Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01.
OBJECTIVE
To assess the benefit and toxicity and quality-of-life (QOL) outcomes of pelvic nodes irradiation in nonmetastatic prostate carcinoma patients.


METHODS
Between December 1998 and June 2004, 444 patients with T1b-T3, N0 pNx, M0 prostate carcinoma were randomly assigned to either pelvic and prostate radiotherapy or prostate radiotherapy only. Patients were stratified according to the prognostic factor of lymph node involvement (LNI). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for patients in the high-risk group. The pelvic dose was 46 Gy. The total dose recommended to the prostate was changed during the course of the study from 66 Gy to 70 Gy. Criteria for progression-free survival (PFS) included biologic prostate-specific antigen recurrences or a local or metastatic evolution. Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group and Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic scales, respectively. The QOL outcome was recorded with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, the International Prostatic Symptom Score, and the Sexual Function Index scales.


RESULTS
With a 42.1-month median follow-up time, the 5-year PFS and overall survival were similar in the two treatment arms for the whole series and for each stratified group. On multivariate analysis, low LNI risk and hormonal therapy were statistically associated with increased PFS. However, subgroup analyses based on these factors did not show any benefit for pelvic irradiation. There were no significant differences in acute and late digestive toxicities and in QOL outcomes.


CONCLUSIONS
Pelvic node irradiation was well tolerated but did not improve PFS.
Centre Léon Bérard, Department of Radiotherapy, Lyon, France. pommier@lyon.fnclcc.fr
Pascal
P
Pommier
Sylvie
S
Chabaud
Jean Leon
JL
Lagrange
Pierre
P
Richaud
François
F
Lesaunier
Elisabeth
E
Le Prise
Jean Philippe
JP
Wagner
Meng Huor
MH
Hay
Veronique
V
Beckendorf
Jean Philippe
JP
Suchaud
Pierre Marie
PM
Pabot du Chatelard
Valerie
V
Bernier
Nicolas
N
Voirin
David
D
Perol
Christian
C
Carrie
D000230:Adenocarcinoma / Q000473:pathology / Q000532:radiotherapy*; D000368:Aged; D018572:Disease-Free Survival; D006801:Humans; D008198:Lymph Nodes / Q000528:radiation effects; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects / Q000379:methods