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JOURNAL ARTICLE
Maria Lucia Iacovino, Simone Celant, Luca Tomassini, Laura Arenare, Andrea Caglio, Andrea Canciello, Flavio Salerno, Pier Paolo Olimpieri, Susanna Di Segni, Antonella Sferrazza, Maria Carmela Piccirillo, Giordano Domenico Beretta, Carmine Pinto, Livio Blasi, Saverio Cinieri, Luigi Cavanna, Massimo Di Maio, Pierluigi Russo, Francesco Perrone
BACKGROUND: Generalizability of registrative clinical trials to real-world clinical practice is influenced by comparability of patients in the two settings. We compared characteristics of cancer patients in registrative trials with real-world clinical practice in Italy. METHODS: Data on age, sex and performance status (PS) were derived from web-based monitoring registries developed by Italian Medicines Agency (AIFA) and corresponding registrative trials reported in the European Public Assessment Reports (EPAR) of European Medicines Agency (EMA)...
June 2024: The Lancet regional health. Europe
#2
JOURNAL ARTICLE
Lance Turtle, Sarah Elliot, Thomas M Drake, Mathew Thorpe, Emma G Khoury, William Greenhalf, Hayley E Hardwick, Gary Leeming, Andy Law, Wilna Oosthuyzen, Riinu Pius, Catherine A Shaw, J Kenneth Baillie, Peter J M Openshaw, Annemarie B Docherty, Malcolm G Semple, Ewen M Harrison, Carlo Palmieri
BACKGROUND: Patients with cancer are at greater risk of dying from COVID-19 than many other patient groups. However, how this risk evolved during the pandemic remains unclear. We aimed to determine, on the basis of the UK national pandemic protocol, how factors influencing hospital mortality from COVID-19 could differentially affect patients undergoing cancer treatment. We also examined changes in hospital mortality and escalation of care in patients on cancer treatment during the first 2 years of the COVID-19 pandemic in the UK...
April 12, 2024: Lancet Oncology
#3
JOURNAL ARTICLE
Amy Berrington de González, Scott A Masten, Parveen Bhatti, Renée Turzanski Fortner, Susan Peters, Tiina Santonen, Marianna G Yakubovskaya, Robert Barouki, Silvia B M Barros, Dinesh Barupal, Laura E Beane Freeman, Gloria M Calaf, Joakim Dillner, Karima El Rhazi, Lin Fritschi, Shoji Fukushima, Lode Godderis, Manolis Kogevinas, Dirk W Lachenmeier, Daniele Mandrioli, Mazvita M Muchengeti, Richard T Niemeier, Jane J Pappas, Jingbo Pi, Mark P Purdue, Elio Riboli, Teresa Rodríguez, Vivi Schlünssen, Lamia Benbrahim-Tallaa, Aline de Conti, Caterina Facchin, Elisa Pasqual, Roland Wedekind, Ayat Ahmadi, Shirisha Chittiboyina, Zdenko Herceg, Shalini Kulasingam, Béatrice Lauby-Secretan, Richard MacLehose, Moez Sanaa, Joachim Schüz, Eero Suonio, Jiri Zavadil, Heidi Mattock, Federica Madia, Mary K Schubauer-Berigan
No abstract text is available yet for this article.
April 12, 2024: Lancet Oncology
#4
JOURNAL ARTICLE
Louise Emmett, Shalini Subramaniam, Megan Crumbaker, Andrew Nguyen, Anthony M Joshua, Andrew Weickhardt, Sze-Ting Lee, Siobhan Ng, Roslyn J Francis, Jeffrey C Goh, David A Pattison, Thean Hsiang Tan, Ian D Kirkwood, Craig Gedye, Natalie K Rutherford, Shahneen Sandhu, Aravind Ravi Kumar, David Pook, Shakher Ramdave, David P Nadebaum, Mark Voskoboynik, Andrew D Redfern, William Macdonald, Laurence Krieger, Geoff Schembri, Wei Chua, Peter Lin, Lisa Horvath, Patricia Bastick, Patrick Butler, Alison Yan Zhang, Sonia Yip, Hayley Thomas, Ailsa Langford, Michael S Hofman, Margaret McJannett, Andrew James Martin, Martin R Stockler, Ian D Davis
BACKGROUND: Enzalutamide and lutetium-177 [177 Lu]Lu-prostate-specific membrane antigen (PSMA)-617 both improve overall survival in patients with metastatic castration-resistant prostate cancer. Androgen and PSMA receptors have a close intracellular relationship, with data suggesting complementary benefit if targeted concurrently. In this study, we assessed the activity and safety of enzalutamide plus adaptive-dosed [177 Lu]Lu-PSMA-617 versus enzalutamide alone as first-line treatment for metastatic castration-resistant prostate cancer...
