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- Title
Overall survival and histology-specific subgroup analyses from a phase 3, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma.
- Authors
Patel, Shreyaskumar; von Mehren, Margaret; Reed, Damon R.; Kaiser, Pamela; Charlson, John; Ryan, Christopher W.; Rushing, Daniel; Livingston, Michael; Singh, Arun; Seth, Rahul; Forscher, Charles; D'Amato, Gina; Chawla, Sant P.; McCarthy, Sharon; Wang, George; Parekh, Trilok; Knoblauch, Roland; Hensley, Martee L.; Maki, Robert G.; Demetri, George D.
- Abstract
<bold>Background: </bold>We performed a randomized phase 3 study of trabectedin versus dacarbazine in previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS).<bold>Methods: </bold>Patients were randomized 2:1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every 3 weeks. The primary objective was overall survival (OS). Secondary objectives were progression-free survival, objective response rate, safety, and patient-reported outcomes, all previously reported and demonstrating superior disease control with trabectedin. Results of the final OS analysis in preplanned subgroups of patients with LPS/LMS are presented.<bold>Results: </bold>At the time of the final OS analysis, 577 patients had been assigned randomly, including 423 (73%) with LMS and 154 (27%) with LPS. The median duration of treatment exposure was higher in the trabectedin arm compared with the dacarbazine arm (4 vs 2 cycles), as was the proportion of patients receiving an extended number of therapy courses (≥6 cycles: 42% vs 22%). This pattern was consistent across histological subgroups: the median number of treatment cycles (4 vs 2 for both subgroups) and proportion of patients with ≥6 treatment cycles (LMS, 43% vs 24%; LPS, 40% vs 16%). Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49). Sensitivity analyses of OS suggest confounding by post-study anticancer therapies, which were utilized in most patients in both treatment arms (71% vs 69%, respectively).<bold>Conclusion: </bold>The final OS results demonstrated comparable survival between LPS/LMS patients receiving trabectedin or dacarbazine, which is consistent with the interim analysis results. Both LPS and LMS demonstrated improved disease control with trabectedin.
- Subjects
DACARBAZINE; LIPOSARCOMA; SUBGROUP analysis (Experimental design); PROGRESSION-free survival; THERAPEUTICS
- Publication
Cancer (0008543X), 2019, Vol 125, Issue 15, p2610
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.32117