Talcott JA, Rossi C, Shipley WU, Clark JA, Slater JD, Niemierko A, Zietman ALPatient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer. JAMA 303: 1046-1053

Center for Outcomes Research, MGH Cancer Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 03/2010; 303(11):1046-53. DOI: 10.1001/jama.2010.287
Source: PubMed


Increased radiation doses improve prostate cancer control but also increase toxicity to adjacent normal tissue. Proton radiation may attenuate adverse effects.
To determine long-term, patient-reported, dose-related toxicity.
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.
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.
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.
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.

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Available from: Andrzej Niemierko
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    • "Thus, critics argue this study has only compared high-dose versus low-dose. However, the data remain a randomized trial comparing proton dose escalation, and further studies must still show that outcome and toxicity are comparable with photon dose escalation [16]. Future study designs must aim at comparison of these highly advanced techniques in patients with prostate cancer [21]. "
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    ABSTRACT: A brainstorming and consensus meeting organized by the German Cancer Aid focused on modern treatment of prostate cancer and promising innovative techniques and research areas. Besides optimization of screening algorithms, molecular-based stratification and individually tailored treatment regimens will be the future of multimodal prostate cancer management. Effective interdisciplinary structures, including biobanking and data collection mechanisms are the basis for such developments.
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    • "Data on prior treatment of urinary retentive and obstructive symptoms, prostatitis, and co-morbidities that might impact tolerance of radiation therapy, such as diabetes (DM), hypertension (HTN), blood, cardiovascular (CD) and chronic obstructive pulmonary (COPD) disease, smoking history, and the use of anticoagulants were extracted from patient records and histories and reported previously [3], but reviewed and confirmed for this study. Median prostate volume estimated by transrectal ultrasound at the time of fiducial-marker placement was 36.6 cm3 (range, 11.3–135.0 "
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    ABSTRACT: Background. To assess genitourinary (GU) function and toxicity in patients treated with image-guided proton therapy (PT) for early- and intermediate-risk prostate cancer and to analyze the impact of pretreatment urinary obstructive symptoms on urinary function after PT. Material and methods. Two prospective trials accrued 171 prostate cancer patients from August 2006 to September 2007. Low-risk patients received 78 cobalt gray equivalent (CGE) in 39 fractions and intermediate-risk patients received 78–82 CGE. Median follow-up was five years. The International Prostate Symptom Score (IPSS) and GU toxicities (per CTCAE v3.0 and v4.0) were documented prospectively. Results. Five transient GU events were scored Gr 3 per CTCAE v4.0, for a cumulative late GU toxicity rate of 2.9% at five years. There were no Gr 4 or 5 events. On multivariate analysis (MVA), the only factor predictive of Gr 2 + GU toxicity was pretreatment GU symptom management (p = 0.0058). Patients with pretreatment IPSS of 15–25 had a decline (clinical improvement) in median IPSS from 18 before treatment to 10 at their 60-month follow-up. At last follow-up, 18 (54.5%) patients had a > 5-point decline, 14 (42.5%) remained stable, and two patients (3%) had a > 5-point rise (deterioration) in IPSS. Patients with IPSS < 15 had a stable median IPSS of 6 before treatment and at 60 months. Conclusion. Urologic toxicity at five years with image-guided PT has been uncommon and transient. Patients with pretreatment IPSS of < 15 had stable urinary function five years after PT, but patients with 15–25 showed substantial improvement (decline) in median IPSS, a finding not explained by initiation or dose adjustment of alpha blockers. This suggests that PT provides a minimally toxic and effective treatment for low and intermediate prostate cancer patients, including those with significant pretreatment GU dysfunction (IPSS 15–25).
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    • "No direct head - to - head comparison between the two has yet been done , although a multicenter randomised trial has recently been launched ( discussed below ) . Talcott et al ( 2010 ) did make comparisons between two separate , though contemporary , cohorts of patients treated with proton beam or either IMRT or 3 - D conformal therapy and found no overt differences . The principal concerns of patients , erectile dysfunction , voiding dysfunction , and rectal dysfunction , appear to occur with similar acceptably low frequency . "
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    ABSTRACT: Proton therapy is a promising, but costly, treatment for prostate cancer. Theoretical physical advantages exist; yet to date, it has been shown only to be comparably safe and effective when compared with the alternatives and not necessarily superior. If clinically meaningful benefits do exist for patients, more rigorous study will be needed to detect them and society will require this to justify the investment of time and money. New technical advances in proton beam delivery coupled with shortened overall treatment times and declining device costs have the potential to make this a more cost-effective therapy in the years ahead.
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