To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the ...2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time.
A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey.
Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments.
An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.
To update the 2005 Cancer Care Ontario practice guidelines for the diagnosis and treatment of adult patients with a suspected or confirmed diagnosis of extradural malignant spinal cord compression ...(MESCC).
A review and analysis of data published from January 2004 to May 2011. The systematic literature review included published randomized control trials (RCTs), systematic reviews, meta-analyses, and prospective/retrospective studies.
An RCT of radiation therapy (RT) with or without decompressive surgery showed improvements in pain, ambulatory ability, urinary continence, duration of continence, functional status, and overall survival. Two RCTs of RT (30 Gy in eight fractions vs. 16 Gy in two fractions; 16 Gy in two fractions vs. 8 Gy in one fraction) in patients with a poor prognosis showed no difference in ambulation, duration of ambulation, bladder function, pain response, in-field failure, and overall survival. Retrospective multicenter studies reported that protracted RT schedules in nonsurgical patients with a good prognosis improved local control but had no effect on functional or survival outcomes.
If not medically contraindicated, steroids are recommended for any patient with neurologic deficits suspected or confirmed to have MESCC. Surgery should be considered for patients with a good prognosis who are medically and surgically operable. RT should be given to nonsurgical patients. For those with a poor prognosis, a single fraction of 8 Gy should be given; for those with a good prognosis, 30 Gy in 10 fractions could be considered. Patients should be followed up clinically and/or radiographically to determine whether a local relapse develops. Salvage therapies should be introduced before significant neurologic deficits occur.
•Single (SFRT) and short course multifraction (MFRT) regimens for spinal cord compression were compared in a systematic review and meta-analysis.•There was no observed difference with respect to ...motor response, bladder dysfunction and OS between SFRT and MFRT for MESCC, based on moderate quality evidence.•Firm conclusions cannot be drawn for SFRT versus MFRT in terms of pain control, QOL or toxicity.•Future investigations should focus on these outcomes and treatment for patients with a better expected prognosis.
While multifraction radiotherapy (RT) regimens (MFRT) have been considered the standard of care in patients with metastatic epidural spinal cord compression (MESCC) with limited prognosis, recent randomized evidence has demonstrated that single fraction RT (SFRT) may be equivalent in terms of functional and overall outcomes. A systematic review and meta-analysis was conducted to determine the effects of SFRT compared to short course MFRT in patients with MESCC.
A search of OVID, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to February 2018 was conducted. Randomized and prospective non-randomized trials comparing SFRT and short course MFRT for MESCC were included. Data were analyzed using a random effects model, and relative risks (RR) or hazard ratios (HR) were reported with corresponding 95% confidence intervals (CI). Quality of evidence was assessed using the GRADE criteria.
Overall 1717 articles were reviewed. Three randomized trials were eligible for inclusion (n = 712 patients). The pooled treatment effect for SFRT versus MFRT with respect to motor response was RR = 0.96 (95% CI = 0.86–1.07, I2 = 19%), HR = 1.00 (95% CI = 0.88–1.13, I2 = 0%) for OS, and RR = 0.97, (95% CI = 0.85–1.11, I2 = 61%) for bladder function. There was insufficient data to perform a meta-analysis on quality of life, toxicity or pain response, however available information suggests pain response appears similar between SFRT and MFRT. Overall quality of evidence was deemed moderate due to risk of bias.
There was no evidence of an observed difference with respect to motor response, bladder dysfunction and OS between SFRT and MFRT for MESCC in patients with a limited prognosis.
To prospectively capture acute toxicities and pain associated with postmastectomy radiation therapy (PMRT), to analyze patient and treatment risk factors for severe side effects.
Women referred for ...PMRT were prospectively enrolled and assessed weekly during and after radiation therapy. The endpoint included severe National Cancer Institute Common Terminology Criteria for Adverse Effects grade 3 moist desquamation, other skin symptoms, and pain.
Of 257 patients, 73 (28.4%) experienced extensive moist desquamation, 84 (32.7%) Common Terminology Criteria for Adverse Effects skin toxicity grade 3, and 57 (22.2%) a pain impacting on daily life activities. Among symptoms only grade 3 moist desquamation was significantly associated with severe pain (P<.001). On multivariate analysis, smoking, high-energy photons, and skin bolus were significantly associated with severe moist desquamation. Skin toxicity doubled for smokers, with 40% severe pain, 48% grade 3 moist desquamation, and 64% grade 3 skin toxicity. Without skin bolus 4.2% had severe pain, none moist desquamation, and 2.1% grade 3 skin toxicity. When skin bolus was used on alternate days, the frequency increased to 15% for pain, 22% for moist desquamation, and 26% for grade 3 skin toxicity. When bolus was used daily, 32% had pain, 41% moist desquamation, and 47% grade 3 skin toxicity. Symptoms peaked 1 to 2 weeks after the end of PMRT.
The present cohort study suggests excessive radiation toxicity after PMRT. Among factors associated with an increase of toxicity are smoking habits and the use of skin bolus.
To describe the outcomes of peer review across all 14 cancer centers in Ontario.
