Department of Medical Oncology, Breast Disease Management Group, Tata Memorial Centre (TMC), Mumbai, India
Sudeep Gupta , Govind K. Babu , Raju Titus Chacko , Dinesh Doval , Chirag Desai , Nalini Kilara , Shona Milon Nag , Chirag A. Shah , SVS Deo , Smruti B. Koppikar , Binay Swarup , Anil Arjundas Kukreja , Vinod Raina
Background: There is a higher burden (29.2%-46%) of TNBC patients in India. This single arm, phase II trial evaluated the efficacy and safety of bevacizumab in combination with gemcitabine and carboplatin as first line treatment in Indian patients with metastatic TNBC. Methods: TNBC patients with prior adjuvant anthracycline and taxane therapy and no prior treatment for metastatic disease received bevacizumab (15mg/kg) with gemcitabine and carboplatin, every three weeks until disease progression or unacceptable toxicity. Results: Forty patients were accrued at 10 Indian centers between February 2011 to April 2013. At median follow-up of 12 (0.5 –59.3) months there were 27 disease progressions and 23 deaths. Using EORTC QLQ-30 questionnaire, improvements were observed in physical function (P = 0.0435), emotional function (P = 0.002) and pain perception (P = 0.0243) domains from baseline to cycle 6. Median duration of study treatment was 4.6 (0.3 – 18.4) months. Overall, 24 (60%) patients reported 133 adverse events (99 non-serious, 34 serious) including proteinuria, rectal hemorrhage (grade 3) and fatigue (grade 4) in 1 patient each. A total of 34 serious adverse events were reported in 17 (42.5%) patients. No new safety signals were identified and bevacizumab was found to be well tolerated by Indian patients. Conclusions: Bevacizumab in combination with gemcitabine and carboplatin as first line treatment in metastatic TNBC, resulted in favorable survival outcomes with acceptable toxicity. The patients also experienced significant improvement in several domains of health related QoL during the first 6 cycles of this treatment. Efficacy results Clinical trial information: NCT01201265
Primary Endpoint | N = 40 |
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Median PFS | 8.5 months (95% CI: 5.2 – 15.3) |
Secondary Endpoints | N = 40 |
Median OS (protocol-defined end of study) | 15.8 months (95% CI: 11.8 – 24.9) |
Updated Median OS (additional 14.5 months follow-up) | 23.1 months (95% CI: 9.6 – 36.0) |
TTP | 8.9 months (95% CI: 6.0 – 18.1) |
Complete Response (CR) | 2 (5%) |
Partial Response (PR) | 18 (45%) |
Stable Disease (SD) | 17 (42.5%) |
Overall Response Rate (CR+PR) | 20 (50%) |
Clinical Benefit Rate (CR+PR+SD) | 37 (92.5%) |
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