Concurrent and adjuvant docetaxel with three-dimensional conformal radiation therapy plus androgen deprivation for high-risk prostate cancer: preliminary results of a multicentre phase II trial.
OBJECTIVE
We evaluate the feasibility of concomitant and adjuvant docetaxel combined with three-dimensional conformal radiotherapy (3D-CRT) and androgen deprivation in high-risk prostate carcinomas.


METHODS
Fifty men with high-risk localized prostate cancer (16), locally advanced (28) or very high-risk prostate cancer (6) were included. Seventy Gy were delivered on prostate and seminal vesicles in 35 fractions, concurrently with weekly docetaxel (20mg/m(2)). Three weeks after the completion of 3D-CRT, docetaxel was given for 3 cycles (60mg/m(2)), every 3 weeks. Patients had to receive LHRH agonist during 3 years.


RESULTS
The intent to treat analysis shows that four patients out of 15 stopped prematurely the chemotherapy due to grade 3-4 acute toxicity. In the per protocol analysis, 46 patients completed a full-dose chemoradiation regimen representing 413 cycles: five patients experienced a grade 3 toxicity, and 15 patients experienced a grade 2 toxicity. With a median follow-up of 54 months, the 5-year clinical disease-free survival was 66.72% and the 5-year survival was 92.15%.


CONCLUSIONS
3D-CRT with androgen deprivation and concurrent weekly docetaxel, followed by three cycles of adjuvant docetaxel may be considered as feasible in high-risk prostate cancer and deserved to be evaluated in a phase III randomized trial.
Bolla
Michel
M
Department of Oncology-Radiotherapy, Centre Hospitalier Universitaire, Grenoble, France. Michel.bolla@ujf-grenoble.fr
Hannoun-Levi
Jean Michel
JM
Ferrero
Jean-Marc
JM
Maingon
Philippe
P
Buffet-Miny
Joëlle
J
Bougnoux
Agnès
A
Bauer
Jacques
J
Descotes
Jean-Luc
JL
Fourneret
Philippe
P
Jover
Florence
F
Colonna
Marc
M
D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D018714:Radiotherapy, Adjuvant; D020266:Radiotherapy, Conformal; D012307:Risk Factors; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel