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Stereotactic Body Radiation Therapy for Lung CancerStereotactic Body Radiation Therapy in Lung Cancer FREE TO VIEW

Charles B. Simone, II, MD; Brian Wildt, BSA; Andrew R. Haas, MD, PhD, FCCP; Greg Pope, BA; Ramesh Rengan, MD, PhD; Stephen M. Hahn, MD
Author and Funding Information

From the Department of Radiation Oncology (Drs Simone, Rengan, and Hahn and Mr Wildt); Department of Medicine (Dr Haas), Pulmonary, Allergy, and Critical Care Division; and Medical Management Billing and Compliance (Mr Pope), Hospital of the University of Pennsylvania, Philadelphia, PA.

Correspondence to: Charles B. Simone II, MD, Department of Radiation Oncology, Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine, TRC 2 W, 3400 Civic Center Blvd, Philadelphia, PA 19104; e-mail: charles.simone@uphs.upenn.edu


Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;143(6):1784-1790. doi:10.1378/chest.12-2580
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Lung cancer remains the leading cause of death worldwide. Because many patients with non-small cell lung cancer are elderly and have multiple comorbid conditions, many with potentially curable disease are unfit to undergo definitive surgical resection. Stereotactic body radiation therapy (SBRT) is increasingly being used to treat patients with medically inoperable stage I non-small cell lung cancer. SBRT combines reproducible and accurate anatomic targeting with the delivery of a very high dose per fraction of radiation to a target. Planning and delivery of SBRT is a coordinated effort between the radiation oncology team and consulting services. Clinical outcomes, toxicity profiles, treatment delivery, and indications for SBRT are reviewed. Services currently billed during planning and treatment of SBRT are detailed. This article introduces to consulting specialists and subspecialists a new Current Procedural Terminology code that has been proposed to more accurately reflect work performed during SBRT by these consulting providers. This code is described, and its implications for patient care are discussed.

In 2012, 226,160 people in the United States were projected to receive a diagnosis of lung or bronchus cancer. Although there has been a reduction in lung cancer death rate over the past 2 decades, it remains the greatest cause of mortality from cancer, accounting for 160,340 deaths in the United States in 2012.1 Non-small cell lung cancer (NSCLC) is the predominant histologic type of lung cancer and accounts for about 85% of new diagnoses. Approximately 15% of patients with NSCLC present with localized diseased confined to their primary tumor site.2,3 With advances in imaging and findings of the National Lung Screening Trial, in which screening with low-dose CT imaging in persons at high risk for lung cancer was shown to significantly reduce lung cancer mortality,4 the proportion of patients receiving a diagnosis of stage I disease may increase in the future.

Surgery has been well established as the standard treatment modality for patients with NSCLC tumors that are ≤ 5 cm in size without local invasion and ≥ 2 cm distal to the carina. However, 15% to 20% of patients with stage I NSCLC do not undergo definitive resection,5,6 with some population-based studies reporting as many as two-thirds of patients with stage I do not receive definitive surgery.7 Radiotherapy has historically been reserved for patients with a borderline ability to undergo a definitive operation and who are considered to be better served by a nonoperative treatment modality as well as for patients with medically inoperable conditions, such as cardiovascular or chronic pulmonary diseases, and those who refuse surgery.810 Patients treated with definitive radiotherapy, therefore, have tended to be older with higher medical comorbidity scores and higher rates of intercurrent noncancer mortality. As such, the reported 3-year survival rates for patients with stage I disease treated with conventionally fractionated radiotherapy (typically in 1.8 to 2.0 Gy fractions) have ranged from 17% to 55%,11,12 compared with 50% to 80% survival at 5 years following definitive surgical management.13

In addition, the 5-year local control rates of 40% to 70% with definitive radiotherapy are inferior to surgical series.14,15 Local recurrence has been the primary failure after conventional fractionated radiotherapy, suggesting a need for an alternative method of localized radiotherapy delivery. Early reports of dose escalation16 and hypofractionation with sizes greater than the standard 1.8 to 2.0 Gy fractions,17 and more mature results with hypofraction from the phase 1 Cancer and Leukemia Group B (CALGB 39904) study of 39 patients treated to 70 Gy in 17 to 29 fractions,18 have demonstrated improved local control and survival compared with conventional doses and fractionated radiotherapy. Treating smaller radiation fields without prophylactic mediastinal irradiation with hypofractionated doses, therefore, has allowed for dose escalation beyond what was previously achievable.

