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Published on: February 12, 2017
Survival Outcomes of Gemcitabine-Cisplatin-S-1 Versus Gemcitabine-Cisplatin in Unresectable Biliary Tract Cancer: A
Hisashi Kosaka1, Masahiko Kinoshita2, Satoshi Yasuda3
1Department of Hepatobiliary Surgery Kansai Medical University Hirakata Japan.
Background:
Gemcitabine plus cisplatin (GC) has been the global standard for advanced biliary tract cancer (BTC). The triplet regimen gemcitabine-cisplatin-S-1 (GCS) demonstrated superiority in the MITSUBA trial, but its real-world effectiveness remains unclear. We compared survival outcomes of GCS versus GC, focusing on conversion surgery (CS).
Methods:
We retrospectively analyzed 542 patients with unresectable BTC treated between 2017 and 2024 at 19 Japanese institutions. Patients received GC (n = 310) or GCS (n = 232). Survival was evaluated using multivariable Cox regression, 90-day landmark analysis, and propensity score matching (PSM) to adjust for baseline imbalances.
Results:
Patients treated with GCS achieved greater tumor shrinkage (median -23.0% vs. -10.0%, p = 0.014) and a higher CS rate (16.4% vs. 4.5%, p < 0.001) than GC. Median progression-free survival was 8.6 versus 5.4 months (p = 0.002), and median overall survival (OS) was 17.2 versus 11.6 months (p = 0.006). In multivariable analysis, GCS was associated with a lower risk of death (HR 0.80, 95% CI 0.65-0.98, p = 0.035), with consistent results after PSM. Fifty-two patients underwent CS, with comparable perioperative safety and R0 resection rates between regimens. Patients who underwent CS achieved markedly longer OS; in the overall cohort, median OS was 31.0 months in the GCS with CS group and not reached in the GC with CS group (p = 0.131).
Conclusions:
Treatment with GCS was associated with longer survival compared with GC in unresectable BTC, alongside a higher rate of conversion surgery, which was associated with favorable long-term outcomes.
