{"entity":{"id":"calgb-90401","kind":"trial","name":"CALGB 90401","aka":["CALGB 90401","Alliance 90401","bevacizumab with docetaxel in mCRPC"],"tldr":"Adding the anti-angiogenic antibody bevacizumab to chemotherapy delayed progression and shrank more tumours, but men did not live longer and four times as many died of the treatment.","summary":"CALGB 90401 randomly assigned 1,050 men with chemotherapy-naive progressive metastatic castration-resistant prostate cancer to docetaxel and prednisone with bevacizumab 15 mg/kg every 3 weeks or placebo.\n\nMedian overall survival was 22.6 months with bevacizumab against 21.5 months without, hazard ratio 0.91 (95 percent confidence interval 0.78 to 1.05, stratified log-rank p=0.181). Median progression-free survival was better with bevacizumab, 9.9 against 7.5 months (stratified log-rank p<0.001), as was objective response, 49.4 against 35.5 percent (p=0.0013).\n\nThe harm is in the safety table. Grade 3 or greater treatment-related toxicity occurred in 75.4 percent with bevacizumab against 56.2 percent (p at most 0.001), and treatment-related deaths in 4.0 against 1.2 percent (p=0.005).\n\nAn intervention that improves progression-free survival and objective response while quadrupling the treatment-related death rate and not extending life is the clearest possible argument against reading those endpoints as proxies for benefit. Bevacizumab is not used in prostate cancer.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00110214","url":"https://clinicaltrials.gov/study/NCT00110214"},{"label":"CALGB 90401 (Journal of Clinical Oncology 2012)","url":"https://doi.org/10.1200/JCO.2011.39.4767"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["antiangiogenic","cytotoxic-chemotherapy"],"targets":[],"drugs":["bevacizumab","docetaxel","prednisone"],"companies":["alliance-oncology","roche-genentech"],"institutions":[],"pathways":[],"terms":["castration-resistance"],"trials":["comet-1","ready-dasatinib","tax-327"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00110214","phase":"3","setting":"Chemotherapy-naive progressive metastatic castration-resistant prostate cancer with ECOG performance status 2 or better: docetaxel 75 mg/m2 over 1 hour every 21 days with prednisone 5 mg twice daily, plus bevacizumab 15 mg/kg every 3 weeks or placebo, with overall survival as the primary endpoint","sponsor":"Cancer and Leukemia Group B, now part of the Alliance for Clinical Trials in Oncology, funded by the National Cancer Institute","result":"Median overall survival 22.6 against 21.5 months (hazard ratio 0.91, 95 percent confidence interval 0.78 to 1.05, p=0.181) despite progression-free survival 9.9 against 7.5 months and response 49.4 against 35.5 percent; treatment-related deaths 4.0 against 1.2 percent.","yearReported":2012,"enrolled":1050,"enrolledBasis":"randomised","enrolledNote":"1,050 men were randomly assigned.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel, prednisone and bevacizumab","value":22.6},{"name":"Docetaxel and prednisone","value":21.5}],"hr":0.91,"ci":[0.78,1.05],"p":"0.181","source":"https://doi.org/10.1200/JCO.2011.39.4767"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Docetaxel, prednisone and bevacizumab","value":9.9},{"name":"Docetaxel and prednisone","value":7.5}],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2011.39.4767"},{"endpoint":"Treatment-related deaths","unit":"%","arms":[{"name":"Docetaxel, prednisone and bevacizumab","value":4},{"name":"Docetaxel and prednisone","value":1.2}],"p":"0.005","source":"https://doi.org/10.1200/JCO.2011.39.4767"}],"replication":"COMET-1 with cabozantinib and 10TASQ10 with tasquinimod produced the same dissociation; no anti-angiogenic agent has improved survival in prostate cancer."},"route":"/trials/calgb-90401/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"alliance-oncology","kind":"company","name":"Alliance for Clinical Trials in Oncology","route":"/companies/alliance-oncology/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"prostate-failed-programmes","kind":"term","name":"Prostate cancer programmes that failed, and what each failure taught","route":"/terms/prostate-failed-programmes/"}],"trial":[{"id":"comet-1","kind":"trial","name":"COMET-1","route":"/trials/comet-1/"},{"id":"ready-dasatinib","kind":"trial","name":"READY","route":"/trials/ready-dasatinib/"},{"id":"tax-327","kind":"trial","name":"TAX 327","route":"/trials/tax-327/"}]}}