title: A phase II study of nintedanib in patients with relapsed small cell lung cancer.
abstract: Nintedanib is an oral triple angiokinase inhibitor. This study was conducted to evaluate the efficacy and safety of nintedanib in patients (pts) with relapsed/refractory small cell lung cancer (SCLC).
  
  
  
  Pts with an ECOG PS from 0 to 2 who exhibited progression after one or two prior chemotherapy or chemo/radiotherapy were enrolled. Pts received nintedanib 200mg BID daily in a 4-week cycle until progression or intolerable toxicity. The primary end point was the objective response rate (ORR). A two-stage design was employed. To continue to stage 2, ≥2 responders out of 22 pts were required.
  
  
  
  From Dec 2011 to June 2014, 24 pts were enrolled. Twenty-two pts completed treatment and were evaluable for response. The median follow-up was 9.7 (0.5-19.8) months. The median age was 64 (46-77) years. Twenty-two pts were male. Six pts had sensitive relapse. Eight pts received one prior chemotherapy. A median of one (range 1-5) cycle was administered. One pt had a partial response, and seven pts exhibited stable disease. The ORR was 5% (95% confidence interval [CI], 0.1-22.8). Median progression-free survival was 1.0 (95% CI, 0.9-1.1) month, and overall survival was 9.8 (95% CI, 8.4-11.2) months. The response criteria to proceed to full accrual were not met. The most frequent drug-related adverse events (AE) included hepatic enzyme elevation (86%), anemia (73%), anorexia (59%), and nausea (50%). Most AEs were mild and manageable. Grade 3 hepatic enzyme elevation occurred in 5 pts (23%).
  
  
  
  Nintedanib exhibited only limited activity with a manageable AE profile in relapsed or refractory SCLC (NCT01441297).
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea. Electronic address: jymama@ncc.re.kr.
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Han
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.
authors.forename: Hyae Young
authors.initials: HY
authors.lastname: Kim
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.
authors.forename: Kun Young
authors.initials: KY
authors.lastname: Lim
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.
authors.forename: Bin
authors.initials: B
authors.lastname: Hwangbo
authors.affiliation: Center for Lung Cancer, Research Institute and Hospital, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea.
authors.forename: Jin Soo
authors.initials: JS
authors.lastname: Lee
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; C530716:nintedanib
keywords: Nintedanib; SCLC; VEGFR