Addition of gemcitabine to standard therapy in locally advanced cervical cancer: A randomized comparative study

BACKGROUND: The concurrent chemoradiotherapy for cervical cancer treatment is well accepted since 1999. This randomized, phase III trial aimed to observe if any improved outcome could be obtained capitalizing on the synergistic activity of gemcitabine, cisplatin, XRT. MATERIALS AND METHODS: Stage IIB-IIIB, 18-70 years of age, KPS score ≥70, were randomized to control group and study group. Control group received cisplatin 40 mg/m(2) weekly with concurrent XRT, followed by brachytherapy and study group received gemcitabine 125 mg/m(2) weekly top of the same control group treatment. The primary end point was pathological response and toxicities along with patient compliance to treatment, late reactions, DFS and OS. Fifty patients were randomized between two arms. RESULTS: The complete response in study and control arm was 96% and 88% respectively. Toxicities was significantly high in the study group compared to control group [leucopenia (P=0.015), skin reaction (P=0.03) and bleeding (P=0.019)]. Local recurrence rate: 8% in study arm, none in control arm. The distant failure prevailed in control arm (20% vs. 8%). On a median follow up of 21 months in control arm, the DFS was 73% whereas 83% in study arm in 16 months (P=0.69). OS in the study arm was 100% and 84.5% in the control arm (P=0.14). CONCLUSIONS: If the toxicity can be managed adequately in the combination chemo radiation group, it may produce an improvement in response. Survival benefit can also be obtained by introducing gemcitabine to cisplatin as radio sensitizer.