Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial.

Autor:	Mariados NF; Cancer Care of Western New York, Buffalo, New York., Orio PF 3rd; Brigham and Women's Hospital, Boston, Massachusetts.; Dana Farber Cancer Institute, Boston, Massachusetts., Schiffman Z; Houston Metro Urology, Houston, Texas., Van TJ; Houston Metro Urology, Houston, Texas., Engelman A; Florida Urology Partners, Tampa, Florida., Nurani R; Western Radiation Oncology, Campbell, California.; Interventional Radiation Oncology of California, Campbell., Kurtzman SM; Western Radiation Oncology, Campbell, California., Lopez E; Vithas La Milagrosa Hospital, Calle de Modesto Lafuente, Madrid, Spain., Chao M; Ringwood Private Hospital, East Victoria, Australia., Boike TP; GenesisCare, Troy, Michigan., Martinez AA; GenesisCare, Troy, Michigan., Gejerman G; New Jersey Urology, Saddle Brook, New Jersey., Lederer J; The Cancer Center of Hawaii, Honolulu., Sylvester JE; GenesisCare, Lakewood Ranch, Florida., Bell G; Austin Cancer Center, Austin, Texas., Rivera D; Austin Cancer Center, Austin, Texas., Shore N; Carolina Urologic Research Center, Myrtle Beach, South Carolina., Miller K; M Squared Associates, New York, New York., Sinayuk B; Rhode Island Medical Imaging, Warwick, Rhode Island., Steinberg ML; University of California, Los Angeles., Low DA; University of California, Los Angeles., Kishan AU; University of California, Los Angeles., King MT; Brigham and Women's Hospital, Boston, Massachusetts.; Dana Farber Cancer Institute, Boston, Massachusetts.
Jazyk:	angličtina
Zdroj:	JAMA oncology [JAMA Oncol] 2023 Apr 01; Vol. 9 (4), pp. 511-518.
DOI:	10.1001/jamaoncol.2022.7592
Abstrakt:	Importance: Hypofractionated radiation therapy (RT) for prostate cancer has been associated with greater acute grade 2 gastrointestinal (GI) toxic effects compared with conventionally fractionated RT. Objective: To evaluate whether a hyaluronic acid rectal spacer could (1) improve rectal dosimetry and (2) affect acute grade 2 or higher GI toxic effects for hypofractionated RT. Design, Setting, and Participants: This randomized clinical trial was conducted from March 2020 to June 2021 among 12 centers within the US, Australia, and Spain, with a 6-month follow-up. Adult patients with biopsy-proven, T1 to T2 prostate cancer with a Gleason score 7 or less and prostate-specific antigen level of 20 ng/mL or less (to convert to μg/L, multiply by 1) were blinded to the treatment arms. Of the 260 consented patients, 201 patients (77.3%) were randomized (2:1) to the presence or absence of the spacer. Patients were stratified by intended 4-month androgen deprivation therapy use and erectile quality. Main Outcomes and Measures: For the primary outcome, we hypothesized that more than 70% of patients in the spacer group would achieve a 25% or greater reduction in the rectal volume receiving 54 Gy (V54). For the secondary outcome, we hypothesized that the spacer group would have noninferior acute (within 3 months) grade 2 or higher GI toxic effects compared with the control group, with a margin of 10%. Results: Of the 201 randomized patients, 8 (4.0%) were Asian, 26 (12.9%) Black, 42 (20.9%) Hispanic or Latino, and 153 (76.1%) White; the mean (SD) age for the spacer group was 68.6 (7.2) years and 68.4 (7.3) years for the control group. For the primary outcome, 131 of 133 (98.5%; 95% CI, 94.7%-99.8%) patients in the spacer group experienced a 25% or greater reduction in rectum V54, which was greater than the minimally acceptable 70% (P < .001). The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) in the control group experienced acute grade 2 or higher GI toxic effects (difference, -10.9%; 95% 1-sided upper confidence limit, -3.5; P = .01). Conclusions and Relevance: The trial results suggest that rectal spacing with hyaluronic acid improved rectal dosimetry and reduced acute grade 2 or higher GI toxic effects. Rectal spacing should potentially be considered for minimizing the risk of acute grade 2 or higher toxic effects for hypofractionated RT. Trial Registration: ClinicalTrials.gov Identifier: NCT04189913.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu