Subject:
Radiation Therapy for Gastric Cancer
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Over the past several decades, methods to plan and deliver radiation therapy have evolved in ways that permit more precise targeting of tumors with complex geometries. Earlier methods involved two-dimensional treatment planning based on flat images, and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes. These methods were collectively termed conventional external beam radiation therapy (EBRT).
Subsequent enhancement evolved using 3-dimensional images, usually from computed tomography (CT) scans, to delineate the tumor, its boundaries with adjacent normal tissue, and organs at risk for radiation damage. Radiation oncologists used these images, displayed from a "beam's-eye-view", to shape each of several beams (e.g., with compensators, blocks, or wedges) to conform to the patient's tumor geometry perpendicular to the beam's axis. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. Methods also were developed to position the patient and the radiation portal reproducibly for each fraction, and immobilize the patient, thus maintaining consistent beam axes across treatment sessions. However, "forward" planning used a trial and error process to select treatment parameters (the number of beams and the intensity, shape, and incident axis of each beam). The planner/radiotherapist modified one or more parameters and recalculated dose distributions, if analysis predicted underdosing for part of the tumor or overdosing of nearby normal tissue. Furthermore, since beams had uniform cross-sectional intensity wherever they bypassed shaping devices, it was difficult to match certain geometries (e.g., concave surfaces). Collectively, these methods are termed 3-dimensional conformal radiation therapy (3D-CRT).
Other methods were subsequently developed to permit beam delivery with non-uniform cross-sectional intensity. This often relies on a device (multi-leaf collimator, MLC) situated between the beam source and patient that moves along an arc around the patient. As it moves, a computer varies aperture size independently and continuously for each leaf. Thus, MLCs divide beams into narrow "beamlets", with intensities that range from zero to 100% of the incident beam. Beams may remain on as MLCs move around the patient (dynamic MLC), or they may be off during movement and turned on once the MLC reaches prespecified positions ("step and shoot" technique). Another method of delivering radiation beam uses a small radiation portal emitting a single narrow beam that moves spirally around the patient, with intensity varying as it moved. This method, also known as tomotherapy or helical tomotherapy, is described as the use of a linear accelerator inside a large "donut" that spirals around the body while the patient laid on the table during treatment. Each method (MLC-based or tomotherapy) is coupled to a computer algorithm for "inverse" treatment planning. The planner/radiotherapist delineates the target on each slice of a CT scan, and specifies that target's prescribed radiation dose, acceptable limits of dose heterogeneity within the target volume, adjacent normal tissue volumes to avoid, and acceptable dose limits within the normal tissues. Based on these parameters and a digitally-reconstructed radiographic image of the tumor and surrounding tissues and organs at risk, computer software optimizes the location and shape of beam ports, and beam and beamlet intensities, to achieve the treatment plan's goals. Collectively, these methods are termed intensity-modulated radiation therapy (IMRT).
According to ECRI Institute, there are two different approaches to image-guided radiation therapy that are in current use: pre-treatment imaging and real-time guidance. IMRT is an example of a method that uses pre-treatment imaging to prepare a treatment plan. In contrast, real-time guidance utilizes real-time imaging (at the time of treatment) to guide treatment. It provides real-time, online images of the radiation target area from a computed tomography (CT) scanner before, during, and after therapy. Patient positioning, radiation field alignment, and collimator positioning can be verified and adjusted before and during irradiation. This approach should, in theory, provide more accurate radiation delivery than conventional IMRT. Organ motion, day-to-day variations in tumor position, and differences in patient positioning in each treatment session could be taken into account with real-time imaging.
Policy:
(NOTE: This policy only applies to adult members. It does not apply to pediatric members.
For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
I. Neoadjuvant treatment
For an individual with stage T2-T4 or node-positive disease, the use of up to 28 fractions of three-dimensional conformal radiation therapy (3DCRT) is considered medically necessary.
II. Adjuvant treatment (if no preoperative or prior irradiation given)
For an individual with at least pT2 or node-positive disease, positive margins, microscopic or macroscopic residual disease or high risk features such as poor differentiation, lymphovascular invasion, neural invasion, and age less than 50, the use of up to 28 fractions of 3DCRT is considered medically necessary.
