2013, Number 1
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VacciMonitor 2013; 22 (1)
Safety of Racotumomab in the treatment of patients with non-small cell lung cancer
Pérez L, Estévez D, Gastón Y, Macías A, Viada CE
Language: Spanish
References: 13
Page: 10-14
PDF size: 88.35 Kb.
ABSTRACT
In Cuba, lung cancer ranks second in incidence and first in mortality. Therefore, it is necessary to identify new
therapeutical options. Immunological approaches are interesting because of the potential activity without the
toxicities of conventional chemotherapy. The Center of Molecular Immunology developed a vaccine called
Racotumomab; it acts on the lung carcinoma inducing an increase in tumor apoptosis and a decrease in the
number of tumor vessels. A expanded access, multicenter, open study was conducted in 86 patients with nonsmall cell lung cancer in order to assess its safety. The administered dose was 1 mg/mL intradermically. The first
5 doses were administered every 14 days and the remaining 10 every 28 days until completing the treatment. The
follow-up re immunizations were every 28 days. The occurrence of adverse events (AE) was analyzed and they
were classified according to CTC v4.02 criteria. Adverse events were reported by 58 patients (67.4%), making a
total of 215 events. burning at the injection site was the most frequently reported event, 32 (14.9%). The use of the
vaccine in the patients under study showed good safety and tolerance.
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