Phase III Soft Tissue Sarcoma Trials: Success or Failure?
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Date
2017-03-01Author
Lee, ATJ
Pollack, SM
Huang, P
Jones, RL
Type
Journal Article
Metadata
Show full item recordAbstract
Two recently reported phase III randomised control trials (RCTs) have resulted in the registration of two new systemic therapies for advanced soft tissue sarcoma. Both of these trials' designs were informed by phase II data that guided the selection of sensitive STS diagnoses, enabling the demonstration of benefit in certain subtypes. A number of other phase III trials reported in the last 18 months have seemingly fit into a recurrent pattern of failure-promising efficacy signals in earlier phase studies being lost in the survival follow-up of large, highly heterogeneous cohorts. Greater effort is needed to identify histological and molecularly defined subgroups associated with differential treatment response in order to avoid the tremendous disappointment and loss of resources associated with a failed phase III trial. Additionally, improvements in available treatment of advanced STS have underpinned a prolongation in overall survival (OS). Consequently, surrogate efficacy endpoints are of increasing importance to STS drug trials. Whilst progression-free survival (PFS) should arguably replace overall survival as the primary endpoint of choice in first-line studies, more work is required to provide definitive validation of surrogacy, as well as developing more sophisticated techniques of assessing radiological response and expanding the inclusion of quality-of-life-related endpoints.
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Subject
Humans
Sarcoma
Antineoplastic Combined Chemotherapy Protocols
Neoplasm Staging
Treatment Outcome
Treatment Failure
Research Design
Randomized Controlled Trials as Topic
Clinical Trials, Phase III as Topic
Standard of Care
Research team
Protein Networks
Sarcoma Clinical Trials (R Jones)
Molecular and Systems Oncology
Language
eng
License start date
2017-03
Citation
Current treatment options in oncology, 2017, 18 (3), pp. 19 - ?
Publisher
SPRINGER