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Aim Prediction of posttreatment lung mean dose (LMD) during liver radioembolization (RE) work-up is essential for risk evaluation of radiation pneumonitis, especially when treating large hepatocellular carcinoma (HCC) where the chance of arteriovenous shunting is not negligible. In case of holmium-166-([ 166 Ho])-RE, either [ 99m Tc]TcMAA or 166 Ho-microspheres can be used as scout tracers. Safety of use of 166 Ho-scout has been demonstrated previously, but, to our notice, evaluation of lung radiation dose due to 166 Ho-scout activity in case of significant lung shunting has not been described so far. Therefore, a retrospective study was conducted to evaluate the presence of pulmonary shunting in HCC patients influencing therapeutical approach and to assess lung 166 Ho-scout dose in these patients. Materials and Methods Twenty-nine HCC patients referred for RE were retrospectively evaluated. All work-ups were performed with 166 Ho-microspheres. Scout imaging consisted of a hybrid SPECT/CT acquisition covering the thoraco-abdominal region. As mentioned in the manufacturer’s instruction for use of 166 Ho-microspheres, the possibility of > 30 Gy lung radiation exposure in a single treatment is withheld as contra-indication for RE. In patients with lung shunt resulting in predicted posttreatment LMD > 30 Gy, lung 166 Ho-scout dose due to patient-specific injected activity was calculated, alongside two hypothetical scenarios: lung 166 Ho-scout dose related to patient’s lung shunt fraction (LSF) assuming administration of leaflet prescribed maximum 166 Ho-scout activity and in case of 100% LSF according to patient-specific injected scout activity. Afterwards, these patients were followed for 3 months or till death. Results In the 29 patients, average predicted posttreatment LMD was 10.0 Gy (range 0.1–138.9 Gy), four of them revealing predicted LMD > 30 Gy. Based on patient-specific injected 166 Ho-scout activity (range 100–200 MBq), average lung 166 Ho-scout dose of 0.5 Gy (range 0.1–0.8 Gy) was calculated in these 4 patients. Assuming administration of leaflet prescribed maximum activity of 250 MBq, average lung 166 Ho-scout dose would be 0.9 Gy (range 0.4–1.7 Gy). In case of a 100% LSF, average lung 166 Ho-scout dose would be 2.2 Gy (range 1.5–2.7 Gy) due to patient-specific scout activity. In these 4 patients, RE was denied and alternative treatment was started. No pulmonary adverse events related to 166 Ho-scout were recorded. Conclusion This study supports previous reports that 166 Ho-scout is a safe alternative to [ 99m Tc]TcMAA -scout and underlines the importance of predicting posttreatment LMD when treating large HCC since 13.8% of our patient group presented arteriovenous shunting with impact on treatment planning.

No adjuvant treatment has been established for patients who remain at high risk for hepatocellular carcinoma recurrence after curative-intent resection or ablation. We aimed to assess the efficacy of adjuvant atezolizumab plus bevacizumab versus active surveillance in patients with high-risk hepatocellular carcinoma. In the global, open-label, phase 3 IMbrave050 study, adult patients with high-risk surgically resected or ablated hepatocellular carcinoma were recruited from 134 hospitals and medical centres in 26 countries in four WHO regions (European region, region of the Americas, South-East Asia region, and Western Pacific region). Patients were randomly assigned in a 1:1 ratio via an interactive voice–web response system using permuted blocks, using a block size of 4, to receive intravenous 1200 mg atezolizumab plus 15 mg/kg bevacizumab every 3 weeks for 17 cycles (12 months) or to active surveillance. The primary endpoint was recurrence-free survival by independent review facility assessment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT04102098. The intention-to-treat population included 668 patients randomly assigned between Dec 31, 2019, and Nov 25, 2021, to either atezolizumab plus bevacizumab (n=334) or to active surveillance (n=334). At the prespecified interim analysis (Oct 21, 2022), median duration of follow-up was 17·4 months (IQR 13·9–22·1). Adjuvant atezolizumab plus bevacizumab was associated with significantly improved recurrence-free survival (median, not evaluable [NE]; [95% CI 22·1–NE]) compared with active surveillance (median, NE [21·4–NE]; hazard ratio, 0·72 [adjusted 95% CI 0·53–0·98]; p=0·012). Grade 3 or 4 adverse events occurred in 136 (41%) of 332 patients who received atezolizumab plus bevacizumab and 44 (13%) of 330 patients in the active surveillance group. Grade 5 adverse events occurred in six patients (2%, two of which were treatment related) in the atezolizumab plus bevacizumab group, and one patient (<1%) in the active surveillance group. Both atezolizumab and bevacizumab were discontinued because of adverse events in 29 patients (9%) who received atezolizumab plus bevacizumab. Among patients at high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation, recurrence-free survival was improved in those who received atezolizumab plus bevacizumab versus active surveillance. To our knowledge, IMbrave050 is the first phase 3 study of adjuvant treatment for hepatocellular carcinoma to report positive results. However, longer follow-up for both recurrence-free and overall survival is needed to assess the benefit–risk profile more fully. F Hoffmann-La Roche/Genentech.

