Phase II study of topotecan and paclitaxel for recurrent, persistent, or metastatic cervical carcinoma

Objective. This trial investigated the safety and efficacy of paclitaxel and topotecan combination chemotherapy for patients with advanced cervical cancer (ACC). Methods. Patients with recurrent, persistent, or metastatic ACC and an ECOG performance status ≤2 were treated with 175 mg/m 2 paclitaxel...

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Bibliographic Details
Published in:	Gynecologic oncology Vol. 92; no. 2; pp. 635 - 638
Main Authors:	Tiersten, Amy D, Selleck, Meredith J, Hershman, Dawn L, Smith, D, Resnik, Edward E, Troxel, Andrea B, Brafman, Lois B, Shriberg, Laureen
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-02-2004
Subjects:	Adenocarcinoma - drug therapy Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Squamous Cell - drug therapy Cervical cancer Combination therapy Female Humans Middle Aged Neoplasm Recurrence, Local - drug therapy Paclitaxel Paclitaxel - administration & dosage Paclitaxel - adverse effects Topotecan Topotecan - administration & dosage Topotecan - adverse effects Uterine Cervical Neoplasms - drug therapy Topotecan Combination therapy Cervical cancer Paclitaxel
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Summary:	Objective. This trial investigated the safety and efficacy of paclitaxel and topotecan combination chemotherapy for patients with advanced cervical cancer (ACC). Methods. Patients with recurrent, persistent, or metastatic ACC and an ECOG performance status ≤2 were treated with 175 mg/m 2 paclitaxel on Day 1 and 1 mg/m 2 topotecan on Days 1–5 of a 21-day cycle with G-CSF support and the standard pretreatment regimen for paclitaxel. Patients were treated until disease progression or unacceptable toxicity. Results. Fifteen patients were enrolled, and 86 cycles of therapy (median, 5; range, 1–14) were administered. Grade 3/4 toxicities included anemia (47%), leukopenia (27%), neurotoxicity (13%), thrombocytopenia (13%), and diarrhea (13%). Among 13 evaluable patients, 7 (54%) responded (1 complete and 6 partial; 95% confidence interval = 29.2%, 76.8%). Three (23%) patients experienced stable disease. Progression-free and overall survival were 3.77 and 8.62 months, respectively. Conclusion. The combination of paclitaxel/topotecan was generally well tolerated and active in the relapsed, recurrent, or metastatic ACC setting, with response rates comparable with those of other current ACC systemic therapies.
ISSN:	0090-8258 1095-6859
DOI:	10.1016/j.ygyno.2003.11.019