Four Cycles Versus Six Cycles of Docetaxel and Prednisone for The Treatment of High Volume Castrate Sensitive Metastatic Prostate Cancer

ABSTRACT

Background: Chemotherapy docetaxel improve survival rate of high volume castrate sensitive metastatic prostate cancer according to CHAARTED trial. The aim of our study is to compare the 2 years progression free survival rate, efficacy and toxicity of four cycles of docetaxel, prednisone & ADT versus six cycles of same regimen for mCSPC (high volume Castrate Sensitive Metastatic Prostate Cancer). Methods: We performed a prospective, Double arms, randomized clinical trial. The study carried out on 70 patients (35 in each arm) with high volume castrate sensitive metastatic prostate cancer (Metastatic prostate cancer i.e. involving bone metastases 4 or more at least one extra axial bone skeleton and/or visceral metastases). To evaluate the 2 years progression free survival (PFS), efficacy and toxicity of four cycles of docetaxel, prednisone &ADT versus six cycles of the same regimen for high volume castrate sensitive metastatic prostate cancer. Result: There is a statistically significant shorter PFS (months) in 4 cycles group (14.2 versus 21.4 months) than 6 cycles group with p value 0.0001.median PFS for 4 cycles group was 13 months (95% CI 10.2 – 15.8), Cox hazard proportional model showed that 6 cycles regimen reduced the hazard of relapse to 0.27 (95% CI 0.12- 0.57) compared to 4 cycles one with p values 0.001. Comparison of study groups in terms of adverse events and chemotherapy toxicity showed that there was no statistically significant difference between study groups in terms of prevalence of toxicity and side effects with p values >0.05 each. (N.B we use G1-2 vs. G3-4) Conclusion: The combination of standard ADT and six cycles of docetaxel resulted in significantly longer progression free survival than that with ADT and four cycles of decetaxel in men with hormone-sensitive metastatic prostate cancer. The clinical benefit at this early analysis was more pronounced among patients with a higher burden of disease.

FULL TEXT