Phase II study of concurrent gemcitabine and radiotherapy in locally advanced stage IIIB cervical carcinoma.

OBJECTIVE

The aims of this phase II study were to investigate the feasibility, efficacy, and safety of gemcitabine in combination with radiation in chemonaive patients with advanced cervical cancer.

METHODS

Nineteen patients with advanced stage IIIB cervical cancer received 300 mg/m2 of gemcitabine once weekly with concurrent standard radiotherapy, 5000 cGy, for 5 weeks including one insertion of brachytherapy.

RESULTS

A complete response was observed in 17 (89.5%) of the 19 eligible patients at the end of the third month after completing radiation therapy; 1 patient had a partial response while another showed no response. Adverse events of grade 3 or higher included 1 case each of diarrhea (1/19) and anemia (1/19). Other minor complications (grade 1/2) were cystitis in 8 cases (12 cycles), proctitis in 2 cases (4 cycles), nausea and vomiting in 8 cases (8 cycles), diarrhea in 8 cases (19 cycles), and anemia in 8 cases (40 cycles). At 1 year, 16 patients (84.2%) showed good control of disease, while 2 cases had residual disease and 1 had distant metastasis. Grade 3 cystitis and grade 1-2 proctitis were seen in 1 and 2 cases, respectively. After a median follow-up time of 19.9 months, the results show a disease-free survival of 84.2% and overall survival of 100%.

CONCLUSIONS

Gemcitabine and concurrent radiation is well tolerated and effective for the treatment of cervical cancer. Further study of this regimen should concentrate on the dosage and the sequence of administration. The combination of gemcitabine with other chemotherapeutic agents should also be investigated.