Survival of melanoma patients treated with novel drugs: retrospective analysis of real-world data

Polkowska, M; Ekk-Cierniakowski, P; Czepielewska, Edyta; Wysoczański, Wojciech; Matusewicz, W; Kozłowska−Wojciechowska, Małgorzata

doi:10.1007/s00432-017-2453-z

Cited by 15 publications

(17 citation statements)

References 24 publications

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“…To date, only one published study has examined the real-world comparative effectiveness of second-line ipilimumab compared to standard chemotherapy. This study, conducted in Poland, found similar survival benefit as the trial (adjusted HR = 0.65), but observed differences in median OS from the clinical trial experience, including attenuated median OS and less evident survival tail plateau compared to that observed in the trial [2,5]. Additionally, correction for possible lead-time bias or differences in patient comorbidity between groups was not undertaken and notably the comparison group was contemporary rather than historic.…”

Section: Introductionmentioning

confidence: 74%

Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada

et al. 2020

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Background: For novel cancer treatments, effectiveness in clinical practice is not always aligned with clinical efficacy results. As such it is important to understand a treatment's real-world effectiveness. We examined real-world population-based comparative effectiveness of second-line ipilimumab versus non-ipilimumab treatments (chemotherapy or targeted treatments). Methods: We used a cohort of melanoma patients receiving systemic treatment for advanced disease since April 2005 from Ontario, Canada. Patients were identified from provincial drug databases and the Ontario Cancer Registry who received second-line ipilimumab from 2012 to 2015 (treated) or second-line non-ipilimumab treatment prior to 2012 (historical controls). Historical controls were chosen, to permit the most direct comparison to pivotal trial findings. The cohort was linked to administrative databases to identify baseline characteristics and outcomes. Kaplan-Meier curves and multivariable Cox regression models were used to assess overall survival (OS). Observed potential confounders were adjusted for using inverse probability of treatment weighting (IPTW). Results:We identified 329 patients with metastatic melanoma (MM) who had received second-line treatments (189 treated; 140 controls). Patients receiving second-line ipilimumab were older (61.7 years vs 55.2 years) compared to historical controls. Median OS were 6.9 (95% CI: 5.4-8.3) and 4.95 (4.3-6.0) months for ipilimumab and controls, respectively. The crude 1-year, 2-year, and 3-year OS probabilities were 34.3% (27-41%), 20.6% (15-27%), and 15.2% (9.6-21%) for ipilimumab and 17.1% (11-23%), 7.1% (2.9-11%), and 4.7% (1.2-8.2%) for controls. Ipilimumab was associated with improved OS (IPTW HR = 0.62; 95% CI: 0.49-0.78; p < 0.0001).Conclusions: This real-world analysis suggests second-line ipilimumab is associated with an improvement in OS for MM patients in routine practice.

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Section: Introductionmentioning

confidence: 74%

Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada

et al. 2020

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“…1 In recent years, novel drugs for melanoma have provided a significant advantage in survival over classic chemotherapy, especially for immunotherapy-treated patients, achieving long-lasting results in terms of overall survival. 2 Ipilimumab was the first immunotherapeutic drug that demonstrated a survival benefit over the long-standing standard therapy with dacarbazine in advanced melanoma. 3 Costs associated with cutaneous melanoma have been extensively discussed and reviewed in literature, 4,5 but new scenarios are opening up because the new immunotherapeutic drugs are very expensive treatments and are likely to cause an increasing economic impact on public and private healthcare systems.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Optimization of resources by drug management: A multicentred web-administered study on the use of ipilimumab in Italy

Damuzzo

Russi

Chiumente³

et al. 2018

J Oncol Pharm Pract

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Objective: In a scenario of new expensive cancer therapies entering the market, strategies of optimisation and cost containment are crucial in oncology care. Better management of drug waste and centralization of drug preparation can be effective strategies to achieve these goals. The aim of this work is to describe the economic management of a high cost anticancer drug (ipilimumab) in some Italian reference centres. Methods: This was an observational, multicentred study in which economical and clinical data of 21 cancer centres (418 patients) were collected during the enrollment period from February 2013 to August 2014. The follow-up period ended in July 2015. Results: Participants purchased 10.7% more vials of ipilimumab than necessary for compounding. The results were variable among centres, and only five centres had a deviation lower than 5% between the drug purchased and the drug prescribed. Hospitals applying the drug day reached a statistically significant residual of drug effectively used compared to the amount prescribed (P ¼ 0.018). Consequently, the price for treating a model patient was significantly lower in those hospitals (median spare of 7456 euro per patient). Conclusions: This study demonstrated that the careful management of drug waste and the application of drug-day, through a proper selection of vial and the ability to use the leftover drug, can generate economic savings. However, tailoring the drug stock to clinical need is still an open issue which deserves further analysis.

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“…To date, only low-quality evidence is available to inform treatment sequencing decisions, but randomized studies are currently underway. Retrospective analyses, mostly involving ipilimumab, have suggested that prior treatment with a BRAFi is associated with an inferior response to subsequent immunotherapy [ 19 – 21 ], whereas recent analyses involving nivolumab and pembrolizumab are more controversial [ 22 , 23 , 25 – 27 ]. In the current analysis, patients who received initial ppRx with immunotherapy or targeted therapy had similar OS outcomes across the cobimetinib plus vemurafenib, vemurafenib monotherapy, and dacarbazine cohorts.…”

Section: Discussionmentioning

confidence: 99%

Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials

et al. 2020

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Background We sought to identify patient subgroups with distinct postprogression overall survival (ppOS) outcomes and investigate the impact of original treatment assignment and initial postprogression treatment (ppRx) on ppOS. Methods Recursive partitioning analysis (RPA) was performed to model relationships between prespecified covariates and ppOS in patients with BRAFV600-mutated metastatic melanoma who had experienced progressive disease (PD) following treatment with cobimetinib plus vemurafenib, vemurafenib monotherapy, or dacarbazine in the BRIM-2, BRIM-3, BRIM-7, and coBRIM studies. Prognostic subgroups identified by RPA were then applied to pooled treatment cohorts. The primary endpoint was ppOS, defined as time from first PD to death from any cause. Results RPA identified baseline lactate dehydrogenase (LDH), baseline disease stage, Eastern Cooperative Oncology Group performance status at PD, and ppRx as significant prognostic factors for ppOS. Median ppOS was longest in patients with normal baseline LDH, stage M1c disease at baseline, and ppRx with immunotherapy or targeted therapy (12.2 months; 95% CI 10.3–16.1) and shortest in those with elevated baseline LDH > 2 × upper limit of normal (2.3 months; 95% CI 1.8–2.7). Original treatment assignment did not impact ppOS. Across treatment cohorts, patients treated with immunotherapy or targeted therapy after PD had better ppOS than those given other treatments. Conclusion A combination of factors at baseline (LDH, disease stage) and PD (performance status, ppRx) impact ppOS outcomes. ppRx with immunotherapy or targeted therapy is an independent prognostic factor for improved overall survival following progression regardless of original treatment. Trial registration The trials included in this analysis are registered with ClinicalTrials.gov: NCT00949702 (BRIM-2), NCT01006980 (BRIM-3), NCT01271803 (BRIM-7), and NCT01689519 (coBRIM).

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Survival of melanoma patients treated with novel drugs: retrospective analysis of real-world data

Cited by 15 publications

References 24 publications

Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada

Real-world comparative effectiveness of second-line ipilimumab for metastatic melanoma: a population-based cohort study in Ontario, Canada

Optimization of resources by drug management: A multicentred web-administered study on the use of ipilimumab in Italy

Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials

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