A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non-Small Cell Lung Cancer Patients
| Autor: | Ricardo Fleytas, Yoanna I. Flores, Zaima Mazorra, Jenelin Parra, Niurka Futiel, Lina Arzuaga, Odeth Martínez, Maria A. Marrero, Mauricio Catala, Carmen Viada, Delmairis Reyes, Loisel Vello, Silvia Mendoza, Gryssell Rodriguez, Patricia Sierra, Nadia Aguilera, Pedro C. Rodriguez, Tatiana Crespo, Yaisel Pomares, Liuba Alonso, Teresa Sabates, Mireysi Cala, Eduardo Santiesteban, Yanine Otero, Beatriz García, Tania Crombet, Soraida Acosta, Agustin Lage, Rosa Maria Amador, Patricia Lorenzo-Luaces, Gala N. Romero, Xitllaly Popa, Elia Neninger, Ana de la Torre |
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| Rok vydání: | 2015 |
| Předmět: |
0301 basic medicine
Oncology Male Cancer Research medicine.medical_specialty Lung Neoplasms medicine.medical_treatment CimaVax-EGF Kaplan-Meier Estimate Cancer Vaccines 03 medical and health sciences 0302 clinical medicine Maintenance therapy Adjuvants Immunologic Epidermal growth factor Internal medicine Carcinoma Non-Small-Cell Lung medicine Humans Epidermal growth factor receptor Lung cancer Neoplasm Staging biology Epidermal Growth Factor business.industry Immunotherapy Active medicine.disease Prognosis Vaccination 030104 developmental biology Treatment Outcome 030220 oncology & carcinogenesis Immunology Retreatment biology.protein Female Cancer vaccine business Adjuvant |
| Zdroj: | Clinical cancer research : an official journal of the American Association for Cancer Research. 22(15) |
| ISSN: | 1557-3265 |
| Popis: | Purpose: EGFR is a well-validated target for patients with non–small cell lung cancer (NSCLC). CIMAvax-EGF is a therapeutic cancer vaccine composed of human recombinant EGF conjugated to a carrier protein and Montanide ISA51 as adjuvant. The vaccine is intended to induce antibodies against self EGFs that block EGF–EGFR interaction. Experimental Design: To evaluate overall survival, safety, immunogenicity, and EGF concentration in serum after CIMAvax-EGF, a randomized phase III trial was done in patients with advanced NSCLC. Four to 6 weeks after first-line chemotherapy, 405 patients with stage IIIB/IV NSCLC were randomly assigned to a vaccine group, which received CIMAvax-EGF or a control group, treated with best supportive care. Results: Long-term vaccination was very safe. Most frequent adverse reactions were grade 1 or 2 injection-site pain, fever, vomiting, and headache. Vaccination induced anti-EGF antibodies and decreased serum EGF concentration. In the safety population, median survival time (MST) was 10.83 months in the vaccine arm versus 8.86 months in the control arm. These differences were not significant according the standard log rank (HR, 0.82; P = 0.100), but according a weighted log rank (P = 0.04) that was applied once the nonproportionality of the HR was verified. Survival benefit was significant (HR, 0.77; P = 0.036) in the per-protocol setting (patients receiving at least four vaccine doses): MST was 12.43 months for the vaccine arm versus 9.43 months for the control arm. MST was higher (14.66 months) for vaccinated patients with high EGF concentration at baseline. Conclusions: Switch maintenance with CIMAvax-EGF was well tolerated and significantly increased MST of patients that completed induction vaccination. Baseline EGF concentration predicted survival benefit. Clin Cancer Res; 22(15); 3782–90. ©2016 AACR. |
| Databáze: | OpenAIRE |
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