| Coverage Policy Manual | |
| Policy #: | 1999013 |
| Category: | Radiology |
| Initiated: | June 1999 |
| Last Review: | November 2023 |
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| Brachytherapy, Endobronchial | |
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| Description: |
Endobronchial brachytherapy is the delivery of radiotherapy directly to endobronchial lesions, either intraluminally or interstitially, using permanently implanted radioactive seeds or a temporary afterloading implant. The technique permits targeted radiation while minimizing exposure to surrounding radiosensitive structures, such a normal lung, heart and spinal cord.
Endobronchial brachytherapy has been primarily investigated as a palliative treatment of obstructing primary or metastatic tumors, particularly in non-small cell lung cancer (Bilaceroglu, 2018; Shepherd, 2019). Endobronchial brachytherapy has also been used as a tool in the curative treatment for some primary bronchial and tracheal tumors. Two to 4 fractions delivered weekly is a typical schedule. Median overall survival of patients with obstructing endobronchial tumors is typically less than 9 months.
In the outpatient setting, the patient receives local anesthesia and monitored sedation. A flexible bronchoscope is passed transnasally; a separate port on the bronchoscope allows passage of the afterloading catheter to the target lesion. Once the catheter is placed the radioisotope can be administered by the high dose rate radiotherapy afterloading machine. Patients with potential airway compromise due to bleeding may require treatment with a rigid bronchoscope, which requires general anesthesia and frequently an overnight hospitalization.
Other Treatments
Endobronchial brachytherapy is an approach to the local treatment of endobronchial lesions. Other technologies include electrocoagulation, cryosurgery, laser resection, endosurgery, and endobronchial stent placement. In some instances, the therapies may be used together, such as using laser therapy for initial debulking followed by brachytherapy.
Regulatory Status
Several bronchoscopes (Food and Drug Administration product code: EOQ) and remote-controlled afterload/radionuclide applicator systems (Food and Drug Administration product code: JAQ) have been cleared for marketing by the Food and Drug Administration through the 510(k) process. Examples of both include the Video Sciences BRS-5000 Video Bronchoscopy with EndoSheath System (Vision-Sciences) and microSelectron (Nucletron), respectively.
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Policy/ Coverage: |
Effective August 1, 2021, for members of plans that utilize a radiation oncology benefits management program, Prior Approval is required for this service and is managed through the radiation oncology benefits management program.
EFFECTIVE MARCH 13, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Endobronchial brachytherapy meets primary coverage criteria for effectiveness and is covered in the following clinical situations:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Any application of endobronchial brachytherapy other than listed above does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, any application of endobronchial brachytherapy other than listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to March 13, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Endobronchial brachytherapy meets primary coverage criteria for effectiveness and is covered in the following clinical situations:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Other applications of endobronchial radiotherapy including, but not limited to, its use as a radiation "boost" to external beam radiotherapy do not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, other applications of endobronchial radiotherapy including, but not limited to, its use as a radiation "boost" to external beam radiotherapy are considered investigational. Investigational services are an exclusion in the member certificate of coverage.
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| Rationale: |
Endobronchial brachytherapy is used as both palliative treatment and curative treatment; either alone or in combination with other modalities such as surgery, external beam radiation or other endoscopic interventions.
Endobronchial brachytherapy as palliative treatment
Many patients with non-small cell carcinoma are initially treated with external beam radiation therapy but ultimately experience local recurrence. Unfortunately, many are not candidates for further external beam radiation therapy due to the limited tolerance of normal tissue. If symptoms persist following external beam radiation, endobronchial brachytherapy is well-accepted as a short-term palliation for such symptoms as hemoptysis, cough, dyspnea and resolution of obstructive atelectasis or pneumonitis. A European prospective study on 270 patients who had previously received radiation therapy were given high-dose brachytherapy with a total response rate of 80% for symptoms of dyspnea, cough, hemoptysis and post-obstructive pneumonia with a median duration of palliation of five months with a range of 2 to 14 months. (Kubaszewska, 2008) In a summary of studies of palliative endobronchial brachytherapy between 1985 and 1994, Villanueva and colleagues (1995) reported effective palliation in 60%–100% of patients. The median survival of these patients is typically less than 9 months.
