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.
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| Title: | 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. |
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| Authors: | Sur, Ranjan1 (AUTHOR), Pond, Gregory2 (AUTHOR), Falkson, Conrad3 (AUTHOR), Pan, Ming4 (AUTHOR), Wright, James1 (AUTHOR), Bezjak, Andrea5 (AUTHOR), Dagnault, Anne6 (AUTHOR), Yu, Edward7 (AUTHOR), Almahmudi, Maha8 (AUTHOR), Puksa, Serge9 (AUTHOR), Gopaul, Darin10 (AUTHOR), Tsakiridis, Theos1 (AUTHOR), Swaminath, Anand1 (AUTHOR), Ellis, Peter11 (AUTHOR), Whelan, Timothy1 (AUTHOR) twhelan@hhsc.ca |
| Source: | International Journal of Radiation Oncology, Biology, Physics. Jul2023, Vol. 116 Issue 3, p601-610. 10p. |
| Subjects: | Non-small-cell lung carcinoma, External beam radiotherapy, Radioisotope brachytherapy |
| Abstract: | Uncontrolled studies suggest that the addition of high-dose-rate intraluminal brachytherapy (HDRIB) to external beam radiation therapy (EBRT) may improve palliation for patients with advanced non-small cell lung cancer (NSCLC). The purpose of this study was to evaluate the potential clinical benefit of adding HDRIB to EBRT in a multicenter randomized trial. Patients with symptomatic stage III or IV NSCLC with endobronchial disease were randomized to EBRT (20 Gy in 5 daily fractions over 1 week or 30 Gy in 10 daily fractions over 2 weeks) or the same EBRT plus HDRIB (14 Gy in 2 fractions separated by 1 week). The primary outcome was the proportion of patients who achieved symptomatic improvement in patient-reported overall lung cancer symptoms on the Lung Cancer Symptom Scale (LCSS) at 6 weeks after randomization. Secondary outcomes included improvement in individual symptoms, symptom-progression-free survival, overall survival, and toxicity. The planned sample size was 250 patients based on detection of symptomatic improvement from 40% to 60% with a 2-sided α of.05 and 80% power. A total of 134 patients were randomized over 4.5 years: 67 to each arm. The study closed early owing to slow accrual. The mean age was 69.8 years, and 67% of patients had metastatic disease. At 6 weeks, 19 patients (28.4%) in the EBRT arm and 20 patients (29.9%) in the EBRT plus HDRIB arm experienced an improvement in lung cancer symptoms (P =.84). When limited to patients who completed the LCSS, percentages were 40.4% versus 47.6%, respectively (P =.49). Between group differences in mean change scores (0.3-0.5 standard deviations) in favor of EBRT plus HDRIB were observed for overall symptoms, but only hemoptysis was significantly improved (P =.03). No significant differences were observed in progression-free or overall survival. Grade 3/4 toxicities were similar between groups. Small to moderate improvements were seen in symptom relief with the combined therapy, but they did not reach statistical significance. Further research is necessary before recommending HDRIB in addition to EBRT for palliation of lung cancer symptoms. [ABSTRACT FROM AUTHOR] |
| Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Engineering Source |
| FullText | Text: Availability: 0 |
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| Header | DbId: egs DbLabel: Engineering Source An: 163931465 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Sur%2C+Ranjan%22">Sur, Ranjan</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pond%2C+Gregory%22">Pond, Gregory</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Falkson%2C+Conrad%22">Falkson, Conrad</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pan%2C+Ming%22">Pan, Ming</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wright%2C+James%22">Wright, James</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bezjak%2C+Andrea%22">Bezjak, Andrea</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dagnault%2C+Anne%22">Dagnault, Anne</searchLink><relatesTo>6</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Yu%2C+Edward%22">Yu, Edward</searchLink><relatesTo>7</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Almahmudi%2C+Maha%22">Almahmudi, Maha</searchLink><relatesTo>8</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Puksa%2C+Serge%22">Puksa, Serge</searchLink><relatesTo>9</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gopaul%2C+Darin%22">Gopaul, Darin</searchLink><relatesTo>10</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tsakiridis%2C+Theos%22">Tsakiridis, Theos</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Swaminath%2C+Anand%22">Swaminath, Anand</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ellis%2C+Peter%22">Ellis, Peter</searchLink><relatesTo>11</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Whelan%2C+Timothy%22">Whelan, Timothy</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> twhelan@hhsc.ca</i> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22International+Journal+of+Radiation+Oncology%2C+Biology%2C+Physics%22">International Journal of Radiation Oncology, Biology, Physics</searchLink>. Jul2023, Vol. 116 Issue 3, p601-610. 