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ADJUVANT Study: Quality of Life with Adjuvant Gefitinib versus Vinorelbine plus Cisplatin in Patients with EGFR-Mutant NSCLC

2020 Year in Review - Non–Small-Cell Lung Cancer - Lung Cancer

Treatment with gefitinib in the adjuvant setting is associated with enhanced quality of life in patients with early-stage NSCLC and <em>EGFR</em> mutations.

The standard of care for patients with resected stage II to stage IIIA non–small-cell lung cancer (NSCLC) is cisplatin-based adjuvant chemotherapy.1 Findings from the RADIANT and SELECT trials support the idea that use of EGFR tyrosine kinase inhibitors in the adjuvant setting could improve outcomes in patients with EGFR-mutated stage IB to stage IIIA resected NSCLC.1 The ADJUVANT study compared the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin (VP) in patients with completely resected EGFR-mutant stage II to IIIA (N1 to N2) NSCLC.1

Patients with completely resected stage II to stage IIIA (N1 or N2), EGFR-mutant NSCLC were randomized in the ADJUVANT trial to receive either gefitinib for 24 months or VP every 3 weeks for 4 cycles.1 The results indicated that adjuvant gefitinib was associated with significantly longer disease-free survival compared with VP in patients with EGFR-mutated NSCLC.1

Health-related quality-of-life (HRQOL) information can be used to compare adjuvant gefitinib with chemotherapy in patients with early-stage and EGFR mutations.2 HRQOL was assessed as a secondary end point in the ADJUVANT trial using the Trial Outcome Index (TOI) questionnaires, Lung Cancer Symptom Scale (LCSS), and Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L).2 Researchers compared HRQOL improvements, dynamics, and time to deterioration between groups.2

At study initiation, 104 of 106 patients being treated with gefitinib and 80 of 87 patients who were receiving VP completed 3 HRQOL questionnaires.2 The researchers reported that baseline scores were balanced between groups and that HRQOL fluctuated and gradually improved in both groups.2 However, the gefitinib group achieved longitudinally higher (improved) scores compared with the VP group (FACT-L: odds ratio 418.16, 95% confidence interval [CI] 2.75-63509.05, P = .019; LCSS: odds ratio 1.13 [1.04-1.22], P = .003; TOI: odds ratio, 88.39 [4.4-1775.05], P = .003).2 Time to deterioration in HRQOL was delayed with gefitinib compared with VP (FACT-L: median 69 vs 6 weeks, hazard ratio 0.62, 95% CI 0.42-0.90, P = .013; LCSS: median 45 vs 6 weeks, 0.63 [0.43-0.93], P = .020; TOI: median 164 vs 9 weeks, 0.51 [0.33-0.77], P = .001).2

The researchers who conducted the HRQOL analysis concluded that adjuvant use of gefitinib is associated with improved HRQOL compared with use of adjuvant vinorelbine plus cisplatin. These conclusions support the use of gefitinib as adjuvant therapy for patients with early-stage NSCLC and EGFR mutations.2

References
1. Zhong W, et al. Lancet Oncol. 2018;19:139-148.
2. Zeng J, et al. Ann Oncol. 2020;31(S4):S804.

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Last modified: July 22, 2021