A phase II randomized trial of gemcitabine plus cisplatin (GP) versus gemcitabine plus carboplatin (GC) as the first-line treatment of patients with metastatic triple-negative breast cancer - PubMed
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- #randomized controlled trial
- #platinum agents
- #triple-negative breast cancer
- Phase II randomized trial comparing gemcitabine plus cisplatin (GP) versus gemcitabine plus carboplatin (GC) as first-line treatment for metastatic triple-negative breast cancer (TNBC).
- 150 untreated metastatic TNBC patients were randomized 1:1 to GP or GC until disease progression or intolerable toxicity.
- Primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival, objective response rate (ORR), and safety.
- Median PFS was 7.8 months for GP and 7.0 months for GC (P = 0.43); median overall survival was 20.3 months and 19.3 months, respectively (P = 0.79).
- ORR was higher for GP (49.3%) than GC (41.3%), but not statistically significant (P = 0.33).
- GP group had more grade 3-4 non-hematological adverse events (nausea, vomiting, hearing impairment), while GC group had slightly higher hematological adverse events (leukopenia, thrombocytopenia, neutropenia, anemia).
- No survival advantage for cisplatin over carboplatin was observed, though GP showed numerically longer PFS and higher ORR.
- Safety profile differences may guide individualized treatment decisions.