Current Oncology

(1) Background: the evaluation of app-based ePROs is increasingly being used in clinical trials with cancer patients while a medical effect for patients is a matter of controversy; (2) Methods: in the randomized (1:1) controlled PRO2 trial the effect of the medidux^TM app on the rate of “high-grade AEs” (HAEs, CTCAE severity ≥3) within patients receiving HER2-directed breast cancer treatment (arm A) was compared to a control-group that did not use the app (arm B); (3) Results: Among patients with observed (non-imputed) HAE data (n = 180 of N = 189 in the ITT population), the rates of documented HAEs were 21.51% in arm B and 17.24% in arm A. Logistic regression of HAE incidence in the full ITT population (N = 189), using reference-based multiple imputation for missing values, showed a positive tendency towards app use, but no significant difference (odds ratio arm (A/B): 0.797, 95% CI: 0.363, 1.752; p-value 0.569). Also, AE-related secondary endpoints “emergency consultations” (risk ratio arm (A/B): 0.842, 95% CI: 0.464, 1.522; p-value 0.570) and “hospitalizations” (risk ratio arm (A/B): 0.575, 95% CI: 0.237, 1.329; p-value 0.201) had no significant differences in negative binomial regression. (4) Conclusions: Although the effect on HAE rates was not statistically significant, intensive app use was observed and adverse events recorded by participants corresponded well with the known drug-side-effect-profiles. These exploratory findings suggest a potential supporting role of the app during out-patient cancer treatment, which needs confirmation in adequately powered studies.

Background: Limited data exist regarding the safety and efficacy of photon re-irradiation with whole-brain radiotherapy (WBRT) or craniospinal irradiation (CSI) in children with recurrent or second primary CNS tumors. Materials and methods: In this retrospective single-institution study, 23 patients < 21 years who underwent photon re-irradiation with WBRT (n = 9) or CSI (n = 14) for CNS tumors between 2013 and 2026 were included. Clinical and treatment characteristics were collected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method. Toxicities were graded using CTCAE v5.0. Results: In our cohort, the median age at diagnosis was 8.5 years (range: 0.2–19.7 years), and medulloblastoma was the most common histology (30%). Median time to the first relapse after initial irradiation was 12.0 months (range: 0.9–92.5 months). Median re-irradiation dose to the whole brain or craniospinal axis was 24.0 Gy (range: 20.0–36.0 Gy). For 15 patients who received involved field boosts, median total dose was 30.6 Gy (range: 20.0–54.0 Gy). With median follow-up after re-RT of 12.2 months (range: 1.0–106.8), 12-month PFS and OS were 24.2% and 67.0%, respectively. Four patients who received curative-intent re-CSI remain alive with median follow-up of 20.4 months (range: 5.8–106.8). The crude rate of grade >2 CNS toxicity was 8.7%. Of 10 patients with new neurologic symptoms before re-irradiation, 7 (70%) had symptomatic improvement after treatment. Conclusions: Photon re-irradiation with WBRT or CSI was feasible and achieved disease control in a subset of patients and meaningful symptom palliation with acceptable acute toxicity. Careful attention to cumulative dose constraints is essential, and longer follow-up is needed to assess durability and late effects.

Immune checkpoint inhibitors (ICIs) improve outcomes in metastatic renal cell carcinoma (mRCC) but may be associated with pneumonitis. We retrospectively studied adults with mRCC who began first- or second-line ICI therapy at the University of Virginia Medical Center between 2015 and 2023. Potential cases underwent multidisciplinary clinical review, and two thoracic radiologists independently reviewed available computed tomography scans. Among 146 ICI-treated patients, 13 developed pneumonitis (8.9%; 95% CI 4.8–14.7%). Incidence did not differ significantly by treatment line or ICI regimen. Incidence was higher with prior chest radiation than without (31.8% vs. 4.8%; unadjusted odds ratio 9.2, 95% CI 2.7–31.0; Benjamini–Hochberg-adjusted p = 0.005). Five cases (38%) were grade 3–4 at diagnosis, and seven (54%) reached grade ≥ 3. Nine patients (69%) received high-dose systemic corticosteroids. Eleven patients (85%) improved or resolved with initial management; two, both with grade 1–2 pneumonitis at diagnosis, worsened and died (grade 5). Five patients underwent ICI rechallenge after clinical recovery, without recurrent pneumonitis. In this exploratory cohort, pneumonitis was sometimes fatal despite a low grade at presentation. The association with prior chest radiation is hypothesis-generating and warrants evaluation in larger studies with detailed radiation and confounder data.