Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
Abstract Background Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity. Methods Among 123 women consenting to p...
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| Language: | English |
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BMC
2021-11-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-021-08916-z |
| _version_ | 1818724073967976448 |
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| author | Hilde Van Parijs Vincent Vinh-Hung Christel Fontaine Guy Storme Claire Verschraegen Dung M. Nguyen Nele Adriaenssens Nam P. Nguyen Olena Gorobets Mark De Ridder |
| author_facet | Hilde Van Parijs Vincent Vinh-Hung Christel Fontaine Guy Storme Claire Verschraegen Dung M. Nguyen Nele Adriaenssens Nam P. Nguyen Olena Gorobets Mark De Ridder |
| author_sort | Hilde Van Parijs |
| collection | DOAJ |
| description | Abstract Background Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity. Methods Among 123 women consenting to participate, 64 were randomized to CR, 59 to TT. CR delivered 50 Gy in 25 fractions/5 weeks to breast/chest wall and regional nodes if node-positive, with a sequential boost (16 Gy/8 fractions/1.6 weeks) after lumpectomy. TT delivered 42 Gy/15 fractions/3 weeks to breast/chest wall and regional nodes if node-positive, 51 Gy simultaneous-integrated-boost in patients with lumpectomy. PRO were assessed using the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30. PRO scores were converted into a symptom-free scale, 100 indicating a fully symptom-free score, 0 indicating total loss of freedom from symptom. Changes of PRO over time were analyzed using the linear mixed-effect model. Survival analysis computed time to > 10% PRO-deterioration. A post-hoc cardiorespiratory outcome was defined as deterioration in any of dyspnea, fatigue, physical functioning, or pain. Results At 10.4 years median follow-up, patients returned on average 9 questionnaires/patient, providing a total of 1139 PRO records. Item completeness was 96.6%. Missingness did not differ between the randomization arms. The PRO at baseline were below the nominal 100% symptom-free score, notably the mean fatigue-free score was 64.8% vs. 69.6%, pain-free was 75.4% vs. 75.3%, and dyspnea-free was 84.8% vs. 88.5%, in the TT vs. CR arm, respectively, although the differences were not significant. By mixed-effect modeling on early ≤2 years assessment, all three scores deteriorated, significantly for fatigue, P ≤ 0.01, without effect of randomization arm. By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035. By survival analysis of the time to PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration from 66.9% with CR to 84.5% with TT, P = 0.029. Conclusion Modern radiation therapy can significantly improve long-term PRO. Trial registration Trial registration number ClinicalTrials.gov NCT00459628 , April 12, 2007 prospectively. |
| first_indexed | 2024-12-17T21:20:37Z |
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| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-17T21:20:37Z |
| publishDate | 2021-11-01 |
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| spelling | doaj.art-84a1938cdab54b1daefba478f0804a582022-12-21T21:32:13ZengBMCBMC Cancer1471-24072021-11-0121111110.1186/s12885-021-08916-zCardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancerHilde Van Parijs0Vincent Vinh-Hung1Christel Fontaine2Guy Storme3Claire Verschraegen4Dung M. Nguyen5Nele Adriaenssens6Nam P. Nguyen7Olena Gorobets8Mark De Ridder9Universitair Ziekenhuis Brussel, Vrije Universiteit BrusselUniversitair Ziekenhuis Brussel, Vrije Universiteit BrusselUniversitair Ziekenhuis Brussel, Vrije Universiteit BrusselUniversitair Ziekenhuis Brussel, Vrije Universiteit BrusselOhio State UniversitySchool of Medicine, Vietnam National UniversityUniversitair Ziekenhuis Brussel, Vrije Universiteit BrusselHoward UniversityCentre Hospitalier Universitaire (CHU) de MartiniqueUniversitair Ziekenhuis Brussel, Vrije Universiteit BrusselAbstract Background Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity. Methods Among 123 women consenting to participate, 64 were randomized to CR, 59 to TT. CR delivered 50 Gy in 25 fractions/5 weeks to breast/chest wall and regional nodes if node-positive, with a sequential boost (16 Gy/8 fractions/1.6 weeks) after lumpectomy. TT delivered 42 Gy/15 fractions/3 weeks to breast/chest wall and regional nodes if node-positive, 51 Gy simultaneous-integrated-boost in patients with lumpectomy. PRO were assessed using the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30. PRO scores were converted into a symptom-free scale, 100 indicating a fully symptom-free score, 0 indicating total loss of freedom from symptom. Changes of PRO over time were analyzed using the linear mixed-effect model. Survival analysis computed time to > 10% PRO-deterioration. A post-hoc cardiorespiratory outcome was defined as deterioration in any of dyspnea, fatigue, physical functioning, or pain. Results At 10.4 years median follow-up, patients returned on average 9 questionnaires/patient, providing a total of 1139 PRO records. Item completeness was 96.6%. Missingness did not differ between the randomization arms. The PRO at baseline were below the nominal 100% symptom-free score, notably the mean fatigue-free score was 64.8% vs. 69.6%, pain-free was 75.4% vs. 75.3%, and dyspnea-free was 84.8% vs. 88.5%, in the TT vs. CR arm, respectively, although the differences were not significant. By mixed-effect modeling on early ≤2 years assessment, all three scores deteriorated, significantly for fatigue, P ≤ 0.01, without effect of randomization arm. By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035. By survival analysis of the time to PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration from 66.9% with CR to 84.5% with TT, P = 0.029. Conclusion Modern radiation therapy can significantly improve long-term PRO. Trial registration Trial registration number ClinicalTrials.gov NCT00459628 , April 12, 2007 prospectively.https://doi.org/10.1186/s12885-021-08916-zQuality of lifePatient reported outcome measuresDyspneaFatiguePain |
| spellingShingle | Hilde Van Parijs Vincent Vinh-Hung Christel Fontaine Guy Storme Claire Verschraegen Dung M. Nguyen Nele Adriaenssens Nam P. Nguyen Olena Gorobets Mark De Ridder Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer BMC Cancer Quality of life Patient reported outcome measures Dyspnea Fatigue Pain |
| title | Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer |
| title_full | Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer |
| title_fullStr | Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer |
| title_full_unstemmed | Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer |
| title_short | Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer |
| title_sort | cardiopulmonary related patient reported outcomes in a randomized clinical trial of radiation therapy for breast cancer |
| topic | Quality of life Patient reported outcome measures Dyspnea Fatigue Pain |
| url | https://doi.org/10.1186/s12885-021-08916-z |
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