Experiencia institucional con Palbociclib. Estudio Prospectivo / Institutional experience with Palbociclib. Prospective Study

La ANMAT aprobó en diciembre de 2015 el uso de palbociclib en combinación con letrozol para el tratamiento de primera línea del cáncer de mama metastásico con receptores hormonales positivos y HER2 negativo, y en agosto de 2016 la combinación de palbociclib con fulvestrant para pacientes progresadas a terapia endocrina previa. El propósito del presente estudio fue realizar una evaluación prospectiva de la seguridad y eficacia del tratamiento con palbociclib en el Instituto de Oncología Ángel Roffo. Se evaluaron en forma prospectiva 71 pacientes con cáncer de mama metastásico que calificaron para tratamiento con palbociclib desde marzo de 2016 hasta junio de 2017 inclusive. Las participantes fueron tratadas con palbociclib/letrozol (n = 49) o palbociclib/fulvestrant (n = 22). La mediana de tratamiento con palbociclib/ letrozol fue de 5 meses; 3 pacientes presentaron progresión de la enfermedad, y 36 se encuentran en respuesta parcial. La mediana de tratamiento con palbociclib/fulvestrant fue de 2.6 meses; 3 experimentaron progresión de la enfermedad, mientras que el resto de las participantes de este grupo se encuentran con respuesta parcial. En total, 26 tratadas con palbociclib presentaron toxicidades hematológicas, destacándose la neutropenia de grados I a III, anemia de grados I a II, y plaquetopenia grado III. No se registraron toxicidades de grado IV. A pesar del breve período de seguimiento (16 meses), nuestras pacientes evolucionaron con escasa cantidad de progresiones (8.4%), de acuerdo con lo descrito en la literatura, y con menor toxicidad que la comunicada (36.7%) (AU)

In December 2015, ANMAT approved the use of palbociclib in combination with letrozole for the first-line treatment of hormone-receptor-positive and HER2-negative metastatic breast cancer. Subsequently, the combination of palbociclib with fulvestrant was approved in August 2016 for patients progressing from previous endocrine therapy. The purpose of the present study was to conduct a prospective evaluation of safety and efficacy of palbociclib treatment at Instituto de Oncología Ángel H. Roffo. Seventy one patients with metastatic breast cancer who qualified for treatment with palbociclib from March 2016 to June 2017, were evaluated prospectively. Participants were treated with palbociclib/letrozole (n = 49) or palbociclib/ fulvestrant (n = 22). Median of treatment with palbociclib/letrozole was 5 months; 3 patients showed progression of the disease, and 36 are in partial response. Median of treatment with palbociclib/fulvestrant was 2.6 months; 3 patients experienced disease progression, while the rest of the participants in this group were in partial response. In total, 26 treated with palbociclib presented haematological toxicities, including neutropenia grades I to III, anaemia in grades I to II, and thrombocytopenia grade III. No grade IV toxicities were recorded. Despite the brief follow-up period (16 months), our patients experienced a low number of progression (8.4%), as described in the literature, and with less toxicity than reported (36.7%) (AU)

[Time of extubation and postoperative outcome after thoracotomy]. / Momento da extubação e evolução pós-operatória de toracotomia.

OBJECTIVE: Early tracheal extubation following surgical procedures favors clinical evolution of patients and reduces incidence and time of stay in the Intensive Care Unit (ICU), minimizing hospital costs. Immediate postoperative period of pulmonary resections often takes place in the ICU and patients are kept intubated. This study evaluated hospital records of patients submitted to thoracotomy and a correlation between extubation time, postoperative evolution and ICU stay was established. METHODS: Retrospective cohort study of records of 121 patients submitted to pulmonary parenchyma resection (not biopsies) was carried out. Stay in the ICU and time of tracheal extubation were related. Postoperative evolution was classified as good or bad according to occurrence of some of the following conditions: infections, respiratory disorders (reintubation, bronchospasm, acute pulmonary edema, need of tracheotomy, atelectasis, fistulae), re-operation due to bleeding and death. Among the two groups preoperative conditions, anesthetic physical status (American Society of Anesthesiologists--ASA criteria), presence of associated diseases, respiratory functional evaluation and duration of surgery were analyzed. Relative risk was used to evaluate effect of time of extubation (immediate or non-immediate) on the postoperative evolution of patients. RESULTS: Patient distribution related to extubation time was: 81% immediate extubation, 15% non-immediate extubation and 4% not extubated. Destination after surgery was: 73% ICU and 27% post-anesthetic recovery room. Incidence of associated diseases (arterial hypertension, diabetes, obstructive or restrictive pulmonary disease and cardiopathy) among the immediately extubated group and non-immediately extubated group was 37% and 41.6%, respectively. Related to ASA physical status: 62% ASA 1 or 2 in the immediately extubated group and 58.3% ASA 1 or 2 in the non- immediately extubated group. Surgical time was (mean +/- standard deviation) 372.34 +/- 107.84 minutes and 432.61 +/- 117.30 minutes in immediately extubated and non- immediately extubated group, respectively. Relative risk of immediate extubation leading to a poor evolution was of 0.81, while non- immediate extubation leading to a poor evolution was of 1.5. CONCLUSIONS: Safe immediate tracheal extubation of patients submitted to pulmonary resection surgery is possible. This kind of management favors postoperative recuperation out of ICU, which results in patients and hospital benefits, mainly referred to costs.

