Stereotactic Radiation Therapy in Early Non-Small Cell Lung Cancer and Interstitial Lung Disease: A Nonrandomized Clinical Trial.

Autor:	Palma DA; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Bahig H; Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada., Hope A; Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Harrow S; Edinburgh Cancer Centre, Edinburgh, Scotland., Debenham BJ; Department of Radiation Oncology, University of Alberta, Edmonton, Alberta, Canada., Louie AV; Department of Radiation Oncology, University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Vu TTTT; Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada., Filion E; Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada., Bezjak A; Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Campeau MP; Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada., Duimering A; Department of Radiation Oncology, University of Alberta, Edmonton, Alberta, Canada., Giuliani ME; Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Laba JM; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Lang P; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Lok BH; Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Qu XM; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Raman S; Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada., Rodrigues GB; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Goodman CD; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Gaede S; Department of Medical Physics, Western University, London, Ontario, Canada., Morisset J; Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada., Warner A; Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada., Dhaliwal I; Department of Respirology, London Health Sciences Centre, London, Ontario, Canada., Ryerson CJ; Department of Medicine and Centre for Heart Lung Innovation, University of British Columbia, Vancouver, British Columbia, Canada.
Jazyk:	angličtina
Zdroj:	JAMA oncology [JAMA Oncol] 2024 May 01; Vol. 10 (5), pp. 575-582.
DOI:	10.1001/jamaoncol.2023.7269
Abstrakt:	Importance: Patients with interstitial lung disease (ILD) and early-stage non-small cell lung cancer (NSCLC) have been reported to be at high risk of toxic effects after stereotactic ablative radiotherapy (SABR), but for many patients, there are limited alternative treatment options. Objective: To prospectively assess the benefits and toxic effects of SABR in this patient population. Design, Setting, and Participants: This prospective cohort study was conducted at 6 academic radiation oncology institutions, 5 in Canada and 1 in Scotland, with accrual between March 7, 2019, and January 12, 2022. Patients aged 18 years or older with fibrotic ILD and a diagnosis of T1-2N0 NSCLC who were not candidates for surgical resection were enrolled. Intervention: Patients were treated with SABR to a dose of 50 Gy in 5 fractions every other day. Main Outcomes and Measures: The study prespecified that SABR would be considered worthwhile if median overall survival-the primary end point-was longer than 1 year, with a grade 3 to 4 risk of toxic effects less than 35% and a grade 5 risk of toxic effects less than 15%. Secondary end points included toxic effects, progression-free survival (PFS), local control (LC), quality-of-life outcomes, and changes in pulmonary function. Intention-to-treat analysis was conducted. Results: Thirty-nine patients enrolled and received SABR. Median age was 78 (IQR, 67-83) years and 59% (n = 23) were male. At baseline, 70% (26 of 37) of patients reported dyspnea, median forced expiratory volume in first second of expiration was 80% (IQR, 66%-90%) predicted, median forced vital capacity was 84% (IQR, 69%-94%) predicted, and median diffusion capacity of the lung for carbon monoxide was 49% (IQR, 38%-61%) predicted. Median follow-up was 19 (IQR, 14-25) months. Overall survival at 1 year was 79% (95%, CI 62%-89%; P < .001 vs the unacceptable rate), and median overall survival was 25 months (95% CI, 14 months to not reached). Median PFS was 19 months (95% CI, 13-28 months), and 2-year LC was 92% (95% CI, 69%-98%). Adverse event rates (highest grade per patient) were grade 1 to 2: n = 12 (31%), grade 3: n = 4 (10%), grade 4: n = 0, and grade 5: n = 3 (7.7%, all due to respiratory deterioration). Conclusions and Relevance: In this trial, use of SABR in patients with fibrotic ILD met the prespecified acceptability thresholds for both toxicity and efficacy, supporting the use of SABR for curative-intent treatment after a careful discussion of risks and benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT03485378.
Databáze:	MEDLINE
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