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Shepherd, F.A., Dancey, J., Ram Lau, R., Mattson, K., Gralla, R., O’Rouke, M., et al. (2000) Prospective Randomized Trial of Docetaxel versus Best Supportive Care in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy. Journal of Clinical Oncology, 18, 2095-2103.

has been cited by the following article:

  • 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.