Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting.

Autor: Pivot X; Institute of Cancer Strasbourg, 17 Rue Albert Calmette, 67033, Strasbourg, France. x.pivot@icans.eu., Manikhas AG; St Petersburg GBUZ City Clinical Oncology Dispensary, St Petersburg, Russia., Shamrai V; Vinnytsia Regional Clinical Oncological Dispensary, Vinnytsia, Ukraine., Dzagnidze G; S. Khechinashvili University Hospital, Tbilisi, Georgia., Soo Hoo HF; Penang General Hospital, Penang Island, Malaysia., Kaewkangsadan V; Department of Surgery, Phramongkutklao Hospital, Bangkok, Thailand., Petrelli F; Oncology Unit, ASST Bergamo Ovest, Bergamo, Trevigilio, Italy., Villanueva C; Clinique Clementville, Montpellier, Montpellier, France., Kim J; Prestige BioPharma Ltd, Singapore, Singapore., Pradhan S; Prestige BioPharma Ltd, Singapore, Singapore., Jaison L; Prestige BioPharma Ltd, Singapore, Singapore., Feyaerts P; Prestige BioPharma Ltd, Singapore, Singapore., Kaufman L; DICE, Naamloze Vennootschap, Dilbeek, Belgium., Derde MP; DICE, Naamloze Vennootschap, Dilbeek, Belgium., Deforce F; DICE, Naamloze Vennootschap, Dilbeek, Belgium., Cox DG; Institute of Cancer Strasbourg, 17 Rue Albert Calmette, 67033, Strasbourg, France.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2023 Jan 31; Vol. 23 (1), pp. 112. Date of Electronic Publication: 2023 Jan 31.
DOI: 10.1186/s12885-023-10574-2
Abstrakt: Background: The TROIKA trial established that HD201 and trastuzumab were equivalent in terms of primary endpoints (total pathological complete response) following neoadjuvant treatment. The objective of the present analysis was to compare survival outcomes and final safety.
Methods: In the TROIKA trial, patients with ERBB2-positive early breast cancer were randomized and treated with either HD201 or the referent trastuzumab. Eligible patients received 8 cycles of either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in combination with 8 cycles of chemotherapy (4 cycles of docetaxel, 75 mg/m 2 , followed by 4 cycles of epirubicin, 75 mg/m 2 , and cyclophosphamide, 500 mg/m 2 ) in the neoadjuvant setting. The patients then underwent surgery followed by 10 cycles of adjuvant HD201 or referent trastuzumab according to their initial randomization to complete one year of trastuzumab-directed therapy. Event-free and overall survival rates were calculated using Kaplan-Meier analysis. The hazard ratio for event-free survival was estimated by Cox proportional hazards regression.
Results: The final analysis was performed after all patients completed the study at a median follow-up of 37.7 months (Q1-Q3, 37.3-38.1 months). A total of 502 randomized patients received either HD201 or the referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. In this population, the 3-year event-free survival rates were 85.6% (95% CI: 80.28-89.52) and 84.9% (95% CI: 79.54-88.88) in the HD201 and referent trastuzumab groups, respectively (log rank p = 0.938) (HR 1.02, 95% CI: 0.63-1.63; p = 0.945). The 3-year overall survival rates were comparable between the HD201 (95.6%; 95% CI: 91.90-97.59) and referent trastuzumab treatment groups (96.0%, 95% CI: 92.45-97.90) (log rank p = 0.606). During the posttreatment follow-up period, adverse events were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the reference trastuzumab groups, respectively. Serious adverse events were rare and none of which were related to the study treatment.
Conclusions: This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.
Trial Registration: ClinicalTrials.gov identifier: NCT03013504.
(© 2023. The Author(s).)
Databáze: MEDLINE
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