A physical examination with vital signs, complete blood cell counts with differentials, and blood chemistry tests were performed before every administration of gemcitabine in each subsequent cycle. Toxicity was evaluated and graded according to version 4.0 of the Common Terminology Criteria for Adverse Events of the National Cancer Institute. All of the patients who received at least one dose of treatment were included in the toxicity assessment. For the toxicity analysis, the data indicating the worst toxicity for each patient from all of the chemotherapy cycles were used. The proportion of patients who experienced adverse events was calculated by dividing the number of patients who experienced adverse events during the treatment period by the number of patients evaluable for safety analysis. Response to treatment according to RECIST version 1.1 was evaluated every 2 cycles. Patients with CR or PR required a confirmatory disease assessment at least 4 weeks later. PFS was defined as the interval from the date of treatment initiation to the first date of documented disease progression or death due to any cause. OS was defined as the interval from the date of treatment initiation to the date of death.

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