Background: Complete responses (CRs) occur in a minority of patients receiving first-line pembrolizumab plus chemotherapy (P+C) for advanced triple-negative breast cancer (TNBC), and their optimal management remains undefined.
Methods: CEBCC-101 is a multicentre retrospective cohort of 178 patients from Poland, Slovakia and Czech republic with PD-L1-positive advanced TNBC treated with first-line P+C. Patients with investigator-assessed CR by RECIST v1.1 were identified. The first documented CR date was used to calculate time to CR and post-CR follow-up. Clinical features, treatment exposure, toxicity, management, progression, and survival were summarised descriptively.
Results: CR was documented in 8/178 patients (4.5%). Median age was 57.1 years; seven had ECOG performance status 1, and five had de novo metastatic disease. All had one or two metastatic sites; five had visceral disease and none had brain metastases. Median CPS was 25 (range, 12–100). Six patients received gemcitabine–carboplatin and two taxane-based chemotherapy. Median time to CR was 4.9 months (range, 2.7–10.7). Median chemotherapy and pembrolizumab exposure were 7.0 and 11.0 months; treatment remained ongoing in two and four patients, respectively. Grade 3–4 adverse events occurred in six patients, and three required chemotherapy dose reductions >20%. One patient progressed 21.1 months after CR; the other seven had no documented progression after a median post-CR follow-up of 7.1 months (range, 2.4–15.6). One patient underwent breast surgery after radiological CR and achieved ypT0N0. All were alive at data cut-off.
Conclusions: CR occurred in a small subset, often with de novo but limited-site metastatic disease, and was maintained in most despite frequent grade 3–4 toxicity and treatment modification. The observed rate was lower than the 17% reported in KEYNOTE-355 for CPS ≥10, although response ascertainment differed. Larger datasets are needed to identify predictors of CR and define the role of local surgery and optimal treatment duration after CR.