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Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation.

ABSTRACT: BACKGROUND:We performed a prospective phase II study to compare acute toxicity among five different hypofractionated schedules using proton therapy. This study was an exploratory analysis to investigate the secondary end-point of biochemical failure-free survival (BCFFS) of patients with long-term follow-up. METHODS:Eighty-two patients with T1-3bN0M0 prostate cancer who had not received androgen-deprivation therapy were randomized to one of five arms: Arm 1, 60 cobalt gray equivalent (CGE)/20 fractions/5?weeks; Arm 2, 54 CGE/15 fractions/5?weeks; Arm 3, 47 CGE/10 fractions/5?weeks; Arm 4, 35 CGE/5 fractions/2.5?weeks; and Arm 5, 35 CGE/5 fractions/4?weeks. In the current exploratory analysis, these ardms were categorized into the moderate hypofractionated (MHF) group (52 patients in Arms 1-3) and the extreme hypofractionated (EHF) group (30 patients in Arms 4-5). RESULTS:At a median follow-up of 7.5?years (range, 1.3-9.6?years), 7-year BCFFS was 76.2% for the MHF group and 46.2% for the EHF group (p?=?0.005). The 7-year BCFFS of the MHF and EHF groups were 90.5 and 57.1% in the low-risk group (p?=?0.154); 83.5 and 42.9% in the intermediate risk group (p?=?0.018); and 41.7 and 40.0% in the high risk group (p?=?0.786), respectively. Biochemical failure tended to be a late event with a median time to occurrence of 5?years. Acute GU toxicities were more common in the MHF than the EHF group (85 vs. 57%, p?=?0.009), but late GI and GU toxicities did not differ between groups. CONCLUSIONS:Our results suggest that the efficacy of EHF is potentially inferior to that of MHF and that further studies are warranted, therefore, to confirm these findings. TRIAL REGISTRATION:This study is registered at ClinicalTrials.gov, no. NCT01709253 ; registered October 18, 2012; retrospectively registered).

SUBMITTER: Ha B

PROVIDER: S-EPMC6327508 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation.

Ha Boram B Cho Kwan Ho KH Lee Kang Hyun KH Joung Jae Young JY Kim Yeon-Joo YJ Lee Sung Uk SU Kim Hyunjung H Suh Yang-Gun YG Moon Sung Ho SH Lim Young Kyung YK Jeong Jong Hwi JH Kim Haksoo H Park Weon Seo WS Kim Sun Ho SH

Radiation oncology (London, England) 20190110 1

<h4>Background</h4>We performed a prospective phase II study to compare acute toxicity among five different hypofractionated schedules using proton therapy. This study was an exploratory analysis to investigate the secondary end-point of biochemical failure-free survival (BCFFS) of patients with long-term follow-up.<h4>Methods</h4>Eighty-two patients with T1-3bN0M0 prostate cancer who had not received androgen-deprivation therapy were randomized to one of five arms: Arm 1, 60 cobalt gray equival ...[more]

PMID: 30630500

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Project description:IntroductionThere has been an interest in studying the efficacy of extreme hypofractionation in low and intermediate risk prostate cancer utilising the low alpha/beta ratio of prostate. Its role in high-risk and node-positive prostate cancer, however, is unknown. We hypothesise that a five-fraction schedule of extreme hypofractionation will be non-inferior to a moderately hypofractionated regimen over 5 weeks in efficacy and will have acceptable toxicity and quality of life while reducing the cost implications during treatment.Methods and analysisThis is an ongoing, non-inferiority, multicentre, randomised trial (NCT03561961) of two schedules for National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate. The standard arm will be a schedule of 68 Gy/25# over 5 weeks while the test arm will be extremely hypofractionated radiotherapy with stereotactic body radiation therapy to 36.25 Gy/5# (7 to 10 days). The block randomisation will be stratified by nodal status (N0/N+), hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy) and centre. All patients will receive daily image-guided radiotherapy.The primary end point is 4-year biochemical failure free survival (BFFS). The power calculations assume 4-year BFFS of 80% in the moderate hypofractionation arm. With a 5% one-sided significance and 80% power, a total of 434 patients will be randomised to both arms equally (217 in each arm). The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure.DiscussionThe trial aims to establish a therapeutically efficacious and cost-efficient modality for high-risk and node-positive prostate cancer with an acceptable toxicity profile. Presently, this is the only trial evaluating and answering such a question in this cohort.Ethics and disseminationThe trial has been approved by IEC-III of Tata Memorial Centre, Mumbai.Trial registration numberRegistered with CTRI/2018/05/014054 (http://ctri.nic.in) on 24 May 2018.

Project description:PurposeTo assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer.Methods and materialsBetween 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models.ResultsA total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores.ConclusionsIn this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.

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Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation.

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Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation.

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