Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial

Mitsudomi, Tetsuya; Morita, Satoshi; Yatabe, Yasushi; Negoro, Shunichi; Okamoto, Isamu; Tsurutani, Junji; Seto, Takashi; Satouchi, Miyako; Tada, Hirohito; Hirashima, Tomonori; Asami, Kazuhiro; Katakami, Nobuyuki; Takada, Minoru; Yoshioka, Hiroshige; Shibata, Kazuhiko; Kudoh, Shinzoh; Shimizu, Eiji; Saito, Hiroshi; Toyooka, Shinichi; Nakagawa, Kazuhiko; Fukuoka, Masahiro

doi:10.1016/s1470-2045(09)70364-x

Cited by 4,090Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial

Mitsudomi, Tetsuya, Morita, Satoshi, Yatabe, Yasushi, Negoro, Shunichi, Okamoto, Isamu, Tsurutani, Junji, Seto, Takashi, Satouchi, Miyako +13 more·2010·The Lancet Oncology

DOI 10.1016/s1470-2045(09)70364-x

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Abstract

Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor (EGFR) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain.Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m(2), intravenously) plus docetaxel (60 mg/m(2), intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539.Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9.2 months (95% CI 8.0-13.9) versus 6.3 months (5.8-7.8; HR 0.489, 95% CI 0.336-0.710, log-rank p<0.0001). Myelosuppression, alopecia, and fatigue were more frequent in the cisplatin plus docetaxel group, but skin toxicity, liver dysfunction, and diarrhoea were more frequent in the gefitinib group. Two patients in the gefitinib group developed interstitial lung disease (incidence 2.3%), one of whom died.Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel.Funding West Japan Oncology Group (WJOG): a non-profit organisation supported by unrestricted donations from several pharmaceutical companies.

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First-generation EGFR TKIs gefitinib and erlotinib have shown improved efficacy and tolerability compared with chemotherapy in phase III trials.
“have shown improved efficacy and tolerability compared with chemotherapy in numerous phase III trials”
From Afatinib for the treatment of EGFR mutation-positive NSCLC: A review of clinical findings (2020) · cites this paper as [30]
Eight randomised controlled phase III trials have demonstrated that first-generation or second-generation EGFR-TKIs represent the best first-line treatment option in patients with advanced NSCLC whose tumours harbour EGFR mutations, when compared with chemotherapy, because they significantly improved the RR and PFS.
“Eight randomised controlled phase III trials (table 1) have demonstrated that first-generation or second-generation EGFR-TKIs represent the best first-line treatment option in patients with advanced NSCLC whose tumours harbour EGFR mutations, when compared with chemotherapy, because they significantly improved the RR and progression-free survival (PFS).4–11”
From Mechanisms of resistance to EGFR-targeted drugs: lung cancer (2016) · cites this paper as [5]
Patients with EGFR-mutant NSCLC usually respond to first-generation TKIs but most progress after about 9-14 months.
“Unfortunately, whilst patients with EGFRm+ tumors typically show good initial responses to first generation TKIs, most patients who respond to therapy ultimately develop disease progression after about 9-14 months of treatment (7-11).”
From AZD9291, an Irreversible EGFR TKI, Overcomes T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer (2014) · cites this paper as [8]
Most patients with exon 19 deletions or L858R have radiographic responses to gefitinib, erlotinib, and afatinib.
“Most patients whose tumors harbor exon 19 deletions or L858R EGFR activating mutations have radiographic responses to monotherapy with the reversible adenosine triphosphate (ATP)-competitive EGFR tyrosine kinase inhibitors (TKIs) gefitinib and erlotinib 17–23 and the irreversible EGFR TKI afatinib 24.”
From Structural, Biochemical, and Clinical Characterization of Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations in Lung Cancer (2013) · cites this paper as [21]
Randomized trials show that EGFR TKIs improve response rate and progression-free survival compared with chemotherapy as initial systemic therapy for advanced EGFR-mutant NSCLC.
“Several randomized clinical trials have demonstrated that EGFR TKIs are more effective, as measured by response rate (RR) and progression free survival (PFS), than chemotherapy when used as initial systemic treatment for advanced EGFR mutant NSCLC (1, 4–9).”
From EGFR Mutations and Resistance to Irreversible Pyrimidine-Based EGFR Inhibitors (2015) · cites this paper as [9]

