Category: 12 (December 2019)
National Prostate Cancer Audit
National Prostate Cancer Audit: Prostate Biopsy Short Report | Healthcare Quality Improvement Partnership
This report evaluates the current national use of transperineal (TP) prostate biopsies and compares differences in the outcomes of TP and transrectal (TR) biopsies. It also examines how the risk of complications is affected by the biopsy approach.
The report finds that the proportion of men undergoing a TP biopsy has nearly doubled within 3 years (14% – 25%), highlighting the increased desire to use this biopsy in certain hospitals.
Full detail at Healthcare Quality Improvement Partnership
NHS cancer programme report
NHS England has published a report on performance of the cancer programme in the first half of the financial year 2019/20
The NHS Cancer Programme leads the delivery of the NHS Long Term Plan ambitions for cancer. Leading change at the local level are Cancer Alliances, who work in collaboration with their local Sustainability and Transformation Partnerships (STPs) and Integrated Care Systems (ICSs). This report provides an update on what has been achieved so far to deliver on the NHS Long Term Plan ambitions in quarters one and two for 2019/20.
Full report: NHS cancer programme. Update report April to September 2019
Manchester research: One dose of radiotherapy as effective as five doses for cancer in the spine
University of Manchester| December 2019 | One dose of radiotherapy as effective as five doses for cancer in the spine
A study conducted by a team of researchers from the Universities of Manchester and University College London aimed to test whether administering just one dose (single-fraction) of radiotherapy could be used instead of five doses (multi-fraction) which requires several hospital visits. The findings of the SCORAD randomised clinical trial, now published in JAMA, indicate that one dose of radiotherapy should be used instead of five doses for most patients with spinal canal compression, this finding is supported by all of the other statistical criteria and multiple patient outcomes.
The lead trial investigator, Professor Peter Hoskin (University of Manchester, Mount Vernon Cancer Centre (NHS), said: “In the UK, NICE guidelines do not currently stipulate a standard treatment regimen, though most patients with spinal canal compression or other metastatic bone disease are given several fractions.
“We believe our findings, which show equal clinical effectiveness for single-dose radiotherapy, provide strong evidence for NICE guidelines, and those in other countries, to be changed to stipulate a one-dose one-visit approach, reducing unnecessary discomfort for end of life cancer patients without compromising efficacy” (Source: University of Manchester).
Key points
Question Is treatment with a single dose of radiotherapy noninferior to multifraction radiotherapy delivered over 5 days among patients with metastatic cancer who have spinal canal compression?
Findings In a clinical trial of 686 patients, the percentage who were ambulatory at 8 weeks was 69.3% in the single-fraction group vs 72.7% in the multifraction radiotherapy group. The lower CI limit for the risk difference (−11.5%) did not meet the predefined noninferiority margin of −11.0%.
Meaning Treatment with single-fraction radiotherapy did not meet the criterion for noninferiority compared with multifraction radiotherapy for ambulatory response rate at 8 weeks, but consideration should be given to the extent to which the lower bound of the CI overlapped with the noninferiority margin.
See also:
University of Manchester One dose of radiotherapy as effective as five doses for cancer in the spine
University College London One dose of radiotherapy as effective as five doses for cancer in the spine
Full reference:
Hoskin, P.J., et al.|2019| Effect of Single-Fraction vs Multifraction Radiotherapy on Ambulatory Status Among Patients With Spinal Canal Compression From Metastatic Cancer: The SCORAD Randomized Clinical Trial | JAMA|322| 21| P. 2084–2094 |doi:https://doi.org/10.1001/jama.2019.17913
The full article is available from JAMA
Abstract
Importance Malignant spinal canal compression, a major complication of metastatic cancer, is managed with radiotherapy to maintain mobility and relieve pain, although there is no standard radiotherapy regimen.
Objective To evaluate whether single-fraction radiotherapy is noninferior to 5 fractions of radiotherapy.
Design, Setting, and Participants Multicenter noninferiority randomized clinical trial conducted in 42 UK and 5 Australian radiotherapy centers. Eligible patients (n = 686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area. Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017.
