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Breast intensity modulated radiation therapy versus tissue compensation: What's in a name?
Practical Radiation Oncology (2014) 4, 3–5
www.practicalradonc.org
Commentary
Breast intensity modulated radiation therapy versus tissue compensation: What's in a name? Kevin Roof MD a , Lawrence B. Marks MD b,⁎ a
Southeast Radiation Oncology and the Levine Cancer Institute, Charlotte, North Carolina University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
b
Received 4 February 2013; accepted 21 February 2013
What’s in a name? Two articles in Practical Radiation Oncology raise this question in relation to “Breast IMRT” (intensity modulated radiation therapy). The “Breast IMRT” in these papers used 2 tangent fields. Shah et al 1 used forward planned field-in-field techniques. They noted decreased acute and late toxicity in patients receiving conventionally fractionated whole breast radiation with “IMRT” versus wedges. Their finding is consistent with the results of 3 prospective randomized trials of “Breast IMRT” delivered with tangent fields. 2-4 Taunk and Prosnitz 5 used both inverse- and forward-planning approaches to modulate the tangent fields. They conclude that cardiac sparing is comparable between plans with simple heart blocks compared with IMRT-based approaches. These papers confirm widely held beliefs that “Breast IMRT” via tangent fields improves dose homogeneity but does not spare adjacent critical organs any better than simpler, more cost-effective, techniques. We question the following: (1) Is “Breast IMRT” via tangents truly IMRT? and (2) Can our society bear the expense of “Breast IMRT” at current reimbursement rates?
IMRT versus tissue compensation IMRT affords the ability to deliver highly conformal dose distributions to irregularly shaped targets. IMRT is particularly useful when the target volumes have concavities, and/ or when the distribution of normal tissues surrounding a ⁎ Corresponding author. CB #7512, 101 Manning Dr, Chapel Hill, NC 27599. E-mail address: [email protected] (L.B. Marks).
target is complex. This technology increases the therapeutic ratio for radiation therapy in many settings. IMRT is timeconsuming, requires specialized expertise, equipment, and oversight, thus justifying higher reimbursement rates. Many have labeled “field-in-field” forward-planned breast treatment as “IMRT.” While such plans do technically modulate beam intensities, they lack many other essential features of “traditional IMRT.” We believe it is more accurate to refer to this as “tissue compensation,” a related but different concept. Physical and dynamic wedges are tissue compensators as they help provide more uniform dose distributions. However, they provide a relatively uniform degree of modulation within 1 of the 2 primary axes orthogonal to the central ray (and no modulation in the other primary axis orthogonal to the central ray). Multileaf collimators (MLCs) facilitate beam modulation in a relatively unconstrained manner. Different from wedges, MLCs enable each “beamlet” to have its own intensity; ie, in all directions orthogonal to the central ray. Such techniques allow “compensation” of beam fluence to account for differences in breast separation throughout all dimensions of the tangent field. Studies have reported superior dosimetric and clinical outcomes with this compared with traditional techniques. 2-4 IMRT is a nonspecific, overly simple term. Considering tangential breast fields, wedges can be considered “onedimensional intensity modulators” as they vary beam intensity in 1 direction orthogonal to the central ray. Customized compensators enable beam intensity modulation in 2 directions orthogonal to the central ray. MLCs afford these same capabilities. Therefore, “two-dimensional” intensity modulation can be used (1) as part of a complex multifield intensity modulation plan aimed to
1879-8500/$ – see front matter © 2014 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.prro.2013.02.010
4
K. Roof, L.B. Marks
deliver an unusual dose distribution, or (2) for customized missing-tissue compensation in 2 directions. The same billing codes have been used for both goals. We contend such tissue compensation does not warrant the reimbursement intended for labor-intensive “traditional IMRT.” The model IMRT policy of the American Society for Radiation Oncology (ASTRO) states “IMRT is particularly useful for obtaining highly conformal dose distributions needed to irradiate complex targets near or immediately adjacent to sensitive normal tissues. IMRT is considered reasonable and medically necessary in instances where sparing surrounding normal tissue is of added benefit and at least one of the following conditions is met: 1) Target volume is in close proximity to critical structures that must be protected, 2) The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structure, 3) An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision, 4) The target volume is concave or convex and critical normal tissues are within or around that convexity or concavity, 5) Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.” (ASTRO, personal communication, November 19, 2012) “Breast IMRT” would meet these standards if there were reason to believe it affords pulmonary or cardiac protection beyond that achievable with conventional opposed tangential beam-based approaches. As shown by Taunk and Prosnitz, 5 tangent IMRT affords no advantage in cardiac sparing over conventional approaches. They also note, “Planning studies have shown that multi-field IMRT employing non-tangential beams creates a more concave dose distribution than standard 2 field RT, but at the expense of exposing more heart, lungs, and contra-lateral breast to low doses of radiation.” While such “traditional multi-beam-orientation IMRT” approaches for breast cancer have been described (ie, treating the breast with beams beyond opposed tangents), they are not widely applied.
