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A Prospective Multi-Institutional Phase I/II Trial of Step-Wise Dose-per-Fraction Escalation in Low and Intermediate
Mark A Ritter1, Patrick A Kupelian2, Daniel G Petereit3
1Department of Human Oncology, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.
Practical Radiation Oncology
|March 15, 2020
Summary
Hypofractionated radiation therapy (HPFX) up to 4.3 Gy per fraction shows excellent outcomes for localized prostate cancer. This approach offers a shorter treatment schedule, potentially benefiting patients seeking alternatives to conventional radiation therapy.
Area of Science:
- Radiation Oncology
- Prostate Cancer Treatment
- Clinical Trials
Background:
- Conventional radiation therapy for prostate cancer involves prolonged treatment schedules.
- Hypofractionation (HPFX) offers a potentially shorter alternative.
- Exploring higher fraction sizes in HPFX is crucial for optimizing treatment.
Purpose of the Study:
- To evaluate the safety and effectiveness of stepwise increasing hypofractionation (HPFX) radiation therapy regimens.
- To assess tolerance and efficacy of fraction sizes up to 4.3 Gy in localized prostate cancer.
- To compare biochemical control and toxicity across different HPFX schedules.
Main Methods:
- Phase I/II multi-institutional trial with 347 patients.
- Sequential HPFX levels delivering 2.94 Gy, 3.63 Gy, and 4.3 Gy per fraction.
- Primary endpoints: biochemical control and toxicity (GI/GU).
- Median follow-up of 83.2 months.
Main Results:
- Excellent 8-year biochemical control rates (88.5%-92.7%) across HPFX levels.
- Gastrointestinal (GI) and genitourinary (GU) toxicities were acceptable and similar between groups.
- Cumulative incidence of grade 2+ GI and GU toxicities at 7 years were 16.3% and 22.1%, respectively.
Conclusions:
- HPFX with fraction sizes of 3.6-4.3 Gy/fraction achieves excellent oncologic outcomes in prostate cancer.
- These schedules provide a viable option for patients desiring shorter treatment durations.
- HPFX represents a valuable alternative to conventional fractionated radiation therapy.
