Kinnosuke Matsumoto1, Akihiro Tamiya2, Yuji Inagaki2, Yoshihiko Taniguchi2, Yoshinobu Matsuda2, Hayato Kawachi3, Motohiro Tamiya3, Satoshi Tanizaki4, Junji Uchida4, Kiyonobu Ueno4, Takafumi Yanase5, Hidekazu Suzuki5, Shinji Atagi6. 1. Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: m.kinnosuke@gmail.com. 2. Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. 3. Department of Respiratory Medicine, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-Ku, Osaka City, Osaka 541-8567, Japan. 4. Department of Respiratory Medicine, Osaka General Medical Center, 3-1-56 Mandai Higashi, Sumiyoshi-Ku, Osaka City, Osaka 558-8558, Japan. 5. Department of Respiratory Medicine, Osaka Prefectural Medical Center for Respiratory and Allergic Disease, 3-7-1 Habikino, Habikino City, Osaka 583-8588, Japan. 6. Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan.
Abstract
OBJECTIVE: Ramucirumab (RAM) plus Docetaxel (DOC) is one of the standard treatments after first-line treatment failure in patients with advanced non-small cell lung cancer (NSCLC). However, little is known about the efficacy and safety of RAM plus DOC in older patients. We aimed to clarify these and elucidate the prognostic factors. MATERIALS AND METHODS: In this multicenter retrospective study, conducted at four medical facilities in Japan, we evaluated the efficacy and safety data for two groups (<65 and ≥ 65 years). Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method and log-rank test. Multivariate analysis was performed to reveal the prognostic factors for better PFS and OS. Patient characteristics and adverse events (AEs) in both groups were compared using the Mann-Whitney's U and Fisher's exact tests for categorical variables. RESULTS: A total of 237 patients were included, of whom 43% (n = 103), and 57% (n = 134) were aged <65, and ≥ 65 years. Median OS was 12.2 (95% CI: 9.4-15.0), and 14.8 months (95% CI: 10.8-18.8), respectively, and there were no significant differences between the groups (p = 0.534). Multivariate analysis identified DOC dose reduction (none vs performed, HR: 2.66, 95% CI: 1.62-4.35, p < 0.001) as an independent prognostic factor for OS in older patients, and a similar result was shown for the PFS. Grade ≥ 3 all AEs were identified in 42.7% and 56.7% of younger and older patients, respectively, and there was a significant difference between the groups (p = 0.033); however, the difference between the groups disappeared with primary DOC dose reduction (p = 0.526). CONCLUSION: The efficacy of RAM plus DOC administration in older, pretreated patients with advanced NSCLC was comparable to those of younger patients, whereas RAM plus DOC should be cautiously administered to older patients because of severe toxicity. Moreover, appropriate DOC dose reduction may be recommended for increased survival benefit and safety in such patients.
OBJECTIVE: Ramucirumab (RAM) plus Docetaxel (DOC) is one of the standard treatments after first-line treatment failure in patients with advanced non-small cell lung cancer (NSCLC). However, little is known about the efficacy and safety of RAM plus DOC in older patients. We aimed to clarify these and elucidate the prognostic factors. MATERIALS AND METHODS: In this multicenter retrospective study, conducted at four medical facilities in Japan, we evaluated the efficacy and safety data for two groups (<65 and ≥ 65 years). Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method and log-rank test. Multivariate analysis was performed to reveal the prognostic factors for better PFS and OS. Patient characteristics and adverse events (AEs) in both groups were compared using the Mann-Whitney's U and Fisher's exact tests for categorical variables. RESULTS: A total of 237 patients were included, of whom 43% (n = 103), and 57% (n = 134) were aged <65, and ≥ 65 years. Median OS was 12.2 (95% CI: 9.4-15.0), and 14.8 months (95% CI: 10.8-18.8), respectively, and there were no significant differences between the groups (p = 0.534). Multivariate analysis identified DOC dose reduction (none vs performed, HR: 2.66, 95% CI: 1.62-4.35, p < 0.001) as an independent prognostic factor for OS in older patients, and a similar result was shown for the PFS. Grade ≥ 3 all AEs were identified in 42.7% and 56.7% of younger and older patients, respectively, and there was a significant difference between the groups (p = 0.033); however, the difference between the groups disappeared with primary DOC dose reduction (p = 0.526). CONCLUSION: The efficacy of RAM plus DOC administration in older, pretreated patients with advanced NSCLC was comparable to those of younger patients, whereas RAM plus DOC should be cautiously administered to older patients because of severe toxicity. Moreover, appropriate DOC dose reduction may be recommended for increased survival benefit and safety in such patients.