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
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