April 12, 2024: Lancet Oncology
#5
JOURNAL ARTICLE
Matthew T Campbell, Vania Balderrama-Brondani, Camilo Jimenez, Gina Tamsen, Leonardo P Marcal, Jeena Varghese, Amishi Y Shah, James P Long, Miao Zhang, Joshua Ochieng, Cara Haymaker, Mouhammed Amir Habra
BACKGROUND: Adrenocortical carcinoma is a rare malignancy with poor response to systemic chemotherapy. Mitotane is the only approved therapy for adrenocortical carcinoma. Cabozantinib is a multikinase inhibitor approved in multiple malignancies. This is the first prospective trial to explore the anti-tumour activity, safety, and pharmacokinetic profile of cabozantinib in patients with advanced adrenocortical carcinoma. METHODS: This investigator-initiated, single-arm, phase 2 trial in adult patients (aged ≥18 years) with advanced adrenocortical carcinoma was done at the University of Texas MD Anderson Cancer Center (Houston, TX, USA)...
April 9, 2024: Lancet Oncology
#6
JOURNAL ARTICLE
Camilo Jimenez, Mouhammed Amir Habra, Matthew T Campbell, Gina Tamsen, Damaris Cruz-Goldberg, James Long, Roland Bassett, Robert Dantzer, Vania Balderrama-Brondani, Jeena Varghese, Yang Lu
BACKGROUND: Metastatic phaeochromocytomas and paragangliomas (MPPGs) are orphan diseases. Up to 50% of MPPGs are associated with germline pathogenic variants of the SDHB gene. These tumours and many non-familial MPPGs exhibit a phenotype that is characterised by abnormal angiogenesis. We aimed to assess the activity and safety of cabozantinib, an antiangiogenic multi-tyrosine kinase inhibitor, in patients with MPPGs. METHODS: The Natalie Trial is a single-arm, phase 2 clinical trial being conducted at The University of Texas MD Anderson Cancer Center (Houston, TX, USA)...
April 9, 2024: Lancet Oncology
#7
JOURNAL ARTICLE
Ana Oaknin, Kathleen Moore, Tim Meyer, José López-Picazo González, Lot A Devriese, Asim Amin, Christopher D Lao, Valentina Boni, William H Sharfman, Jong Chul Park, Makoto Tahara, Suzanne L Topalian, Manuel Magallanes, Alejandro Molina Alavez, Tariq Aziz Khan, Catherine Copigneaux, Michelle Lee, Charlie Garnett-Benson, Xuya Wang, R Wendel Naumann
BACKGROUND: In preliminary findings from the recurrent or metastatic cervical cancer cohort of CheckMate 358, nivolumab showed durable anti-tumour responses, and the combination of nivolumab plus ipilimumab showed promising clinical activity. Here, we report long-term outcomes from this cohort. METHODS: CheckMate 358 was a phase 1-2, open-label, multicohort trial. The metastatic cervical cancer cohort enrolled patients from 30 hospitals and cancer centres across ten countries...
