Preoperative combination of gemcitabine, carboplatin, and iniparib is active in the treatment of patients with early-stage triple negative and BRCA1/2 mutation-associated breast cancer, a new study published online early in the Journal of Clinical Oncology has shown.
For the single-arm phase II study, researchers sought to assess the safety, efficacy, and predictors of response to the combination of gemcitabine, carboplatin, and iniparib in patients with early-stage triple-negative andBRCA1/2 mutation-associated breast cancer.
Researchers identified 80 patients, 24% of which had germline BRCA1 or BRCA2 mutations. Patients received neoadjuvant gemcitabine 1,000mg/m2 IV and carboplatin AUC 2 IV on days 1 and 8 plus iniparib 5.6mg/kg IV on days 1, 4, 8, and 11 for six 21-day cycles.
Results showed that the overall pathologic complettte response rate was 36% (90% CI: 27-46).
Researchers found that mean LRD-LOH scores were higher in responders compared with nonresponders (P = 0.02).
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When BRCA1/2 germline mutation carriers were excluded, the mean HRD-LOH scores continued to be significantly higher in responders versus nonresponders (P = 0.021).
The authors note that confirmatory controlled trials are warranted.
Preliminary findings were presented at the 49th Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois, in 2013.
- Telli ML, Jensen KC, Vinayak S, et al. Phase II study of gemcitabine, carboplatin, and iniparib as neoadjuvant therapy for triple-negative and BRCA1/2 mutation-associated breast cancer with assessment of a tumor-based measure of genomic instability: PrECOG 0105. J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1200/JCO.2014.57.0085.