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    Association details:
    Biomarker:No biomarker
    Cancer:Gastric Cancer
    Drug:Cyramza (ramucirumab) (VEGFR-2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    04/21/2015
    Excerpt:
    CYRAMZA® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:…in combination with paclitaxel, for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
    Secondary therapy:
    paclitaxel
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    12/19/2014
    Excerpt:
    Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.
    Secondary therapy:
    paclitaxel
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    12/19/2014
    Excerpt:
    Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    04/21/2014
    Excerpt:
    CYRAMZA® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated:…as a single agent...for treatment of advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Gastric Cancer: Useful in Certain Circumstances…Fluorouracil and irinotecan + ramucirumab…Preferred Regimens…Ramucirumab and paclitaxel…Other Recommended Regimes…Irinotecan and Ramucirumab
    Secondary therapy:
    5-fluorouracil + irinotecan; irinotecan; paclitaxel
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Gastric Cancer: Other Recommended Regimens…Ramucirumab (category 1)...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Gastric Cancer
    Title:

    Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study

    Published date:
    03/09/2023
    Excerpt:
    The presence of LM was associated with earlier progression than those without LM, particularly in patients receiving PL+PAC (hazard ratio [HR], 1.68). RAM+PAC treatment improved OS and PFS irrespective of LM status but showed greater improvement in LM+ than that in LM- (OS HR, 0.71 [LM+] vs. 0.88 [LM-]; PFS HR, 0.47 [LM+] vs. 0.76 [LM-])...Therefore, RAM+PAC is a clinically meaningful therapeutic option for patients with mGEA and LM.
    Secondary therapy:
    paclitaxel
    DOI:
    10.5230/jgc.2023.23.e15
    Trial ID:
    RAINBOW
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Gastroenterol Hepatol
    Title:

    Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial

    Published date:
    10/06/2021
    Excerpt:
    Median progression-free survival was 4·14 months (95% CI 3·71–4·30) in the ramucirumab plus paclitaxel group compared with 3·15 months (2·83–4·14) in the placebo plus paclitaxel group (hazard ratio [HR] 0·765, 95% CI 0·613–0·955, p=0·0184)….These findings, along with the results from RAINBOW, support the use of ramucirumab plus paclitaxel as second-line therapy in a predominantly Chinese population with advanced gastric or GEJ adenocarcinoma.
    Secondary therapy:
    paclitaxel
    DOI:
    https://doi.org/10.1016/S2468-1253(21)00313-7
    Trial ID:
    RAINBOW-Asia
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    RAINBOW-Asia: A randomized, multicenter, double-blind, phase III study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in the treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line chemotherapy with platinum and fluoropyrimidine.

    Published date:
    01/22/2021
    Excerpt:
    The combination of RAM+PTX as 2nd-line therapy demonstrated a statistically significant PFS benefit, and OS benefit consistent with RAINBOW study in a predominantly Chinese population with advanced gastric and GEJ cancer.
    Secondary therapy:
    paclitaxel
    DOI:
    10.1200/JCO.2021.39.3_suppl.199
    Trial ID:
    RAINBOW-Asia
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    The Oncologist
    Title:

    Tumor response and symptom palliation from RAINBOW, a phase 3 trial of ramucirumab plus paclitaxel in previously treated advanced gastric cancer

    Published date:
    12/03/2020
    Excerpt:
    In patients with measurable disease (78% of ITT), ORR was 36% versus 20%; DCR was 81% versus 61% in the ramucirumab versus control arms. Waterfall plots demonstrated more tumor shrinkage in the ramucirumab versus control arm...Treatment with ramucirumab plus paclitaxel yielded the highest ORR reported to date for patients with previously treated advanced gastric/gastroesophageal junction adenocarcinoma.
    Secondary therapy:
    paclitaxel
    DOI:
    oi.org/10.1002/onco.13623
    Trial ID:
    RAINBOW