April 9, 2024: Lancet Oncology
#8
JOURNAL ARTICLE
Anna van der Voort, Fleur M Louis, Mette S van Ramshorst, Rob Kessels, Ingrid A Mandjes, Inge Kemper, Mariette J Agterof, Wim A van der Steeg, Joan B Heijns, Marlies L van Bekkum, Ester J Siemerink, Philomeen M Kuijer, Astrid Scholten, Jelle Wesseling, Marie-Jeanne T F D Vrancken Peeters, Ritse M Mann, Gabe S Sonke
BACKGROUND: Patients with stage II-III HER2-positive breast cancer have good outcomes with the combination of neoadjuvant chemotherapy and HER2-targeted agents. Although increasing the number of chemotherapy cycles improves pathological complete response rates, early complete responses are common. We investigated whether the duration of chemotherapy could be tailored on the basis of radiological response. METHODS: TRAIN-3 is a single-arm, phase 2 study in 43 hospitals in the Netherlands...
April 5, 2024: Lancet Oncology
#9
JOURNAL ARTICLE
Jean-Pascal Machiels, Yungan Tao, Lisa Licitra, Barbara Burtness, Makoto Tahara, Danny Rischin, Gustavo Alves, Iane Pinto Figueiredo Lima, Brett G M Hughes, Yoann Pointreau, Sercan Aksoy, Simon Laban, Richard Greil, Martin Burian, Marcin Hetnał, Jean-Pierre Delord, Ricard Mesía, Miren Taberna, John N Waldron, Christian Simon, Vincent Grégoire, Kevin J Harrington, Ramona F Swaby, Yayan Zhang, Burak Gumuscu, Behzad Bidadi, Lillian L Siu
BACKGROUND: Despite multimodal therapy, 5-year overall survival for locally advanced head and neck squamous cell carcinoma (HNSCC) is about 50%. We assessed the addition of pembrolizumab to concurrent chemoradiotherapy for locally advanced HNSCC. METHODS: In the randomised, double-blind, phase 3 KEYNOTE-412 trial, participants with newly diagnosed, high-risk, unresected locally advanced HNSCC from 130 medical centres globally were randomly assigned (1:1) to pembrolizumab (200 mg) plus chemoradiotherapy or placebo plus chemoradiotherapy...
March 29, 2024: Lancet Oncology
#10
JOURNAL ARTICLE
Xiao-Peng Tian, Jun Cai, Yi Xia, Yu-Chen Zhang, Liang Wang, Pan-Pan Liu, Hui-Qiang Huang, Ya-Jun Li, Hui Zhou, Zhi-Ming Li, Jing Yang, Li-Qiang Wei, Qi-Hua Zou, Ying Huang, Jun Li, Li Ling, Wen-Long Zhong, Qing-Qing Cai
BACKGROUND: Programmed cell death protein 1 (PD-1) inhibitor sintilimab is effective in relapsed and refractory extranodal natural killer/T cell lymphoma (ENKTL), nasal type. We aimed to assess the safety and activity of sintilimab plus P-GEMOX (pegaspargase, gemcitabine, and oxaliplatin) in the first-line setting for advanced ENKTL. METHODS: The multicentre, single-arm, phase 2 trial was done at three medical centres in China. Patients aged 18-75 years with treatment-naive pathologically confirmed advanced ENKTL and an with Eastern Cooperative Oncology Group performance status score of 0-2 were eligible...
