Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA)

Kawaguchi, Tomoya; Ando, Masahiko; Asami, Kazuhiro; Okano, Yoshio; Fukuda, Masaaki; Nakagawa, Hideyuki; Ibata, Hidenori; Kozuki, Toshiyuki; Endo, Takeo; Tamura, Atsuhisa; Kamimura, Mitsuhiro; Sakamoto, Kazuhiro; Yoshimi, Michihiro; Soejima, Yoshifumi; Tomizawa, Yoshio; Isa, Shun-ichi; Takada, Minoru; Saka, Hideo; Kubo, Akihito

doi:10.1200/jco.2013.52.4694

Cited by 260Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA)

Kawaguchi, Tomoya, Ando, Masahiko, Asami, Kazuhiro, Okano, Yoshio, Fukuda, Masaaki, Nakagawa, Hideyuki, Ibata, Hidenori, Kozuki, Toshiyuki +11 more·2014·Journal of Clinical Oncology

DOI 10.1200/jco.2013.52.4694

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Abstract

PURPOSE: To investigate the efficacy of erlotinib versus docetaxel in previously treated patients with advanced non-small-cell lung cancer (NSCLC) in an epidermal growth factor receptor (EGFR) -unselected patient population. PATIENTS AND METHODS: The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate, safety, and analyses on EGFR wild-type tumors. Patients with stage IIIB or IV NSCLC, previous treatment with one or two chemotherapy regimens, evaluable or measurable disease, and performance status of 0 to 2 were eligible. RESULTS: From August 2009 to July 2012, 150 and 151 patients were randomly assigned to erlotinib (150 mg daily) and docetaxel (60 mg/m(2) every 3 weeks), respectively. EGFR wild-type NSCLC was present in 109 and 90 patients in the erlotinib and docetaxel groups, respectively. Median PFS for erlotinib versus docetaxel was 2.0 v 3.2 months (hazard ratio [HR], 1.22; 95% CI, 0.97 to 1.55; P = .09), and median OS was 14.8 v 12.2 months (HR, 0.91; 95% CI, 0.68 to 1.22; P = .53), respectively. In a subset analysis of EGFR wild-type tumors, PFS for erlotinib versus docetaxel was 1.3 v 2.9 months (HR, 1.45; 95% CI, 1.09 to 1.94; P = .01), and OS was 9.0 v 10.1 months (HR, 0.98; 95% CI, 0.69 to 1.39; P = .91), respectively. CONCLUSION: Erlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population.

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Subgroup analyses of a phase III trial of erlotinib versus docetaxel as second- or third-line therapy showed superior PFS but not OS for docetaxel in EGFR wild-type patients.
“Subgroup analyses of a phase III trial of erlotinib versus docetaxel as second-or third-line therapy demonstrated superior PFS but not OS for docetaxel treatment in WT EGFR [92].”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [92]
Concerns about docetaxel's toxicities persist in this patient population.
“concerns about its toxicities persist.”
From Sacituzumab tirumotecan versus docetaxel for previously treated EGFR -mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial (2025) · cites this paper as [5]
The efficacy of docetaxel in patients with previously treated EGFR-mutated advanced NSCLC remains suboptimal.
“the efficacy of docetaxel in this patient population remains suboptimal”
From Sacituzumab tirumotecan versus docetaxel for previously treated EGFR -mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial (2025) · cites this paper as [5]

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Authors: Kawaguchi, T., Ando, M., Asami, K., Okano, Y., Fukuda, M., Nakagawa, H., Ibata, H., Kozuki, T., Endo, T., Tamura, A., Kamimura, M., Sakamoto, K., Yoshimi, M., Soejima, Y., Tomizawa, Y., Isa, S.-I., Takada, M., Saka, H., & Kubo, A.
Affiliations: Aichi Medical University (JP)
ORCID: Kawaguchi, Tomoya
Ando, Masahiko
Kozuki, Toshiyuki
Endo, Takeo
Tamura, Atsuhisa
Kamimura, Mitsuhiro
Sakamoto, Kazuhiro
Takada, Minoru
Saka, Hideo
Kubo, Akihito
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2014-06-20
Volume: 32
Issue: 18
Pages: 1902-1908
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2013.52.4694
OpenAlex: W2144180913
Cited by: 260
References: 25
Citations by year: 2026: 2 · 2025: 7 · 2024: 3 · 2023: 8 · 2022: 3 · 2021: 14 · 2020: 20 · 2019: 25 · 2018: 27 · 2017: 27 · 2016: 44 · 2015: 62 · 2014: 17 · 2013: 1
FWCI: 40.03
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: Japan Society for the Promotion of Science (25460896, 23501314)
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: erlotinib, docetaxel, non-small cell lung cancer, EGFR tyrosine kinase inhibitors, second-line therapy, third-line therapy, progression-free survival, overall survival, advanced lung cancer
MeSH terms: Erlotinib Hydrochloride, Docetaxel, Adult, Aged, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Quinazolines, Biomarkers, Tumor, Proportional Hazards Models, Odds Ratio, Treatment Outcome, Disease-Free Survival, Taxoids, Kaplan-Meier Estimate, ErbB Receptors

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Randomized phase III trial of erlotinib versus docetaxel as second- or third-line therapy in patients with advanced non-small-cell lung cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA)

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