Stereotactic radiosurgery (SRS) has been used for > 50 years to treat medical conditions within the cranial vault.19 Since 2001, SRS has been approved by the US Food and Drug Administration to treat conditions throughout the body. Early uses of this modality to treat lung cancer, termed stereotactic body radiation therapy (SBRT), began in the late 1990s. SBRT delivers an ultrahigh dose per fraction of radiation to a target. By delivering ablative radiotherapy doses, SBRT achieves superior tumor killing likely because it delivers higher biologic-equivalent doses of radiotherapy than is achievable with conventionally fractionated irradiation. SBRT also minimizes the dose received by surrounding organs because of a rapid dose falloff gradient encompassing the tumor. During treatment planning, every effort should be made to limit the volume of surrounding critical structures receiving high-dose levels of irradiation.20 The rapid dose falloff gradient, however, also requires highly accurate delineation of the target lesion.

SBRT delivery requires expertise and complex equipment. Patients should be simulated by CT scan, and slice spacing between images should be no > 3 mm over the complete tumor trajectory.21 Accurate and reproducible localization of the target lesion is imperative and performed relative to a known three-dimensional reference system. Stereotactic tumor localization can occur with image-guided radiotherapy, which uses daily imaging to verify correct patient positioning and tumor localization prior to each treatment or with active or passive markers because fiducial markers can be implanted and then visualized before and during treatment.20 Tumor movement can be accounted for or minimized by tracking the tumor during treatment delivery, imaging the tumor before treatment delivery, and providing breathing coaching to patients or using external devices that minimize diaphragm motion and tumor movement during the respiratory cycle.21 SBRT can be delivered as either a single fraction or a limited number of up to five fractions with doses of 6 to 34 Gy given per fraction.20,21

SBRT is a coordinated effort among radiation oncologists, medical physicists, medical dosimetrists, radiation therapists, and consulting services. The treating radiation oncologist is primarily responsible for target delineation. Tumors are contoured as a gross tumor volume, with those < 5 cm in maximum dimension most optimally treated with SBRT. Only visible tumors, as assessed radiographically, are targeted, with expansions added to the target volume to account for tumor motion. Additional expansions of 3 to 5 mm are added to account for geometric uncertainties.20,21

The radiation oncologist may seek consultation from other specialists for SBRT planning and delivery. Consulting specialties and subspecialties include thoracic surgeons, pulmonologists, general surgeons, and interventional radiologists. Their roles might include working with the radiation oncologist to verify that the target is optimally imaged during simulation, selecting and fusing optimal image sets to the simulation image set, performing target delineation by determining tumor borders and, thus, identifying tumor volumes and relationships with adjacent structures, specifying plan objectives and dose constraints, preparing the dosimetry treatment plan, selecting the plan that achieves the greatest radiation dose to the target with the least radiation-induced risk to important surrounding tissues, making changes to the treatment plan if optimal positioning cannot be achieved once the patient is aligned on the treatment table, and radiographically verifying the correct positioning of the patient and validating the target prior to treatment delivery.6,20 This work is akin to the collaboration between neurosurgeons and radiation oncologists during SRS, in which neurosurgeons may place and remove a stereotactic head frame, locate and specify the target volume and relevant normal tissues, participate in the iterative process of plan development, and ensure the patient’s positioning on the treatment table.6

Equipment used for SBRT delivery should have mechanical tolerances for treatment delivery of within 2 mm. Under the direction of a qualified medical physicist, the SBRT system should be commissioned and tested, and a comprehensive quality control program for the SBRT system, image-guided system, and treatment delivery system should be performed. Quality assurance measures for thoracic SBRT are imperative because of inherent organ motion, large field apertures, and high doses delivered per fraction.20

Building on early dose escalation studies, SBRT was assessed as an alternative to conventionally fractionated radiotherapy in an attempt to further improve local control among patients with medically inoperable stage I NSCLC or among those refusing surgery.810 In one of the earlier SBRT trials, 47 patients with stage I inoperable NSCLC were treated with escalating SBRT doses. The crude local control rate was 79%.22 In a single-institution phase 2 study of 70 patients treated with SBRT to doses of 60 to 66 Gy in three fractions, the 2-year local control rate was 95%, and the overall survival was 54.7%.23 In a multicenter phase 2 study (Radiation Therapy Oncology Group [RTOG 0236]) of 55 patients with stage I NSCLC treated with SBRT to 54 Gy in three fractions, the 3-year primary tumor local control rate was 97.6%, the locoregional control rate was 87.2%, and the overall survival was 55.8%.24 In one of the larger and more mature retrospective series of SBRT or hypofractionation for lung cancer, 257 patients with stage I NSCLC were treated to 18 to 75 Gy in one to 22 fractions at 14 institutions. At a median of 38 months, local progression occurred in 14.0%. The overall 3- and 5-year survival rates for all patients were 56.8% and 47.2%, respectively. Additionally, local control and overall survival rates were improved among patients treated to biologic-equivalent doses of ≥ 100 Gy.25 Across prospective and retrospective studies, local control of 85% to 100% and overall survival of 40% to 80% at 3 years have been achieved with SBRT in patients with medically inoperable tumors24,2630 (Table 1).

