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A randomized phase II study comparing trabectedin (T) and best supportive care (BSC) in patients (pts) with translocation-related sarcomas (TRS).
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: T binds to the minor groove of DNA and blocks DNA repair machinery following the inhibition of cell cycle and proliferation. In addition, T inhibits interactions of transcription factors including TRS-related transcription factors with the DNA in a competitive manner. This is the first time that the progression-free survival (PFS) of T is compared with BSC as a second or later line treatment in pts with TRS in a multi-center, open, phase II trial. Methods: Main inclusion criteria were the following: histologically proven TRS; unresponsiveness or intolerability to standard chemotherapy regimens (pts with extraskeletal Ewing sarcoma (EES), myxoid liposarcoma (ML), or synovial sarcoma (SS) should have received anthracyclines); at least 1 measurable baseline lesion (RECIST v1.1); confirmed disease progression (per RECIST) compared with the image assessment performed during the previous 6 months(m). Pts stratified by subtype (alveolar rhabdomyosarcoma, ESS, ML, SS vs other TRS) were randomly assigned 1:1 to T (1.2 mg/m2 in 24h continuous infusion every 21 days) or BSC. The primary endpoint was PFS by independent review assessment (IR). This study had 80% power for a one-sided 5% significance level test given a hazard ratio (HR) (T relative to BSC) of 0.50. Sample size goal was 74 pts with an event goal of 52 events by IR requiring a total of 60 events by investigator’s assessment (IA). PFS and overall survival (OS) were analyzed using a stratified log-rank test. Results: Data cut-off date was 8th February 2014. Total of 76 pts were enrolled. Number of pts for efficacy analysis was 73 (T: 37 pts and BSC: 36 pts). Median PFS (90% confidence interval(CI))for T and BSC were 5.6 m (4.2-7.5) and 0.9 m (0.9-1.0), respectively (p<0.0001; HR=0.07, 90% CI: 0.03-0.14). Median OS (95% CI) for T and BSC were not reached (NR) (12.8-NR) and 8.0 m (7.0-NR), respectively (p=0.025; HR=0.38, 95% CI: 0.16-0.91) under permission of crossover. Conclusions: T is an active drug in TRS pts pretreated by available chemotherapies with a significant increase in PFS and OS. Clinical trial information: JapicCTI-121850.
Abstracts by Shunji Takahashi:
Risk factors of pneumothorax in advanced and/or metastatic soft tissue sarcoma patients during pazopanib treatment.Meeting: 2015 ASCO Annual Meeting | Abstract No: e21527Category: Sarcoma - Soft Tissue
Phase I clinical study of cabazitaxel plus prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in a Japanese population.Meeting: 2014 Genitourinary Cancers Symposium | Abstract No: 237Category: Genitourinary Cancer - Prostate Cancer