Interventions Patients were randomized to receive external beam single-fraction 8-Gy radiotherapy (n = 345) or 20 Gy of radiotherapy in 5 fractions over 5 consecutive days (n = 341).
Main Outcomes and Measures The primary end point was ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power). The noninferiority margin for the difference in ambulatory status was −11%. Secondary end points included ambulatory status at weeks 1, 4, and 12 and overall survival.
Results Among 686 randomized patients (median [interquartile range] age, 70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point (255 patients died before the 8-week assessment). Ambulatory status grade 1 or 2 at week 8 was achieved by 115 of 166 (69.3%) patients in the single-fraction group vs 128 of 176 (72.7%) in the multifraction group. The difference in ambulatory status grade 1 or 2 in the single-fraction vs multifraction group was −0.4% at week 1, −0.7%; P value for noninferiority = .01) at week 4, and 4.1%; P value for noninferiority = .002) at week 12. Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group. Of the 11 other secondary end points that were analyzed, the between-group differences were not statistically significant or did not meet noninferiority criterion.
Conclusions and Relevance Among patients with malignant metastatic solid tumors and spinal canal compression, a single radiotherapy dose, compared with a multifraction dose delivered over 5 days, did not meet the criterion for noninferiority for the primary outcome (ambulatory at 8 weeks). However, the extent to which the lower bound of the CI overlapped with the noninferiority margin should be considered when interpreting the clinical importance of this finding.
Trial Registration ISRCTN Identifiers: ISRCTN97555949 and ISRCTN97108008
The full paper is available from JAMA
Robotic surgery for rectal cancer produces similar results to keyhole surgery
NIHR Signal | December 2019 |Robotic surgery for rectal cancer produces similar results to keyhole surgery
Robotic rectal cancer surgery does not appear technically easier than standard keyhole surgery. The researchers, in this trial, judged this by measuring the need to ‘convert’ a keyhole procedure to open surgery when operating. This NIHR-funded trial also found that robotic surgery produced similar clinical results to standard laparoscopic (keyhole) surgery in treating rectal cancer.
In the trial, 28 out of 230 patients (12%) who received keyhole surgery were converted to open surgery, compared with 19 out of 236 (8%) who received robotic surgery. This difference did not achieve statistical significance. There were also no differences in the likelihood of removing the whole tumour, surgery-related complications and bladder or sexual function. Longer-term outcomes such as three-year recurrence and overall survival were also similar.
These results suggest robotic rectal surgery, which costs £1,000 more than laparoscopic surgery due to ongoing equipment costs and longer operating time, may not be cost-effective (Source: NIHR).
The full details of the trial are available from the NIHR
Full reference:
Jayne, D. | 2019| Robotic-assisted Surgery Compared With Laparoscopic Resection Surgery for Rectal Cancer: The ROLARR RCT | Efficacy and Mechanism Evaluation | DOI: 10.3310/eme06100
Abstract
Background
Robotic rectal cancer surgery is gaining popularity, but there are limited data about its safety and efficacy. Objective To undertake an evaluation of robotic compared with laparoscopic rectal cancer surgery to determine its safety, efficacy and cost-effectiveness.
Design
This was a multicentre, randomised trial comparing robotic with laparoscopic rectal resection in patients with rectal adenocarcinoma.
Setting
The study was conducted at 26 sites across 10 countries and involved 40 surgeons. Participants The study involved 471 patients with rectal adenocarcinoma. Recruitment took place from 7 January 2011 to 30 September 2014 with final follow-up on 16 June 2015. Interventions Robotic and laparoscopic rectal cancer resections were performed by high anterior resection, low anterior resection or abdominoperineal resection. There were 237 patients randomised to robotic and 234 to laparoscopic surgery. Follow-up was at 30 days, at 6 months and annually until 3 years after surgery.