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Table 1 —Local Control and Overall Survival Outcomes for Patients With Stage I Non-small Cell Lung Cancer Treated Prospectively With SBRT

SBRT = stereotactic body radiation therapy.

Of note, surgical series define local failure variably as recurrence occurring within the same lobe, another lobe of the ipsilateral lung, hilar lymph nodes, or even ipsilateral mediastinal lymph nodes. In contrast, SBRT series have most commonly defined local failure as progression occurring at the site of the primary tumor. Few data exist to date that characterize the rates of marginal recurrences occurring within 1 cm of the treated radiation planning target volume or involved lobe recurrences within the same lobe in which the primary tumor arose.

Although lobectomy or greater resection is associated with decreased rates of locoregional recurrence and death compared with sublobar resections with wedge resection or segmentectomy,31 the American College of Chest Physicians evidence-based clinical practice guidelines from 2007 recommend sublobar resection over nonsurgical intervention for patients with stage I NSCLC who are able to tolerate operative intervention but not a lobar resection.10,32 The excellent outcomes associated with SBRT have more recently challenged the paradigm that surgery should be performed for all patients with potentially operable stage I NSCLC.33,34 However, most patients who have undergone SBRT to date have been medically inoperable or of borderline ability to undergo a definitive operation and were considered to be better served by a nonoperative treatment modality. Many of these patients received less extensive or less invasive mediastinal nodal staging than those undergoing definitive surgical therapy, making direct comparisons of survival between SBRT and surgery difficult.

Among 87 patients with medically operable stage I NSCLC who refused surgery and were treated with SBRT (45-72.5 Gy in three to 10 fractions), the 5-year cumulative local control rate was 92% for T1 tumors and 73% for T2 tumors, with overall survival rates of 72% for stage IA and 62% for stage IB, which is comparable to previously reported outcomes after surgical resection.35 In a retrospective study of 124 patients with stage I NSCLC who were ineligible for lobectomy, 58 underwent SBRT (48 Gy for T1, 60 Gy for T2, four to five fractions), and 69 underwent wedge resection, with patients who underwent SBRT being older and having higher comorbidity scores. Compared with wedge resection, SBRT was associated with a lower risk of local recurrence (5% vs 24%, P = .05) and locoregional recurrence (5% vs 29%, P = .03) and no difference in cause-specific survival (93% vs 94%, P = .53), despite an inferior overall survival (72% vs 87%, P = .01).36

Mature data from completed phase 2 trials of SBRT in patients with medically operable tumors are forthcoming from the Japan Clinical Oncology Group (JCOG 0403) and Radiation Therapy Oncology Group (RTOG 0618).37 Furthermore, randomized trials in the United States (American College of Surgeons [ACOSOG Z4099]) and abroad (VU University Medical Center ROSEL [A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection] and Accuray Incorporated STARS [Stereotactic Radiation Therapy vs Surgery Study]) have recently been designed to compare SBRT to surgery in patients with operable early stage NSCLC, although these trials have been accruing subjects very slowly.37 As such, definitive randomized data comparing surgery and SBRT may continue to be lacking for the foreseeable future.

Like SBRT for stage I NSCLC, thoracic SBRT for parenchymal metastases is increasingly being used. In a recent review of SBRT to treat lung metastases, SBRT delivered with a wide range of techniques and fractionation regimens was found to be safe and effective. Among 334 patients with 564 lesions treated with SBRT of more than one fraction, the 2-year local control and overall survival rates were 77.9% and 53.7%, respectively, whereas they were 78.6% and 50.3% for the 154 patients treated in a single fraction.38

Focal SBRT is generally well tolerated. However, increased morbidity and mortality have been reported with SBRT delivered to central lesions within 2 cm of the proximal bronchial tree.23 Such lesions may be more safely treated with SBRT regimens of more than three fractions,39 although regimens beyond five fractions are not currently billable as SBRT.

