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Cancer. 2019 Aug 1;125(15):2610-2620. doi: 10.1002/cncr.32117. Epub 2019 Jun 7.

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.

Author information

1
The University of Texas MD Anderson Cancer Center, Houston, Texas.
2
Fox Chase Cancer Center, Philadelphia, Pennsylvania.
3
Moffitt Cancer Center, Tampa, Florida.
4
Lutheran General Advanced Care Center, Park Ridge, Illinois.
5
Medical College of Wisconsin, Milwaukee, Wisconsin.
6
Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.
7
Simon Cancer Center, Indiana University, Indianapolis, Indiana.
8
Blumenthal Cancer Center, Carolinas HealthCare System, Charlotte, North Carolina.
9
UCLA Medical Center, Los Angeles, California.
10
SUNY Upstate University Hospital, Syracuse, New York.
11
Cedars-Sinai Medical Center, Los Angeles, California.
12
Georgia Cancer Specialists, Northside Hospital Cancer Institute, Atlanta, Georgia.
13
Sarcoma Oncology Center, Santa Monica, California.
14
Janssen Research & Development, LLC, Raritan, New Jersey.
15
Memorial Sloan Kettering Cancer Center, New York, New York.
16
Mount Sinai Medical Center, New York, New York.
17
Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Harvard Medical School, Boston, Massachusetts.

Abstract

BACKGROUND:

We performed a randomized phase 3 study of trabectedin versus dacarbazine in previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS).

METHODS:

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.

RESULTS:

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).

CONCLUSION:

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.

KEYWORDS:

dacarbazine; leiomyosarcoma; liposarcoma; soft tissue sarcoma; trabectedin

PMID:
31173362
DOI:
10.1002/cncr.32117

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