Total neoadjuvant therapy (TNT) is an evolving treatment schedule for locally advanced rectal cancer (LARC), allowing for organ preservation in a relevant number of patients in the case of complete response. Patients who undergo this so-called “watch and wait” approach are likely to benefit regarding their quality of life (QoL), especially if definitive ostomy could be avoided. In this work, we performed the first cost-effectiveness analysis from the patient perspective to compare costs for TNT with radical resection after neoadjuvant chemoradiation (CRT) in the German health care system. Individual costs for patients insured with a statutory health insurance were calculated with a Markov microsimulation. A subgroup analysis from the prospective “FinTox” trial was used to calibrate the model’s parameters. We found that TNT was less expensive (−1540 EUR) and simultaneously resulted in a better QoL (+0.64 QALYs) during treatment and 5-year follow-up. The average cost for patients under TNT was 4711 EUR per year, which was equivalent to 3.2% of the net household income. CRT followed by resection resulted in higher overall costs for ostomy care, medication and greater loss of earnings. Overall, TNT appeared to be more efficacious and cost-effective from a patient’s point of view in the German health care system.

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. Eligibility criteria included i.) head and neck cancer and ii.) palliative radiotherapy indicated (EQD_2Gy < 60 Gy). The primary follow-up date was eight weeks after radiotherapy (t_8w). 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. 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 t_8w. The MID was not met for the predefined domains in terms of mean values as compared from first fraction to t_8w. Individually in those patients with available HrQoL data at t_8w, 71% (5/7) improved in their primary and 40% (2/5) in their secondary symptom domain reaching the MID from first fraction to t_8w, respectively. There was a significant improvement in pain per NRS in those patients with available data at t_8w 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. 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.

Background/Objectives: Pneumonitis caused by radiotherapy for lung cancer may be missed since it often occurs only several months later. In a previous trial including patients of any age, a scoring system was tested to facilitate the correct diagnosis of radiation pneumonitis. Since elderly lung cancer patients have a greater risk of developing this complication, a separate scoring system for this group appears useful. Our prospective multi-center trial (NCT06480734) investigates a specific tool for elderly patients irradiated for lung cancer. Methods: Patients aged ≥65 years with lung cancer will complete paper-based questionnaires and rate symptoms potentially caused by pneumonitis weekly during and up to 24 weeks following radiotherapy. The total score of this symptom-based scoring system ranging from 0 to 9 points is correlated to pneumonitis. The discriminative power of the scoring system is evaluated by calculating the area under the receiver operating characteristic curve. Optimality is defined as a cut-off score with sensitivity ≥90% and specificity ≥80%. Moreover, the Youden index will be applied. Fifty-nine patients are required for the full analysis set. Assuming 5% will not qualify for this set, 65 patients should be enrolled. Moreover, patient satisfaction with the scoring system is evaluated. If the dissatisfaction rate is >20%, the system needs modifications; if the dissatisfaction rate is >40%, it is considered not useful. An optimal cut-off score facilitating the diagnosis of pneumonitis and its discrimination from other lung diseases will contribute to a corresponding mobile application to be used by elderly lung cancer patients at home.

Cumulative cisplatin doses of ≥ 200 mg/m² improve survival in adults with head-and-neck squamous cell carcinoma (HNSCC) undergoing chemoradiation, but many older adults with HNSCC cannot receive this prognostically relevant dose due to toxicities. This study aims to develop predictive models to assess the likelihood of older adults with HNSCC receiving ≥ 200 mg/m² cisplatin during chemoradiation. 366 patients from the SENIOR database, an international cohort of adults ≥ 65 years with HNSCC, received definitive chemoradiation with single-agent cisplatin and were analyzed. A Generalized Linear Model (GLM), Support Vector Machine (SVM), and Random Forest Model (RFM) were trained and compared for their performance in predicting a cumulative cisplatin dose of ≥ 200 mg/m². 195 (53 %) patients achieved a cumulative cisplatin dose of ≥ 200 mg/m². In the GLM, laryngeal carcinoma (β = 1.37, p = 0.01), tumoral p16 positivity (β = 0.69, p = 0.04), higher hemoglobin levels (β = 0.26, p = 0.002), elevated C-reactive protein (CRP) concentration (β = 0.02, p = 0.003), and increased estimated glomerular filtration rate (eGFR) (β = 0.02, p = 0.008) were associated with a higher probability of reaching ≥ 200 mg/m² cisplatin. Hemoglobin, CRP, eGFR, and p16 status constituted the most important features in the SVM and RFM. AUC values for the GLM, SVM, and RFM were 0.70 (95 % CI, 0.67-0.73), 0.71 (95 % CI, 0.68-0.73), and 0.73 (95 % CI, 0.71-0.75), respectively. We developed predictive models to support clinicians in identifying older adults with HNSCC capable of tolerating ≥ 200 mg/m² cumulative cisplatin during chemoradiation. Once validated, these models could improve personalized treatments and enhance shared decision-making in older adults with HNSCC.

Background/Objectives: During radiotherapy for prostate cancer, the risk of radiation cystitis is increased if the volume of the bladder is small. According to previous studies, it is important that bladder volumes are ≥200 mL. Drinking protocols may be helpful in this context. Adherence to such protocols can be challenging, and may be improved by an app reminding patients before each session of radiotherapy to drink a certain amount of water. Our prospective phase 2 trial (REFILL-PAC-HYPO, NCT06784115) evaluates the impact of a reminder app on bladder filling in prostate cancer patients treated with hypo-fractionated radiotherapy. Methods: Twenty-seven patients need to be recruited for the REFILL-PAC-HYPO trial. Radiotherapy, preferably with volumetric-modulated arc therapy, uses hypo-fractionation with 20 × 3.0 Gy over four weeks. An app reminds patients to drink water (300 mL) 45 min before each session of hypo-fractionated irradiation. On the last day of their treatment, patients are asked about their satisfaction with the app. In the case of a dissatisfaction rate of >20%, the app requires modifications. If this rate is >40%, the app is considered not useful. Additionally, patients are asked about the impact of their participation in the trial and using the app on their general attitude towards health technology. Furthermore, the phase 2 cohort is compared to a historical control group treated with hypo-fractionated radiotherapy during recent years but not supported by an app. The REFILL-PAC-HYPO trial will contribute to identifying the potential value of a reminder app for bladder filling during hypo-fractionated radiotherapy for prostate cancer.