Archive for month: August, 2020

Proton therapy, a type of external beam radiation therapy, is a safe and effective treatment for prostate cancer, according to two new studies.
In the first study, researchers at the University of Florida in Jacksonville, Fla., prospectively studied 211 men with low-, intermediate-, and high-risk prostate cancer. The men were treated with proton therapy, a specialised type of external beam radiation therapy that uses protons instead of X-rays. After a two year follow-up, the research team led by Nancy Mendenhall, MD, of the University of Florida Proton Therapy Institute, reported that the treatment was effective and that the gastrointestinal and genitourinary side effects were generally minimal.
‘This study is important because it will help set normal tissue guidelines in future trials,’ Dr. Mendenhall, said.
In the second study, researchers from Massachusetts General Hospital in Boston, Loma Linda University Medical Center in Loma Linda, Calif., and the Radiation Therapy Oncology Group in Philadelphia performed a case-matched analysis comparing high-dose external beam radiation therapy using a combination of photons (X-rays) and protons with brachytherapy (radioactive seed implants).
Over three years, 196 patients received the external beam treatments. Their data was compared to 203 men of similar stages who received brachytherapy over the same time period. Researchers then compared the biochemical failure rates (a statistical measure of whether the cancer relapses) and determined that men who received the proton/photon therapy had the same rate of recurrence as the men who received brachytherapy.
‘For men with prostate cancer, brachytherapy and external beam radiation therapy using photons and protons are both highly effective treatments with similar relapse rates,’ John J. Coen, MD, a radiation oncologist at Massachusetts General Hospital in Boston, said. ‘Based on this data, it is our belief that men with prostate cancer can reasonably choose either treatment for localised prostate cancer based on their own concerns about quality of life without fearing they are compromising their chance for a cure.’ EurekAlert

Abiraterone has been approved since September 2011 for men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel. In an early benefit assessment pursuant to the ‘Act on the Reform of the Market for Medicinal Products’ (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.
IQWiG finds an indication of a considerable added benefit of abiraterone in patients who are not eligible for further treatment with docetaxel. In contrast, an added benefit is not proven in patients who can still be treated with docetaxel, as the dossier submitted by the drug manufacturer provides inadequate information for this group of patients.
In accordance with the specifications of the Federal Joint Committee (G-BA), IQWiG separately assessed abiraterone in two groups of patients. The G-BA has specified different appropriate comparator therapies for the two groups.
The ‘best supportive care population’ contains patients who are not eligible for further treatment with docetaxel. The appropriate comparator therapy for this group is palliative treatment with dexamethasone, prednisone, prednisolone or methylprednisolone, as well as ‘best supportive care’.
‘Best supportive care’ means the therapy that provides the patient with the best possible individually optimised supportive treatment to alleviate symptoms (e.g. adequate pain therapy) and improve quality of life.
The ‘docetaxel-retherapy population’ comprises patients who are still eligible for further treatment with docetaxel. The appropriate comparator therapy for this patient population is docetaxel in combination with prednisone or prednisolone.
Indication of increase in survival and delay in consequences of disease
One study (COU-AA-301), which considers patient-relevant outcomes and provides relevant data, was included in the assessment of added benefit in the ‘best supportive care population’. This study compared treatment with abiraterone versus placebo, in each case combined with prednisone and ‘best supportive care’.
IQWiG finds an indication of an added benefit in patients treated with abiraterone: the above study provides indications that abiraterone can prolong survival and delay consequences of prostate cancer, such as fractures or operations due to bone metastases. In addition, the ‘time to pain progression’ was prolonged in study participants receiving abiraterone.
IQWiG classifies the extent of this added benefit as ‘considerable’. The corresponding legal ordinance has specified three grades to determine the extent of added benefit: ‘minor’, ‘considerable’ and ‘major’.
The study data presented on health-related quality of life assessments cannot be used; an added benefit of abiraterone is therefore not proven for this outcome.
The indications of advantages for abiraterone are not accompanied by proof of greater harm. Institute for Quality and Efficiency in Health Care