Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer.
BACKGROUND
Increased radiation doses improve prostate cancer control but also increase toxicity to adjacent normal tissue. Proton radiation may attenuate adverse effects.


OBJECTIVE
To determine long-term, patient-reported, dose-related toxicity.


METHODS
We performed a post hoc cross-sectional survey of surviving participants in the Proton Radiation Oncology Group (PROG) 9509--a randomized trial comparing 70.2 Gy vs 79.2 Gy of combined photon and proton radiation for 393 men with clinically localized prostate cancer (stage T1b-T2b, prostate-specific antigen <15 ng/mL, and no radiographic evidence of metastasis). The estimated 10-year biochemical progression rate for patients receiving standard dose was 32% (95% confidence interval, 26%-39%) compared with 17% (95% confidence interval, 11%-23%) for patients receiving high dose (P < .001). We surveyed 280 of the surviving 337 patients (83%) from April 2007 to September 2008.


METHODS
Prostate Cancer Symptom Indices, a validated measure of urinary incontinence, urinary obstruction and irritation, bowel problems, and sexual dysfunction, and related quality-of-life instruments.


RESULTS
At a median of 9.4 years after treatment (range, 7.4-12.1 years), participants' demographic and clinical characteristics were similar. Patient-reported outcomes were reported as mean (SD) scale score for standard dose vs high dose: urinary obstruction/irritation (23.3 [13.7] vs 24.6 [14.0]; P = .36), urinary incontinence (10.6 [17.7] vs 9.7 [15.8]; P = .99), bowel problems (7.7 [7.8] vs 7.9 [9.1]; P = .70), sexual dysfunction (68.2 [34.6] vs 65.9 [34.7]; P = .65), and most other outcomes were also similar, although patients receiving standard dose whose cancers had more often progressed expressed less confidence that their cancers were under control (mean [SD] scale score for standard dose, 76.0 [25.4] vs high dose, 86.2 [17.9]; P < .001). Many patients characterized their urinary and bowel function as normal despite reporting symptoms that, for other prostate cancer patients before and early after cancer treatment, caused substantial distress.


CONCLUSIONS
Among men with clinically localized prostate cancer, treatment with higher-dose radiation compared with standard dose was not associated with an increase in patient-reported prostate cancer symptoms after a median of 9.4 years.
Talcott
James A
JA
Center for Outcomes Research, MGH Cancer Center, Massachusetts General Hospital, Boston, Massachusetts, USA. jtalcott@partners.org
Rossi
Carl
C
Shipley
William U
WU
Clark
Jack A
JA
Slater
Jerry D
JD
Niemierko
Andrzej
A
Zietman
Anthony L
AL
D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D003625:Data Collection; D004307:Dose-Response Relationship, Radiation; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D061766:Proton Therapy; D011832:Radiation Injuries / Q000453:epidemiology*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D011522:Protons
D011522:Protons