A Phase II Study of Erlotinib in Patients with Previously Treated Non-Small Cell Lung Cancer

Kubota, Tetsuya and Okano, Yoshio and Sakai, Mizu and Yamane, Takashi and Shiota, Naoki and Ohnishi, Hiroshi and Machida, Hisanori and Hatakeyama, Nobuo and Takeuchi, Eiji and Urata, Tomoyuki and Ogushi, Fumitaka and Yokoyama, Akihito (2014) A Phase II Study of Erlotinib in Patients with Previously Treated Non-Small Cell Lung Cancer. Advances in Lung Cancer, 03 (01). pp. 10-20. ISSN 2169-2718

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Abstract

Background: Erlotinib has been reported to be effective for the treatment of non-small cell lung cancer (NSCLC). To evaluate the efficacy and safety of erlotinib under conditions similar to daily clinical practice, a phase II trial was conducted in Japanese patients with previously treated NSCLC. Methods: The eligibility criteria were stage IIIB/IV NSCLC, a performance status (PS) of 0 - 2, and previous treatment with 1 - 2 non-EGFR-TKI regimens. Patients received erlotinib (150 mg/day) orally until disease progression or intolerable toxicity occurred. The primary endpoint was the objective response rate (ORR). In addition, the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and EGFR gene mutation status were evaluated. Results: Thirty-eight patients were enrolled, and 37 patients were evaluated. The median age was 69 years (range, 50 - 80 years). Patient characteristics were as follows: 26 were male and 11 were female; 12 had a PS of 0, 20 had a PS of 1, and 5 had a PS of 2; and 26 had adenocarcinoma, and 11 had non-adenocarcinoma histology. The ORR and DCR were 21.6% (95% confidence interval [CI], 11.4% - 37.2%) and 54.1% (95% CI, 35.9% - 66.6%), respectively. Twenty-seven patients could be evaluated for EGFR gene status (12, mutated; 15, wild-type). The ORR for EGFR-mutated patients was 41.7%, while that for patients with wild-type EGFR was 13.3%. The median PFS was evaluated as 4.4 months (95% CI, 2.2 - 10.7 months). The median OS was 14.9 months (95% CI, 9.2 months - not reached). Common adverse events were tolerable skin toxicities, diarrhea, and stomatitis. In addition, interstitial lung disease occurred in 8.1% of patients. Conclusion: As efficacy and safety were similar to previous studies, erlotinib was found to be effective for Japanese patients with previously treated NSCLC in clinical practice.

Item Type: Article
Subjects: ScienceOpen Library > Medical Science
Depositing User: Managing Editor
Date Deposited: 11 Jan 2023 10:58
Last Modified: 22 Aug 2024 12:45
URI: http://scholar.researcherseuropeans.com/id/eprint/300

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