Objective: Recurrent and advanced cervical cancers are associated with high mortality and a lack of effective treatment options, especially for women who are poor candidates for surgery or radiation therapy. The broad clinical effectiveness and low toxicity of gemcitabine in other human malignancies suggest that it might be useful in treating cervical tumors.
Methods: Fifteen phase I/II clinical trials on the use of gemcitabine, both as a single agent and in combination with cisplatin, in patients with recurrent or advanced carcinoma of the cervix were reviewed. Data from studies in which gemcitabine was used in combination with radiotherapy for induction therapy and with cisplatin for neoadjuvant chemotherapy were also evaluated.
Results: Although single-agent gemcitabine was generally inferior to cisplatin, when used concurrently with cisplatin and/or radiation therapy, objective response rates were high and survival was prolonged. The drug also showed promise when used with cisplatin as neoadjuvant therapy.
Conclusions: Initial studies suggest that gemcitabine may be useful in the management of recurrent or advanced cervical cancer when used concurrently with cisplatin. Accordingly, a large phase III study will compare cisplatin/gemcitabine with the current standard, and further evaluation of gemcitabine appears to be warranted in conjunction with radiotherapy and in the neoadjuvant setting.