PERSEPHONE: 6 versus 12 months (m) of adjuvant trastuzumab in patients (pts) with HER2 positive (+) early breast cancer (EBC): Cost effectiveness analysis results

Hulme, Claire; Hall, Peter; Shinkins, Bethany; Chehadah, Fadi; McCabe, Christopher; Hiller, Louise; Dunn, Janet A.; Earl, Helena

doi:10.1093/annonc/mdy424.001

Cited by 6 publications

(5 citation statements)

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“…Furthermore, 6 months of trastuzumab was shown to be cost effective compared to 1-year treatment. Indeed, it was associated with cost savings while maintaining similar quality-adjusted life years (QALY) at 2 years [38]. Therefore, shorter-duration trastuzumab could reduce cardiotoxicity and costs, and enhance the convenience of treatment and compliance of patients.…”

Section: Discussionmentioning

confidence: 99%

Short-duration versus 1-year adjuvant trastuzumab in early HER2 positive breast cancer: A meta-analysis of randomized controlled trials

Chen

Zhou

et al. 2019

Cancer Treatment Reviews

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Background: One year of adjuvant trastuzumab treatment is the standard of care for early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients; however, controversy remains regarding the optimal schedule of trastuzumab because the selection of the 1-year schedule was arbitrary. After the remarkable results of the PERSEPHONE trial as well as the updated final results of the PHARE trial, we performed an updated meta-analysis to reassess the efficacy and safety of shorter durations of trastuzumab. Methods: A literature search of databases was conducted to identify randomized controlled trials reporting the efficacy and cardiotoxicity of shorter-duration and standard 1-year trastuzumab treatment. The hazard ratios (HRs) of disease-free survival (DFS) and overall survival (OS), and the odds ratios (ORs) of cardiac events were also estimated and pooled. Results: Six studies were eligible, including a total of 11,496 patients. Both DFS (HR = 1.13; 95% confidence interval [CI] = 1.03-1.25; p = 0.01) and OS (HR = 1.16; 95% CI = 1.01-1.32; p = 0.03) were significantly improved with conventional 1-year trastuzumab treatment compared with shorter treatments. The more pronounced survival benefits observed in patients with negative estrogen receptor (ER) tumor and nodal involvement should be interpreted cautiously because of the lack of interaction between the survival benefit and ER, as well as the nodal status (interaction test, ER status: p = 0.26; nodal status: p = 0.60). One year of trastuzumab treatment resulted in a substantial DFS benefit compared with shorter schedules when administered concurrently with chemotherapy (HR = 1.22; 95% CI = 1.09-1.38; p = 0.0008; p = 0.02 for the interaction test). Patients in the shorter duration group experienced significantly fewer cardiac events (OR = 0.52; 95% CI = 0.43-0.62; p < 0.00001). Conclusions: Though correlated with an increasing risk of cardiotoxicity, 1 year of adjuvant trastuzumab treatment conferred substantial survival benefits and should remain as the preferred treatment for early stage HER2positive breast cancer. Shorter durations of trastuzumab may serve as an alternative choice for patients with cardiac disease and those at lower risk of recurrence.

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Section: Discussionmentioning

confidence: 99%

Short-duration versus 1-year adjuvant trastuzumab in early HER2 positive breast cancer: A meta-analysis of randomized controlled trials

Chen

Zhou

et al. 2019

Cancer Treatment Reviews

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“…In fact, this conclusion was similar to other CEAs that were conducted in different settings worldwide. For example, a recent study presented in the European Society for Medical Oncology (ESMO) showed that 6-month adjuvant trastuzumab treatment was more cost-effective than one-year adjuvant trastuzumab treatment [43]. Therefore, further studies regarding the cost-effectiveness of the 6-month adjuvant trastuzumab strategy should be conducted in LMICs.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness analyses of breast cancer medications use in developing countries: a systematic review

