Objetive:

To assess the effectiveness and safety of ramucirumab in the treatment of metastatic gastric adenocarcinoma (MGA) or metastatic gastroesophageal junction adenocarcinoma (MGJA) in a class 5 hospital.

Methods:

Retrospective observational study in which all patients treated with ramucirumab in the hospital were included.

A follow-up was carried out through the electronic medical history (HCE) from which age, sex, diagnosis, functional status according to ECOG and previous treatment lines were collected. As effectiveness variables, progression-free survival (PFS) and overall survival (OS) were calculated. As safety variables, the adverse effects recorded in the HCE were analyzed and categorized by severity according to CTCAE (v.5).

Results:

A total of 40 patients (20% women) with a mean age at the start of treatment of 62.5±12.4 years were analyzed. At the beginning of treatment, 67,5% of patients had ECOG 1.

78% of the treatments with ramucirumab were in the second line and 22% in the third. Regarding the first line, 100% of the schemes were based on platinum and fluoropyrimidines.

90.1% of the patients were treated with the combination of paclitaxel 80 mg/m2 plus ramucirumab 8 mg/kg; The rest was treated in monotherapy. Patients received on average 5.1±4.1 cycles. The PFS was 4 (3.1-8.9) months and the OS was 5.8 (4.6-13) months.

Regarding safety, 75.6% of the patients (n=31) presented some adverse effect. The most observed adverse effect was asthenia in 48.8% of the patients (n=20). It was also observed: hypertension (17.1%), skin rash (12.2%), alopecia (12.2%), neutropenia (9.7%), mucositis (9.7%) and nausea (9.7%).

Conclusions:

The PFS was similar in this study to that obtained in the pivotal clinical trial RAINBOW, although the value of the OS obtained was almost half. Safety was similar to that observed in the clinical trial.

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