A phase II trial of erlotinib monotherapy in pretreated patients with advanced non-small cell lung cancer who do not possess active egfr mutations

Okayama lung cancer study group trial 0705

Hiroshige Yoshioka, Katsuyuki Hotta, Katsuyuki Kiura, Nagio Takigawa, Hidetoshi Hayashi, Shingo Harita, Shoichi Kuyama, Yoshihiko Segawa, Haruhito Kamei, Shigeki Umemura, Akihiro Bessho, Masahiro Tabata, Mitsune Tanimoto

Research output: Contribution to journalArticle

58 Citations (Scopus)

Abstract

BACKGROUNDS: Efficacy of gefitinib therapy strongly depends on epidermal growth factor receptor (EGFR)-mutation status in Asian patients with non-small cell lung cancer. Recently, the survival advantage of erlotinib, another tyrosine kinase inhibitor, was not affected by EGFR mutation status in a phase III trial, indicating that patients with EGFR-wild-type (EGFR-wt) tumors might also benefit from this tyrosine kinase inhibitor. The aim of this trial was to evaluate the efficacy and toxicity of erlotinib in Japanese patients with EGFR-wt tumors. METHODS: The primary end point was an objective response. Patients with EGFR-wt tumors previously receiving one to three chemotherapy regimens were enrolled in this trial. The mutation status was assessed using the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method. Erlotinib was administered (150 mg/d) until disease progression or unacceptable toxicities occurred. RESULTS: Thirty patients were enrolled between January and December 2008. Objective response was observed in one patient (3.3%), and the disease became stable in 18 patients (60.0%). Skin rash was the most common side effect. Grades 3-4 adverse events included pulmonary embolism, keratitis, and anemia. Two other patients developed interstitial lung disease (grades 1 and 2). Nevertheless, all these events were reversible, resulting in no treatment-related deaths. With a median follow-up time of 10.7 months, the median survival time and median progression-free survival times were 9.2 and 2.1 months, respectively. CONCLUSION: This is the first prospective biomarker study showing that erlotinib therapy for pretreated patients with EGFR-wt tumors seems to have a modest activity with no irreversible toxicity.

Original languageEnglish
Pages (from-to)99-104
Number of pages6
JournalJournal of Thoracic Oncology
Volume5
Issue number1
DOIs
Publication statusPublished - Jan 2010

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Non-Small Cell Lung Carcinoma
Lung Neoplasms
Epidermal Growth Factor Receptor
Mutation
Protein-Tyrosine Kinases
Neoplasms
Peptide Nucleic Acids
Erlotinib Hydrochloride
Survival
Keratitis
Interstitial Lung Diseases
Exanthema
Pulmonary Embolism
Disease-Free Survival
Disease Progression
Anemia
Therapeutics
Biomarkers
Prospective Studies
Drug Therapy

Keywords

  • EGFR mutation
  • Erlotinib
  • Non-small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

A phase II trial of erlotinib monotherapy in pretreated patients with advanced non-small cell lung cancer who do not possess active egfr mutations : Okayama lung cancer study group trial 0705. / Yoshioka, Hiroshige; Hotta, Katsuyuki; Kiura, Katsuyuki; Takigawa, Nagio; Hayashi, Hidetoshi; Harita, Shingo; Kuyama, Shoichi; Segawa, Yoshihiko; Kamei, Haruhito; Umemura, Shigeki; Bessho, Akihiro; Tabata, Masahiro; Tanimoto, Mitsune.

In: Journal of Thoracic Oncology, Vol. 5, No. 1, 01.2010, p. 99-104.

Research output: Contribution to journalArticle

Yoshioka, Hiroshige ; Hotta, Katsuyuki ; Kiura, Katsuyuki ; Takigawa, Nagio ; Hayashi, Hidetoshi ; Harita, Shingo ; Kuyama, Shoichi ; Segawa, Yoshihiko ; Kamei, Haruhito ; Umemura, Shigeki ; Bessho, Akihiro ; Tabata, Masahiro ; Tanimoto, Mitsune. / A phase II trial of erlotinib monotherapy in pretreated patients with advanced non-small cell lung cancer who do not possess active egfr mutations : Okayama lung cancer study group trial 0705. In: Journal of Thoracic Oncology. 2010 ; Vol. 5, No. 1. pp. 99-104.
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abstract = "BACKGROUNDS: Efficacy of gefitinib therapy strongly depends on epidermal growth factor receptor (EGFR)-mutation status in Asian patients with non-small cell lung cancer. Recently, the survival advantage of erlotinib, another tyrosine kinase inhibitor, was not affected by EGFR mutation status in a phase III trial, indicating that patients with EGFR-wild-type (EGFR-wt) tumors might also benefit from this tyrosine kinase inhibitor. The aim of this trial was to evaluate the efficacy and toxicity of erlotinib in Japanese patients with EGFR-wt tumors. METHODS: The primary end point was an objective response. Patients with EGFR-wt tumors previously receiving one to three chemotherapy regimens were enrolled in this trial. The mutation status was assessed using the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method. Erlotinib was administered (150 mg/d) until disease progression or unacceptable toxicities occurred. RESULTS: Thirty patients were enrolled between January and December 2008. Objective response was observed in one patient (3.3{\%}), and the disease became stable in 18 patients (60.0{\%}). Skin rash was the most common side effect. Grades 3-4 adverse events included pulmonary embolism, keratitis, and anemia. Two other patients developed interstitial lung disease (grades 1 and 2). Nevertheless, all these events were reversible, resulting in no treatment-related deaths. With a median follow-up time of 10.7 months, the median survival time and median progression-free survival times were 9.2 and 2.1 months, respectively. CONCLUSION: This is the first prospective biomarker study showing that erlotinib therapy for pretreated patients with EGFR-wt tumors seems to have a modest activity with no irreversible toxicity.",
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AU - Harita, Shingo

AU - Kuyama, Shoichi

AU - Segawa, Yoshihiko

AU - Kamei, Haruhito

AU - Umemura, Shigeki

AU - Bessho, Akihiro

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