Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma

Mok, Tony S.; Wu, Yi-Long; Thongprasert, Sumitra; Yang, Chih-Hsin; Chu, Da-Tong; Saijo, Nagahiro; Sunpaweravong, Patrapim; Han, Baohui; Margono, Benjamin; Ichinose, Yukito; Nishiwaki, Yutaka; Ohe, Yuichiro; Yang, Jin-Ji; Chewaskulyong, Busyamas; Jiang, Haiyi; Duffield, Emma L.; Watkins, Claire L.; Armour, Alison A.; Fukuoka, Masahiro

doi:10.1056/nejmoa0810699

Cited by 8,261Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma

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Mok, Tony S., Wu, Yi-Long, Thongprasert, Sumitra, Yang, Chih-Hsin, Chu, Da-Tong, Saijo, Nagahiro, Sunpaweravong, Patrapim, Han, Baohui +11 more·2009·New England Journal of Medicine

DOI 10.1056/nejmoa0810699

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Abstract

BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. METHODS: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival. RESULTS: The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin-paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, progression-free survival was significantly longer among those who received carboplatin-paclitaxel (hazard ratio for progression or death with gefitinib, 2.85; 95% CI, 2.05 to 3.98; P<0.001). The most common adverse events were rash or acne (in 66.2% of patients) and diarrhea (46.6%) in the gefitinib group and neurotoxic effects (69.9%), neutropenia (67.1%), and alopecia (58.4%) in the carboplatin-paclitaxel group. CONCLUSIONS: Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. (ClinicalTrials.gov number, NCT00322452.)

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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 [31]
The Results report better progression-free survival with gefitinib than with carboplatin–paclitaxel in the clinically selected trial population, and the Discussion reports lower rates of several chemotherapy-associated adverse effects. But this paper does not establish the same comparative benefit for erlotinib or across numerous phase III trials; it also reports better progression-free survival with chemotherapy in patients without an EGFR mutation. The indexed passages provide section labels but no page numbers. (LLM, conf=0.88)
Experimental — accuracy not yet measured
Reduced sensitivity to gefitinib or erlotinib in NSCLC was linked to EGFR-specific activating mutations.
“Afterwards, studies revealed that the reduced sensitivity to gefitinib or erlotinib in NSCLC was linked to EGFR-specific activating mutations.112–116”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [115]
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 [4]
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 [9]
Duration of response, progression-free survival, and overall survival are even more variable across these trials.
“Even more variable are duration of response to targeted therapy, progression-free survival and overall survival16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [16]

