PMID- 34941463
OWN - NLM
STAT- MEDLINE
DCOM- 20220502
LR  - 20231213
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 21
IP  - 5
DP  - 2022 May
TI  - Safety and effectiveness of ramucirumab and docetaxel: a single-arm, prospective, 
      multicenter, non-interventional, observational, post-marketing safety study of 
      NSCLC in Japan.
PG  - 691-698
LID - 10.1080/14740338.2022.2023127 [doi]
AB  - BACKGROUND: This study evaluated the safety and effectiveness of ramucirumab and 
      docetaxel for non-small cell lung cancer (NSCLC) in real-world settings. RESEARCH 
      DESIGN AND METHODS: This single-arm, prospective, multicenter, 
      non-interventional, post-marketing study was conducted in Japan between August 
      2016 and January 2020. Patients diagnosed with unresectable advanced/recurrent 
      NSCLC were eligible for study inclusion. Data on adverse events (AEs) and 
      survival were collected electronically. RESULTS: Of 401 enrolled patients, 398 
      were eligible for study inclusion. Most patients were male (68.6%) with a median 
      age of 67.0 years. Patients were predominantly diagnosed with adenocarcinoma 
      (78.1%) or squamous cell carcinoma (16.6%); 46.2% received prior treatment with 
      bevacizumab and 38.7% with immune-checkpoint inhibitors. AEs (any grade) were 
      observed in 323 patients (81.2%; grade >/= 3: n = 174, 43.7%). The most common AEs 
      (any grade) were malaise (14.3%), decreased appetite (13.0%), and neutrophil 
      count decrease (11.6%). At 12 months from treatment commencement, 93.2% of 
      patients had discontinued, mostly due to progressive disease (53.4%) or AEs 
      (28.3%). The 12-month survival rate was 56.7% (95% confidence interval: 
      51.5-61.8). CONCLUSIONS: Data from real-world settings demonstrate ramucirumab 
      and docetaxel treatment appears to be tolerable and effective in Japanese 
      patients regardless of patient baseline characteristics and prior treatment.
FAU - Chen, Yucherng
AU  - Chen Y
AD  - Safety Science, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Nagaoka, Soshi
AU  - Nagaoka S
AD  - Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Katayose, Taeko
AU  - Katayose T
AD  - Global Patient Safety and Solutions, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Sekine, Nobuyuki
AU  - Sekine N
AD  - Oncology, Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, 
      Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20220124
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 15H5577CQD (Docetaxel)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/pathology
MH  - Docetaxel/adverse effects
MH  - Female
MH  - Humans
MH  - Japan
MH  - *Lung Neoplasms/drug therapy/pathology
MH  - Male
MH  - Marketing
MH  - Neoplasm Recurrence, Local/chemically induced
MH  - Prospective Studies
MH  - Ramucirumab
OTO - NOTNLM
OT  - Japan
OT  - non-small cell lung cancer
OT  - post-marketing surveillance
OT  - ramucirumab
EDAT- 2021/12/24 06:00
MHDA- 2022/05/03 06:00
CRDT- 2021/12/23 17:16
PHST- 2021/12/24 06:00 [pubmed]
PHST- 2022/05/03 06:00 [medline]
PHST- 2021/12/23 17:16 [entrez]
AID - 10.1080/14740338.2022.2023127 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2022 May;21(5):691-698. doi: 10.1080/14740338.2022.2023127. 
      Epub 2022 Jan 24.