Several other trials conducted in Asia confirmed the superiority of Gefitinib over chemotherapy in EGFR-mutated patients.
“Several other trials conducted in Asia confirmed the superiority of Gefitinib over chemotherapy in EGFR-mutated patients [16, 44, 64].”
From A decade of EGFR inhibition in EGFR-mutated non small cell lung cancer (NSCLC): Old successes and future perspectives (2015) · cites this paper as [16]
Targeted therapies for EGFR-mutant lung cancers were established based on 7 phase III randomized trials.
“Targeted therapies for these lung cancers were established based on 7 phase III randomized trials.5, 6, 7, 8, 9, 10, 11”
From Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy (2016) · cites this paper as [6]
Randomized phase III trials demonstrated superiority of gefitinib and erlotinib in progression-free survival to conventional chemotherapy in patients with EGFR-mutant lung cancers.
“Randomized phase III trials have demonstrated the superiority of these TKI, in terms of progression free survival (PFS), to conventional chemotherapy in patients with lung cancers harboring EGFR mutations.5, 6, 11”
From Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy (2016) · cites this paper as [6]
In prospective trials of common EGFR mutations, gefitinib, erlotinib and afatinib showed objective response rates of approximately 60% and progression-free survival of 9-13 months.
“Evidence of these common mutations has been developed in prospective trials: gefitinib, erlotinib and afatinib showed ORR of approximately 60% and PFS of 9–13 months.5, 6, 7, 8, 9, 10, 11”
From Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy (2016) · cites this paper as [6]
Disease progresses in most patients after 9 to 13 months of first-line EGFR-TKI therapy.
“Despite high tumor response rates with first-line EGFR-TKIs, disease progresses in a majority of patients after 9 to 13 months of treatment.5–12”
From Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer (2017) · cites this paper as [6]
Several studies have consistently shown that EGFR TKIs (gefitinib, erlotinib, afatinib) produce higher response rates, longer PFS and improved quality of life compared with platinum-based doublet chemotherapy in PS 0-2 patients whose tumours have an activating EGFR mutation.
“Several studies have consistently demonstrated that the EGFR TKIs (gefitinib, erlotinib and afatinib) produce higher RRs, longer PFS and improve QoL compared with standard platinum-based doublet chemotherapy in patients with good PS (PS 0-2), whose tumour harbours an activating (sensitising) EGFR mutation [105-112].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [109]

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“Randomized phase 3 studies have shown better progression-free survival (PFS) and responses with gefitinib or erlotinib than platinum-based chemotherapy for NSCLC harboring epidermal growth factor receptor (EGFR) (3-8).”
Background
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Authors: Mitsudomi, T., Morita, S., Yatabe, Y., Negoro, S., Okamoto, I., Tsurutani, J., Seto, T., Satouchi, M., Tada, H., Hirashima, T., Asami, K., Katakami, N., Takada, M., Yoshioka, H., Shibata, K., Kudoh, S., Shimizu, E., Saito, H., Toyooka, S., Nakagawa, K., & Fukuoka, M.
Affiliations: Aichi Cancer Center (JP)
Yokohama City University Medical Center (JP)
Hyogo Prefectural Cancer Center (JP)
Kindai University (JP)
National Hospital Organization Kyushu Cancer Center (JP)
Osaka City General Hospital (JP)
Osaka Habikino Medical Center (JP)
NHO Kinki Chuo Chest Medical Center (JP)
Kobe City Medical Center General Hospital (JP)
Kurashiki Central Hospital (JP)
Kouseiren Takaoka Hospital (JP)
Osaka City University (JP)
Tottori University (JP)
Okayama University (JP)
Corresponding author: Mitsudomi, Tetsuya
ORCID: Mitsudomi, Tetsuya
Morita, Satoshi
Yatabe, Yasushi
Okamoto, Isamu
Tsurutani, Junji
Seto, Takashi
Satouchi, Miyako
Tada, Hirohito
Katakami, Nobuyuki
Takada, Minoru
Yoshioka, Hiroshige
Shibata, Kazuhiko
Shimizu, Eiji
Saito, Hiroshi
Toyooka, Shinichi
Nakagawa, Kazuhiko
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2010-02
Volume: 11
Issue: 2
Pages: 121-128
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(09)70364-x
OpenAlex: W2129360604
Cited by: 4,090
References: 5
Citations by year: 2026: 31 · 2025: 110 · 2024: 130 · 2023: 140 · 2022: 211 · 2021: 228 · 2020: 236 · 2019: 264 · 2018: 318 · 2017: 329 · 2016: 312 · 2015: 382 · 2014: 372 · 2013: 352 · 2012: 300
FWCI: 187.49
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: AstraZeneca
Sanofi
European Society for Medical Oncology
Chugai Pharmaceutical
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords: gefitinib, non-small cell lung cancer, EGFR mutation, EGFR tyrosine kinase inhibitors, exon 19 deletion, L858R mutation, progression-free survival, platinum-based chemotherapy, first-line therapy, myelosuppression, postoperative recurrence
MeSH terms: Docetaxel, Gefitinib, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Cisplatin, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Quinazolines, Taxoids, ErbB Receptors

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Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial

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