Letters to the editor
Alberto Larghi, Vasco Eguia, Cesare Hassan, Elizabeth C. Verna, Ilaria Tarantino, Tamas A. Gonda Economic crisis: the right time to widen endoscopic ultrasound utilization
The global burden of cancer continues to grow and is a major economic expenditure for all the developed countries, where cancer treatment represents 4.1 % – 9.3 % of total health care spending [1 – 3]. Along with universally growing health care costs, this is of particular concern in this period of financial crisis, with many countries facing a potential period of economic recession or stagnation. The increase in cost is not simply the result of an increase in the absolute number of cancer patients due to the aging of the population, but also to the introduction of very costly new antineoplastic agents and technologies [4]. Moreover, a substantial proportion of the costs for patients with solid tumors are related to surgery, which is perceived as the sole cure for patients with cancer [5]. Appropriate patient selection and accurate preoperative diagnosis and staging are therefore critical to avoiding unnecessary or ineffective surgery [4]. For cancers of the gastrointestinal tract, such as esophageal, gastric, rectal, and pancreatic cancers, and for non-small-cell lung cancer (NSCLC), once radiological imaging modalities have excluded distant metastasis, proper locoregional staging is of paramount importance to select the most appropriate treatment. On the basis of preoperative locoregional staging, surgical candidates are stratified to undergo surgical resection alone or after neoadjuvant therapy (NAT). Nonsurgical candidates are treated palliatively [6 – 9]. Despite limited evidence of survival advantages, the use of NAT in appropriately staged individuals may further strengthen selection by discouraging surgical resection in patients with tumor progression despite NAT. This is a particularly important consideration in esophageal and pancreatic cancers, for which surgery still carries significant risk of morbidity and mortality even in tertiary care referral centers [10]. For luminal gastrointestinal cancers and for NSCLC, lymph node status (N status) remains the key determinant to establishing the need for NAT. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently the most accurate
Endoscopy 2014; 46: 80–81
minimally invasive procedure available for the objective determination of N status, allowing lymph nodes to be sampled that would be difficult to reach by other nonsurgical modalities [11]. Similarly, for pancreatic cancers, EUS-FNA makes it possible to evaluate invasion of major locoregional vascular structures while obtaining a tissue diagnosis, both of which are necessary to determining the best treatment strategy [12]. Despite these special properties, however, EUS continues to be underutilized in the United States and in Europe [13 – 16]. Several factors that limit the widespread utilization of EUS have been pointed out elsewhere: chiefly, the limited availability and accessibility of EUS in some countries, and the low perceived utility of EUS in others. The former appears to be closely related to training (limited opportunities for hands-on training and no adequate training guidelines or certifications) and to the high cost of equipment and accessories, while the latter is probably related to provider education and concern about the diagnostic accuracy and reproducibility of EUS findings. This concern may be due to the perception that EUS is highly operator-dependent. The retrieval by EUS of cytologic rather than histologic specimens has been, in our opinion, an additional major factor limiting the widespread use of the procedure. Cytology does indeed require a high degree of expertise rarely found outside high-volume tertiary care centers, and this has created a barrier to the dissemination of EUS in the community, where the lack of cytology expertise may have resulted in low diagnostic accuracy and, therefore, in a limited perceived utility of EUS. The negative perception that EUS is highly operator-dependent could be improved through the implementation of specific training and practice guidelines, thus eliminating the concern about inadequate EUS training, as recently described in the United States [17]. A joint task force involving both European and North American Endoscopy Societies should be formed, with the aim of developing common training guidelines and defining standards of quality by which training centers can be credentialed. This is particularly important as EUS is naturally evolving from a diagnostic into a more therapeutic/interventional procedure, requiring a higher degree of expertise with constant and frequent changes. Government financial support for training centers might help the process to take place more rigor-
