By Marilynn Larkin
NEW YORK (Reuters Health) - 22/2/2019
Hypofractionated radiotherapy (HRT) should be a new practice standard for men with low-risk prostate cancer, based on a secondary analysis of a phase III trial.
"The NRG Oncology Group previously demonstrated that men with low-risk prostate cancer had similar 5-year disease-free survival of about 85% when treated with either conventional radiotherapy (CRT) of 73.8 Gy in 41 fractions over 8.2 weeks, or with HRT of 70 Gy in 28 fractions over 5.6 weeks," Dr. Deborah Bruner of Emory University in Atlanta told Reuters Health by email.
"However, late physician-reported side effects of mild bowel and bladder symptoms were increased in patients treated with HRT and raised questions whether the HRT arm is acceptable to patients," she noted.
"The current study asked patients directly about their bowel, bladder, sexual function, anxiety, depression and general quality of life using valid patient-reported questionnaires," she said. "Results showed that patients were unable to detect any difference in any of their symptoms or quality of life between treatments."
"The same level of survival with less radiation and no noticeable differences in patient-reported symptoms is of significant benefit to patients," she said.
Dr. Bruner and colleagues studied quality of life in 962 men (mean age, 66.6) with localized prostate cancer using the Expanded Prostate Index Composite questionnaire to assess bowel, urinary, sexual, and hormonal domains; the 25-item Hopkins Symptom Checklist to measure anxiety and depression; and the EuroQol-5 Dimension questionnaire to evaluate global quality of life.
All patients had biopsy-proven Gleason scores of 2 to 6, prostate-specific antigen levels below 10 ng/mL, and had not been treated previously for prostate cancer.
Data were collected at baseline and at six, 12, 24, and 60 months. Change scores were compared between HRT and CRT treatment arms. Clinical significance was determined for the Expanded Prostate Index Composite change scores by an effect size of 0.5.
As reported online February 14 in JAMA Oncology, no differences in change score were seen between arms with respect to any of the Expanded Prostate Index Composite questionnaire domain scores except at 12 months, when the HRT arm had a larger decline than the CRT arm in the bowel domain (mean score, −7.5 vs. −3.7); however, the difference was not clinically significant.
There were no differences between arms at any time point for the Hopkins Symptom Checklist or the EuroQol-5 Dimension questionnaire.
"This study provides evidence to affirm that HRT is a practice standard for men with low-risk prostate cancer," the authors conclude.
Dr. Bruner noted, "HRT decreases (more than) 2.6 weeks of treatment time and daily visits to the hospital, as well as a decrease in cost of approximately $7,700 per patient, just for the radiation treatments, excluding travel, parking, time off work and inconvenience."
"This study is a practice-changing tipping as it adds the patient perspective to similar published studies that provide evidence that HRT should be a clinical practice standard for treatment of men with low-risk prostate cancer who choose treatment over observation," she concluded.
Dr. Robert Wollman, medical director of radiation oncology at Providence Saint John's Health in Santa Monica, told Reuters Health, "Hypofractionated radiation is great for patients. We applied this to breast cancer about a decade ago when we moved from 6-7 weeks to 3-4 weeks."
"Now, men can enjoy the shorter schedule of radiation therapy with no loss of cure rates and no increase in side effects," he said by email. "Payers will love the savings as well."
"However," he stressed, "only early-stage, low-risk patients who do not need radiation therapy to the pelvic lymph nodes are eligible."
Dr. Alam Nisar Syed, a radiation oncologist at MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, California, also highlighted that patients at high risk and advanced stage cancer are not suitable for the approach.
Further, he said in an email to Reuters Health, "Hypofractionation treatments require advanced linear accelerators, CT simulators, '3 D' treatment planning, and proper patient positioning during each treatment. It needs experienced radiation oncologists, medical physicists, dosimetrists and technologists."
JAMA Oncol 2019.