Neoadjuvant tislelizumab plus nab-paclitaxel and carboplatin for triple-negative breast cancer: a multicenter, open-label, phase II cTRIO study
Mené en Chine sur 62 patientes atteintes d'un cancer du sein triple négatif, cet essai multicentrique de phase II évalue l'efficacité, du point de vue du taux de réponse complète, et la toxicité d'un traitement néoadjuvant combinant tislélizumab, nab-paclitaxel et carboplatine
Background: To investigate the efficacy and safety of adding tislelizumab to neoadjuvant chemotherapy with nab-paclitaxel and carboplatin (TP) followed by adjuvant tislelizumab for early TNBC to explore the optimal neoadjuvant chemotherapy backbone and courses.
Methods: The cTRIO study (ChiCTR2100041675) is a multicenter, prospective, open-label phase II trial across 8 sites in China, evaluating the efficacy and safety of neoadjuvant tislelizumab plus TP followed by adjuvant tislelizumab in patients with early triple-negative breast cancer (TNBC). We included women aged ≥18 years with histologically confirmed early TNBC defined by estrogen receptor immunohistochemistry (IHC) with T1 N1-3 or T2-4 N0-3 stage. Participants received six cycles of neoadjuvant tislelizumab (200 mg on day 1) plus nab-paclitaxel and carboplatin (TP; 125 mg/m2 on days 1 and 8), definitive surgery 3–6 weeks after completion of neoadjuvant therapy, followed by adjuvant tislelizumab every 3 weeks for 1 year. The primary endpoint was pathologic complete response (pCR).
Findings: Sixty-two patients were enrolled from March 2021 to October 2022, including 44 cases with programmed cell death ligand 1 (PD-L1) positive and 9 cases at N3. At final analysis, 35/62 patients had achieved pathologic complete response (pCR, 56%; 95% confidence interval [CI], 43%–69%), with 33% (3/9) of N3 cases achieving pCR. The 3-year EFS and OS rates were 82.2% (95% CI, 70.2%–89.7%) and 87.7% (95% CI, 75.6%–94.0%), respectively. The incidence rates of grade ≥3 treatment-related adverse events (TRAEs) and grade ≥3 immune-related adverse events (irAEs) were 53% (33/62) and 5% (3/62), respectively. Patients with a higher PD-L1 combined positive score were less likely to experience relapse (P = 0.0090).
Interpretation: Despite being a de-escalating and anthracycline-free neoadjuvant treatment approach, the triplet combination therapy showed promising efficacy and safety, signifying a crucial step toward the optimization of chemoimmunotherapy for early TNBC.
eClinicalMedicine , résumé, 2025