Orphan disease status of cancer cachexia in the USA and in the European Union: a systematic review
Background Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for e...
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| Published in | Journal of cachexia, sarcopenia and muscle Vol. 10; no. 1; pp. 22 - 34 |
|---|---|
| Main Authors | , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Germany
John Wiley & Sons, Inc
01.02.2019
John Wiley and Sons Inc Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2190-5991 2190-6009 2190-6009 |
| DOI | 10.1002/jcsm.12402 |
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| Abstract | Background
Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called ‘orphan diseases’. The cut‐off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population).
Methods
For this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top‐10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non‐hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status.
Results
We estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer).
Conclusions
The absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease. |
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| AbstractList | Background
Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called ‘orphan diseases’. The cut‐off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population).
Methods
For this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top‐10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non‐hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status.
Results
We estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer).
Conclusions
The absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease. Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called 'orphan diseases'. The cut-off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population). For this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top-10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non-hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status. We estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer). The absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease. Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called 'orphan diseases'. The cut-off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population).BACKGROUNDCachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called 'orphan diseases'. The cut-off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population).For this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top-10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non-hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status.METHODSFor this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top-10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non-hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status.We estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer).RESULTSWe estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer).The absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease.CONCLUSIONSThe absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease. BackgroundCachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called ‘orphan diseases’. The cut‐off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population).MethodsFor this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top‐10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non‐hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status.ResultsWe estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer).ConclusionsThe absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease. Abstract Background Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced stages, but prevalence data for the overall population are lacking. Good quality estimates of cancer cachexia in general and for each of the major cancer types would be highly relevant for potential treatment development efforts in this field. Both the USA and European Union (EU) have implemented special clinical development rules for such rare disorders what are called ‘orphan diseases’. The cut‐off level for a disease to be considered an orphan disease in the USA is 200 000 people (0.06% of the population) and EU is 5 per 10 000 people (0.05% of the population). Methods For this systematic review, we searched at PubMed (from inception to 31 January 2018) to identify clinical studies that assessed the prevalence of cachexia in cancer patients at risk. Studies reporting the prevalence of either cancer cachexia or wasting disease in the top‐10 cancer types and 4 other selected cancer types known to be particularly commonly complicated by cachexia were included in this analysis (i.e. prostate cancer, breast cancer, colorectal cancer, melanoma, endometrial cancer, thyroid cancer, urinary bladder cancer, non‐hodgkin lymphoma, lung cancer, kidney and renal pelvis cancer, head and neck cancer, gastric cancer, liver cancer, and pancreatic cancer). We calculated the current burden of cancer cachexia, disease by disease, in the USA and in the EU and compared them to the current guidelines for the definition of orphan disease status. Results We estimate that in 2014 in the USA, a total of 527 100 patients (16.5 subjects per 10 000 people of the total population), and in 2013 in the EU, a total of 800 300 patients (15.8 subjects per 10 000 people of the total population) suffered from cancer cachexia (of any kind). In the 14 separately analysed cancer types, the prevalence of cancer cachexia in the USA ranged between 11 300 (0.4/10 000, gastric cancer) and 92 000 patients (2.9/10 000, lung cancer) and in the EU between 14 300 (0.3/10 000, melanoma of the skin) and 150 100 (3.0/10 000, colorectal cancer). Conclusions The absolute number of patients affected by cancer cachexia in each cancer group is lower than the defined thresholds for orphan diseases in the USA and EU. Cancer cachexia in each subgroup separately should be considered an orphan disease. |
| Author | Haverkamp, Wilhelm Strasser, Florian Jatoi, Aminah Coats, Andrew J.S. Anker, Markus S. Morley, John E. Muscaritoli, Maurizio Haehling, Stephan Landmesser, Ulf Holcomb, Richard Anker, Stefan D. |
