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.
Cancer
; 125(15): 2610-2620, 2019 08 01.
Article
em En
| MEDLINE
| ID: mdl-31173362
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 21 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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Antineoplásicos Alquilantes
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Dacarbazina
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Trabectedina
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Leiomiossarcoma
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Lipossarcoma
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
Cancer
Ano de publicação:
2019
Tipo de documento:
Article