NDLI: Phase II study of pemetrexed plus intermittent erlotinib combination therapy for pretreated advanced non-squamous non-small cell lung cancer with documentation of epidermal growth factor receptor mutation status.

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Phase II study of pemetrexed plus intermittent erlotinib combination therapy for pretreated advanced non-squamous non-small cell lung cancer with documentation of epidermal growth factor receptor mutation status.

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Phase II study of pemetrexed plus intermittent erlotinib combination therapy for pretreated advanced non-squamous non-small cell lung cancer with documentation of epidermal growth factor receptor mutation status.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Minami, Seigo Kijima, Takashi Hamaguchi, Masanari Nakatani, Takeshi Koba, Taro Takahashi, Ryo Takeuchi, Yoshiko Kida, Hiroshi Nagatomo, Izumi Yamamoto, Suguru Tachibana, Isao Komuta, Kiyoshi Kawase, Ichiro
Description	Country affiliation: Japan Author Affiliation: Minami S ( Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka 543-0035, Japan.)
Abstract	INTRODUCTION: Erlotinib and pemetrexed have been approved for the second-line and maintenance treatment of non-small cell lung cancer (NSCLC). With the recommended doses determined by our previous phase I study, we conducted a phase II study to evaluate the efficacy and safety of combination of the two agents in pretreated non-squamous NSCLC patients. METHODS: This study was performed in patients with stage IIIB/IV or post-surgically recurrent non-squamous NSCLC whose disease had progressed on or after receiving first-line chemotherapy. Patients received 500 mg/m(2) of intravenous pemetrexed every 21 days and 150 mg of oral erlotinib on days 2-16 until disease progression, unacceptable toxicity, or withdrawal of consent. The expected response rate and threshold were defined as 33.5% and 10%, respectively. Assuming a one-sided alpha of 5%, a power of 80%, the possible deviation from assessment, 26 patients were necessary. RESULTS: A total of 27 patients, 16 males and 11 females were recruited. Patients had the median age of 70 years (range, 48-80 years) and included 21 stage IV diseases, 22 adenocarcinomas. Epidermal growth factor receptor (EGFR) mutations were examined in all patients. One patient had positive EGFR mutation, but the other 26 patients had wild-type EGFR. The median number of treatment courses was 3 (range, 1 to over 19). The best overall response rate and disease control rate were 11.1% and 63.0%, respectively. The median progression-free survival and overall survival were 2.8 months (95% confidence interval (CI); 1.9-7.5 months) and 15.8 months (95% CI; 9.3 months to not available), respectively. Dermal, hepatic, gastrointestinal and hematological disorders were the frequently observed adverse events. One patient experienced grade 3 drug-induced interstitial lung disease. CONCLUSIONS: We could not demonstrate the add-on effect of intermittent erlotinib on pemetrexed in a second-line setting for patients with non-squamous NSCLC without EGFR mutations.
File Format	HTM / HTML
ISSN	01695002
Issue Number	2
Volume Number	82
e-ISSN	18728332
Journal	Lung Cancer
Language	English
Publisher	Elsevier
Publisher Date	2013-11-01
Publisher Place	Ireland
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Oncology Antineoplastic Combined Chemotherapy Protocols Therapeutic Use Carcinoma, Non-small-cell Lung Drug Therapy Genetics Lung Neoplasms Mutation Receptor, Epidermal Growth Factor Aged Aged, 80 And Over Adverse Effects Mortality Pathology Erlotinib Hydrochloride Female Glutamates Administration & Dosage Guanine Analogs & Derivatives Humans Male Middle Aged Neoplasm Staging Pemetrexed Quinazolines Retreatment Risk Factors Treatment Outcome Clinical Trial, Phase Ii Journal Article
Content Type	Text
Resource Type	Article
Subject	Pulmonary and Respiratory Medicine Cancer Research Oncology

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