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.
Total neoadjuvant therapy (TNT) improves local control and complete response (CR) rates in locally advanced rectal cancer (LARC). CR is associated with favorable local tumor control, allowing non-operative management (NOM). However, it remains unclear whether short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCRT) is preferable within TNT. LARC patients undergoing TNT between 2015 and 2024 were included in this retrospective multicenter analysis (DRKS00033000). The primary endpoint was CR. Secondary endpoints comprised NOM rates, toxicity, and tumor control. Multivariable logistic regression modelling was used to assess the influence of LCRT. Of 295 included patients with a median age at diagnosis of 62 (Q1-Q3: 54-68) years and 210 (71.2 %) men, 172 (58.3 %) underwent LCRT. CR was achieved in 46 (37.4 %) SCRT and 96 (55.8 %) LCRT patients. Acute toxicity grade ≥ 3 occurred in 24 (20.5 %) of 117 SCRT and in 62 (36.3 %) of 171 LCRT patients. Within a median follow-up of 19.4 months (SCRT) and 19.6 months (LCRT), 23 (19.8 %) of 116 and 30 (19.4 %) of 155 patients experienced recurrence, respectively. Regression modelling revealed an increased likelihood for CR (adjusted odds ratio: 3.11; 95 % confidence interval: 1.37-7.07) and NOM (4.40; 1.46-13.21) with LCRT, whereas no significant associations of LCRT with acute toxicity (0.90; 0.40-2.02), chronic toxicity (1.16; 0.48-2.78), postoperative complications (0.89; 0.62-1.28) or recurrence (0.81; 0.31-2.16) were observed. LCRT was associated with higher CR and NOM rates. Whether it might be preferred over SCRT for intended NOM remains a relevant question to be answered by ongoing randomized trials.
Background and Objectives: Ultra-hypofractionated radiotherapy (uhRT) is increasingly used for low- and intermediate-risk localized prostate cancer, necessitating exceptional precision compared to conventional fractionation. CBCT-based online-adaptive uhRT may help mitigate pelvic organ motion but has not yet been established in clinical routine. We report initial clinical experiences focusing on the feasibility and technical aspects of treatment delivery. Materials and Methods: Seven patients (35 fractions) with low- or intermediate-risk prostate cancer were treated with online-adaptive uhRT on the Varian Ethos® system within routine clinical care. The target included the prostate and proximal seminal vesicles (CTV1, 5 × 7.25 Gy), with an integrated boost to the prostate (CTV2, 5 × 8.00 Gy). For each fraction, dose–volume histogram (DVH) parameters for targets and organs at risk (OARs) were recorded retrospectively for both scheduled and adaptive plans, along with the plan selection decision. Plan quality was evaluated per clinical DVH constraints and target coverage. The treatment time was recorded. Results: Online-adaptive uhRT was successfully delivered every day in 5 patients and on alternate days in 2 patients. Mean treatment time was 30:17 (±05:49 SD) minutes per fraction. The median recorded change in target and OAR volumes was <10%. Adaptive plans resulted in a statistically significantly improved target coverage for CTV1 (V100%, p = 0.01), PTV1 (D98%, p < 0.001), PTV2 boost (D98%, p < 0.001) in Wilcoxon signed-rank tests. OAR dose reduction was limited, with a small improvement in bladder V40Gy (p = 0.02). Adaptive plans were applied in 32/35 fractions (91.4%). To encompass intra-fractional motion in 95% of fractions, positional adjustments up to 0.77 cm (longitudinal), 0.37 cm (lateral), and 0.59 cm (sagittal) were required. Conclusions: Online-adaptive uhRT appears feasible, leading to optimized target volume coverage. Considerable treatment times must be taken into account. A second CBCT is recommended to compensate for intra-fractional motion. Further research regarding patient-related endpoints and cost-effectiveness is highly needed.
This retrospective monocentric cohort study analyzed patients with head and neck cancer according their nutritional status and association of percutaneous endoscopic gastrostomy (PEG) from admission to six months after treatment at a tertiary hospital in Germany from 2017 to 2019. A total of 289 patients (76.5% men; median age 62 years; 63.3% stage IV) were included. Univariate analyses and ANOVAs with repeated measures were performed to analyze differences over time. The percentage of patients requiring PEG was 14.9% (43 of 289 patients) before start of treatment (Z0), 14% (40 of 286 patients alive) after one week (Z1), 22.7% (58 of 255 patients) after six weeks (Z2) and 23% (53 of 230 patients) after six months (Z3) from the end of treatment. PEG placement was associated with alcohol or nicotine consumption, in oropharyngeal and hypopharyngeal carcinoma, squamous cell carcinoma, cancer stage III/IV, chemotherapy and impairment of food intake (all p < 0.05). Weight loss between Z1 and Z3 with PEG did not differ from patients without PEG at Z0 (p = 0.074), although patients with PEG at Z0 had a lower mean weight at the beginning. PEG was important for a quarter of the patients alive at Z3 and helped to prevent weight loss.
Background: Head and neck squamous cell carcinoma (HNSCC) is among the top 10 most common cancer entities worldwide. For patients with locally advanced, non-metastatic HNSCC, the standard of care treatment often includes concomitant chemoradiotherapy with cisplatin. However, a considerable number of these patients are cisplatin-ineligible. To inform treatment selection for cisplatin-unfit patients undergoing radiotherapy (RT) for HNSCC, a network meta-analysis was performed. Method: In November 2023 a systematic search was conducted and updated in January 2026 searching four electronic databases (Medline, Web of Science, Cochrane Library, and Scopus) to identify randomized controlled trials (RCTs) analyzing overall survival (OS), progression-free survival (PFS), locoregional control (LC) and adverse events (AE) of RT combined with chemo-/immunotherapy with relevance to treatment selection in cisplatin-ineligible patients with HNSCC. Results: From all (15,551) search results, 52 publications concerning 28 RCTs reporting on approximately 7000 patients were included. The therapeutic concepts in the experimental group included all combinations of RT with concurrent systemic therapy, excluding cisplatin-based regimens, and were compared with any control treatment. All studies had sufficient quality for inclusion. None of the systemic agents showed a significant improvement in OS, PFS, or LC compared to cisplatin. Carboplatin + 5-FU and mitomycin C + 5-FU improved LC compared to hyperfractionated accelerated radiotherapy (HART). Compared to cisplatin, durvalumab and cetuximab were associated with less dysphagia, cetuximab with less renal impairment, and panitumumab and cetuximab with less weight loss. Conclusions: Carboplatin + 5-FU and Mitomycin C + 5-FU achieve superior LC compared to HART. Targeted therapy and immunotherapy were associated with less severe AEs.