Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial:The DBCG HYPO Trial
Autor: | Jens Overgaard, M.H. Nielsen, Unn miriam Kasti, Mechthild Krause, Andreas Schreiber, Birgitte Vrou Offersen, Ingvil Mjaaland, Lars Stenbygaard, Jan Alsner, Erik Jakobsen, Hanne Melgaard Nielsen |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty Breast surgery medicine.medical_treatment Pain Breast Neoplasms Adenocarcinoma Mastectomy Segmental 030218 nuclear medicine & medical imaging Cicatrix 03 medical and health sciences 0302 clinical medicine Breast cancer Internal medicine Carcinoma medicine Edema Humans Telangiectasis Survival rate Aged Aged 80 and over business.industry Carcinoma Ductal Breast Middle Aged Ductal carcinoma medicine.disease Cardiotoxicity Radiation Pneumonitis Survival Rate Radiation therapy Regimen Patient Satisfaction 030220 oncology & carcinogenesis Female Radiation Dose Hypofractionation Radiotherapy Adjuvant Lymph Nodes Neoplasm Recurrence Local business Pigmentation Disorders Carcinoma in Situ Mastectomy |
Zdroj: | Offersen, B V, Alsner, J, Nielsen, H M, Jakobsen, E H, Nielsen, M H, Krause, M, Stenbygaard, L, Mjaaland, I, Schreiber, A, Kasti, U M, Overgaard, J & Danish Breast Cancer Group Radiation Therapy Committee 2020, ' Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial : The DBCG HYPO Trial ', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 38, no. 31, pp. 3615-3625 . https://doi.org/10.1200/JCO.20.01363 Journal of Clinical Oncology 38(2020)31, 3615 Offersen, B V, Alsner, J, Nielsen, H M, Jakobsen, E H, Nielsen, M H, Krause, M, Stenbygaard, L, Mjaaland, I, Schreiber, A, Kasti, U M, Overgaard, J & Danish Breast Cancer Group Radiation Therapy Committee 2020, ' Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial : The DBCG HYPO Trial ', Journal of Clinical Oncology, vol. 38, no. 31, pp. 3615-3625 . https://doi.org/10.1200/JCO.20.01363 |
Popis: | PURPOSE Given the poor results using hypofractionated radiotherapy for early breast cancer, a dose of 50 Gy in 25 fractions (fr) has been the standard regimen used by the Danish Breast Cancer Group (DBCG) since 1982. Results from more recent trials have stimulated a renewed interest in hypofractionation, and the noninferiority DBCG HYPO trial (ClincalTrials.gov identifier: NCT00909818 ) was designed to determine whether a dose of 40 Gy in 15 fr does not increase the occurrence of breast induration at 3 years compared with a dose of 50 Gy in 25 fr. PATIENTS AND METHODS One thousand eight hundred eighty-two patients > 40 years of age who underwent breast-conserving surgery for node-negative breast cancer or ductal carcinoma in situ (DCIS) were randomly assigned to radiotherapy at a dose of either 50 Gy in 25 fr or 40 Gy in 15 fr. The primary end point was 3-year grade 2-3 breast induration assuming noninferiority regarding locoregional recurrence. RESULTS A total of 1,854 consenting patients (50 Gy, n = 937; 40 Gy, n = 917) were enrolled from 2009-2014 from eight centers. There were 1,608 patients with adenocarcinoma and 246 patients with DCIS. The 3-year rates of induration were 11.8% (95% CI, 9.7% to 14.1%) in the 50-Gy group and 9.0% (95% CI, 7.2% to 11.1%) in the 40-Gy group (risk difference, −2.7%; 95% CI, −5.6% to 0.2%; P = .07). Systemic therapies and radiotherapy boost did not increase the risk of induration. Telangiectasia, dyspigmentation, scar appearance, edema, and pain were detected at low rates, and cosmetic outcome and patient satisfaction with breast appearance were high with either no difference or better outcome in the 40-Gy cohort compared with the 50-Gy cohort. The 9-year risk of locoregional recurrence was 3.3% (95% CI, 2.0% to 5.0%) in the 50-Gy group and 3.0% (95% CI, 1.9% to 4.5%) in the 40-Gy group (risk difference, −0.3%; 95% CI, −2.3% to 1.7%). The 9-year overall survival was 93.4% (95% CI, 91.1% to 95.1%) in the 50-Gy group and 93.4% (95% CI, 91.0% to 95.2%) in the 40-Gy group. The occurrence of radiation-associated cardiac and lung disease was rare and not influenced by the fractionation regimen. CONCLUSION Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy. Other normal tissue effects were minimal, with similar or less frequent rates in the 40-Gy group. The 9-year locoregional recurrence risk was low. |
Databáze: | OpenAIRE |
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