P G Rose1, J A Blessing, D M Gershenson, R McGehee. 1. Case Western Reserve University, Division of Gynecologic Oncology, Department of Reproductive Biology, University Hospitals of Cleveland, Cleveland, OH, USA.
Abstract
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 > or = 3,000/microL, platelet count > or = 100, 000/microL, serum creatinine > or = 2 mg/100 mL, and adequate 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 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.
RCT Entities:
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 > or = 3,000/microL, platelet count > or = 100, 000/microL, serum creatinine > or = 2 mg/100 mL, and adequate 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 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.
Authors: Israel Zighelboim; Nicholas P Taylor; Matthew A Powell; Randall K Gibb; Janet S Rader; David G Mutch; Perry W Grigsby Journal: Radiat Med Date: 2006-11-24
Authors: C Kosmas; N Mylonakis; G Tsakonas; G Vorgias; N Karvounis; N Tsavaris; T Daladimos; N Kalinoglou; N Malamos; T Akrivos; A Karabelis Journal: Br J Cancer Date: 2009-09-08 Impact factor: 7.640