Oncology Research and Treatment最新文献

{"title":"Epidemiology, Real-World Treatment Patterns, and Patient Outcomes of Primary Advanced or Recurrent Endometrial Cancer in Germany between 2015-2021.","authors":"Antje Mevius, Johanna Lutter, Florian M Karl, Liam Tuffy, Fabienne Schochter, Andreas Fuchs, Thomas Wilke","doi":"10.1159/000542773","DOIUrl":"https://doi.org/10.1159/000542773","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-20"},"PeriodicalIF":2.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Survivorship in Chimeric Antigen Receptor T-Cell Therapy Recipients: Infections, Secondary Malignancies, and Non-Relapse Mortality.","authors":"Tobias Tix, Marion Subklewe, Michael von Bergwelt-Baildon, Kai Rejeski","doi":"10.1159/000542631","DOIUrl":"10.1159/000542631","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Key messages: </strong>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.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-7"},"PeriodicalIF":2.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142676237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Palbociclib in Combination with either Aromatase Inhibitors or Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer in Germany: Final Results of the Phase 2 Multicohort INGE-B Trial.","authors":"Manfred Welslau, Karin Potthoff, Matthias Zaiss, Lothar Müller, Cosima Brucker, Christoph Salat, Michael Untch, Johannes Meiler, Diana Lüftner, Anja Welt, Steffen Dörfel, Volker Hagen, Alexander Stein, Rüdiger Liersch, Thomas Kuhn, Hans Ulrich Siebenbach, Gerlinde Bing, Corinne Vannier, Norbert Marschner, Katja Gratzke","doi":"10.1159/000542459","DOIUrl":"10.1159/000542459","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-11"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sex-Disaggregated Analysis of Central Venous Catheter-Related Bloodstream Infections in Patients with Cancer.","authors":"Enrico Schalk, Alva Seltmann, Boris Böll, Nicola Giesen, Judit Grans-Siebel, Oliver Kriege, Julia Lanznaster, Antrea Minti, Jan-Hendrik Naendrup, Julia Neitz, Jens Panse, Martin Schmidt-Hieber, Ruth Seggewiss-Bernhardt, Daniel Teschner, Philipp Weber, Kai Wille, Marie von Lilienfeld-Toal, Marcus Hentrich","doi":"10.1159/000542535","DOIUrl":"10.1159/000542535","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-10"},"PeriodicalIF":2.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142625178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardizing Nutritional Care for Cancer Patients: Implementation and Evaluation of a Malnutrition Risk Screening.","authors":"Viktoria Mathies, Anna P Kipp, Jakob Hammersen, Karin G Schrenk, Sebastian Scholl, Ulf Schnetzke, Andreas Hochhaus, Thomas Ernst","doi":"10.1159/000542460","DOIUrl":"10.1159/000542460","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-10"},"PeriodicalIF":2.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Follow-Up Psycho-Oncology Consultations in Urological Cancer after Transition from Inpatient to Outpatient Care.","authors":"Dominik Fugmann, Steffen Holsteg, Ralf Schäfer, Lars Kreuznacht, Daniela Speer, Günter Niegisch, Ulrike Dinger, André Karger","doi":"10.1159/000542458","DOIUrl":"10.1159/000542458","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":" ","pages":"1-9"},"PeriodicalIF":2.0,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142605897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EGFR plus MET targeted therapies for overcoming treatment resistance in EGFR mutant NSCLC. A Case Report.","authors":"Maria F Martínez-Hernandez,Luis Lara-Mejía,Carlos Izquierdo-Tolosa,Luis Cabrera-Miranda,Oscar Arrieta","doi":"10.1159/000541496","DOIUrl":"https://doi.org/10.1159/000541496","url":null,"abstract":"INTRODUCTIONOncogenic-addicted non-small cell lung cancer (NSCLC) has emerged as the most prevalent form of lung cancer, presenting a dynamic