3-year invasive disease-free survival with chemotherapy de-escalation using an 18F-FDG-PET-based, pathological complete response-adapted strategy in HER2-positive early breast cancer (PHERGain): a randomised, open-label, phase 2 trial.

作者：J. Pérez-García, Javier Cortés, M. Ruíz-Borrego, M. Colleoni, A. Stradella, B. Bermejo, F. Dalenc, S. Escrivá-de-Romaní, Lourdes Calvo Martínez, N. Ribelles, F. Marmé, A. Cortés, C. Albacar, G. Gebhart, A. Prat, K. Kerrou, P. Schmid, S. Braga, S. Di Cosimo, M. Gion, G. Antonarelli, C. Popa, Emilia Szóstak, D. Alcalá-López, Petra Gener, J. Rodríguez-Morató, L. Mina, M. Sampayo-Cordero, A. Llombart-Cussac · 发表于：The Lancet · 年份：2024 · DOI：10.1016/s0140-6736(24)00054-0 · 被引用次数：71 · 研究领域：Medicine

BACKGROUND PHERGain was designed to assess the feasibility, safety, and efficacy of a chemotherapy-free treatment based on a dual human epidermal growth factor receptor 2 (HER2) blockade with trastuzumab and pertuzumab in patients with HER2-positive early breast cancer (EBC). It used an 18fluorine-fluorodeoxyglucose-PET-based, pathological complete response (pCR)-adapted strategy. METHODS PHERGain was a randomised, open-label, phase 2 trial that took place in 45 hospitals in seven European countries. It randomly allocated patients in a 1:4 ratio with centrally confirmed, HER2-positive, stage I-IIIA invasive, operable breast cancer with at least one PET-evaluable lesion to either group A, where patients received docetaxel (75 mg/m2, intravenous), carboplatin (area under the curve 6 mg/mL per min, intravenous), trastuzumab (600 mg fixed dose, subcutaneous), and pertuzumab (840 mg loading dose followed by 420 mg maintenance doses, intravenous; TCHP), or group B, where patients received trastuzumab and pertuzumab with or without endocrine therapy, every 3 weeks. Random allocation was stratified by hormone receptor status. Centrally reviewed PET was conducted at baseline and after two treatment cycles. Patients in group B were treated according to on-treatment PET results. Patients in group B who were PET-responders continued with trastuzumab and pertuzumab with or without endocrine therapy for six cycles, while PET-non-responders were switched to receive six cycles of TCHP. Aft...