DI-074 Efficacy and safety of trastuzumab in metastatic gastric cancer

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Abstract

Background

HER-2 protein is expressed in some metastatic gastric cancers (MGC), where targeted therapies such as trastuzumab can be used.

Purpose

To evaluate the efficacy and safety of trastuzumab in the treatment of MGC and to compare the results with pivotal studies.

Material and methods

A retrospective study was conducted including patients diagnosed with MGC and for which treatment with trastuzumab had been evaluated (loading dose of 8 mg/kg and maintenance dose of 6 mg/kg every 3 weeks) in combination with cisplatin and capecitabine or fluorouracil, initiated from April 2013 to October 2016. Data were obtained from the electronic health record (SIAS) and dispensation module (Farmis). Variables were: age, sex, Herceptest result, Karnofsky index (IK), previous treatments, adverse effect (AE), reductions in dose, progression free survival (PFS) and overall survival (OS). Data were compared with the results of the ToGA trial for MGC (PFS median 6.7 months and OS 13.8 months).

Results

The treatment was requested for 9 patients; 3 dies before starting treatment and 6 began treatment. The distribution of patients starting treatment was: 1 women and 5 men, average age 62 years. 83% had triple positive Herceptest and 17% wee double positive. IK median was 90% (95% CI 60–90%). All patients who started treatment had previously received another line of therapy. The main treatments received were cisplatin–fluorouracil and capecitabine–oxaliplatin.

Results

During treatment, all patients had AE. 67% of these patients had diarrhoea, 50% anorexia and 33% anaemia, fatigue and chest pain. 33% were admitted for febrile neutropenia. Other effects with a lower incidence were: alopecia, vertigo and dry mouth. These AE caused a reduction of 20% in the dose in 50% of patients. At the time of the study, treatment was suspended in 50% of patients. The cause of discontinuation for these patients was due to progression of disease. Median PFS was 6.2 months (95% CI 2.1–13.07) and median OS was 9 months (95% CI 2.8–28.23). 50% of patients died.

Conclusion

Our results, compared with the ToGA trial, showed similar results in terms of PFS but a lower OS than that obtained in this study, but we must take into account the limited sample size (n=6). Regarding the safety profile, the reactions described in the data sheet as very frequent appeared.

References and/or acknowledgements

Pharmacy.

References and/or acknowledgements

No conflict of interest

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