Oncology Research and Treatment最新文献

Introduction: Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ALL) is treated as standard of care (SoC) by imatinib-based treatment combined with induction and consolidation chemotherapy followed by allogeneic stem cell transplantation (SCT) in first remission. The German Multicenter ALL Study Group for Adult ALL (GMALL) reports about a trial to evaluate the impact of ponatinib-based therapy, blinatumomab treatment for suboptimal responders, and the possibility of omission of SoC Allo SCT in optimal responders entitled GMALL-EVOLVE.

Methods: Herein, imatinib is randomized versus ponatinib as frontline treatment combined with chemotherapy, optimal responders also get randomized between SCT and chemo-immunotherapy, and suboptimal responders receive immunotherapy before SCT. The trial is registered under the EudraCT number 2022-000760-21.

Conclusion: This trial will answer several major questions in the treatment of Ph+ALL.

Introduction: The development of secondary hypogammaglobulinemia (sHGG) because of tumor treatment and/or the primary underlying hematologic disorder holds substantial clinical significance. B-cell-derived malignancies and anti-CD20 monoclonal antibodies (mAbs) represent important risk factors for the development of sHGG. In addition, the occurrence of acute thrombocytopenia (AT) induced by anti-CD20 therapy is a known, albeit rare, phenomenon.

Case presentation: A 54-year-old patient experiencing the first relapse of classical follicular lymphoma has commenced salvage therapy following the R-DHAP protocol. After rituximab infusion, platelet count dropped from 116 × 109/L to 13 × 109/L within 24 h. Reduced immunoglobulin G levels indicated moderate HGG; thus, we immediately administered intravenous immunoglobulins (IVIg). Within 5 days after initiation of IVIg, platelet count increased and stabilized at >50 × 109/L.

Conclusions: It seems possible that anti-CD20 mAbs act like or activate similar mechanisms as autoantibodies in immune thrombocytopenia (ITP). Assuming that anti-CD20 therapy-induced AT is an ITP-like condition, HGG could be considered a potential risk factor. Thus, appropriate treatment of HGG with IVIg prior to anti-CD20 mAb therapy could potentially alleviate anti-CD20 therapy-induced AT.

Introduction: Palliative care physicians (Pcps) face special challenges caring for terminally ill patients. We conducted this study to evaluate the burnout (bo) prevalence among pcps and sought to identify risk as well as protective factors as a basis for the development of preventive measures.

Methods: Participants (Pcs) were invited via e-mail to complete an online survey between May and June 2022. Besides the Oldenburg Burnout Inventory assessing the bo dimensions of exhaustion (exh) and disengagement (dis), sociodemographic data were collected.

Results: The study found that 58% (cut-off mean value [M] ≥2.18) or more specifically, 38% (cut-off M ≥2.5) of the pcs showed increased scores in the exh subscale as a key dimension of bo. All dimensions were correlated with the level of medical and palliative care training, with higher scores for physicians in training. Furthermore, pcs without preventive measures like employee appraisals at work were more likely to be considered exhausted, disengaged, or burned out. The discrepancy between high exh and low dis scores shows that the polled pcps, despite feeling exh, nevertheless considered their work meaningful.

Conclusion: Bo prevalence among pcps exceeds that of the general population and other specialties, whereas inexperienced pcps might be at high risk of shifting from exh to bo and could therefore benefit from tailored support. Further preventive measures including individual and organizational aspects are necessary to prevent bo and promote health among medical staff, thereby preserving quality of patient care. Elementary preventive measures such as employee appraisals can have a protective effect against bo.

Introduction: Active malignancies have been identified as an independent risk factor for severity and mortality in COVID-19. However, direct comparisons between SARS-CoV-2-infected patients with active (acP) and non-active cancers (n-acP) remain scarce.

Patients and methods: We retrospectively analyzed a cohort of cancer patients with PCR-confirmed SARS-CoV-2 infection, enrolled from March 16, 2020, to July 31, 2021. Data on demographics, cancer, and laboratory findings were collected. Descriptive and subsequent regression analyses were performed. Endpoints were "deterioration to severe COVID-19" and "infection-associated mortality."

Results: In total, 987 cancer patients (510 acP vs. 477 n-acP) were included in our analysis. The majority was >55 years old, more men than women were included. At detection of SARS-CoV-2, 65.5% of patients had mild/moderate symptoms, while deterioration to severe COVID-19 was slightly more common in acP (19 vs. 16%; p = 0.284). COVID-19-associated mortality was significantly higher in acP (24 vs. 17.5%, p < 0.001). In terms of laboratory tests, severe cytopenia and elevated levels of inflammatory markers were common findings in acP at baseline, particularly in those who developed a severe infection or died. Multivariate analysis revealed that ferritin (HR 14.24 [2.1-96], p = 0.006) and CRP (HR 2.85 [1.02-8.02], p = 0.046) were associated with severity and mortality. In n-acP, association was seen for ferritin only (HR 4.1 [1.51-11.17], p = 0.006).

Conclusion: Comparing patients with active and non-active cancer, the former showed higher mortality rates. Also, inflammatory markers were significantly increased, assuming higher levels of inflammation may play a role in the adverse outcome of COVID-19 in aCP.

Introduction: The interdisciplinary empowerment seminar aims to familiarize patients and informal caregivers (ICs) with supportive measures, focusing on understanding disease, therapy, and side effect management.

Methods: The seminar, conducted in two courses over 1-month intervals prior to chemotherapy, included lectures, supportive materials, Q and A sessions, and individual discussions with experts in nutrition, exercise, psycho-oncology, and complementary medicine. Evaluation is based on a self-developed questionnaire and questionnaires on QoL (EORTC-QLQ-C30, BR23, CX24, OV28), anxiety and depression (HADS-D) at week 0, 5, 9, and 12. A control group with standard of care was evaluated at baseline and after 12 weeks.

