journal
https://read.qxmd.com/read/39002360/a-first-in-human-phase-i-study-of-a-novel-mdm2-p53-inhibitor-alrizomadlin-in-advanced-solid-tumors
#1
JOURNAL ARTICLE
X Zhang, X Wen, R Peng, Q Pan, D Weng, Y Ma, Y Zhang, J Yang, L Men, H Wang, E Liang, C Wang, D Yang, L Zhang, Y Zhai
BACKGROUND: The mouse double minute 2 homolog (MDM2) oncogene exerts oncogenic activities in many cancers and represents a potential therapeutic target. This trial evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of alrizomadlin (APG-115), a novel MDM2/p53 inhibitor, in patients with advanced solid tumors. PATIENTS AND METHODS: Patients with histologically confirmed advanced solid tumors who had progressed to standard treatment or lacked effective therapies were recruited...
July 11, 2024: ESMO Open
https://read.qxmd.com/read/39002179/maintenance-durvalumab-after-first-line-chemotherapy-in-patients-with-her2-negative-advanced-oesophago-gastric-adenocarcinoma-results-from-the-randomised-platform-study
#2
JOURNAL ARTICLE
C Fong, B Patel, C Peckitt, E Bourmpaki, L Satchwell, S Cromarty, S Kidd, K von Loga, M Uhlik, R Begum, T Rana, T Waddell, S Darby, A Bradshaw, T Roques, C Morgan, C Rees, R Herbertson, P Das, C Thompson, M Hewish, R Petty, F Thistlethwaite, S Rao, N Starling, I Chau, D Cunningham
BACKGROUND: PLAnning Treatment For Oesophago-gastric Cancer: a Randomised Maintenance Therapy Trial (PLATFORM) is an adaptive phase II study assessing the role of maintenance therapies in advanced oesophago-gastric (OG) adenocarcinoma. We evaluated the role of the anti-programmed death-ligand 1 (PD-L1) inhibitor durvalumab in these patients. PATIENTS AND METHODS: Patients with human epidermal growth factor receptor 2-negative locally advanced or metastatic OG adenocarcinoma with disease control or response to 18 weeks of platinum-based first-line chemotherapy were randomised to active surveillance or maintenance durvalumab...
July 11, 2024: ESMO Open
https://read.qxmd.com/read/38996520/vascular-fingerprint-tool-to-identify-patients-with-testicular-cancer-treated-with-cisplatin-based-chemotherapy-at-high-risk-of-early-cardiovascular-events
#3
JOURNAL ARTICLE
A T Meuleman, E L D Volders, S Lubberts, J M Kerst, A N M Wymenga, M J B Aarts, M B Goncalves, J D Lefrandt, G Steursma, J Meijer, J Nuver, J A Gietema
BACKGROUND: Patients with testicular cancer treated with chemotherapy have an increased risk of developing early cardiovascular events. Identification of patients with testicular cancer at a high risk of these events enables the development of preventative strategies. This study validates the vascular fingerprint tool to identify these patients. PATIENTS AND METHODS: We carried out a multicenter prospective study in patients with metastatic testicular cancer [International Germ Cell Cancer Collaborative Group (IGCCCG) good or intermediate risk; retroperitoneal mass <5 cm]...
July 11, 2024: ESMO Open
https://read.qxmd.com/read/38996519/dermatology-related-quality-of-life-outcomes-in-patients-with-ras-wild-type-metastatic-colorectal-cancer-treated-with-fluorouracil-and-folinic-acid-with-or-without-panitumumab-pmab-maintenance-after-folfox%C3%A2-pmab-induction-a-prespecified-secondary-analysis-of
#4
JOURNAL ARTICLE
A Ballhausen, M Karthaus, S Fruehauf, U Graeven, L Müller, A O König, L F von Weikersthal, G Sommerhäuser, I Jelas, A H S Alig, A Kurreck, A Stahler, E Goekkurt, S Held, S Kasper, K Heinrich, V Heinemann, S Stintzing, T Trarbach, D P Modest
BACKGROUND: The key endpoints for the assessment of the effect of maintenance therapy for metastatic colorectal cancer (mCRC) are survival and quality-of-life outcomes. We aimed to compare dermatology-related quality of life (DRQOL) in patients with RAS wild-type (wt) mCRC treated with fluorouracil and folinic acid (FU/FA) + panitumumab (Pmab) versus FU/FA alone as maintenance therapy after folinic acid, fluorouracil and oxaliplatin + Pmab induction. PATIENTS AND METHODS: The phase II randomized PanaMa (AIO KRK 0212; NCT01991873) trial included 387 patients at 70 community/academic sites in Germany...