landscape in treatment modalities. Among these, epidermal growth factor receptor (EGFR)-mutant NSCLC remains the predominant oncogenic mutation, particularly prevalent in regions such as Asia and Latin America.CASE PRESENTATIONThis case study highlights the experience of a woman diagnosed with EGFR-sensitive (del exon 19) mutant NSCLC who demonstrated an extended duration of response (DOR) to third-generation EGFR-TKI therapy. Upon disease progression, detection of MET gene amplification prompted the addition of a selective MET inhibitor to the existing EGFR-TKI regimen, resulting in a complete response for the patient.DISCUSSION/CONCLUSIONThe molecular heterogeneity of this condition has significantly increased in complexity over recent years, marked by the identification of baseline co-alterations and development of a broad spectrum of resistance mechanisms post-EGFR tyrosine kinase inhibitor (TKI) therapy. This complexity poses a substantial challenge to clinicians. Despite the rapid advancement of targeted therapies and the implementation of treatment escalation through combination strategies, there remains an ongoing debate regarding which patients would benefit most from combination therapies, both in the initial treatment phase and in the setting of disease progression, particularly when off-target resistance mechanisms or co-alterations are identified.","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"19 1","pages":"1-16"},"PeriodicalIF":2.4,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142265367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EGFR-TKI combined with radiotherapy in 105 patients of lung adenocarcinoma with brain metastasis: a retrospective study of prognostic factors analysis.","authors":"Wenjuan Yu,Yuan Xing,Xiao Song,Tian Li,Mi Zhang","doi":"10.1159/000541494","DOIUrl":"https://doi.org/10.1159/000541494","url":null,"abstract":"INTRODUCTIONThis study aimed to retrospectively analyze the response and prognosis factors for patients of lung adenocarcinoma with brain metastasis and epidermal growth factor receptor (EGFR) mutation, who were treated by EGFR-tyrosine kinase inhibitor (TKI) combined with brain radiotherapy (RT).METHODSFrom Jan 2021 to Jan 2024, the clinicopathological data of lung adenocarcinoma patients were collected from the First Affiliated Hospital of Hebei North University. SPSS version 26.0 statistical software was used for statistical analysis. P &lt; 0.05 was determined to be statistically significant.RESULTS105 patients were included. The 1, 2, 3-year overall survival (OS) rate was 82.9%, 61.2%, and 33.7%, respectively. 1, 2 ,3-year progression-free survival 1 (PFS1) rate was 62.7%, 36.6%, 22.1%. 1,2,3-year PFS2 rate was 80.8%, 54.6%, and 31.4%. The median OS, PFS1 and PFS2 was 29.8, 18.0 and 28.1 months, respectively. The COX multivariate analysis showed that gene mutation status and brain radiation dose were independent prognostic factors for OS; Gene mutation status, brain radiation dose, and response evaluation to initial treatment (response evaluation) are independent prognostic factors for PFS1; Clinical stage, gene mutation status, brain radiation dose, and response evaluation are independent prognostic factors for PFS2.CONCLUSIONTKI combined with brain radiotherapy is effective on lung adenocarcinoma patients with EGFR mutation and brain metastasis. Patients with 19 Del or 21 L858R mutation and brain radiation doses ≥ 40 Gy have longer OS, PFS1, and PFS2, and complete remission (CR) + partial remission (PR) is associated with longer PFS1 and PFS2, Patients in stage IVA have longer PFS2.","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"189 1","pages":"1-32"},"PeriodicalIF":2.4,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142265368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Guidelines: onkopedia - what´s new? Locally advanced