Al-Ziftawi

Shafie

Ibrahim

2020

Expert Review of Pharmacoeconomics & Outcomes Research

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Background: Pharmacoeconomic evaluation is important for breast-cancer medications due to their high costs. To our knowledge, no systematic literature reviews of pharmacoeconomic studies for breastcancer medication use are present in developing-countries. Objectives: To systematically review the existing cost-effectiveness evaluations of breast-cancer medication in developing-countries. Methodology: A systematic literature search was performed in PubMed, EMBASE, SCOPUS, and EconLit. Two researchers determined the final articles, extracted data, and evaluated their quality using the Quality of Health-Economic Studies (QHES) tool. The interclass-correlation-coefficient (ICC) was calculated to assess interrater-reliability. Data were summarized descriptively. Results: Fourteen pharmacoeconomic studies published from 2009 to 2019 were included. Thirteen used patient-life-years as their effectiveness unit, of which 10 used quality-adjusted life-years. Most of the evaluations focused on trastuzumab as a single agent or on regimens containing trastuzumab (n = 10). The conclusion of cost-effectiveness analysis varied among the studies. All the studies were of high quality (QHES score >75). Interrater reliability between the two reviewers was high (ICC = 0.76). Conclusion:In many studies included in the review, the use of breast-cancer drugs in developing countries was not cost-effective. Yet, more pharmacoeconomic evaluations for the use of recently approved agents in different disease stages are needed in developing countries.

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“…Nonetheless, in a setting of economic constraints, mainly low/low-middle-income countries where trastuzumab and anthracycline-based chemotherapy are still the best option, the higher pORs for clinically relevant cardiac outcomes found is an additional argument in favour of shorter trastuzumab durations, particularly 6 months, in light of the non-inferiority result for disease-free survival shown in PERSEPHONE for this regimen 3. Since decreased costs can be expected both from less monoclonal antibody use and, to a lesser extent, fewer treatments and hospital admissions elicited towards cardiotoxicity, it is reasonable to pursue 6 months of treatment from a pharmaco-economic stand point of view 44…”

Section: Discussionmentioning

confidence: 99%

Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials

et al. 2020

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BackgroundTreatment de-escalation in early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) has been attempted in order to decrease costs and toxicities. One of the strategies pursued is decreasing trastuzumab treatment duration, with mixed results thus far. Trastuzumab-associated cardiotoxicity, however, may be more frequent with 12 months of trastuzumab compared with shorter treatment lengths. Therefore, we have conducted a meta-analysis to address this question.Materials and methodsA meta-analysis of trials testing 12 months of adjuvant trastuzumab versus shorter regimens, reporting cardiac outcomes in patients with HER2-positive BC was performed with the random effects model with inverse variance weighting.ResultsClinical cardiac dysfunction associated with 12 months of trastuzumab versus shorter trastuzumab regimens, including 11 250 patients, showed a pooled OR (pOR) of 1.90 (95% CI 1.37 to 2.64; p value <0.001; I2=65.7%); in the subgroup comparison of 12 versus 6 months, the pOR was 1.57 (95% CI 1.30 to 1.90; p<0.001; I2=5.7%). pOR for low left ventricular ejection fraction was 1.45 (95% CI 1.19 to 1.75; p<0.001; I2=11.9%), 1.55 (95% CI 1.00 to 2.42; p=0.052; I2=0.0%) for congestive heart failure and 3.70 (95% CI 0.27 to 51.60; p=0.33; I2=78.8%) for premature trastuzumab discontinuation due to cardiotoxicity for 12 months versus shorter trastuzumab regimens. Funnel plot analyses indicated a low risk of publication bias.ConclusionsCompared to shorter treatment durations, there is sufficient evidence that 12 months of trastuzumab yields higher odds for the occurrence of relevant cardiac events. An individual patient-level data meta-analysis is needed in order to provide adequate data on risk factors for cardiotoxicity.

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PERSEPHONE: 6 versus 12 months (m) of adjuvant trastuzumab in patients (pts) with HER2 positive (+) early breast cancer (EBC): Cost effectiveness analysis results

Cited by 6 publications

References 0 publications

Short-duration versus 1-year adjuvant trastuzumab in early HER2 positive breast cancer: A meta-analysis of randomized controlled trials

Short-duration versus 1-year adjuvant trastuzumab in early HER2 positive breast cancer: A meta-analysis of randomized controlled trials

Cost-effectiveness analyses of breast cancer medications use in developing countries: a systematic review

Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials

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