ously. Decreases by manufacturing companies in the cost of EUS equipment and accessories could also help this process of expansion. Improving the perceived utility of EUS may also help to increase its utilization. Specific courses would expand levels of knowledge about indications for EUS and could have an impact on the appropriateness of EUS referral patterns [18]. Improving communication and interaction between the endosonographers and the referring physicians, with more information in print and lectures, has also been found to be valuable [19]. Finally, alternative endoscopic techniques have been developed, together with dedicated needles for obtaining a core tissue biopsy specimen for histologic examination under EUS guidance [20 – 22]. These efforts may lead to a shift in this field from cytology to histology, which is easier to interpret, thus potentially contributing to the widespread use of the procedure. This shift will likely pave the way for targeted therapies and better approaches to the treatment of most gastrointestinal malignancies, because tissue samples for histologic examination are more appropriate for performing predictive molecular marker tests or cell cultures with chemosensitivity testing to guide individualized therapy [23, 24]. We believe that having a dedicated pathologist to read EUS samples is still of paramount importance [22], and that efforts to establish pathology expertise by combining the educational activities of pathologists with those of endosonographers should be encouraged. Is this the right time to widen the utilization of EUS? We say yes, because a crisis can be used as an opportunity to influence and change behaviors. We believe the time for the proper utilization of EUS has arrived. EUS represents the right diagnostic strategy in a time with cost constraints, and its wider implementation will open the door to targeted therapy and monitoring of treatment response in a more biologically driven manner than has been available in the past. Competing interests: None
References 1 Mariotto AB, Yabroff KR, Shao Y et al. Projections of the cost of cancer care in the United States: 2010 – 2020. J Natl Cancer Inst 2011; 103: 117 – 128
Downloaded by: Collections and Technical Services Department. Copyrighted material.
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2 National Health System, UK Department of Health. National Expenditure Data. http:// www.dh.gov.uk/en/Managingyourorganisation/Financeandplanning/Programmebudgeting/ DH_075743 3 Jönsson B, Wilking N. The burden and cost of cancer. Ann Oncol 2007; 18: 8 – 22 4 Sullivan R, Peppercorn J, Sikora K et al. Delivering affordable cancer care in high-income countries. Lancet Oncol 2011; 12: 933 – 980 5 Warren JL, Yabroff KR, Meekins A et al. Evaluation of trends in the cost of initial cancer treatment. J Natl Cancer Inst 2008; 100: 888 – 897 6 Matuschek C, Bölke E, Peiper M et al. The role of neoadjuvant and adjuvant treatment for adenocarcinoma of the upper gastrointestinal tract. Eur J Med Res 2011; 16: 265 – 274 7 Kosinski L, Habr-Gama A, Ludwig K et al. Shifting concepts in rectal cancer management: a review of contemporary primary rectal cancer treatment strategies. CA Cancer J Clin 2012; 62: 173 – 202 8 Hidalgo M. Pancreatic cancer. N Engl J Med 2010; 362: 1605 – 1617 9 Felip E, Cedrés S, Checa E et al. How to integrate current knowledge in selecting patients for first line in NSCLC? Ann Oncol 2010; 21: vii230 – 233 10 Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high-risk surgery. N Engl J Med 2011; 364: 2128 – 2137 11 Hawes RH. The evolution of endoscopic ultrasound: improved imaging, higher accuracy for fine needle aspiration and the reality of endoscopic ultrasound-guided interven-
12
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14
15
16
17
18
19