March 27, 2024: Lancet Haematology
#11
JOURNAL ARTICLE
Ayse Bahar Ercan, Melyssa Aronson, Nicholas R Fernandez, Yuan Chang, Adrian Levine, Zhihui Amy Liu, Logine Negm, Melissa Edwards, Vanessa Bianchi, Lucie Stengs, Jiil Chung, Abeer Al-Battashi, Agnes Reschke, Alex Lion, Alia Ahmad, Alvaro Lassaletta, Alyssa T Reddy, Amir F Al-Darraji, Amish C Shah, An Van Damme, Anne Bendel, Aqeela Rashid, Ashley S Margol, Bethany L Kelly, Bojana Pencheva, Brandie Heald, Brianna Lemieux-Anglin, Bruce Crooks, Carl Koschmann, Catherine Gilpin, Christopher C Porter, David Gass, David Samuel, David S Ziegler, Deborah T Blumenthal, Dennis John Kuo, Dima Hamideh, Donald Basel, Dong-Anh Khuong-Quang, Duncan Stearns, Enrico Opocher, Fernando Carceller, Hagit Baris Feldman, Helen Toledano, Ira Winer, Isabelle Scheers, Ivana Fedorakova, Jack M Su, Jaime Vengoechea, Jaroslav Sterba, Jeffrey Knipstein, Jordan R Hansford, Julieta Rita Gonzales-Santos, Kanika Bhatia, Kevin J Bielamowicz, Khurram Minhas, Kim E Nichols, Kristina A Cole, Lynette Penney, Magnus Aasved Hjort, Magnus Sabel, Maria Joao Gil-da-Costa, Matthew J Murray, Matthew Miller, Maude L Blundell, Maura Massimino, Maysa Al-Hussaini, Mazin F Al-Jadiry, Melanie A Comito, Michael Osborn, Michael P Link, Michal Zapotocky, Mithra Ghalibafian, Najma Shaheen, Naureen Mushtaq, Nicolas Waespe, Nobuko Hijiya, Noemi Fuentes-Bolanos, Olfat Ahmad, Omar Chamdine, Paromita Roy, Pavel N Pichurin, Per Nyman, Rachel Pearlman, Rebecca C Auer, Reghu K Sukumaran, Rejin Kebudi, Rina Dvir, Robert Raphael, Ronit Elhasid, Rose B McGee, Rose Chami, Ryan Noss, Ryuma Tanaka, Salmo Raskin, Santanu Sen, Scott Lindhorst, Sebastien Perreault, Shani Caspi, Shazia Riaz, Shlomi Constantini, Sophie Albert, Stanley Chaleff, Stefan Bielack, Stefano Chiaravalli, Stuart Louis Cramer, Sumita Roy, Suzanne Cahn, Suzanne Penna, Syed Ahmer Hamid, Tariq Ghafoor, Uzma Imam, Valerie Larouche, Vanan Magimairajan Issai, William D Foulkes, Yi Yen Lee, Paul C Nathan, Yosef E Maruvka, Mary-Louise C Greer, Carol Durno, Adam Shlien, Birgit Ertl-Wagner, Anita Villani, David Malkin, Cynthia Hawkins, Eric Bouffet, Anirban Das, Uri Tabori
BACKGROUND: Constitutional mismatch repair deficiency (CMMRD) syndrome is a rare and aggressive cancer predisposition syndrome. Because a scarcity of data on this condition contributes to management challenges and poor outcomes, we aimed to describe the clinical spectrum, cancer biology, and impact of genetics on patient survival in CMMRD. METHODS: In this cohort study, we collected cross-sectional and longitudinal data on all patients with CMMRD, with no age limits, registered with the International Replication Repair Deficiency Consortium (IRRDC) across more than 50 countries...
March 26, 2024: Lancet Oncology
#12
JOURNAL ARTICLE
Alexandre Bazinet, Hagop Kantarjian, Alex Bataller, Naveen Pemmaraju, Gautam Borthakur, Kelly Chien, Yesid Alvarado, Prithviraj Bose, Elias Jabbour, Musa Yilmaz, Courtney DiNardo, Ghayas Issa, Guillermo Montalban-Bravo, Nicholas Short, Koji Sasaki, Debra Bull-Linderman, Naval Daver, Guillermo Garcia-Manero, Farhad Ravandi, Tapan Kadia
BACKGROUND: Patients with acute myeloid leukaemia have high rates of relapse, especially if they are unable to complete standard consolidation strategies or allogeneic haematopoietic stem-cell transplantation (HSCT). The phase 3 QUAZAR AML-001 study showed an overall survival benefit with oral azacitidine maintenance. The BCL2 inhibitor venetoclax is highly active in acute myeloid leukaemia and synergistic with azacitidine. We aimed to evaluate the efficacy and safety of low dose azacitidine plus venetoclax as maintenance therapy in acute myeloid leukaemia...