We identified all peer-reviewed, curative treatment plans delivered in Ontario within a 3-month study period from 2013 ...to 2014 using a provincial cancer treatment database and collected additional data on the peer-review outcomes.
Considerable variation was found in the proportion of peer-reviewed plans across the centers (average 70.2%, range 40.8%-99.2%). During the study period, 5561 curative plans underwent peer review. Of those, 184 plans (3.3%) had changes recommended. Of the 184 plans, the changes were major (defined as requiring repeat planning or having a major effect on planning or clinical outcomes, or both) in 40.2% and minor in 47.8%. For the remaining 12.0%, data were missing. The proportions of recommended changes varied among disease sites (0.0%-7.0%). The disease sites with the most recommended changes to treatment plans after peer review and with the greatest potential for benefit were the esophagus (7.0%), uterus (6.7%), upper limb (6.3%), cervix and lower limb (both 6.0%), head and neck and bilateral lung (both 5.9%), right supraclavicular lymph nodes (5.7%), rectum (5.3%), and spine (5.0%). Although the heart is an organ at risk in left-sided breast treatment plans, the proportions of recommended changes did not significantly differ between the left breast treatment plans (3.0%, 95% confidence interval 2.0%-4.5%) and right breast treatment plans (2.4%, 95% confidence interval 1.5%-3.8%). The recommended changes were more frequently made when peer review occurred before radiation therapy (3.8%) than during treatment (1.4%-2.8%; P=.0048). The proportion of plans with recommended changes was not significantly associated with patient volume (P=.23), peer-review performance (P=.36), or center academic status (P=.75).
Peer review of treatment plans directly affects the quality of care by identifying important clinical and planning changes. Provincial strategies are underway to optimize its conduct in radiation oncology.
PURPOSE
Choosing Wisely Africa (CWA) builds on Choosing Wisely (CW) in the United States, Canada, and India and aims to identify low-value, unnecessary, or harmful cancer practices that are ...frequently used on the African continent. The aim of this work was to use physicians and patient advocates to identify a short list of low-value practices that are frequently used in African low- and middle-income countries.
METHODS
The CWA Task Force was convened by the African Organization for Research and Training in Cancer and included representatives from surgical, medical, and radiation oncology, the private and public sectors, and patient advocacy groups. Consensus was built through a modified Delphi process, shortening a long list of practices to a short list, and then to a final list. A voting threshold of ≥ 60% was used to include an individual practice on the short list. A consensus was reached after a series of teleconferences and voting processes.
RESULTS
Of the 10 practices on the final list, one is a new suggestion and 9 are revisions or adaptations of practices from previous CW campaign lists. One item relates to palliative care, 8 concern treatment, and one relates to surveillance.
CONCLUSION
The CWA initiative has identified 10 low-value, common interventions in Africa’s cancer practice. The success of this campaign will be measured by how the recommendations are implemented across sub-Saharan Africa and whether this improves the delivery of high-quality cancer care.
The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration developed an MCDA rating tool to assess and prioritize potential post-market real-world evidence (RWE) ...questions/uncertainties emerging from public drug funding decisions in Canada. In collaboration with a group of multidisciplinary stakeholders from across Canada, the rating tool was developed following a three-step process: (1) selection of criteria to assess the importance and feasibility of an RWE question; (2) development of rating scales, application of weights and calculating aggregate scores; and (3) validation testing. An initial MCDA rating tool was developed, composed of seven criteria, divided into two groups. Group A criteria assess the importance of an RWE question by examining the (1) drug's perceived clinical benefit, (2) magnitude of uncertainty identified, and (3) relevance of the uncertainty to decision-makers. Group B criteria assess the feasibility of conducting an RWE analysis including the (1) feasibility of identifying a comparator, (2) ability to identify cases, (3) availability of comprehensive data, and (4) availability of necessary expertise and methodology. Future directions include partnering with the Canadian Agency for Drugs and Technology in Health's Provincial Advisory Group for further tool refinement and to gain insight into incorporating the tool into drug funding deliberations.
The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration was established to develop a framework for generating and using real-world evidence (RWE) to inform the ...reassessment of cancer drugs following initial health technology assessment (HTA). The Reassessment and Uptake Working Group (RWG) is one of the five established CanREValue Working Groups. The RWG aims to develop considerations for incorporating RWE for HTA reassessment and strategies for using RWE to reassess drug funding decisions. Between February 2018 and December 2019, the RWG attended four teleconferences (with follow-up surveys) and two in-person meetings to discuss recommendations for the development of a reassessment process and potential barriers and facilitators. Modified Delphi methods were used to gather input. A draft report of recommendations (to December 2018) was shared for public consultation (December 2019 to January 2020). Initial considerations for developing a reassessment process were proposed. Specifically, reassessment can be initiated by diverse stakeholders, including decision makers from public drug plans or industry stakeholders. The reassessment process should be modelled after existing deliberation and recommendation frameworks used by HTA agencies. Proposed reassessment outcome categories include maintaining status quo, revisiting funding criteria, renegotiating price, or disinvesting. Overall, these initial considerations will serve as the basis for future advancements by the Collaboration.
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