Oncology Research and Treatment最新文献

Introduction: Endometrium cancer is the most common gynecological malignancy in developed countries. In this study, we aimed to investigate the effect of HER2 positivity on prognosis in endometrial cancer.

Methods: In our study, patients admitted to our clinic with a diagnosis of endometrial cancer between September 2019 and December 2023 were retrospectively evaluated. Human epidermal growth factor receptor 2 (HER2) immunohistochemistry was performed in 121 patients. HER2-low group (HER2 score: 0 and 1) and HER2-high group (HER2 score: 2 and 3) were defined according to the HER2 immunohistochemistry score in the pathology, and patients were compared accordingly.

Results: We observed that 97 (80.2%) of the patients were in the HER2-low group, while 24 (19.8%) were in the HER2-high group. In the OS analysis, age (p = 0.381), menopausal status (p = 0.511), ECOG performance status (p = 0.087), histological type of tumor (p = 0.727), pathological grade (p = 0.206), serum LDH (p = 0.091), and albumin (p = 0.315) levels did not affect the prognosis. Patients with lower FIGO stage (p = 0.003) and HER2-high patients (p = 0.040) had better survival outcomes. Multivariable analysis showed that FIGO stage (p = 0.004) and HER2 status (p = 0.040) were independent risk factors affecting survival in endometrial cancer.

Conclusion: As a result of our study, it was observed that FIGO stage and HER2 status were independent risk factors affecting OS in endometrial cancer patients. HER2-high group had a better prognosis than HER2-low group.

Introduction: Significant progress has been made in the targeted therapy of metastatic breast cancer (mBC) in recent years. In this context, new biomarkers enable personalized therapy management and individualized therapy monitoring. Therefore, the systemic treatment is based increasingly on the biological characteristics of the tumor disease. Given the challenges of obtaining fresh tumor tissue through biopsies, the significance of liquid biopsies for assessing circulating tumor cells (CTCs) or circulating tumor DNA is of growing importance for the detection of prognostic and predictive biomarkers. Multiple studies have shown that the number of CTCs decreases under therapy, especially under anti-HER2-targeted therapy, and that the expression of the HER2 status on CTCs could play a role in predicting therapy response and therapeutic monitoring. The aim of this study was to analyze the HER2 status of CTCs in mBC patients before and after 3 months of systemic therapy to evaluate changes in the number of HER2-positive CTCs. The study focuses on HER2-low, which plays an increasingly important role in clinical practice due to new developments of HER2 targeting antibody-drug conjugates. In this context, temporal and spatial heterogeneity of the disease represent a major diagnostic challenge.

Methods: A total of 324 patients with complete immunohistochemistry of biopsied metastases were divided into five groups: HER2 negative (-)/hormone receptor (HR) negative (-), HER2 -/HR positive (+), HER2 +/HR±, HER2-low/HR+, and HER2-low/HR-. Before and after 3 months of a new therapeutic line for mBC, CTCs were enumerated and analyzed for HER2 expression using the CellSearch® system. Overall survival of all subgroups was calculated.

Results: The analyses revealed a discrepancy between the HER2 status of CTCs and corresponding tumor tissues in 98 patients (30.2%). The number of CTCs in general and the number of HER2+ CTCs decreased during systemic treatment, mainly in HER2+ tumors, but also in the other subgroups.

Conclusions: Discrepancy in the HER2 status of the metastases and of CTCs was observed in approximately one-third of patients. Measuring HER2 on CTCs could potentially offer a means to longitudinally monitor HER2 status during therapy and simultaneously address challenges such as tumor heterogeneity. Therefore, the predictive value of HER2 on CTCs should be further investigated in clinical trials.

Introduction: The aim of this study was to describe the epidemiology of primary advanced or recurrent endometrial cancer and the outcomes from real-world treatment patterns of patients affected in Germany between 2015 to 2021.

Methods: In this retrospective cohort study covering the period from 1 January 2015 to 31 December 2021, data from patients with primary advanced or recurrent endometrial cancer who initiated systemic treatment for their disease were extracted from an anonymized claims dataset. Epidemiologic outcomes were cumulative incidence of endometrial cancer and point prevalence. Overall survival after the index date was assessed, with all-cause death used as an event. Endometrial cancer-related real-world treatment patterns were described for the post-index period.

