Neoadjuvant chemotherapy of docetaxel and carboplatin in patients with stage Ib2 to IIb nonsquamous cervix cancer of the uterus.
5103 Background: Non-squamous carcinoma of the uterine cervix has a resistance to radiation therapy and chemotherapy, and this is associated with worse prognosis compared with squamous carcinoma. This is a phase II study to assess an efficacy and safety of neoadjuvant chemotherapy of docetaxel and carboplatin (DC therapy) in patients with stage Ib2 to II non-squamous cervix cancer of the uterus. Methods: Patients with histologically confirmed, stage Ib2-II non-squamous uterine cervix cancer were received DC therapy prior to type III radical hysterectomy. IV doceaxel was administered at 60 mg/m2 followed by IV carboplatin administration based on AUC=6. The treatment was repeated every 21 days for a total of 1 to 3 cycles. Surgery was performed as soon as sufficient response was obtained. Results: Fifty-three women with non-squamous cervical carcinoma (FIGO stage Ib2,15; IIa, 7; IIb, 31) received DC therapy. Median age and tumor size were 49 years old (range: 27-71) and 52mm (range: 10-92), respectively. Fourty of 47 patients (74%) received 2 cycles of chemotherapy. Clinical response occurred in 69.8% of patients (complete response, 5; partial response, 32; stable disease, 15; disease progression, 1), and 96% (52/54) of patients completed the surgery. Incidences of grade 3/4 hematological toxicities were 98% (53/54) for neutrocytopenia, 4% (2/54) for thrombocytopenia, and 9% (5/54) for anemia. Febrile neutropenia was observed in three patients. Observed grade 3/4 non-hematological toxicities included were 5 for nausea, 2 for vomiting, 3 for constipation, 4 for allergic reaction. Median follow-up duration was 860 days with a range of 147- 1635 days. The 2-years progression-free survival rate and 2-years overall survival rate were 63% and 79% in stage IB2, 71% and 86% in stage IIA2, and 67% and 86% in stage IIB, respectively.Twenty patients recurred and twelve patients died. Conclusions: Neoadjuvant chemotherapy using DC therapy was well tolerated and had good response. It seems to be benefical in patients with satge Ib2 to II nonsquamous cervical cancer.