Abstract INTRODUCTION Racotumomab is a therapeutic vaccine based on a monoclonal anti-idiotypic antibody developed by the Molecular Immunology Center in Havana, Cuba, that is registered in Cuba and Argentina for treatment of non-small cell lung cancer. It induces a specific humoral and cellular immuneresponse against the N-glycolyl GM3 (NeuGcGM3) ganglioside present in tumor cells, thereby provoking the death of these cells. OBJECTIVE Evaluate racotumomab vaccine use as switch maintenance and second-line therapy for patients with inoperable non-small cell lung cancer in routine clinical practice, outside the framework of clinical studies, and assess the overall survival, stage-specific survival and safety in these patients. METHODS A descriptive, retrospective study was carried out in patients diagnosed with non-small cell lung cancer not suitable for surgical treatment, who received racotumomab as a part of switch maintenance or second-line treatments. Overall survival was defined from diagnosis and from the first immunization, until death. RESULTS We included 71 patients treated with racotumomab, 57.7% (41/71) of whom were in stages IIIB and IV of non-small cell lung cancer. Of the patients, 84.5% (60/71) had no adverse events, and 15.5% (11/71) had mild adverse reactions. The median overall survival was 24.5 months, calculated from the first immunization, 17.2 months for those who received racotumomab as switch maintenance and 6.8 months for patients who had progressed after the first line of treatment. CONCLUSIONS Racotumomab in routine clinical practice prolonged overall survival in patients with non-small cell lung cancer treated in switch maintenance, and in stage IV patients who received the treatment as second-line therapy. The vaccine was well tolerated.

Survival from 201 patients was studied, which were diagnosed with bronchogenic carcinoma (155 with non-small cell carcinoma and 46 with small cell carcinoma) different modalities of specific oncotherapy from 1997 to 2002. Sample was described and the survival was analyzed by Kaplan Meier method according to variables including age, histological lineage, clinical status and treatment used. We noted that 5-years global survival was of 18,5% for non-small cells lung carcinoma. Main predisposing factors of disease were the probability of surgical treatment. Use of chemotherapy as surgery adjuvant regime improves survival of patients operated on. 5-years mean survival achieved in patients presenting with in small cells non-differentiated carcinoma was of 4,5%.

Se estudió la supervivencia de 201 pacientes a quienes se les diagnosticó un carcinoma broncógeno (155 con carcinoma de células no pequeñas y 46 con carcinoma de células pequeñas) y recibieron tratamiento oncoespecífico, en sus diferentes modalidades, entre el año 1997 y el 2002. Se describió la muestra y se analizó la supervivencia mediante el método de Kaplan Meier en función de variables como edad, estirpe histológica, estadio clínico y tratamiento empleado. Se halló que la supervivencia global de los pacientes incluidos en el estudio fue de 15 %. La probabilidad de sobrevivir a los 5 años fue de 18,5 %, para el carcinoma de pulmón de células no pequeñas. Los principales factores predictores pronósticos de la enfermedad fueron los estadios potencialmente curables (I y II) en el momento del diagnóstico con la posibilidad de recibir tratamiento quirúrgico. La edad no influyó significativamente en la supervivencia. La utilización de quimio-radioterapia, como régimen adyuvante a la cirugía mejoró la supervivencia de los pacientes operados. La supervivencia media a los 5 años lograda en los pacientes con carcinoma indiferenciado de células pequeñas fue de 4,5 %.

The results of a descriptive and retrospective study based on the therapeutic standardization of the patients with inoperable non-small cell lung cancer that received cisplatin-vinblastine combined chemotherapy were reported to determine their survival. It was observed that 185 were administered endovenous treatment (cisplatin 100 mg/m2 and vinblastine 6 mg/m2) the first day and, later, every 21 days; 125 (78 %) received between 4 and 6 treatment cycles. It was found that the global survival of all the patients was 11.82 months (mean 8.43), whereas in the stages IIIB and IV it was 9.11 (mean 7.60) and 8.96 months (mean 5.80), respectively. In these stages, it was obtained 48 % of control of the disease considered as an objective response plus stabilization. Toxicity was mainly digestive, renal and haematological. A trend towards survival was observed among females. No differences were detected in the survival between the stages IIIB and IV. However, in those patients among whom a control of the disease was attained, the survival was significantly higher. It was concluded that the patients in stages IIIB and IV with a good general condition had a greater survival, as well as those that presented only one comorbidity.

Se reportaron los resultados de un estudio descriptivo y retrospectivo basado en la estandarización terapéutica de los pacientes con cáncer de pulmón de células no pequeñas, no operables, que recibieron quimioterapia de combinación cisplatino-vinblastina para determinar su supervivencia. Se observó que 185 recibieron tratamiento (cisplatino 100 mg/m² y vinblastina 6 mg/m²) endovenoso el día 1 y, posteriormente, cada 21 d; 125 (78 %) recibieron entre 4 y 6 ciclos de tratamiento. Se halló que la supervivencia global de todos los pacientes fue de 11,82 meses (mediana 8,43), mientras que en los estadios IIIB y IV fue de 9,11 (mediana 7,60) y 8,96 meses (mediana 5,80), respectivamente. En estos estadios se obtuvo 48 % de control de la enfermedad considerada como respuesta objetiva más estabilización. La toxicidad fue fundamentalmente digestiva, renal y hematológica. Se observó tendencia a una mayor supervivencia en el sexo femenino. No se encontraron diferencias en la supervivencia entre los estadios IIIB y IV, sin embargo, en aquellos pacientes en los cuales se obtuvo control de la enfermedad, la supervivencia fue significativamente mayor. Se halló que los pacientes en estadios IIIB y IV con buen estado general tuvieron mayor supervivencia al igual que los que presentaron una sola comorbilidad.