tions. Curr Opin Gastroenterol 2010; 26: 436 – 444 Hasan MK, Hawes RH. EUS-guided FNA of solid pancreas tumors. Gastrointest Endosc Clin N Am 2012; 22: 155 – 167 Ahmad NA, Kochman ML, Ginsberg GG. Practice patterns and attitudes toward the role of endoscopic ultrasound in staging of gastrointestinal malignancies: a survey of physicians and surgeons. Am J Gastroenterol 2005; 100: 2662 – 2668 Yusuf TE, Harewood GC, Clain JE et al. International survey of knowledge of indications for EUS. Gastrointest Endosc 2006; 63: 107 – 111 Reddy NK, Markowitz AB, Abbruzzese JL et al. Knowledge of indications and utilization of EUS: a survey of oncologists in the United States. J Clin Gastroenterol 2008; 42: 892 – 896 Kalaitzakis E, Panos M, Sadik R et al. Clinicians’ attitudes towards endoscopic ultrasound: a survey of four European countries. Scand J Gastroenterol 2009; 44: 100 – 107 Azad JS, Verma D, Kapadia AS et al. Can U.S. GI fellowship programs meet American Society for Gastrointestinal Endoscopy recommendations for training in EUS? A survey of U.S. GI fellowship program directors Gastrointest Endosc 2006; 64: 235 – 241 Harewood GC, Yusuf TE, Clain JE et al. Assessment of the impact of an educational course on knowledge of appropriate EUS indications. Gastrointest Endosc 2005; 61: 554 – 559 Lachter J, Feldman R, Krief I et al. Satisfaction of the referring physician: a quality control study focusing on EUS. J Clin Gastroenterol 2007; 41: 889 – 893
20 Larghi A, Verna EC, Ricci R et al. EUS-guided fine-needle tissue acquisition by using a 19gauge needle in a selected patient population: a prospective study. Gastrointest Endosc 2011; 74: 504 – 510 21 Larghi A, Capurso G, Carnuccio A et al. Ki-67 grading of nonfunctioning pancreatic neuroendocrine tumors on histologic samples obtained by EUS-guided fine-needle tissue acquisition: a prospective study. Gastrointest Endosc 2012; 76: 570 – 577 22 Iglesias-Garcia J, Poley JW, Larghi A et al. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc 2011; 73: 1189 – 1196 23 Braat H, Bruno M, Kuipers EJ et al. Pancreatic cancer: promise for personalised medicine? Cancer Lett 2012; 318: 1 – 8 24 Wakatsuki T, Irisawa A, Terashima M et al. ATP assay-guided chemosensitivity testing for gemcitabine with biopsy specimens obtained from unresectable pancreatic cancer using endoscopic ultrasonography-guided fine-needle aspiration. Int J Clin Oncol 2011; 16: 387 – 394
Alberto Larghi, MD, PhD Digestive Endoscopy Unit Università Cattolica del Sacro Cuore Largo A. Gemelli 8, 00168 Rome Italy Fax: +39-06-30156581 [email protected]
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Downloaded by: Collections and Technical Services Department. Copyrighted material.
Letters to the editor
Alberto Larghi, Vasco Eguia, Cesare Hassan, Elizabeth C. Verna, Ilaria Tarantino, Tamas A. Gonda Economic crisis: the right time to widen endoscopic ultrasound utilization
The global burden of cancer continues to grow and is a major economic expenditure for all the developed countries, where cancer treatment represents 4.1 % – 9.3 % of total health care spending [1 – 3]. Along with universally growing health care costs, this is of particular concern in this period of financial crisis, with many countries facing a potential period of economic recession or stagnation. The increase in cost is not simply the result of an increase in the absolute number of cancer patients due to the aging of the population, but also to the introduction of very costly new antineoplastic agents and technologies [4]. Moreover, a substantial proportion of the costs for patients with solid tumors are related to surgery, which is perceived as the sole cure for patients with cancer [5]. Appropriate patient selection and accurate preoperative diagnosis and staging are therefore critical to avoiding unnecessary or ineffective surgery [4]. For cancers of the gastrointestinal tract, such as esophageal, gastric, rectal, and pancreatic cancers, and for non-small-cell lung cancer (NSCLC), once radiological imaging modalities have excluded distant metastasis, proper locoregional staging is of paramount importance to select the most appropriate treatment. On the basis of preoperative locoregional staging, surgical candidates are stratified to undergo surgical resection alone or after neoadjuvant therapy (NAT). Nonsurgical candidates are treated palliatively [6 – 9]. Despite limited evidence of survival advantages, the use of NAT in appropriately staged individuals may further strengthen selection by discouraging surgical resection in patients with tumor progression despite NAT. This is a particularly important consideration in esophageal and pancreatic cancers, for which surgery still carries significant risk of morbidity and mortality even in tertiary care referral centers [10]. For luminal gastrointestinal cancers and for NSCLC, lymph node status (N status) remains the key determinant to establishing the need for NAT. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently the most accurate
Endoscopy 2014; 46: 80–81
