TABLE III.
Clinical outcomes for each chemotherapy regimen in advanced uterine leiomyosarcoma
| Regimen | 1st- or 2nd-line therapy | Median os (months) | Median pfs (months) | Response rate, cr+pr [% (95% ci)] | Grades 3–4 toxicity (%) |
|---|---|---|---|---|---|
| Doxorubicin5,a | 1st and 2nd | 12.1 | nr | 25 (9–41) | Leukopenia: 16 Thrombocytopenia: 4 Questionable cardiac toxicity: 3 (no detail) |
| Gemcitabine6,b | 2nd | nr | nr | 21 (7–31) | Leukopenia: 27 Thrombocytopenia: 11 Red blood cell transfusion: 9 Neurotoxicity: 5 Pulmonary toxicity: 5 Cardiovascular toxicity: 5 (no detail) |
| Gemcitabine plus docetaxel7–9,c | 1st and 2nd | 14.7–16.1 | 4.4–6.7 | 27 to 53 (15–42 to 35–70) | Leukopenia: 14–23 Thrombocytopenia: 14–40 Red blood cell transfusion: 43–50 Neurotoxicity: 0–6 Pulmonary toxicity: 0–8 |
| Gemcitabine versus | 1st and 2nd | nr | 4.9 | 18 (2–34) | nr |
| Gemcitabine plus docetaxel (abstract)d | 1st and 2nd | nr | 6.0 | 23 (8–38) | nr |
Adverse effects were assessed using study-defined criteria.
Standard Gynecologic Oncology Group response criteria were used for toxicity grading.
The U.S. National Cancer Institute Common Toxicity Criteria were used for toxicity grading.
Duffaud F, Pautier P, Nguyen BB, et al. A pooled analysis of the final results of the 2 randomized phase ii studies comparing gemcitabine vs. gemcitabine+docetaxel in patients with metastatic/relapsed leiomyosarcoma [abstract 898573]. Presented at the Connective Tissue Oncology Society 16th Annual Meeting; Paris, France; November 11–13, 2010.
os = overall survival; pfs = progression-free survival; cr = complete response; pr = partial response; ci = confidence interval; nr = not reported.