Docetaxel as Neoadjuvant Chemotherapy in Patients With Advanced Cervical Carcinoma

Abstract

The purpose of this study was to evaluate the efficacy and toxicity of docetaxel as single-agent neoadjuvant chemotherapy in locoregionally advanced cervical carcinoma. Between April 1998 and August 2000, 38 untreated patients with International Federation of Gynecology and Obstetrics stages IIB to IVA were entered onto this study. The median age was 44 years (range: 25-66 years). Stages: IIB 22 patients, IIIB 15 patients, and IVA 1 pt. Treatment consisted of docetaxel 100 mg/m2 IV infusion during 1 hour. Standard premedication with dexamethasone, diphenhydramine, and ranitidine was used. Cycles were repeated every 3 weeks for three courses, followed by radical surgery when it was judged appropriate, or definitive radiotherapy. Both staging and response assessment were performed by a multidisciplinary team. 106 cycles of therapy were administered; all patients were evaluable for TX, whereas 35 were evaluable for response (3 patients refused further treatment after the first cycle of therapy). Complete response (CR): 1 patient (3%); partial response: 11 patients (31%), for an overall objective response rate of 34% (95% CI: 15-53%); no change (NC): 16 patients (46%); and progressive disease: 7 patients (20%). Six patients (17%) underwent surgery and a pathologic CR was confirmed in 1 of them. The median time to treatment failure and the median survival have not been reached yet. The limiting toxicity was leukopenia in 25 patients (69%) (G1-G2: 14 patients, G3: 10 patients, and G4: 1 patient). Neutropenia: 28 patients (78%) (G1-G2: 10 patients, G3: 8 and G4: 10). Myalgias: 17 patients (47%) (G1-G2: 15 patients and G3: 2 patients). Emesis: 21 patients (55%) (G1-G2: 19 patients and G3: 2 patients). Alopecia G3: 13 patients (36%); rash cutaneous 26 patients (68%) (G1-G2: 22 patients and G3: 4 patients). There were no hypersensitivity reactions or fluid-retention syndrome. The received dose intensity was 91% of that projected. Docetaxel is an active drug against advanced cervical carcinoma with moderate toxicity. Further evaluation in association with other agents is clearly justified.

Phase II Clinical Trial of Docetaxel in Refractory Squamous Cell Carcinoma of the Cervix

“…More recently, Vallejo et al reported modest activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced cervical carcinoma. 25 These two studies suggest that a higher response to docetaxel may be seen in patients who have not been heavily pretreated.…”

Villoglandular papillary adenocarcinoma of the uterine cervix responding to neoadjuvant chemotherapy with docetaxel and cisplatin: a case report

“…Combined therapy with cisplatin and paclitaxel achieved a higher response rate of 45% in patients with advanced/recurrent squamous cell carcinoma (12) , better than that obtained with paclitaxel alone. Vallejo et al (13) performed neoadjuvant chemotherapy for advanced/recurrent squamous cell carcinoma with docetaxel (100 mg/m 2 administered at 3-week intervals for three courses) and achieved a response rate of 34.5% (complete response in 1/35 and partial response in 11/35 patients). In a phase I clinical trial of weekly carboplatin (area under the curve [AUC] 2-3 mg/mL/min) and docetaxel (25-35 mg/m 2 ), Rein et al (14) achieved a response rate of 77% in patients with previously untreated advanced cervical cancer.…”

Role of Difucosylated Lewis Y Antigen in Outcome of Locally Advanced Cervical Squamous Cell Carcinoma Treated with Cisplatin Regimen

“…The remaining 52 patients received cisplatin at standard doses concurrent with pelvic radiotherapy. Eligibility criteria, clinical staging, response criteria, treatment strategy, toxicity evaluation as well as dose schedules, number of chemotherapy cycles and criteria for surgery or radiotherapy have been described in previous reports by our group (13)(14)(15).…”