Acute complications of SBRT are typically transient and occur in 5% to 40% of patients.33 The most common side effects are constitutional symptoms and fatigue, skin erythema, mild hematologic suppression, and cough. Subacute and late complications are less common and can include radiation pneumonitis, hypoxia and decreased pulmonary function, hemoptysis, chest wall pain or rib fracture, bronchial stenosis or necrosis, esophageal injury, or brachial plexopathy.24 As additional data are gathered on tolerances of normal structures adjacent to pulmonary tumors treated with SBRT, abiding by more rigid dose constraints of these structures may minimize treatment morbidity further. Evaluation for complications following definitive SBRT should be performed by the radiation therapy treatment team and last at least 6 months40 and preferably up to 2 years because radiation pneumonitis, pulmonary fibrosis, pneumonias, ribs fractures, bronchial stenosis or necrosis, and hemoptysis can all occur > 6 months after treatment.23

Long-term treatment outcome and toxicity data following SBRT are most mature and robust for treating stage I NSCLC, the current focus of this analysis. Reimbursement coverage based on International Classification of Diseases, Ninth Revision, Clinical Modification, codes for SBRT, however, is provided for primary (162.0-162.9) and metastatic (197.0) tumors of the lung, as well as for recurrent lung cancer amenable to salvage therapy. SBRT is also covered for spinal and paraspinous tumors; low- and intermediate-risk prostate cancer; and primary and secondary liver, kidney, adrenal, and pancreatic lesions. SBRT can treat lesions immediately adjacent to previously irradiated fields or with recurrences after conventional radiation modalities for lesions in such organs as the bone, breast, head and neck, paranasal sinuses, uterus, ovary, or other internal organs, all in an attempt to avoid surrounding normal tissue exposure.41,42

SBRT may not be covered for patients when it is unlikely to result in clinical cancer control or functional improvement or when patients have widely disseminated disease and would be unlikely to obtain clinical benefit from local therapy. Coverage for thoracic SBRT depends on the patient’s general medical condition to justify aggressive local therapy in an attempt to achieve total tumor resolution or clinically beneficial reduction in the overall tumor burden. As such, patient performance status and life expectancy should be reasonably good to justify SBRT delivery. Consideration of SBRT should take into account other focal treatment options available to patients, including radiofrequency ablation and cryotherapy. SBRT coverage is also limited unless the tumor being treated can be completely targeted with acceptable risk to adjacent important structures.41,42

When billing for SBRT delivery, only one treatment delivery code can be billed on the same day of service, even if the delivery has elements of multiple modalities, such as the delivery of SBRT with intensity-modulated radiotherapy. Furthermore, because a goal of SBRT is to intensify the efficacy of radiotherapy by allowing for the entire treatment course to be completed in an accelerated time frame, treatment extending beyond five fractions is not considered SBRT and is not able to be billed with SBRT codes.41,42

Akin to other radiation therapy services, charges for SBRT are incurred for simulation, treatment immobilization devices, treatment planning, dosimetry calculations, setup, weekly medical physics consultations, treatment delivery, and, when appropriate, special treatment procedures (Table 2). The treatment delivery codes for SBRT, however, are unique compared with other radiotherapy services. SBRT is billed on the basis of the number of fractions used, with the total course comprising five or fewer fractions. Code G0251 is billed for linear accelerator-based SBRT, whereas G0339 and G0340 are billed for robotic-based SBRT. These codes are used for hospital outpatient treatment, are mutually exclusive, and cannot both be billed. For freestanding facilities, Current Procedural Terminology (CPT) code 77373 should be billed for SBRT treatment delivery. CPT/Healthcare Common Procedure Coding System codes 77373, G0339, or G0340 will be paid only once per treatment day, regardless of the number of lesions treated. Of note, SBRT codes used for the lung are also used to code spinal SRS and cranial SRS treatments when given in two to five fractions. Cranial SRS delivered in a single fraction, however, is billed using separate coding (G0173 linear accelerator-based hospital outpatient, G0339 robotic hospital based, 77372 linear accelerator-based office, 77371 cobalt-60 based). Akin to code 77432 for SRS, the treatment management code for SBRT (77435) is unique and paid only once per treatment course.41,42

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Table 2 —Commonly Used Services Currently Billed During SBRT

HCPC = Healthcare Common Procedure Coding System. See Table 1 legend for expansion of other abbreviation.

a 

Simple simulation can only be billed if performed prior to the first day of treatment. Code 77280 is bundled with the SBRT treatment code if the simulation is performed on the day of treatment.

b 

G0251 is billed for linear accelerator-based SBRT, whereas G0339 and G0340 are billed for robotic-based SBRT. These codes are used for hospital outpatient treatment, are mutually exclusion, and cannot both be billed. For freestanding facilities, Current Procedural Terminology code 77373 should be billed for SBRT treatment delivery.

c 

Used for situations that are patient specific (eg, effort above and beyond the planning of a typical case) and not assigned as routine for SBRT.

