|The following article features coverage from the European Society for Medical Oncology (ESMO) Congress 2021. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Adding carboplatin to neoadjuvant paclitaxel significantly improves event-free survival (EFS) in patients with triple-negative breast cancer (TNBC), but incorporating a third drug, veliparib, does not confer additional improvement, according to long-term results from the phase 3 BrighTNess trial.1
These results were presented at the European Society for Medical Oncology (ESMO) Congress 2021 by Sibylle Loibl, MD, PhD, of the German Breast Group in Neu-Isenburg, Germany.
The BrighTNess trial (ClinicalTrials.gov Identifier: NCT02032277) enrolled 634 adults with previously untreated, stage II/III TNBC. They had to have a performance status of 0-1, be candidates for potentially curative surgery, and have documented germline BRCA status.
The patients were randomly assigned (2:1:1) to receive paclitaxel plus carboplatin and veliparib (316 patients), paclitaxel plus carboplatin (160 patients), or paclitaxel alone (158 patients). Patients in all 3 arms went on to receive 4 cycles of doxorubicin plus cyclophosphamide every 2-3 weeks, followed by surgery.
The patients were stratified by germline BRCA status, nodal stage, and planned schedule of doxorubicin and cyclophosphamide administration. Approximately 14% of patients were carriers of germline BRCA mutations, and nearly 60% had node-negative disease.
In the primary analysis, paclitaxel plus carboplatin, with or without veliparib, improved the rate of pathological complete response (pCR) when compared with paclitaxel alone.2
At a median follow-up of 4.5 years, there was a significant improvement in EFS for the 2 carboplatin-containing arms compared with the paclitaxel-alone arm.1
Compared with paclitaxel alone, the hazard ratio (HR) for EFS was 0.63 for paclitaxel plus carboplatin and veliparib (95% CI, 0.43-0.92, P =.02) and 0.57 for paclitaxel plus carboplatin (95% CI, 0.36-0.91; P =.02).
There was no significant difference in EFS between the carboplatin-containing arms. Compared with paclitaxel plus carboplatin, the HR for EFS was 1.12 for paclitaxel plus carboplatin and veliparib (95% CI, 0.72-1.72, P =.62).
Dr Loibl noted that patients who achieved a pCR had significantly better EFS compared with those who did not achieve a pCR (HR, 0.26; 95% CI, 0.18-0.38; P <.0001), regardless of BRCA mutation status.
The overall survival (OS) was not significantly different across the 3 treatment arms, but there was a trend toward superiority in the carboplatin-containing arms.
The HR for OS was:
- 0.63 for paclitaxel plus carboplatin vs paclitaxel alone (95% CI, 0.33-1.21, P =.17)
- 0.82 for paclitaxel plus carboplatin and veliparib vs paclitaxel alone (95% CI, 0.48-1.38, P =.45)
- 1.25 for paclitaxel plus carboplatin and veliparib vs paclitaxel and carboplatin (95% CI, 0.70-2.24, P =.46).
The rates of myelodysplastic syndrome, acute myeloid leukemia, and other secondary malignancies were similar across the treatment arms.
Dr Loibl noted that the higher rates of hematologic adverse events in the carboplatin-containing arms, which were previously reported,2 did not compromise treatment delivery or efficacy.
“These findings, overall, support the inclusion of carboplatin into neoadjuvant chemotherapy for stage II-III triple-negative breast cancer patients, regardless of the germline BRCA status,” Dr Loibl concluded.
Disclosures: This research was supported by AbbVie Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
- Loibl S, Sikov W, Huober J, et al. Event-free survival (EFS), overall survival (OS), and safety of adding veliparib (V) plus carboplatin (Cb) or carboplatin alone to neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) after ≥4 years of follow-up: BrighTNess, a randomized phase III trial. Presented at: European Society for Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract 119O.
- Loibl S, O’Shaughnessy J, Untch M, et al. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): A randomised, phase 3 trial. Lancet Oncol. 2018;19(4):497-509. doi:10.1016/S1470-2045(18)30111-6