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    Association details:
    Biomarker:HER-2 negative
    Cancer:Gastric Cancer
    Drug:Cyramza (ramucirumab) (VEGFR-2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2020
    Title:

    Perioperative ramucirumab in combination with FLOT versus FLOT alone for resectable esophagogastric adenocarcinoma (RAMSES/FLOT7): Results of the phase II-portion—A multicenter, randomized phase II/III trial of the German AIO and Italian GOIM.

    Published date:
    05/13/2020
    Excerpt:
    Pts with resectable, Her2-negative, adenocarcinoma of the stomach and GEJ (≥ cT2 or cN+) were enrolled...91% of pts with FLOT and 92% with FLOT-RAM completed the 4 pre- cycles. R0-resection (in the full set) could be achieved in 83% of pts with FLOT and 97% of pts with FLOT-RAM (p = 0.0049). The rate of major path response was similar in both arms and was 30% for FLOT and 27% for FLOT-RAM. Surgical morbidity was observed in 37% of pts with FLOT and 44% of pts with FLOT-RAM. Mortality was 2.5% with FLOT and 5.9% with FLOT-RAM including GEJ type I tumors and dropped to 2.9% in both arms after excluding type I tumors per amendment.
    Secondary therapy:
    FLOT
    DOI:
    10.1200/JCO.2020.38.15_suppl.4501
    Trial ID:
    RAMSES
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers

    Excerpt:
    ...Unresectable locally advanced or metastatic, histopathologically confirmed, HER-2 negative adenocarcinoma of gastric or GEJ cancer with measurable and/or evaluable disease based on RECIST, v1.1 6....
    Trial ID:
    ARMANI
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    FLOT vs. FLOT/Ramucirumab for Perioperative Therapy of Gastric or GEJ Cancer (RAMSES)

    Excerpt:
    ...Negative HER-2 detection (score IHC HER-2 0 or IHC HER-2 1+ ); IHC HER-2 2+ and negative by FISH, SISH or CISH1 2....
    Trial ID:
    RAMSES
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Assessment of Ramucirumab plus paclitaxel as switch MANteInance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III Trial Valutazione della terapia di mantenimento con paclitaxel e ramucirumab a confronto con la prosecuzione della prima linea di trattamento in pazienti con carcinoma gastrico o della giunzione gastroesofagea avanzato ed HER-2 negativo

    Excerpt:
    ...Unresectable locally advanced or metastatic, carcinoma histologically confirmed, HER-2 negative gastric or GEJ cancer with measurable and/or non measurable disease based on RECIST, v1.1.6. ...
    Trial ID:
    2016-001783-12
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Pharmazie
    Title:

    Identifying prognostic factors associated with overall survival in second-line paclitaxel plus ramucirumab treated human epidermal growth factor receptor 2-negative advanced/recurrent gastric cancer

    Published date:
    07/01/2021
    Excerpt:
    This study aimed to identify the overall survival prolongation index in patients who received paclitaxel plus ramucirumab as second line chemotherapy for human epidermal growth factor receptor (HER) 2-negative advanced/ recurrent gastric cancer (AGC)…. In the multivariate analysis, grade ≥1 neutropenia (yes) and the number of anti-cancer drugs used (≥5) were independently and significantly associated with survival....This study demonstrated that AGC patients with initial neutropenia may benefit from paclitaxel plus ramucirumab therapy.
    Secondary therapy:
    paclitaxel
    DOI:
    10.1691/ph.2021.1432