Prior to 2009, CPT code 61793 was created as a neurosurgery code and often used to account for consulting physician work involved in treatment planning and delivery. However, this code was eliminated in January 2010. As a result, thoracic surgeons began using the unlisted code 32999 to report their participation in SBRT delivered to the lungs or pleura. The code 32999, however, has not accurately described or accounted for this work. Additionally, this code had no relative value unit and was priced by the surgeon performing the work. Furthermore, the newer stereotactic codes relate only to SRS to the brain or spine, and they are not appropriate when treating with SBRT for intrathoracic lesions. Therefore, code 32701, which denotes target delineation for SBRT, has been proposed to better define the work (as detailed previously in the SBRT delivery section) performed by consulting providers, such as thoracic surgeons or pulmonologists, when they are involved in the planning and delivery of SBRT for conditions in the lung (Table 3).41,42

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Table 3 —American Medical Association-Recommended Changes in CPT Codes and RVUs for SBRT

Based on the American Medical Association Specialty Society RVS Update Committee Summary of Recommendations, January 2012.6 CPT = Current Procedural Terminology; N/A = not available; RVU = relative value unit; SRS = stereotactic radiosurgery. See Table 1 legend for expansion of other abbreviation.

a 

Code 32701 should not be used in conjunction with codes 77261 to 77799. Placement of fiducial markers, when used, should be billed separately. Code 32701 is intended for consulting providers and cannot be billed separately by radiation oncology providers.

SBRT is increasingly being used to treat patients with medically inoperable stage I lung cancer. SBRT has a limited toxicity profile, particularly for peripheral and small lesions, and it has dramatically improved the treatment outcomes compared with conventional fractionated radiotherapy, with local control approaching that achievable with definitive surgical resection. SBRT planning and delivery is a coordinated effort among radiation oncologists, medical physicists, medical dosimetrists, and radiation therapists. Consulting services, including thoracic surgery and pulmonology, play key roles in SBRT. However, the work performed by these consultants for SBRT has not been accurately described or accounted for to date. Therefore, a new CPT code has been proposed for consulting providers. This new coding may allow for improved collaboration between radiation oncologists and other healthcare professionals caring for patients with lung cancer and lung metastases. By improving target delineation and treatment delivery, this code may also allow for decreased toxicities and improved clinical outcomes for patients.

Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

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Tables

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Table 1 —Local Control and Overall Survival Outcomes for Patients With Stage I Non-small Cell Lung Cancer Treated Prospectively With SBRT

SBRT = stereotactic body radiation therapy.

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Table 2 —Commonly Used Services Currently Billed During SBRT

HCPC = Healthcare Common Procedure Coding System. See Table 1 legend for expansion of other abbreviation.

a 

Simple simulation can only be billed if performed prior to the first day of treatment. Code 77280 is bundled with the SBRT treatment code if the simulation is performed on the day of treatment.

b 

G0251 is billed for linear accelerator-based SBRT, whereas G0339 and G0340 are billed for robotic-based SBRT. These codes are used for hospital outpatient treatment, are mutually exclusion, and cannot both be billed. For freestanding facilities, Current Procedural Terminology code 77373 should be billed for SBRT treatment delivery.

c 

Used for situations that are patient specific (eg, effort above and beyond the planning of a typical case) and not assigned as routine for SBRT.

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Table 3 —American Medical Association-Recommended Changes in CPT Codes and RVUs for SBRT

Based on the American Medical Association Specialty Society RVS Update Committee Summary of Recommendations, January 2012.6 CPT = Current Procedural Terminology; N/A = not available; RVU = relative value unit; SRS = stereotactic radiosurgery. See Table 1 legend for expansion of other abbreviation.

a 

Code 32701 should not be used in conjunction with codes 77261 to 77799. Placement of fiducial markers, when used, should be billed separately. Code 32701 is intended for consulting providers and cannot be billed separately by radiation oncology providers.

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