medwireNews: Phase 2 data point to a favorable benefit–risk balance of stereotactic ablative radiotherapy (SABR) in many patients with early-stage, non-small-cell lung cancer (NSCLC) and concomitant interstitial lung disease (ILD).
The ASPIRE-ILD trial “met its prespecified acceptability thresholds for toxicity and efficacy, supporting the use of SABR for curative-intent treatment after a careful discussion of risks and benefits,” say David Palma (London Health Sciences Centre, Ontario, Canada) and team in JAMA Oncology.
The authors of a linked commentary say that “from a practical perspective, this study may not change the treatment management paradigm for many patients” since “a large proportion of patients opt for treatment” in the absence of other options.
“However, it provides treating radiation oncologists with the ability to be more reassuring in terms of the therapeutic ratio and allows patients to be more comfortable and less anxious with their decisions,” write Ashley Weiner and Lawrence Marks, both from the University of North Carolina School of Medicine in Chapel Hill, USA.
The study included 39 patients with early-stage NSCLC (T1–T2 N0) and fibrotic ILD who were not candidates for surgical resection. Participants were aged a median of 78 years and more than half (59%) were men. The majority (82%) had symptoms attributable to ILD at baseline, most commonly dyspnea (70%), and 15% were oxygen dependent.
All participants received SABR to a dose of 50 Gy given in five fractions every other day, and the protocol included “a built-in dose de-escalation protocol in case of unacceptable toxic effects,” explain the researchers.
After a median follow-up of 19 months, the median overall survival (OS) duration was 25 months, which was “more than double the expected median survival in untreated patients, meeting the primary end point of the trial,” they report.
The OS rate at 1 year was 79%, while the progression-free survival rate was 74% and the median duration was 19 months. The rates of local, regional, and distant control at 2 years were 92%, 86%, and 91%, respectively.
With regard to safety, adverse events of grade 1 or 2 occurred in 30.8% of participants, grade 3 in 10.3%, and grade 5 in 7.7%; there were no grade 4 events.
These rates were within the prespecified limits of 35% for grade 3–4 events and 15% for grade 5 events, note Palma and colleagues.
They continue: “Although we were careful in estimating toxic effect risks by automatically attributing pulmonary toxic effects to radiation, there remains the risk that toxic effect rates are underestimated, and future studies with a larger sample size would be helpful in this regard.”
Weiner and Marks say that “these results are reassuring and suggest that patients with ILD can be safely treated with [SABR] for early-stage NSCLC.”
But they still stress the need for patient-specific shared decision-making. “[F]or example, it is perhaps still prudent to observe a patient with severe ILD and a slowly growing ground-glass nodule that is clinically and radiographically consistent with a low-grade adenocarcinoma,” write the commentators.
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JAMA Oncol 2024; doi:10.1001/jamaoncol.2023.7269
JAMA Oncol 2024; doi:10.1001/jamaoncol.2023.7039