Since the last policy review, several studies have tried to expand the utility of endobronchial brachytherapy to first-line palliative treatment. A 2008 Cochrane review of palliative endobronchial brachytherapy for non-small cell lung carcinoma analyzed 13 randomized controlled trials but could not combine them into a meta-analysis because of heterogeneity in the doses of radiotherapy delivered, patient characteristics and outcomes measured. The authors concluded that external beam radiation therapy alone is still more effective for palliation of symptoms than endobronchial brachytherapy alone. Their findings did not provide conclusive evidence that endobronchial brachytherapy plus external beam radiation therapy improved symptom relief over external beam radiation alone, nor did it improve complication rates or extend survival. In summary, the authors were not able to provide conclusive evidence to recommend endobronchial brachytherapy as an add-on to first-line external beam radiation therapy, chemotherapy or Nd-Yag laser palliative treatment. For patients previously treated by external beam radiation who are still symptomatic, endobronchial brachytherapy may be considered an option (Cardona, 2008).
In agreement with the Cochrane review, a 2006 prospective randomized trial from India with just 45 patients suggested that endobronchial brachytherapy alone and endobronchial brachytherapy with external radiation had similar efficacy and safety profiles in the palliative management of non-small cell lung cancer. (Mallick, 2006)
Also in agreement to the Cochrane review, Ung and colleagues (2006) conducted a 2006 systematic review of endobronchial brachytherapy in the palliative treatment of non-small cell lung cancer with 29 studies and 6 randomized trials. The authors concluded that external beam radiation therapy alone is more effective than endobronchial brachytherapy alone for symptom palliation in previously untreated patients. In contrast to the Cochrane review though, the Ung review concluded that endobronchial brachytherapy with external beam radiation seems to provide better symptom relief than external beam radiation alone, yet their final recommendation is to only use endobronchial brachytherapy with symptomatic recurrent endobronchial obstruction following external beam radiation.
Most studies evaluate the use of endobronchial brachytherapy in lung cancer, but a 2007 French study reported on the use of endobronchial brachytherapy in small number of patients with endobronchial metastases secondary to colorectal carcinomas. All patients had primary resection of the colorectal carcinoma then 7 received intrabronchial therapies including brachytherapy and 7 did not. Patients receiving intrabronchial therapies had a median survival of 55.7 months versus 12.7 months for the controls. (Coriat, 2007) It is difficult to draw conclusions from this small study, larger trials are still needed.
Endobronchial brachytherapy as primary treatment
Candidates for primary treatment have principally included patients with early-stage endobronchial tumors who are not candidates for surgical resection or external beam radiation due to co-morbidities or the location of the tumor. Results have predominantly been reported in case series where complete response rates in the range of 50%–80% have been noted. (Raben, 1997; Perol, 1997; Hennequin, 2006)
There have also been early investigations for the use of brachytherapy to deliver a focused radiation boost to patients undergoing curative external beam radiation therapy. External beam radiation therapy is typically the primary treatment for the majority of patients with non-small cell carcinoma of the lung (NSCCL) due to the fact that patients usually present with surgically unresectable disease and that NSCCL is unresponsive to chemotherapy.
A 2005 case study from Brazil involving four patients with nonresectable primary tracheal tumors used endobronchial brachytherapy in recurrences or as a boost for external beam radiation and achieved immediate palliation of symptoms and local control for at least 6 months. (Carvalho, 2005) Currently, larger studies are needed to further evaluate the use of endobronchial brachytherapy as a curative boost therapy with external beam radiation in tracheal tumors.
Endobronchial brachytherapy in the treatment of hyperplastic granulation tissue
Endobronchial brachytherapy has also been investigated to treat hyperplastic granulation tissue causing recurrent airway stenosis complicating lung transplantation or stent placement. A 2008 case series reported on the use of endobronchial brachytherapy in 8 patients following excision of obstructive granulation tissue; 6 had a good or excellent subjective early response for the first 6 months (Tendulkar, 2008). A 2006 case series used endobronchial brachytherapy in 5 patients with benign granulation tissue following lung transplantation that was refractory to multiple other bronchoscopic interventions. After a median follow-up of 12 months, 3 out of the 5 patients had marked symptom improvement (Madu, 2006). While these cases series offer positive outcomes, larger trials with adequate follow-up are needed to fully evaluate the potential role of endobronchial brachytherapy in the treatment of granulation tissue.
