Phase II study of docetaxel, carboplatin and 5fu in recurrent cancer of the cervix

الملخص EN

Background : Standard chemotherapy for recurrent cancer of the cervix is still platinum based.

The toxicity profile of cisplatin and the availability of less toxic platinum analogues has encouraged its replacement by carboplatin in clinical trials and the desire for higher survival benefit continues to fuel the search for more effective combinations.

The current phase II study assessed docetaxel with carboplatin and 5-Fluorouracil given weekly for 24 weeks, for recurrent cancer of the uterine cervix.

Methods : Forty patients with histological confirmed, recurrent uterine cervix cancer were enrolled.

The patients eligible for this study had histological confirmed recurrent uterine cervix cancer.

Patients received weekly docetaxel 20 mg / m2 and carboplatin area under the curve (AUC2) weekly with bolus 5FU 500 mg / m2.

The response status of the patients was assessed using the common ECOG response criteria.

Results : 40 patients were entered in this study.

The distribution of intial stage at first presentation was IB, 6 ; IIB, 16 ; IIIB, 10 ; IVB, 8.

There were 30 squamous cell carcinomas, 6 adenocarcinomas, 4 adenosquamous cell carcinoma.

: All patients were evaluable, and completed all planned therapy.

The most frequent maximum toxicities during chemotherapy were Grade 2 mucositis with neutopenia.

Nonhematological toxicity was generally mild, except for ubiquitous complete alopecia.

Responses after 6 months included 6 patients with complete responses, 22 patients with Partial response (PR) and 12 patients with Stable disease (SD).

No progression of disease was observed.

Conclusions : This regimen was feasible, safe, and particularly well tolerated.

Early Phase II outcomes revealed promising activity in patients completing all treatment