Icotinib versus chemotherapy as adjuvant treatment for stage II–IIIA EGFR-mutant non-small-cell lung cancer (EVIDENCE): a randomised, open-label, phase 3 trial

He, Jianxing; Su, Chunxia; Liang, Wenhua; Xu, Shidong; Wu, Lin; Fu, Xiangning; Zhang, Xiaodong; Ge, Di; Chen, Qun; Mao, Weimin; Xu, Lin; Chen, Chun; Hu, Bing; Shao, Guoguang; Hu, Jian; Zhao, Jian; Liu, Xiaoqing; Liu, Zhidong; Wang, Zheng; Xiao, Zemin; Gong, Taiqian; Lin, Wen; Li, Xingya; Ye, Feng; Yang, Liu; Ma, Hu; Huang, Yunchao; Zhou, Jianying; Wang, Zhong Lin; Fu, Junke; Ding, Lieming; Mao, Li; Zhou, Caicun

doi:10.1016/s2213-2600(21)00134-x

Cited by 122 publications

(115 citation statements)

References 29 publications

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“… 20 A study 21 has shown that gefitinib can effectively inhibit a variety of tumor cell lines xenografted in nude mice and can also improve the antitumor effects of chemotherapy and radiotherapy. The clinical study of He et al 22 showed that these patients were significantly and effectively treated with gefitinib, and the disease-related symptoms were significantly improved, which improves the quality of life. However, drug resistance is also predictable in long-term use.…”

Section: Discussionmentioning

confidence: 97%

Effect of Gefitinib Combined with Chemotherapy in Patients with Advanced NSCLC: A Retrospective Cohort Study

Dai

Wang

et al. 2022

IJGM

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Background There are currently no methods for the treatment of reversible drug-resistant EGFR-TKI lung cancer in the clinical setting, and thus, the patients finally return to the currently used drugs. This study aimed to compare the efficacy of chemotherapy alone and gefitinib combined with chemotherapy in the treatment of non-small cell lung cancer (NSCLC) patients in advanced stage with the mutation of epidermal growth factor receptor (EGFR). Methods A retrospective analysis was carried out on 120 patients with advanced EGFRm+ NSCLC who were divided into the control group (CG, received chemotherapy alone) or the observation group (OG, received chemotherapy and gefitinib) according to the treatment methods. Results Comparison of the objective response rates (ORRs) showed no statistical significant difference between OG (36.92%) and CG (29.09%, P > 0.05), whereas in OG, disease control rate (DCR) was significantly increased in comparison with CG (P < 0.05). The medians of progression-free survival (PFS) and overall survival (OS) in OG were 8.0 months and 24.0 months, respectively, which were longer than 5.0 months and 18.0 months in CG (P = 0.031). The univariate analysis revealed that clinical stage of tumor (HR = 1.590, 95% CI: 1.097–2.343) was the prognostic factor for advanced lung cancer. Multi-factor Cox regression analysis revealed that clinical analysis was an independent prognostic factor (HR = 1.701, 95% CI: 1.099–2.632). Conclusion In PFS patients, the OS rate was significantly improved, which was worth for clinical use.

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Section: Discussionmentioning

confidence: 97%

Effect of Gefitinib Combined with Chemotherapy in Patients with Advanced NSCLC: A Retrospective Cohort Study

Dai

Wang

et al. 2022

IJGM

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“…It was worth noted that the DFS was prolonged with statistically significant in patients with EGFR mutations in RADIANT trial [ 20 ]. Moreover, the recent studies of ADAURA and EVIDENCE showed that adjuvant osimertinib or icotinib could provide significant survival benefits against placebo or adjuvant chemotherapy in NSCLC patients with EGFR mutations [ 23 , 24 ]. The reasons for the contradictory results might be caused, at least in part, by that as follows: (1) there was apparent inconsistency in clinical stage; (2) the percentages of EGFR mutations were different, which varied from 4% in BR19 to 100% in most of studies; (3) different generation of EGFR-TKIs was chosen as intervention therapies; (4) the duration of EGFR-TKIs was non-uniform.…”

Section: Discussionmentioning

confidence: 99%

“…Whereas only osimertinib is recommended historically initially as a considerable adjuvant treatment followed adjuvant chemotherapy by NCCN guideline, and none of the other EGFR-TKIs are recommended by guideline [ 29 ]. The reason might be that although the DFS benefits of first generation of EGFR-TKIs were significant in EVIDENCE, ADJUVANT, EVAN and other studies, the DFS advantage associated with adjuvant icotinib, gefitinib and erlotinib did not translate into a significant OS improvement [ 21 , 22 , 24 ]. However, in ADAURA study, the median DFS was not reached in adjuvant osimertinib versus 27.5 months in placebo group [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

