nab-Paclitaxel Plus Carboplatin or Gemcitabine vs Gemcitabine Plus Carboplatin as First-Line Treatment for Patients With Triple-Negative Metastatic Breast Cancer: Results From the tnAcity Trial
Mené sur 191 patientes atteintes d'un cancer du sein triple négatif de stade métastatique, cet essai de phase II compare l'efficacité, du point de vue de la survie sans progression, et la toxicité de trois modalités thérapeutiques, l'une combinant nab-paclitaxel et carboplatine, l'autre combinant nab-paclitaxel et gemcitabine, et enfin une dernière combinant gemcitabine et carboplatine, en traitement de première ligne
Background : Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and/safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. Patients and methods : Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1:1:1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 plus C AUC 2, all on days 1, 8 q3w. Phase II primary endpoint: investigator-assessed progression-free survival (PFS); secondary endpoints included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. Results : In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C vs nab-P/G (median, 8.3 vs 5.5 months; HR, 0.59 [95% CI, 0.38-0.92]; P = .02) or G/C (median, 8.3 vs 6.0 months; HR, 0.58 [95% CI, 0.37-0.90]; P = .02). OS was numerically longer with nab-P/C vs nab-P/G (median, 16.8 vs 12.1 months; HR, 0.73 [95% CI, 0.47-1.13]; P = .16) or G/C (median, 16.8 vs 12.6 months; HR, 0.80 [95% CI, 0.52-1.22]; P = .29). ORR was 73%, 39%, and 44% respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. Conclusions : First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile vs nab-P/G or G/C.