Paclitaxel and Cisplatin as First-Line Therapy in Recurrent or Advanced Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

PURPOSE: On the basis of the activity of paclitaxel as a single agent in chemotherapy-naive squamous cell carcinoma of the cervix in a prior Gynecologic Oncology Group (GOG) trial, a phase II study of paclitaxel and cisplatin as first-line therapy was conducted by the GOG. PATIENTS AND METHODS: Eligibility included squamous cell cancer of the cervix not curable by surgery or radiation, measurable disease, WBC count ≥ 3,000/μL, platelet count ≥ 100,000/μL, serum creatinine ≥ 2 mg/100 mL, and adequate hepatic function. The starting dose was paclitaxel 135 mg/m2 infused over 24 hours followed by cisplatin 75 mg/m2 every 21 days. On the basis of toxicity, a dose escalation of paclitaxel to a maximum dose of 170 mg/m2/d was prescribed. RESULTS: Forty-seven patients were enrolled onto this study; 44 patients were assessable for toxicity and 41 for response. Forty (90.9%) had received prior radiation therapy. A median of six courses of chemotherapy was given (range, one to 10 courses). Neutropenia grade 3 (15.9%) and 4 (61.4%) was the most frequent severe adverse effect and was associated with fever in 13 patients (27.7%). Two patients (4.5%) died from neutropenic sepsis. Grade 4 thrombocytopenia occurred in 6.8% of patients. Of 41 assessable patients, five (12.2%) had complete responses and 14 (34.1%) had partial responses for an overall response rate of 46.3% (95% confidence interval, 30.7% to 62.6%). The median progression-free interval, was 5.4+ months (range, 0.3 to 22+ months) with a median survival of 10.0+ months (range, 0.9 to 22.2 months). Response was more frequent in patients with disease in nonirradiated sites (70% v 23%, P = .008). CONCLUSION: This regimen seems highly active in advanced and recurrent squamous cell carcinoma of the cervix and is currently being evaluated by the GOG in a phase III randomized study comparing the combination of paclitaxel and cisplatin with cisplatin alone.

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Phase II Study of Cisplatin and Vinorelbine in Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

Journal of Clinical Oncology ◽

10.1200/jco.2004.12.006 ◽

2004 ◽

Vol 22 (16) ◽

pp. 3340-3344 ◽

Cited By ~ 45

Author(s):

Mitchell Morris ◽

John A. Blessing ◽

Bradley J. Monk ◽

Ramon McGehee ◽

David H. Moore

Keyword(s):

Squamous Cell Carcinoma ◽

Cell Carcinoma ◽

Squamous Cell ◽

Gynecologic Oncology ◽

Phase Iii ◽

Moderate Activity ◽

Gynecologic Oncology Group ◽

Oncology Group ◽

Median Response ◽

Recurrent Squamous Cell Carcinoma

Purpose To evaluate the efficacy and toxicity of intravenous cisplatin and vinorelbine as combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the cervix. Patients and Methods Between August 1997 and January 2001, 73 patients with advanced or recurrent squamous cell carcinoma of the cervix were entered onto this study. Eligible patients had received no prior therapeutic chemotherapy, except when administered concurrent with primary radiation therapy. The initial doses administered were cisplatin 75 mg/m2 every 4 weeks and vinorelbine 30 mg/m2 weekly. Subsequent doses were unchanged, reduced, escalated, or omitted according to observed toxicity and protocol guidelines. Patients were evaluated for response and toxicity using standard Gynecologic Oncology Group criteria. Results Of 73 patients, 67 were eligible and assessable. The overall response rate was 30% (five complete and 15 partial responses). The overall median response duration was 5.5+ months. The major toxicity was neutropenia, with 16% grade 3 and 67% grade 4 reported. Gastrointestinal and neurotoxicity were infrequent and mild. Conclusion The combination of cisplatin and vinorelbine has moderate activity in advanced or recurrent squamous cell carcinoma of the cervix. Additional study of this regimen in a phase III setting is justified in this patient population.

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