Main outcome measures The primary outcome was conversion to laparotomy. Secondary end points included intra- and postoperative complications, pathological outcomes, quality of life (QoL) [measured using the Short Form questionnaire-36 items version 2 (SF-36v2) and the Multidimensional Fatigue Inventory-20 (MFI-20)], bladder and sexual dysfunction [measured using the International Prostatic Symptom Score (I-PSS), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI)], and oncological outcomes. An economic evaluation considered the costs of robotic and laparoscopic surgery, including primary and secondary care costs up to 6 months post operation.
Results Among 471 randomised patients [mean age 64.9 years, standard deviation (SD) 11.0 years; 320 (67.9%) men], 466 (98.9%) patients completed the study. Data were analysed on an intention-to-treat basis. The overall rate of conversion to laparotomy was 10.1% and occurred in 19 (8.1%) patients in the robotic-assisted group and in 28 (12.2%) patients in the conventional laparoscopic group. Of the nine prespecified secondary end points, including circumferential resection margin positivity, intraoperative complications, postoperative complications, plane of surgery, 30-day mortality and bladder and sexual dysfunction, none showed a statistically significant difference between the groups. No difference between the treatment groups was observed for longer-term outcomes, disease-free and overall survival (OS). Males were at a greater risk of local recurrence than females and had worse OS rates. The costs of robotic and laparoscopic surgery, excluding capital costs, were £11,853 (SD £2940) and £10,874 (SD £2676) respectively.
Conclusions
There is insufficient evidence to conclude that robotic rectal surgery compared with laparoscopic rectal surgery reduces the risk of conversion to laparotomy. There were no statistically significant differences in resection margin positivity, complication rates or QoL at 6 months between the treatment groups. Robotic rectal cancer surgery was on average £980 more expensive than laparoscopic surgery, even when the acquisition and maintenance costs for the robot were excluded. Future work The lower rate of conversion to laparotomy in males undergoing robotic rectal cancer surgery deserves further investigation. The introduction of new robotic systems into the market may alter the cost-effectiveness of robotic rectal cancer surgery.
The full article is available from PubMed
Blood test for breast cancer may be a step closer
NCRI Cancer Research Institute |nd | Clinical Utility of Autoantibodies in Early Detection of Breast Cancer
A team of researchers including experts from the University of Nottingham have developed a blood test which could detect breast cancer up to five years earlier before its clinical presentation.
Abstract
Background
Autoantibodies against numbers of tumour-associated antigens (TAAs) were shown to be relevant tumor biomarkers and can be detected up to 5 years before the tumour is overt clinically. Early diagnosis of cancer is paramount to improved survival by enabling treatment prior to cancer spreading, when tumours should be both surgically removable and curable. The NHS in Scotland is currently carrying out a RCT (ECLS) involving 12,000 individuals at high risk of developing lung cancer being randomised to having (or not) an autoantibody ELISA blood test (EarlyCDT-Lung®) – followed by CT scans over 2 years follow-up in those individuals with a positive test – for early lung cancer detection.
We are aiming to develop a blood test enabling the early detection of breast cancer to significantly improve clinical outcome.
Method
In this pilot study, 180 breast cancer matched control samples were screened for the presence of autoantibodies against 67 TAAs which have already been shown to involve in breast cancer pathology. Optimised Protein microarray technology was applied for this study.
Results
The results confirmed our hypothesis that BC induce autoantibodies (AAbs) against different panels of specific tumour associated antigens (TAAs) used in the pilot study. The assay provided cancer/control discrimination through detection of AAbs against TAAs.
Conclusion
We identified antigen panels of sufficient sensitivity and specificity for early detection of BC based upon serum profiling of autoantibody response. This opens the possibility of a blood test for screening and detection of breast cancer.
The research has been recently presented at NCRI Cancer Conference, in Glasgow, Scotland on Sunday 3 November.