April 2024: Lancet Haematology
#13
REVIEW
Twalib Ngoma, Isaac Adewole, Victoria Ainsworth, David Chin, Jennifer Chin, Ahmed Elzawawy, Adedayo Joseph, Abba Mallum, Ntokozo Ndlovu, Mamsau Ngoma, Aishat Oladipo, William Swanson, Wilfred Ngwa
Over the past decade, China has emerged as Africa's largest trade partner and source of foreign direct investment, with public health ranked as a top priority in China-Africa collaborations. During the same period, cancer has emerged as a leading cause of death in Africa, with more than 700 000 deaths per year and projections of more than 1 million deaths per year by 2030. In this Review, we explore the effects of increasing China-Africa collaborations on cancer control in Africa. We review the published literature on health-care assistance, research, education and training, and infrastructure and present the results of an institutional review board-approved survey of African oncology health-care professionals and institutional leaders that assessed their perception of the effects of China-Africa collaborations...
April 2024: Lancet Oncology
#14
REVIEW
Michael Schlander, Wim van Harten, Valesca P Retèl, Phu Duy Pham, Julie M Vancoppenolle, Jasper Ubels, Olaya Seoane López, Camila Quirland, Felipe Maza, Eline Aas, Bernd Crusius, Agustín Escobedo, Nora Franzen, Jeanette Fuentes-Cid, Diego Hernandez, Karla Hernandez-Villafuerte, Iva Kirac, Artus Paty, Thierry Philip, Sigbjørn Smeland, Richard Sullivan, Elena Vanni, Sinisa Varga, Thomas Vermeulin, Rachel D Eckford
Loss of income and out-of-pocket expenditures are important causes of financial hardship in many patients with cancer, even in high-income countries. The far-reaching consequences extend beyond the patients themselves to their relatives, including caregivers and dependents. European research to date has been limited and is hampered by the absence of a coherent theoretical framework and by heterogeneous methods and terminology. To address these shortages, a task force initiated by the Organisation of European Cancer Institutes (OECI) produced 25 recommendations, including a comprehensive definition of socioeconomic impact from the perspective of patients and their relatives, a conceptual framework, and a consistent taxonomy linked to the framework...
April 2024: Lancet Oncology
#15
REVIEW
Iseult M Browne, Fabrice André, Sarat Chandarlapaty, Lisa A Carey, Nicholas C Turner
The growing availability of targeted therapies for patients with advanced oestrogen receptor-positive breast cancer has improved survival, but there remains much to learn about the optimal management of these patients. The PI3K-AKT and mTOR pathways are among the most commonly activated pathways in breast cancer, whose crucial role in the pathogenesis of this tumour type has spurred major efforts to target this pathway at specific kinase hubs. Approvals for oestrogen receptor-positive advanced breast cancer include the PI3K inhibitor alpelisib for PIK3CA-mutated tumours, the AKT inhibitor capivasertib for tumours with alterations in PIK3CA, AKT1, or PTEN, and the mTOR inhibitor everolimus, which is used irrespective of mutation status...
April 2024: Lancet Oncology
#16
RANDOMIZED CONTROLLED TRIAL
Stefano Kim, Francois Ghiringhelli, Christelle de la Fouchardière, Ludovic Evesque, Denis Smith, Nicolas Badet, Emmanuelle Samalin, Daniel Lopez-Trabada Ataz, Aurelie Parzy, Jérôme Desramé, Nabil Baba Hamed, Bruno Buecher, David Tougeron, Olivier Bouché, Laetitia Dahan, Benoist Chibaudel, Farid El Hajbi, Laurent Mineur, Olivier Dubreuil, Meher Ben Abdelghani, Solange Pecout, Frederic Bibeau, Michael Herfs, Marie-Line Garcia, Aurelia Meurisse, Dewi Vernerey, Julien Taïeb, Christophe Borg
BACKGROUND: The modified docetaxel, cisplatin, and fluorouracil (mDCF) regimen has shown efficacy and safety as first-line treatment for advanced squamous cell carcinoma of the anus, making it a standard regimen. Inhibitors of programmed cell death protein 1 and its ligand, such as pembrolizumab, nivolumab, retifanlimab, avelumab, and atezolizumab, have shown some antitumour activity as monotherapy in advanced squamous cell carcinoma of the anus that is refractory to chemotherapy. This phase 2 study evaluated the combination of mDCF and atezolizumab as first-line treatment in advanced squamous cell carcinoma of the anus...