Results: The incidence of primary advanced or recurrent endometrial cancer in 2021 was 4.77 cases/100 000 persons, with no substantial change over time (4.63 in 2018; 4.93 in 2019; 4.45 in 2020). The point prevalence on 1 January 2022 was 0.023%, with a slight increase in prevalence observed from 1 January 2019 onwards. Among 466 patients with confirmed endometrial cancer, the mean (standard deviation) age was 68.0 (11.6) years; the tumor material from 86 patients (18.5%) underwent immunohistochemistry or polymerase chain reaction testing. Median overall survival was estimated to be 47.5 months (95% CI 35.1 to 70.4) and the 5-year survival probability was 46.2%. The most frequent first-line systemic therapies were carboplatin (45.7%) and paclitaxel (43.1%). Second-line therapy was received by 153 patients (32.8%).

Conclusion: The analysis of the German claims data produced contemporary epidemiologic estimates for advanced or recurrent endometrial cancer. Treatments were aligned with guideline recommendations during the study period, with tumor testing yet to enter mainstream practice.

Background: Chimeric antigen receptor (CAR) T-cell therapy has significantly advanced the treatment of hematologic malignancies, offering curative potential for patients with relapsed or refractory disease. However, the long-term survivorship of these patients is marked by unique challenges, particularly immune deficits and infectious complications, second primary malignancies (SPMs), and non-relapse mortality (NRM). Understanding and addressing these risks is paramount to improving patient outcomes and quality of life.

Summary: This review explores the incidence and risk factors for NRM and long-term complications following CAR T-cell therapy. Infections are the leading cause of NRM, accounting for over 50% of cases, driven by neutropenia, hypogammaglobulinemia, and impaired cellular immunity. SPMs, including secondary myeloid and T-cell malignancies, are increasingly recognized, prompting the FDA to issue a black box warning, although their direct link to CAR T cells remains disputed. While CAR T-cell-specific toxicities like cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome contribute to morbidity, they represent only a minority of NRM cases. The management of these complications is critical as CAR T-cell therapy is being evaluated for broader use, including in earlier treatment lines and for non-malignant conditions like autoimmune diseases.

Key messages: CAR T-cell therapy has revolutionized cancer treatment, but survivorship is complicated by infections, SPMs, and ultimately endangered by NRM. Prophylactic strategies, close monitoring, and toxicity management strategies are key to improving long-term outcomes.

Introduction: The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. In addition, so far lacking evidence for efficacy and safety on the combination of PAL with anastrozole, exemestane (1L), or letrozole (later line) was investigated.

Methods: The prospective, multicenter, multicohort phase 2 trial INGE-B enrolled adult patients with locally advanced, inoperable, or metastatic HR+/HER2- breast cancer in Germany. The primary endpoint was the clinical benefit rate (CBR) in patients with measurable disease according to RECIST v1.1. Secondary endpoints were overall response rate, progression-free survival (PFS), overall survival (OS), safety, and quality of life. Data were analyzed with descriptive statistics.

Results: Between 2016 and 2018, 388 patients were enrolled at 64 German sites. Among patients with measurable disease treated with PAL in 1L (n = 157), the CBR was 63.7% (100/157). Among all patients treated with PAL 1L (n = 219), PFS was 20.1 months (95% CI 14.6-24.0), and OS was 40.9 months (95% CI 35.1-49.2). The most common grade 3/4 adverse event was neutropenia (33.4% n = 77). There were no treatment-related deaths.

Conclusion: The INGE-B trial demonstrated good efficacy and tolerability of PAL with letrozole (1L) or fulvestrant (first and later line) in accordance with the PALOMA trials. In addition, the so far lacking proof of efficacy and safety of PAL in combination with anastrozole or exemestane in 1L and with letrozole in later line was provided by INGE-B.

Introduction: Men are generally more susceptible to bacterial infections than women. Central venous catheters (CVCs), often used to administer systemic treatment in patients with cancer, are an important source of infection. However, little is known about sex-specific differences of CVC-related bloodstream infections (CRBSIs) in patients with cancer. This study aimed to compare CRBSIs in men versus women in a large cohort of patients with cancer.

Methods: Data were derived from the SECRECY registry including nonselected patients with centrally inserted non-tunneled internal jugular or subclavian vein CVCs in 10 hematology and oncology sites in Germany. Only CRBSIs classified as definite CRBSI (dCRBSI) or probable CRBSI were included, and the combination of both was summarized as dpCRBSI. CVCs were matched 1:1 for underlying disease, anatomic site of CVC insertion, type of CVC dressing, antimicrobial coated CVC, complicated CVC insertion, and CVC in situ time by propensity score matching (PSM). Endpoints were CRBSI rates and incidences in CVCs inserted in men versus women.

