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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease.
Secondary therapy:
capecitabine; cisplatin + 5-fluorouracil
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer

Excerpt:
...- Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

Excerpt:
...- Patients diagnosed with metastatic gastric or gastro-esophageal junction adenocarcinoma (HER2-positive), unresectable and histologically confirmed Measurable disease, following the new RECIST criteria,...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy

Excerpt:
...HER2-positive: (IHC 3+ or IHC 2+ and FISH positive)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Margetuximab in Combination with INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in HER2-Positive Gastric or Gastroesophageal Junction Cancer

Excerpt:
...Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma - Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%), per central review. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II, III of HER-2 Positive Gastroesophageal Junction Adenocarcinoma: A Randomized, Controlled trial

Excerpt:
...The her-2 positive was detected by immunohistochemistry or FISH; 3. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Herceptin (Trastuzumab) in Combination With Cisplatin/Capecitabine Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastric or Gastro-Esophageal Junction Cancer

Excerpt:
...- HER2-positive primary or metastatic tumor as assessed by central laboratory...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ,III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma: A Randomized, Controlled Clinical Study

Excerpt:
...The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study

Published date:
06/14/2023
Excerpt:
As of data cutoff for the updated analysis (median follow-up 10·2 months [IQR 5·6-12·9]), a confirmed objective response was reported in 33 (42% [95% CI 30·8-53·4]) of 79 patients, including four (5%) complete responses and 29 (37%) partial responses, as assessed by independent central review...These clinically meaningful results support the use of trastuzumab deruxtecan as second-line therapy in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.
DOI:
10.1016/S1470-2045(23)00215-2
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Real-World (RW) United States (US) First-Line (1L) Treatment (TX) Patterns and Overall Survival (OS) of Patients (PTS) with Unresectable Advanced or Metastatic (ADV/MET) Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenoc ...

Published date:
04/22/2022
Excerpt:
...clinical characteristics and 1L tx were described by HER2 status for adult pts diagnosed with adv/met GC/GEJC/EAC from January 2011 to December 2020...a majority (65%) of HER2+ pts received trastuzumab…. Median OS for HER2+, HER2− and HER2un pts was 12.2, 9.8 and 7.6 months, respectively.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Interest of the Addition of Taxanes to Standard Treatment in First-Line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients

Published date:
03/07/2022
Excerpt:
We performed a retrospective cohort study to evaluate the interest of taxanes among HER2-positive advanced GEA patients treated with PFT...Treatment by taxanes was significantly associated with a better PFS in univariate (HR 0.49; 95%CI 0.25 to 0.98, p=0.042) and multivariate Cox regression analysis (HR 0.44; 95%CI 0.21 to 0.94, p=0.033)...OS was prolonged (19.0 months (95%CI 7.8 to 45.2) vs 13.0 months (95%CI 5.5 to 14.8), log-rank p=0.033) in favor of the T group. Treatment by taxanes was significantly associated with a better OS in univariate Cox regression analysis...Given the improvement in PFS and OS, the addition of taxanes to standard chemotherapy could be considered as a promising treatment for selected HER2-positive advanced GEA patients...
Secondary therapy:
5-fluorouracil
DOI:
10.3389/fonc.2022.763926
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Association between timely targeted treatment and outcomes in patients with metastatic HER2-overexpressing gastroesophageal adenocarcinoma

Published date:
02/04/2022
Excerpt:
Relative to nontimely initiation, timely trastuzumab was associated with significantly higher OS (2-year OS, 32.1% vs 15.3%; adjusted hazard ratio [HR], 0.67; 95% CI, 0.51-0.88) and PFS (2-year PFS, 9.2% vs 3.7%; adjusted HR, 0.71; 95% CI, 0.55-0.93)...Improved survival was observed among metastatic HER2+ GEA patients treated with trastuzumab versus those who were not, regardless of timing of initiation.
DOI:
10.1002/cncr.34117
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Safety and efficacy of HER2 blockade by trastuzumab-based chemotherapy-containing combination strategies in HER2+ gastroesophageal adenocarcinoma

