Clinical Brief – September 26th
ESMO, or the European Society of Medical Oncology Congress, is an annual gathering of cancer experts and patient advocates. Here are some studies from this year’s ESMO that may be of use.
Researchers from the EU and Canada found that “in patients with advanced solid tumors, fewer than half of randomized controlled trials supporting FDA approval meet the threshold for clinically meaningful benefit” using the ESMO-designed scale.
Researchers found 109 randomized controlled trials from the FDA’s database, which supported the approval of 63 drugs for 118 indications. The ESMO Magnitude of Clinical Benefit Scale could be applied to 105 of these trials.
Only 44% of the trials met the clinically meaningful benefit threshold as outlined by ESMO. All seven trials in the neo/adjuvant setting met their threshold, and only 41% of the 98 trials in the palliative setting did.
Among the palliative trials, the odds of a phase III trial meeting the meaningful clinical benefit threshold was 38-times higher vs a phase II trial. Similarly, trials with overall survival as a primary endpoint had a 8-time higher odds of meeting the threshold vs trials where survival was only an intermediate endpoint.
Inclusion of elderly cancer patients in trials drop dramatically for those over 80, reports a French study.
Researchers followed nearly 600 patients over 65 who were living with colorectal cancer from 2013 to 2016.
Overall, only 12% of patients were included in a trial. Among patients with an available trial, 73% were found to be non-eligible most often because of their tumor characteristics, requests for para-clinical exams, history of cancer treatments, and comorbidities.
Of patients who were eligible for a trial, about 34% were not invited to participate. Of those who were invited to participate, 19% refused participation.
Trial inclusion was highest in the 65~69-year-old group at 19%. The rate drops to about 3% in the 80 or over group.
“Over a quarter of all randomized controlled trials in common cancers are reported in the lay media before they are reported scientifically,” says a study led by researchers in Canada.
Researchers looked through clinicaltrials.gov for phase III randomized controlled trials in breast, colorectal, lung, and prostate cancers between 2005 and 2016.
Of the 180 trials found, 52% were reported by the lay media. Positive trials had nearly twice as much coverage vs negative trials (66% vs 38%).
In 27% of cases, trials were reported by the lay media before they were presented scientifically. There was a significant trend that this phenomenon is becoming more prevalent.
Reporting in the lay media before scientific reporting was associated with positive results, industry sponsorship, and palliative intent.
Strange observation: The odds of trials in prostate cancer getting coverage was nearly 5-times higher vs those in breast cancer.
Researchers from the Royal Free Hospital in London, UK, shared their experience with educating oncologists and nurses about metastatic spinal cord compression.
“Metastatic spinal cord compression affects up to 10% of patients with disseminated malignancies”, says the abstract authors. They also suggest that early diagnosis is linked to better clinical outcomes.
Researchers surveyed all oncologists and specialist nurses at the Royal Free on their knowledge of national guidelines and clinical practice, and provided participants presentations, case discussions, and patient counselling materials. They were surveyed again after 3 months.
After 3 months, they found that oncologists and nurses were
- More familiar with the guidelines (57% to 84%)
- More knowledgeable about the information leaflets for patients (32% to 47%)
- More likely to give at-risk patients written information about metastatic spinal cord compression at least every month (3% to 15%)
- More likely to give high-risk patients written information about this complication (19% to 61%)
“By increasing awareness, we can increase the proportion of early self-presentation and diagnosis. This will lead to prompt intervention and improvement of neurological outcomes.”
– Mahaligam P, et al.
A robot designed by pharmacists in Japan may potentially help limit exposure to hazardous cancer meds.
Pharmacist from the Kyushu University Hospital, Japan, developed the Cancer Drug Compounding Assist System (CDCAS) in collaboration with two industry partners.
They tested the system with preparing chemo meds like 5-FU and cyclophosphamide.
The robot’s accuracy was about par compared to a pharmacist. Contamination of cyclophosphamide was found in eight out of 25 sites in the machine’s isolator. Pollution of 5-FU was confirmed on the bags of two out of 15 prep.
I’m not sure what to make of their data to be honest, but CDCAS? Personally, I’d have called something like this Hazard Mix 3000 but, that might just be me.
For more presentations from #ESMO17, take a look at my hand-curated Twitter moment 🤓.