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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Trastuzumab with trimodality treatment for esophageal adenocarcinoma with HER2 overexpression: NRG Oncology/RTOG 1010.

Published date:
05/13/2020
Excerpt:
The primary objective of RTOG 1010 was to determine if trastuzumab increases disease-free survival (DFS) when combined with trimodality treatment for patients with HER2 overexpressing esophageal adenocarcinoma...ER2 status was determined by IHC and gene amplification by FISH...The median DFS time is 19.6 months (13.5-26.2) for the CXRT +trastuzumab arm compared to 14.2 months (10.5-23.0) for the CXRT arm. The hazard ratio (95% CI) comparing the DFS of CXRT+trastuzumab arm to the CXRT arm was 0.97 (0.69, 1.36). The median OS time was 38.5 months (26.2-70.4) for the CXRT+trastuzumab arm compared to 38.9 months (29.0-64.5) for the CXRT arm, hazard ratio (95% CI): 1.01 (0.69, 1.47).
Secondary therapy:
carboplatin + paclitaxel
DOI:
10.1200/JCO.2020.38.15_suppl.4500
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

Published date:
08/28/2010
Excerpt:
Trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2; also known as ERBB2), was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer...Median follow-up was 18.6 months (IQR 11-25) in the trastuzumab plus chemotherapy group and 17.1 months (9-25) in the chemotherapy alone group. Median overall survival was 13.8 months (95% CI 12-16) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months (10-13) in those assigned to chemotherapy alone (hazard ratio 0.74; 95% CI 0.60-0.91; p=0.0046).
Secondary therapy:
cisplatin + capecitabine; cisplatin + 5-fluorouracil
DOI:
10.1016/S0140-6736(10)61121-X
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or Stomach

Excerpt:
...- Detection of an adenocarcinoma with HER2 3+ (IHC) or HER2 2+ (IHC) with amplification proven by FISH, SISH or CISH by an accredited local pathologist (for quality assurance tumor samples have to be available for a subsequent central review)...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

ERBB2 copy number (CN) as a quantitative biomarker for real-world (RW) outcomes to anti-HER2 therapy in advanced gastroesophageal adenocarcinoma (adv GEA).

Published date:
05/19/2021
Excerpt:
ERBB2amp was detected in 15% of GEA tissue samples, with significant diversity in ERBB2 CN and amplicon focality...ERBB2 CN was predictive of rwPFS as a continuous variable for pts with GEA treated with T in the RW setting.
DOI:
10.1200/JCO.2021.39.15_suppl.4045