Paclitaxel and cisplatin as first-line therapy in recurrent or advanced squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study

Citation
Pg. Rose et al., Paclitaxel and cisplatin as first-line therapy in recurrent or advanced squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study, J CL ONCOL, 17(9), 1999, pp. 2676-2680
Citations number
21
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
JOURNAL OF CLINICAL ONCOLOGY
ISSN journal
0732-183X → ACNP
Volume
17
Issue
9
Year of publication
1999
Pages
2676 - 2680
Database
ISI
SICI code
0732-183X(199909)17:9<2676:PACAFT>2.0.ZU;2-I
Abstract
Purpose: On the basis of the activity of paclitaxel as a single agent in ch emotherapy-naive squamous cell carcinoma of the cervix in a prior Gynecolog ic 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 cerv ix not curable by surgery or radiation, measurable disease, WBC count great er than or equal to 3,000/mu L, platelet count greater than or equal to 100 ,000/mu L, serum creatinine greater than or equal to 2 mg/100 mt, and adequ ate hepatic function. The starting dose was paclitaxel 135 mg/m(2) infused over 24 hours followed by cisplatin 75 mg/m(2) every 21 days. On the basis of toxicity, a dose escalation of paclitaxel to a maximum dose of 170 mg/m( 2)/d was prescribed. Results: Forty-seven patients were enrolled onto this study; 44 patients we re assessable for toxicity and 41 for response. Forty(90.9%) had received p rior 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 th e most frequent severe adverse effect and was associated with fever in 13 p atients (27.7%). Two patients (4.5%) died from neuropenic sepsis. Grade 4 t hrombocytopenia occurred in 6.8% of patients. Of 41 assessable patients, fi ve (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 22months) 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 squa mous cell carcinoma of the cervix and is currently being evaluated by the G OG in a phase III randomized study comparing the combination of paclitaxel and cisplatin with cisplatin alone. (C) 1999 by American Society of Clinica l Oncology.