S tereotactic Ablative Radiotherapy for oligo-progressive disease refractory to systemic therapy in Non-Small Cell Lung Cancer: A registry-based phase II randomized trial (SUPPRESS-NSCLC)

Houda Bahig, Marion Tonneau, Normand Blais, Philip Wong, Edith Filion, Marie-Pierre Campeau, Toni Vu, Afnan Al-Saleh, Mustapha Tehfé, Marie Florescu, David Roberge, Laura Masucci, Corentin Richard, Cynthia Menard, Bertrand Routy, Houda Bahig, Marion Tonneau, Normand Blais, Philip Wong, Edith Filion, Marie-Pierre Campeau, Toni Vu, Afnan Al-Saleh, Mustapha Tehfé, Marie Florescu, David Roberge, Laura Masucci, Corentin Richard, Cynthia Menard, Bertrand Routy

Abstract

Background: Management of Non-Small Cell Lung Cancer (NSCLC) patients with oligoprogression remains controversial. There is limited data to support the strategy of Stereotactic Ablative Radiotherapy (SABR) targeting the oligoprogressive disease in combination with ongoing systemic treatment. We aim to assess the benefit of this approach compared to standard of care in the treatment of oligoprogressive NSCLC.

Methods: This phase II study will enroll 68 patients with oligoprogressive NSCLC, defined as 1-5 progressive extracranial lesions ≤5 cm involving ≤3 organs. Patients on active systemic therapy (chemotherapy, immunotherapy, targeted therapy or a combination) will be randomized 1:1 to either continue their current systemic therapy in combination with SABR to all lesions or the standard of care (switch to the next line of treatment, continue same treatment or observation). The co-primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints include time to next systemic treatment, patient-reported quality of life, cost effectiveness as well as translational analysis to characterize both adaptive immunity and immunogenic cell death markers in the peripheral blood.

Discussion: There is an unmet need to carefully examine the efficacy, safety and quality of life impact of SABR in the context of oligoprogressive disease. The present study will provide higher level randomized evidence on the role of SABR in oligoprogressive NSCLC.

Keywords: ICI, Immune Checkpoint Inhibitors; NSCLC, Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; OS, Overall Survival; Oligoprogression; PFS, Progression Free Survival; PTC, Planning Target Volume; RECIST, Response Evaluation Criteria in Solid Tumor; SABR, Stereotactic Ablative Radiotherapy; Stereotactic body radiation therapy; TKIs, Tyrosine Kinase Inhibitors.

Conflict of interest statement

HB and BR have received a research grant from Astra Zeneca to support the lung cancer registry within which this study takes place. HB, EF, DR, CM have received research grants from Varian Medical Systems, unrelated to the current work.

© 2021 Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology.

Figures

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Fig. 1
Study diagram.

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