Costs of “Breast IMRT” Calling field-in-field tangential radiation beams (or other means of modulating simple tangents) “IMRT” results in unjustifiably high reimbursements that our society cannot afford. The Office of Inspector General projects a 27% increase in U.S. cancer treatment costs between 2010 and 2020, reaching $158 billion in 2020 (http://www.nih.gov/news/health/jan2011/nci-12.htm). The Institute of Medicine recent workshop titled “Delivering Affordable Cancer Care in the 21st Century” aimed to discuss policy issues related to the value, cost containment, and reimbursement of cancer care. In this spirit, several professional organizations are taking steps to reduce medical costs; for example, through the Choosing Wisely
Practical Radiation Oncology: January-February 2014
campaign. We propose that addressing breast IMRT reimbursement issues may be an efficient means for ASTRO to reduce radiation oncology costs, as breast cancer is one of the most common diagnoses associated with an IMRT charge. We certainly are not the first to raise these concerns. For example, a 2003 editorial by Potters et al, 6 published after one of the early articles on breast IMRT by Vicini et al, 7 raised concern about using the term IMRT to describe such modulation for tangential breast treatments, and foresaw the associated economic implications. A 2007 editorial by Haffty et al, 8 published with Pignol et al’s Journal of Clinical Oncology article on breast IMRT, 2 also summarized the difference between this form of field-in-field “IMRT" versus more complicated IMRT and suggested the option of multiple IMRT coding levels. A 2011 editorial by Kachnic and Powell 9 also raised these same concerns in their comments regarding a SEER-based review that noted increases in IMRT billing for breast cancer. 10 We agree with sentiments raised in these prior editorials. Recently, Palmetto GBA J-1 (California’s Medicare carrier) released a draft local coverage determination for IMRT. Similarly, national Blue Cross Blue Shield distributed a proposed IMRT policy. Both of these policies include broad coverage for IMRT for breast cancer. We submit that such an approach is too broad, and allows for over-utilization of “Breast IMRT” resulting in significant financial burden on the healthcare system. In collaboration with several radiation oncology centers in North Carolina, and colleagues at Blue Cross Blue Shield North Carolina, we generated a proposed policy that we believe better represents the appropriate utilization of IMRT services for breast cancer. In essence, we identified several situations wherein the anatomy of the targeted tissues (eg, involvement of the internal mammary nodal area) might call for the use of “traditional IMRT” (ie, the use of multiple beam orientations). Further, we stipulated that treatment must be delivered using beam orientations beyond the “traditional tangent fields” and that the resultant dose distribution was meaningfully superior to tangents based on objective quantitative dose-volume thresholds. The details are available at www.bcbsnc.com/ assets/services/public/pdfs/medicalpolicy/intensity_ modulated_radiation_therapy_imrt_of_breast_and_lung. pdf. As shown by Taunk and Prosnitz, 5 for most patients being treated with left-sided tangents, the dose to the heart can be easily reduced by shaping the deep border of the inferior aspect of the field, and does not require IMRT. The IMRT limited to tangent fields improves dose homogeneity and decreases toxicity, but this is essentially tissue compensation by another name. In our opinion, this should not be billed as IMRT at current reimbursement levels. IMRT will likely replace 3-dimensional planning for many cancers. Ideally, we would allow evidence to guide us in its use. In the absence of evidence, however, reimbursement will steer the ship. Palmetto-GBA’s draft
Practical Radiation Oncology: January-February 2014
Local Coverage Determination for IMRT follows ASTRO’s model policy, which includes International Statistical Classifications of Diseases (ICD)-9s for essentially all malignancies (including metastases). As IMRT becomes more routinely adapted, our field should work to create a more rational coding structure that better reflects the efforts and expense of different types of IMRT, including “tangent-field breast IMRT.” We acknowledge that tangential beams for breast cancer can lead to injury to the adjacent normal tissues (eg, heart and lung). Our field has a strong track record for rationally applying technologies to improve the therapeutic ratio of radiation therapy, and we should do all that we reasonably can to minimize these risks. However, “breast IMRT” via tangent fields appears to provide no sparing of these normal tissues beyond that achievable with simpler methods (eg, shaping the deep border of the tangents and/or using gating to displace the heart away from the breast). As healthcare expenditures continue to rise, we need to critically assess whether more advanced, expensive technologies actually provide clinically significant benefits. Requesting IMRT reimbursement for “tissue compensation” seems inappropriate.