“…Previous cohort study demonstrated that adjuvant erlotinib for 2 years after standard adjuvant chemotherapy with or without radiotherapy could improve the survival of patients with surgically resected EGFR -mutant stage IA-IIIA NSCLC, with a remarkable improved 2-year DFS greater than 85% [ 16 ]. Nevertheless, subsequent randomized controlled trials (RCTs) yielded conflicting results with respect to whether adjuvant EGFR-TKIs treatment compared to placebo or adjuvant chemotherapy could improve the prognosis of patients with operable NSCLC [ 17 – 24 ].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of adjuvant EGFR-TKIs for resected non-small cell lung cancer: a systematic review and meta-analysis based on randomized control trials

et al. 2022

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Background Postoperative adjuvant cisplatin-based chemotherapy had been the standard care in patients with completely resected high-risk stage IB to IIIA non-small cell lung cancer (NSCLC) for decades. However, the survival benefits were far from satisfactory in clinical practice. Thus, this meta-analysis was performed to compare the efficacy and safety of adjuvant epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in patients with resected NSCLC based on updated literature and research. Methods A systematic literature search based on random control trials (RCTs) was conducted with keywords on PubMed, Embase and the Cochrane library databases. All articles compared EGFR-TKIs to placebo or chemotherapy as adjuvant therapies for early-stage resected NSCLC. A meta-analysis was performed to generate combined hazard ratio (HR) with 95% confidence intervals (CI) for disease-free survival (DFS), overall survival (OS), and risk ratio (RR) with 95% CI for disease recurrence and adverse events (AEs). The Stata statistical software (version 14.0) was used to synthesis the data. Results A total of 9 RCTs comprising 3098 patients were included. Adjuvant EGFR-TKIs could significantly prolong DFS in patient with resected NSCLC harboring epidermal growth factor receptor (EGFR) mutations (HR 0.46, 95% CI 0.29–0.72), but had no impact on OS (HR 0.87, 95% CI 0.69–1.11). The subgroup analyses indicated that adjuvant EGFR-TKIs were superior in regard to DFS in most subgroups, including varied smoking status, EGFR mutations type, gender, age, Eastern Cooperative Oncology Group performance status and adenocarcinoma. Osimertinib resulted in decreased brain recurrence than first generation of EGFR-TKIs (RR 0.12, 95% CI 0.04–0.34 vs. RR 1.07, 95% CI 0.64–1.78, respectively). The AEs were generally manageable and tolerable. The incidence of high-grade (≥ 3) AEs including diarrhea (RR 5.68, 95% CI 2.94–10.98) and rash (RR 27.74, 95% CI 11.43–67.30) increased after adjuvant EGFR-TKIs treatment. Conclusions Adjuvant EGFR-TKIs therapy could significantly prolong DFS in patients with completely resected early-stage EGFR mutation-positive NSCLC, but had no impact on OS. Adjuvant EGFR-TKIs could be an important treatment option in patients with resected early-stage EGFR-mutant NSCLC.

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“…This approval was based on the results from EVIDENCE trial, in which icotinib showed an improved median DFS of 46.9 months compared with 22.1 months in standard chemotherapy group. 110 Icotinib is now under evaluation by the U.S. FDA for the treatment of EGFR mutation‐positive NSCLC patients.…”

Section: Targeted Therapy For Nsclcmentioning

confidence: 99%

Therapeutic advances in non‐small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy

Yuan

Zhang

2021

MedComm

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Lung cancer still contributes to nearly one‐quarter cancer‐related deaths in the past decades, despite the rapid development of targeted therapy and immunotherapy in non‐small cell lung cancer (NSCLC). The development and availability of comprehensive genomic profiling make the classification of NSCLC more precise and personalized. Most treatment decisions of advanced‐stage NSCLC have been made based on the genetic features and PD‐L1 expression of patients. For the past 2 years, more than 10 therapeutic strategies have been approved as first‐line treatment for certain subgroups of NSCLC. However, some major challenges remain, including drug resistance and low rate of overall survival. Therefore, we discuss and review the therapeutic strategies of NSCLC, and focus on the development of targeted therapy and immunotherapy in advanced‐stage NSCLC. Based on the latest guidelines, we provide an updated summary on the standard treatment for NSCLC. At last, we discussed several potential therapies for NSCLC. The development of new drugs and combination therapies both provide promising therapeutic effects on NSCLC.

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Icotinib versus chemotherapy as adjuvant treatment for stage II–IIIA EGFR-mutant non-small-cell lung cancer (EVIDENCE): a randomised, open-label, phase 3 trial

Cited by 122 publications

References 29 publications

Effect of Gefitinib Combined with Chemotherapy in Patients with Advanced NSCLC: A Retrospective Cohort Study

Effect of Gefitinib Combined with Chemotherapy in Patients with Advanced NSCLC: A Retrospective Cohort Study

Efficacy and safety of adjuvant EGFR-TKIs for resected non-small cell lung cancer: a systematic review and meta-analysis based on randomized control trials

Therapeutic advances in non‐small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy

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