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    Association details:
    Biomarker:HER-2 positive
    Cancer:Gastric Cancer
    Drug:Herceptin (trastuzumab) (HER2 inhibitor) +
    Perjeta (pertuzumab) (HER2 dimerization inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Gastric Cancer
    Title:

    Pertuzumab, trastuzumab, and chemotherapy in HER2-positive gastric/gastroesophageal junction cancer: end-of-study analysis of the JACOB phase III randomized clinical trial

    Published date:
    09/06/2022
    Excerpt:
    Median follow-up was ≥ 44.4 months. Median OS was increased by 3.9 months (hazard ratio 0.85 [95% confidence intervals, 0.72-0.99]) and median PFS by 1.3 months (hazard ratio 0.73 [95% confidence intervals, 0.62-0.85]) in the pertuzumab vs. the placebo arm. ORR was numerically higher (57.0% vs. 48.6%) and median DoR 1.8 months longer with pertuzumab treatment...evidence of treatment activity and an acceptable safety profile for pertuzumab plus trastuzumab and chemotherapy in previously untreated HER2-positive metastatic gastric or gastroesophageal junction cancer after long-term follow-up.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1007/s10120-022-01335-4
    Trial ID:
    JACOB
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Int J Clin Oncol
    Title:

    Pertuzumab plus trastuzumab and chemotherapy for Japanese patients with HER2-positive metastatic gastric or gastroesophageal junction cancer: a subgroup analysis of the JACOB trial

    Published date:
    10/16/2019
    Excerpt:
    The phase III JACOB trial (NCT01774786) compared the efficacy and safety of pertuzumab and trastuzumab plus chemotherapy with placebo and trastuzumab plus chemotherapy in patients with previously untreated human epidermal growth factor receptor 2 (HER2)-positive metastatic gastric or gastroesophageal junction cancer. We conducted a subgroup analysis in Japanese patients. Results from this subgroup analysis of the JACOB trial suggest similar efficacy of pertuzumab in Japanese patients and patients in the overall population, encouraging continued investigation of new agents for gastric cancer in Japanese patients.
    Secondary therapy:
    cisplatin + capecitabine
    DOI:
    10.1007/s10147-019-01558-z
    Trial ID:
    JACOB
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Lancet Oncol
    Title:

    Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study

    Excerpt:
    NON-SUPPORTIVE EVIDENCE:...overall survival was not significantly different between treatment groups (median overall survival 17·5 months [95% CI 16·2-19·3] in the pertuzumab group and 14·2 months [12·9-15·5] in the control group; hazard ratio 0·84 [95% CI 0·71-1·00]; p=0·057)....pertuzumab to trastuzumab and chemotherapy did not significantly improve overall survival in patients with HER2-positive metastatic gastric or gastro-oesophageal junction cancer compared with placebo.
    DOI:
    10.1016/S1470-2045(18)30481-9
    Trial ID:
    JACOB
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for HER2 Positive Breast Cancer)
    New
    Title:

    pertuzumab/trastuzumab (Phesgo) is accepted for restricted use within NHSScotland.

    Excerpt:
    pertuzumab/trastuzumab (Phesgo) is accepted for restricted use within NHSScotland....In combination with chemotherapy in...the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence...In combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma

    Excerpt:
    ...To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer....
    Trial ID:
    INNOVATION
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    TRAstuzumab and Pertuzumab for HER2+ Resectable Oesophageal Cancer

    Excerpt:
    ...- HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the local laboratory on a primary tumor biopsy....
    Trial ID:
    TRAP-2
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Feasibility Study of Chemoradiation, TRAstuzumab and Pertuzumab in Resectable HER2+ Esophageal Carcinoma

    Excerpt:
    ...- HER2-positive tumor defined as either IHC 3+ or IHC 2+, the latter in combination with ISH+, as assessed by the sponsor-designated central laboratory (pathology AMC) on a primary tumor biopsy....
    Trial ID:
    TRAP
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

    Excerpt:
    ...- HER2-positive tumor...
    Trial ID:
    NCT01461057