Defining breast IMRT
2.
3.
4.
5.
6.
7.
8.
9.
References 10. 1. Shah C, Wobb J, Grills I, et al. Use of intensity modulated radiation therapy to reduce acute and chronic toxicities of breast cancer patient
5
treated with traditional and accelerated breast irradiation. Pract Radiat Oncol. 2012;2:e45-e51. Pignol JP, Olivotto I, Rakovitch E, et al. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008;26:2085-2092. Donovan E, Bleakley N, Denholm E, et al. Randomised trial of standard 2D radiotherapy (RT) versus intensity modulated radiotherapy (IMRT) in patients prescribed breast radiotherapy. Radiother Oncol. 2007;82:254-264. Barnett GC, Wilkinson JS, Moody AM, et al. Randomized controlled trial of forward-planned intensity modulated radiotherapy for early breast cancer: interim results at 2 years. Int J Radiat Oncol Biol Phys. 2012;82:715-723. Taunk NK, Prosnitz RG. Planning comparison of intensity modulated radiation therapy delivered with 2 tangential fields versus 3-dimensional conformal radiotherapy for cardiac sparing in women with left-sided breast cancer. Pract Radiat Oncol. 2012;2: 248-256. Potters L, Steinberg M, Wallner P, Hevezi J. How one defines intensity-modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2003;56:609-610. Vicini FA, Sharpe M, Kestin L, et al. Optimizing breast cancer treatment efficacy with intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2002;54:1336-1344. Haffty BG, Buchholz TA, McCormick B. Should intensitymodulated radiation therapy be the standard of care in the conservatively managed breast cancer patient? J Clin Oncol. 2008;26:2072-2074. Kachnic LA, Powell SN. IMRT for breast cancer–balancing outcomes, patient selection, and resource utilization. J Natl Cancer Inst. 2011;103:777-779. Smith BD, Pan IW, Shih YC, et al. Adoption of intensity-modulated radiation therapy for breast cancer in the United States. J Natl Cancer Inst. 2011;103:798-809.
www.practicalradonc.org
Commentary
Breast intensity modulated radiation therapy versus tissue compensation: What's in a name? Kevin Roof MD a , Lawrence B. Marks MD b,⁎ a
Southeast Radiation Oncology and the Levine Cancer Institute, Charlotte, North Carolina University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
b
Received 4 February 2013; accepted 21 February 2013
What’s in a name? Two articles in Practical Radiation Oncology raise this question in relation to “Breast IMRT” (intensity modulated radiation therapy). The “Breast IMRT” in these papers used 2 tangent fields. Shah et al 1 used forward planned field-in-field techniques. They noted decreased acute and late toxicity in patients receiving conventionally fractionated whole breast radiation with “IMRT” versus wedges. Their finding is consistent with the results of 3 prospective randomized trials of “Breast IMRT” delivered with tangent fields. 2-4 Taunk and Prosnitz 5 used both inverse- and forward-planning approaches to modulate the tangent fields. They conclude that cardiac sparing is comparable between plans with simple heart blocks compared with IMRT-based approaches. These papers confirm widely held beliefs that “Breast IMRT” via tangent fields improves dose homogeneity but does not spare adjacent critical organs any better than simpler, more cost-effective, techniques. We question the following: (1) Is “Breast IMRT” via tangents truly IMRT? and (2) Can our society bear the expense of “Breast IMRT” at current reimbursement rates?
IMRT versus tissue compensation IMRT affords the ability to deliver highly conformal dose distributions to irregularly shaped targets. IMRT is particularly useful when the target volumes have concavities, and/ or when the distribution of normal tissues surrounding a ⁎ Corresponding author. CB #7512, 101 Manning Dr, Chapel Hill, NC 27599. E-mail address: [email protected] (L.B. Marks).