minimally invasive procedure available for the objective determination of N status, allowing lymph nodes to be sampled that would be difficult to reach by other nonsurgical modalities [11]. Similarly, for pancreatic cancers, EUS-FNA makes it possible to evaluate invasion of major locoregional vascular structures while obtaining a tissue diagnosis, both of which are necessary to determining the best treatment strategy [12]. Despite these special properties, however, EUS continues to be underutilized in the United States and in Europe [13 – 16]. Several factors that limit the widespread utilization of EUS have been pointed out elsewhere: chiefly, the limited availability and accessibility of EUS in some countries, and the low perceived utility of EUS in others. The former appears to be closely related to training (limited opportunities for hands-on training and no adequate training guidelines or certifications) and to the high cost of equipment and accessories, while the latter is probably related to provider education and concern about the diagnostic accuracy and reproducibility of EUS findings. This concern may be due to the perception that EUS is highly operator-dependent. The retrieval by EUS of cytologic rather than histologic specimens has been, in our opinion, an additional major factor limiting the widespread use of the procedure. Cytology does indeed require a high degree of expertise rarely found outside high-volume tertiary care centers, and this has created a barrier to the dissemination of EUS in the community, where the lack of cytology expertise may have resulted in low diagnostic accuracy and, therefore, in a limited perceived utility of EUS. The negative perception that EUS is highly operator-dependent could be improved through the implementation of specific training and practice guidelines, thus eliminating the concern about inadequate EUS training, as recently described in the United States [17]. A joint task force involving both European and North American Endoscopy Societies should be formed, with the aim of developing common training guidelines and defining standards of quality by which training centers can be credentialed. This is particularly important as EUS is naturally evolving from a diagnostic into a more therapeutic/interventional procedure, requiring a higher degree of expertise with constant and frequent changes. Government financial support for training centers might help the process to take place more rigor-
ously. Decreases by manufacturing companies in the cost of EUS equipment and accessories could also help this process of expansion. Improving the perceived utility of EUS may also help to increase its utilization. Specific courses would expand levels of knowledge about indications for EUS and could have an impact on the appropriateness of EUS referral patterns [18]. Improving communication and interaction between the endosonographers and the referring physicians, with more information in print and lectures, has also been found to be valuable [19]. Finally, alternative endoscopic techniques have been developed, together with dedicated needles for obtaining a core tissue biopsy specimen for histologic examination under EUS guidance [20 – 22]. These efforts may lead to a shift in this field from cytology to histology, which is easier to interpret, thus potentially contributing to the widespread use of the procedure. This shift will likely pave the way for targeted therapies and better approaches to the treatment of most gastrointestinal malignancies, because tissue samples for histologic examination are more appropriate for performing predictive molecular marker tests or cell cultures with chemosensitivity testing to guide individualized therapy [23, 24]. We believe that having a dedicated pathologist to read EUS samples is still of paramount importance [22], and that efforts to establish pathology expertise by combining the educational activities of pathologists with those of endosonographers should be encouraged. Is this the right time to widen the utilization of EUS? We say yes, because a crisis can be used as an opportunity to influence and change behaviors. We believe the time for the proper utilization of EUS has arrived. EUS represents the right diagnostic strategy in a time with cost constraints, and its wider implementation will open the door to targeted therapy and monitoring of treatment response in a more biologically driven manner than has been available in the past. Competing interests: None
References 1 Mariotto AB, Yabroff KR, Shao Y et al. Projections of the cost of cancer care in the United States: 2010 – 2020. J Natl Cancer Inst 2011; 103: 117 – 128
Downloaded by: Collections and Technical Services Department. Copyrighted material.
