OBJECTIVES: This is a pilot study for a future trial to assess the efficacy and safety of combination chemotherapy with docetaxel and carboplatin in advanced or recurrent uterine cervix cancer. METHODS: The patients eligible for this study had histologically confirmed, advanced (stage IB2-IV) or recurrent uterine cervix cancer. Eligible patients had measurable lesions and must have sufficient bone marrow, renal, and liver functions. Docetaxel was administered intravenously (IV) at 60 mg/m2 followed by IV carboplatin administration based on AUC = 6. Chemotherapy was repeated in 1-6 courses depending on the purpose of the therapy. The response was evaluated based on RECIST criteria. The toxicity grade was determined by NCI-CTC version 2. RESULTS: During January 2001 and April 2004, 17 patients were entered in this study. The distribution of stage was IB2, 3; IIB, 8; IIIB, 3; IVB, 1; recurrent, 2. There were 9 squamous cell carcinomas, 6 adenocarcinomas, 1 adenosquamous cell carcinoma, and 1 small cell carcinoma. The overall response rate was 76% (2 CR, 11 PR, and 4 SD). No progression of disease was observed. All 5 adenocarcinoma patients in the neoadjuvant chemotherapy group responded including 1 pathological CR. The incidences of grade 3/4 toxicities were 76% for neutrocytopenia, 12% for thrombocytopenia, and 6% for anemia. No grade 3/4 neurotoxicity was observed. CONCLUSIONS: The combination of docetaxel and carboplatin is an effective and safe treatment for uterine cervix cancer. Further evaluation particularly targeted on cervical adenocarcinoma is warranted.
OBJECTIVES: This is a pilot study for a future trial to assess the efficacy and safety of combination chemotherapy with docetaxel and carboplatin in advanced or recurrent uterine cervix cancer. METHODS: The patients eligible for this study had histologically confirmed, advanced (stage IB2-IV) or recurrent uterine cervix cancer. Eligible patients had measurable lesions and must have sufficient bone marrow, renal, and liver functions. Docetaxel was administered intravenously (IV) at 60 mg/m2 followed by IV carboplatin administration based on AUC = 6. Chemotherapy was repeated in 1-6 courses depending on the purpose of the therapy. The response was evaluated based on RECIST criteria. The toxicity grade was determined by NCI-CTC version 2. RESULTS: During January 2001 and April 2004, 17 patients were entered in this study. The distribution of stage was IB2, 3; IIB, 8; IIIB, 3; IVB, 1; recurrent, 2. There were 9 squamous cell carcinomas, 6 adenocarcinomas, 1 adenosquamous cell carcinoma, and 1 small cell carcinoma. The overall response rate was 76% (2 CR, 11 PR, and 4 SD). No progression of disease was observed. All 5 adenocarcinomapatients in the neoadjuvant chemotherapy group responded including 1 pathological CR. The incidences of grade 3/4 toxicities were 76% for neutrocytopenia, 12% for thrombocytopenia, and 6% for anemia. No grade 3/4 neurotoxicity was observed. CONCLUSIONS: The combination of docetaxel and carboplatin is an effective and safe treatment for uterine cervix cancer. Further evaluation particularly targeted on cervical adenocarcinoma is warranted.
Authors: Israel Zighelboim; Nicholas P Taylor; Matthew A Powell; Randall K Gibb; Janet S Rader; David G Mutch; Perry W Grigsby Journal: Radiat Med Date: 2006-11-24