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Long-Term Complications with Prostate Implants: Iodine-125 vs. Palladium-103, Richard E. Peschel, MD, PhD, Zhe Chen, PhD, Kenneth Roberts, MD, and Ravinder Nath, PhD. Radiation Oncology Investigations, 1999;7(5):278-288.
| Type of Study |
To compare long-term complications resulting from brachytherapy with iodine-125 (I-125) and palladium-103 (Pd-103) (using the TheraSeed® device). Complications studied included urethral stricture, urethritis, cystitis, prostatitis, proctitis, urinary retention, hematuria, rectal fissure, rectal ulcer or fistula and severe pain. Sexual potency and urinary incontinence were not evaluated. In addition, authors conducted a literature review. |
| Purpose |
To compare clinical data with radiobiology predictions and determine future research directions for prostate implants. |
| Issue |
How do palladium-103 (Pd-103) implants compare to iodine-125
(I-125) implants?
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| Number of Patients |
123 |
| Type of Patients |
Early stage T1c – T2 prostate cancer. In general, those with:
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Gleason scores of 3-7 received brachytherapy with I-125. |
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Gleason scores of 5-9 received brachytherapy with Pd-103. |
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Some patients also had hormonal therapy. |
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| Length of Time
Patients Were Followed |
From nine months to seven years. |
| Results and/or
Conclusions |
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“No patient with a Pd-103 implant has had a long-term complication.” |
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Overall, 13 percent of patients undergoing brachytherapy with I-125 experienced complications and 9% were long-term. |
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Authors noted, “This study must be considered preliminary in nature.” |
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This Yale University study compared the long-term complications produced by prostate implants composed of I-125 and Pd-103. The authors noted the "biologically effective dose" (BED) for normal tissues of Pd-103 is lower than that of I-125, suggesting the lower BED should be associated with lower long-term complication rates than iodine-based brachytherapy.
“Most patients develop short-term urinary irritative or obstructive symptoms within the first 1-2 half-lives following IMP (ultrasound-guided transperineal prostate implant therapy). Generally, these are transient, mild effects which resolve spontaneously or require minor intervention with medication or catheterization.2,6 These short-term effects are caused by the edema or swelling in the prostate during the initial rapid build-up of the dose to the prostate during the first two half-lives of the IMP.”
Of 123 prostate cancer patients implanted, 41 were treated with Pd-103 (using the TheraSeed® device) brachytherapy and 82 received iodine-based implants. The article reported a "significantly lower overall complication rate” with Pd-103. The complication rate was 0% for Pd-103 and 13% for I-125. Most important, the study indicated, was the comparison of the most serious complications. Of I-125 patients, 6% experienced grade III or grade IV complications, defined as "distressing symptoms altering lifestyle and requiring minor surgical intervention or hospitalization” (grade III) and "major symptoms requiring major surgical intervention or prolonged hospitalization” (grade IV). No Pd-103 patients experienced these complications.
In addition, research demonstrated the three-year probability of remaining free of long-term complications was 100% with Pd-103 as compared to 82% with I-125. “Our own clinical data from Yale suggests that there may be a significantly lower complication rate from Pd-103 vs. I-125,” the article stated. The report also noted that a literature review of 992 patients receiving I-125 implants and 540 patients with Pd-103 implants revealed a consistently lower complication rate for those with Pd-103.
[2] Blasko JC, Grimm PD, Ragde H, Schumacher D. Implant Therapy for Localized Prostate Cancer. In: Ernstoff MS, Heaney JA, Peschel RE, editors, Prostate Cancer. Cambridge, Massachusetts and Oxford, England: Blackwell Science; 1998; p 137-155.
[6] Kaye KW, Olson DJ, Payne JT. Detailed Preliminary Analysis of Iodine-125 Implantation for Localized Prostate Cancer using Percutaneous Approach. J. Urol 1995; 153: 1020-1025.
Principal Investigator: Richard E. Peschel, M.D., Yale University School of Medicine, New Haven, Conn.
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