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Cited by 475Lung Cancer Treatments and MutationsLung Cancer Diagnosis and TreatmentLung Cancer Research Studies

Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): a randomised controlled trial

Garassino, Marina Chiara, Martelli, Olga, Broggini, Massimo, Farina, Gabriella, Veronese, Silvio, Rulli, Eliana, Bianchi, Filippo, Bettini, Anna +12 more·2013·The Lancet Oncology
DOI 10.1016/s1470-2045(13)70310-3
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Abstract

Background Erlotinib is registered for treatment of all patients with advanced non-small-cell lung cancer (NSCLC). However, its efficacy for treatment of patients whose tumours are EGFR wild-type-which includes most patients-is still contentious. We assessed the efficacy of erlotinib compared with a standard second-line chemotherapy in such patients.Methods We did this randomised controlled trial in 52 Italian hospitals. We enrolled patients who had metastatic NSCLC, had had platinum-based chemotherapy, and had wild-type EGFR as assessed by direct sequencing. Patients were randomly assigned centrally (1:1) to receive either erlotinib orally 150 mg/day or docetaxel intravenously 75 mg/m(2) every 21 days or 35 mg/m(2) on days 1, 8, and 15, every 28 days. Randomisation was stratified by centre, stage, type of first-line chemotherapy, and performance status. Patients and investigators who gave treatments or assessed outcomes were not masked to treatment allocation, investigators who analysed results were. The primary endpoint was overall survival in the intention-to-treat population. The study is registered at ClinicalTrials.gov, number NCT00637910.Findings We screened 702 patients, of whom we genotyped 540. 222 patients were enrolled (110 assigned to docetaxel vs 112 assigned to erlotinib). Median overall survival was 8·2 months (95% CI 5·8-10·9) with docetaxel versus 5·4 months (4·5-6·8) with erlotinib (adjusted hazard ratio [HR] 0·73, 95% CI 0·53-1·00; p=0·05). Progression-free survival was significantly better with docetaxel than with erlotinib: median progression-free survival was 2·9 months (95% CI 2·4-3·8) with docetaxel versus 2·4 months (2·1-2·6) with erlotinib (adjusted HR 0·71, 95% CI 0·53-0·95; p=0·02). The most common grade 3-4 toxic effects were: low absolute neutrophil count (21 [20%] of 104 in the docetaxel group vs none of 107 in the erlotinib group), skin toxic effects (none vs 15 [14%]), and asthenia (ten [10%] vs six [6%]).Interpretation Our results show that chemotherapy is more effective than erlotinib for second-line treatment for previously treated patients with NSCLC who have wild-type EGFR tumours.

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Authors
Garassino, M. C., Martelli, O., Broggini, M., Farina, G., Veronese, S., Rulli, E., Bianchi, F., Bettini, A., Longo, F., Moscetti, L., Tomirotti, M., Marabese, M., Ganzinelli, M., Lauricella, C., Labianca, R., Floriani, I., Giaccone, G., Torri, V., Scanni, A., & Marsoni, S.
Affiliations
  • Azienda Ospedaliera Fatebenefratelli e Oftalmico (IT)
  • Azienda Ospedaliera San Giovanni Addolorata (IT)
  • Mario Negri Institute for Pharmacological Research (IT)
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT)
  • Ospedale Papa Giovanni XXIII (IT)
  • Policlinico Umberto I (IT)
  • Ospedale di Belcolle (IT)
  • Georgetown University (US)
  • Candiolo Cancer Institute (IT)
ORCID
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2013-09
Volume
14
Issue
10
Pages
981-988
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(13)70310-3
OpenAlex
W2097026987
Cited by
475
References
39
Citations by year
2026: 1 · 2025: 5 · 2024: 9 · 2023: 7 · 2022: 8 · 2021: 19 · 2020: 23 · 2019: 33 · 2018: 46 · 2017: 56 · 2016: 71 · 2015: 104 · 2014: 83 · 2013: 8 · 2012: 2
FWCI
72.04
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Oncology (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
erlotinib, docetaxel, advanced non-small cell lung cancer, EGFR wild-type, second-line therapy, oral tyrosine kinase inhibitor, overall survival, progression-free survival, platinum-based chemotherapy, metastatic lung cancer, treatment toxicity, neutropenia, hyperbilirubinemia, EGFR mutation testing, targeted therapy
MeSH terms
Erlotinib Hydrochloride, Docetaxel, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Proto-Oncogene Proteins, Quinazolines, Proto-Oncogene Proteins p21(ras), Disease-Free Survival, ras Proteins, Taxoids, Protein Kinase Inhibitors, ErbB Receptors

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