2005-2006 Update
A search of the literature for the period of 2003 through December 2005 focusing on clinical trials did not identify any published studies that would prompt reconsideration of the policy statement. Therefore the policy is unchanged.
2007 Update
A literature review was conducted using MEDLINE for January 2006 through June 2007. None of the articles identified led to a change in the policy statement. Some articles discussed approaches being studied in an attempt to decrease the hemoptysis that may accompany this treatment. Another paper described a feasibility study using electromagnetically navigated brachytherapy for peripheral pulmonary tumors.
2010 Update
A literature search using MEDLINE was performed through October 2010. The search identified 1 case series of 158 patients, a set of guidelines published by the American College of Radiology, and updated guidelines from the National Comprehensive Cancer Network (NCCN).
Symptom Palliation
Ozkok et al published a case series from Turkey on the use of high dose rate endobronchial brachytherapy for palliation of symptoms for 158 patients in 3 patient groups (Ozkok, 2008). Group A consisted of 43 patients with stage IIIA and IIIB NSCLC who received endobronchial brachytherapy in combination with external beam radiation; Group B consisted of 74 previously untreated patients with incurable, locally advanced lung cancer; and Group C consisted of 41 patients with symptomatic endobronchial recurrences and who had previously been irradiated with full doses of radiation therapy. Participants in Group A were from a previously reported prospective trial (Gejerman, 2002); data from these participants were reanalyzed for palliation of symptoms in the current report. Not all patients received the intended number of fractions due to patient refusal or deterioration in performance status. A few patients required more than the prescribed doses due to repetitive obstructive symptoms. Response rates for cough, dyspnea, and hemoptysis were measured by the Speiser symptom index scoring system. The response rates in Group A were 58% for cough (30% complete response), 77% for dyspnea (76% complete response), and 100% for hemoptysis (92% complete response). Groups B and C had response rates of 57% and 55% for cough and 90% and 78% for dyspnea, respectively. Eighteen patients (11%) died of hemoptysis, with a median time to event of 7 months. Significant prognostic factors for fatal hemoptysis were use of brachytherapy intended as a treatment (as opposed to strictly palliation, p<0.001), total radiobiological equivalent dose (p<0.001) and the number of high dose rate endobronchial brachytherapy fractions (p<0.001). The authors conclude that high dose rate endobronchial brachytherapy is effective for the palliation of symptoms related to inoperable lung cancer, either alone or in combination with external-beam radiation. They caution that optimal dose, fractionation, and combination schedule with external-beam radiation are yet to be determined. Further, they state that any benefit must be weighed against potentially serious treatment-related morbidity or mortality. Without a comparison group, it is not possible to draw conclusions from this case series.
The American College of Radiology (ACR) published ACR Appropriateness Criteria on nonsurgical treatment for NSCLC. These criteria were agreed upon by an expert panel. The panel considers endobronchial brachytherapy a palliative treatment, “providing relief for patients with endobronchial lesions causing obstruction or hemoptysis.” (Rosenzweig, 2009)
In the 2009, NCCN practice guidelines for NSCLC under surveillance and treatment of recurrences and metastases concluded that relieving airway obstruction may increase both survival and quality of life, especially in severely compromised patients. Brachytherapy is one of the treatments listed for the palliation of symptoms from and treatment of obstructed airways. Brachytherapy is specifically listed as a recommended treatment for severe hemoptysis.
While endobronchial brachytherapy is often used to palliate hemoptysis, historically, concern has existed of an observed association between treatment with endobronchial brachytherapy and fatal hemoptysis. The largest study was a retrospective review of 938 patients treated with external irradiation and/or endobronchial brachytherapy for inoperable NSCLC (Langendijk, 1998). In this study, 101 (10.8%) patients died from massive hemoptysis; 78 (77%) of those had clinical or radiological evidence of tumor progression, while 23 did not. On multivariate analysis, intrabronchial tumor extension in the main bronchus, hemoptysis prior to radiotherapy, and tumor location in the upper bronchus were independently associated with the incidence of massive hemoptysis. A dose-response relationship between the fraction dose and massive hemoptysis was also found, and in all subsets higher incidence of massive hemoptysis was seen after fraction dose of 15 Gy. These data were largely consistent with the data published by Hennequin et al who reported that hemoptysis is most likely due to disease progression, with brachytherapy facilitating the bleeding, rather than a direct complication of the brachytherapy itself (Hennequin, 1998). They noted that when tumors are located in the upper lobes, brachytherapy may be causal. Tumor location was cited as the most important factor in predicting pulmonary hemoptysis in a case series reported by Bedwinek et al in which 32% of patients died of massive hemoptysis following brachytherapy (Bedwinek, 1991). Given that endobronchial brachytherapy has been used successfully to treat severe hemoptysis and that this application is also supported by NCCN guidelines, use of endobronchial brachytherapy for this indication was added as a medically necessary indication.