Momento da extubação e evolução pós-operatória de toracotomia / Time of extubation and postoperative outcome after thoracotomy

OBJETIVO: A extubação traqueal precoce após cirurgias favorece a evolução dos pacientes e reduz o tempo de internação em Unidade de Terapia Intensiva (UTI), reduzindo custos hospitalares. Em cirurgias de ressecção pulmonar, tradicionalmente o pós-operatório imediato é realizado em UTI com pacientes entubados. Nesse estudo avaliou-se prontuários de pacientes submetidos a toracotomia e estabeleceu-se correlação entre o momento da extubação, a evolução pós-operatória e a internação em UTI. MÉTODOS: Estudo tipo coorte retrospectivo de prontuários de 121 pacientes submetidos a cirurgias de ressecção pulmonar. Foram relacionados o tempo de internação em UTI e o momento da extubação traqueal. A evolução pós-operatória foi classificada em boa ou ruim de acordo com a ausência ou a presença de: infecções, problemas respiratórios (reintubação, broncospasmo, edema agudo de pulmão, necessidade de traqueostomia, atelectasias, fístulas), reabordagem por sangramento, óbito. Entre os grupos foram analisadas as condições pré-operatórias, classificação de estado físico anestésico (critério da American Society of Anesthesyologists - ASA), presença de comorbidades, avaliação funcional respiratória e duração do procedimento cirúrgico. Utilizou-se o risco relativo para avaliar o efeito do tempo de extubação na evolução pós-operatória dos pacientes. RESULTADOS: A distribuição dos pacientes quanto ao tempo de extubação foi: 81 por cento extubações imediatas, 15 por cento não imediatas e 4 por cento não-extubados. Em relação ao destino, 73 por cento foram encaminhados à UTI e 27 por cento à sala de recuperação anestésica. A incidência de comorbidades (hipertensão arterial, diabetes melito, distúrbio ventilatório restritivo ou obstrutivo e cardiopatias) entre o grupo extubado imediatamente e aquele com extubação não imediata foi de 37 por cento e 41,6 por cento, respectivamente. Quanto ao estado físico (ASA), observou-se: pacientes ASA 1 ou 2 - 62 por cento no ...

OBJECTIVE: Early tracheal extubation following surgical procedures favors clinical evolution of patients and reduces incidence and time of stay in the Intensive Care Unit (ICU), minimizing hospital costs. Immediate postoperative period of pulmonary resections often takes place in the ICU and patients are kept intubated. This study evaluated hospital records of patients submitted to thoracotomy and a correlation between extubation time, postoperative evolution and ICU stay was established. METHODS: Retrospective cohort study of records of 121 patients submitted to pulmonary parenchyma resection (not biopsies) was carried out. Stay in the ICU and time of tracheal extubation were related. Postoperative evolution was classified as good or bad according to occurrence of some of the following conditions: infections, respiratory disorders (reintubation, bronchospasm, acute pulmonary edema, need of tracheotomy, atelectasis, fistulae), re-operation due to bleeding and death. Among the two groups preoperative conditions, anesthetic physical status (American Society of Anesthesyologists - ASA criteria), presence of associated diseases, respiratory functional evaluation and duration of surgery were analyzed. Relative risk was used to evaluate effect of time of extubation (immediate or non-immediate) on the postoperative evolution of patients. RESULTS: Patient distribution related to extubation time was: 81 percent immediate extubation, 15 percent non-immediate extubation and 4 percent not extubated. Destination after surgery was: 73 percent ICU and 27 percent post-anesthetic recovery room. Incidence of associated diseases (arterial hypertension, diabetes, obstructive or restrictive pulmonary disease and cardiopaty) among the immediately extubated group and non-immediately extubated group was 37 percent and 41.6 percent, respectively. Related to ASA physical status: 62 percent ASA 1 or 2 in the immediately extubated group and 58.3 percent ASA 1 or ...