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

A six-year collaboration between two faculty members at the Miller School of Medicine

Respiratory movement during radiotherapy makes it difficult to hit the right treatment target and this in turn can lead to an under-dose of radiation to the tumour, or a potentially toxic over-dose to the surrounding healthy tissue. Getting this right is a real challenge for the radiotherapist, but new techniques are helping to deliver the correct dose to the right place.
Dr. Amira Ziou

The use of symptom indices to identify patients with symptoms associated with ovarian cancer who may need further screening is increasing in both the UK and the US in an attempt to promote earlier diagnosis, but they may need to be reassessed in order to help better detect cancer.
Ovarian cancer is a disease which is perceived to rarely produce symptoms until the disease has spread to other organs of the body, allowing the disease to reach an advanced stage before it is caught. Some evidence suggests patient-reported symptoms may help detect the cancer early on, and in fact, the Goff index, which uses questionnaire data, has been reported to be effective in identifying women who are at a low to moderate risk of ovarian cancer. However, symptom assessment may greatly influence index performance.
To determine the effectiveness of the symptom indices, Anita Wey Wey Lim of the Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, at Queen Mary University of London and associates looked at data from 194 women who had recently been diagnosed with ovarian cancer and 268 control subjects who underwent ovarian cancer screenings. The symptom data was assessed through questionnaires, telephone interviews, and general practitioner notes. The sensitivity of the symptoms reported within a few months of the diagnosis was also determined by comparing two 12 month periods (0-11 and 3-14 months before diagnosis).
The researchers found that the results were similar to those found in previous reports on the Goff index and that the sensitivity of the symptoms were stronger in late- vs early-stage disease. The assessment also shows that there is only a slight variation in the symptoms reported by women with early- vs late-stage disease.
The authors note that a strong point in the study comes from a comparison of multiple data sources, which had never been done before. Even so, they write that, ‘The small differences between the three indices indicate that there is little to gain from deriving new symptom indices.’ They also suggest that while a symptom index could advance the diagnosis of ovarian cancer, the benefits of such are greatly overemphasised, given that most symptoms of the disease emerge within three months before diagnosis. They write, ‘At best, a symptom index might advance diagnosis of ovarian cancer by 3 months or more in two-thirds of women. For a more specific index, the sensitivity would be approximately one-third.’
In an accompanying editorial, Patricia Hartge, ScD, at National Cancer Institute’s Division of Cancer Epidemiology and Genetics, and James L. Speyer, MD, from the NYU Langone Cancer Center, write that symptom indices such as the Goff index and two novel indices described in the study are viewed as good for detecting early-stage ovarian cancer with the assumption that an early detection and therapy can achieve a better patient outcome. While this can be true, they caution that these indices were not highly specific and that the screeners found the cancer symptoms close to the time in which the patient was diagnosed. ‘The study design permits no calculation of years of life that might have been saved or lost if screeners actually were used

About one baby is born every hour addicted to opiate drugs in the United States, according to new research from University of Michigan physicians.
In the research, U-M physicians found that diagnosis of neonatal abstinence syndrome, a drug withdrawal syndrome among new-borns, almost tripled between 2000 and 2009.
By 2009, the estimated number of new-borns with the syndrome was 13,539