Asymptomatic Recurrence of NSCLC
NCCN specifically addresses the use of brachytherapy for patients who have a recurrence detected only by positive sputum cytology. The guidelines indicate that after the positive sputum cytology leads to a diagnosis of tumor in situ, brachytherapy is one of the recommended treatment options (repeat bronchoscopy in 3 months is also listed as an option.) No supportive studies demonstrating impact on health outcomes were identified for this application of endobronchial radiotherapy. The policy statement for this indication is unchanged.
Treatment of Hyperplastic Granulation Tissue
Since the last update, no additional data have been published on the use of endobronchial brachytherapy for the treatment of hyperplasic granulation tissue, the policy statement is unchanged.
2012 Update
A literature search through January 2012 did not identify any new information that would prompt a change in the coverage statement.
2013 Update
A literature search conducted through February 2013 found no new information that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
A 2008 Cochrane review of palliative endobronchial brachytherapy for NSCLC, updated in 2012, (Cardona, 2008; Reveiz, 2012) analyzed 13 randomized, controlled trials (RCTs) but could not combine them into a meta-analysis because of heterogeneity in the doses of radiotherapy delivered, patient characteristics, and outcomes measured. The authors concluded that external-beam radiation therapy alone is still more effective for palliation of symptoms than endobronchial brachytherapy alone. Their findings did not provide conclusive evidence that endobronchial brachytherapy plus external-beam radiation therapy improved symptom relief over external-beam radiation alone, nor did it improve complication rates or extend survival. In summary, the authors were not able to provide conclusive evidence to recommend endobronchial brachytherapy as an add-on to first-line external beam radiation therapy, chemotherapy, or Nd-YAG laser palliative treatment. For patients previously treated by external-beam radiation who are still symptomatic, endobronchial brachytherapy may be considered an option.
The Third International Lung Cancer Consensus Workshop generated consensus statements on palliative
radiotherapy and symptom control. For endobronchial brachytherapy (EBB), they concluded that there is no evidence to routinely recommend EBB alone or in conjunction with other palliative maneuvers in the initial palliative management of endobronchial obstruction resulting from lung cancer. However, they felt that for the palliative management of patients with recurrent endobronchial obstruction after external radiation therapy (XRT) or to treat a central obstruction before definitive radiation therapy to open the airway, it was a reasonable option (Rodrigues, 2012).
2014 Update
A literature search conducted through February 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Endobronchial Brachytherapy as Palliative Treatment
A 2013 comparative effectiveness review on prepared for the Agency for Healthcare Research and Quality reviewed local nonsurgical therapies for symptomatic obstructive NSCLC (Ratko, 2013). For patients with obstruction due to inoperable NSCLC, 4 RCTs (total N=268) examined endobronchial brachytherapy alone or in combination with external-beam radiation therapy or Nd-YAG laser therapy for palliative or curative intent. All RCTs were determined to be of poor quality. Seven single-arm studies (total N=740) examined endobronchial brachytherapy alone or in combination with external-beam radiation therapy, stent placement, or chemotherapy plus photodynamic therapy for palliative or curative intent. The evidence was considered “insufficient to permit conclusions on the comparative effectiveness of local nonsurgical therapies for…inoperable NSCLC patients with endoluminal tumor causing pulmonary symptoms.”