III. Definitive treatment
For an individual who is inoperable (i.e., due to co-morbidity), the use of up to 28 fractions of 3DCRT is considered medically necessary.
IV. Palliation
The use of 15 fractions of 3DCRT is considered medically necessary.
Medicare Coverage:
Medicare Advantage Products follow CMS National Coverage Determinations, Local Coverage Determinations and other CMS Guidance (eg, Medicare Benefit Policy Manual, Medicare Learning Network Articles (MLN Matters Articles), Medicare Claims Processing Manual)). If CMS does not have a coverage or noncoverage position on a service, Medicare Advantage Products will follow Horizon BCBSNJ Medical Policy. If there is no CMS Guidance and no Horizon BCBSNJ Medical Policy, then eviCore Radiation Guidelines will be applied.
EG: Medicare Advantage Products follow LCD L36711 for Intensity Modulated Radiation Therapy (IMRT). For additional information and eligibility, refer to Local Coverage Determination (LCD): Intensity Modulated Radiation Therapy (IMRT) (L36711).
NCDs available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx
LCDs available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46
DME LCDS available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.
Providers are responsible for reviewing CMS Medicare Coverage Center Guidance and in the event of a conflict between the Medicare Coverage section of the medical policy and the CMS Medicare Coverage Center Guidance, the CMS Medicare Coverage Center Guidance will control.
[INFORMATIONAL NOTE: According to Eighth Edition of the AJCC Cancer Staging Manual, “…if a tumor involves the esophagogastric junction (EGJ) and its epicenter is < 2 cm into the proximal stomach (i.e., < 2 cm distal to the EGJ)…” it is classified as esophageal cancer. “Tumors involving the EGJ with their epicenter > 2 cm into the proximal stomach (i.e., > 2 cm distal to the EGJ)…” are classified as gastric cancer.
In the postoperative treatment of gastric carcinoma, chemoradiation is indicated for an individual with stage IB-IV (M0) based on the INT 0116 study. In INT 0116, 559 patients with stage IB-IV adenocarcinoma of the stomach or GEJ (20% of patients) following R0 resection were randomized to chemoradiotherapy (CRT) (5-FU/leucovorin before, during and concurrent with radiation to 45 Gy) or to no further treatment. In the most recent update with a 10-year median follow up, CRT continues to show a significant improvement in overall survival (OS) (HR 1.32) and for relapse-free survival (RFS) (HR 1.51). This benefit extended to all T stages, N stages as well as location in the GEJ.
In terms of historical progression of treatment planning techniques; after the Intergroup 0116 trial, which used AP-PA field arrangement, Soyfer et al (2007) published data concluding that a non-coplanar 3D conformal approach yielded better results than AP-PA plans. In 2008 this same group compared IMRT to 3D conformal techniques for adjuvant management of gastric cancer, concluded that IMRT confers only marginal benefit, and should be used “...only in the small subset of patients with risk factors for kidney disease or those with preexisting nephropathy.”
In 2010, the group at Stanford (Minn et al.) published on sequential groups of patients treated in the adjuvant setting, initially 3DCRT (26 patients), and after 2002 with IMRT (33 patients). The two-year OS for the 3DCRT and IMRT groups was 51% and 65%, respectively (p=0.5). The two-year disease-free survival (DFS) for the 3DCRT and IMRT groups was 60% and 54%, respectively (p=0.8). The two-year local control rate for the 3DCRT and IMRT groups was 83% and 81%, respectively (p=0.9). The Stanford group interpreted this data to show that IMRT could be delivered effectively without compromising outcome. In terms of toxicity, 3 patients required a treatment break of a median duration of 7 days due to toxicity in the 3DCRT group (range, 4 to 10 days), whereas no patient in the IMRT group required a treatment break. Grade 2 or higher acute GI toxicity was noted in 61.5% and 61.2% of patients in the 3DCRT and IMRT groups, respectively. Regarding late toxicity, among the 3DCRT patients, 1 patient died of small bowel perforation requiring surgical intervention (grade 5). Grade 3 late toxicity was experienced by 3 individuals who developed small bowel obstruction. Two patients developed grade 2 late toxicity (jaundice and esophagitis). In the IMRT group, grade 3 late toxicity was experienced by 1 patient who had a stricture requiring surgery. Grade 2 late toxicity was experienced by 3 patients: 1 with gastritis, 1 with esophagitis, and 1 with an ulcer. The conclusion of this paper was “…although locoregional control is good with adjuvant chemoradiotherapy, overall outcomes for gastric cancer remain poor. Improvements in both local and systemic therapy are required. Adjuvant chemoradiotherapy was well tolerated with either 3DCRT or IMRT, with similar acute and late toxicities reported. Despite higher doses used, IMRT provides sparing to the liver and possibly the kidneys.”