10p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Non-small-cell+lung+carcinoma%22">Non-small-cell lung carcinoma</searchLink><br /><searchLink fieldCode="DE" term="%22External+beam+radiotherapy%22">External beam radiotherapy</searchLink><br /><searchLink fieldCode="DE" term="%22Radioisotope+brachytherapy%22">Radioisotope brachytherapy</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Uncontrolled studies suggest that the addition of high-dose-rate intraluminal brachytherapy (HDRIB) to external beam radiation therapy (EBRT) may improve palliation for patients with advanced non-small cell lung cancer (NSCLC). The purpose of this study was to evaluate the potential clinical benefit of adding HDRIB to EBRT in a multicenter randomized trial. Patients with symptomatic stage III or IV NSCLC with endobronchial disease were randomized to EBRT (20 Gy in 5 daily fractions over 1 week or 30 Gy in 10 daily fractions over 2 weeks) or the same EBRT plus HDRIB (14 Gy in 2 fractions separated by 1 week). The primary outcome was the proportion of patients who achieved symptomatic improvement in patient-reported overall lung cancer symptoms on the Lung Cancer Symptom Scale (LCSS) at 6 weeks after randomization. Secondary outcomes included improvement in individual symptoms, symptom-progression-free survival, overall survival, and toxicity. The planned sample size was 250 patients based on detection of symptomatic improvement from 40% to 60% with a 2-sided α of.05 and 80% power. A total of 134 patients were randomized over 4.5 years: 67 to each arm. The study closed early owing to slow accrual. The mean age was 69.8 years, and 67% of patients had metastatic disease. At 6 weeks, 19 patients (28.4%) in the EBRT arm and 20 patients (29.9%) in the EBRT plus HDRIB arm experienced an improvement in lung cancer symptoms (P =.84). When limited to patients who completed the LCSS, percentages were 40.4% versus 47.6%, respectively (P =.49). Between group differences in mean change scores (0.3-0.5 standard deviations) in favor of EBRT plus HDRIB were observed for overall symptoms, but only hemoptysis was significantly improved (P =.03). No significant differences were observed in progression-free or overall survival. Grade 3/4 toxicities were similar between groups. Small to moderate improvements were seen in symptom relief with the combined therapy, but they did not reach statistical significance. Further research is necessary before recommending HDRIB in addition to EBRT for palliation of lung cancer symptoms. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/j.ijrobp.2022.12.049 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 10 StartPage: 601 Subjects: – SubjectFull: Non-small-cell lung carcinoma Type: general – SubjectFull: External beam radiotherapy Type: general – SubjectFull: Radioisotope brachytherapy Type: general Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Sur, Ranjan – PersonEntity: Name: NameFull: Pond, Gregory – PersonEntity: Name: NameFull: Falkson, Conrad – PersonEntity: Name: NameFull: Pan, Ming – PersonEntity: Name: NameFull: Wright, James – PersonEntity: Name: NameFull: Bezjak, Andrea – PersonEntity: Name: NameFull: Dagnault, Anne – PersonEntity: Name: NameFull: Yu, Edward – PersonEntity: Name: NameFull: Almahmudi, Maha – PersonEntity: Name: NameFull: Puksa, Serge – PersonEntity: Name: NameFull: Gopaul, Darin – PersonEntity: Name: NameFull: Tsakiridis, Theos – PersonEntity: Name: NameFull: Swaminath, Anand – PersonEntity: Name: NameFull: Ellis, Peter – PersonEntity: Name: NameFull: Whelan, Timothy IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 07 Text: Jul2023 Type: published Y: 2023 Identifiers: – Type: issn-print Value: 03603016 Numbering: – Type: volume Value: 116 – Type: issue Value: 3 Titles: – TitleFull: International Journal of Radiation Oncology, Biology, Physics Type: main |
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