Weekly cisplatin or gemcitabine concomitant with radiation in the management of locally advanced carcinoma cervix: results from an observational study.

OBJECTIVE

The use of non-platinum drugs in concurrent chemoradiation in carcinoma cervix has not been well explored and hence a two arm study was planned to compare the outcome of concomitant cisplatin or gemcitabine in locally advanced carcinoma cervix.

METHODS

Thirty six patients were evaluated in this study for response rates and complications. These patients were divided into two arms, sixteen patients in the cisplatin arm and twenty patients in the gemcitabine arm. Cisplatin and gemcitabine were given as i.v. infusion at doses of 40 mg/m(2) and 150 mg/m(2) respectively for five weeks concomitant with radiotherapy. All patients had received pelvic radiotherapy to a dose of 50 Gy/25 fraction/5 weeks by four field box technique followed by high-dose-rate brachytherapy (3 sessions, each of 7.5 Gy to point A).

RESULTS

Median follow up was of 10.4 months (range, 3 to 36 months) and 10.9 months (range, 2 to 49 months) in the cisplatin and gemcitabine arms, respectively. At first follow up, 68.8% in the cisplatin arm and 70% in the gemcitabine arm had achieved complete response (p=0.93). Similar response rates were noted in different stages in both arms. None of the patients except one developed grade 4 toxicity. Similar toxicity profiles were observed in both arms. Local disease control, distant disease free survival and overall survival was 68.8% vs. 70%, 93.8% vs. 85%, 68.8% vs. 60% in the cisplatin and gemcitabine arms, respectively.

CONCLUSION

Weekly gemcitabine had similar disease control and tolerable toxicity profile with cisplatin. Gemcitabine may be used as an alternative to cisplatin in patients with compromised renal function.