clinically significant cardiovascular