The new combination docetaxel, prednisone and curcumin in patients with castration-resistant prostate cancer: a pilot phase II study
Oncology. 2016;90(2):69–78. doi:10.1159/000441148.
Combination therapy can be defined as the treatment for a disease with two or more drugs aiming to attain higher efficacy even at reduced doses or lower toxicity drugs, chemo-sensitize the cancer cells which render other compounds more potent, to gain additive or synergistic effects, and to reduce the chances of acquired resistance against standard chemotherapy. Curcumin is one such natural component, studied with other anticancer agents, with the potential to improve the quality of the treatment and to reduce the risk of side effects.
The phase II study was the extension of the previous phase I trial, aiming to study the efficacy and safety of docetaxel/curcumin combination in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (CRPC).
Thirty patients with progressing CRPC and a rising prostate-specific antigen (PSA) received docetaxel/prednisone in standard conditions for 6 cycles in combination with per orally supplemented curcumin, 6,000 mg/day (day -4 to day +2 of docetaxel regime). The co-primary endpoint was the overall response rate determined by PSA and target assessments. An ancillary study assessed the service values of chromogranin A (CgA) and neuron-specific enolase (NSE).
- Twenty-six patients received the scheduled treatment, 2 progressed and 2 died before the end of treatment.
- Prostate-specific antigen response was observed in 59% of patients (14% of PSA normalization) and achieved within the first three cycles for 88% of responders. Partial response was reached for 40% of evaluable patients.
- The curcumin/docetaxel regimen was well tolerated, and no adverse event was attributed to curcumin.
- Twenty patients were 100% curcumin compliant.
This study produced additional data on curcumin as a treatment for cancer, with a high response rate, good tolerability, and patient acceptability, justifying the interest to conduct a randomized trial.