Results: A total of 5,075 CVCs registered from March 2013 to March 2024 were included in the analysis, of which 3,024 comprise the PSM cohort. A total of 1,512 (50.0%) CVCs were inserted in men. Underlying diseases mainly were hematological malignancies (96.4%). While there was no statistically significant difference between men and women in the dCRBSI rate (5.4% vs. 4.1%; p = 0.12) and the dCRBSI incidence (3.8 vs. 2.9/1,000 CVC days; p = 0.11), the rate of dpCRBSI (9.9% vs. 6.7%; p = 0.002) and the dpCRBSI incidence (7.0 vs. 4.7/1,000 CVC days; p = 0.002) were significantly higher in men versus women. The proportion of coagulase-negative staphylococci as causative agent of both dCRBSI and dpCRBSI was higher in men than in women (58.8% vs. 41.2%; p = 0.07 and 61.5% vs. 38.5%; p = 0.002, respectively). A multivariable regression revealed neutropenia as an independent risk factor for dCRBSI and male sex as risk factor for dCRBSI and dpCRBSI.

Conclusion: In patients with hematological malignancies, men have a higher risk of CRBSI than women. This finding may be attributed to the high number of jugular vein-inserted CVCs, which in men may be associated with higher rates of skin colonization than in women. Special preventive measures such as earlier removal of CVCs in men may be studied in future.

Introduction: Cancer-related malnutrition is a highly prevalent, yet often overlooked concern in clinical practice. Although cancer-related management guidelines recommend standardized nutritional care, its implementation is scarce. The aim of this study was to investigate the prevalence of malnutrition and the medical need for nutrition counseling in cancer patients employing a novel standardized nutritional management program (containing malnutrition risk screening, nutritional assessment, and counseling). Furthermore, differences of malnutrition parameters in different cancer patient cohorts were examined.

Methods: Cancer patients were screened for malnutrition using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) on the first day of their inpatient admission to the internal oncology or hematology wards. PG-SGA total score and classification into the three PG-SGA nutrition stages (A, B, C) were used to determine nutritional status. In case of a positive screening, nutritional assessment and individualized counseling by a nutritionist followed. For group comparisons, patients were divided into different groups (e.g., age, gender, tumor entity) and were evaluated accordingly.

Results: A total of 1,100 inpatients were included. 56.8% of the patients had suspected or already existing malnutrition. The most common nutrition impact symptom was loss of appetite (26.7%), followed by fatigue (16.5%) and pain (16.0%). Female (p < 0.001), elderly (p < 0.001), and patients with upper gastrointestinal tract tumors (p < 0.001) showed an unfavorable nutritional status and higher need for counseling. Despite suffering from malnutrition, patients had body mass indices within the upper end of the normal range.

Conclusion: This study shows a high prevalence of malnutrition in hospitalized cancer patients and highlights the need for a standardized nutritional management in the clinical setting. Therefore, it is recommended to provide a malnutrition risk screening for all cancer patients and a following adequate assessment and personalized nutritional care if needed.

Introduction: In urological oncology, the physical and psychological effects of cancer and its treatment post-discharge highlight the importance of follow-up psycho-oncology consultations. This study examines their utilisation and identifies predictors in urological cancer patients after inpatient care.

Methods: A prospective, single-centre clinical observational study was conducted. Inpatients with urological cancer and ≥5 points on the Distress Thermometer and/or request for psycho-oncological support were recruited, offered an initial psycho-oncology consultation, and can attend up to five online or on-site appointments within 3 months of discharge. The following variables were collected: socio-demographics, psycho-oncological baseline documentation (PO-BADO), psychosocial distress (Distress Thermometer with problem list), anxiety and depressive symptoms (GAD-2 and PHQ-2), and performance status (ECOG).

Results: A total of 501 patients were screened, 139 were included, and 108 were analysed. Twenty five patients used psycho-oncological follow-up care (n = 16 online). The final hierarchical model predicting the use of follow-up psycho-oncological support included the two predictors: age (OR 0.93, 95% CI 0.90-0.96) and anxiety (OR 1.60, 95% CI 1.11-2.44).

Conclusion: Nearly 1 in 4 urological cancer patients use follow-up psycho-oncology consultations, mostly online. Predictors for this usage are younger age and higher levels of anxiety. To improve care, (1) online services reduce barriers; (2) older patients require support with these services; and (3) screening specifically for depression is crucial to ensure that follow-up appointments are scheduled as a mandatory part of hospitalisation.