CONCOMITANT CHEMORADIATION IN LOCALLY ADVANCED CARCINOMA CERVIX: COMPARING DOUBLET VERSUS SINGLE AGENT CHEMOTHERAPY.

Abstract

Purpose: To compare the efficacy and toxicity of two definitive concomitant chemoradiotherapy schedules (doublet combination and single agent) along with radical external beam radiotherapy (EBRT) in the management of locally advanced carcinoma of the uterine cervix (LACCx).

Material and method: Previously untreated, 60 patients of LACCx (FIGO stage IIB-IIIB) were taken for definitive treatment by concurrent chemo-radiation. These patients were randomly assigned either; Study group I, the Doublet chemotherapy(Gemcitabine + Cisplatin) administration and Control group II, the Single-agent chemotherapy(Cisplatin) administration group. EBRT was given as 50Gy/ 25Fr/ 5 weeks. Chemoradiation was followed by weekly HDR Intra-cavitory brachytherapy (ICBT), 3 sessions of 700cGy each. Observations were made at the end of treatment and 6 months of follow up. Response to treatment and toxicity were investigated.

Results: At the end of treatment, disease response in study and control respectively at the end of treatment was as follows: Stage IIB (CR- 52.63% versus 38.09%), Stage IIIA (CR- 100% versus 100%) and Stage IIIB (CR- 55.56% versus 25.0%). Overall disease response for the group I and II, at the end of sixth months follow up was as follows: CR- 93.33% versus 83.33%, PR- 3.33% versus 13.33%, and recurrence- 3.33% versus 3.33% respectively.

Most severe acute hematological toxicity observed was Grade 2 in 40.0% versus 16.67% patients, respectively. Similar was the trend of acute skin & mucosal reactions and acute gastrointestinal toxicity. Though a higher number of patients in the study group experienced more acute toxicities, these were acceptable and manageable. Skin and mucosal reactions at 6 months follow up were not significantly higher in the doublet group compared to the single agent group.

Conclusion: Administration of doublet combination chemotherapy; is better compared to single-agent chemotherapy administration in terms of disease control (though not statistically significant)with manageable toxicity profile; given concurrent with EBRT, for management of locally advanced carcinoma cervix. A larger study may establish the very role of the new regimen, especially in a resource-limited setup where patients present with advanced/ bulky disease.