Maurenis Hernández

A Randomized, Multicenter, Placebo-Controlled Clinical Trial of Racotumomab-Alum Vaccine as Switch Maintenance Therapy in Advanced Non–Small Cell Lung Cancer Patients

Purpose: Racotumomab-alum is an anti-idiotype vaccine targeting the NeuGcGM3 tumor-associated ganglioside. This clinical trial was conducted to provide a preliminary estimate of efficacy and safety of racotumomab as switch maintenance for patients with advanced non–small cell lung cancer (NSCLC). Experimental design: Patients with stage IIIb/IV NSCLC who have at least stable disease after first-line chemotherapy were randomized 1:1 to racotumomab-alum (5 immunizations every 2 weeks and re-immunizations every 4 weeks) or placebo. Treatment was administered beyond progressive disease, until severe performance status worsening or toxicity. At progression, only five patients per group received further anticancer therapy. The primary endpoint was overall survival (OS). Results: One-hundred and seventy-six patients were randomized to racotumomab-alum (n = 87) and placebo (n = 89). Median OS was 8.23 and 6.80 months, respectively [HR, 0.63; 95% confidence interval (CI), 0.46–0.87; P = 0.004]. Median progression-free survival (PFS) in vaccinated patients was 5.33 versus 3.90 months for placebo (HR, 0.73; 95% CI 0.53–0.99; P = 0.039). The most common adverse events in the racotumomab-alum arm were burning and pain at the injection site, bone pain, and asthenia. A high antibody response of IgM and IgG isotype against the NeuGcGM3 ganglioside was obtained. Hyperimmune sera were able to specifically recognize and kill the NeuGcGM3-expressing L1210 cell line. Patients who developed anti-NeuGcGM3 antibodies capable to bind and kill ≥30% L1210 cells showed longer median survival times. Conclusions: Switch maintenance with racotumomab-alum is an effective and a well-tolerated treatment option for patients with advanced NSCLC. Clin Cancer Res; 20(14); 3660–71. ©2014 AACR.

Heart rate recovery in the diagnosis of diabetic Cardiovascular Autonomic Neuropathy

Cardiovascular Autonomic Neuropath (CAN) is a poorly understood chronic complication of Diabetes Mellitus (DM). A single instrument to evaluate CAN is not available yet, because of the complex balance between both sympathetic and parasympathetic drives. Heart Rate Recovery (HRR) is a promising parameter for clinicians to use, which is the difference between the maximal heart rate achieved at the end of the exercise phase and the heart rate at different stages of the recovery. The objective of this study was to characterize parameters obtained from RR trends during the recovery phase of the Exercise ECG. Our preliminary analysis is performed with 23 patients enrolled in the DM group and 6 patients in the control group. It showed that both HRR1 after the first minute of recovery and HRR2 after the second minute of recovery are able to discriminate between groups. These results are encouraging and more trends analysis within a different window period is still needed.

Quantitative comparison of atrial activity detection approaches

This work presents a quantitative performance comparison, bared on Receiver Operating Characteristics (ROC) curve analysis, of different approaches for atrial electrical activity detection on both the electrocardiogram (ECG) and the esophageal electrocardiogram (EECG). Three classical methods are evaluated and compared with a proposed detection scheme based on data fusion techniques. Results obtained from the fusion scheme indicated a better performance over the classical methods, and suggest the potential advantages of the use of data fusion techniques for event detection on noise corrupted environments, where multiple sensors are already available.

P2.40: CIMAvaxEGF Vaccine for the Treatment of Real-World NSCLC Patients: Track: Immunotherapy

Maurenis Hernandez, Ramon A. Ortiz, Elia Neninger, Rosa M. Amador, Mireisy Cala, Kirenia Camacho, Eva Salomon, Pedro P. Guerra, Ivis Mendoza, Carlos Sanchez, Carmen Viada, Matilde Gonzalez, Lourdes T. Torres, Vivian Fonseca, Ivon Garcia, Loisel Bello, Maribel Alonso, Maria C. Rodriguez, Aivin Cruz, Rolando Valdes, Geidy Lorenzo, Meylan Cepeda, Yaimarelis Saumel, Tania Crombet Clinical Research, Center of Molecular Immunology, Havana/ CUBA, Celestino Hernandez Robau Hospital, Villa Clara/ CUBA, Hermanos Ameijeiras Hospital, Havana/CUBA, III Congreso Hospital, PInar del Rio/CUBA, Juan Bruno Zayas Hospital, Santiago de Cuba/CUBA, Jose Ramon Lopez Tabranes Hospital, Matanzas/CUBA, Joaquin Albarran Hospital, Havana/CUBA, National Coordinating Center for Clinical Trials, Havana/CUBA, Luis A. Turcius Lima Policlinic Area, Havana/CUBA, Mario Munoz Policlinic Area, Havana/CUBA, Carlos Manuel Portuondo Policlinic Area, Havana/CUBA, Ramon Gonzalez Coro Policlinic Area, Havana/CUBA, Antonio Luaces Iraola Hospital, Ciego de Avila/CUBA, Santa Clara Policlinic Area, Villa Clara/CUBA, Jose R. Leon Acosta Policlinic Area, Villa Clara/CUBA, Antonio Guiteras Policlinic Area, Havana/CUBA, Marcio Manduley Policlinic Area, Havana/CUBA, Clinical Immunology, Center of Molecular Immunology, Havana/CUBA

Data fusion in autonomic nervous system event detection

Data fusion is an evolving discipline which provides a way to integrate data from multiple sensors and sources, deriving new comprehensive information. Due to the multisensor nature of many clinical procedures, data handling and interpretation may be improved by the proper definition and application of these techniques. This work presents a data fusion approach to multisensor autonomic nervous system (ANS) evaluation, and an example of the application of these techniques to multisensor autonomic event detection. The example involves two levels of data fusion, combining information related to the chronotropic, inotropic and dromotropic effects of the ANS on the heart. The latter being calculated from the esophageal electrocardiogram, which is not to often used as a signal source.