Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study Journal Article
| Authors: | Hensley, M. L.; Blessing, J. A.; DeGeest, K.; Abulafia, O.; Rose, P. G.; Homesley, H. D. |
| Article Title: | Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study |
| Abstract: | Objective: Doxorubicin-based treatment is standard therapy for metastatic uterine leiomyosarcoma. There is no standard second-line therapy. We determined activity of fixed-dose rate gemcitabine plus docetaxel as second-line treatment for metastatic uterine leiomyosarcoma. Methods: Eligible women with unresectable uterine leiomyosarcoma progressing after prior cytotoxic therapy were treated with gemcitabine 900 mg/m2 days one and eight over 90 min, plus docetaxel 100 mg/m2 on day 8 of a 21-day cycle with granulocyte growth factor. Patients with prior pelvic radiation received lower doses. Response Evaluation Criteria in Solid Tumors (RECIST) response was assessed by computed tomography (CT). Results: Forty-eight of 51 women were evaluable for response (one wrong histology, two never treated). Prior therapy was doxorubicin-based in 90%, and ifosfamide-based in 6%. The overall objective response rate is 27%, with complete response in 6.3% (3/48), and partial response in 20.8% (10/48). An additional 50% (24/48) had stable disease (median duration 5.4 months). The median number of cycles per patient was 5.5 (range 1-22); 73% of patients remained progression-free at 12 weeks and 52% at 24 weeks. The predominant toxicity was uncomplicated myelosuppression: thrombocytopenia grade 3 (29%), grade 4 (10.4%); neutropenia grade 3 (12.5%), grade 4 (8.3%) anemia grade 3 (20.8%), grade 4 (4.2%). While pulmonary toxicity was reported, no patient had drug-related pneumonitis/hypoxia-type toxicity. Median progression-free survival (PFS) was 5.6+ months (range 0.7-27+ months). The median duration of objective response was 9+ months (range 3.9-24.5+ months). Conclusion: Fixed-dose rate gemcitabine plus docetaxel is active second-line therapy for uterine leiomyosarcoma. © 2008 Elsevier Inc. All rights reserved. |
| Keywords: | adult; cancer survival; clinical article; treatment response; aged; disease-free survival; middle aged; antibiotic agent; clinical trial; fatigue; neutropenia; cisplatin; doxorubicin; cancer combination chemotherapy; cancer growth; side effect; unspecified side effect; skin manifestation; gemcitabine; paclitaxel; cancer radiotherapy; disease free survival; temozolomide; neurotoxicity; edema; metastasis; computer assisted tomography; infection; lung toxicity; multiple cycle treatment; phase 2 clinical trial; neoplasm recurrence, local; anemia; bone marrow suppression; allergy; bleeding; gastrointestinal symptom; kidney disease; leukopenia; thrombocytopenia; antineoplastic combined chemotherapy protocols; dexamethasone; deep vein thrombosis; ifosfamide; docetaxel; aspartate aminotransferase blood level; dyspnea; febrile neutropenia; lymphocytopenia; pneumonia; hypoxia; survival time; cardiovascular disease; nausea and vomiting; liver disease; disease duration; taxoids; leiomyosarcoma; recombinant granulocyte colony stimulating factor; drug dose regimen; deoxycytidine; urogenital tract disease; alopecia; uterine neoplasms; granulocyte colony stimulating factor; metabolic disorder; musculoskeletal disease; uterine leiomyosarcoma; endocrine disease; eye toxicity; uterus sarcoma; fluid retention |
| Journal Title: | Gynecologic Oncology |
| Volume: | 109 |
| Issue: | 3 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2008-06-01 |
| Start Page: | 323 |
| End Page: | 328 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2008.02.024 |
| PUBMED: | 18394689 |
| PROVIDER: | scopus |
| PMCID: | PMC2692926 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 31" - "Export Date: 17 November 2011" - "CODEN: GYNOA" - "Source: Scopus" |
