Cyclin-dependent kinase 4/6 inhibitors as first-line treatment for post-menopausal metastatic hormone receptor-positive breast cancer patients: a systematic review and meta-analysis of phase III randomized clinical trials.

BACKGROUND: To compare the efficacy and toxicity of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and nonsteroidal aromatase inhibitors (AI) versus AI alone as first-line therapy for patients with advanced hormone receptor-positive breast cancer. MATERIALS AND METHODS: Phase III randomized clinical trials (RCT) were identified after a systematic review of electronic databases. A random-effect model was used to determine the pooled hazard ratio (HR) for progression-free survival (PFS) using the inverse-variance method. The Mantel-Haenszel method was used to calculate the pooled odds ratio (OR) for overall response, clinical benefit rate and treatment-related side effects. Heterogeneity was measured using the tau-squared and I2 statistics. RESULTS: After a systematic search, three phase III RCT (n = 1827) were included. The use of CDK 4/6 inhibitors (abemaciclib, palbociclib, and ribociclib) in combination with an AI was significantly associated with longer PFS compared to the use of letrozole or anastrozole alone (HR: 0.57; 95% CI 0.50-0.65; p < 0.00001), with no significant heterogeneity among trials. Similarly, overall response rate and clinical benefit rate were higher for patients who received the combination therapy than for patients allocated to AI alone. Grade 3 or higher treatment-related side effects were more frequently reported for patients who received CDK 4/6 inhibitors (OR: 7.51; 95% CI 6.01-9.38; p < 0.00001), these included mainly neutropenia, leukopenia and anemia. CONCLUSION: The addition of CDK 4/6 inhibitors (either abemaciclib, palbociclib, or ribociclib) to an AI (anastrozole or letrozole) significantly improved PFS, overall response rate, and clinical benefit rate in comparison with a nonsteroidal AI alone.

Nutritional status and body composition are already affected before oncology treatment in ovarian cancer.

Poor nutritional status is a common problem among ovarian cancer patients. In order to detect changes in nutritional status and body composition this study investigates anthropometrical and biochemical parameters among these patients. This study included women with ovarian cancer and woman without cancer. Body composition was assessed by bioelectrical impedance analysis (BIA), anthropometrically, and with DXA scan, and total serum protein, albumin, transferrin, hemoglobin, hematocrit levels and total lymphocyte count was also measured. Data from DXA scan and body composition as assessed by BIA was collected from thirty-one women. Student t-test was used to compare differences in means between groups. This study included 120 women, 57 with ovarian cancer and 63 with benign tumors. Both groups of women were overweight. Body fat by skin-fold thickness, arm circumference, serum albumin, total lymphocytes count, as well as transferrin levels were significantly lower in the ovarian cancer group (p<0.05). Ovarian cancer women had lower fat reserves by skin-fold thickness and lower serum proteins even though they were overweight. However, further studies need to use a body composition assessment on all subjects to confirm these results.

Diferencias en parámetros nutricionales: pacientes con tumor de ovario maligno vs. benigno / Differences in parameters nutritional in patients with malignant ovarian tumor vs. bening tumor

Determinar diferencias en los marcadores del estado de nutrición entre pacientes con diagnóstico de tumor de ovario de acuerdo a su estirpe (benigno o maligno), a manera de sugerir una prueba diagnóstica previa al estudio histopatológico. Se realizó un estudio transversal en él, se evaluó la antropométrica: peso, talla, pliegues cutáneos, y funcional con escala de Karnofsky, bioquímicamente (albúmina, transferrina, proteínas totales, hemoglobina, hematocrito, cuenta linfocitaria total, así como el CA-125 a pacientes con diagnóstico de tumor de ovario. El análisis histopatológico,las pacientes se clasificaron acuerdo a la estirpe tumoral, con el objetivo de comparar los resultados entre ambos grupos (U de Mann-Whitney). Se evaluaron 58 pacientes: 35 de estirpe benigna, 23 maligna. Se obtuvieron diferencias significativas en: albúmina, transferrina y el CA-125. Para estos indicadores se realizaron curvas ROC, donde se encontró (con una sensibilidad mayor de 80 por ciento la posibilidad de asociar la transferrina a la malignidad del tumor. La paciente con tumor de ovario maligno presenta una mayor tendencia a la desnutrición a comparación con pacientes cuya estirpe es benigna. La composición corporal no es significativa en este estudio, pero se recomienda utilizar métodos más fidedignos como el DEXA). No fue posible determinar una prueba diagnóstica, sin embargo, se muestra evidencia de que existen marcadores bioquímicos asociados a la malignidad tumoral.

To determine the nutritional status differences between the patients with ovarian tumor diagnosis, according to their stripes malignancy in benign or malign, in order to suggest a diagnostic test previous to the histopathology study. We conducted a transversal study in which we evaluated patients with ovarian tumor diagnosis by an anthropometric form: Weight, height, skin folds, and the functional (Karnofsky scale), also the biochemical: Albumin, transferrin, total protein, hemoglobine, hematocrite, total lymphocyte count and the CA-125. After the histopathology analysis, the patients were classified according to their tumor’s malignancy, in order to compare the results between the two groups with a Mann-Whitney U test. We assessed 58 patients: 35 with benign tumor, and 23 malignant. We found significant differences in albumin, transferrin and the tumor marker CA-125. For these indicators, we constructed the ROC curves, and finding (with a specificity mayor of 80 per cent) the possibility of associating the transferrin to the tumors’ malignancy. The patients with a malignant ovarian tumor present an increased tendency to the malnutrition, comparing with patients whose tumor is benign. The body composition wasn’t significant in this study’s results, but we recommend using more accurate methods how the DEXA. No diagnostic test was determined, but we found an evidence of the biochemical markers associated to the malignancy of the tumor.