Radiotherapy and concurrent metronomic chemotherapy in hormone-refractory prostate carcinoma: a Phase I study.

AIM: To determine the maximum tolerated dose of hypofractionated radiotherapy (HFRT) plus concurrent metronomic chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

PATIENTS AND

METHODS

A Phase I clinical trial was performed with cohorts of three to six patients per group. Eligible patients had HRPC without distant metastases. The radiotherapy dose was escalated in a stepwise fashion as follows: 60, 65, and 70 Gy at levels 1, 2, and 3, respectively (25 fractions: levels 1-2, and 26 fractions: level 3).

RESULTS

Nine patients were enrolled. The radiotherapy dose was escalated from 60 to 70 Gy without any dose-limiting toxicity. The most common grade 1/2 toxicities were hematuria, dysuria, diarrhea and rectal-perirectal pain. The overall objective response rate was 9/9 (100%) (95% CI=66.4%-100%). The median time-to-progression was 19 months.

CONCLUSION

In the challenging setting of HRPC, HFRT up to 70 Gy with concurrent metronomic chemotherapy was well-tolerated and yielded encouraging disease control.