PurposeSystematic assessment of QOL and care needs was applied in two gastroenterology departments to support “Cancer Care for the Whole Patient.”MethodsPatients with digestive cancer were asked to complete the Cancer Rehabilitation Evaluation System-Short Form (CARES-SF) at the start of treatment and 3 months later. Both times CARES data were processed, and summary reports on the retained insights were sent to the reference nurse for use in further follow-up of the patient. Patients’ and reference nurse’s experiences with the systematic CARES-assessment were explored with several survey questions and semi-structured interviews, respectively.ResultsThe mean age of the 51 participants was 63 years (SD11.17), 52.9% was male. With the CARES-SF, a large variety of problems and care needs was detected. Problems most frequently experienced, and most burdensome for QOL are a mix of physical complaints, side effects from treatment, practical, relational, and psychosocial difficulties. Only for a limited number of experienced problems a desire for extra help was expressed. All patients positively evaluate the timing and frequency of the CARES-assessment. The majority believes that this assessment could contribute to the discussion of problems and needs with healthcare professionals, to get more tailored care. Reference nurses experienced the intervention as an opportunity to systematically explore patients’ well-being in a comprehensive way, leading to detection and discussion of specific problems or needs in greater depth, and more efficient involvement of different disciplines in care.ConclusionsSystematic QOL and needs assessment with the CARES-SF in oncology can contribute to more patient-centeredness and efficiency of care.

Prediction of posttreatment lung mean dose (LMD) during liver radioembolization (RE) work-up is essential for risk evaluation of radiation pneumonitis, especially when treating large hepatocellular carcinoma (HCC) where the chance of arteriovenous shunting is not negligible. In case of holmium-166-([ Ho])-RE, either [ Tc]TcMAA or Ho-microspheres can be used as scout tracers. Safety of use of Ho-scout has been demonstrated previously, but, to our notice, evaluation of lung radiation dose due to Ho-scout activity in case of significant lung shunting has not been described so far. Therefore, a retrospective study was conducted to evaluate the presence of pulmonary shunting in HCC patients influencing therapeutical approach and to assess lung Ho-scout dose in these patients. Twenty-nine HCC patients referred for RE were retrospectively evaluated. All work-ups were performed with Ho-microspheres. Scout imaging consisted of a hybrid SPECT/CT acquisition covering the thoraco-abdominal region. As mentioned in the manufacturer's instruction for use of Ho-microspheres, the possibility of > 30 Gy lung radiation exposure in a single treatment is withheld as contra-indication for RE. In patients with lung shunt resulting in predicted posttreatment LMD > 30 Gy, lung Ho-scout dose due to patient-specific injected activity was calculated, alongside two hypothetical scenarios: lung Ho-scout dose related to patient's lung shunt fraction (LSF) assuming administration of leaflet prescribed maximum Ho-scout activity and in case of 100% LSF according to patient-specific injected scout activity. Afterwards, these patients were followed for 3 months or till death. In the 29 patients, average predicted posttreatment LMD was 10.0 Gy (range 0.1-138.9 Gy), four of them revealing predicted LMD > 30 Gy. Based on patient-specific injected Ho-scout activity (range 100-200 MBq), average lung Ho-scout dose of 0.5 Gy (range 0.1-0.8 Gy) was calculated in these 4 patients. Assuming administration of leaflet prescribed maximum activity of 250 MBq, average lung Ho-scout dose would be 0.9 Gy (range 0.4-1.7 Gy). In case of a 100% LSF, average lung Ho-scout dose would be 2.2 Gy (range 1.5-2.7 Gy) due to patient-specific scout activity. In these 4 patients, RE was denied and alternative treatment was started. No pulmonary adverse events related to Ho-scout were recorded. This study supports previous reports that Ho-scout is a safe alternative to [ Tc]TcMAA -scout and underlines the importance of predicting posttreatment LMD when treating large HCC since 13.8% of our patient group presented arteriovenous shunting with impact on treatment planning.

Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA <50 IU/mL) were conducted in 951 Caucasian, noncirrhotic genotype (G)1 patients assigned to peginterferon alfa-2a/ribavirin for 48 weeks. The probability of SVR24 was identified by a baseline scoring system (range: 0-9 points) on which scores of 5 to 9 and <5 represent high and low probability of SVR24, respectively. SVR24 rates were 46.1% (754/1634), 77.1% (279/362), 68.0% (514/756), and 51.3% (203/396), respectively, in G1, 2, 3, and 4 patients. Overall, 16.9% and 21.8% patients experienced ≥1 sr-RD for peginterferon alfa and ribavirin, respectively. Among Caucasian noncirrhotic G1 patients: female sex, lower body mass index, pre-existing cardiovascular/pulmonary disease, and low hematological indices were prognostic factors of sr-RD; SVR24 was lower in patients with ≥1 vs. no sr-RD by Week 4 (37.9% vs. 54.4%; P = 0.0046) and Week 12 (41.7% vs. 55.3%; P = 0.0016); sr-RD by Week 4/12 significantly reduced SVR24 in patients with scores <5 but not ≥5. In conclusion, sr-RD to peginterferon alfa-2a/ribavirin significantly impacts on SVR24 rates in treatment-naive G1 noncirrhotic Caucasian patients. Baseline characteristics can help select patients with a high probability of SVR24 and a low probability of sr-RD with peginterferon alfa-2a/ribavirin.