Tobias Arkenau Infusional 5-FU/FA plus Oxaliplatin (FUFOX) vs. Capecitabine plus Oxaliplatin (CAPOX) as first-line treatment for metastatic colorectal.
Veröffentlicht von:Elise EcklGeändert vor über 2 Jahren
Präsentation zum Thema: "Tobias Arkenau Infusional 5-FU/FA plus Oxaliplatin (FUFOX) vs. Capecitabine plus Oxaliplatin (CAPOX) as first-line treatment for metastatic colorectal."— Präsentation transkript:
1TobiasArkenauInfusional 5-FU/FA plus Oxaliplatin (FUFOX) vs. Capecitabine plus Oxaliplatin (CAPOX)as first-line treatment for metastatic colorectal cancer: safety and efficacy analysis from a phase III trial of the German AIO
2Rationale for CAPOX in 1st-line ACRC Addition of oxaliplatin to i.v. 5-FU/LV (FOLFOX/FUFOX) significantly improves efficacyCapecitabine provides superior response rates and safety vs. bolus 5-FU/LVIn phase II trials, XELOX/CAPOX showed clear antitumor efficacy and good tolerability
3Prospective, randomized, multicenter phase III study of CAPOX vs. FUFOX Metastatic CRC, no prior chemotherapy for metastatic CRC, adjuvant treatment > 6 months,Measurable disease (RECIST), Age >18 years; ECOG PS 2Normal renal, hepatic and hematological parametersStratification: WBC, Alk. Phos., No. of sites, ECOG PS, CenterRandomization (n=476) 08/02 – 08/ German centers
6Endpoints/statistical design Primary endpoint: progression-free survival (PFS)Secondary endpoints: OS, RR, toxicity, TTF, QOLStatistical design: patients needed to exclude inferiority of 41% vs. 50% PFS rate at 9 months calculating a one-sided 95% CI for the HR (power: 80%)The study was monitored by an external review committee
15Conclusions Similar safety profile for CAPOX and FUFOX: significantly higher HFS grade 2/3 with CAPOXCAPOX shows no inferiority compared to FUFOX within our statistical assumptions:response rate: 47% vs. 49%median PFS: 7.0 vs. 8.0 months (p=0.11)median OS: 16.3 vs months (p=0.72)