HERCEPTIN (trastuzumab), monoclonal antibody - GASTRIC CANCER

ONCOLOGY - Investigation
Opinions on drugs - Posted on Sep 28 2016

Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

Minor improvement in combination with chemotherapy in the treatment of metastatic HER2+ gastric or gastro-oesophageal junction cancer

  • HERCEPTIN has Marketing Authorisation in the treatment of metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, with tumour HER2 overexpression, in combination with fluoropyrimidine (5FU or capecitabine) and cisplatin, in patients who have not been previously treated for their metastatic disease.
  • In the only available comparative study, its addition to chemotherapy was associated with a modest benefit in terms of median overall survival (gain of 4.2 months) without benefit in quality of life. No new clinical data confirmed these results, resulting from a post-hoc subgroup analysis.
  • The only targeted therapy available in this indication, it is nevertheless the standard treatment in combination with chemotherapy.




Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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