Endobronchial Brachytherapy as Primary Treatment:
Skowronek et al (2013) reported on a small cohort of 34 patients in Poland who had stage IB-III lung cancer (74% squamous cell carcinoma histology; all distant metastasis-free) who had undergone lobar resection (Skowronek, 2013). Thirteen patients (38%) developed postoperative recurrence in the bronchial stump, and 21 patients (72%) had histopathologically positive margins after nonradical resection. All patients had dyspnea and cough, and 8 patients (24%) had hemoptysis. Median patient age was 57 years (range, 47-73). Median time to recurrence after surgery was 11 months. It was not specified if patients were candidates for reoperation. Nine patients received high-dose-rate endobronchial brachytherapy (total dose, 12 Gy) in combination with external-beam radiation therapy (total dose, 50 Gy), and 25 patients received brachytherapy alone (total dose, 30 Gy). At 1 month, complete local and radiologic response was observed in 25 patients (74%), with 100% complete remission in the nonradical surgery group. All partial responses occurred in the recurrent tumor group (9 [69%] 13 patients). Median overall survival for the entire cohort was 19 months. With 2 years median follow-up, 2-year overall survival was 15% in the group with recurrent tumor and 48% in the nonradical resection group (Kaplan-Meier log-rank test, p=0.05). Adverse events were not reported.
Rochet et al (2013) reported on a cohort of 35 patients in Germany who had stage I-III (31% squamous cell carcinoma histology; all distant metastasis-free) inoperable NSCLC and received primary treatment with high-dose-rate endobronchial brachytherapy (median total dose, 15 Gy) in combination with external-beam radiation therapy (median total dose, 50 Gy) (Rochet, 2013). Mean age was 64 years (range, 45-75). With 26 months median follow-up, median overall survival was 39 months. One-, 2-, and 5-year overall survival was 76%, 61%, and 28%, respectively. Median progression-free and local progression-free survival was 17 months and 42 months, respectively. In patients without mediastinal node involvement, 5-year local progression-free survival was 56% versus 11% with positive mediastinal nodes (Kaplan-Meier method log-rank test, p=0.008). Grade 3 adverse events were hemoptysis in 2 patients and necrosis in 1 patient. Fatal hemoptysis in 1 patient resulted from tumor recurrence.
2015 Update
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement.
2017 Update
A literature search was conducted using the MEDLINE database through November 2017. There was no information identified that would prompt a change in the coverage statement.
Several guidelines or positions statements were identified.
ACR and American Brachytherapy Society
Practice guidelines published jointly by ACR and the American Brachytherapy Society in 2017 addressed the use of high-dose-rate brachytherapy (≥12 gray per hour) in the treatment of multiple medical conditions, including malignancies in the endobronchial region (Erickson, 2017). The guidelines cited studies on the use of high-dose-rate brachytherapy as palliative care and as primary care and noted that brachytherapy might be combined with EBRT.
Both groups also published guidelines in 2017 on the use of low-dose-rate radionuclide brachytherapy, defined as treatment between 4 and 200 centigraGy per hour.31 The guidelines considered low-dose-rate brachytherapy an appropriate treatment for a number of malignancy types, including those found in the bronchus or trachea. Such treatment may be especially appropriate when used to augment EBRT, or when the target volume may be defined.
Both guidelines provided a standard for procedural protocol, as well as a summary of the potential treatment sites of the respective types of brachytherapy.
American College of Chest Physicians
Guidelines on the treatment of a cough as a symptom of lung cancer from the American College of Chest Physicians were updated in 2017 (Molassiotis, 2017). The systematic review used to inform the guidelines included a number of low-quality studies and the strength of the recommendations was diminished, accordingly. Acknowledging a lack of studies about the effect of brachytherapy on specific lung cancer symptoms (eg, cough), the College recommended that endobronchial brachytherapy is used in patients who cannot receive surgery, chemotherapy, or EBRT (grade 2C evidence). Citing the accompanying risk of side effects such as hemoptysis, the College suggested that a pharmacologic therapy trial is considered initially, or, if endobronchial brachytherapy is used, that caregivers administer the lowest dose.
American Brachytherapy Society
In 2016, the Society issued consensus guidelines on thoracic brachytherapy for lung cancer (Stewart, 2016). The guidelines included the following recommendations:
2018 Update
A literature search was conducted through October 2018. There was no new information identified that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Practice Guidelines and Position Statements
The National Comprehensive Cancer Network Guidelines (v.4.2019) for non-small-cell lung cancer include external-beam radiotherapy (EBRT) and brachytherapy as treatment options for severe hemoptysis in locoregional recurrent disease (category 2A) (NCCN, 2019).