rectal cancer.","authors":"Ralf-Dieter Hofheinz,Dirk Arnold,Markus Borner,Wolfgang Eisterer,Gunnar Folprecht,Michael Ghadimi,Ullrich Graeven,Birgit Grünberger,Holger Hebart,Susanna Hegewisch-Becker,Volker Heinemann,Ron Pritzkuleit,Claus Rödel,Holger Rumpold,Tanja Trarbach,,Bernhard Wörmann","doi":"10.1159/000541376","DOIUrl":"https://doi.org/10.1159/000541376","url":null,"abstract":"This article briefly summarizes clinically relevant new aspects of the recently published German, Austrian and Swiss onkopedia guideline for the treatment of locally advanced rectal cancer. Main aspects comprise (i) the use of total neoadjuvant therapy (TNT) for rectal cancers with high risk features, (ii) treatment with neoadjuvant chemotherapy for patient with a low risk for local recurrence, (iii) immunotherapy using dostarlimab in patients with MSI high /dMMR rectal cancer as well as (iv) intended organ preservation as a treatment goal. The availability of several evidence-based treatment options requires intensive discussion within the multidisciplinary team as well as dedicated information for patients about treatment goals, options and risks of individual treatment approaches.","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"1 1","pages":"1-9"},"PeriodicalIF":2.4,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142265369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Paclitaxel/Ramucirumab vs. Paclitaxel in 2nd-line therapy of advanced esophageal squamous cell carcinoma: Randomized Phase II IKF-AIO-RAMOS Trial.","authors":"Magdalena K Scheck,Thorsten O Goetze,Thomas J Ettrich,Harald Schmalenberg,Michael Clemens,Rolf Mahlberg,Steffen Heeg,Stephan Kanzler,Gunnar Hapke,Peter Thuss-Patience,Angelika Kestler,Anne Treschl,Stefan Heidel,Moritz Schiemer,Disorn Sookthai,Sabine Junge,Claudia Pauligk,Salah-Eddin Al-Batran,Sylvie Lorenzen","doi":"10.1159/000541174","DOIUrl":"https://doi.org/10.1159/000541174","url":null,"abstract":"INTRODUCTIONIn squamous cell carcinoma of the esophagus (ESCC), therapeutical options in 2nd-line treatment are scarce with immune checkpoint inhibition being the only approved one. Ramucirumab/paclitaxel is an approved 2nd-line treatment in metastatic esophagogastric adenocarcinoma. We assessed safety and efficacy of ramucirumab/paclitaxel for ESCC.METHODSThis prospective, randomized, open-label, multicenter, phase II trial evaluated paclitaxel (80 mg/m2 d1, 8, 15) plus ramucirumab (8 mg/kg d1, 15) (investigational arm A) vs. paclitaxel alone (80 mg/m2 d1, 8, 15) (standard arm B), both q4w, in advanced/metastatic ESCC refractory or intolerant to fluoropyrimidine and platinum-based drugs. Primary endpoint was overall survival (OS) rate at 6 months.RESULTSFrom 3/2019 to 4/2021, 21/186 planned patients were included (arm A 11 pts; arm B 10 pts) in 9 German centres. Due to slow accrual, the study was terminated prematurely. OS at 6 months was 72.7% for ramucirumab/paclitaxel and 50.0% for paclitaxel. The study design did not allow statistical comparison of the arms. PFS (3.8 vs. 3.5 months), OS (12.1 vs. 9.2 months), ORR (18.2% vs. 20.0%) and DCR (54.5% vs. 60.0%) were comparable in both arms. Most common treatment related adverse events (TRAEs) in arm A were leucopenia (54.5%), fatigue (27.3%) and peripheral sensory neuropathy (18.2%). 27.3% in arm A and 50.0% in arm B had TRAEs ≥ grade 3.CONCLUSIONRamucirumab/paclitaxel shows an acceptable tolerability and numerically improved OS at 6 months. Due to the small number of patients the current trial must be considered exploratory and more data are needed in this indication.REGISTRATIONClinicalTrials.gov, NCT03762564. IKF-s627 RAMOS Study.","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":"16 1","pages":"1-20"},"PeriodicalIF":2.4,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142224928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}