Ranked importance of outcomes of first-line versus repeated chemotherapy among ovarian cancer patients

Beesley, Vanessa L.; Clavarino, Alexandra; Webb, Penelope M.; Wyld, David; Francesconi, Alessandra; Horwood, Keith; Doecke, James D.; Loos, C.; Green, Adèle C.

doi:10.1007/s00520-009-0734-z

Cited by 8 publications

(13 citation statements)

References 31 publications

(38 reference statements)

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“…If participants had recently received or were on treatment, the item worry about the results of treatment could reflect worry about whether the patients' cancer responded to treatment, which might be interpreted by some people as whether they have been "cured" or not. Previous studies have shown that patients with advanced relapsed disease still hope for a cure while acknowledging their doctor's advice that their disease is incurable [32]. Alternatively, or additionally, this item might reflect worry about prognosis or results of future treatments.…”

Section: Discussionmentioning

confidence: 99%

End-of-life care for Aboriginal and Torres Strait Islander people with cancer: an exploratory study of service utilisation and unmet supportive care needs

Bernardes

Beesley

Shahid

et al. 2020

Support Care Cancer

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Background Indigenous Australians diagnosed with cancer have substantially higher cancer mortality rates compared with non-Indigenous Australians, yet there is a paucity of information about their end-of-life service utilisation and supportive care needs. Purpose To describe the service utilisation and supportive care needs of Aboriginal and Torres Strait Islander people with cancer at end-of-life. Method Hospital admission data were linked to self-reported data from a study of Indigenous cancer patients from Queensland, Australia during the last year of their life. Needs were assessed by the Supportive Care Needs Assessment Tool for Indigenous Cancer Patients which measures 26 need items across 4 domains (physical/psychological; hospital care; information/ communication; practical/cultural). A descriptive analysis of health service utilisation and unmet needs was conducted. Results In total, 58 Indigenous cancer patients were included in this analysis. All patients had at least one hospital admission within the last year of their life. Most hospital admissions occurred through emergency (38%) and outpatient (31%) departments and were for acute care (85%). Palliative care represented 14% of admissions and 78% died in hospital. Approximately half (48%) did not report any unmet needs. The most frequently reported moderate-to-high unmet need items were worry about the treatment results (17%), money worries (16%) and anxiety (16%). Conclusions Utilisation of palliative care services that manage a full range of physical and psychosocial needs was low. Addressing worries about treatment results, finances and generalised anxiety are priorities in this population.

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Section: Discussionmentioning

confidence: 99%

End-of-life care for Aboriginal and Torres Strait Islander people with cancer: an exploratory study of service utilisation and unmet supportive care needs

Bernardes

Beesley

Shahid

et al. 2020

Support Care Cancer

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“…The strong patient reaction may have also stemmed from patients needing to maintain high expectations as a coping strategy or not to be seen to be ‘giving up’ and hastening death [ 43 ]. In this context, women with advanced breast cancer may have perceived the FDA withdrawal decision as taking away their only and last hope of survival.…”

Section: Discussionmentioning

confidence: 99%

Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Vitry

Nguyen

Entwistle

et al. 2015

J of Pharm Policy and Pract

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BackgroundWithdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. ObjectivesWe present a case study of the US Food and Drug Administration (FDA)’s decision to withdraw the indication of bevacizumab for the treatment of advanced breast cancer and include an analysis of the reactions of stakeholders with a view to identifying opportunities for improving risk management for new medicines with conditional approval or funding.MethodsWe drew on a range of information sources, including FDA documents, medical journals and media reports, to describe the evidentiary basis of the FDA decisions. We analysed the reactions and perspectives of the stakeholders.ResultsIn 2008 bevacizumab was granted conditional approval for treatment of advanced breast cancer by the FDA pending submission of supplementary satisfactory evidence. In 2011 the FDA decision to withdraw the indication was met with a hostile reaction from many clinicians and cancer survivors. There were different interpretations of the therapeutic value of bevacizumab with strong beliefs among cancer survivors that the medicine was effective and potential harm was manageable. High expectations of the public may have been encouraged by overly positive media reports and limited understanding by the public of the complexity of the scientific evaluation of new medicines and of the regulatory processes.ConclusionsImproving understanding and acceptance of approval or coverage schemes conditional to evidence development may require the development of risk management plans by regulatory and funding institutions. They may include a range of strategies such as requirements for formal patient acknowledgment of the conditional availability of the medicine, ‘black-triangle’ equivalent labels that identify full approval is based on pending evidence, and ongoing communication with the media, public and health professionals.

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“…[20][21][22][23][24][25][26][27][28] Six studies used formal tradeoff methods that did include overall survival as an anchoring attribute choice (ie, as a comparison or contrast to PFS [29][30][31] ) or fixed the length of overall survival for a given PFS (ie, for a given level of PFS, patients were told that the overall survival was fixed at a specific number of months). [32][33][34] All but 2 studies 18,22 assessed patient values at a single time point. All but 3 studies 18,19,22 used hypothetical choice sets in which the patients were asked to picture themselves in a situation in which they needed treatment and had to choose between 2 treatment options based on the risks and benefits presented.…”

Section: Characteristics Of Studiesmentioning

confidence: 99%

“…[32][33][34] All but 2 studies 18,22 assessed patient values at a single time point. All but 3 studies 18,19,22 used hypothetical choice sets in which the patients were asked to picture themselves in a situation in which they needed treatment and had to choose between 2 treatment options based on the risks and benefits presented. Patients were recruited from ambulatory clinics in 7 studies 18,19,[21][22][23]25,27 and online in 9 studies (via an external research agency 20, [29][30][31]34 or via emails from patient advocacy organizations 24,28,32,33 ).…”

Section: Characteristics Of Studiesmentioning

confidence: 99%

The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer

et al. 2019

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IMPORTANCEIt is unclear whether patients with advanced cancer value surrogate end points, particularly progression-free survival (PFS). Despite this uncertainty, surrogate end points form the basis of regulatory approval for the majority of new cancer treatments.OBJECTIVE To summarize and qualitatively assess studies evaluating whether patients with advanced cancer understand and value PFS.EVIDENCE REVIEW MEDLINE, Embase, the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature databases were searched from database inception to November 12, 2018. Articles eligible for inclusion investigated patient understanding, preference, or perceived value of disease progression or PFS in the setting of advanced cancer. Three authors independently reviewed and extracted data from all studies eligible for inclusion. FINDINGS In total, 17 studies representing 3646 patients were included. Of these studies, 15 specifically aimed to assess patients' values toward, and their willingness to trade off toxic effects for gains or losses in the end point of PFS. All studies examined used widely disparate definitions when attempting to describe the meaning of PFS to patients. Ten studies specifically presented patients with the term progression-free survival as an attribute choice. In the words used to define the attribute of PFS, 6 studies used the term survival. Five studies clarified that PFS may not translate into better overall survival, and 5 studies explained that improvements in PFS may not reflect how well the patient may feel. No study clarified that a PFS event could represent either progression or death, and no study defined for the patient what constituted progression. The studies assessed herein underrepresented ethnic and racial minorities (mean percentage of white patients, 88%; range, 77%-96%). Values and preferences may vary across cultural backgrounds given that different relative preferences were assigned to cost and efficacy outcomes in North American vs Asian studies, although only a few studies were evaluated. CONCLUSIONS AND RELEVANCEThe existing literature evaluating patients' understanding, preferences, and values toward the end point of PFS was severely limited by the heterogeneity of methods, attribute selection, and descriptions used to define PFS to patients. High-quality studies are needed that clearly define PFS for patients and that systematically document their understanding of the term. Only then can it be assessed whether PFS is an end point of value to patients with advanced cancer.

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Ranked importance of outcomes of first-line versus repeated chemotherapy among ovarian cancer patients

Cited by 8 publications

References 31 publications

End-of-life care for Aboriginal and Torres Strait Islander people with cancer: an exploratory study of service utilisation and unmet supportive care needs

End-of-life care for Aboriginal and Torres Strait Islander people with cancer: an exploratory study of service utilisation and unmet supportive care needs

Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

The Value of Progression-Free Survival as a Treatment End Point Among Patients With Advanced Cancer

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