Hiroshige Yoshioka1, Kiyoshi Komuta2, Fumio Imamura3, Shoji Kudoh4, Akihiro Seki5, Masahiro Fukuoka6. 1. Department of Respiratory Medicine, Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki-shi, Okayama 710-8602, Japan. Electronic address: hirotin@kchnet.or.jp. 2. Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka 543-0035, Japan. 3. Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan. 4. Double-Barred Cross Hospital Japan Anti-Tuberculosis Association, 3-1-24 Matsuyama, Kiyose-shi, Tokyo 204-8522, Japan. 5. Chugai Pharmaceutical Co. Ltd., 2-1-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-8324, Japan. 6. Izumi Municipal Hospital, 4-10-10 Fuchu-cho, Izumi-shi, Osaka 594-0071, Japan.
Abstract
OBJECTIVE: More tolerable treatment options are needed for the large number of elderly patients with non-small-cell lung cancer (NSCLC). An analysis of the phase IV POLARSTAR surveillance study examined the safety and efficacy of erlotinib in elderly Japanese patients with previously treated NSCLC. MATERIALS AND METHODS: From December 2007 to October 2009, all erlotinib-treated patients with unresectable, recurrent/advanced NSCLC in Japan were enrolled. Efficacy and safety data were stratified by age (<75 years, 75-84 years, ≥85 years). Kaplan-Meier methodology was used to estimate median progression-free survival (PFS). Safety data were collected with a focus on interstitial lung disease (ILD). RESULTS: A total of 9907 patients were eligible for safety assessment (<75 years, n=7848; 75-84 years, n=1911; ≥85 years, n=148) and 9651 for efficacy assessment (<75 years, n=7701; 75-84 years, n=1815; ≥85 years, n=135). Other baseline characteristics were balanced. The incidence of ILD (all grades) was 4.2% (<75 years), 5.1% (75-84 years), and 3.4% (≥85 years). The mortality rate due to ILD was ≤1.7% in all age groups. Other toxicities (including rash) were similar between age groups. The median PFS was 65 days (95% confidence interval [CI], 62-68) for patients aged <75 years, 74 days (95% CI, 69-82) for patients aged 75-84 years, and 72 days (95% CI, 56-93) for patients aged ≥85 years. CONCLUSIONS: Efficacy and tolerability of erlotinib for elderly patients was not numerically inferior to that reported in younger patients. Erlotinib could be considered for elderly patients with recurrent/advanced NSCLC.
OBJECTIVE: More tolerable treatment options are needed for the large number of elderly patients with non-small-cell lung cancer (NSCLC). An analysis of the phase IV POLARSTAR surveillance study examined the safety and efficacy of erlotinib in elderly Japanese patients with previously treated NSCLC. MATERIALS AND METHODS: From December 2007 to October 2009, all erlotinib-treated patients with unresectable, recurrent/advanced NSCLC in Japan were enrolled. Efficacy and safety data were stratified by age (<75 years, 75-84 years, ≥85 years). Kaplan-Meier methodology was used to estimate median progression-free survival (PFS). Safety data were collected with a focus on interstitial lung disease (ILD). RESULTS: A total of 9907 patients were eligible for safety assessment (<75 years, n=7848; 75-84 years, n=1911; ≥85 years, n=148) and 9651 for efficacy assessment (<75 years, n=7701; 75-84 years, n=1815; ≥85 years, n=135). Other baseline characteristics were balanced. The incidence of ILD (all grades) was 4.2% (<75 years), 5.1% (75-84 years), and 3.4% (≥85 years). The mortality rate due to ILD was ≤1.7% in all age groups. Other toxicities (including rash) were similar between age groups. The median PFS was 65 days (95% confidence interval [CI], 62-68) for patients aged <75 years, 74 days (95% CI, 69-82) for patients aged 75-84 years, and 72 days (95% CI, 56-93) for patients aged ≥85 years. CONCLUSIONS: Efficacy and tolerability of erlotinib for elderly patients was not numerically inferior to that reported in younger patients. Erlotinib could be considered for elderly patients with recurrent/advanced NSCLC.