April 2024: Lancet Oncology
#17
MULTICENTER STUDY
Robert C Stassen, Carolien C H M Maas, Astrid A M van der Veldt, Serigne N Lo, Robyn P M Saw, Alexander H R Varey, Richard A Scolyer, Georgina V Long, John F Thompson, Piotr Rutkowski, Ulrich Keilholz, Alexander C J van Akkooi, Cornelis Verhoef, David van Klaveren, Dirk J Grünhagen
BACKGROUND: The introduction of adjuvant systemic treatment for patients with high-risk melanomas necessitates accurate staging of disease. However, inconsistencies in outcomes exist between disease stages as defined by the American Joint Committee on Cancer (8th edition). We aimed to develop a tool to predict patient-specific outcomes in people with melanoma rather than grouping patients according to disease stage. METHODS: Patients older than 13 years with confirmed primary melanoma who underwent sentinel lymph node biopsy (SLNB) between Oct 29, 1997, and Nov 11, 2013, at four European melanoma centres (based in Berlin, Germany; Amsterdam and Rotterdam, the Netherlands; and Warsaw, Poland) were included in the development cohort...
April 2024: Lancet Oncology
#18
JOURNAL ARTICLE
Benjamin L Musher, Eric K Rowinsky, Brandon G Smaglo, Wasif Abidi, Mohamed Othman, Kalpesh Patel, Salmaan Jawaid, James Jing, Amanda Brisco, Ann M Leen, Mengfen Wu, Linda C Sandin, Jessica Wenthe, Emma Eriksson, Gustav J Ullenhag, Bambi Grilley, Justyna Leja-Jarblad, Susan G Hilsenbeck, Malcolm K Brenner, Angelica S I Loskog
BACKGROUND: Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, activates cytotoxic T cells, and induces tumour regression in preclinical models. The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma. METHODS: LOKON001 was a non-randomised, phase 1/2 study conducted at the Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA, and consisted of two arms conducted sequentially; the results of arm 1 are presented here...
April 2024: Lancet Oncology
#19
MULTICENTER STUDY
Rachel M Layman, Hyo S Han, Hope S Rugo, Erica M Stringer-Reasor, Jennifer M Specht, E Claire Dees, Peter Kabos, Samuel Suzuki, Sarah C Mutka, Brian F Sullivan, Igor Gorbatchevsky, Robert Wesolowski
BACKGROUND: The PI3K-mTOR pathway is frequently dysregulated in breast cancer. Combining an inhibitor targeting all class I PI3K isoforms and mTOR complex 1 (mTORC1)-mTOR complex 2 (mTORC2) with endocrine therapy and a CDK4/6 inhibitor might provide more effective tumour control than standard-of-care therapy. To evaluate this hypothesis, gedatolisib, a pan-PI3K-mTOR inhibitor, was assessed in a phase 1b trial combined with palbociclib and endocrine therapy in patients with hormone receptor-positive, HER2-negative, advanced breast cancer...
April 2024: Lancet Oncology
#20
JOURNAL ARTICLE
Egbert F Smit, Enriqueta Felip, Dipesh Uprety, Misako Nagasaka, Kazuhiko Nakagawa, Luis Paz-Ares Rodríguez, Jose M Pacheco, Bob T Li, David Planchard, Christina Baik, Yasushi Goto, Haruyasu Murakami, Andreas Saltos, Kaline Pereira, Ayumi Taguchi, Yingkai Cheng, Qi Yan, Wenqin Feng, Zenta Tsuchihashi, Pasi A Jänne
BACKGROUND: DESTINY-Lung01 is a multicentre, open-label, phase 2 study evaluating the antitumour activity and safety of trastuzumab deruxtecan, a HER2-directed antibody-drug conjugate, in patients with HER2-overexpressing or HER2 (ERBB2)-mutant unresectable or metastatic non-small-cell lung cancer (NSCLC). The results of the HER2-mutant cohort (cohort 2) have been reported elsewhere. Herein, we report the primary analysis of cohorts 1 and 1A, which aimed to evaluate the activity and safety of trastuzumab deruxtecan 5·4 mg/kg and 6·4 mg/kg in patients with HER2-overexpressing NSCLC...
April 2024: Lancet Oncology
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