Nivolumab plus docetaxel in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer: results from the phase II CheckMate 9KD trial.

BACKGROUND: Docetaxel has immunostimulatory effects that may promote an immunoresponsive prostate tumour microenvironment, providing a rationale for combination with nivolumab (programmed death-1 inhibitor) for metastatic castration-resistant prostate cancer (mCRPC). METHODS: In the non-randomised, multicohort, global phase II CheckMate 9KD trial, 84 patients with chemotherapy-naive mCRPC, ongoing androgen deprivation therapy and ≤2 prior novel hormonal therapies (NHTs) received nivolumab 360 mg and docetaxel 75 mg/m2 every 3 weeks with prednisone 5 mg twice daily (≤10 cycles) and then nivolumab 480 mg every 4 weeks (≤2 years). The co-primary end-points were objective response rate (ORR) and prostate-specific antigen response rate (PSA50-RR; ≥50% decrease from baseline). RESULTS: The confirmed ORR (95% confidence interval [CI]) was 40.0% (25.7-55.7), and the confirmed PSA50-RR (95% CI) was 46.9% (35.7-58.3). The median (95% CI) radiographic progression-free survival (rPFS) and overall survival (OS) were 9.0 (8.0-11.6) and 18.2 (14.6-20.7) months, respectively. In subpopulations with versus without prior NHT, the ORR was 38.7% versus 42.9%, the PSA50-RR was 39.6% versus 60.7%, the median rPFS was 8.5 versus 12.0 months and the median OS was 16.2 months versus not reached. Homologous recombination deficiency status or tumour mutational burden did not appear to impact efficacy. The most common any-grade and grade 3-4 treatment-related adverse events were fatigue (39.3%) and neutropenia (16.7%), respectively. Three treatment-related deaths occurred (1 pneumonitis related to nivolumab; 2 pneumonias related to docetaxel). CONCLUSIONS: Nivolumab plus docetaxel has clinical activity in patients with chemotherapy-naïve mCRPC. Safety was consistent with the individual components. These results support further investigation in the ongoing phase III CheckMate 7DX trial. CLINICALTRIALS. GOV REGISTRATION: NCT03338790.

Recurrence rate of localized prostate cancer after radical prostatectomy according to D'amico risk classification in a tertiary referral hospital: association study.

OBJETIVO: Determinar la tasa de recurrencia del cáncer de próstata localizado después de la prostatectomía radical según la clasificación D'Amico. MÉTODOS: Estudio de cohorte retrospectivo comparativo de 5 años. Se obtuvieron datos de registros clínicos de pacientes con cáncer de próstata localizado, que se sometieron a prostatectomía radical y se evaluó la tasa de recurrencia de la enfermedad. Se analizó con pruebas estadísticas descriptivas y comparativas. Una p < 0.05 se consideró significativo. RESULTADOS: Se analizó 108 pacientes, la edad promedio 65.3 años. Acerca de la clasificación de riesgo de D'Amico, 33.33% de bajo riesgo, 55.56% riesgo intermedio y 11.11% alto riesgo. La tasa de recurrencia de APE fue 14,81%. Los pacientes de bajo riesgo tuvieron recurrencia del 13.89%, riesgo intermedio 18.33% y alto riesgo no tuvieron recurrencia. Sobre piezas quirúrgicas, el 25.93% presentaron características adversas. La escala de Gleason postoperatoria muestra un aumento de 44.44% en bajo riesgo, 26.67% en riesgo intermedio y 41.67% en alto riesgo. CONCLUSIONES: La prostatectomía radical ofrece un control adecuado del cáncer de próstata localizado. La tasa de recurrencia del APE fue menor que otros informes internacionales. Asimismo, la recurrencia bioquímica del riesgo bajo, intermedio y alto fue similar a la tendencia global. OBJECTIVE: The objective of the study was to determine the recurrence rate of localized prostate cancer after radical prostatectomy according to the D'Amico classification. METHODS: This was a observational and 5-year comparative retrospective cohort study. Data were obtained from clinical records of patients with localized prostate cancer who underwent radical prostatectomy and the recurrence rate of the disease was evaluated. It was analyzed with descriptive and comparative statistical tests, p<0.05 was considered significant. RESULTS: One hundred and eight patients were analyzed, and the average age was 65.3 years. About D'Amico's risk classification, 33.33% low risk, 55.56% intermediate risk, and 11.11% high risk. The prostate-specific antigen (PSA) recurrence rate was 14.81%. Low-risk patients had recurrence of 13.89%, intermediate risk 18.33%, and high risk had no recurrence. Regarding surgical pieces, 25.93% presented adverse characteristics. The post-operative Gleason scale shows an increase of 44.44% in low risk, 26.67% in intermediate risk, and 41.67% in high risk. CONCLUSIONS: Radical prostatectomy offers adequate control of localized prostate cancer. The PSA recurrence rate was lower than other international reports. Likewise, the biochemical recurrence of low, intermediate, and high risk was similar to the global trend.