Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma

Luca F Valle; Nicholas Bernthal; Fritz C Eilber; Jacob E Shabason; Meena Bedi; Anusha Kalbasi

doi:10.1155/2021/3735874

Evaluating Thresholds to Adopt Hypofractionated Preoperative Radiotherapy as Standard of Care in Sarcoma

Sarcoma. 2021 Oct 26:2021:3735874. doi: 10.1155/2021/3735874. eCollection 2021.

Authors

Luca F Valle¹, Nicholas Bernthal², Fritz C Eilber³, Jacob E Shabason⁴, Meena Bedi⁵, Anusha Kalbasi¹

Affiliations

¹ Department of Radiation Oncology, Jonsson Comprehensive Cancer Center and David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.
² Department of Orthopedic Surgery, Jonsson Comprehensive Cancer Center and David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.
³ Departments of Surgery, Jonsson Comprehensive Cancer Center and David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles, CA, USA.
⁴ Department of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA.
⁵ Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI, USA.

Abstract

Introduction: Data supporting hypofractionated preoperative radiation therapy (RT) for patients with extremity and trunk soft tissue sarcoma (STS) are currently limited to phase II single-institution studies. We sought to understand the type and thresholds of clinical evidence required for experts to adopt hypofractionated RT as a standard-of-care option for patients with STS.

Methods: An electronic survey was distributed to multidisciplinary sarcoma experts. The survey queried whether data from a theoretical, multi-institutional, phase II study of 5-fraction preoperative RT could change practice. Using endpoints from RTOG 0630 as a reference, the survey also queried thresholds for acceptable local control, wound complication, and late toxicity for the study protocol to be accepted as a standard-of-care option. Responses were logged from 8/27/2020 to 9/8/2020 and summarized graphically.

Results: The survey response rate was 55.3% (47/85). Local control is the most important clinical outcome for sarcoma specialists when evaluating whether an RT regimen should be considered standard of care. 17% (8/47) of providers require randomized phase III evidence to consider hypofractionated preoperative RT as a standard-of-care option, whereas 10.6% (5/47) of providers already view this as a standard-of-care option. Of providers willing to change practice based on phase II data, most (78%, 29/37) would accept local control rates equivalent to or less than those in RTOG 0630, as long as the rate was higher than 85%. However, 51.3% (19/37) would require wound complication rates superior to those reported in RTOG 0630, and 46% (17/37) of respondents would accept late toxicity rates inferior to RTOG 0630.

Conclusion: Consensus building is needed among clinicians regarding the type and threshold of evidence needed to evaluate hypofractionated RT as a standard-of-care option. A collaborative consortium-based approach may be the most pragmatic means for developing consensus protocols and pooling data to gradually introduce hypofractionated preoperative RT into routine practice.