KEY TAKEAWAYS
- In the BrighTNess phase III trial, adding carboplatin to neoadjuvant chemotherapy enhanced TNBC pCR rates.
- Untreated stage II-III TNBC patients received paclitaxel, carboplatin, doxorubicin, and cyclophosphamide.
- Carboplatin was added to weekly paclitaxel neoadjuvant chemotherapy for early-stage TNBC after 4.5 years.
- It has long-term EFS advantages and acceptable safety without raising second malignancies.
- For early-stage TNBC, carboplatin, paclitaxel, doxorubicin, and neoadjuvant cyclophosphamide treatment are recommended.
Pathological complete response (pCR) rates were considerably increased in patients with triple-negative breast cancer (TNBC) who had neoadjuvant chemotherapy that included carboplatin with or without veliparib, with acute toxicity within acceptable limits. Researchers present 4.5-year follow-up results from the study. Untreated stage II-III TNBC women were randomly assigned (2: 1: 1) to receive either I paclitaxel (weekly for 12 doses) with carboplatin (every 3 weeks for four cycles) plus veliparib (twice daily) or carboplatin plus veliparib placebo (twice daily). Four rounds of doxorubicin and cyclophosphamide were administered to all patients. pCR was used as the critical metric. The secondary outcomes were time-to-event-free survival (EFS), overall survival (OS), and safety. The secondary analyses are descriptive since the co-primary endpoint of higher pCR with carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel was not reached.
About 632 patients were assigned to receive carboplatin + veliparib with paclitaxel, 160 to receive carboplatin with paclitaxel, and 158 to receive paclitaxel alone. With a median follow-up of 4.5 years, the hazard ratio for event-free survival (EFS) was 0.63 (95% confidence interval [CI] 0.43-0.92, P = 0.02] for carboplatin plus veliparib with paclitaxel compared to paclitaxel alone, but 1.12 (95% CI [CI] 0.72-1.72, P = 0.62) for carboplatin alone. Post hoc analysis compared carboplatin with paclitaxel to paclitaxel alone and found a hazard ratio for EFS of 0.57 (95% CI 0.36-0.91, P = 0.02).
The incidence of myelodysplastic syndromes, acute myeloid leukemia, other secondary malignancies, and OS were similar across therapy groups. Carboplatin’s long-term EFS benefit with a tolerable safety profile and without raising the risk of second malignancies was connected with improved pCR, while veliparib’s addition did not affect EFS. Based on these results, neoadjuvant chemotherapy for early-stage TNBC should include carboplatin and weekly paclitaxel, doxorubicin, and cyclophosphamide.
Source: https://pubmed.ncbi.nlm.nih.gov/35093516/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02032277
Geyer CE, Sikov WM, Huober J, Rugo HS, Wolmark N, O’Shaughnessy J, Maag D, Untch M, Golshan M, Lorenzo JP, Metzger O, Dunbar M, Symmans WF, Rastogi P, Sohn JH, Young R, Wright GS, Harkness C, McIntyre K, Yardley D, Loibl S. Long-term efficacy and safety of the addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial. Ann Oncol. 2022 Apr;33(4):384-394. doi: 10.1016/j.annonc.2022.01.009. Epub 2022 Jan 31. PMID: 35093516.
