PMID- 30202801
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220321
IS  - 2452-1094 (Print)
IS  - 2452-1094 (Electronic)
IS  - 2452-1094 (Linking)
VI  - 3
IP  - 3
DP  - 2018 Jul-Sep
TI  - Initial toxicity, quality-of-life outcomes, and dosimetric impact in a randomized 
      phase 3 trial of hypofractionated versus standard fractionated proton therapy for 
      low-risk prostate cancer.
PG  - 322-330
LID - 10.1016/j.adro.2018.02.004 [doi]
AB  - PURPOSE: Randomized evidence for extreme hypofractionation in prostate cancer is 
      lacking. We aimed to identify differences in toxicity and quality-of-life 
      outcomes between standard fractionation and extreme hypofractionated radiation in 
      a phase 3 randomized trial. METHODS AND MATERIALS: We analyzed the results of the 
      first 75 patients in our phase 3 trial, comparing 38 Gy relative biologic 
      effectiveness (RBE) in 5 fractions (n = 46) versus 79.2 Gy RBE in 44 fractions 
      (n = 29). Patients received proton radiation using fiducials and daily image 
      guidance. We evaluated American Urological Association Symptom Index (AUASI), 
      adverse events (AEs), and Expanded Prostate Index Composite (EPIC) domains. The 
      primary endpoint of this interim analysis was the cumulative incidence of grade 2 
      (G2) or higher AEs. The randomized patient allocation scheme was a 2:1 ratio 
      favoring the 38 Gy RBE arm. RESULTS: The median follow-up was 36 months; 30% of 
      patients reached 48-month follow-up. AUASI scores differed <5 points (4.4 vs 8.6; 
      P = .002) at 1 year, favoring the 79.2 Gy arm. Differences in AUASI were not 
      significant at >/=18 months. EPIC urinary symptoms favored the 79.2 Gy arm at 1 
      year (92.3 vs 84.5; P = .009) and 18 months (92.3 vs 85.3; P = .03); bother 
      scores were not significant at other time points. Cumulative >/=G2 genitourinary 
      toxicity was similar between the 79.2 Gy and 38 Gy arms (34.5% vs 30.4%; 
      P = .80). We found no differences in the EPIC domains of bowel symptoms, sexual 
      symptoms, or bowel >/=G2 toxicities. Bladder V80 (79.2 Gy arm; P = .04) and V39 
      (38 Gy arm; P = .05) were predictive for cumulative G2 genitourinary AEs. 
      CONCLUSIONS: Low AE rates were seen in both study arms. Early temporary 
      differences in genitourinary scores disappeared over time. Bladder constraints 
      were associated with genitourinary AEs.
FAU - Vargas, Carlos E
AU  - Vargas CE
AD  - Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.
FAU - Schmidt, Matthew Q
AU  - Schmidt MQ
AD  - Creighton University School of Medicine, Phoenix, Arizona.
FAU - Niska, Joshua R
AU  - Niska JR
AD  - Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.
FAU - Hartsell, William F
AU  - Hartsell WF
AD  - Northwestern Medicine Chicago Proton Center, Warrenville, Illinois.
FAU - Keole, Sameer R
AU  - Keole SR
AD  - Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona.
FAU - Doh, Lucius
AU  - Doh L
AD  - Radiation Medicine Associates, PC Radiation Oncology, Oklahoma City, Oklahoma.
FAU - Chang, John Han-Chih
AU  - Chang JH
AD  - Northwestern Medicine Chicago Proton Center, Warrenville, Illinois.
FAU - Sinesi, Christopher
AU  - Sinesi C
AD  - Hampton University Proton Therapy Institute, Hampton, Virginia.
FAU - Rodriquez, Rossio
AU  - Rodriquez R
AD  - Proton Collaborative Group, Warrenville, Illinois.
FAU - Pankuch, Mark
AU  - Pankuch M
AD  - Northwestern Medicine Chicago Proton Center, Warrenville, Illinois.
FAU - Larson, Gary L
AU  - Larson GL
AD  - Radiation Medicine Associates, PC Radiation Oncology, Oklahoma City, Oklahoma.
LA  - eng
PT  - Journal Article
DEP - 20180223
PL  - United States
TA  - Adv Radiat Oncol
JT  - Advances in radiation oncology
JID - 101677247
PMC - PMC6128091
EDAT- 2018/09/12 06:00
MHDA- 2018/09/12 06:01
PMCR- 2018/02/23
CRDT- 2018/09/12 06:00
PHST- 2017/08/01 00:00 [received]
PHST- 2018/02/09 00:00 [revised]
PHST- 2018/02/13 00:00 [accepted]
PHST- 2018/09/12 06:00 [entrez]
PHST- 2018/09/12 06:00 [pubmed]
PHST- 2018/09/12 06:01 [medline]
PHST- 2018/02/23 00:00 [pmc-release]
AID - S2452-1094(18)30029-0 [pii]
AID - 10.1016/j.adro.2018.02.004 [doi]
PST - epublish
SO  - Adv Radiat Oncol. 2018 Feb 23;3(3):322-330. doi: 10.1016/j.adro.2018.02.004. 
      eCollection 2018 Jul-Sep.