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Clinical Trial
. 2022 Feb 3;27(1):22-29.
doi: 10.1002/onco.13976.

Patient-Reported Outcomes with Selpercatinib Among Patients with RET Fusion-Positive Non-Small Cell Lung Cancer in the Phase I/II LIBRETTO-001 Trial

Anna Minchom  1 , Aaron C Tan  2 , Erminia Massarelli  3 , Vivek Subbiah  4 , Valentina Boni  5 , Bruce Robinson  6 , Lori J Wirth  7 , Lisa M Hess  8 , Min-Hua Jen  8 , Jennifer Kherani  9 , Elizabeth Olek  9 , Caroline E McCoach  10
Affiliations
Free PMC article
Clinical Trial

Patient-Reported Outcomes with Selpercatinib Among Patients with RET Fusion-Positive Non-Small Cell Lung Cancer in the Phase I/II LIBRETTO-001 Trial

Anna Minchom et al. Oncologist. .
Free PMC article

Abstract

Background: LIBRETTO-001 is an ongoing, global, open-label, phase I/II study of selpercatinib in patients with advanced or metastatic solid tumors. We report interim patient-reported outcomes in patients with RET fusion-positive non-small cell lung cancer (NSCLC).

Patients and methods: Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) version 3.0 at baseline (cycle 1, day 1), approximately every other 28-day cycle until cycle 13, and every 12 weeks thereafter. Data were evaluated through cycle 13 as few patients had reached later time points. A change of ≥10 points from baseline in domain scores was considered clinically meaningful.

Results: Among 253 selpercatinib-treated patients, 239 were categorized into subgroups by prior therapy: treatment-naïve (n = 39), one prior line of therapy (n = 64), or two or more prior lines of therapy (n = 136). The QLQ-C30 was completed by >85% of patients at each time point. Most patients overall and in each subgroup maintained or improved in all health-related quality of life (HRQoL) domains during treatment. The percentage of patients who experienced clinically meaningful improvements ranged from 61.1% to 66.7% for global health status, 33.3% to 61.1% for dyspnea, and 46.2% to 63.0% for pain. The 61.1% of patients with improved dyspnea had two or more prior lines of therapy; median time to first improvement was 3.4 months. At the first postbaseline evaluation (cycle 3), 45.9% of all patients reported a ≥10-point reduction in pain.

Conclusion: In this interim analysis, the majority of patients with RET fusion-positive NSCLC remained stable or improved on all QLQ-C30 subscales at each study visit, demonstrating favorable HRQoL as measured by the QLQ-C30 during treatment with selpercatinib.

Keywords: dyspnea; health; non; pain; patient; related quality of life; reported outcomes; selpercatinib; small cell lung cancer.

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Figures

Figure 1.
Figure 1.
Change in global health status/quality of life from baseline by cycle of study treatment as measured by the Quality of Life Questionnaire (QLQ-C30) in patients with RET fusion–positive NSCLC. For each respective cycle, the percentage of patients whose status improved (blue bar), remained stable (orange bar), or worsened (gray bar) from baseline was calculated using the number of patients with both baseline and corresponding postbaseline assessment as the denominator. Abbreviations: NSCLC, non-small cell lung cancer; Tx, treatment.
Figure 2.
Figure 2.
Change in physical function from baseline by cycle of study treatment as measured by the Quality of Life Questionnaire (QLQ-C30) in patients with RET fusion–positive NSCLC. For each respective cycle, the percentage of patients whose status improved (blue bar), remained stable (orange bar), or worsened (gray bar) from baseline was calculated using the number of patients with both baseline and corresponding postbaseline assessment as the denominator. Abbreviations: NSCLC, non-small cell lung cancer; Tx, treatment.
Figure 3.
Figure 3.
Change in dyspnea from baseline by cycle of study treatment as measured by the Quality of Life Questionnaire (QLQ-C30) in patients with RET fusion–positive NSCLC. For each respective cycle, the percentage of patients whose status improved (blue bar), remained stable (orange bar), or worsened (gray bar) from baseline was calculated using the number of patients with both baseline and corresponding postbaseline assessment as the denominator. Abbreviations: NSCLC, non-small cell lung cancer; Tx, treatment.
Figure 4.
Figure 4.
Change in insomnia from baseline by cycle of study treatment as measured by the Quality of Life Questionnaire (QLQ-C30) in patients with RET fusion–positive NSCLC. For each respective cycle, the percentage of patients whose status improved (blue bar), remained stable (orange bar), or worsened (gray bar) from baseline was calculated using the number of patients with both baseline and corresponding postbaseline assessment as the denominator. Abbreviations: NSCLC, non-small cell lung cancer; Tx, treatment.
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