2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
Randomized phase III study comparing carboplatin plus pemetrexed followed by pemetrexed versus docetaxel in elderly patients with advanced non-squamous non-small-cell lung cancer (JCOG1210/WJOG7813L).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #354)
J Clin Oncol 37, 2019 (suppl; abstr 9031)
Author(s): Isamu Okamoto, Hiroshi Nokihara, Kiyotaka Yoh, Shunichi Sugawara, Hidehito Horinouchi, Koichi Azuma, Yasuto Yoneshima, Haruyasu Murakami, Haruko Daga, Yukio Hosomi, Shinji Atagi, Tomohiro Ozaki, Atsushi Horiike, Yuka Fujita, Hiroaki Okamoto, Masahiko Ando, Shogo Nomura, Nobuyuki Yamamoto, Yuichiro Ohe, Kazuhiko Nakagawa; Kyushu University Hospital, Fukuoka, Japan; Tokushima University Hospital, Tokushima, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan; Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan; Kyushu University, Fukuoka, Japan; Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan; Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan; Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan; Department of Thoracic Oncology, Kinki-chuo Chest Medical Center, Sakai, Japan; Kishiwada City Hospital, Osaka, Japan; Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan; Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan; Nagoya University Hospital, Nagoya, Japan; JCOG Data Center/Operation Office, National Cancer Center Hospital, Tokyo, Japan; Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan; Kindai University Hospital, Osaka, Japan
Background: The aim of this phase III randomized trial is to determine the efficacy of pemetrexed and carboplatin followed by pemetrexed for elderly patients (pts) with advanced non-squamous non-small-cell lung cancer (NSCLC). Methods: Cytotoxic chemotherapy-naïve, ECOG-PS 0-1, aged 75 years or older, and advanced stage non-squamous NSCLC pts were randomized to receive either docetaxel 60 mg/m2 on day 1 every 3 weeks [DOC] or carboplatin AUC 5 mg/ml/min and pemetrexed 500 mg/m2 on day 1 every 3 weeks followed by maintenance therapy with pemetrexed 500 mg/m2 every 3 weeks after 4 cycles of carboplatin and pemetrexed [CBDCA/PEM] given until disease progression or unacceptable toxicities. The primary endpoint was OS. Non-inferiority of CBDCA/PEM arm was planned to be demonstrated if upper limit of 95% confidence interval (CI) for hazard ratio (HR) did not exceed 1.154. Results: Between August 2013 to February 2017, 433 pts with a median age of 78 years (range, 75 to 88) were randomly assigned to the DOC arm (n = 217) or the CBDCA/PEM arm (n = 216). Non-inferiority of CBDCA/PEM arm was confirmed in all enrolled patients (HR for OS, 0.850; 95% CI, 0.684 to 1.056, P < 0.01). The median OS for DOC and CBDCA/PEM arms were 15.5 months and 18.7 months, respectively. In the CBDCA/PEM arm, PFS was significantly better (HR, 0.739; 95% CI, 0.609 to 0.89) and response rate was better (28.2% vs. 36.8%; P = 0.07), and incidence of neutropenia or febrile neutropenia of grade 3 or 4 was significantly lower. Grade 3 or 4 thrombocytopenia or anemia was more common in the CBDCA/PEM arm. Four treatment-related deaths (two in each treatment arm) occurred. QOL (FACT-LCS) was favorable for CBDCA/PEM arm throughout 18 weeks after enrollment. Conclusions: Pemetrexed/carboplatin followed by pemetrexed maintenance is a valid therapeutic option for the first-line treatment of elderly pts with advanced non-squamous NSCLC. Clinical trial information: 000011460.