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Soror et al conducted a single-center retrospective review of palliative high-dose rate (HDR) endobronchial brachytherapy in 347 patients with lung cancer (Soror, 2021). Prominent symptoms at the time of brachytherapy included dyspnea (56.2%), hemoptysis (21.9%), and cough (4.6%). Most patients (78.9%) had been diagnosed within the prior 18 months, and the median study follow-up was 13.4 months. Complete symptom relief or major improvement in symptoms was reported in 28% and 59.7% of patients, respectively. Complete or major symptom improvement was common in patients with hemoptysis (90.7%) or airway obstruction (90.9%). The OS rate was 55.2% at 1 year, 18.3% at 2 years, and 3.5% at 5 years.
Ji et al reported retrospective outcomes of 99 patients with unresectable early-stage NSCLC who received low dose ablative brachytherapy with radioactive seed implantation (Ji, 2021). The median follow-up was 46.3 months. At 1, 3, and 5 years, OS was 96.7%, 70.1%, and 54.4%, respectively and local control rates were 89.1%, 77.5%, and 75.7%, respectively.
Yoon et al reported on a series of 25 patients with centrally located lung tumors with HDR ablative brachytherapy (Yoon, 2021). After a median follow-up of 19 months, 2-year local tumor control was 96.2%, PFS was 29.7%, and OS was 65.5%. Adverse effects included 1 minor pulmonary hemorrhage, 4 major pneumothorax, and 13 minor pneumothorax.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A multicenter randomized controlled trial of EBRT with or without endobronchial brachytherapy in patients with advanced NSCLC with endobronchial disease did not indicate a difference between groups in 6-week improvement in overall lung cancer symptoms; however, the study did not achieve its sample size requirement (N=134 patients out of 250-patient planned sample size) due to slow accrual (Sur, 2023). Patient-reported hemoptysis scores were significantly improved in the combination arm (p=.03).
A phase 2 clinical trial conducted at a single center in China enrolled patients with inoperable or unresectable stage III NSCLC to receive HDR endobronchial brachytherapy in combination with intensity-modulated radiation therapy to involved regional lymph nodes, with or without concurrent or sequential chemotherapy (Xiang, 2023). The primary endpoint was 5-year OS. Among 83 patients enrolled, 5 did not undergo treatment due to revised staging or unspecified economic reasons and 3 were lost to follow-up. Among 75 patients included in the final analysis, median age was 64 years; most patients were male (74.7%), had an Eastern Cooperative Oncology Group performance status of 1 (62.7%), and underwent concurrent or sequential chemotherapy (96%). With median follow-up of 53.7 months, 5-year OS was 44.5% (95% confidence interval [CI], 33.8% to 58.6%) and median OS was 38.0 months (95% CI, 26.1 to 49.8). No major procedure-related complications were reported; minor complications included asymptomatic pneumothorax (16%), bleeding without hemoptysis or hemothorax (20%), and pain (9.3%).
The National Comprehensive Cancer Network Guidelines (v. 3.2023) for non-small cell lung cancer include EBRT and brachytherapy as treatment options for severe hemoptysis or endobronchial obstruction in locoregional recurrent disease or symptomatic local disease (category 2A) (NCCN, 2023).
