Concurrent cisplatin/gemcitabine chemotherapy along with radiotherapy in locally advanced cervical carcinoma: a phase II trial.

OBJECTIVE: To evaluate the efficacy and safety of a concurrent regimen of gemcitabine/cisplatin and radiotherapy in women with locally advanced cervical carcinoma (LACC). METHODS: From April 2001 to June 2002, we enrolled women diagnosed with histologically proven LACC (FIGO stages IIA through IIIB), for treatment with concurrent regimen of chemo-radiotherapy. The treatment consisted of: cisplatin 40 mg/m(2), followed by gemcitabine 125 mg/m(2), once weekly, given about 1 to 2 h before radiotherapy. External beam radiation was delivered 5 days/week to entire pelvic radiation field for a total of 50 Gy in 25 fractions over 5 weeks. After completion of external radiation, patients received brachytherapy with cesium-137 via standard Fletcher-suit applicators delivering 30 Gy to point A. RESULTS: Of the 23 enrolled patients (mean age 47 years), 20 completed the treatment and were evaluable for response and safety. The complete response rate was 90% (18/20), and partial response rate was 10% (2 patients with persistent disease after therapy). Toxicity was moderate: 2 patients required blood transfusions; 5% patients had grade 2 leukopenia or thrombocytopenia; 40% had grade 1-2 nausea-vomiting, and 50% had grade 1 diarrhea. At a median follow-up of 12 months, all patients are alive, and 16/20 (80%) are disease-free. CONCLUSIONS: The gemcitabine/cisplatin combination administered concurrently with radiotherapy is highly active in locally advanced cervical carcinoma. The tolerable toxicity and synergistic activity of this concurrent chemoradiation regimen are consistent with prior reports. Definitive results are awaited from an on-going large, randomized trial comparing this regimen with standard treatment.