Tuberc Respir Dis > Volume 86(1); 2023 > Article |
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Study | Description | Outcome | Reference | |
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Targeted therapy as adjuvant treatment | ||||
RADIANT study | A phase 3 randomized double-blind, placebo-controlled study on the efficacy of erlotinib as adjuvant treatment in stage IB-IIIA NSCLC. There were 161 patients with EGFR mutation among 973 study patients. | DFS of the erlotinib arm tended to be superior to the placebo arm, but no statistically significant difference was present. | [7] | |
Goss et al. | A phase 3 randomized double-blind placebo-controlled study, comparing the efficacy of gefitinib and placebo in resectable IB-IIIA NSCLC. | There was no difference in DFS and OS between the two arms. | [6] | |
SELECT study | Open-label phase 2 single-arm study evaluating the efficacy of erlotinib as an adjuvant treatment. | In all patients with EGFR mutation, 2-year DFS was 88% which was better than the historical genotype-matched control. | [8] | |
CTONG trial | Open-label phase 3 study comparing the efficacy of gefitinib versus vinorelbine plus cisplatin in completely resected stage II-IIIA patients with exon 19 deletion or exon 21 Leu858Arg mutation. | Gefitinib showed significantly better DFS when compared with the vinorelbine+cisplatin arm (HR, 0.60; 95% CI, 0.42-0.87; p=0.0054) in the intention-to-treat population. However, better DFS did not translate to evident benefits in OS. | [10] | |
ADAURA trial | A phase 3 randomized double-blind placebo study, including 682 EGFR mutant patients with NSCLC. | In stage II-IIIA disease of 470 patients, the osimertinib group showed significantly better DFS than the placebo group (HR, 0.17; 95% CI, 0.11-0.26; p=0.001). In stage IB-IIIA NSCLC, the superiority in DFS for osimertinib was maintained (HR, 0.20; 95% CI, 0.14-0.30; p<0.001). | [11] | |
ALINA study (NCT03456076) | A phase III study on efficacy and safety of alectinib as adjuvant therapy in patients with stage IB-IIIA ALK- positive NSCLC. The efficacy of alectinib and platinum-based regimen is to be compared. | No results reported yet. | [14] | |
Immunotherapy as adjuvant treatment | ||||
Impower010 | A randomized, multicenter, open-label, phase 3 study including patients with completely resected stage 1B (tumors ≥4 cm) to IIIA NSCLC according to AJCC 7th edition. | In patients with PD-L1 TC ≥1% (SP263) stage II-IIIA, atezolizumab showed significantly better DFS than in best supportive care (HR, 0.66; 95% CI, 0.50-0.88; p=0.004). In patients with stage II-IIIA and stage IB-IIIA NSCLC, atezolizumab showed significantly better DFS when compared to the best supportive care group. | [15] | |
PEARLS study (NCT02504372) | Assesses the effectiveness of pembrolizumab as adjuvant treatment in participants with stage IB/II-IIIA who have undergone complete resection, regardless of adjuvant chemotherapy. | Adjuvant pembrolizumab showed a statistically significant DFS improvement in patients who had undergone complete resection. | [18] | |
MK-3475-671/KEYNOTE-671 | A phase III, randomized trial evaluating the efficacy of pembrolizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery, and also in the adjuvant phase in patients with resectable T3-4N2 NSCLC. | No results reported yet. | [19] | |
ANVIL study | Evaluates the potential efficacy of nivolumab in improving OS and DFS in patients with stage IB-IIIA NSCLC. | No results reported yet. | [47] |
NSCLC: non-small cell lung cancer; EGFR: epidermal growth factor receptor; DFS: disease-free survival; OS: overall survival; HR: hazard ratio; CI: confidence interval; ALK: anaplastic lymphoma kinase; AJCC: American Joint Committee on Cancer; PD-L1: programmed death-ligand 1; TC: tumor cell; PEARLS: Study of Pembrolizumab (MK-3475) vs. Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091); ANVIL: Adjuvant Nivolumab in Resected Lung Cancers.
Jeong Uk Lim
https://orcid.org/0000-0001-8364-2380