Phase II trial of Neoadjuvant Paclitaxel and Cisplatin in Carcinoma of the Uterine Cervix

Park, Dong Choon; Kim, Jae Hoon; Lew, Young Ok; Kim, Dae Hoon; Namkoong, Sung Eun

Abstract

OBJECTIVE
The toxicity and effectivity of intravenous paclitaxel and cisplatin as neoadjuvant chemotherapy were assessed in cervical cancer patients.
METHODS
Thirty seven consecutive patients affected by FIGO stage IB2 to \\'a5\\'b1B were treated with paclitaxel 60 mg/m2 that was administered intravenously over a 3-hour period, followed by cisplatin 60 mg/m2, 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 for one week. The size of the tumor mass was measured prior to the neoadjuvant chemotherapy by means of pelvic examination and pelvic magnetic resonance imaging (MRI). The response to the treatment was determined 10 days after 3 cycles of chemotherapy by means of 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.
RESULTS
A total of 37 patients were given a radical hysterectomy and enrolled in this study. Mild myalgia was the most common toxicity. Granulocytopenia was seen in four patients but there was no grade 3 or 4. Grade 1 neurotoxicities developed in four patients. Clinical responses occurred in 94.6% (35/37) of patients, including 35.1% (13/37) with a complete response, 10.8% (4/37) with a pathologically determined complete response, 59.5% (22/37) with a partial response, and 5.4% (2/37) showed stable disease. A down-staging response was seen in 75.7% (28/37) of those patients showing a response.
CONCLUSIONS
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 surgically or radologically optimal time. A larger number of cases need to be studied in order to confirm the efficacy of the treatment.