Adjuvant icotinib versus observation in patients with completely resected EGFR-mutated stage IB NSCLC (GASTO1003, CORIN): a randomised, open-label, phase 2 trial

Clinical efficacy and safety of adjuvant EGFR‐TKIs for resected stage IB lung adenocarcinoma: A real‐world study based on propensity score matching

“…As described previously, the ADAURA trial revealed that adjuvant osimertinib administered for 3 years after chemotherapy could reduce the risk of relapse or death by 61% in the stage IB subgroup 19 . The CORIN study showed that adjuvant icotinib for 1 year significantly improved the 3‐year DFS rate (95.3% vs. 86.7%, respectively; HR: 0.20; 95% CI: 0.04–0.89; p = 0.018) 20 . However, there were 50 patients in stage IB according to the latest edition of lung cancer stage classification in the ADAURA trial, comprising patients who received adjuvant chemotherapy and sequential osimertinib 27 .…”

“…Precision medicine plays a leading role in lung cancer healthcare. With the groundbreaking progress made in targeted therapy for metastatic NSCLC, many clinical trials have focused on early stage and locally advanced NSCLC 19,20,24–26 . As described previously, the ADAURA trial revealed that adjuvant osimertinib administered for 3 years after chemotherapy could reduce the risk of relapse or death by 61% in the stage IB subgroup 19 .…”

“…Based on these positive outcomes, the ADAURA trial was the first study to investigate the efficacy and safety of third‐generation EGFR‐TKIs as an adjuvant option for resected stage IB patients, which suggested that adjuvant osimertinib may reduce the risk of relapse or death by 61% in subgroup analysis 19 . Similarly, the CORIN study evaluated the use of icotinib in stage IB NSCLC patients and revealed that icotinib significantly improved the 3‐year disease‐free survival (DFS) rate, compared with the observation group 20 . However, the ADAURA and CORIN studies used the 7th, instead of the latest 8th edition of the American Joint Committee on Cancer and Union International Contre le Cancer (AJCC/UICC) staging system for lung cancer 4,21 …”

“…19 Similarly, the CORIN study evaluated the use of icotinib in stage IB NSCLC patients and revealed that icotinib significantly improved the 3-year disease-free survival (DFS) rate, compared with the observation group. 20 However, the ADAURA and CORIN studies used the 7th, instead of the latest 8th edition of the American Joint Committee on Cancer and Union International Contre le Cancer (AJCC/ UICC) staging system for lung cancer. 4,21 Thus, we devised and conducted this real-world study to evaluate the efficacy and safety of adjuvant EGFR-TKIs for completely resected stage IB lung adenocarcinoma.…”

Should adjuvant treatment be offered to patients with stage IB non-small cell lung cancer?

“…In this issue of eClinicalMedicine , Ou and colleagues published the results of the CORIN (GASTO1003), phase II, randomised trial, comparing adjuvant therapy with first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), icotinib, versus clinical observation in 128 patients with surgically resected, EGFR-mutant, stage IB (7th TNM edition) non-small cell lung cancer (NSCLC) without adjuvant chemotherapy. 1 The study met its primary endpoint showing a significant increase of 3-year disease free survival (DFS), reported to be 96% in the icotinib group compared to 86% in the observation group, with a reduction in the risk of progression/death around 77% for icotinib-treated patients, confirmed also when adopting the 8th edition of the TNM staging system. The median duration of icotinib therapy was 12 months and the treatment was overall well tolerated with only 6% of grade 3–4 AEs reported in the icotinib-treated patients, including rash, diarrhoea, and pain.…”