The impact of palliative radiotherapy on health-related quality of life in patients with head and neck cancer - Results of a multicenter prospective cohort study.

Purpose: Palliative radiotherapy for patients with head and neck cancer can be used to alleviate symptoms. Only a few studies have investigated its impact on patient-reported outcomes (PRO). Therefore, we conducted a prospective multicenter observational study. The primary objective was to assess changes in health-related quality of life (HrQoL) per PRO. Methods: Eligibility criteria included i.) head and neck cancer and ii.) palliative radiotherapy indicated (EQD2Gy < 60 Gy). The primary follow-up date was eight weeks after radiotherapy (t8w). PRO measures included the EORTC QLQ-C30 and EORTC QLQ-H&N43 and pain per Numeric Rating Scale (NRS). Per protocol, five PRO domains were to be reported in detail as well as PRO domains corresponding to a primary and secondary symptom as determined by the individual patient. We defined a minimal important difference (MID) of 10 points. Results: From 06/2020 to 06/2022, 61 patients were screened and 21 patients were included. Due to death or decline in health-status, HrQoL data was available for 18 patients at the first fraction and for eight patients at t8w. The MID was not met for the predefined domains in terms of mean values as compared from first fraction to t8w. Individually in those patients with available HrQoL data at t8w, 71% (5/7) improved in their primary and 40% (2/5) in their secondary symptom domain reaching the MID from first fraction to t8w, respectively. There was a significant improvement in pain per NRS in those patients with available data at t8w per Wilcoxon signed rank test (p = 0.041). Acute mucositis of grade ≥3 per CTCAE v5.0 occurred in 44% (8/18) of the patients. The median overall survival was 11 months. Conclusion: Despite low patient numbers and risk of selection bias, our study shows some evidence of a benefit from palliative radiotherapy for head and neck cancer as measured by PRO.German Clinical Trial Registry identifier: DRKS00021197.

Lessons learned after one year of COVID-19 from a urologist and radiotherapist view: A German survey on prostate cancer diagnosis and treatment.

INTRODUCTION: Since the beginning of the pandemic in 2020, COVID-19 has changed the medical landscape. International recommendations for localized prostate cancer (PCa) include deferred treatment and adjusted therapeutic routines. MATERIALS AND METHODS: To longitudinally evaluate changes in PCa treatment strategies in urological and radiotherapy departments in Germany, a link to a survey was sent to 134 institutions covering two representative baseline weeks prior to the pandemic and 13 weeks from March 2020 to February 2021. The questionnaire captured the numbers of radical prostatectomies, prostate biopsies and case numbers for conventional and hypofractionation radiotherapy. The results were evaluated using descriptive analyses. RESULTS: A total of 35% of the questionnaires were completed. PCa therapy increased by 6% in 2020 compared to 2019. At baseline, a total of 69 radiotherapy series and 164 radical prostatectomies (RPs) were documented. The decrease to 60% during the first wave of COVID-19 particularly affected low-risk PCa. The recovery throughout the summer months was followed by a renewed reduction to 58% at the end of 2020. After a gradual decline to 61% until July 2020, the number of prostate biopsies remained stable (89% to 98%) during the second wave. The use of RP fluctuated after an initial decrease without apparent prioritization of risk groups. Conventional fractionation was used in 66% of patients, followed by moderate hypofractionation (30%) and ultrahypofractionation (4%). One limitation was a potential selection bias of the selected weeks and the low response rate. CONCLUSION: While the diagnosis and therapy of PCa were affected in both waves of the pandemic, the interim increase between the peaks led to a higher total number of patients in 2020 than in 2019. Recommendations regarding prioritization and fractionation routines were implemented heterogeneously, leaving unexplored potential for future pandemic challenges.

Reducing radiation-associated toxicity using online image guidance (IGRT) in prostate cancer patients undergoing dose-escalated radiation therapy.

AIM: To determine the influence of IGRT in terms of toxicities compared to non-IGRT patients undergoing definitive RT. BACKGROUND: Image-guided radiotherapy (IGRT) enables immediate correction of target movement by online imaging. For prostate cancer patients undergoing radiation therapy (RT), a geographical miss of the prostate may result in increased dose-volume effects in the rectum and bladder. METHODS: A total of 198 prostate cancer patients treated between 2003 and 2013 were recruited randomly for this evaluation. The rates of genitourinary (GU) and gastrointestinal (GI) toxicity for 96 non-IGRT patients (total dose: 72/73.8 Gy) were compared to those for 102 IGRT patients (total dose: 77.4 Gy) according to the Common Toxicity Criteria Version 3.0 (CTCAEv3.0). Follow-up information included treatment-related symptoms and PSA relapse. RESULTS: After a median follow-up of 55.4 months, a statistically significant difference was noted for acute GI toxicities ≥1 in favour of IGRT. Significantly more patients treated by IGRT were free of acute GI symptoms (43% vs. 19%, p = 0.0012). In the non-IGRT group, more patients experienced acute GU side effects (89% vs. 80%, p = 0.07). Late toxicity scores were comparable for both cohorts. CONCLUSIONS: Based on the data, we demonstrated that despite dose escalation, IGRT enabled us to reduce the GI side effects of radiation. IGRT can therefore be considered to be the standard of care for dose-escalated RT of localized prostate cancer.

Does mean heart dose sufficiently reflect coronary artery exposure in left-sided breast cancer radiotherapy? : Influence of respiratory gating.