target is complex. This technology increases the therapeutic ratio for radiation therapy in many settings. IMRT is timeconsuming, requires specialized expertise, equipment, and oversight, thus justifying higher reimbursement rates. Many have labeled “field-in-field” forward-planned breast treatment as “IMRT.” While such plans do technically modulate beam intensities, they lack many other essential features of “traditional IMRT.” We believe it is more accurate to refer to this as “tissue compensation,” a related but different concept. Physical and dynamic wedges are tissue compensators as they help provide more uniform dose distributions. However, they provide a relatively uniform degree of modulation within 1 of the 2 primary axes orthogonal to the central ray (and no modulation in the other primary axis orthogonal to the central ray). Multileaf collimators (MLCs) facilitate beam modulation in a relatively unconstrained manner. Different from wedges, MLCs enable each “beamlet” to have its own intensity; ie, in all directions orthogonal to the central ray. Such techniques allow “compensation” of beam fluence to account for differences in breast separation throughout all dimensions of the tangent field. Studies have reported superior dosimetric and clinical outcomes with this compared with traditional techniques. 2-4 IMRT is a nonspecific, overly simple term. Considering tangential breast fields, wedges can be considered “onedimensional intensity modulators” as they vary beam intensity in 1 direction orthogonal to the central ray. Customized compensators enable beam intensity modulation in 2 directions orthogonal to the central ray. MLCs afford these same capabilities. Therefore, “two-dimensional” intensity modulation can be used (1) as part of a complex multifield intensity modulation plan aimed to
1879-8500/$ – see front matter © 2014 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.prro.2013.02.010
4
K. Roof, L.B. Marks
deliver an unusual dose distribution, or (2) for customized missing-tissue compensation in 2 directions. The same billing codes have been used for both goals. We contend such tissue compensation does not warrant the reimbursement intended for labor-intensive “traditional IMRT.” The model IMRT policy of the American Society for Radiation Oncology (ASTRO) states “IMRT is particularly useful for obtaining highly conformal dose distributions needed to irradiate complex targets near or immediately adjacent to sensitive normal tissues. IMRT is considered reasonable and medically necessary in instances where sparing surrounding normal tissue is of added benefit and at least one of the following conditions is met: 1) Target volume is in close proximity to critical structures that must be protected, 2) The volume of interest must be covered with narrow margins to adequately protect immediately adjacent structure, 3) An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision, 4) The target volume is concave or convex and critical normal tissues are within or around that convexity or concavity, 5) Dose escalation is planned to deliver radiation doses in excess of those commonly utilized for similar tumors with conventional treatment.” (ASTRO, personal communication, November 19, 2012) “Breast IMRT” would meet these standards if there were reason to believe it affords pulmonary or cardiac protection beyond that achievable with conventional opposed tangential beam-based approaches. As shown by Taunk and Prosnitz, 5 tangent IMRT affords no advantage in cardiac sparing over conventional approaches. They also note, “Planning studies have shown that multi-field IMRT employing non-tangential beams creates a more concave dose distribution than standard 2 field RT, but at the expense of exposing more heart, lungs, and contra-lateral breast to low doses of radiation.” While such “traditional multi-beam-orientation IMRT” approaches for breast cancer have been described (ie, treating the breast with beams beyond opposed tangents), they are not widely applied.
Costs of “Breast IMRT” Calling field-in-field tangential radiation beams (or other means of modulating simple tangents) “IMRT” results in unjustifiably high reimbursements that our society cannot afford. The Office of Inspector General projects a 27% increase in U.S. cancer treatment costs between 2010 and 2020, reaching $158 billion in 2020 (http://www.nih.gov/news/health/jan2011/nci-12.htm). The Institute of Medicine recent workshop titled “Delivering Affordable Cancer Care in the 21st Century” aimed to discuss policy issues related to the value, cost containment, and reimbursement of cancer care. In this spirit, several professional organizations are taking steps to reduce medical costs; for example, through the Choosing Wisely
Practical Radiation Oncology: January-February 2014
