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Economic Burden of Adverse Events Associated with Immunotherapy and Targeted Therapy for Metastatic Melanoma in the Elderly.

ABSTRACT: Background:Immunotherapies and targeted therapies have drastically improved survival in metastatic melanoma, but they can cause a range of adverse events (AEs). Understanding the costs of these events would facilitate an accurate comparison of melanoma treatments. Objective:To compare the costs and frequency of AEs associated with immunotherapy and with targeted therapy in elderly patients with metastatic melanoma. Methods:We conducted a retrospective cohort study using Medicare claims data from 2011 to 2014. Patients included had to have ?1 diagnoses of metastatic melanoma and ?1 claims for an immunotherapy or targeted therapy. We compared the 30-day expenditures of patients with and without each AE using a generalized linear model to determine the incremental cost per AE in patients who received immunotherapy or targeted therapy. The baseline demographic and clinical differences were adjusted for using propensity score with inverse probability of treatment. We also compared the mean costs of AEs associated with immunotherapy and targeted therapy. Results:A total of 844 patients were included in the study (mean age, 75 years; standard deviation, 14 years). The mean baseline Charlson Comorbidity Index score was 8.4, and 65% of the patients were male. The mean cost for AEs was highest for respiratory events (ie, $24,150). Gastrointestinal, respiratory, and hematologic AEs were more common in patients who received immunotherapy, whereas general and administration-site AEs and other AEs (eg, fatigue, infections, muscular weakness) were more frequent in patients who received targeted therapy. AE-related costs with immunotherapy were highest for gastrointestinal, respiratory, and pain-related AEs; AEs with targeted therapy were highest for cardiovascular and general and administration-site events. Conclusion:These findings suggest that incremental costs associated with treatment-related AEs among elderly patients with metastatic melanoma were substantial, but the risks for and costs of the various types of AEs differed by therapy. Understanding the risks for and costs of AEs associated with the various therapeutic options can inform treatment decision-making in elderly patients with metastatic melanoma.

SUBMITTER: Ghate SR

PROVIDER: S-EPMC6306100 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Economic Burden of Adverse Events Associated with Immunotherapy and Targeted Therapy for Metastatic Melanoma in the Elderly.

Ghate Sameer R SR Li Zhiyi Z Tang Jackson J Nakasato Antonio Reis AR

American health & drug benefits 20181001 7

<h4>Background</h4>Immunotherapies and targeted therapies have drastically improved survival in metastatic melanoma, but they can cause a range of adverse events (AEs). Understanding the costs of these events would facilitate an accurate comparison of melanoma treatments.<h4>Objective</h4>To compare the costs and frequency of AEs associated with immunotherapy and with targeted therapy in elderly patients with metastatic melanoma.<h4>Methods</h4>We conducted a retrospective cohort study using Med ...[more]

PMID: 30647822

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Project description:Opinion statementMelanoma has several clinically and pathologically distinguishable subtypes, which also differ genetically. Mutation patterns vary among different melanoma subtypes, and efficacy of immune-checkpoint inhibitors differs depending on the subtype of melanoma. In spite of the recent revolution of systemic therapies for advanced melanoma, access to innovative agents is still restricted in many countries. This review article aimed to describe the epidemiology and current status of systemic therapies for melanoma in Japan, where melanoma is rare, but access to innovative agents is available. Acral and mucosal melanomas, which are common in Asian populations, predominantly occur in sun-protected areas and share several biological features. Both the melanomas harbor KIT mutation in approximately 15% of the cases; BRAF or NRAS mutation is found in approximately 10-15% of acral melanoma, but these mutations are less frequent in mucosal melanoma. Combined use of BRAF and MEK inhibitors is one of the standards of care for patients with advanced BRAF-mutant melanoma. In patients with melanoma harboring KIT mutation in exon 11 or 13, KIT inhibitors can be a treatment option; however, none of them have been approved in Japan. Immune-checkpoint inhibitors are expected to be less effective against acral and mucosal melanomas because their somatic mutation burden is lower than those in non-acral cutaneous melanomas. A recently completed phase II trial of nivolumab and ipilimumab combination therapy in 30 Japanese patients with melanoma, including seven with acral and 12 with mucosal melanoma, demonstrated an objective response rate of 43%. Regarding oncolytic viruses, canerpaturev (C-REV, also known as HF10) and talimogene laherparepvec (T-VEC) are currently under review in early phase trials. In the adjuvant setting, dabrafenib plus trametinb combination, nivolumab monotherapy, and pembrolizumab monotherapy were approved in July, August, and December 2018 in Japan, respectively. However, most of the adjuvant phase III trials excluded patients with mucosal melanoma. A phase III trial of adjuvant therapy with locoregional interferon (IFN)-β versus surgery alone is ongoing in Japan (JCOG1309, J-FERON), in which IFN-β is injected directly into the site of the primary tumor postoperatively, so that it would be drained through the untreated lymphatic route to the regional node basin. After the recent approval of these new agents, the JCOG1309 trial will be revised to focus on patients with stage II disease. In conclusion, acral and mucosal melanomas have been treated based on the available medical evidence for the treatment of non-acral cutaneous melanomas. Considering the differences in genetic backgrounds and therapeutic efficacy of immunotherapy, specialized therapeutic strategies for these subtypes of melanoma should be established in the future.

Project description:BACKGROUND:A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity. PATIENTS AND METHODS:Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform. RESULTS:One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P?=?0.983), in the overall number of AEs (P?=?0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P?=?0.009) and there was a tendency towards patients in the intervention group having more extra visits (P?=?0.156). CONCLUSION:It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded. TRIAL REGISTRATION:Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.

Dataset Information

Economic Burden of Adverse Events Associated with Immunotherapy and Targeted Therapy for Metastatic Melanoma in the Elderly.

Publications

Economic Burden of Adverse Events Associated with Immunotherapy and Targeted Therapy for Metastatic Melanoma in the Elderly.

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