July 11, 2024: ESMO Open
https://read.qxmd.com/read/38986210/open-label-dose-escalation-fight-101-study-of-pemigatinib-combined-with-targeted-therapy-chemotherapy-or-immunotherapy-in-patients-with-advanced-malignancies
#5
JOURNAL ARTICLE
M Saleh, M Barve, V Subbiah, K P Papadopoulos, D Morgensztern, N B Mettu, S Roychowdhury, I Spanggaard, M L Veronese, C Tian, I M Silverman, M Gutierrez
BACKGROUND: Pemigatinib is an oral, potent, selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor. FIGHT-101, a three-part, open-label, first-in-human, phase I/II study (NCT02393248), evaluated pemigatinib in patients with advanced solid tumors. In parts 1 and 2, pemigatinib monotherapy had a manageable safety profile and antitumor activity in FGFR-altered tumors. Part 3 (pemigatinib combination therapies) results are presented here. PATIENTS AND METHODS: Patients received 9, 13...
July 9, 2024: ESMO Open
https://read.qxmd.com/read/38981309/pan-cancer-analysis-of-heterogeneity-of-tumor-mutational-burden-and-genomic-mutation-under-treatment-pressure
#6
JOURNAL ARTICLE
R J Huang, Y S Huang, N An, J J Hu, C Y Wu, Y X Chen, J Y Chen, Q Zhao, R H Xu, S Q Yuan, F Wang
BACKGROUND: High tumor mutational burden (TMB) is one of the widely researched predictive biomarkers of immune checkpoint inhibitors and has been shown to be closely related with response to immunotherapy in multiple cancer types. However, for patients who have failed conventional therapy and are about to undergo immunotherapy, there is no consensus recommendation on the timing of tumor sampling for TMB analysis, and the effects of different therapies on TMB have not been clarified. This retrospective observational study aimed to investigate the heterogeneity of TMB and genomic mutation under the treatment pressure...
July 8, 2024: ESMO Open
https://read.qxmd.com/read/38970842/functional-hrd-by-rad51-identifies-brca1-vus-associated-with-loss-of-gene-function-and-response-to-dna-damaging-agents
#7
LETTER
C Casartelli, C Tommasi, A Lazzarin, M Corianò, C Tornali, O Serra, N Campanini, S Gutiérrez-Enríquez, A Sikokis, D Zanoni, R Minari, B Bortesi, M Michiara, D Boggiani, V Uliana, A Llop-Guevara, V Serra, A Musolino, B Pellegrino
No abstract text is available yet for this article.
July 5, 2024: ESMO Open
https://read.qxmd.com/read/38970841/an-innovative-model-of-delivering-cancer-care-in-the-community-the-experience-of-a-tertiary-cancer-centre-in-singapore
#8
JOURNAL ARTICLE
R S J Wong, S G W Ow, Y M Lee, B Tan, C J Teo, X S Saw, S C Lee
BACKGROUND: Cancer care has evolved rapidly, increasing the demand on healthcare resources. While many non-oral cancer treatments are administered in the hospital, not all necessitate complex medical care. Treatments that can be administered subcutaneously, intramuscularly, or as short intravenous infusions with a low risk of extravasation can be safely administered in the community. PATIENTS AND METHODS: Since 2017, the National University Cancer Institute, Singapore (NCIS) has operated a program called NCIS on-the-go (NOTG) comprising a network of community cancer treatment clinics located within 20 km of the hospital...
July 5, 2024: ESMO Open
https://read.qxmd.com/read/38970840/a-1-year-follow-up-study-on-checkpoint-inhibitor-induced-colitis-results-from-a-european-consortium
#9
JOURNAL ARTICLE
M V Lenti, D G Ribaldone, F Borrelli de Andreis, M Vernero, B Barberio, M De Ruvo, E V Savarino, T Kav, A Blesl, M Franzoi, H P Gröchenig, D Pugliese, G Ianiro, S Porcari, G Cammarota, A Gasbarrini, R Spagnuolo, P Ellul, K Foteinogiannopoulou, I Koutroubakis, K Argyriou, M Cappello, A Jauregui-Amezaga, M G Demarzo, N Silvestris, A Armuzzi, F Sottotetti, L Bertani, S Festa, P Eder, P Pedrazzoli, A Lasagna, A Vanoli, G Gambini, G Santacroce, C M Rossi, M Delliponti, C Klersy, G R Corazza, A Di Sabatino
BACKGROUND: Data regarding the clinical outcome of patients with immune checkpoint inhibitor (ICI)-induced colitis are scant. We aimed to describe the 12-month clinical outcome of patients with ICI-induced colitis. MATERIALS AND METHODS: This was a retrospective, European, multicentre study. Endoscopy/histology-proven ICI-induced colitis patients were enrolled. The 12-month clinical remission rate, defined as a Common Terminology Criteria for Adverse Events diarrhoea grade of 0-1, and the correlates of 12-month remission were assessed...
July 5, 2024: ESMO Open
https://read.qxmd.com/read/38968929/u-pro-crm-designing-patient-centred-dose-finding-trials-with-patient-reported-outcomes
#10
JOURNAL ARTICLE
E Alger, S M Lee, Y K Cheung, C Yap
BACKGROUND: Determining the maximum tolerated dose (MTD) remains the primary objective for the majority of dose-finding oncology trials. Whilst MTD determination often relies upon clinicians to identify dose-limiting toxicities (DLTs) experienced by patients during the trial, research suggests that clinicians may underreport patient's adverse events. Therefore, contemporary practice may be exposed to recommending intolerable doses to patients for further investigation in subsequent trials...
July 4, 2024: ESMO Open
https://read.qxmd.com/read/38959698/a-phase-ib-randomized-multicenter-trial-of-isolated-hepatic-perfusion-in-combination-with-ipilimumab-and-nivolumab-for-uveal-melanoma-metastases-scandium-ii-trial
#11
JOURNAL ARTICLE
R Olofsson Bagge, A Nelson, A Shafazand, C Cahlin, A Carneiro, H Helgadottir, M Levin, M Rizell, G Ullenhag, S Wirén, P Lindnér, J A Nilsson, L Ny
BACKGROUND: Uveal melanoma (UM) is a rare malignancy where 50% of patients develop metastatic disease primarily affecting the liver. Approximately 40% of patients with metastatic UM respond to one-time isolated hepatic perfusion (IHP) with high-dose melphalan. This phase I trial investigates the safety and clinical efficacy of IHP combined with ipilimumab (IPI) and nivolumab (NIVO). PATIENTS AND METHODS: Immunotherapy-naïve patients were randomized in this phase I trial to receive either IHP followed by IPI 3 mg/kg and NIVO 1 mg/kg (IPI3/NIVO1) for four cycles (post-operative arm), or one cycle of preoperative IPI3/NIVO1, IHP and then three cycles of IPI3/NIVO1 (pre-post-operative arm), followed by maintenance therapy with NIVO 480 mg for 1 year...
