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Published on: July 25, 2020
Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial
Antoine Italiano1, Derek Dinart2,3, Isabelle Soubeyran4
1Department of Medical Oncology, Institut Bergonié, University of Bordeaux, INSERM, Unité ACTION U1218, Bordeaux, France.
Background:
Soft-tissue sarcomas (STS) represent a heterogeneous group of rare tumors including more than 70 different histological subtypes. High throughput molecular analysis (next generation sequencing exome [NGS]) is a unique opportunity to identify driver mutations that can change the usual one-size-fits-all treatment paradigm to a patient-driven therapeutic strategy. The primary objective of the MULTISARC trial is to assess whether NGS can be conducted for a large proportion of metastatic STS participants within a reasonable time, and, secondarily to determine whether a NGS-guided therapeutic strategy improves participant's outcome.
Methods:
This is a randomized, multicentre, phase II/III trial inspired by the design of umbrella and biomarker-driven trials. The setting plans up to 17 investigational centres across France and the recruitment of 960 participants. Participants aged at least 18 years, with unresectable locally advanced and/or metastatic STS confirmed by the French sarcoma pathological reference network, are randomized according to 1:1 allocation ratio between the experimental arm "NGS" and the standard "No NGS". NGS will be considered feasible if (i) NGS results are available and interpretable, and (ii) a report of exome sequencing including a clinical recommendation from a multidisciplinary tumor board is provided to investigators within 7 weeks from reception of the samples on the biopathological platform. A feasibility rate of more than 70% is expected (null hypothesis: 70% versus alternative hypothesis: 80%). In terms of care, participants randomized in "No NGS" arm and who fail treatment will be able to switch to the NGS arm at the request of the investigator.
Discussion:
The MULTISARC trial is a prospective study designed to provide high-level evidence to support the implementation of NGS in routine clinical practice for advanced STS participants, on a large scale.
Trial Registration:
clinicaltrial.gov NCT03784014 .
Insights
The MULTISARC trial assesses if next-generation sequencing (NGS) is feasible for metastatic soft-tissue sarcomas (STS). This study aims to determine if an NGS-guided strategy improves patient outcomes in rare cancers.
Area of Science:
- Oncology
- Genomics
- Clinical Trials
Background:
- Soft-tissue sarcomas (STS) are rare, heterogeneous tumors with over 70 subtypes.
- Next-generation sequencing (NGS) offers a personalized approach to identify driver mutations for tailored cancer treatment.
- Current STS treatment often follows a standard paradigm, lacking individualization based on molecular profiles.
Purpose of the Study:
- To evaluate the feasibility of conducting next-generation sequencing (NGS) in a large cohort of metastatic STS patients within a clinically relevant timeframe.
- To determine if a therapeutic strategy guided by NGS improves outcomes for participants with advanced soft-tissue sarcomas.
- To provide high-level evidence for integrating NGS into routine clinical practice for advanced STS.
Main Methods:
- A randomized, multicentre, phase II/III trial (MULTISARC) involving 960 participants across 17 centers.
- Participants are randomized 1:1 to either an experimental arm receiving NGS or a standard care arm ('No NGS').
- NGS feasibility is defined by timely, interpretable results and a multidisciplinary tumor board recommendation within 7 weeks.
Main Results:
- The study expects a feasibility rate exceeding 70% for NGS implementation.
- Participants in the 'No NGS' arm failing treatment can switch to the NGS arm upon investigator request.
- The trial design is inspired by umbrella and biomarker-driven studies, facilitating adaptable treatment strategies.
Conclusions:
- The MULTISARC trial is designed to generate robust evidence for the widespread adoption of NGS in advanced STS care.
- Implementing NGS can potentially shift STS treatment from a one-size-fits-all approach to a patient-specific therapeutic strategy.
- This study supports the integration of molecular profiling into routine oncological practice for rare cancers like STS.
