Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II trial Journal Article
| Authors: | Hensley, M. L.; Blessing, J. A.; Mannel, R.; Rose, P. G. |
| Article Title: | Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II trial |
| Abstract: | Objectives: Fixed-dose rate gemcitabine plus docetaxel is active as second-line therapy for metastatic uterine leiomyosarcoma. We sought to determine the activity of this regimen as first-line treatment. Methods: Eligible women with advanced uterine leiomyosarcoma were treated with gemcitabine 900 mg/m2 over 90 min, on days one and eight, plus docetaxel 100 mg/m2 on day eight, with granulocyte growth factor support on day nine of a 21-day cycle. Patients with prior pelvic radiation received lower doses. Patients were treated until progression or unacceptable toxicity. Response was assessed every other cycle by RECIST. Results: Forty-two women enrolled, with 39 evaluable for response. Objective responses were observed in 15 of 42 patients (35.8% overall; complete response 4.8%, partial response 31%, 90% confidence interval 23.5 to 49.6%), with an additional 11 (26.2%) having stable disease. Nineteen of 38 (50%) received six or more cycles of study treatment. Myelosuppression was the major toxicity: neutropenia grade 3 in 5%, grade 4 in 12%; anemia grade 3 in 24%; thrombocytopenia grade 3 in 9.5%, grade 4 in 5%. One patient had a grade 3 allergic reaction, 17% had grade 3 fatigue. One possibly-related grade 4 pulmonary toxicity was observed. The median progression-free survival (PFS) was 4.4 months (range 0.4 to 37.2+ months). Among 15 women with objective response, median response duration was 6 months (range 2.1 to 33.4+ months). Median overall survival was 16+ months (range:.4-41.3 months). Conclusion: Fixed-dose rate gemcitabine plus docetaxel achieves high objective response rates as first-line therapy in metastatic uterine leiomyosarcoma. © 2008 Elsevier Inc. All rights reserved. |
| Keywords: | adult; cancer survival; clinical article; treatment response; aged; disease-free survival; middle aged; overall survival; clinical trial; fatigue; neutropenia; advanced cancer; cancer combination chemotherapy; cancer growth; side effect; skin manifestation; gemcitabine; cancer radiotherapy; neurotoxicity; metastasis; infection; lung toxicity; multiple cycle treatment; pain; phase 2 clinical trial; anemia; blood toxicity; gastrointestinal symptom; kidney disease; leukopenia; nausea; thrombocytopenia; antineoplastic combined chemotherapy protocols; peripheral neuropathy; weight reduction; deep vein thrombosis; docetaxel; alanine aminotransferase blood level; aspartate aminotransferase blood level; fever; hyperglycemia; hypoxia; confidence interval; hypoalbuminemia; hypokalemia; hyponatremia; survival time; liver disease; taxoids; leiomyosarcoma; periorbital edema; recombinant granulocyte colony stimulating factor; blood clotting disorder; drug dose regimen; deoxycytidine; urogenital tract disease; uterine neoplasms; granulocyte colony stimulating factor; hearing disorder; photophobia; allergic reaction; musculoskeletal disease; uterine leiomyosarcoma; endocrine disease; uterus sarcoma; blurred vision; epiphora |
| Journal Title: | Gynecologic Oncology |
| Volume: | 109 |
| Issue: | 3 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2008-06-01 |
| Start Page: | 329 |
| End Page: | 334 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2008.03.010 |
| PUBMED: | 18534250 |
| PROVIDER: | scopus |
| PMCID: | PMC2504727 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 46" - "Export Date: 17 November 2011" - "CODEN: GYNOA" - "Source: Scopus" |