| AuthorAffiliation | 4 Department of Clinical Medicine Sapienza University of Rome Rome Italy 7 Mayo Clinic Rochester MN USA 10 DZHK (German Centre for Cardiovascular Research), Partner Site Berlin Berlin Institute of Health (BIH) Berlin Germany 5 Department of Cardiology and Pneumology, DZHK (German Center for Cardiovascular Research) University of Göttingen Medical Center (UMG) Göttingen Germany 6 Department of Internal Medicine and Cardiology Charité University Medicine Berlin Germany 2 Department of Cardiology Charité Campus Benjamin Franklin Berlin Germany 3 Independent biostatistician Minneapolis MN USA 1 Division of Cardiology and Metabolism, Department of Cardiology & Berlin‐Brandenburg Center for Regenerative Therapies (BCRT) DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Charité‐Universitätsmedizin Berlin (CVK) Berlin Germany 8 Division of Geriatric Medicine Saint Louis University School of Medicine Saint Louis MO 63104 USA 9 Oncological Palliative Medicine, Clinic Medical Oncology |
| AuthorAffiliation_xml | – name: 11 Department of Cardiology Campus Benjamin Franklin Charité Universitätsmedizin Berlin Berlin Germany – name: 2 Department of Cardiology Charité Campus Benjamin Franklin Berlin Germany – name: 3 Independent biostatistician Minneapolis MN USA – name: 12 IRCCS San Raffaele Hospital, Pisana Rome Italy – name: 1 Division of Cardiology and Metabolism, Department of Cardiology & Berlin‐Brandenburg Center for Regenerative Therapies (BCRT) DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Charité‐Universitätsmedizin Berlin (CVK) Berlin Germany – name: 6 Department of Internal Medicine and Cardiology Charité University Medicine Berlin Germany – name: 7 Mayo Clinic Rochester MN USA – name: 4 Department of Clinical Medicine Sapienza University of Rome Rome Italy – name: 8 Division of Geriatric Medicine Saint Louis University School of Medicine Saint Louis MO 63104 USA – name: 9 Oncological Palliative Medicine, Clinic Medical Oncology and Haematology, Department of Internal Medicine Cantonal Hospital, St Gallen and Integrated Cancer Rehabilitation Klinik Gais Switzerland – name: 10 DZHK (German Centre for Cardiovascular Research), Partner Site Berlin Berlin Institute of Health (BIH) Berlin Germany – name: 5 Department of Cardiology and Pneumology, DZHK (German Center for Cardiovascular Research) University of Göttingen Medical Center (UMG) Göttingen Germany |
| Author_xml | – sequence: 1 givenname: Markus S. surname: Anker fullname: Anker, Markus S. email: markus.anker@charite.de organization: Charité Campus Benjamin Franklin – sequence: 2 givenname: Richard surname: Holcomb fullname: Holcomb, Richard organization: Independent biostatistician – sequence: 3 givenname: Maurizio surname: Muscaritoli fullname: Muscaritoli, Maurizio organization: Sapienza University of Rome – sequence: 4 givenname: Stephan surname: Haehling fullname: Haehling, Stephan organization: University of Göttingen Medical Center (UMG) – sequence: 5 givenname: Wilhelm surname: Haverkamp fullname: Haverkamp, Wilhelm organization: Charité University Medicine – sequence: 6 givenname: Aminah surname: Jatoi fullname: Jatoi, Aminah organization: Mayo Clinic – sequence: 7 givenname: John E. surname: Morley fullname: Morley, John E. organization: Saint Louis University School of Medicine – sequence: 8 givenname: Florian surname: Strasser fullname: Strasser, Florian organization: Cantonal Hospital, St Gallen and Integrated Cancer Rehabilitation – sequence: 9 givenname: Ulf surname: Landmesser fullname: Landmesser, Ulf organization: Charité Universitätsmedizin Berlin – sequence: 10 givenname: Andrew J.S. surname: Coats fullname: Coats, Andrew J.S. organization: San Raffaele Hospital, Pisana – sequence: 11 givenname: Stefan D. surname: Anker fullname: Anker, Stefan D. organization: DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Charité‐Universitätsmedizin Berlin (CVK) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30920776$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
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| References | 1993; 7 2017; 8 1980; 69 2013; 4 2017; 4 1997; 22 2002; 52 1983; 1 2015; 94 2015; 121 2010; 102 2008; 12 2006; 176 2003; 170 2011; 12 2012; 14 1999; 8 Nov1932 2014; 22 1991; 6 2005; 24 1996; 12 1992; 6 2015; 372 1988; 4 2016; 7 2009; 2009 2017; 96 2010; 26 2014; 3 2018; 4 2017; 35 2008; 27 1986; 5 2004; 171 2014; 38 2013; 132 2011; 185 1994; 3 1998; 34 2016; 22 e_1_2_8_28_1 e_1_2_8_24_1 e_1_2_8_47_1 e_1_2_8_26_1 e_1_2_8_49_1 e_1_2_8_5_1 e_1_2_8_7_1 e_1_2_8_9_1 e_1_2_8_20_1 e_1_2_8_43_1 e_1_2_8_22_1 e_1_2_8_45_1 Ferraro CD (e_1_2_8_3_1) 2012; 14 e_1_2_8_41_1 e_1_2_8_17_1 e_1_2_8_19_1 e_1_2_8_13_1 e_1_2_8_36_1 e_1_2_8_15_1 e_1_2_8_38_1 e_1_2_8_32_1 e_1_2_8_11_1 e_1_2_8_34_1 e_1_2_8_51_1 e_1_2_8_30_1 e_1_2_8_29_1 e_1_2_8_25_1 e_1_2_8_46_1 e_1_2_8_27_1 e_1_2_8_48_1 e_1_2_8_2_1 e_1_2_8_4_1 e_1_2_8_6_1 e_1_2_8_8_1 e_1_2_8_21_1 e_1_2_8_42_1 e_1_2_8_23_1 e_1_2_8_44_1 e_1_2_8_40_1 e_1_2_8_18_1 e_1_2_8_39_1 e_1_2_8_14_1 e_1_2_8_35_1 e_1_2_8_16_1 e_1_2_8_37_1 e_1_2_8_10_1 e_1_2_8_31_1 e_1_2_8_12_1 e_1_2_8_33_1 e_1_2_8_50_1 30920780 - J Cachexia Sarcopenia Muscle. 2019 Feb;10(1):3-5 |
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Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in... Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in advanced... BackgroundCachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer, especially in... Abstract Background Cachexia has significant impact on the patients' quality of life and prognosis. It is frequently observed in patients with cancer,... |
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| SubjectTerms | Bladder cancer Breast cancer Cachexia Cachexia - epidemiology Colorectal cancer Disease Endometrial cancer Epidemiology Estimates European Union Gastric cancer Head & neck cancer Humans Liver cancer Lung cancer Lymphoma Melanoma Neoplasms - epidemiology Original Orphan disease Pancreatic cancer Prevalence Prostate cancer Rare Diseases - epidemiology Systematic review Thyroid cancer United States - epidemiology USA |
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| Title | Orphan disease status of cancer cachexia in the USA and in the European Union: a systematic review |
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