Sudeep Gupta, MBBS, professor, medical oncology, Tata Memorial Hospital, Mumbai, discusses key efficacy and safety data from a phase 3 trial of platinum plus standard neoadjuvant chemotherapy in operable, locally advanced triple-negative breast cancer.
Sudeep Gupta, MBBS, professor, medical oncology, Tata Memorial Hospital, Mumbai, discusses key efficacy and safety data from a phase 3 trial of platinum plus standard neoadjuvant chemotherapy in operable, locally advanced triple-negative breast cancer (TNBC).
The randomized trial assessed the effect of adding carboplatin to sequential taxane-anthracycline neoadjuvant chemotherapy on long-term patient outcomes. The study population consisted of 720 patients who were randomly assigned 1:1 to the experimental vs control regimens. These patients were stratified according to menopausal status and tumor stage. After completing the study regimen, patients proceeded to surgery followed by radiotherapy.
The study’s primary end point was event-free survival (EFS) followed by overall survival (OS) as a secondary end point, Gupta begins. Results demonstrated an absolute increase in both EFS and OS with weekly carboplatin plus paclitaxel, he states. EFS increased by 6.6 percentage points in the total population, and by 12.5% in patients under 50 years of age. Subgroup analyses found that both OS and EFS benefits with carboplatin were limited to young, premenopausal patients, Gupta notes. This finding indicates that there is a significant interaction between treatment and age thatrequires further investigation.
Safety data showed an increased risk of hematological toxicities with the addition of carboplatin, consistent with previous expectations, Gupta continues. However, this increase did not result in treatment discontinuation for most patients in both arms. Regarding compliance to neoadjuvant chemotherapy in the experimental arm, 94.5% and 77.6% of patients completed 8 and 12 treatment cycles, respectively. Conversely, 97.2% and 80.1% of patients in the control arm completed 8 and 12 treatment cycles. Accordingly, carboplatin plus neoadjuvant chemotherapy was considered well tolerated in this patient population, Gupta says.
Overall, neoadjuvant platinum therapy not only produces a clinically meaningful survival benefit in young patients but should be considered a new standard-of-care component for this patient subset, Gupta concludes.