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Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel

BACKGROUND: Immunotherapy (IO) has been associated with improved outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC). The primary objective of SPEAR‐Merkel was to explore treatment patterns, clinical outcomes, and health care resource...

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Autores principales: Bhanegaonkar, Abhijeet, Liu, Frank X., Boyd, Marley, Fulcher, Nicole, Kim, Ruth, Krulewicz, Stan, Smith, Jodi, Cowey, C. Lance
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8417847/
https://www.ncbi.nlm.nih.gov/pubmed/34101298
http://dx.doi.org/10.1002/onco.13845
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author Bhanegaonkar, Abhijeet
Liu, Frank X.
Boyd, Marley
Fulcher, Nicole
Kim, Ruth
Krulewicz, Stan
Smith, Jodi
Cowey, C. Lance
author_facet Bhanegaonkar, Abhijeet
Liu, Frank X.
Boyd, Marley
Fulcher, Nicole
Kim, Ruth
Krulewicz, Stan
Smith, Jodi
Cowey, C. Lance
author_sort Bhanegaonkar, Abhijeet
collection PubMed
description BACKGROUND: Immunotherapy (IO) has been associated with improved outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC). The primary objective of SPEAR‐Merkel was to explore treatment patterns, clinical outcomes, and health care resource utilization (HCRU) in patients with laMCC or mMCC initiating first‐line (1L) treatment with avelumab, non‐avelumab IO, or chemotherapy in a U.S. community oncology setting. METHODS: Adult patients with laMCC or mMCC initiating 1L avelumab, non‐avelumab IO, or chemotherapy from January 1, 2015, to March 31, 2019, were identified from the U.S. Oncology Network electronic health care record database and followed up through September 30, 2019. Baseline characteristics and HCRU were analyzed descriptively, including physician‐stated overall response rate in the real‐world clinical setting. Kaplan‐Meier methods were used to measure duration of response, real‐world progression‐free survival (rwPFS), and overall survival (OS). RESULTS: Among the overall population (n = 94), 28 received 1L avelumab (9 laMCC, 19 mMCC), 26 received 1L non‐avelumab IO (8 laMCC, 18 mMCC), and 40 received 1L chemotherapy (10 laMCC, 30 mMCC). The real‐world overall response rate was 64.3%, 61.5%, and 42.5%, respectively. From 1L treatment initiation, median rwPFS was 11.4, 8.1, and 6.1 months, and median OS was 20.2 months, not reached, and 14.7 months for the respective cohorts. CONCLUSION: SPEAR‐Merkel showed that patients with laMCC or mMCC treated with IO had improved outcomes compared with chemotherapy in clinical practice. The study provides insight on utilization and clinical outcomes associated with newer, more innovative therapies in clinical practice, which may help clinicians understand the variety of newer treatment options for both laMCC and mMCC. IMPLICATIONS FOR PRACTICE: To the authors’ knowledge, SPEAR‐Merkel is the first study to evaluate real‐world clinical outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC) receiving first‐line (1L) avelumab, non‐avelumab immuno‐oncology therapies, or chemotherapy in a real‐world setting. SPEAR‐Merkel showed clinical benefit for immuno‐oncology therapies compared with chemotherapy. The study provides insight on uses and clinical outcomes associated with innovative therapies in clinical practice, which may help clinicians understand the variety of newer treatment options for both laMCC and mMCC. The study is of particular importance as it shows that chemotherapy is still being used as 1L treatment despite its inferior clinical and safety profile.
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spelling pubmed-84178472021-09-08 Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel Bhanegaonkar, Abhijeet Liu, Frank X. Boyd, Marley Fulcher, Nicole Kim, Ruth Krulewicz, Stan Smith, Jodi Cowey, C. Lance Oncologist Melanoma and Cutaneous Malignancies BACKGROUND: Immunotherapy (IO) has been associated with improved outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC). The primary objective of SPEAR‐Merkel was to explore treatment patterns, clinical outcomes, and health care resource utilization (HCRU) in patients with laMCC or mMCC initiating first‐line (1L) treatment with avelumab, non‐avelumab IO, or chemotherapy in a U.S. community oncology setting. METHODS: Adult patients with laMCC or mMCC initiating 1L avelumab, non‐avelumab IO, or chemotherapy from January 1, 2015, to March 31, 2019, were identified from the U.S. Oncology Network electronic health care record database and followed up through September 30, 2019. Baseline characteristics and HCRU were analyzed descriptively, including physician‐stated overall response rate in the real‐world clinical setting. Kaplan‐Meier methods were used to measure duration of response, real‐world progression‐free survival (rwPFS), and overall survival (OS). RESULTS: Among the overall population (n = 94), 28 received 1L avelumab (9 laMCC, 19 mMCC), 26 received 1L non‐avelumab IO (8 laMCC, 18 mMCC), and 40 received 1L chemotherapy (10 laMCC, 30 mMCC). The real‐world overall response rate was 64.3%, 61.5%, and 42.5%, respectively. From 1L treatment initiation, median rwPFS was 11.4, 8.1, and 6.1 months, and median OS was 20.2 months, not reached, and 14.7 months for the respective cohorts. CONCLUSION: SPEAR‐Merkel showed that patients with laMCC or mMCC treated with IO had improved outcomes compared with chemotherapy in clinical practice. The study provides insight on utilization and clinical outcomes associated with newer, more innovative therapies in clinical practice, which may help clinicians understand the variety of newer treatment options for both laMCC and mMCC. IMPLICATIONS FOR PRACTICE: To the authors’ knowledge, SPEAR‐Merkel is the first study to evaluate real‐world clinical outcomes in patients with locally advanced Merkel cell carcinoma (laMCC) and metastatic Merkel cell carcinoma (mMCC) receiving first‐line (1L) avelumab, non‐avelumab immuno‐oncology therapies, or chemotherapy in a real‐world setting. SPEAR‐Merkel showed clinical benefit for immuno‐oncology therapies compared with chemotherapy. The study provides insight on uses and clinical outcomes associated with innovative therapies in clinical practice, which may help clinicians understand the variety of newer treatment options for both laMCC and mMCC. The study is of particular importance as it shows that chemotherapy is still being used as 1L treatment despite its inferior clinical and safety profile. John Wiley & Sons, Inc. 2021-07-02 2021-09 /pmc/articles/PMC8417847/ /pubmed/34101298 http://dx.doi.org/10.1002/onco.13845 Text en © 2021 EMD Serono Inc. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Melanoma and Cutaneous Malignancies
Bhanegaonkar, Abhijeet
Liu, Frank X.
Boyd, Marley
Fulcher, Nicole
Kim, Ruth
Krulewicz, Stan
Smith, Jodi
Cowey, C. Lance
Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel
title Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel
title_full Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel
title_fullStr Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel
title_full_unstemmed Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel
title_short Real‐World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR‐Merkel
title_sort real‐world clinical outcomes in patients with locally advanced or metastatic merkel cell carcinoma treated in u.s. oncology clinical practices: results from spear‐merkel
topic Melanoma and Cutaneous Malignancies
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8417847/
https://www.ncbi.nlm.nih.gov/pubmed/34101298
http://dx.doi.org/10.1002/onco.13845
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