title: Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09.
abstract: PURPOSE To test the hypothesis that increasing radiation dose delivered to men with early-stage prostate cancer improves clinical outcomes. PATIENTS AND METHODS Men with T1b-T2b prostate cancer and prostate-specific antigen </= 15 ng/mL were randomly assigned to a total dose of either 70.2 Gray equivalents (GyE; conventional) or 79.2 GyE (high). No patient received androgen suppression therapy with radiation. Local failure (LF), biochemical failure (BF), and overall survival (OS) were outcomes. Results A total of 393 men were randomly assigned, and median follow-up was 8.9 years. Men receiving high-dose radiation therapy were significantly less likely to have LF, with a hazard ratio of 0.57. The 10-year American Society for Therapeutic Radiology and Oncology BF rates were 32.4% for conventional-dose and 16.7% for high-dose radiation therapy (P < .0001). This difference held when only those with low-risk disease (n = 227; 58% of total) were examined: 28.2% for conventional and 7.1% for high dose (P < .0001). There was a strong trend in the same direction for the intermediate-risk patients (n = 144; 37% of total; 42.1% v 30.4%, P = .06). Eleven percent of patients subsequently required androgen deprivation for recurrence after conventional dose compared with 6% after high dose (P = .047). There remains no difference in OS rates between the treatment arms (78.4% v 83.4%; P = .41). Two percent of patients in both arms experienced late grade >/= 3 genitourinary toxicity, and 1% of patients in the high-dose arm experienced late grade >/= 3 GI toxicity. CONCLUSION This randomized controlled trial shows superior long-term cancer control for men with localized prostate cancer receiving high-dose versus conventional-dose radiation. This was achieved without an increase in grade >/= 3 late urinary or rectal morbidity.
authors.affiliation: Department of Radiation Oncology, Cox 3, Massachusetts General Hospital, Boston MA 02114, USA. azietman@partners.org
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Zietman
authors.forename: Kyounghwa
authors.initials: K
authors.lastname: Bae
authors.forename: Jerry D
authors.initials: JD
authors.lastname: Slater
authors.forename: William U
authors.initials: WU
authors.lastname: Shipley
authors.forename: Jason A
authors.initials: JA
authors.lastname: Efstathiou
authors.forename: John J
authors.initials: JJ
authors.lastname: Coen
authors.forename: David A
authors.initials: DA
authors.lastname: Bush
authors.forename: Margie
authors.initials: M
authors.lastname: Lunt
authors.forename: Daphna Y
authors.initials: DY
authors.lastname: Spiegel
authors.forename: Rafi
authors.initials: R
authors.lastname: Skowronski
authors.forename: B Rodney
authors.initials: BR
authors.lastname: Jabola
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Rossi
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D000368:Aged; D000369:Aged, 80 and over; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods