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Acute and Late Toxicity After Dose Escalation to 82 GyE Using Conformal Proton Radiation for Localized Prostate Cancer: Initial Report of American College of Radiology Phase II Study 03-12
- Source :
- International Journal of Radiation Oncology*Biology*Physics. 81:1005-1009
- Publication Year :
- 2011
- Publisher :
- Elsevier BV, 2011.
-
Abstract
- Purpose Several randomized trials have shown a benefit of dose escalation to 78 to 79 Gy for men treated with external radiation for localized prostate cancer. Single-institution data suggest a benefit with even higher doses. American College of Radiology 03-12 is a Phase II trial testing the safety and efficacy of 82 GyE (Gray equivalent) delivered with conformal proton radiation. Methods and Materials From 2003–2006, 85 men with localized prostate cancer were accrued to American College of Radiology 03-12. Eighty-four were eligible for analysis. They were treated with conformal proton radiation alone to a total dose of 82 GyE. The study was designed to test whether the rate of 18-month Grade 3+ late toxicity was greater than 10%. Results The median follow-up was 31.6 months. Regarding treatment-related acute toxicity, there were 39 Grade 1 cases (46%), 19 Grade 2 cases (23%) and 2 Grade 3 cases (2%). Regarding genitourinary/gastrointestinal toxicity, there were 42 Grade 1 cases (50%), 12 Grade 2 cases (14%) and 1 Grade 3 case (1%). Regarding late toxicity, there were 28 Grade 1 cases (33%), 22 Grade 2 cases (26%), 6 Grade 3 cases (7%), and 1 Grade 4 case (1%). The late genitourinary/gastrointestinal rates were the same. The estimated rate of Grade 3+ late toxicity at 18 months was 6.08%. Conclusions Although not free of late toxicity, 82 GyE at 2 GyE per fraction delivered with conformal proton radiation did not exceed the late morbidity target tested in this trial. There was sufficient morbidity, however, that this may be the maximal dose that can be delivered safely with this technique and fractionation.
- Subjects :
- Adult
Male
Cancer Research
Dose-volume histogram
medicine.medical_specialty
Maximum Tolerated Dose
medicine.medical_treatment
Urogenital System
Phases of clinical research
Prostate cancer
Prostate
Proton Therapy
medicine
Humans
Radiology, Nuclear Medicine and imaging
Radiation Injuries
Proton therapy
Aged
Aged, 80 and over
Radiation
business.industry
Prostatic Neoplasms
Radiotherapy Dosage
Middle Aged
medicine.disease
United States
Acute toxicity
Gastrointestinal Tract
Radiation therapy
medicine.anatomical_structure
Oncology
Toxicity
Radiation Oncology
Radiology
Protons
Radiotherapy, Conformal
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 03603016
- Volume :
- 81
- Database :
- OpenAIRE
- Journal :
- International Journal of Radiation Oncology*Biology*Physics
- Accession number :
- edsair.doi.dedup.....a02bbb64bbfc0216ce39e5ad338bed6d