2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Oral Abstract Session
Time: Monday June 3, 8:00 AM to 11:00 AM
Location: Hall B1
A randomized phase III study of continuous maintenance bevacizumab with or without pemetrexed after induction therapy with carboplatin (Car), pemetrexed (Pem), and bevacizumab (Bev) for advanced non-squamous non-small cell lung cancer (nSQ-NSCLC) without sensitizing EGFR mutations: The COMPASS study (WJOG5610L).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 9003)
Author(s): Takashi Seto, Koichi Azuma, Takeharu Yamanaka, Shunichi Sugawara, Hiroshige Yoshioka, Akira Ono, Shinji Atagi, Yasuo Iwamoto, Hidetoshi Hayashi, Isamu Okamoto, Hideo Saka, Mitsuoka Shigeki, Daichi Fujimoto, Kazumi Nishino, Atsushi Horiike, Haruko Daga, Takashi Sone, Nobuyuki Yamamoto, Kazuhiko Nakagawa, Yoichi Nakanishi; National Kyushu Cancer Center, Fukuoka, Japan; Kurume University School of Medicine, Kurume, Japan; Yokohama City University, Yokohama, Japan; Sendai Kousei Hospital, Sendai, Japan; Kansai Medical University Hospital, Hirakata, Japan; Shizuoka Cancer Center, Shizuoka, Japan; Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan; Hiroshima Citizens Hospital, Hiroshima, Japan; Kindai University Faculty of Medicine, Osaka, Japan; Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; National Hospital Organization, Nagoya Medical Center, Nagoya, Japan; Osaka City University Hospital, Osaka, Japan; Kobe City Medical Center General Hospital, Kobe, Japan; Osaka International Cancer Institute, Osaka, Japan; The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Osaka City General Hospital, Osaka, Japan; Kanazawa University Hospital, Kanazawa, Japan; Wakayama Medical University, Wakayama, Japan; Kindai University Hospital, Osaka, Japan
Background: Two continuous maintenance therapies, “Pem after Pem+Platinum” and “Bev after Bev+Plt-doublet”, demonstrated the prolongation of survival for advanced nSQ-NSCLC. We conducted a randomized trial of Bev versus Bev+Pem as continuation maintenance therapy after Car+Pem+Bev induction therapy. Methods: Patients were eligible if they had previously untreated advanced nSQ-NSCLC whose EGFR status was either wild-type, unknown, or other than Del19 or L858R. They received the induction treatment with Car (AUC6), Pem (500 mg/m2), and Bev (15mg/kg) every 3 weeks for 4 cycles. Those who showed no progression during the induction therapy were randomized to receive maintenance therapy using Bev or Bev+Pem in a 1:1 ratio. The primary endpoint was overall survival (OS) from randomization. The planned sample size was 620 to provide a power of 85% at one-sided significance level of 5%. Violations found at a study site led us to conduct source document verification for 95.4% of patients to assure data quality. (Trial Identifier, UMIN000004194). Results: Between September 2010 and September 2015, 907 patients had the induction therapy. Of those, 621 patients were randomized; five did not receive study treatment and 22 did not meet the eligibility criteria. Among 594 patients for evaluable (299 in the Bev+Pem arm and 295 in the Bev arm), median age was 65 years; Male, 72%; PS 0/1, 60/40%; Stage IV, 83%; EGFR status, wild-type/others, 91/7%. Median OS was 23.3 vs 19.6 months (mo) with a hazard ratio (HR) of 0.87 (95%CI, 0.72-1.04) and one-sided logrank P= 0.069; in patients with wild-type EGFR tumor, HR for OS was 0.82 (0.68-0.99). Median progression-free survival was 5.7 vs 4.0 mo with a HR of 0.67 (0.57-0.79). 87.4% of patients received subsequent therapy. No new safety signals were observed. Conclusions: The primary analysis was not met. However, the incorporation of Pem significantly prolonged OS in patients with wild-type EGFR. Clinical trial information: UMIN000004194.