Five-year results from a phase I/II study of moderately hypofractionated intensity-modulated radiation therapy (IMRT) for localized prostate cancer including simultaneously integrated boost and pelvic lymph node (LN) coverage.

Authors

null

Anthony Ricco

Virginia Commonwealth University Massey Cancer Center, Department of Radiation Oncology, Richmond, VA

Anthony Ricco , Nitai Mukhopadhyay , Diane Holdford , Vicki Skinner , Siddharth Saraiya , Drew Moghanaki , Mitchell Steven Anscher , Michael G. Chang , Xiaoyan Deng

Organizations

Virginia Commonwealth University Massey Cancer Center, Department of Radiation Oncology, Richmond, VA, Virginia Commonwealth University Massey Cancer Center, Richmond, VA, McGuire Veterans Affairs Medical Center, Richmond, VA, University of Toledo Medical Center, Toledo, OH, U.S. Department of Veterans Affairs, Atlanta, GA, Virginia Commonwealth University Medical Center, Richmond, VA, Hunter Holmes McGuire VA Medical Center and Virginia Commonwealth University, Richmond, VA

Research Funding

U.S. National Institutes of Health
U.S. National Institutes of Health, Massey Cancer Center, and the Hunter-Holmes McGuire Veterans Administration Medical Center.

Background: This study reports the 5 year toxicity and efficacy data of a phase I/II trial of moderately hypofractionated intensity modulated radiation therapy (IMRT) for localized prostate cancer utilizing a simultaneous integrated boost and pelvic lymph node (LN) coverage. Methods: Men with localized prostate cancer were prospectively enrolled and received IMRT to the prostate +/- seminal vesicles (SVs) +/- LNs based on National Comprehensive Cancer Network (NCCN) guidelines. Low-risk (LR) patients received 69.6 Gy in 29 fractions to the prostate alone; intermediate-risk (IR) and high-risk (HR) patients received 72Gy to the prostate, 54Gy to the SVs, and 50.4Gy to LNs (if risk of LN involvement > 15% by the Roach formula) all in 30 fractions. IR and HR patients received androgen deprivation therapy. Results: Fifty-five patients were enrolled and 49 patients evaluable with a median follow up of 60 months. There were 11 (20%) LR, 23 (41.8%) IR, and 21 (38.2%) HR patients. Twenty-five patients (51%) received prostate and LN treatment. At 5 years, the cumulative incidence of late grade 2+ gastrointestinal (GI) and genitourinary (GU) toxicity was 22.6% and 38.2% respectively. Prevalence rates of late grade 2 GI toxicity at 1, 3, and 5 years was 5.8%, 3.9%, and 5.8% respectively. Late grade 2+ GI toxicities that did not resolve by 60 months included 3 out of 52 patients (5.8%). Prevalence rates of late grade 2 GU toxicity at 1, 3, and 5 years rates were 15.4%, 7.7%, and 13.5% respectively. There were 3 patients (5.8%) who experienced grade 3 GU toxicity and no grade 3 GI toxicities. The biochemical relapse free survival at 5 years for the cohort was 88.3%. There were no local, regional, or distant failures, with all patients still alive at last follow up. Conclusions: Moderate hypofractionation of localized prostate cancer utilizing a simultaneous integrated boost and LN coverage produces excellent biochemical control and acceptable acute/late toxicity. This phase I/II trial adds to maturing data with 5 year outcomes which justify its use for cost and patient convenience factors. Clinical trial information: NCT01117935

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Clinical Trial Registration Number

NCT01117935

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 299)

Abstract #

299

Poster Bd #

L5

Abstract Disclosures

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