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.
Highlights
Lung cancer is currently the leading cause of cancer-related deaths in Japan [1] and worldwide [2], as it has been for years
Because sensitive epidermal growth factor receptor (EGFR) gene mutations are generally seen in patients with adenocarcinoma, and because this is the most important prognostic factor for treatment with EGFR-tyrosine kinase inhibitor (TKI) [19] [20], a high proportion of patients with adenocarcinoma in the previous studies may have resulted in the better outcome observed
The TOPICAL trial demonstrated that first-line erlotinib treatment for patients in a poor health condition is controversial [24] and the recent TAILOR trial in Italy showed that second-line erlotinib treatment for patients with wild-type EGFR was not superior to standard chemotherapy [25]], our results indicate that erlotinib is beneficial for Japanese non-small cell lung cancer (NSCLC) patients even after failure of first-line therapy
Summary
Lung cancer is currently the leading cause of cancer-related deaths in Japan [1] and worldwide [2], as it has been for years. Non-small cell lung cancer (NSCLC) is the most common form (approximately 85%), with many patients presenting with advanced disease at initial diagnosis [3]. Advanced NSCLC is currently considered an incurable disease for which standard chemotherapy provides marginal improvement in overall survival. Erlotinib has been reported to be effective for the treatment of non-small cell lung cancer (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. The disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and EGFR gene mutation status were evaluated. Twenty-seven patients could be evaluated for EGFR gene status (12, mutated; 15, wild-type). Conclusion: As efficacy and safety were similar to previous studies, erlotinib was found to be effective for Japanese patients with
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