In first-line targeted therapy trials for oncogene-addicted NSCLC, objective response rates typically range from 50% to 83%, complete responses are rare, and some patients show de novo resistance.
“Across clinical trials of first-line targeted therapy for oncogene-addicted subgroups of NSCLC, rates of objective response [G] typically range between 50% and 83% and complete responses [G] are rare; in addition, some patients exhibit de novo resistance16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [16]
The magnitude of progression-free survival improvement in this study is similar to that in studies of EGFR-mutation-positive tumors treated with first-line EGFR tyrosine kinase inhibitors.
“The magnitude of the improvement in progression-free survival observed in the current study is similar to that observed in studies of EGFR-mutation-positive tumors treated with firstline EGFR tyrosine kinase inhibitors.[24][25][26]”
From First-Line Crizotinib versus Chemotherapy in ALK -Positive Lung Cancer (2014) · cites this paper as [24]
A sensitizing EGFR mutation usually predicts a high likelihood of response to first-generation TKIs, but most patients develop resistance within 12 to 24 months.
“The presence of a sensitizing EGFR mutation usually indicates a high likelihood of response to first-generation tyrosine kinase inhibitors (TKIs), but most patients will develop resistance within 12–24 months of treatment initiation (7–9).”
From Detection of Therapeutically Targetable Driver and Resistance Mutations in Lung Cancer Patients by Next-Generation Sequencing of Cell-Free Circulating Tumor DNA (2016) · cites this paper as [7]
EGFR exon 19 deletions and EGFR exon 21 L858R are exquisitely sensitive to approved EGFR TKIs such as erlotinib, gefitinib, and afatinib.
“EGFR exon 19 deletions and EGFR exon 21 L858R represent the vast majority of EGFR activating mutations, and are exquisitely sensitive to approved EGFR TKIs such as erlotinib, gefitinib, and afatinib”
From Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC (2018) · cites this paper as [1]
Acquired resistance to first- and second-generation EGFR tyrosine kinase inhibitors develops after a median of 9 to 13 months.
“acquired resistance develops after a median of 9 to 13 months [2][3][4]”
From Rociletinib in EGFR-Mutated Non–Small-Cell Lung Cancer (2015) · cites this paper as [2]
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 [22]
Response rates to EGFR TKIs in patients with NSCLC with sensitizing EGFR mutations (exon 19 deletions or L858R) are approximately 60% to 80%.
“Response rates to EGFR TKIs in patients with NSCLC with sensitizing EGFR mutations (exon 19 deletions or L858R) are approximately 60% to 80%, 3,5”
From Osimertinib for Patients With Non–Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09) (2020) · cites this paper as [5]
EGFR tyrosine kinase inhibitors are effective clinical treatments for advanced non-small cell lung cancer with EGFR mutations.
“Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective clinical therapies for EGFR mutant advanced non small cell lung cancer (NSCLC) patients (1–4).”
From EGFR Mutations and Resistance to Irreversible Pyrimidine-Based EGFR Inhibitors (2015) · cites this paper as [1]
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 [1]
Gefitinib was the first EGFR TKI receiving regulatory approval for EGFR-mutated NSCLC patients after the IPASS trial reported a significant advantage in PFS and ORR for first-line Gefitinib versus Carboplatin/Paclitaxel.
“Gefitinib was the first EGFR TKI receiving regulatory approval for EGFR-mutated NSCLC patients after the publication of the results of the IPASS (Iressa Pan-Asia Study) trial, reporting a significant advantage in terms of PFS and ORR for first-line Gefitinib versus Carboplatin/Paclitaxel [63].”
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 [63]
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 [11]
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 [12]
Acquired resistance to conventional EGFR-TKIs develops after a median of 10 to 12 months and is most commonly mediated by an acquired T790M mutation.
“Resistance to conventional EGFR-TKIs develops after a median of 10 to 12 months and is most commonly mediated by an acquired mutation, T790M1-5.”
From Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non–Small-Cell Lung Cancer (2016) · cites this paper as [2]
EGFR mutation-positive NSCLC has a distinct clinical course characterized by high response rates to tyrosine kinase inhibitors.
“As a classic oncogene-driven solid tumor, EGFR mutation-positive NSCLC has a unique disease course typified by high response rates to tyrosine kinase inhibitors (TKIs).6”
From The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation–Positive Non–Small Cell Lung Cancer: Status in 2016 (2016) · 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 [105]
In the IPASS trial comparing gefitinib with carboplatin plus paclitaxel, a statistically significant PFS was found for all patients treated with gefitinib, including those whose tumors were EGFR mutation positive.
“A statistically significant PFS was found for all patients in the trial treated with gefitinib, including those whose tumors were EGFR mutation positive.61”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [61]
In the IPASS trial, in the subgroup of patients with unknown EGFR mutation status, gefitinib produced statistically significantly longer PFS and higher response rates than carboplatin plus paclitaxel.
“In the IPASS trial comparing gefitinib with carboplatin plus paclitaxel, in the subgroup of patients with unknown EGFR mutation status, there were statistically significantly longer PFS and higher response rates.61”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [61]
Lung cancers harboring EGFR mutations are highly responsive to single-agent EGFR inhibitors with RECIST response rates of ~55%-75%.
“It is now well established that lung cancers harboring these EGFR mutations are highly responsive to single-agent EGFR inhibitors with RECIST response rates of ~55%–75% (Mok et al., 2009; Rosell et al., 2012; Sequist et al., 2013b).”
From ERBB Receptors: From Oncogene Discovery to Basic Science to Mechanism-Based Cancer Therapeutics (2014) · cites this paper as Mok et al., 2009

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Authors: Mok, T. S., Wu, Y.-L., Thongprasert, S., Yang, C.-H., Chu, D.-T., Saijo, N., Sunpaweravong, P., Han, B., Margono, B., Ichinose, Y., Nishiwaki, Y., Ohe, Y., Yang, J.-J., Chewaskulyong, B., Jiang, H., Duffield, E. L., Watkins, C. L., Armour, A. A., & Fukuoka, M.
Affiliations: Chinese University of Hong Kong (HK)
Maharaj Nakorn Chiang Mai Hospital (TH)
National Taiwan University Hospital (TW)
Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
National Cancer Center Hospital East (JP)
Prince of Songkla University (TH)
Shanghai Chest Hospital (CN)
Rumah Sakit Dokter Soetomo (ID)
National Hospital Organization Kyushu Cancer Center (JP)
National Cancer Center Hospital (JP)
Guangdong General Hospital (CN)
AstraZeneca (Japan) (JP)
AstraZeneca (United Kingdom) (GB)
Kindai University Hospital (JP)
ORCID: Mok, Tony S.
Wu, Yi-Long
Sunpaweravong, Patrapim
Han, Baohui
Ohe, Yuichiro
Yang, Jin-Ji
Jiang, Haiyi
Watkins, Claire L.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2009-09-03
Volume: 361
Issue: 10
Pages: 947-957
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa0810699
OpenAlex: W2166084034
Cited by: 8,261
References: 32
Citations by year: 2026: 188 · 2025: 268 · 2024: 238 · 2023: 317 · 2022: 373 · 2021: 408 · 2020: 474 · 2019: 529 · 2018: 545 · 2017: 615 · 2016: 601 · 2015: 693 · 2014: 674 · 2013: 656 · 2012: 623
FWCI: 470.13
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
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, carboplatin, paclitaxel, lung adenocarcinoma, non-small cell lung cancer, EGFR mutation, progression-free survival, first-line therapy, non-inferiority, EGFR tyrosine kinase inhibitors, East Asia, non-smokers, light smokers, neurotoxicity, neutropenia, hair loss
MeSH terms: Gefitinib, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Quinazolines, Proportional Hazards Models, Carboplatin, Paclitaxel, Disease-Free Survival, Protein Kinase Inhibitors, Kaplan-Meier Estimate, ErbB Receptors

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Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma

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