Abstract
To assess impact of relative total dose intensity (RTDI) on clinical benefit among patients with locally advanced carcinoma gall bladder receiving gemcitabine-cisplatin (GemCis). Comparison of clinical benefit among patients receiving variable RTDI was the primary objective. The secondary objective was an impact of RTDI on chemotherapy toxicity. One-hundred twenty-one patients with locally advanced inoperable carcinoma gall bladder undergoing chemotherapy with three weekly gemcitabine-cisplatin chemotherapies (gemcitabine 1000 mg/m(2) on day 1 and 8, cisplatin 70 mg/m(2) on day 1) were studied. Clinical benefit and treatment toxicity was assessed. Total dose of chemotherapy and relative total dose intensity, the proportion of planned dose actually received was calculated. RTDI of at least 50 % conferred substantial clinical benefit compared to lower RTDI (75.49 vs. 21.05 %). RTDI above 50-59 % did not improve clinical benefit; two-tailed p values of RTDI >60 % vs. RTDI >50 % and RTDI >70 % vs. RTDI >50 % were 1.000 and 0.4266, respectively. Subsequent extended cholecystectomy rates did not significantly improve among patients who received RTDI greater than 50-59 %; two-tailed p values of RTDI >60 % vs. RTDI >50 % and RTDI >70 % vs. >50 % were 0.0920 and 0.5648, respectively. Significantly higher neutropenia and anemia of at least grade 2 occurred with RTDI >70 % vs. RTDI 50-59 %; two-tailed p values 0.0019 and 0.0048, respectively. Relative total dose intensity of chemotherapy higher than 60 % among patients with inoperable locally advanced carcinoma gall bladder conferred no significant improvement in clinical benefit and subsequent rates of extended cholecystectomy. Higher RTDI however led to significantly increased toxicity among these patients.
Published Version
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