Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study
PURPOSETo evaluate the toxicity profile and efficacy of postoperative ultra-hypofractionated radiation therapy in elderly patients with breast cancer.MATERIALS AND METHODSThis is a nonrandomized, single-center, prospective Phase II trial. Patients with breast cancer older than 65 years were treated...
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American Society of Clinical Oncology
2025-04-01
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| Series: | JCO Global Oncology |
| Online Access: | https://ascopubs.org/doi/10.1200/GO-24-00277 |
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| author | Marcel Fang Vinicius de Carvalho Gico Lucas Casimiro Bruno Takatsu Elson Santos Neto Rossana Veronica Mendoza Lopez Gustavo Vilela Costa Pinto Gustavo Nader Marta |
| author_facet | Marcel Fang Vinicius de Carvalho Gico Lucas Casimiro Bruno Takatsu Elson Santos Neto Rossana Veronica Mendoza Lopez Gustavo Vilela Costa Pinto Gustavo Nader Marta |
| author_sort | Marcel Fang |
| collection | DOAJ |
| description | PURPOSETo evaluate the toxicity profile and efficacy of postoperative ultra-hypofractionated radiation therapy in elderly patients with breast cancer.MATERIALS AND METHODSThis is a nonrandomized, single-center, prospective Phase II trial. Patients with breast cancer older than 65 years were treated with ultra-hypofractionated radiation therapy in 5 fractions of 5.7 Gy on alternate days in the breast or chest wall, or regional lymph nodes. The primary end point was acute toxicity.RESULTSA total of 60 patients were analyzed, with a median follow-up of 42.5 months (range, 13.8-66.2). Most patients presented pathologic stage I (56.6%, n = 34) or stage II (33.3%, n = 20) disease. Regional lymph node irradiation was performed in 22% (n = 13) of patients. During treatment, 51% (n = 31) of patients experienced grade 1 or 2 acute toxicity, with no cases of grade 3 acute toxicity reported. Late toxicity included 1.7% (n = 1) of patients developing grade 3 fibrosis and 1.7% (n = 1) developing grade 3 pneumonitis. Regional lymph node irradiation was not associated with a statistically significant increase in toxicity risk (P = .194). Cosmesis evaluations revealed no significant changes when comparing pretreatment assessments with evaluations at 10 weeks (P = .223) and 26 weeks (P = .615) post-treatment. Quality of life was not adversely affected, regardless of whether regional lymph nodes were irradiated. Recurrence rates included two patients with both locoregional and distant recurrence and five patients with distant recurrence. The 3-year disease-free survival probability was 81.7%, and the 3-year overall survival probability was 86.7%.CONCLUSIONThis study demonstrates the safety of ultra-hypofractionated radiation therapy in terms of toxicity in patients with breast cancer. The findings for side effects, cosmesis, quality of life, and survival outcomes are consistent with those observed in moderately hypofractionated radiation therapy regimens, suggesting its use as a viable treatment option in this demographic. |
| format | Article |
| id | doaj-art-c5c7ceb9b60644d983ee4fbf01f2b23c |
| institution | OA Journals |
| issn | 2687-8941 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | American Society of Clinical Oncology |
| record_format | Article |
| series | JCO Global Oncology |
| spelling | doaj-art-c5c7ceb9b60644d983ee4fbf01f2b23c2025-08-20T02:16:45ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412025-04-011110.1200/GO-24-00277Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective StudyMarcel Fang0Vinicius de Carvalho Gico1Lucas Casimiro2Bruno Takatsu3Elson Santos Neto4Rossana Veronica Mendoza Lopez5Gustavo Vilela Costa Pinto6Gustavo Nader Marta7Department of Radiology and Oncology, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilInstituto de Pesquisa Prevent Senior, Sao Paulo, BrazilCentro de Referência da Saúde da Mulher, Sao Paulo, BrazilFaculdade de Ciências Médicas de Santos, São Paulo, BrazilDivision of Radiation Oncology, AC Camargo Cancer Center- Sao Paulo, BrazilCentro de Estudos e Tecnologias Convergentes para Oncologia de Precisão (Comprehensive Center for Precision Oncology), Centro de Investigação Translacional em Oncologia, Instituto do Câncer do Estado de São Paulo, São Paulo, BrazilInstituto de Pesquisa Prevent Senior, Sao Paulo, BrazilDepartment of Radiology and Oncology, Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, BrazilPURPOSETo evaluate the toxicity profile and efficacy of postoperative ultra-hypofractionated radiation therapy in elderly patients with breast cancer.MATERIALS AND METHODSThis is a nonrandomized, single-center, prospective Phase II trial. Patients with breast cancer older than 65 years were treated with ultra-hypofractionated radiation therapy in 5 fractions of 5.7 Gy on alternate days in the breast or chest wall, or regional lymph nodes. The primary end point was acute toxicity.RESULTSA total of 60 patients were analyzed, with a median follow-up of 42.5 months (range, 13.8-66.2). Most patients presented pathologic stage I (56.6%, n = 34) or stage II (33.3%, n = 20) disease. Regional lymph node irradiation was performed in 22% (n = 13) of patients. During treatment, 51% (n = 31) of patients experienced grade 1 or 2 acute toxicity, with no cases of grade 3 acute toxicity reported. Late toxicity included 1.7% (n = 1) of patients developing grade 3 fibrosis and 1.7% (n = 1) developing grade 3 pneumonitis. Regional lymph node irradiation was not associated with a statistically significant increase in toxicity risk (P = .194). Cosmesis evaluations revealed no significant changes when comparing pretreatment assessments with evaluations at 10 weeks (P = .223) and 26 weeks (P = .615) post-treatment. Quality of life was not adversely affected, regardless of whether regional lymph nodes were irradiated. Recurrence rates included two patients with both locoregional and distant recurrence and five patients with distant recurrence. The 3-year disease-free survival probability was 81.7%, and the 3-year overall survival probability was 86.7%.CONCLUSIONThis study demonstrates the safety of ultra-hypofractionated radiation therapy in terms of toxicity in patients with breast cancer. The findings for side effects, cosmesis, quality of life, and survival outcomes are consistent with those observed in moderately hypofractionated radiation therapy regimens, suggesting its use as a viable treatment option in this demographic.https://ascopubs.org/doi/10.1200/GO-24-00277 |
| spellingShingle | Marcel Fang Vinicius de Carvalho Gico Lucas Casimiro Bruno Takatsu Elson Santos Neto Rossana Veronica Mendoza Lopez Gustavo Vilela Costa Pinto Gustavo Nader Marta Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study JCO Global Oncology |
| title | Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study |
| title_full | Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study |
| title_fullStr | Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study |
| title_full_unstemmed | Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study |
| title_short | Phase II Evaluation of Ultra-Hypofractionated Postoperative Radiation Therapy for Breast Cancer: Toxicity and Efficacy in a Single-Center Nonrandomized Prospective Study |
| title_sort | phase ii evaluation of ultra hypofractionated postoperative radiation therapy for breast cancer toxicity and efficacy in a single center nonrandomized prospective study |
| url | https://ascopubs.org/doi/10.1200/GO-24-00277 |
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