PMID- 37103777
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230922
IS  - 2199-1154 (Print)
IS  - 2198-9788 (Electronic)
IS  - 2198-9788 (Linking)
VI  - 10
IP  - 3
DP  - 2023 Sep
TI  - Post-Marketing Safety Study of Ramucirumab Plus FOLFIRI: Analysis of Age and 
      Initial Dose of Irinotecan in Patients with Metastatic Colorectal Cancer.
PG  - 405-413
LID - 10.1007/s40801-023-00366-2 [doi]
AB  - BACKGROUND: There is limited real-world evidence regarding the safety of 
      ramucirumab plus FOLFIRI in patients with metastatic colorectal cancer (mCRC). 
      OBJECTIVE: We evaluated the safety of ramucirumab plus FOLFIRI in patients with 
      mCRC by age and initial dose of irinotecan. PATIENTS AND METHODS: This 
      single-arm, prospective, multicenter, non-interventional, observational study was 
      conducted between December 2016 and April 2020. Patients were observed for 
      12 months. RESULTS: Of 366 enrolled Japanese patients, 362 were eligible for 
      study inclusion. The frequency of grade >/= 3 adverse events (AEs) by age 
      (>/= 75 years vs < 75 years) was 56.1% versus 50.2%, indicating no substantial 
      differences between age groups. Grade >/= 3 notable AEs, including neutropenia, 
      proteinuria, and hypertension, were also similar in both age groups, but the 
      frequency of any grade venous thromboembolic events was higher in those aged 
      >/= 75 years than in those aged < 75 years (7.0% vs 1.3%). The frequency of grade 
      >/= 3 AEs was slightly lower in patients receiving > 150 mg/m(2) of irinotecan than 
      in those receiving </= 150 mg/m(2) of irinotecan (42.1% vs 53.6%); however, the 
      frequency of grade >/= 3 diarrhea, but not any grade diarrhea, and liver 
      failure/injury was higher in patients receiving > 150 mg/m(2) of irinotecan than 
      in those receiving </= 150 mg/m(2) of irinotecan (4.6% vs 1.9% and 9.1% vs 2.3%, 
      respectively). CONCLUSIONS: The safety profile of ramucirumab plus FOLFIRI in 
      mCRC patients was similar in subgroups by age and initial irinotecan dose in 
      real-world settings.
CI  - (c) 2023. The Author(s).
FAU - Masuishi, Toshiki
AU  - Masuishi T
AD  - Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
FAU - Nagaoka, Soshi
AU  - Nagaoka S
AD  - Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, 
      Kobe, Hyogo, 651-0086, Japan.
FAU - Jin, Long
AU  - Jin L
AD  - Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, 
      Kobe, Hyogo, 651-0086, Japan.
FAU - Yoshizawa, Kenichi
AU  - Yoshizawa K
AUID- ORCID: 0000-0003-4406-8122
AD  - Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, 
      Kobe, Hyogo, 651-0086, Japan. yoshizawa_kenichi@lilly.com.
LA  - eng
PT  - Journal Article
DEP - 20230427
PL  - Switzerland
TA  - Drugs Real World Outcomes
JT  - Drugs - real world outcomes
JID - 101658456
PMC - PMC10491555
OAB - Colorectal cancer (CRC), also known as bowel cancer, is a common cancer and a 
      leading cause of death. Chemotherapy is a treatment option for CRC. It consists 
      of one or more powerful medications to destroy cancer cells with the aim of 
      prolonging life and reducing symptoms. These medications can cause side effects 
      such as nausea, vomiting, infections, and high blood pressure. Sometimes these 
      side effects can be so severe that patients stop or reduce their treatment. The 
      safety and efficacy of these anti-cancer drugs are established from clinical 
      trials, but, in daily clinical practice, patient outcomes are affected by various 
      factors, such as general health, age, prior treatments, and lifestyle. 
      Ramucirumab plus FOLFIRI is considered a standard treatment for CRC in patients 
      who have disease progression after first-line treatment. In this study, we 
      collected data from patients with CRC who were given ramucirumab plus FOLFIRI 
      under routine clinical practice in Japan. Data were collected for 12 months from 
      the start of treatment and based on various patient demographics such as age less 
      than or greater than 75 years and treatment with a lower or higher dose of the 
      anti-cancer drug irinotecan. We found that ramucirumab plus FOLFIRI is manageable 
      in patients with CRC regardless of these patient demographics and initial 
      irinotecan dose. This article aims to inform patients and primary care providers 
      regarding real-world treatment outcomes to assist with CRC treatment decision 
      making.
OABL- eng
COIS- Toshiki Masuishi has received personal fees from Takeda, Chugai, Merck Bio 
      Pharma, Taiho, Bayer, Eli Lilly Japan K.K., Yakult Honsha, Ono, Bristol Myers 
      Squibb, Daiichi Sankyo, and Sanofi, and grants from MSD, Daiichi Sankyo, Ono, and 
      Novartis. Soshi Nagaoka is an employee of Eli Lilly Japan K.K. and a shareholder 
      of Eli Lilly and Company. Long Jin is an employee of Eli Lilly Japan K.K. Kenichi 
      Yoshizawa is an employee of Eli Lilly Japan K.K. and a shareholder of Eli Lilly 
      and Company, Bristol-Myers Squibb Company, and Merck & Co., Inc.
EDAT- 2023/04/27 12:41
MHDA- 2023/04/27 12:42
PMCR- 2023/04/27
CRDT- 2023/04/27 11:16
PHST- 2023/03/15 00:00 [accepted]
PHST- 2023/04/27 12:42 [medline]
PHST- 2023/04/27 12:41 [pubmed]
PHST- 2023/04/27 11:16 [entrez]
PHST- 2023/04/27 00:00 [pmc-release]
AID - 10.1007/s40801-023-00366-2 [pii]
AID - 366 [pii]
AID - 10.1007/s40801-023-00366-2 [doi]
PST - ppublish
SO  - Drugs Real World Outcomes. 2023 Sep;10(3):405-413. doi: 
      10.1007/s40801-023-00366-2. Epub 2023 Apr 27.