Phase II trial of neoadjuvant paclitaxel and cisplatin in uterine cervical cancer

The toxicity and effectivity of intravenous paclitaxel and cisplatin as neoadjuvant chemotherapy were assessed in cervical cancer patients. Patients and methods. Forty-three consecutive patients affected by International Federation of Gynecology and Obstetrics (FIGO) stage IB2 to IIB were treated with paclitaxel 60 mg/m(2) that was administered intravenously over a 3-h period, followed by cisplatin 60 mg/m(2), also administered intravenously. The chemotherapy was administered every 10 days and for three courses. The toxicity of the regimen in each cycle was determined according to the WHO toxicity criteria and in cases with grade 3 or 4 toxicity, chemotherapy was postponed until the toxicity was disappeared. Before the neoadjuvant chemotherapy, the lesion was pathologically confirmed by punch biopsy, and the size of the tumor mass was measured by pelvic examination and pelvic magnetic resonance imaging (MRI). The response to the treatment was determined 10 days after three cycles of chemotherapy by pelvic examination and pelvic MRI. Two weeks after the neoadjuvant chemotherapy was completed, the patients were either given an operation or radiation therapy, depending on their overall condition, the operational risks, and personal willingness for an operation.

A total of 43 patients were enrolled in this study and all of them were given an operation. Hematologic toxicity was seen in 17 patients. But most of them were anemia and there was no grade 3 or 4. Grade 1 neurotoxicities developed in 29 patients and all of them were peripheral neurotoxicity. Clinical responses occurred in 90.7% (39/43) of patients, including 39.5% (17/43) with a complete response (CR), 11.6% (5/43) with a pathologically determined complete response, 51.2% (22/43) with a partial response (PR), and 9.3% (4/43) showed stable disease (ST). A down-staging response was seen in 72.1% (31/43) of those patients showing a response.

The combination of paclitaxel with cisplatin for use in neoadjuvnant chemotherapy seems to be tolerated and very active in cervical cancer. Especially, every 10 days treatment did not delay the optimal time of main treatment. A larger number of cases need to be studied to confirm the efficacy of the treatment.