70 Gy Versus 80 Gy in Localized Prostate Cancer: 5-Year Results of GETUG 06 Randomized Trial;Prostate cancer; Dose escalation; Conformal radiotherapy; Randomized trial

Journal Article · Fri Jul 15 04:00:00 EDT 2011 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2010.03.049· OSTI ID:21587628

Beckendorf, Veronique ^[1]; Guerif, Stephane ^[2]; Le Prise, Elisabeth ^[3]; Cosset, Jean-Marc ^[4]; Bougnoux, Agnes ^[5]; Chauvet, Bruno ^[6]; Salem, Naji ^[7]; Chapet, Olivier ^[8]; Bourdain, Sylvain ^[9]; Bachaud, Jean-Marc ^[10]; Maingon, Philippe ^[11]; Hannoun-Levi, Jean-Michel ^[12]; Malissard, Luc ^[13]; Simon, Jean-Marc ^[14]; Pommier, Pascal ^[15]; Hay, Men ^[16]; Dubray, Bernard ^[17]; Lagrange, Jean-Leon ^[18]; Luporsi, Elisabeth ^[1]; Bey, Pierre ^[4]

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1. Centre Alexis Vautrin, Vandoeuvre les Nancy (France)
2. Centre Hospitalier Universitaire, Poitiers (France)
3. Centre Eugene Marquis, Rennes (France)
4. Institut Curie, Paris (France)
5. Hopital Bretonneau Tours (France)
6. Institut Sainte-Catherine, Avignon (France)
7. Institut Paoli-Calmette, Marseille (France)
8. Centre Hospitalier Lyon-Sud, Pierre-Benite (France)
9. Centre Rene Gauducheau, Saint Herblain (France)
10. Centre Claudius Regaud, Toulouse (France)
11. Centre George-Francois Leclerc, Dijon (France)
12. Centre Antoine Lacassagne, Nice (France)
13. La Chaussee Saint Victor (France)
14. Hopital de la Pitie-Salpetriere, Paris (France)
15. Centre Leon Berard, Lyon (France)
16. Centre Val D'Aurelle, Montpellier (France)
17. Centre Henri Becquerel, Rouen (France)
18. Hopital Henri-Mondor, Creteil (France)

Purpose: To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer. Patients and Methods: A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules. Results: The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms. Conclusion: High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity.

• OSTI ID: 21587628
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 4 Vol. 80; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ANDROGENS
ANDROSTANES
ANTIGENS
BLADDER
BODY
DIGESTIVE SYSTEM
DISEASES
DOSES
GASTROINTESTINAL TRACT
GLANDS
HORMONES
INTESTINES
LARGE INTESTINE
MALE GENITALS
MEDICINE
NEOPLASMS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANS
PROSTATE
RADIATION DOSES
RADIOLOGY
RADIOTHERAPY
RECTUM
STEROID HORMONES
STEROIDS
THERAPY
TOXICITY
URINARY TRACT