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STRASS 2 target trial emulation: Bridging the gap between trial efficacy and real-world effectiveness.

Ria Talathi1, Rebecca A Hubbard2, Ponnandai Somasundar3

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Summary

Neoadjuvant chemotherapy before surgery did not improve survival for high-risk retroperitoneal sarcoma patients. Target trial emulation provides real-world data to support ongoing research in rare cancers.

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Area of Science:

  • Oncology
  • Surgical Oncology
  • Medical Oncology

Background:

  • The Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma (STRASS 2) trial investigates neoadjuvant chemotherapy's impact on high-risk retroperitoneal sarcoma.
  • Real-world effectiveness of neoadjuvant chemotherapy for retroperitoneal sarcoma is evaluated using target trial emulation.

Purpose of the Study:

  • To emulate the STRASS 2 trial using real-world data.
  • To assess the impact of neoadjuvant chemotherapy followed by surgery versus upfront surgery on overall survival in retroperitoneal sarcoma patients.

Main Methods:

  • Target trial emulation using the National Cancer Database (2010-2022).
  • Inclusion of patients with dedifferentiated liposarcoma and leiomyosarcoma meeting STRASS 2 eligibility criteria.
  • Comparison of neoadjuvant chemotherapy plus surgery versus upfront surgery using multivariable-adjusted and inverse probability of treatment-weighted Cox regression models.

Main Results:

  • Among 2,215 eligible patients, 9.4% received neoadjuvant chemotherapy followed by surgery, and 90.6% underwent upfront surgery.
  • Neoadjuvant chemotherapy did not improve overall survival compared to upfront surgery across all analytical models (HR 0.73-0.75).
  • Neoadjuvant chemotherapy was not associated with improved R0/R1 resection rates (OR 1.96).

Conclusions:

  • Neoadjuvant chemotherapy does not offer an overall survival benefit for patients with resectable retroperitoneal sarcoma.
  • Target trial emulation is a valuable method for generating real-world evidence in rare and heterogeneous cancers, complementing randomized trials.