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.
BackgroundSolitary fibrous tumors (SFT) of the retroperitoneum are rare spindle cell neoplasms, with a paucity of data on treatment outcomes. We hypothesized that surgical excision offered acceptable outcomes in SFTs.MethodsThe National Cancer Database (NCDB) was used to identify patients with SFT from 2004 to 2011. Primary outcome measures were 30 day mortality and overall survival. Descriptive analyses were performed. Furthermore, a systematic review of published literature was conducted after creating a pre-specified search strategy.ResultsOf 51 patients in the NCDB, 58.8 % (n = 30) were males, with a median age 60 years (IQR 49–72 years). Median tumor size was 16 cm (IQR 11–21 cm). Surgical resection was performed in 92.2 % (n = 47) with 63.8 % (n = 30) having a margin negative resection. Peri-operative mortality was 2.1 % (n = 1). Of survival outcomes available for 18 patients, the median OS was 51.1 months. From the systematic review, we identified 8 studies, with 24 patients. Median age and tumor size was similar to the NCDB [47.5 years (IQR 39–66.5 years), 12 cm (IQR 7–17 cm)]. Majority [91.7 % (n = 22)] underwent surgical excision alone while one received adjuvant chemotherapy and none received radiation. After median follow up of 54 months (IQR 28–144 months), 79.2 % (n = 19) were alive without disease. Three patients (12.5 %) died of disease, one was alive with disease and one was lost to follow up. Recurrence was reported in 16.7 % (n = 4) of patients.ConclusionComplete surgical excision is a viable treatment modality for retroperitoneal SFT leading to long term survival. Low recurrence rates would argue against the need for routine adjuvant radiation or chemotherapy.
This analysis shows that >5 pulmonary metastasis, malignant fibrous histiocytoma histology, stage III disease, and proximal lower extremity sarcomas are associated with decreased metastatic survival. Moreover, aggressive multimodality management of metastatic disease may prolong metastatic survival.
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