Adjuvant Gefitinib versus Vinorelbine plus Cisplatin in Patients with Completely Resected Stage II to IIIA EGFR-Mutant NSCLC (ADJUVANT)

Gefitinib has been found to have better health-related quality of life than use of adjuvant vinorelbine plus cisplatin in early-stage NSCLC.

Cisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II to stage IIIA NSCLC.¹ Findings from the RADIANT and SELECT clinical trials suggest that adjuvant use of EGFR tyrosine kinase inhibitor treatment could benefit patients with EGFR-mutated stage IB to stage IIIA resected NSCLC.¹ The ADJUVANT study compared the efficacy of adjuvant gefitinib (Iressa) versus vinorelbine (Navelbine) plus cisplatin in patients with completely resected EGFR-mutant stage II to IIIA (N1-N2) NSCLC.¹

In the ADJUVANT trial, patients with completely resected, stage II to stage IIIA (N1 or N2), EGFR-mutant NSCLC were randomized to receive either gefitinib for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.¹ Results, which were reported in 2018, showed that adjuvant gefitinib led to significantly longer DFS compared with vinorelbine plus cisplatin in patients with EGFR-mutated NSCLC.¹

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

At baseline, 104 of 106 patients receiving gefitinib and 80 of 87 patients receiving vinorelbine plus cisplatin completed 3 HRQoL questionnaires.² Baseline scores were balanced between groups.² HRQoL fluctuated and gradually improved in both groups.¹ However, longitudinally higher scores were reported with gefitinib compared with vinorelbine plus cisplatin (FACT-L: odds ratio, 418; 95% CI, 2-63,509; P = .019; LCSS: odds ratio, 1.13; 95% CI, 1.04-1.22; P = .003; TOI: odds ratio, 88; 95% CI, 4-1775; P = .003).² Time to deterioration in HRQoL was delayed with gefitinib compared with vinorelbine plus cisplatin (FACT-L: median 69 vs 6 weeks; HR, 0.62; 95% CI, 0.42-0.90; P = .013; LCSS: median 45 vs 6 weeks; HR, 0.63; 95% CI, 0.43-0.93; P = .020; TOI: median 164 vs 9 weeks; HR, 0.51; 95% CI, 0.33-0.77; P = .001).²

Researchers who performed the HRQoL analysis concluded that adjuvant use of gefitinib is associated with enhanced HRQoL compared with use of adjuvant vinorelbine plus cisplatin. This finding supports use of gefitinib as adjuvant therapy for patients with early-stage NSCLC and EGFR mutations.²

References
1. Zhong W, Wang Q, Mao W, et al; for the ADJUVANT Investigators. Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study. Lancet Oncol. 2018;19:139-148.
2. Zeng J, Mao W, Chen Q, Luo T. Quality of life with adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant non-small cell lung cancer: results from the ADJUVANT (CTONG1104) study. Ann Oncol. 2020;31:S804.