campaign. We propose that addressing breast IMRT reimbursement issues may be an efficient means for ASTRO to reduce radiation oncology costs, as breast cancer is one of the most common diagnoses associated with an IMRT charge. We certainly are not the first to raise these concerns. For example, a 2003 editorial by Potters et al, 6 published after one of the early articles on breast IMRT by Vicini et al, 7 raised concern about using the term IMRT to describe such modulation for tangential breast treatments, and foresaw the associated economic implications. A 2007 editorial by Haffty et al, 8 published with Pignol et al’s Journal of Clinical Oncology article on breast IMRT, 2 also summarized the difference between this form of field-in-field “IMRT" versus more complicated IMRT and suggested the option of multiple IMRT coding levels. A 2011 editorial by Kachnic and Powell 9 also raised these same concerns in their comments regarding a SEER-based review that noted increases in IMRT billing for breast cancer. 10 We agree with sentiments raised in these prior editorials. Recently, Palmetto GBA J-1 (California’s Medicare carrier) released a draft local coverage determination for IMRT. Similarly, national Blue Cross Blue Shield distributed a proposed IMRT policy. Both of these policies include broad coverage for IMRT for breast cancer. We submit that such an approach is too broad, and allows for over-utilization of “Breast IMRT” resulting in significant financial burden on the healthcare system. In collaboration with several radiation oncology centers in North Carolina, and colleagues at Blue Cross Blue Shield North Carolina, we generated a proposed policy that we believe better represents the appropriate utilization of IMRT services for breast cancer. In essence, we identified several situations wherein the anatomy of the targeted tissues (eg, involvement of the internal mammary nodal area) might call for the use of “traditional IMRT” (ie, the use of multiple beam orientations). Further, we stipulated that treatment must be delivered using beam orientations beyond the “traditional tangent fields” and that the resultant dose distribution was meaningfully superior to tangents based on objective quantitative dose-volume thresholds. The details are available at www.bcbsnc.com/ assets/services/public/pdfs/medicalpolicy/intensity_ modulated_radiation_therapy_imrt_of_breast_and_lung. pdf. As shown by Taunk and Prosnitz, 5 for most patients being treated with left-sided tangents, the dose to the heart can be easily reduced by shaping the deep border of the inferior aspect of the field, and does not require IMRT. The IMRT limited to tangent fields improves dose homogeneity and decreases toxicity, but this is essentially tissue compensation by another name. In our opinion, this should not be billed as IMRT at current reimbursement levels. IMRT will likely replace 3-dimensional planning for many cancers. Ideally, we would allow evidence to guide us in its use. In the absence of evidence, however, reimbursement will steer the ship. Palmetto-GBA’s draft
Practical Radiation Oncology: January-February 2014
Local Coverage Determination for IMRT follows ASTRO’s model policy, which includes International Statistical Classifications of Diseases (ICD)-9s for essentially all malignancies (including metastases). As IMRT becomes more routinely adapted, our field should work to create a more rational coding structure that better reflects the efforts and expense of different types of IMRT, including “tangent-field breast IMRT.” We acknowledge that tangential beams for breast cancer can lead to injury to the adjacent normal tissues (eg, heart and lung). Our field has a strong track record for rationally applying technologies to improve the therapeutic ratio of radiation therapy, and we should do all that we reasonably can to minimize these risks. However, “breast IMRT” via tangent fields appears to provide no sparing of these normal tissues beyond that achievable with simpler methods (eg, shaping the deep border of the tangents and/or using gating to displace the heart away from the breast). As healthcare expenditures continue to rise, we need to critically assess whether more advanced, expensive technologies actually provide clinically significant benefits. Requesting IMRT reimbursement for “tissue compensation” seems inappropriate.
Defining breast IMRT
2.
3.
4.
5.
6.
7.
8.
9.
References 10. 1. Shah C, Wobb J, Grills I, et al. Use of intensity modulated radiation therapy to reduce acute and chronic toxicities of breast cancer patient
5
treated with traditional and accelerated breast irradiation. Pract Radiat Oncol. 2012;2:e45-e51. Pignol JP, Olivotto I, Rakovitch E, et al. A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. J Clin Oncol. 2008;26:2085-2092. Donovan E, Bleakley N, Denholm E, et al. Randomised trial of standard 2D radiotherapy (RT) versus intensity modulated radiotherapy (IMRT) in patients prescribed breast radiotherapy. Radiother Oncol. 2007;82:254-264. Barnett GC, Wilkinson JS, Moody AM, et al. Randomized controlled trial of forward-planned intensity modulated radiotherapy for early breast cancer: interim results at 2 years. Int J Radiat Oncol Biol Phys. 2012;82:715-723. Taunk NK, Prosnitz RG. Planning comparison of intensity modulated radiation therapy delivered with 2 tangential fields versus 3-dimensional conformal radiotherapy for cardiac sparing in women with left-sided breast cancer. Pract Radiat Oncol. 2012;2: 248-256. Potters L, Steinberg M, Wallner P, Hevezi J. How one defines intensity-modulated radiation therapy. Int J Radiat Oncol Biol Phys. 2003;56:609-610. Vicini FA, Sharpe M, Kestin L, et al. Optimizing breast cancer treatment efficacy with intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2002;54:1336-1344. Haffty BG, Buchholz TA, McCormick B. Should intensitymodulated radiation therapy be the standard of care in the conservatively managed breast cancer patient? J Clin Oncol. 2008;26:2072-2074. Kachnic LA, Powell SN. IMRT for breast cancer–balancing outcomes, patient selection, and resource utilization. J Natl Cancer Inst. 2011;103:777-779. Smith BD, Pan IW, Shih YC, et al. Adoption of intensity-modulated radiation therapy for breast cancer in the United States. J Natl Cancer Inst. 2011;103:798-809.