Consensus-based standards for best supportive care in clinical trials in advanced cancer

2012 ◽  
Vol 13 (2) ◽  
pp. e77-e82 ◽  
Author(s):  
S Yousuf Zafar ◽  
David C Currow ◽  
Nathan Cherny ◽  
Florian Strasser ◽  
Robin Fowler ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Best Supportive Care

scholarly journals How is best supportive care provided in clinical trials for patients with advanced cancer? A review of registered protocols of clinical trials

2019 ◽  
Vol 27 (2) ◽  
Author(s):  
Á. Sanz Rubiales ◽  
M. E. Sánchez-Gutiérrez ◽  
L. A. Flores Pérez ◽  
M. L. Del Valle Ribero
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Consensus Statements ◽  
Definition Of ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Background In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012–2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary Most clinical trials registered during 2012–2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.

Best supportive care (BSC) in published clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9560-9560 ◽  
Author(s):  
Amy Pickar Abernethy ◽  
Ryan David Nipp ◽  
David Currow ◽  
Nathan Cherny ◽  
Florian Strasser ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Supportive Care ◽  
Symptom Management ◽  
Symptom Assessment ◽  
Best Supportive Care ◽  
Delphi Panel ◽  
Random Allocation ◽  
Exclusion Criteria

9560 Background: BSC as a control arm in clinical trials is poorly defined. A systematic review was conducted to evaluate clinical trial concordance with published, consensus-based framework for BSC delivery in trials. Methods: A consensus-based Delphi panel previously identified 4 key domains of BSC delivery in trials: multidisciplinary care; supportive care documentation; symptom assessment at least as often as the intervention arm; and guideline-based symptom management. A systematic review of trials including BSC control arms assessed BSC concordance to the consensus-based domains. Databases were searched from 2002-2012 using search strings: “cancer”; “best supportive care”; “randomized” or “random allocation”; and “supportive” or “palliative.” Exclusion criteria were: no BSC arm, non-human trial, not randomized, not English, not advanced cancer, or not including anticancer therapy. Data were independently extracted by 2 reviewers and scored by 4 reviewers for conformance with consensus-based BSC framework. Results: 373 articles were retrieved, 17 retained after applying exclusion criteria. Overall, trials conformed to <18% of the consensus-based BSC standards. 35% of articles offered a detailed description of BSC. 65% reported baseline and regular symptom assessment, and 47% reported using validated symptom assessment measures. 35% reported symptom assessment at identical intervals in both experimental and BSC arms. None listed an evidence-based guideline for symptom management. None of the multicenter trials reported standardization of BSC across sites. No studies reported educating patients on symptom management or goals of anti-cancer therapy. No studies reported offering access to palliative care specialists, social workers, financial or spiritual counseling. Conclusions: Reporting of BSC in trials is incomplete, resulting in uncertain internal and external validity. Such poorly defined interventions and variation between sites is unacceptable for other aspects of a clinical trial. Unless it is truly best supportive care, such studies may risk systematically over-estimating the clinical effect of the comparator arms. Standardization of a BSC delivery framework is needed to improve trial design and data generalization.

scholarly journals Best supportive care in clinical trials: review of the inconsistency in control arm design

2015 ◽  
Vol 113 (1) ◽  
pp. 6-11 ◽  
Author(s):  
R D Nipp ◽  
D C Currow ◽  
N I Cherny ◽  
F Strasser ◽  
A P Abernethy ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Best Supportive Care

Is best supportive care really best supportive care?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9639-9639
Author(s):  
R. Lee ◽  
J. Von Roenn
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Palliative Medicine ◽  
Randomized Clinical Trials ◽  
Best Supportive Care ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Average Survival ◽  
Cancer Types ◽  
Definition Of

