An open label, single arm, prospective phase II study to evaluate the efficacy and safety of bevacizumab with gemcitabine and carboplatin as first-line treatment for metastatic triple negative breast cancer patients.

Authors

Sudeep Gupta

Sudeep Gupta

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

Organizations

Department of Medical Oncology, Breast Disease Management Group, Tata Memorial Centre (TMC), Mumbai, India, Kidwai Memorial Institute of Oncology, Bangalore, India, Christian Medical College, Vellore, India, Rajiv Gandhi Cancer Institute, Delhi, India, Vedanta Institute of Medical Science, Ahmedabad, India, M.S. Ramaiah Medical College, Banglore, India, Sahyadri Specialty Hospital, Pune, India, Shyam Hem-Onc and Transplant Clinic, Ahmedabad, India, AIIMS, New Delhi, India, Bombay Hospital, Mumbai, India, Roche Products (India) Pvt. Ltd., Mumbai, India, Roche India, Mumbai, India, FMRI, New Delhi, India

Research Funding

Pharmaceutical/Biotech Company

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 EndpointN = 40
Median PFS8.5 months
(95% CI: 5.2 – 15.3)
Secondary EndpointsN = 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)
TTP8.9 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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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Metastatic

Track

Breast Cancer

Sub Track

Triple-Negative

Clinical Trial Registration Number

NCT01201265

Citation

J Clin Oncol 36, 2018 (suppl; abstr 1098)

DOI

10.1200/JCO.2018.36.15_suppl.1098

Abstract #

1098

Poster Bd #

179

Abstract Disclosures