Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial.

摘要: Summary Background Combining bevacizumab with first-line or second-line chemotherapy improves progression-free survival in HER2-negative locally recurrent metastatic breast cancer. We assessed the efficacy and safety of further therapy patients cancer whose disease had progressed after treatment plus chemotherapy. Methods In this open-label, randomised, phase 3 trial, we recruited who that receiving 12 weeks more from 118 centres countries. Patients were randomly assigned (1:1) by use a central interactive voice response system using block randomisation schedule (block size four) stratified hormone receptor status, survival, selected chemotherapy, lactate dehydrogenase concentration, to receive single-agent either alone (15 mg/kg every 10 2 weeks). Second-line was continued until progression, unacceptable toxicity, consent withdrawal. At received third-line without bevacizumab; those The primary endpoint progression death intention-to-treat population. This trial is ongoing, registered ClinicalTrials.gov, number NCT01250379. Findings Between Feb 17, 2011, April 3, 2013, 494 (247 each group). median duration follow-up at time prespecified analysis 15·9 months (IQR 9·1–21·7) chemotherapy-alone group 16·1 (10·6–22·7) combination group. Progression-free significantly longer for treated than (median: 6·3 [95% CI 5·4–7·2] vs 4·2 [3·9–4·7], respectively, hazard ratio [HR] 0·75 0·61–0·93], two-sided log-rank p=0·0068). most common grade adverse events hypertension (33 [13%] 245 17 [7%] 238 alone), neutropenia (29 [12%] 20 [8%]), hand-foot syndrome (27 [11%] 25 [11%]). Grade proteinuria occurred (7%) one ( Interpretation These results suggest VEGF inhibition valid option stabilised responded Funding F Hoffmann-La Roche.