Abstract
BackgroundLong-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.MethodsAmong 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.ResultsAt 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.ConclusionModern radiation therapy can significantly improve long-term PRO.Trial registrationTrial registration number ClinicalTrials.govNCT00459628, April 12, 2007 prospectively.
Highlights
Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce
Treatment toxicities adversely affect quality of life (QOL), and radiation therapy has been associated with increased risks of heart disease and radiation pneumonitis [5]
Functional assessment was implemented under the form of five parallel modules: 1) echocardiographic evaluation under cardiologist guidance [13]; 2) pulmonary function test managed by the pneumology department [11]; 3) shoulder-arm physical evaluation managed by the physiotherapy unit [14]; 4) oncologist’s recording of clinical toxicities using the Late Effects Normal Tissues Subjective, Objective, Management, Analytic (LENTSOMA), and the Radiation Therapy Oncology Group (RTOG) scores [15]; and 5) patient-reported outcomes (PRO) as will be detailed
Summary
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. Breast cancer is the most common cancer among women worldwide, and the second most frequent cause of cancer death in more developed regions [1]. It is a major contributor to the high overall cancer disability-adjusted lifeyears in very high Human Development Index countries, with quite a large contribution of years spent with a disability [2]. Radiotherapy improves tumor control and survival in breast cancer [3, 4]. Quality of life (QOL) is becoming increasingly important. Treatment toxicities adversely affect QOL, and radiation therapy has been associated with increased risks of heart disease and radiation pneumonitis [5]. As radiation techniques evolve continuously [6], there is need to evaluate whether breast cancer patients can benefit from new technologies
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