Neoadjuvant Chemotherapy With Ifosfamide, Cisplatin, and Vinorelbine in Advanced Squamous Cell Carcinoma of the Cervix
作者:
Carlos Vallejo,
Juan Pérez,
María Domínguez,
Bernardo Leone,
Mario Machiavelli,
Juan Lacava,
Alberto Romero,
Eduardo Ortiz,
Sergio Grasso,
Sonia Amato,
Ricardo Rodríguez,
Mario Barbieri,
Juan Acuña,
Guillermo Focaccia,
Guillermo Suttora,
Mirna Scenna,
José Boughen,
Luis Acuña,
Mario Langhi,
期刊:
American Journal of Clinical Oncology: Cancer Clinical Trials
(OVID Available online 2000)
卷期:
Volume 23,
issue 5
页码: 481-486
ISSN:0277-3732
年代: 2000
出版商: OVID
关键词: Ifosfamide;Cisplatin;Vinorelbine;Cervical cancer;Neoadjuvant chemotherapy.
数据来源: OVID
摘要:
A phase II trial was performed to assess the efficacy and toxicity of a combination of ifosfamide (IFX), cisplatin (CDDP), and vinorelbine (VNB) as neoadjuvant chemotherapy (NAC) for untreated advanced cervical carcinoma (ACC). Between October 1995 and February 1998, 40 patients were entered in this study. Their median age was 43 years (range: 23–74 years). International Federation of Gynecology and Obstetrics stages were: IIB, 23; IIIB, 13; and IVA, 4. Therapy consisted of: IFX 2,000 mg/m21-hour (H) IV infusion days 1 to 3; 2-mercaptoethanesulfonic acid sodium salt (mesna) 400 mg/m2IV bolus H 0 and 4, and 800 mg/m2by mouth H 8, days 1 to 3; VNB 25 mg/m220-minute IV infusion days 1 and 8; and CDDP 75 mg/m2IV day 3. Cycles were repeated every 28 days for a total of three courses. Both staging and response (R) assessment were performed by a multidisciplinary team. An objective response (OR) was observed in 24 of 40 patients (60%; 95% confidence interval, 45–75%). Four patients achieved complete response (CR) (10%); 20 partial response (50%); 12 patients stable disease (30%); and 4 progressive disease (10%). Eight of 24 patients (33%) with OR underwent radical surgery, and histologic CRs were recorded in 2 of them. The remaining patients received definitive radiotherapy after NAC. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 32 patients (80%) and was grade III or IV in 14 patients (36%). Peripheral neuropathy occurred in 9 patients (22%), whereas myalgias occurred in 10 (25%). Constipation was observed in 9 patients (23%); emesis occurred in 35 patients (88%). There were no therapy-related deaths. These results indicate that IFX/CDDP/VNB is an active combination for ACC with moderate toxicity. Implementation of this regimen in a multimodal therapy protocol deserves further study.
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