Additional publications have failed to show a definitive benefit to IMRT. Further, NCCN GuidelinesTM state that IMRT “…may be used in clinical settings where reduction in dose to organs at risk (e.g., heart, lungs, liver, kidneys, small bowel) is required, which cannot be achieve by 3-D techniques.” Further, variations in gastric filling and respiratory motion should be accounted for when delivering IMRT. Given this and as data remains mixed with respect to the benefit of IMRT, the use of IMRT is considered not medically necessary.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Radiation Therapy for Gastric Cancer
Radiation Treatment of Gastric Cancer
Radiation Treatment of Gastric Adenocarcinoma
Gastric Cancer, Radiation Treatment for
References:
1. Alani S, Soyfer V, Strauss N, et al. Limited advantages of intensity-modulated radiotherapy over 3D conformal radiation therapy in the adjuvant management of gastric cancer. Int J Radiat Oncol Biol Phys. 2009 Jun 1; 74(2):562-566.
2. Amin, BA. Brookland RK, Byrd DR, Compton CC, Edge SB, Gress DM, et al. Chapter 17: Part III Upper Gastrointestingal Tract, Stomach. In: Amin, BA. Brookland RK, Byrd DR, Compton CC, Edge SB, Gress DM, et al., eds. The AJCC Cancer Staging Manual. 8th ed. Chicago, IL; Springer. 2018:203-220.
3. Chakravarty T, Crane CH, Ajani JA, et al. Intensity-modulated radiation therapy with concurrent chemotherapy as preoperative treatment for localized gastric adenocarcinoma. Int J Radiat Oncol Biol Phys. 2012 Jun 1; 83(2):581-586.
4. Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6; 355(1):11–20.
5. Dikken JL, van Sandick JW, Maurits Swellengrebel HA, et al. BMC Cancer. Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS).
6. Kole TP, Aghayere O, Kwah J, et al. Comparison of heart and coronary artery doses associated with intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy for distal esophageal cancer. Int J Radiat Oncol Biol Phys. 2012 Aug 1; 83(5):1580-1586.
7. Li P, Sheng LM, Deng QH, et al. Treatment of high-risk gastric cancer postoperatively using intensity-modulated radiotherapy; a single-institution experience. Hepatogastroenterology. 2012 Jan-Feb; 59 (113):159-163.
8. Macdonald JS, Smalley SR, Benedetti J, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6; 345(10):725-730.
9. Minn AY, Hsu A, La T, et al. Comparison of intensity-modulated radiotherapy and 3-dimensional conformal radiotherapy as adjuvant therapy for gastric cancer. Cancer. 2010 Aug 15; 116(16):3943-3952.
10. National Comprehensive Cancer Network (NCCN) Guidelines® Version 4.2019 – December 20, 2019. Gastric Cancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer 4.2019. ©2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN®. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org.
11. Smalley SR, Gunderson L, Tepper J, et al. Gastric surgical adjuvant radiotherapy consensus report: rationale and treatment implementation. Int J Radiat Oncol Biol Phys. 2002 Feb 1; 52(2):283-293.
12. Soyfer V, Corn BW, Melamud A, et al. Three-dimensional non-coplanar conformal radiotherapy yields better results than traditional beam arrangements for adjuvant treatment of gastric cancer. Int J Radiat Oncol Biol Phys. 2007 Oct 1; 69(2):364-369.
13. Yu C, Yu R, Zhu W, et al. Intensity-modulated radiotherapy combined with chemotherapy for the treatment of gastric cancer patients after standard D1/D2 surgery. J Cancer Res Clin Oncol. 2012 Feb; 138(2):255-259.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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