TITLE:
Safety and Efficacy of Racotumomab-Alum Vaccine as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer
AUTHORS:
Eduardo Santiesteban, Leslie Perez, Sailyn Alfonso, Elia Neninger, Soraida Acosta, Yoana Flores, Maurenis Hernandez, Carmen Viada, Robin García, Meylán Cepeda, Daymys Estevez, Yoisbel Moreno, Amparo Macías
KEYWORDS:
Non-Small Cell Lung Cancer, Cancer Vaccine, Second-Line Treatment
JOURNAL NAME:
International Journal of Clinical Medicine,
Vol.5 No.14,
July
23,
2014
ABSTRACT: Despite extensive
clinical research in non-small cell lung cancer (NSCLC), overall survival is
still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets
NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate
safety and efficacy of racotumomab-alum in advanced NSCLC patients with
progressive disease. This expanded access program included 86 histologically
confirmed NSCLC patients, 18 years or older age, with advanced disease and
without therapeutic option, with ECOG performance status ≤3, adequate organ
functions and signed informed consent. The primary endpoint was overall
survival and toxicity was measure assessed treatment-related toxicity according
CTCAEv3. The study was approved by ethical review boards of participant institutions.
Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL)
during the induction phase of treatment (2 months). The maintenance phase
consisted in monthly re-immunizations until unacceptable toxicity or PS
worsening. The median overall survival time of all patients treated with racotumomab-alum
was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%,
respectively. Patients that completed the induction phase of treatment (five
doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site
reaction, bone pain, cough and asthenia. Racotumomab-alum cancer
vaccine could be considered an effective and safe treatment option as
second-line therapy for advanced NSCLC. Further clinical studies should be
conducted to confirm this result.