Effect of neoadjuvant epirubicin and total androgen blockade on complete pathological response in patients with clinical stage T3/T4 prostate cancer.
OBJECTIVE
Most patients with stage T3-T4 prostate cancer experience disease relapse despite radiation and/or hormonal therapy, and their management remains controversial. We investigated the feasibility of, and the pathological response induced by neoadjuvant chemo-hormonal treatment in men with clinical stage T3/T4.


METHODS
Fifteen patients underwent neoadjuvant therapy consisting of weekly intravenous infusions of epirubicin 30mg/m(2) and total androgen blockade (TAB) for three months before undergoing radical prostatectomy, after which all received locoregional conformal radiotherapy (66Gy) and then continued with TAB and three additional months of epirubicin.


RESULTS
After neoadjuvant therapy, PSA levels decreased in all 15 patients and became undetectable in two. None of the patients achieved a complete pathological response, but a 35-75% reduction in tumour size was observed in all cases, and all the patients were able to undergo successful prostatectomy. Pathological assessments of the surgical specimens revealed negative margins in 13 patients. After a median follow-up of 34 months (range 11-62), 14 patients (93%) are still clinically and biochemically disease free. No grade 3 or 4 complications occurred.


CONCLUSIONS
This study suggests that neoadjuvant treatment with epirubicin and TAB is feasible and well tolerated in patients with clinical stage T3-T4 prostate cancer.
Francini
G
G
Department of Human Pathology and Oncology, Medical Oncology Section, University of Siena, Policlinico Le Scotte, Viale Bracci 11, 53100 Siena, Italy. francini@unisi.it
Paolelli
L
L
Francini
E
E
Pascucci
A
A
Manganelli
A
A
Salvestrini
F
F
Petrioli
R
R
D000368:Aged; D000726:Androgen Antagonists / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011182:Postoperative Care / Q000379:methods; D011300:Preoperative Care / Q000379:methods; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy / Q000379:methods; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D018714:Radiotherapy, Adjuvant; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome
D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D015251:Epirubicin; D017430:Prostate-Specific Antigen