Results: Between October 2020 and May 2021, 19 patients and 9 ICs participated in the seminar. The control group included 20 patients. 96.4% of participants were highly satisfied with the seminar and would recommend it. QoL deterioration was more pronounced in the control group (control: week 0 = 67.6; week 12 = 61.7; intervention: week 0 = 60.8; week 12 = 60.7). This trend could not be proven by analysis of interaction (mixed ANOVA: p = 0.114). Increased confidence of participants' knowledge about side effects was shown, and ICs reported higher confidence in knowledge and coping with the disease.

Conclusions: The seminar received positive feedback and indicated increased knowledge and a trend toward better QoL preservation. Larger studies are needed for confirmation. The seminar effectively addressed unique needs, bolstering confidence and knowledge. Interdisciplinary patient and caregiver empowerment seminars can improve disease-related knowledge and positively affect QoL at the start of chemotherapy. Informational needs can be satisfied. Offering educational seminars and fostering individualized support networks can increase quality of care.

Introduction: The trend toward personalized medicine leads to very small study cohorts for clinical trials, which makes it difficult to recruit patients in a single study center. On the other hand, the administrative effort required to initiate a clinical trial is very high. As a result, Germany runs the risk of falling behind other countries as a trial location. For this reason, the Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) has been working on the challenge of a new satellite model in which the main trial center is the only one to conclude a trial center contract with the sponsor and also handles all formalities with it. The remaining sites constitute the satellites. In contrast to former satellite models, the entire study-related interventions are carried out at each site in the present model.

Methods: In order to evaluate the approvability of the model, contact was made with both higher federal authorities and the responsible inspectorate, and none of them declared themselves responsible for a possible basic approval. The four ethics committees contacted agreed to the model subject to certain framework conditions. In addition, the model was validated by the preparation of several legal opinions on various issues (medical, labor, antitrust law).

Conclusion: Study participation close to home is a decisive advantage for multimorbid patients. As up to four locations form a trial site in the model, a large catchment area can be covered with reduced administrative costs. The satellite model developed is intended to give patients broader access to medical innovations in cancer therapy.

Introduction: Colorectal cancer (CRC) is the third most prevalent malignant tumor worldwide and the second leading cause of cancer-related death. This study aimed at reporting the disease burden of CRC in China from 1990 to 2019 and predicting the trend of mortality burden over the next 10 years.

Methods: The age-period-cohort model was implemented to analyze the trends of mortality from CRC in China from 1990 to 2019, and the autoregressive integrated moving average (ARIMA) model was used to predict the trends of CRC incidence and mortality from 2020 to 2029.

Results: From 1990 to 2019, the incidence of CRC in China increased from 105,911 cases (95% uncertainty interval [UI]: 93,808-119,021) to 607,900 cases (95% UI: 521,805-708,420). The age-standardized incidence rate increased from 12.52 per 100,000 (95% UI: 11.15-14.03) to 30.55 per 100,000 (95% UI: 26.37-35.5), with an estimated annual percentage change (EAPC) of 3.66 (95% confidence interval [CI]: 3.37-3.95), showing an upward trend. The age-standardized mortality rate increased from 10.18 per 100,000 (95% UI: 9.03-11.37) to 13.86 per 100,000 (95% UI: 11.92-16.01), with an EAPC of 1.39 (95% CI: 1.14-1.63), also showing an upward trend. The age group with the highest incidence and mortality in 2019 was 65-69 years old for both sexes, and the age group with the highest mortality was 70-74 years old. Males had higher relative risks of incidence and mortality than females. Low-calcium diet was the risk factor for both sexes and females alone in 1990, while low-milk diet was the risk factor in 2019; however, smoking remained the risk factor for males. The ARIMA model predicted an increase in both disease and mortality burden of CRC over the next 10 years.

Conclusion: The disease and mortality burden of CRC in China showed an overall upward trend from 1990 to 2019, with higher burden in males than females, and the situation remains extremely severe in the next decade.

Introduction: This multicenter, phase II randomized, non-inferiority study reports from the first prospective two-armed randomized control trial that compared the efficacy, safety, and quality of life (QoL) of pegylated liposomal doxorubicin (PLD)-based and epirubicin-based as adjuvant chemotherapy for stage I-II human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Methods: Patients with stage I/II HER2-negative breast cancer received PLD (37.5 mg/m2, Q3W, 5 cycles, LC arm) plus cyclophosphamide (600 mg/m2) or epirubicin (90 mg/m2, Q3W, 4 cycles, EC arm) plus cyclophosphamide (600 mg/m2). Randomization was stratified by lymph node and ER and PR status. The primary endpoint was disease-free survival (DFS), and secondary endpoints were overall survival (OS), safety profiles, and QoL. QoL was assessed using the EORTC-QLQ-C30 and QLQ-BR23 questionnaires.

Results: A total of 256 patients were assigned to LC (n = 148) and EC (n = 108). There was no difference in 5-year DFS and OS rate between the two groups. LC-based adjuvant regimens had significantly less alopecia and low-grade 3-4 hematologic adverse events (AEs). Significantly improved QoL was observed in the LC arm during and after treatment for symptoms including fatigue, nausea and vomiting, and systemic therapy side effects.

Conclusion: Comparable efficacy and safety between adjuvant PLD and epirubicin for stage I-II HER2-negative breast cancer was observed. There was no difference in the 5-year DFS and OS rates between the two treatment arms. However, low-grade 3-4 AEs and a trend of favorable QoL symptom scales were observed in the LC arm, suggesting that PLD-containing regimen could become a new standard treatment for early-stage HER2-negative breast cancer patients.