80
2 National Health System, UK Department of Health. National Expenditure Data. http:// www.dh.gov.uk/en/Managingyourorganisation/Financeandplanning/Programmebudgeting/ DH_075743 3 Jönsson B, Wilking N. The burden and cost of cancer. Ann Oncol 2007; 18: 8 – 22 4 Sullivan R, Peppercorn J, Sikora K et al. Delivering affordable cancer care in high-income countries. Lancet Oncol 2011; 12: 933 – 980 5 Warren JL, Yabroff KR, Meekins A et al. Evaluation of trends in the cost of initial cancer treatment. J Natl Cancer Inst 2008; 100: 888 – 897 6 Matuschek C, Bölke E, Peiper M et al. The role of neoadjuvant and adjuvant treatment for adenocarcinoma of the upper gastrointestinal tract. Eur J Med Res 2011; 16: 265 – 274 7 Kosinski L, Habr-Gama A, Ludwig K et al. Shifting concepts in rectal cancer management: a review of contemporary primary rectal cancer treatment strategies. CA Cancer J Clin 2012; 62: 173 – 202 8 Hidalgo M. Pancreatic cancer. N Engl J Med 2010; 362: 1605 – 1617 9 Felip E, Cedrés S, Checa E et al. How to integrate current knowledge in selecting patients for first line in NSCLC? Ann Oncol 2010; 21: vii230 – 233 10 Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high-risk surgery. N Engl J Med 2011; 364: 2128 – 2137 11 Hawes RH. The evolution of endoscopic ultrasound: improved imaging, higher accuracy for fine needle aspiration and the reality of endoscopic ultrasound-guided interven-
12
13
14
15
16
17
18
19
tions. Curr Opin Gastroenterol 2010; 26: 436 – 444 Hasan MK, Hawes RH. EUS-guided FNA of solid pancreas tumors. Gastrointest Endosc Clin N Am 2012; 22: 155 – 167 Ahmad NA, Kochman ML, Ginsberg GG. Practice patterns and attitudes toward the role of endoscopic ultrasound in staging of gastrointestinal malignancies: a survey of physicians and surgeons. Am J Gastroenterol 2005; 100: 2662 – 2668 Yusuf TE, Harewood GC, Clain JE et al. International survey of knowledge of indications for EUS. Gastrointest Endosc 2006; 63: 107 – 111 Reddy NK, Markowitz AB, Abbruzzese JL et al. Knowledge of indications and utilization of EUS: a survey of oncologists in the United States. J Clin Gastroenterol 2008; 42: 892 – 896 Kalaitzakis E, Panos M, Sadik R et al. Clinicians’ attitudes towards endoscopic ultrasound: a survey of four European countries. Scand J Gastroenterol 2009; 44: 100 – 107 Azad JS, Verma D, Kapadia AS et al. Can U.S. GI fellowship programs meet American Society for Gastrointestinal Endoscopy recommendations for training in EUS? A survey of U.S. GI fellowship program directors Gastrointest Endosc 2006; 64: 235 – 241 Harewood GC, Yusuf TE, Clain JE et al. Assessment of the impact of an educational course on knowledge of appropriate EUS indications. Gastrointest Endosc 2005; 61: 554 – 559 Lachter J, Feldman R, Krief I et al. Satisfaction of the referring physician: a quality control study focusing on EUS. J Clin Gastroenterol 2007; 41: 889 – 893
20 Larghi A, Verna EC, Ricci R et al. EUS-guided fine-needle tissue acquisition by using a 19gauge needle in a selected patient population: a prospective study. Gastrointest Endosc 2011; 74: 504 – 510 21 Larghi A, Capurso G, Carnuccio A et al. Ki-67 grading of nonfunctioning pancreatic neuroendocrine tumors on histologic samples obtained by EUS-guided fine-needle tissue acquisition: a prospective study. Gastrointest Endosc 2012; 76: 570 – 577 22 Iglesias-Garcia J, Poley JW, Larghi A et al. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc 2011; 73: 1189 – 1196 23 Braat H, Bruno M, Kuipers EJ et al. Pancreatic cancer: promise for personalised medicine? Cancer Lett 2012; 318: 1 – 8 24 Wakatsuki T, Irisawa A, Terashima M et al. ATP assay-guided chemosensitivity testing for gemcitabine with biopsy specimens obtained from unresectable pancreatic cancer using endoscopic ultrasonography-guided fine-needle aspiration. Int J Clin Oncol 2011; 16: 387 – 394
Alberto Larghi, MD, PhD Digestive Endoscopy Unit Università Cattolica del Sacro Cuore Largo A. Gemelli 8, 00168 Rome Italy Fax: +39-06-30156581 [email protected]
Endoscopy 2014; 46: 80–81
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Downloaded by: Collections and Technical Services Department. Copyrighted material.
Letters to the editor