Read the story at Science Daily
OnMedica Blood test for breast cancer may be a step closer
See also:
Nottingham Post Nottingham researchers develop blood test which could detect breast cancer much earlier
The Telegraph Simple blood test could spot breast cancer five years before any symptom
NICE Consultation: Selective internal radiation therapies for treating hepatocellular carcinoma ID1276
NICE | December 2019 | Selective internal radiation therapies for treating hepatocellular carcinoma ID1276 In development [GID-TA10381]
The Department of Health and Social Care has asked the National Institute for Health and Care Excellence (NICE) to produce guidance on using selective internal radiation therapies (SIRT) for treating hepatocellular carcinoma in the NHS in England.
Full details are available from NICE
The consultation closes on 8 January 2020
NICE: Rezum for treating benign prostatic hyperplasia
NICE | December 2019 | Rezum for treating benign prostatic hyperplasia
The NICE medical technologies advisory committee (MTAC) has made draft recommendations on this technology following consideration of the evidence and expert views at a meeting on 15th November, 2019
NICE is now seeking feedback, the consultation is open until 8 Jan 2020.
Full details from NICE
A quarter of cancer patients experience avoidable delay to diagnosis
One in four cancer patients experienced a delay to their diagnosis that could have been avoided, according to a new study | via Cancer Research UK
A new study, published in Cancer Epidemiology, looked at data the national cancer registry of around 14,300 people diagnosed with cancer in England in one year.
It found that nearly 3,400 patients experienced a delay that could have been avoided. Half of these patients waited around two months longer to be diagnosed compared with those who didn’t have an avoidable delay.
The reasons for delays are complex but researchers on this study attempted to identify what could go wrong. The study authors asked GPs to identify when the delay happened – before the patient saw their GP, while they were still being assessed by the GP practice or after they had referred them.
The data showed 13% of all avoidable delays happened before the patient saw their GP and 38% after the GP referred them to hospital. The other half (49%) happened while the patient was being assessed by the GP surgery including waiting for tests to be done and results to be sent back.
Full story at Cancer Research UK
Research article: Swann et al. | The frequency, nature and impact of GP-assessed avoidable delays in a population-based cohort of cancer patients | Cancer Epidemiology | published online 3 December 2019.
Cancer survivors have raised heart risk, reports a US population-based study of cardiovascular disease mortality risk patients with cancer
Sturgeon, K.M , et al | 2019| A population-based study of cardiovascular disease mortality risk in US cancer patients| European Heart Journal| ehz766| https://doi.org/10.1093/eurheartj/ehz766
The European Heart Journal has published research that looked at three million US patients, across 28 types of cancers, over a period of 40 years, the experts behind this analysis found that more than one-tenth of patients died from cardiovascular diseases. The research highlights the incidence of cardiovascular disease (CVD) in patients diagnosed with breast, prostate, or bladder cancer. The team also observed that from the point of cancer diagnosis onward patients with cancer (all sites) are at elevated risk of dying from CVDs compared to the general US population (Source: Sturgeon, et al. 2019).
The journal article is available in full from The European Heart Journal
Abstract
Aims
This observational study characterized cardiovascular disease (CVD) mortality risk for multiple cancer sites, with respect to the following: (i) continuous calendar year, (ii) age at diagnosis, and (iii) follow-up time after diagnosis.
The Surveillance, Epidemiology, and End Results program was used to compare the US general population to 3 234 256 US cancer survivors (1973–2012). Standardized mortality ratios (SMRs) were calculated using coded cause of death from CVDs (heart disease, hypertension, cerebrovascular disease, atherosclerosis, and aortic aneurysm/dissection). Analyses were adjusted by age, race, and sex. Among 28 cancer types, 1 228 328 patients (38.0%) died from cancer and 365 689 patients (11.3%) died from CVDs. Among CVDs, 76.3% of deaths were due to heart disease. In eight cancer sites, CVD mortality risk surpassed index-cancer mortality risk in at least one calendar year. Cardiovascular disease mortality risk was highest in survivors diagnosed at less than 35 years of age. Further, CVD mortality risk is highest within the first year after cancer diagnosis, and CVD mortality risk remains elevated throughout follow-up compared to the general population.
Conclusion
In the news: