Validating a proxy for disease progression in metastatic cancer patients using prescribing and dispensing data

Joshi, Vikram; Adelstein, Barbara‐Ann; Schaffer, Andrea L; Srasuebkul, Preeyaporn; Dobbins, Timothy; Pearson, Sallie‐Anne

doi:10.1111/ajco.12602

Cited by 5 publications

(8 citation statements)

References 21 publications

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“…From 95 publications initially identified, 52 were excluded either because they did not include a gold standard data source, used administrative claims data as the gold standard, or otherwise did not meet our criteria for inclusion. A total of 43 studies from six countries were identified (Table ). Of these, 72.1% ( n = 31) were published within the last 5 years (ie, since 2012).…”

Section: Resultsmentioning

confidence: 99%

“…Of these, five were from Australia and one each from Japan and South Korea. Among Australian studies, cancer outcomes included pancreatic and periamupullary cancers, prostate cancer, colorectal and lung cancer, metastatic cancer patients, and gastro‐intestinal cancer . A variety of gold standard sources were used: registry data (1), medical records (2), and other data sources (cancer surveys; 2).…”

Section: Type Of Outcomes Validatedmentioning

confidence: 99%

“…Overall, the quality of published studies varied. Seven studies used both medical records as a gold standard and a full set of validity measures. These were multiple institution studies published mainly from Australia ( n = 3) and Japan ( n = 2).…”

Section: Type Of Outcomes Validatedmentioning

confidence: 99%

See 2 more Smart Citations

Validation studies of claims data in the Asia‐Pacific region: A comprehensive review

Koram

Delgado

Stark

et al. 2018

Pharmacoepidemiology and Drug

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Section: Resultsmentioning

confidence: 99%

Section: Type Of Outcomes Validatedmentioning

confidence: 99%

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Validation studies of claims data in the Asia‐Pacific region: A comprehensive review

Koram

Delgado

Stark

et al. 2018

Pharmacoepidemiology and Drug

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“…While many of the studies included in this review used the initiation of a medicine as a proxy for the development of an adverse event, other studies have utilised longer-term patterns in dispensing data to indicate safety issues. For example Joshi et al [ 79 ] utilised changes in drug treatment to infer disease progression or treatment failure in cancer. Another study used patterns of accumulation of cardiovascular diseases, indicated by medications used to treat them, to investigate the effectiveness of modifiable disease progression in statin initiators [ 80 ].…”

Section: Discussionmentioning

confidence: 99%

Assessment of Medication Safety Using Only Dispensing Data

Pratt

Roughead

2018

Curr Epidemiol Rep

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Purpose of ReviewThe purpose of this review is to provide an overview of the published studies that have been used to generate evidence on the safety of medicine use when only medication dispensing data are available.Recent FindingsMedication dispensing databases are increasingly available for research on large populations, particularly in countries that provide universal coverage for medicines. These data are often used for drug utilisation studies to identify inappropriate medicine use at the population level that may be associated with known safety issues. Lack of coded diagnoses, to identify outcomes, and lack of data on confounders can limit use of these data in practice for medication safety assessment. To overcome these issues, studies have exploited the fact that symptoms of adverse effects of medications can be treated with other medications, for example antidepressants to treat depression or oxybutynin to treat urinary incontinence. The challenge of unmeasured confounding has been addressed by implementing self-controlled study designs that use within-person comparisons and provide inherent control for confounding. Prescription sequence symmetry analysis (SSA) is a within-person study design that has been demonstrated as a useful tool for safety signal generation in dispensing data.SummaryUsing medicine initiation as a proxy for the development of adverse events can help to generate evidence of the safety of medicines when only medication dispensing data are available. Careful consideration, however, should be given to the sensitivity and specificity of the proxy medicine for the adverse event and potential for time-varying confounding due to trends in medicine utilisation. Data-mining approaches using dispensing data have the potential to improve safety assessments; however, the challenge of unmeasured confounding with these methods remains to be investigated.

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“…Herceptin Program and PBS data do not contain specific information identifying disease progression and proxies for progression using these datasets have been shown to be unreliable. [ 15 ] It is recommended practice to change a chemotherapeutic agent at the time of disease progression, [ 16 ] and during the study period it was also common practice to continue trastuzumab treatment beyond disease progression but change chemotherapeutic agents. [ 17 ] The use of chemotherapy agents with trastuzumab following treatment with a taxane in our cohort likely represents trastuzumab continued beyond progression, however, we did not attempt to identify specific instances of the non-adherent practice of continuing trastuzumab use beyond disease progression.…”

Section: Methodsmentioning

confidence: 99%

Adherence to prescribing restrictions for HER2-positive metastatic breast cancer in Australia: A national population-based observational study (2001-2016)

et al. 2018

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BackgroundTargeted cancer therapy is often complex, involving multiple agents and chemotherapeutic partners. In Australia, prescribing restrictions are put in place to reflect existing evidence of cost-effectiveness of these medicines. As therapeutic options continue to expand, these restrictions may not be perceived to align with best practice and it is not known if their use in the real-world clinic adheres to these restrictions. We examined the treatment of women receiving trastuzumab for HER2-positive metastatic breast cancer (HER2+MBC) to determine the extent to which treatment adhered to national prescribing restrictions.Patients and methodsOur population-based, retrospective cohort study used dispensing records for every Australian woman initiating publicly-subsidised trastuzumab for HER2+MBC between 2001–2013, followed through 2016. We used group-based trajectory models (GBTMs) to cluster patients, first on their patterns of trastuzumab exposure, and then on their patterns of lapatinib and chemotherapy exposure. We described the characteristics of patients within each cluster, and examined their treatments and combinations of treatments to determine restriction adherence.ResultsOf 5,052 patients initiating trastuzumab, 1,795 (36%) received at least one non-adherent HER2-targeted treatment. The most common non-adherent treatments were trastuzumab combinations involving vinorelbine (24% of non-adherent treatments); capecitabine (24%); and anthracyclines (10%). Non-adherent lapatinib use was observed in 4% of patients. GBTM identified three trastuzumab exposure clusters, each containing three further sub-clusters. The largest proportions of non-adherent treatments were in sub-clusters with longer trastuzumab exposure and more non-taxane chemotherapy. Patients in these sub-clusters were younger than those in sub-clusters with less non-adherent treatment.ConclusionsOur study highlights that, even during the relatively simpler treatment era of our study period, a substantial amount of treatment did not adhere to prescribing restrictions. As more trials are conducted exploring pertuzumab and T-DM1 in combination with different chemotherapies and other HER2-targeted therapies, the regulation and funding of HER2-targeted treatment will become more challenging.

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Validating a proxy for disease progression in metastatic cancer patients using prescribing and dispensing data

Cited by 5 publications

References 21 publications

Validation studies of claims data in the Asia‐Pacific region: A comprehensive review

Validation studies of claims data in the Asia‐Pacific region: A comprehensive review

Assessment of Medication Safety Using Only Dispensing Data

Adherence to prescribing restrictions for HER2-positive metastatic breast cancer in Australia: A national population-based observational study (2001-2016)

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