Oncology Research and Treatment最新文献

Introduction: The trend towards 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: 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: Patients with hepatocellular carcinoma (HCC) and inferior vena cava tumor thrombus (IVCTT) have poor prognosis. Combination therapy involving the blockade of programmed cell death protein 1 (PD-1) and tyrosine kinase inhibitors is an efficient treatment strategy for advanced HCC. However, surgical treatment after a combination of systemic therapy and transarterial chemoembolization (TACE) for HCC with IVCTT has not been widely reported, and the efficacy and safety of this treatment have not been studied.

Methods: In the 21 cases reported herein, the patients were treated with TACE, lenvatinib, and PD-1 blockade. The treatment responses, progression-free survival (PFS), overall survival (OS), disease control rate, and toxicities were evaluated, and the related literature was reviewed.

Results: The overall response and disease control rates were 66.7% and 85.7%, respectively. The median PFS time was 16.0 months, with a 1-year PFS rate of 55.60%. The median OS was not reached, with a 1-year OS rate of 66.70%. Four patients underwent hepatectomy without serious complications and survived for 29.1, 24.7, 14.2, and 13.8 months. Three patients survived tumor-free, and 1 patient experienced intrahepatic recurrence. Pathological complete response and major pathological responses were observed in 1 and 3 patients, respectively. Treatment-related adverse events of any grade occurred in 8/9 patients (88.9%), and grade 3 treatment-related adverse events occurred in 1 patient.

Conclusion: The combination of TACE, lenvatinib, and PD-1 is effective for HCC with IVCTT and has acceptable adverse effects.

Introduction: Extraskeletal Ewing sarcoma (EEwS) is a rare malignant tumor, and current international recommendations indicate systemic and local treatment like bone Ewing sarcoma (BEwS); to the best of our knowledge, very few studies tried to explore the clinical and genetic characteristics of this tumor, and the most appropriate treatment strategy remains uncertain.

Methods: We reviewed 35 EEwS cases enrolled at Rizzoli Orthopedic Institute in Bologna, Italy, between 1988-2022. We performed RNA sequencing in 18 Ewing sarcoma cases, including 12 BEwSs and 6 EEwSs. We analyzed overall survival (OS), local relapse-free survival (LRFS), and metastasis-free survival (MFS) and the risk factors associated to survival.

Results: Unsupervised hierarchical clustering showed no differences in the transcriptional profile between EEwS and BEwS. Five-year OS was 67% (95% confidence interval [CI]: 47-80), 5-year LRFS was 61% (95% CI: 43-75), and 5-year MFS was 55% (95% CI: 38-70). Recurrent tumors, larger than 8 cm, and elevated lactate dehydrogenase (LDH) serum value resulted to be negative prognostic factors.

Conclusions: The finding/detection of a genetic profile that is indistinguishable between EEwS and BEwS confirms the view that the two subgroups belong to the same tumor entity and supports the use of a single therapeutic approach for Ewing sarcoma, regardless of the site of origin. Statistical evaluation showed that size bigger than 8 cm, elevated LDH, and recurrent tumors had a worse prognosis, suggesting a risk-stratification method for identifying patients for specific therapy treatment. However, larger, multicenter, prospective trials are called for to validate our findings.

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.

Introduction: Anal mucinous adenocarcinoma (AMAC) is an extremely rare form of anal cancer. Our objective was to examine the incidence, management, and prognostic factors of AMAC.

Methods: We analyzed age-adjusted incidence (AAI) rates over time and compared the prognosis of AMAC with anal squamous cell carcinoma (ASCC) and adenocarcinoma (AAC) using propensity score matching and Kaplan-Meier analysis. Patients were classified based on summary stage and treatments to determine cancer-specific survival.

Results: AAI of AMAC fluctuated within a narrow range (0.082-0.237 per million person-years) from 2000 to 2018. AMAC had a slight non-significant trend of worse prognosis than ASCC (p = 0.348) and a better prognosis than AAC (p < 0.01). Females made up a larger proportion of patients diagnosed with the distant disease (p < 0.05) and unmarried (p < 0.05) and somewhat less probably to need surgical removal (p < 0.01) and radiotherapy (p < 0.01). Elderly patients have lower rates of survival (p < 0.05). Localized stage was associated with better prognosis (p < 0.05). Surgery was associated with a tendency toward better survival (p = 0.095).

Conclusions: AMAC exhibits a low incidence yet favorable prognosis compared to typical AAC and slightly worse compared to ASCC. Elderly age is associated with poorer prognosis, while localized stage indicates better prognosis. Surgery demonstrates a trend toward improved survival.

Introduction Penile metastases (PM) are a rare clinical presentation mainly related to advanced stages of disease. Considering the low incidence, an optimal treatment approach has not yet been defined; surgery, chemotherapy, and radiotherapy are different options used in the vast majority with palliative intent. The advances in modern RT can represent an innovative tool in PM management and a curative option. This paper aims to report the case of a PM patient treated with Stereotactic Body Radiotherapy (SBRT) and perform a systematic literature review of current evidence on the RT approach to PM. Case report We reported the case of an 80-year-old patient with PM from primary bladder cancer. Following the surgical approach for the primary tumor, evidence of PM was shown, and the patient was admitted to SBRT treatment on PM after an adjuvant RT course on the pelvis. A 25 Gy in 5 fractions SBRT treatment was performed, and a complete clinical response was shown at the first follow-up. Methods A Pubmed/MEDLINE and Embase systematic review was carried out. The search strategy terms were [('penile metastasis'/exp OR 'penile metastasis' OR (penile AND ('metastasis'/exp OR metastasis))) AND ('radiotherapy'/exp OR radiotherapy)] and only original articles up to the 24.10.2023 were considered. Results A total of 174 studies were obtained using the previously mentioned search strategy, and the analysis was performed on 15 papers obtained following the complete selection process. All reported evidence was focused on the palliative approach of PM showing good results in terms of symptom control. Discussion The potential role of modern RT in the management of PM has yet to be defined. The reported case showed the feasibility and the clinical impact of SBRT in PM treatment.