GemCis is the standard first-line chemotherapy for patients with advanced BTC. In ABC-02 study, the BTC patients received up to 6-8 cycles of three-weekly GemCis. Currently, treatment strategy and prognostic factors of patients without progression to first-line GemCis is not well defined.
Advanced BTC patients treated with GemCis between April 2010 and February 2016 at Asan Medical Center, Seoul, Korea, were retrospectively analyzed. The patients without progression after 6-8 cycles were included in the study. Univariate and multivariate analyses were performed to identify prognostic factors for overall survival (OS).
Among the 740 BTC patients in the initial screen, 231 cases (31.2%) were eligible for analysis. Median follow-up period was 23.8 months [IQR 5.1-86.3 months], the median OS from the initiation of treatment was 22.3 months [95% CI 19.0-25.7], and the median PFS was 12.5 months [95% CI 11.1-13.9]. Median age was 60 year-old (29-77) and 211 patients (91.3%) had ECOG performance status of 0 or 1 at the time of diagnosis. Objective response was achieved in 49 patients (21.2%). OS was significantly associated with number of metastatic site (>2 vs < 2: Hazard ratio [HR]=1.5, 95% CI 1.0-2.3, p = 0.04), best response to GemCis (stable disease vs partial response: HR = 1.9, 95% CI 1.3-2.7, p = 0.006). Maintenance therapy after durable disease control after at least 6 cycles of GemCis was not associated with OS (p = 0.47).
In patients who showed durable disease control to first-line GemCis, number of metastatic sites and objective response were significant poor prognostic factors. These results might help to design future clinical trials for this patient population.
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