July 2, 2024: ESMO Open
https://read.qxmd.com/read/38943737/unraveling-the-clinicopathological-and-molecular-changes-induced-by-neoadjuvant-chemotherapy-and-endocrine-therapy-in-hormone-receptor-positive-her2-low-and-her2-0-breast-cancer
#12
JOURNAL ARTICLE
F Schettini, S Nucera, F Brasó-Maristany, I De Santo, T Pascual, M Bergamino, P Galván, B Conte, E Seguí, I García Fructuoso, R Gómez Bravo, P Rivera, A B Rodríguez, O Martínez-Sáez, S Ganau, E Sanfeliu, B González-Farre, M J Vidal Losada, B Adamo, I Cebrecos, E Mension, G Oses, P Jares, S Vidal-Sicart, M Mollà, M Muñoz, A Prat
BACKGROUND: The characterization and comparison of gene expression and intrinsic subtype (IS) changes induced by neoadjuvant chemotherapy (NACT) and endocrine therapy in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-low versus HR+/HER2-0 breast cancer (BC) has not been conducted so far. Most evidence on the association of HER2 status with pathologic responses and prognosis in HR+/HER2-negative BC is controversial and restricted to NACT-treated disease...
June 28, 2024: ESMO Open
https://read.qxmd.com/read/38943736/a-cross-sectional-study-evaluating-the-exercise-discussion-with-oncologist-during-cancer-consultation-the-connect-study
#13
JOURNAL ARTICLE
A Avancini, D Giannarelli, A Borsati, S Carnio, O Cantale, A Nepote, F Mangiapane, D Bafunno, D Galetta, V Longo, D Tregnago, I Trestini, L Belluomini, M Sposito, J Insolda, F Schena, M Milella, S Novello, S Pilotto
BACKGROUND: Evidence demonstrates that physical exercise confers several psycho-physical benefits on patients with cancer. This study aims to investigate the role of oncologists in exercise promotion. PATIENTS AND METHODS: A multicenter, cross-sectional study was conducted by distributing an anonymous, self-administered questionnaire to patients with cancer. The questionnaire enclosed demographic, health, and exercise variables. The exercise-related questions included in the study used the Godin-Shephard Leisure-Time Physical Activity Questionnaire to measure the amount of physical exercise...
June 28, 2024: ESMO Open
https://read.qxmd.com/read/38943735/current-unmet-needs-in-locally-advanced-unresectable-or-metastatic-dedifferentiated-liposarcoma-the-relevance-of-progression-free-survival-as-clinical-endpoint-and-expectations-for-future-clinical-trial-design-an-international-delphi-consensus-report
#14
REVIEW
P Schöffski, R L Jones, M Agulnik, J Y Blay, A Chalmers, A Italiano, D Pink, S Stacchiotti, C Valverde, B Vincenzi, M J Wagner, R Maki
BACKGROUND: Locally advanced (unresectable) or metastatic dedifferentiated liposarcoma (DDLPS) is a common presentation of liposarcoma. Despite established diagnostic and treatment guidelines for DDLPS, critical clinical gaps remain driven by diagnostic challenges, symptom burden and the lack of targeted, safe and effective treatments. The objective of this study was to gather expert opinions from Europe and the United States on the management, unmet needs and expectations for clinical trial design as well as the value of progression-free survival (PFS) in this disease...
June 28, 2024: ESMO Open
https://read.qxmd.com/read/38935991/comprehensive-genomic-analysis-of-adrenocortical-carcinoma-reveals-genetic-profiles-associated-with-patient-survival
#15
JOURNAL ARTICLE
A Sun-Zhang, C C Juhlin, T Carling, U Scholl, M Schott, C Larsson, S Bajalica-Lagercrantz
BACKGROUND: Adrenocortical carcinoma (ACC) is one of the most lethal endocrine malignancies and there is a lack of clinically useful markers for prognosis and patient stratification. Therefore our aim was to identify clinical and genetic markers that predict outcome in patients with ACC. METHODS: Clinical and genetic data from a total of 162 patients with ACC were analyzed by combining an independent cohort consisting of tumors from Yale School of Medicine, Karolinska Institutet, and Düsseldorf University (YKD) with two public databases [The Cancer Genome Atlas (TCGA) and Gene Expression Omnibus (GEO)]...
