Racotumomab in Non-Small Cell Lung Cancer as Maintenance and Second-Line Treatment.

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 immune response 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.

Bone Marrow Transplantation in Patients With Acute Leukemia In Cuba: Results From the Last 30 Years and New Opportunities Through International Collaboration.

Blood and marrow transplantation (BMT) has been performed in Cuba for over 30 years with limited resources and without international relationships. Researchers from University of Illinois at Chicago and Hermanos Ameijeiras Hospital (HAH) in Havana collaborated on retrospectively analyzing 101 consecutive patients with adult acute leukemia who received BMT at HAH from June 1986 to January 2016. Of these, 82 had acute myeloid leukemia (AML) and 19 had acute lymphoblastic leukemia (ALL). BMT eligibility criteria included prior morphologic complete remission, no severe comorbidities, and age between 16 and 60 years. Patients with an HLA-matched donor received an allogeneic BMT, whereas the others received an autologous BMT. All patients received fresh stem cells from marrow (80%) or mobilized peripheral blood (19%). Of 82 patients with AML, 35 received an allogeneic (AML-allo) and 47 an autologous (AML-auto) BMT. Both groups had comparable median age (37 years) and follow-up of survivors. Overall survival (OS) was 34% in AML-allo and 38% in AML-auto. The transplant-related mortality rate was 40% in AML-allo and 17% in AML-auto, whereas the relapse-related mortality rates were 25% and 40%, respectively. Of the 19 patients with ALL, six received an allogeneic transplant. Of these, transplant-related mortality occurred in one patient and three died after disease relapse (OS, 33%). Of 13 patients who received autologous transplants, transplant-related mortality occurred in three and six died after disease relapse (OS, 31%). To our knowledge, this is the first scientific report on BMT performed in patients with acute leukemia in Cuba. The collaboration between University of Illinois at Chicago and HAH will further develop capacity building in research and implementation of new diagnostic and therapeutic strategies in Cuba.

Metástasis coroidea de un carcinoma de mama / Choroidal metastasis of a breast carcinoma

Se presenta una paciente de 55 años de edad con diagnóstico de carcinoma ductal infiltrante grado II multicéntrico de mama izquierda. Esta refiere pérdida del hemicampo temporal del ojo izquierdo. A través de la oftalmoscopia binocular indirecta se le diagnosticó una lesión metastásica coroidea y se corroboró por ultrasonido ocular. Se le realizó tratamiento quirúrgico del tumor primario, además de poliquimioterapia, terapia hormonal y radioterapia local externa a la lesión coroidea. A los seis meses de tratamiento hubo regresión total de la lesión con recuperación de la visión a 20/20, valor inicial al diagnóstico de la enfermedad.

The case of a 55-year-old woman with diagnosis of multinodular Grade II ductal infiltrating carcinoma in left breast was presented in this article. She presented with temporal visual field defect in her left eye. A choroidal metastatic tumor was diagnosed by indirect binocular ophthalmoscopy, confirmed by ocular echography. The primary tumor was removed by surgery and the choroidal lesion was treated with systemic chemotherapy, hormonal therapy and external beam radiation therapy. Six months after the treatment, the choroidal metastasis showed complete regression, and the best visual acuity of 20/20 was recovered, which was the initial value at the diagnosis of disease.

Tratamiento del carcinoma de células pequeñas del pulmón y supervivencia a 5 años / Treatment of small cell lung carcinoma survival at 5 years

Se reportaron los resultados de un estudio retrospectivo de pacientes con carcinoma de células pequeñas de pulmón en todos los estadios de la enfermedad, diagnosticado por citología y/o biopsia de la lesión. Métodos: Se estudiaron 68 enfermos que padecían un carcinoma de células pequeñas de pulmón en todos los estadios y recibieron tratamiento de primera línea con cisplatino-etopósido y de segunda línea, con ciclofosfamida, doxorubicina y vincristina. Los pacientes de enfermedad limitada fueron evaluados al final del primer ciclo para planificar el tratamiento con radiaciones; los de enfermedad extendida recibieron radiaciones sobre sitios metastásicos o para mejorar algún síntoma. Resultados: La respuesta al tratamiento fue: 25 por ciento de respuesta objetiva (RC y RP) y 56 por ciento de control de la enfermedad. La mediana de supervivencia global fue 10,10 meses. En el sexo femenino se observó tendencia a un incremento de la supervivencia en relación con el masculino (10,23 vs. 9,33 meses). La supervivencia en la enfermedad limitada fue de 12,5 meses y en la enfermedad extendida, de 6,57 meses lo cual fue estadísticamente significativo (p = 0,004).

The results of a retrospective study of patients with small cell lung carcinoma in all the stages of the disease diagnosed by cytology and/or biopsy of the lesion were reported. Methods: 68 patients that suffered from a small cell lung carcinoma in all the stages that received first-line treatment with cisplatin-etoposide, and second line treatment with cyclophosphamide, doxorubicin and vincristine were studied. The patients with limited disease were evaluated at the end of the first cycle to plan the treatment with radiations; those with extended disease received radiations on metastic sites or to improve some symptom. Results: The response to the treatment was as follows: 25 percent of objective response (CR and PR) and 56 percent of control of the disease. The global mean survival was 10.10 months. Among females, it was observed a trend towards an increase of survival compared with males (10.23 vs. 9.33 months). The survival of the limited disease was 12.5 months, whereas in the extended disease it was 6.57 months, which was statistically significant (p = 0,004).

