SCOTCERV: A phase II trial of docetaxel and gemcitabine as second line chemotherapy in cervical cancer

ObjectiveThe aim of the study was to determine the response rate and response duration of cervical cancer previously treated by cisplatin (with or without radiation) to a combination of docetaxel and gemcitabine. Secondary endpoints were assessment of toxicity and quality of life (QoL) of patients receiving the treatment.MethodsThis was a multicentre phase II trial of 3 weekly docetaxel 75 mg/m2 day 1 (reduced to 60 mg/m2 after 32 cycles had been administered) and gemcitabine 1000 mg/m2 (days 1 and 8). A two stage Gehan design was used initially. Twenty-nine patients recruited had disease outside the irradiated pelvis (Group 1), and 21 had disease confined to the irradiated pelvis (Group 2). The target response for the Gehan 2 design was 25% (Group 1) and 10% (Group 2).ResultsThe overall response rate for Group 1 was 21.4% (95% CI 8.3–41.0%). Amongst those who had at least 3 cycles of chemotherapy the response rate was 27.3% (95% CI 10.7–50.2%). The median survival was 7.3 months (95% CI 5.4 to 9.2 months) with 39.3% (95% CI 21.7–56.5%) alive at 1 year. In Group 2 the overall response rate was 9.5% (95% CI 1.2%–30.4%). The response rate for those who had at least 3 cycles of chemotherapy was 12.5% (95% CI 1.6–38.4%). The median survival was 7.9 months (95% CI 2.2–13.6 months). Toxicity was mainly haematological with 51% developing grade 3 or 4 neutropenia after at least 1 cycle of chemotherapy. QoL showed a significant deterioration from baseline for physical and role function but there was an improvement in emotional function during treatment.ConclusionResponse rates and survival duration were similar to those reported following treatment with platinum based doublets. In view of the relatively poor response rates (no more than 36%) to conventional chemotherapy future developments should be a combination of chemotherapy and biological agents such as VEGFR inhibitors.

Research highlights
► A combination of docetaxel and gemcitabine is active in recurrent carcinoma of cervix after radiation and cisplatin.
► The response rate in extra-pelvic tumours (at least 3 cycles of chemotherapy) was 27.3% : median survival 7.3 months.
► The response rate in the irradiated pelvis was 12.5% : median survival 7.9 months.