Evidence map›Paper›PMID 27507876›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Randomized Phase II Trial of Gefitinib With and Without Pemetrexed as First-Line Therapy in Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations.

Ying Cheng, Haruyasu Murakami, Pan-Chyr Yang, Jianxing He, Kazuhiko Nakagawa, Jin Hyoung Kang, Joo-Hang Kim, Xin Wang, Sotaro Enatsu, Tarun Puri and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05132985 (Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma), which is not on this map. Cited by 93 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 14 pooled it
18.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05132985 phase2not yet recruitingnot on this mapstarted 2022, after this paper: background citation

Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study

TypeinterventionalSponsorLiaoning Cancer Hospital & InstituteRan2022 to 2028Enrolled45ConditionsNSCLC, EGF-R Positive Non-Small Cell Lung CancerArmsIcotinib, Cisplatin, Carboplatin, Pemetrexed
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 14 syntheses or guidelines pooled it, 187 citations in OpenAlex.

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  14. Gefitinib for advanced non-small cell lung cancer.The Cochrane database of systematic reviews · 2018
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33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Ying ChengYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Haruyasu MurakamiYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Pan-Chyr YangYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Jianxing HeYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Kazuhiko NakagawaYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Jin Hyoung KangYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Joo-Hang KimYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Xin WangYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Sotaro EnatsuYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Tarun PuriYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
Mauro OrlandoYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina.
James Chih-Hsin YangYing Cheng, Jilin Provincial Cancer Hospital, Changchun; Jianxing He, The First Affiliated Hospital of Guangzhou Medical University, Guangdong; Xin Wang, Eli Lilly, Shanghai, China; Haruyasu Murakami, Shizuoka Cancer Center, Shizuoka; Kazuhiko Nakagawa, Kinki University School of Medicine, Osaka; Sotaro Enatsu, Eli Lilly Japan, Kobe, Japan; Pan-Chyr Yang and James Chih-Hsin Yang, National Taiwan University Hospital; James Chih-Hsin Yang, National Taiwan University Cancer Center, Taipei, Taiwan; Jin Hyoung Kang, The Catholic University of Korea, Seoul; Joo-Hang Kim, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Korea; Tarun Puri, Eli Lilly, Gurgaon, Haryana, India; and Mauro Orlando, Eli Lilly Interamérica, Buenos Aires, Argentina. chihyang@ntu.edu.tw.
Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo determine whether the addition of pemetrexed to gefitinib (P+G) provides clinical benefit, compared with gefitinib monotherapy, in patients with advanced nonsquamous (NS) non-small-cell lung cancer (NSCLC) and activating epidermal growth factor receptor (EGFR) mutations. PATIENTS AND

methodsChemotherapy-naïve for advanced NSCLC patients from China, Japan, Korea, and Taiwan (35 sites) with advanced, EGFR-mutant, NS NSCLC were randomly assigned (2:1; computer-generated, interactive voice response) to open-label pemetrexed (500 mg/m(2) on day 1 of every 21-day cycle) plus gefitinib (250 mg/d [n = 129]) or gefitinib alone (n = 66). The primary end point was progression-free-survival (PFS); secondary end points were time to progressive disease, overall survival, tumor response rates, duration of response, and safety. All end points were assessed in the intent-to-treat and safety population (P+G, n = 126; gefitinib alone, n = 65).

resultsPFS was significantly longer with P+G (median, 15.8 months; 95% CI, 12.6 to 18.3 months) than with gefitinib (median, 10.9 months; 95% CI, 9.7 to 13.8 months; adjusted hazard ratio [HR], 0.68; 95% CI, 0.48 to 0.96; one-sided P = .014; two-sided P = .029). Results of EGFR exon 19 deletion and EGFR exon 21 L858R point mutation subgroup analyses were consistent with the intent-to-treat result. P+G, compared with gefitinib alone, resulted in significantly longer time to progressive disease (median, 16.2 v 10.9 months, respectively; HR, 0.66; 95% CI, 0.47 to 0.93) and numerically longer duration of response (median, 15.4 v 11.3 months, respectively; HR, 0.74; 95% CI, 0.50 to 1.08). Tumor response rates did not differ. Overall survival data are immature. Drug-related grade 3 or 4 adverse events were more common with P+G, but toxicities were manageable.

conclusionP+G improved PFS compared with gefitinib alone in East Asian patients with advanced NS NSCLC and activating EGFR mutations. This combination may offer EGFR mutation-positive patients new treatment options and improved clinical outcomes compared with the current standard of care.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease-Free SurvivalEnzyme ActivationErbB ReceptorsFemaleGefitinibHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPemetrexedProtein Kinase InhibitorsQuinazolinesEGFR protein, humanErbB ReceptorsGefitinibPemetrexedProtein Kinase InhibitorsQuinazolines

Identifiers

PMID27507876
OpenAlexW2518488558

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.