A phase II study of gemcitabine and cisplatin combination as induction chemotherapy for untreated locally advanced cervical carcinoma

Background: Cisplatin-based chemoradiation for locally advanced cervical ca rcinoma is now the standard of care for most patients with cervical carcino ma. However, induction chemotherapy followed by surgery, particularly with newer agents or combinations remains to be explored. This study was underta ken to evaluate the antitumor activity and toxicity of gemcitabine in combi nation with cisplatin for untreated locally advanced cervical carcinoma. Patients and methods: Open-label, single center, phase II, non-randomized s tudy of neoadjuvant gemcitabine plus cisplatin. Forty-one patients with his tologic diagnosis of cervical carcinoma, with no previous treatment and sta ged as IB2 to IIIB, were treated with three 21-day courses of cisplatin 100 mg/m(2) day 1 and gemcitabine 1000 mg/m(2) days 1 and 8, followed by locor egional treatment with either surgery or concomitant chemoradiation. Respon se and toxicity were evaluated before each course and at the end of chemoth erapy. Results: All patients were evaluated for toxicity and 40 for response. The overall objective response rate was 95% (95% confidence interval (CI): 88%- 100%) being complete in 3 patients (7.5%) and partial in 35 (87.5%). A comp lete pathological response was found in 6 (26%) of the 23 patients that und erwent surgery. Granulocytopenia grades 3-4 occurred in 13.8% and 3.4% of t he courses, respectively, whereas non-hematological toxicity was mild. Conclusions: Induction chemotherapy with the combination of gemcitabine and cisplatin is highly active for untreated cervical cancer patients and has an acceptable toxicity profile.