9639 Background: With the growth of palliative medicine over the past decade, the paradigm of supportive care has evolved to create new standards for cancer patients. The aim of this study was to define “best supportive care” (BSC) during clinical trials of advanced solid tumors. Methods: Systematic review of the literature using Medline and the Cochrane Central Register of Controlled Trials databases. These were searched for randomized controlled trials in which anticancer therapy was compared with a BSC only arm. Results: A total of 43 studies met our inclusion criteria (publication dates, 1980–2008) with the following cancer types: 22 lung cancer, 6 colorectal, 6 pancreas, 2 gastric, and 7 other cancer types. Thirty-eight studies (88%) provided some definition of supportive care and sixteen studies (37%) used the term BSC. The average survival across treatment arms was 27.5 weeks. All but one study described the use of palliative therapies at the discretion of the treating physician without standardization. Over half of all studies (56%) specifically mentioned analgesics and radiotherapy (RT) for pain control. Other specific interventions listed were steroids (14), antibiotics (10), psychological support (10), nutritional support (9), blood transfusions (8), anti-emetics (6), and anti-depressant or anxiolytic medications (3). One-third of trials (15) reported an equivalent clinical evaluation schedule for both the BSC and treatment arms. Quality of life (QoL) was measured with a validated instrument (e.g., QLQ-30) in 55% of trials and 37% compared the utilization of at least one palliative treatment between groups. Trials using the term BSC were more likely to provide multidisciplinary therapy beyond RT and analgesics (50% vs. 19%; p<0.05). Conclusions: The management of subjects in a BSC arm of clinical trials are highly variable. Overall, the trials compare treatment versus no treatment as subjects in the BSC group likely did not receive care according to current palliative medicine standards. Future randomized clinical trials with a BSC arm should provide a comprehensive, multidisciplinary approach that is consistent with practice guidelines. A standardized BSC approach developed with palliative medicine specialists is warranted for further study. No significant financial relationships to disclose.

Consensus-based standards for best supportive care in cancer clinical trials.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. e19507-e19507
Author(s):  
A. P. Abernethy ◽  
D. Currow ◽  
N. Cherny ◽  
F. Strasser ◽  
R. Fowler ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Best Supportive Care ◽  
Cancer Clinical Trials

Cholangiokarzinome

Praxis ◽  
2002 ◽  
Vol 91 (34) ◽  
pp. 1352-1356
Author(s):  
Harder ◽  
Blum
Keyword(s):  
Supportive Care ◽  
Evidence Based Medicine ◽  
Best Supportive Care ◽  
Evidence Based ◽  
Systemische Chemotherapie ◽  
Chirurgische Resektion ◽  
Multimodale Therapiekonzepte ◽  
Based Medicine

Cholangiokarzinome oder cholangiozelluläre Karzinome (CCC) sind seltene Tumoren des biliären Systems mit einer Inzidenz von 2–4/100000 pro Jahr. Zu ihnen zählen die perihilären Gallengangskarzinome (Klatskin-Tumore), mit ca. 60% das häufigste CCC, die peripheren (intrahepatischen) Cholangiokarzinome, das Gallenblasenkarzinom, die Karzinome der extrahepatischen Gallengänge und das periampulläre Karzinom. Zum Zeitpunkt der Diagnose ist nur bei etwa 20% eine chirurgische Resektion als einzige kurative Therapieoption möglich. Die Lebertransplantation ist wegen der hohen Rezidivrate derzeit nicht indiziert. Die Prognose von nicht resektablen Cholangiokarzinomen ist mit einer mittleren Überlebenszeit von sechs bis acht Monaten schlecht. Eine wirksame Therapie zur Verlängerung der Überlebenszeit existiert aktuell nicht. Die wichtigste Massnahme im Rahmen der «best supportive care» ist die Beseitigung der Cholestase (endoskopisch, perkutan oder chirurgisch), um einer Cholangitis oder Cholangiosepsis vorzubeugen. Durch eine systemische Chemotherapie lassen sich Ansprechraten von ca. 20% erreichen. 5-FU und Gemcitabine sind die derzeit am häufigsten eingesetzten Substanzen, die mit einer perkutanen oder endoluminalen Bestrahlung kombiniert werden können. Multimodale Therapiekonzepte können im Einzellfall erfolgreich sein, müssen jedoch erst in Evidence-Based-Medicine-gerechten Studien evaluiert werden, bevor Therapieempfehlungen für die Praxis formuliert werden können.

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