Tratamiento del carcinoma de células pequeñas del pulmón y supervivencia a 5 años / Treatment of small cell lung carcinoma survival at 5 years

Se reportaron los resultados de un estudio retrospectivo de pacientes con carcinoma de células pequeñas de pulmón en todos los estadios de la enfermedad, diagnosticado por citología y/o biopsia de la lesión. Métodos: Se estudiaron 68 enfermos que padecían un carcinoma de células pequeñas de pulmón en todos los estadios y recibieron tratamiento de primera línea con cisplatino-etopósido y de segunda línea, con ciclofosfamida, doxorubicina y vincristina. Los pacientes de enfermedad limitada fueron evaluados al final del primer ciclo para planificar el tratamiento con radiaciones; los de enfermedad extendida recibieron radiaciones sobre sitios metastásicos o para mejorar algún síntoma. Resultados: La respuesta al tratamiento fue: 25 por ciento de respuesta objetiva (RC y RP) y 56 por ciento de control de la enfermedad. La mediana de supervivencia global fue 10,10 meses. En el sexo femenino se observó tendencia a un incremento de la supervivencia en relación con el masculino (10,23 vs. 9,33 meses). La supervivencia en la enfermedad limitada fue de 12,5 meses y en la enfermedad extendida, de 6,57 meses lo cual fue estadísticamente significativo (p = 0,004)(AU)

The results of a retrospective study of patients with small cell lung carcinoma in all the stages of the disease diagnosed by cytology and/or biopsy of the lesion were reported. Methods: 68 patients that suffered from a small cell lung carcinoma in all the stages that received first-line treatment with cisplatin-etoposide, and second line treatment with cyclophosphamide, doxorubicin and vincristine were studied. The patients with limited disease were evaluated at the end of the first cycle to plan the treatment with radiations; those with extended disease received radiations on metastic sites or to improve some symptom. Results: The response to the treatment was as follows: 25 percent of objective response (CR and PR) and 56 percent of control of the disease. The global mean survival was 10.10 months. Among females, it was observed a trend towards an increase of survival compared with males (10.23 vs. 9.33 months). The survival of the limited disease was 12.5 months, whereas in the extended disease it was 6.57 months, which was statistically significant (p = 0,004)(AU)

Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer.

PURPOSE: We show the result of a randomized phase II clinical trial with an epidermal growth factor (EGF)-based cancer vaccine in advanced non-small-cell lung cancer (NSCLC) patients, evaluating immunogenicity, safety, and effect on survival. PATIENTS AND METHODS: Eighty patients with stage IIIB/IV NSCLC after finishing first-line chemotherapy were randomly assigned to receive best supportive care or EGF vaccinations. RESULTS: Vaccination was safe. Adverse events were observed in less than 25% of cases and were grade 1 or 2 according to National Cancer Institute Common Toxicity Criteria. Good anti-EGF antibody response (GAR) was obtained in 51.3% of vaccinated patients and in none of the control group. Serum EGF concentration showed a major decrease in 64.3% of vaccinated patients. GAR patients survived significantly more than those with poor antibody response (PAR). Also, patients whose serum EGF dropped below 168 pg/mL survived significantly more than the rest. There was a trend to an increased survival for vaccinated patients compared with controls. The survival advantage for vaccinated patients compared with controls was statistically significant in the subgroup of patients with age younger than 60 years. CONCLUSION: Vaccination with EGF was safe and provoked an increase in anti-EGF antibody titers and a decrease in serum EGF. There was a direct correlation between antibody response and survival. There was a direct correlation between decrease in serum EGF and survival. In patients younger than 60 years, vaccination was associated with increased survival.

Estudio descriptivo de respuesta a quimioterapia en pacientes con carcinoma de células no pequeñas de pulmón inoperable / Descriptive study of response to chemotherapy in patients with inoperable non-small cell lung carcinoma

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 por ciento) 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 por ciento 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.

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 percent) 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 percent 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.

Estudio descriptivo de respuesta a quimioterapia en pacientes con carcinoma de células no pequeñas de pulmón inoperable / Descriptive study of response to chemotherapy in patients with inoperable non-small cell lung carcinoma

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 por ciento) 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 por ciento 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(AU)

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 percent) 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 percent 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(AU)

Incidencia de infección por el virus de la hepatitis B y C / Incidence of hepatitis B and C viruses infections

Se sabe que los pacientes con tumores malignos y tratamiento con citostáticos se encuentran expuestos a sufrir infecciones virales por el uso frecuente de la vía parenteral. En este estudio se analizó la frecuencia de la hepatitis B y C en pacientes sometidos a tratamiento. Se estudiaron 336 pacientes con diferentes localizaciones tumorales, en los que se analizaron las características serológicas y clínicas de los infestados. Se pesquisó la infección viral mediante marcadores serológicos Umelisa HbsAg y HVC. Se determinaron los valores sanguíneos de alaninoaminotransferasa, aspartatoaminotransfera y bilirrubina. Se realizó biopsia hepática percutánea. Se encontró que el 3,27 porciento de los pacientes contrajo la infección con predominio de infección por el virus B. Se conoció que todos los pacientes habían sido sometidos a tratamiento quirúrgico y que el tiempo de tratamiento con quimioterapia fue entre 4 y 15 meses. Se hallaron como principales factores de riesgo: las intervenciones quirúrgicas, el acceso parenteral frecuente y las transfusiones sanguíneas. El signo clínico más evidenciado fue la hepatomegalia. Los resultados muestran una baja incidencia de infección viral B y C. Se señaló la importancia de realizar el pesquisaje de virus B y C en pacientes sometidos a quimioterapia que presenten elevación de las enzimas hepáticas