Randomized Controlled Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jun 26, 2022; 10(18): 6069-6081
Published online Jun 26, 2022. doi: 10.12998/wjcc.v10.i18.6069
Sequential chemotherapy and icotinib as first-line treatment for advanced epidermal growth factor receptor-mutated non-small cell lung cancer
Sheng-Jie Sun, Jin-Di Han, Wei Liu, Zhi-Yong Wu, Xiao Zhao, Xiang Yan, Shun-Chang Jiao, Jian Fang
Sheng-Jie Sun, Zhi-Yong Wu, Xiao Zhao, Xiang Yan, Department of Medical Oncology, The Fifth Medical Center of General Hospital of Chinese People's Liberation Army, Beijing 100039, China
Jin-Di Han, Jian Fang, Department of Internal Oncology of Chest, Beijing Cancer Hospital, Beijing 100142, China
Wei Liu, Peking Cancer Hospital Palliative Care Center, Beijing Cancer Hospital, Beijing 100142, China
Shun-Chang Jiao, Department of Oncology, The Fifth Medical Center of General Hospital of Chinese People's Liberation Army, Beijing 100039, China
Author contributions: Sun SJ, Jiao SC, and Fang J carried out the studies, participated in collecting data, and drafted the manuscript; Han JD and Liu W performed the statistical analysis and participated in its design; Wu ZY, Zhao X, and Yan X participated in the acquisition, analysis, interpretation of data and drafted the manuscript; All authors have read and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by General Hospital of People's Liberation Army.
Clinical trial registration statement: ClinicalTrials.gov, NCT01665417. Registered on August 12, 2012, https://clinicaltrials.gov/ct2/show/NCT01665417.
Informed consent statement: All patients signed an informed consent form before any study procedure.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: The raw dataset analyzed in the current study are available from the corresponding author on reasonable request.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Shun-Chang Jiao, MD, Chief Doctor, Department of Oncology, The Fifth Medical Center of General Hospital of Chinese People's Liberation Army, No. 100 West Fourth Ring Road, Fengtai District, Beijing 100039, China. jiaosc@vip.sina.com
Received: November 22, 2021
Peer-review started: November 22, 2021
First decision: February 7, 2022
Revised: March 13, 2022
Accepted: April 15, 2022
Article in press: April 15, 2022
Published online: June 26, 2022
Processing time: 207 Days and 0.4 Hours
ARTICLE HIGHLIGHTS
Research background

In 2018, 2.1 million new lung cancers and 1.8 million deaths were reported, and non-small cell lung cancers (NSCLCs) represent the greatest number (85%-90%) of malignant lung tumors. In Asians, 51.4% of epidermal growth factor receptor (EGFR)-mutated NSCLC was reported and EGFR-tyrosine kinase inhibitors (TKIs) have proved to be an effective treatment for this population.

Research motivation

Drug resistance always occurs after 10 mo of EGFR-TKIs treatment, and combination therapy could be an alternative to solve this difficulty. However, the most adequate combinational strategy remains controversial.

Research objectives

Some clinical studies have reported that sequential chemotherapy followed by maintenance EGFR-TKIs might be a potential strategy compared with EGFR-TKIs monotherapy. The efficacy and tolerability of icotinib has been demonstrated in many studies. Therefore, this pilot randomized controlled trial (RCT) aims to evaluate the efficacy and safety of combination therapy compared with monotherapy.

Research methods

This multicenter, open-label, pilot RCT enrolled 68 EGFR-mutated stage IIIB/IV NSCLC patients randomized 2:3 to the icotinib-alone and chemotherapy + icotinib groups.

Research results

A statistically significant difference was observed between the icotinib-alone and chemotherapy + icotinib groups regarding median progression-free survival (P = 0.0249). No statistically significant difference was found between two and four cycles of chemotherapy which means that the sequential combination of chemotherapy and EGFR-TKIs is feasible. Sequential chemotherapy followed by maintenance EGFR-TKIs might be a potential strategy for EGFR-mutated NSCLC patients; however, the optimal regimen remains to be determined.

Research conclusions

The sequential combination of chemotherapy and EGFR-TKIs could be a feasible strategy for stage IV EGFR-mutated NSCLC patients. It is suggested that 2-cycle sequential combination chemotherapy could have similar effectiveness to that of 4-cycle sequential combination chemotherapy in these patients.

Research perspectives

Future studies should involve a large population from multiple centers around the world to further validate the efficacy and safety of sequential treatment in EGFR-mutated NSCLC patients.