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| References: |
Bedwinek J, Petty A, Bruton C.(1991) The use of high dose rate endobronchial brachytherapy to palliate symptomatic endobronchial recurrence of previously irradiated bronchogenic carcinoma. Int J Radiat Oncol Biol Phys 1991; 22(1):23-30. Bilaçeroglu S.(2018) Endobronchial Ablative Therapies. Clin Chest Med. Mar 2018; 39(1): 139-148. PMID 29433710 Cardona AF, Reveiz L, et al.(2008) Palliative endobronchial brachytherapy for non-small cell lung cancer. Cochrane Database Syst Rev, 2008; Apr 16 (2):CD004284. Carvalho Hde A, Figueiredo V, et al.(2005) High dose-rate brachytherapy as a treatment option in primary tracheal tumors. Clinics, 2005; 60:299-304. Coriat R, Diaz O, et al.(2007) Endobronchial metastases from colorectal adenocarcinomas: clinical and endoscopic characteristics and patient prognosis. Oncology, 2007; 73:395-400. Erickson BA, Bittner NH, Chadha M, et al. (2017) The American College of Radiology and the American Brachytherapy Society practice parameter for the performance of radionuclide-based high-dose-rate brachytherapy. Brachytherapy. Jan - Feb 2017;16(1):75-84. Gejerman G, Mullokandov EA, Bagiella E et al.(2002) Endobronchial brachytherapy and external-beam radiotherapy in patients with endobronchial obstruction and extrabronchial extension. Brachytherapy 2002; 1(4):204-10. Gewanter RM, Rosenzweig KE, Chang JY et al.(2010) ACR Appropriateness Criteria® Nonsurgical Treatment for Non-Small-Cell Lung Cancer: Good Performance Status/Definitive Intent. Curr Probl Cancer 2010; 34(3):228-49. Hennequin C, Bleichner O, et al.(2007) Long-term results of endobronchial brachytherapy: a curative treatment. Int J Radiat Oncol Biol Phys, 2007; 67:425-30. Hennequin C, Tredaniel J, Chervret S et al.(1998) Predictive factors for late toxicity after endobronchial brachytherapy: a multivariate analysis. Int J Radiat Oncol Biol Phys 1998; 42(1):21-27. Huber RM, Fischer R, Hautmann H, et al.(1997) Does additional brachytherapy improve the effect of external irradiation? A prospective, randomized study in central lung tumors. In J Radiat Oncol Biol Phys 1997; 38:533-40. Ji Z, Huo B, Liu S, et al.(2021) Clinical Outcome of CT-Guided Stereotactic Ablative Brachytherapy for Unresectable Early Non-Small Cell Lung Cancer: A Retrospective, Multicenter Study. Front Oncol. 2021; 11: 706242. PMID 34604042 Kong FM, Lally BE, Chang JY et al.(2013) ACR Appropriateness Criteria(R) radiation therapy for small-cell lung cancer. Am J Clin Oncol 2013; 36(2):206-13. Kubaszewska M, Skowronek J, et al.(2008) The use of high dose rate endobronchial brachytherapy to palliate symptomatic recurrence of previously irradiated lung cancer. Neoplasma, 2008; 55:239-45. Langendijk JA, Tjwa MK, de Jong JM et al.(1998) Massive haemoptysis after radiotherapy in inoperable non-small cell lung carcinoma: is endobronchial brachytherapy really a risk factor? Radiother Oncol 1998; 49(2):175-83. Madu CN, Machuzak MS, et al.(2006) High-dose-rate (HDR) brachytherapy for the treatment of benign obstructive endobronchial granulation tissue. Int J Radiol Oncol Biol Phys, 2006; 66:1450-6. Mallick I, Sharma SC, et al.(2006) Optimization of dose and fractionation of endobronchial brachytherapy with or without external radiation in the palliative management of non-small celll lung cancer: a prospective randomized study. J Cancer Res Ther, 2006; 2:119-25. Molassiotis A, Smith JA, Mazzone P, et al.(2017) Symptomatic treatment of cough among adult patients with lung cancer CHEST Guideline and Expert Panel Report. Chest. Apr 2017;151(4):861-874. National Comprehensive Cancer Network (NCCN).(2019) NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 4.2019. https://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Accessed May 30, 2019. National Comprehensive Cancer Network (NCCN).(2023) NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer. Version 3.2023. https://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Accessed May 18, 2023. National Comprehensive Cancer Network(2017) Clinical Practice Guidelines in Oncology: Non-small cell lung cancer.Version 1.2018. Available online at https://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Last accessed November 29, 2017. National Comprehensive Cancer Network.