Long-Term Outcomes of Dose-Escalated Pelvic Lymph Node Intensity-Modulated Radiation Therapy (IMRT) With a Simultaneous Hypofractionated Boost to the Prostate for Very High-Risk Adenocarcinoma of the Prostate: A Prospective Phase II Clinical Trial. Pract Radiat Oncol 2021;11(6):527-533
Date
04/14/2021Pubmed ID
33848618Pubmed Central ID
PMC8638529DOI
10.1016/j.prro.2021.03.006Scopus ID
2-s2.0-85107984420 (requires institutional sign-in at Scopus site) 6 CitationsAbstract
PURPOSE: There remains limited data as to the feasibility, safety, and efficacy of higher doses of elective radiation therapy to the pelvic lymph nodes in men with high-risk prostate cancer. We conducted a phase II study to evaluate moderate dose escalation to the pelvic lymph nodes using a simultaneous integrated boost to the prostate.
METHODS AND MATERIALS: Patients were eligible with biopsy-proven adenocarcinoma of the prostate, a calculated lymph node risk of at least 25%, Karnofsky performance scale ≥70, and no evidence of M1 disease. Acute and late toxicity were prospectively collected at each follow-up using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). The pelvic lymph nodes were treated to a dose of 56 Gy over 28 fractions with a simultaneous integrated boost to the prostate to a total dose of 70 Gy over 28 fractions using intensity-modulated radiation therapy.
RESULTS: Thirty patients were prospectively enrolled from October 2010 to August 2014. Median patient age was 70 years (57-83), pretreatment prostate-specific antigen was 11.5 ng/mL (3.23-111.5), T stage was T2c (T1c-T3b), and Gleason score was 9 (6-9). CTCAE v4.0 rate of any grade 1 or 2 genitourinary and gastrointestinal toxicity were 55% and 44%, respectively, and there was 1 reported acute grade 3 genitourinary and gastrointestinal toxicity, both unrelated to protocol therapy. With a median follow-up of 6.4 years, the biochemical failure free survival rate was 80.2%, and mean biochemical progression free survival was 8.3 years (95% confidence interval [CI], 7.2-9.4). The prostate cancer specific survival was 95.2%, and mean prostate cancer specific survival was 8.7 years (95% CI, 8.0-9.4). Five-year distant metastases free survival was 96%. Medians were not reached.
CONCLUSIONS: In this single arm, small, prospective feasibility study, nodal radiation therapy dose escalation was safe, feasible, and seemingly well tolerated. Rates of progression free survival are highly encouraging in this population of predominately National Comprehensive Cancer Network very high-risk patients.
Author List
Hall WA, Bedi M, Kilari D, Bylow KA, Burfeind J, Johnstone C, Siker M, Currey A, See WA, Nelson A, Johnson S, Straza M, Lawton CAFAuthors
John Burfeind MD Staff Physician in the Medicine department at Medical College of WisconsinKathryn A. Bylow MD Associate Professor in the Medicine department at Medical College of Wisconsin
William Adrian Hall MD Chair, Professor in the Radiation Oncology department at Medical College of Wisconsin
Scott C. Johnson MD Associate Professor in the Urology department at Medical College of Wisconsin
Candice A. Johnstone MPH, MD Vice-Chair, Professor in the Radiation Oncology department at Medical College of Wisconsin
Deepak Kilari MD Associate Professor in the Medicine department at Medical College of Wisconsin
Colleen A. Lawton MD Emeritus Professor in the Radiation Oncology department at Medical College of Wisconsin
Malika L. Siker MD Associate Dean, Professor in the Radiation Oncology department at Medical College of Wisconsin
Michael W. Straza PhD, MD Associate Professor in the Radiation Oncology department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
AdenocarcinomaAged
Aged, 80 and over
Humans
Lymph Nodes
Male
Middle Aged
Prospective Studies
Prostate
Prostatic Neoplasms
Radiotherapy, Intensity-Modulated
