Cross-linked hyaluronan gel reduces the acute rectal toxicity of radiotherapy for prostate cancer.
OBJECTIVE
To prospectively analyze whether cross-linked hyaluronan gel reduces the mean rectal dose and acute rectal toxicity of radiotherapy for prostate cancer.


METHODS
Between September 2008 and March 2009, we transperitoneally injected 9 mL of cross-linked hyaluronan gel (Hylaform; Genzyme Corporation, Cambridge, MA) into the anterior perirectal fat of 10 early-stage prostate cancer patients to increase the separation between the prostate and rectum by 8 to 18 mm at the start of radiotherapy. Patients then underwent high-dose rate brachytherapy to 2,200 cGy followed by intensity-modulated radiation therapy to 5,040 cGy. We assessed acute rectal toxicity using the National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grading scheme.


RESULTS
Median follow-up was 3 months. The anteroposterior dimensions of Hylaform at the start and end of radiotherapy were 13 +/- 3mm (mean +/- SD) and 10 +/- 4mm, respectively. At the start of intensity-modulated radiation therapy, daily mean rectal doses were 73 +/- 13 cGy with Hylaform vs. 106 +/- 20 cGy without Hylaform (p = 0.005). There was a 0% incidence of National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 Grade 1, 2, or 3 acute diarrhea in 10 patients who received Hylaform vs. a 29.7% incidence (n = 71) in 239 historical controls who did not receive Hylaform (p = 0.04).


CONCLUSIONS
By increasing the separation between the prostate and rectum, Hylaform decreased the mean rectal dose. This led to a significant reduction in the acute rectal toxicity of radiotherapy for prostate cancer.
Wilder
Richard B
RB
Cancer Center of Irvine, Irvine, CA 92618, USA. richardbwilder@yahoo.com
Barme
Greg A
GA
Gilbert
Ronald F
RF
Holevas
Richard E
RE
Kobashi
Luis I
LI
Reed
Richard R
RR
Solomon
Ronald S
RS
Walter
Nancy L
NL
Chittenden
Lucy
L
Mesa
Albert V
AV
Agustin
Jeffrey
J
Lizarde
Jessica
J
Macedo
Jorge
J
Ravera
John
J
Tokita
Kenneth M
KM
D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000008:administration & dosage*; D001918:Brachytherapy / Q000009:adverse effects* / Q000379:methods; D003967:Diarrhea / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control*; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods; D012007:Rectum / Q000528:radiation effects*
D001672:Biocompatible Materials; C445362:hylan-B gel; D006820:Hyaluronic Acid