(2014) NCCN Clinical Practice Guidelines in Oncology: Non-small cell lung cancer, version 2.2014 (discussion update in progress). Available online at: http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Last accessed January, 2014. NCCN Clinical Practice Guidelines in Oncology.(2010) Non-Small Cell Lung Cancer V.1.2011. Accessible at http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf. Last accessed October 2010. Ozkok S, Karakoyun-Celik O, Goksel T et al.(2008) High dose rate endobronchial brachytherapy in the management of lung cancer: response and toxicity evaluation in 158 patients. Lung Cancer 2008; 62(3):326-33. Perol M, Caliandro R, Pommier P, et al.(1997) Curative irradiation of limited endobronchial carcinomas with high dose rate brachytherapy. Chest 1997;111:1417-23. Raben A, Mychalczak B.(1997) Brachytherapy for non-small cell lung cancer and selected neoplasms of the chest. Chest 1997; 112:276S-286S. Ratko TA, Vats V, Brock J et al.(2013) Local Nonsurgical Therapies for Stage I and Symptomatic Obstructive Non-Small-Cell Lung Cancer, June 2013 . Rockville MD: Agency for Healthcare Research and Quality 2013. Reveiz L, Rueda JR, Cardona AF.(2012) Palliative endobronchial brachytherapy for non-small cell lung cancer. Cochrane Database Syst Rev 2012; 12:CD004284. Rochet N, Hauswald H, Stoiber EM et al.(2013) Primary radiotherapy with endobronchial high-dose-rate brachytherapy boost for inoperable lung cancer: long-term results. Tumori 2013; 99(2):183-90. Rodrigues G, Macbeth F, Burmeister B et al.(2012) Consensus statement on palliative lung radiotherapy: third international consensus workshop on palliative radiotherapy and symptom control. Clin Lung Cancer 2012; 13(1):1-5. Rosenzweig KE, Movsas B, Bradley J et al.(2009) ACR appropriateness criteria on nonsurgical treatment for non-small cell lung cancer: poor performance status or palliative intent. J Am Coll Radiol 2009; 6(2):85-95. Shepherd RW, Radchenko C.(2019) Bronchoscopic ablation techniques in the management of lung cancer. Ann Transl Med. Aug 2019; 7(15): 362. PMID 31516908 Skowronek J, Piorunek T, Kanikowski M et al.(2013) Definitive high-dose-rate endobronchial brachytherapy of bronchial stump for lung cancer after surgery. Brachytherapy 2013; 12(6):560-6. Soror T, Kovacs G, Wecker S, et al.(2021) Palliative treatment with high-dose-rate endobronchial interventional radiotherapy (Brachytherapy) for lung cancer patients. Brachytherapy. Nov-Dec 2021; 20(6): 1269-1275. PMID 34429246 Sur R, Pond G, Falkson C, et al.(2023) BRACHY: A Randomized Trial to Evaluate Symptom Improvement in Advanced Non-Small Cell Lung Cancer Treated With External Beam Radiation With or Without High-Dose-Rate Intraluminal Brachytherapy. Int J Radiat Oncol Biol Phys. Jul 01 2023; 116(3): 601-610. PMID 36610615 Tendulkar RD, Fleming PA, et al.(2008) High dose-rate endobronchial brachytherapy for recurrent airway obstruction from hyperplastic granulation tissue. Int J Radiat Oncol Biol Phys, 2008; 70:701-6. Ung YC, Yu E, Falkson C, et al. Lung Cancer Disease Site Group Of Cancer Care Ontario's Program In Evidence-Based Care.(2006) The role of high-dose-rate brachytherapy in the palliation of symptoms in patients with non-small-cell lung cancer: a systematic review. Brachytherapy, 2006; 5:189-202. Villanueva AG, Lo TCM, Beamis JF.(1995) Endobronchial brachytherapy. Clin Chest Med 1995; 16:445-454. Viswanathan AN, Erickson BA, Ibbott GS, et al.(2017) The American College of Radiology and the American Brachytherapy Society practice parameter for the performance of low-dose-rate brachytherapy. Brachytherapy. Jan - Feb 2017;16(1):68-74. Xiang L, Ren PR, Li HX, et al.(2023) Effect of 3-Dimensional Interstitial High-Dose-Rate Brachytherapy With Regional Metastatic Lymph Node Intensity-Modulated Radiation Therapy in Locally Advanced Peripheral Non-Small Cell Lung Cancer: 5-Year Follow-up of a Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. Feb 01 2023; 115(2): 347-355. PMID 35901979 Yoon SM, Suh R, Abtin F, et al.(2021) Outcomes with multi-disciplinary management of central lung tumors with CT-guided percutaneous high dose rate brachyablation. Radiat Oncol. Jun 07 2021; 16(1): 99. PMID 34098977 |
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