Published date:
12/29/2021
Excerpt:
The safety and efficacy of 23 studies of first-line trastuzumab plus doublet chemotherapy, without checkpoint inhibitors (n = 19) or with checkpoint inhibitors (n = 4), conducted in patients with locally advanced unresectable or metastatic HER2+ GEA...In studies with checkpoint inhibitors, ORR ranged from 39% to 86%, median PFS from 8.0 to 13.0 months, and median OS from 19.3 to 27.3 months. This review provides a historical benchmark on safety and efficacy of available first-line chemotherapy-based standard of care for patients with locally advanced unresectable or metastatic HER2+ GEA.
Secondary therapy:
Immunotherapy
DOI:
10.1016/j.esmoop.2021.100360
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Association between timely targeted therapy initiation and clinical outcomes in patients with advanced HER2+ gastroesophageal adenocarcinoma.

Published date:
05/19/2021
Excerpt:
...significantly higher OS (2-year OS 29.6% vs 14.6%; adjusted HR 0.72, 95% CI 0.57-0.91, p = 0.006) and PFS (2-year PFS 8.3% vs 3.9%; adjusted HR 0.78, 95% CI 0.62-0.98, p = 0.030)...OS and PFS were higher among patients with metastatic HER2+ GEA treated with trastuzumab...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study): A Turkish Oncology Group Study

Published date:
05/12/2021
Excerpt:
The patients with HER2-positive gastric, or gastroesophageal junction adenocarcinoma, after gastrectomy plus D2 dissection, were included. They received 3 cycles of oxaliplatin (100 mg/m2 intravenously day 1) plus capecitabine (850 mg/m2 orally days 1 to 14), trastuzumab (8 mg/kg intravenously day 1 in cycle 1, 6 mg/kg thereafter) every 21 days...After the 25 months follow-up period, 21 patients (61.8%) were alive. Overall survival at 12 and 24 months was 75.0% and 58.0%, while disease-free survival at 12 and 24 months was 65.7% and 55.0%, respectively.
Secondary therapy:
capecitabine + oxaliplatin
DOI:
10.1097/COC.0000000000000825
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial

Published date:
03/01/2021
Excerpt:
This Spanish, multicentre, open-label phase II trial evaluated the efficacy and toxicity of perioperative capecitabine, oxaliplatin and trastuzumab (XELOX-T) in patients with HER2-positive resectable GA or GEJA….Thirty-six patients were included....After a median follow-up of 24.1 months, 18-month DFS was 71% (95% confidence interval [CI], 53–83%); and an update after 102 months of follow-up showed a median OS of 79.9 months and a 60-month OS of 58% (95% CI, 40–73%).
Secondary therapy:
XELOX
DOI:
10.1016/j.ejca.2020.12.005
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Trastuzumab?±?Capecitabine Maintenance After the First-Line Treatment of HER2-Positive Advanced Gastric Cancer: Retrospective Observational Real-Life Data of Turkish Oncology Group

Published date:
02/04/2021
Excerpt:
Trastuzumab maintenance ± capecitabine after 6 cycles of trastuzumab plus combined chemotherapy treatment revealed efficacy and safety in non-progressive HER2-positive advanced gastric and EGJ cancer.
Secondary therapy:
capecitabine
DOI:
10.1007/s12029-021-00594-1
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Trastuzumab?±?Capecitabine Maintenance After the First-Line Treatment of HER2-Positive Advanced Gastric Cancer: Retrospective Observational Real-Life Data of Turkish Oncology Group

Published date:
02/04/2021
Excerpt:
Trastuzumab maintenance ± capecitabine after 6 cycles of trastuzumab plus combined chemotherapy treatment revealed efficacy and safety in non-progressive HER2-positive advanced gastric and EGJ cancer.
DOI:
10.1007/s12029-021-00594-1
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical outcomes of radical gastrectomy following trastuzumab-based chemotherapy for stage IV HER2-positive gastric or gastroesophageal junction cancer

Published date:
05/26/2020
Excerpt:
Combined preoperative T-mab-based chemotherapy and surgery appears to be safe and effective for stage IV HER2-positive gastric or gastroesophageal junction cancer, with a clinically meaningful impact on RFS and OS.
DOI:
10.1007/s00595-020-02011-9