June 26, 2024: ESMO Open
https://read.qxmd.com/read/38935990/feasibility-of-two-levels-of-protein-intake-in-patients-with-colorectal-cancer-findings-from-the-protein-recommendation-to-increase-muscle-prime-randomized-controlled-pilot-trial
#16
JOURNAL ARTICLE
K L Ford, M B Sawyer, S Ghosh, C F Trottier, I R Disi, J Easaw, K Mulder, S Koski, K N Porter Starr, C W Bales, J Arends, M Siervo, N Deutz, C M Prado
BACKGROUND: Low muscle mass (MM) predicts unfavorable outcomes in cancer. Protein intake supports muscle health, but oncologic recommendations are not well characterized. The objectives of this study were to evaluate the feasibility of dietary change to attain 1.0 or 2.0 g/kg/day protein diets, and the preliminary potential to halt MM loss and functional decline in patients starting chemotherapy for stage II-IV colorectal cancer. PATIENTS AND METHODS: Patients were randomized to the diets and provided individualized counseling...
June 26, 2024: ESMO Open
https://read.qxmd.com/read/38925083/accrual-and-statistical-power-failure-in-published-adjuvant-phase-iii-oncology-trials-a-comprehensive-analysis-from-2013-to-2023
#17
JOURNAL ARTICLE
G Villacampa, S Dennett, E Mello, J Holton, X Lai, L Kilburn, J Bliss, J Rekowski, C Yap
BACKGROUND: In a competitive landscape with many ongoing adjuvant randomised controlled trials (RCTs), the prevalence of trials that failed to recruit their targeted sample size and were inadequately powered is unclear. The aims of the study are (i) to determine the percentage of trials with accrual and statistical power failure and (ii) to evaluate their potential impact on the drug development process. MATERIALS AND METHODS: A systematic review was carried out to identify adjuvant phase III oncology RCTs reported between 2013 and 2023 across all solid tumours...
June 25, 2024: ESMO Open
https://read.qxmd.com/read/38901175/bone-health-and-body-composition-in-prostate-cancer-meet-uro-and-aiom-consensus-about-prevention-and-management-strategies
#18
JOURNAL ARTICLE
M C Cursano, A A Valsecchi, F Pantano, M Di Maio, G Procopio, A Berruti, F Bertoldo, M Tucci, U De Giorgi, D Santini
BACKGROUND: Prostate cancer (PCa) treatments are associated with a detrimental impact on bone health (BH) and body composition. However, the evidence on these issues is limited and contradictory. This consensus, based on the Delphi method, provides further guidance on BH management in PCa. MATERIALS AND METHODS: In May 2023, a survey made up of 37 questions and 74 statements was developed by a group of oncologists and endocrinologists with expertise in PCa and BH...
June 19, 2024: ESMO Open
https://read.qxmd.com/read/38901174/prognostic-significance-of-absolute-lymphocyte-count-in-patients-with-metastatic-renal-cell-carcinoma-receiving-first-line-combination-immunotherapies-results-from-the-international-metastatic-renal-cell-carcinoma-database-consortium
#19
JOURNAL ARTICLE
K Takemura, T Yuasa, A Lemelin, E Ferrier, J C Wells, E Saad, R M Saliby, N S Basappa, L A Wood, E Jude, S K Pal, F Donskov, B Beuselinck, B Szabados, T Powles, R R McKay, G Gebrael, N Agarwal, T K Choueiri, D Y C Heng
BACKGROUND: Lymphocytes are closely linked to mechanisms of action of immuno-oncology (IO) agents. We aimed to assess the prognostic significance of absolute lymphocyte count (ALC) in patients with metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: Using the International mRCC Database Consortium (IMDC), patients receiving first-line IO-based combination therapy were analysed. Baseline patient characteristics, objective response rates (ORRs), time to next treatment (TTNT), and overall survival (OS) were compared...
June 19, 2024: ESMO Open
https://read.qxmd.com/read/38897137/concurrent-antibody-drug-conjugates-and-radiotherapy-a-new-perspective-on-radiation-necrosis-in-her2-positive-breast-cancer-brain-metastases-from-the-destiny-breast03-and-her2climb-trials
#20
LETTER
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