PURPOSE: With extensive use of systemic treatment, the issue of cardiac mortality after breast cancer radiation (RT) is still important. The aim of our analysis was to clarify whether the dose to one surrogate parameter (e. g., mean heart dose, as used in most studies) reflects the dose to the other cardiovascular structures especially the left anterior descending artery depending on breathing-adapted RT. PATIENTS AND METHODS: A total of 130 patients who underwent adjuvant RT (50.4 Gy plus boost 9-16 Gy) were evaluated. In all, 71 patients were treated with free-breathing and 59 patients using respiratory monitoring (gated RT). Dosimetric associations were calculated. RESULTS: The mean dose to the heart (Dmean heart) was reduced from 2.7 (0.8-5.2) Gy to 2.4 (1.1-4.6) Gy, the Dmean LAD (left anterior descending artery) decreased from 11.1 (1.3-28.6) Gy to 9.3 (2.2-19.9) Gy with gated RT (p = 0.04). A significant relationship was shown for Dmean heart-Dmean LAD, V25heart-Dmean LAD and Dmax heart-Dmax LAD for gated patients only (p < 0.01). For every 1 Gy increase in Dmean heart, mean LAD doses rose by 3.6 Gy, without gating V25 ≤5 % did not assure a benefit and resulted in Dmean LAD between 1.3 and 28.6 Gy. CONCLUSION: A significant reduction and association of heart and coronary artery (LAD) doses using inspiratory gating was shown. However, in free-breathing plans commonly measured dose constraints do not allow precise estimation of the dose to the coronary arteries.

Impact of p16 Alterations and Pretreatment Anemia on Toxicity in Head and Neck Cancer Patients Undergoing Definitive Radiochemotherapy.

BACKGROUND: Human papilloma virus (HPV) infection, p16 expression and hypoxia may play important roles in the carcinogenesis, treatment response and toxicities of head and neck squamous cell carcinoma (HNSCC). The aim of this analysis was to assess whether there is any correlation between pre-radiotherapy (RT) anemia, p16 expression and toxicities and local control for patients undergoing definitive therapy. METHODS: 79 HNSCC patients who had undergone radiochemotherapy (RCT) or RT-antibody therapy were retrospectively analyzed. p16 (INK4A) expression was detected by immunohistochemical analysis. Factors predisposing for acute side effects were examined by uni- and multivariate analysis. RESULTS: p16 overexpression was detected in 32 cases. Pretreatment anemia was present in one third of patients. Only 5% of patients were characterized by both pre-RT anemia and p16 overexpression. p16 expression was significantly associated with acute grade 3 toxicity. 47% of p16-positive patients developed grade ≥ 3 radiodermatitis compared to 26% of p16-negative patients (p = 0.04). A reduced risk of severe skin toxicities was noted for patients with hypoxic blood values before RT. p16 expression was significantly correlated with local control (p = 0.002). CONCLUSIONS: p16 expression is associated with better response to definitive combined treatment (RCT, RT + cetuximab), but also significantly related to acute high-grade toxicity.

Predictors of overall satisfaction of cancer patients undergoing radiation therapy.

BACKGROUND: Reporting the experiences and satisfaction of patients, as well as their quality of care scores is an emerging recommendation in health care systems. Many aspects of patients' experience determine their overall satisfaction. The aim of this evaluation was to define the main factors contributing to the satisfaction of patients undergoing radiotherapy in an outpatient setting. PATIENTS AND METHODS: A total of 1,710 patients with a histologically proven cancer, who were treated in our department between 2012 and 2014, were recruited for this prospective evaluation. At the end of therapy, each patient was asked to grade the skills and the care provided by radiation therapists, physicians, and physician's assistants, as well as the overall satisfaction during therapy. Statistical analysis was performed to determine which parameters had the greatest influence on overall satisfaction. RESULTS: Overall satisfaction with the provided care was high with a mean satisfaction score of 1.4. Significant correlations were found between overall satisfaction and each of the following survey items: courtesy, protection of privacy, professional skills and care provided by the radiation therapists and physicians, accuracy of provided information, and cleanliness. Linear regression analysis demonstrated that courteous behavior and the protection of privacy were the strongest predictors for overall satisfaction (P<0.001), followed by care and skills of physicians and radiation therapists. Patients suffering from head and neck cancer expressed lower overall satisfaction. CONCLUSION: Based on our prospectively acquired data, we were able to identify and confirm key factors for patient satisfaction in an outpatient radiooncological cancer center. From these results, we conclude that patients want most importantly to be treated with courtesy, protection of privacy and care.

Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients.

PURPOSE: More than 80% of patients with breast cancer undergoing postsurgical radiotherapy (RT) will develop radiodermatitis and approximately 10% of these patients show grade 3 lesions. Side effects may reduce the patient's compliance and can be limiting factors to follow RT protocols. Therefore, there is a high need for more effective prophylactic treatments. In this study, a silymarin-based cream (Leviaderm(®)) was tested in comparison to our standard of care (SOC) at the involved site. METHODS: A total of 101 patients were evaluated after breast-conserving surgery followed by RT with 50.4 Gy plus boost 9-16 Gy. Of these, 51 patients were treated with the silymarin-based cream. In addition, 50 patients were documented receiving a panthenol-containing cream interventionally, if local skin lesions occurred. The acute skin reactions were classified according to the RTOG and VAS (Visual Analogue Scale) scores. RESULTS: The median time to toxicity was prolonged significantly with silymarin-based cream (45 vs. 29 days (SOC), p < 0.0001). Only 9.8% of patients using silymarin-based cream showed grade 2 toxicity in week 5 of RT in comparison to 52% with SOC. At the end of RT, 23.5% of patients in the silymarin-based study group developed no skin reactions vs. 2% with SOC, while grade 3 toxicity occurred only in 2% in the silymarin-based arm compared to 28% (SOC). CONCLUSIONS: Silymarin-based cream Leviaderm(®) may be a promising and effective treatment for the prevention of acute skin lesions caused by RT of breast cancer patients. To confirm the results of this nonrandomized, observational trial, this component should be tested in larger multicenter studies in this setting.