KEY TAKEAWAYS
- The SASCIA (NCT04595565), a phase III trial, aimed to evaluate the safety and efficacy of sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high risk of relapse after neoadjuvant treatment.
- The study randomly assigned patients with residual disease after neoadjuvant chemotherapy (NACT) or hormone receptor (HR)+ with a CPS+EG score ≥3 or 2 and ypN+ after NACT to SG or treatment of physician’s choice (TPC, capecitabine, platinum, observation).
- The study revealed that SG demonstrated a higher rate of adverse events (AEs) than observation-only treatment (TPC). The AEs, including G3-4 AEs, were consistent with the known safety profile of SG but could be managed with recommended supportive measures.
The SASCIA study is an ongoing phase III clinical trial that randomizes patients with HER2-negative breast cancer and residual disease after neoadjuvant chemotherapy (NACT) or hormone receptor-positive (HR+) cancer with a CPS+EG score of greater than equal to 3 or 2 and ypN+ after NACT to either standard of care treatment or physician’s choice of capecitabine, platinum, or observation. In this study, we present the results of the pre-planned SIA analysis.
To conduct the analysis, researchers observed the first 50 randomized patients who had completed four cycles of therapy. Patients were included if they had received ≥2 cycles, were kept for ≥6 weeks, or discontinued earlier. The main goals were to evaluate grade 1-4 adverse events (AEs), grade 3-4 AEs, and compliance with treatment (dose reductions, delays, and withdrawal) between research arms. During the analysis period, 142 patients were randomized for the study, of which 88 were included in the SIA. Among these patients, 45 received SG, 32 were administered capecitabine, and 11 were observed without treatment. The median age of patients in the SG arm was 46 years (range: 24-71 years), whereas it was 51 years (range: 32-74 years) in the TPC arm. The median BMI was (25.8 (20.0-42.6) vs 23.8 (18.2-35.4) kg/m2) in the SG arm, whereas it was 23.8 kg/m2(range: 18.2-35.4 kg/m2) in the TPC arm. More patients in the SG arm had Ki67 >20% (N=29, 64.4%) compared to the TPC arm (N=21, 48.8%). Among the patients, 30 (66.7%) in the SG arm and 29 (67.4%) in the TPC arm were HR-, while 15 (33.3%) in the SG arm and 14 (32.6%) in the TPC arm were HR+. All patients experienced AEs ranging from grade 1 to 4 in the SG arm, while 37 (86.0%) patients in the TPC arm experienced AEs. Moreover, 30 (66.7%) patients in the SG arm experienced G3-4 AEs, while only 9 (20.9%) patients in the TPC arm experienced the same. No deaths occurred during the study. About 6(13.6%) patients under SG therapy discontinued the treatment prematurely, whereas only three (9.4%) patients under capecitabine discontinued treatment. Also, more patients in the SG arm had dose delays 30 (66.7%) vs 13 (43.2%) and dose reductions (12 (26.7%) vs 9 (28.1%) due to AEs, both hematological (N=21, 46.7% vs N=3, 10.0%) and non-hematological (N=3, 6.7% vs N=7, 23.3%). The study concluded that SG showed a higher rate of AEs than TPC, which included observation only; the AEs were manageable using the recommended supportive measures. They were in line with the known safety profile of SG. The study is continuing as planned.
Source: https://cslide.ctimeetingtech.com/breast22hybrid/attendee/confcal/show/session/8
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT04595565
Frederik Marmé, Claus Hanusch, Jenny Furlanetto, Patrick Morris, Theresa Link, Carsten Denkert, Peter A. Fasching, Christian Jackisch, Silvia Antolín, Christine Solbach, Philippe Aftimos, Jens Huober, Michael Untch, Marija Balic, Mattea Reinisch, Jens-Uwe Blohmer, Anthony Gonçalves, Julia Rey, Thomas Büchele, Sibylle Loibl. Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment. https://cslide.ctimeetingtech.com/breast22hybrid/attendee/confcal/show/session/8
