Long-term efficacy and safety of 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

• DOI: 10.1016/j.annonc.2022.01.009
• Publication Date: 2022-01-31T01:55:24Z
• Authors: C.E. Geyer; W.M. Sikov; J. Huober; H.S. Rugo; N. Wolmark; J. O’Shaughnessy; D. Maag; M. Untch; M. Golshan; J. Ponce Lorenzo; O. Metzger; M. Dunbar; W.F. Symmans; P. Rastogi; J.H. Sohn; R. Young; G.S. Wright; C. Harkness; K. McIntyre; D. Yardley; S. Loibl
• Keywords: Carboplatin; Veliparib; Triple-negative breast cancer; Clinical endpoint

Primary analyses of the phase III BrighTNess trial showed addition carboplatin with/without veliparib to neoadjuvant chemotherapy significantly improved pathological complete response (pCR) rates with manageable acute toxicity in patients triple-negative breast cancer (TNBC). Here, we report 4.5-year follow-up data from trial.Women untreated stage II-III TNBC were randomized (2 : 1 1) paclitaxel (weekly for 12 doses) plus: (i) (every 3 weeks four cycles) plus (twice daily); (ii) placebo; or (iii) placebo placebo. All then received doxorubicin and cyclophosphamide every 2-3 cycles. The primary endpoint was pCR. Secondary endpoints included event-free survival (EFS), overall (OS), safety. Since co-primary increased pCR versus not met, secondary are descriptive.Of 634 patients, 316 paclitaxel, 160 158 paclitaxel. With median 4.5 years, hazard ratio EFS 0.63 [95% confidence interval (CI) 0.43-0.92, P = 0.02], but 1.12 (95% CI 0.72-1.72, 0.62) In post hoc analysis, 0.57 0.36-0.91, 0.02) OS did differ between treatment arms, nor myelodysplastic syndromes, myeloid leukemia, other malignancies.Improvement associated long-term benefit a safety profile, without increasing risk second malignancies, whereas adding impact EFS. These findings support weekly followed by early-stage TNBC.