Portal de Periódicos da CAPES

Long-term results of the Dutch randomized prostate cancer trial: Impact of dose-escalation on local, biochemical, clinical failure, and survival

2013; Elsevier BV; Volume: 110; Issue: 1 Linguagem: Inglês

10.1016/j.radonc.2013.09.026

1879-0887

Wilma D. Heemsbergen, Abrahim Al‐Mamgani, Annerie Slot, Michel F.H. Dielwart, Joos V. Lebesque,

Statistical Methods in Clinical Trials

Purpose Nowadays, advanced irradiation techniques make it possible to escalate safely the dose in prostate cancer. We studied the effect of a higher dose on tumor control in a randomized trial with a median follow-up of 110 months. Patients and methods Patients with T1b-T4N0 prostate cancer (n = 664) were randomized between 78 Gy and 68 Gy. Primary endpoint was biochemical and/or clinical failure (BCF) according to the American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines (3 consecutive rises), and to Phoenix (nadir plus 2 μg/L). Secondary endpoints were clinical failure (CF), local failure (LF), prostate cancer death (PCD), and overall survival (OS). Explorative subgroup analyses were performed. Results BCF rate (HR = 0.8; 20% less events) and LF rate (HR = 0.5; 50% less events) were significantly lower in the 78 Gy arm (p < 0.05). CF, PCD and OS were similar in both arms. A significant heterogeneity of treatment effect was found for PSA cutoffs between 7 and 10 μg/L. Conclusion We observed significantly less BCF and LF in the high-dose arm. This suggests improvement of the therapeutic ratio. However, we observed similar rates of CF and PCD at the current update. More follow-up is needed to investigate which patients benefit in terms of prolonged OS.