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Targeting cuproplasia and cuproptosis in cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-03-14 Daolin Tang, Guido Kroemer, Rui Kang
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The promise of AI in personalized breast cancer screening: are we there yet? Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-03-12 Despina Kontos
The benefits and potential harms of mammography-based screening for breast cancer are often a matter of debate. Here, I discuss the promises and limitations of a recent study that tested an artificial intelligence-based tool for the detection of breast cancer in digital mammograms in a large, prospective screening setting.
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FIRSTMAPPP prospectively charts the efficacy of sunitinib for phaeochromocytoma and paraganglioma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-03-08 David Killock
Metastatic phaeochromocytomas and paragangliomas are very rare neuroendocrine cancers that occur in <1 per million individuals. A variety of treatment modalities have been used to manage these cancers, but with limited success and based on weak evidence. Now, the results of FIRSTMAPPP — probably the first randomized trial in this setting — demonstrate the efficacy of sunitinib. Owing to the potentially
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Non-inferiority of simple versus radical hysterectomy in low-risk cervical cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-03-06 Diana Romero
Radical hysterectomy is recommended for women with early stage cervical cancer, although the need for extensive surgery in those with FIGO stage IA2–IB1 disease that meets criteria for low risk (limited stromal invasion and no pelvic node involvement) is questionable based on retrospective evidence indicating that parametrial invasion is very rare in these patients. Now, the results of the phase III
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Pegargiminaseimproves outcomes in nonepithelioid MPM Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-03-04 Peter Sidaway
Nonepithelioid malignant pleural mesotheliomas (MPMs), which comprise approximately a third of all mesotheliomas, often lack argininosuccinate synthetase 1 (ASS1) function (thus creating a metabolic dependence on exogenous arginine) and are therefore vulnerable to interventions that reduce arginine availability. Now, data from the phase II/III ATOMIC-Meso trial demonstrate the efficacy of pegargiminase
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FGFR-targeted therapeutics: clinical activity, mechanisms of resistance and new directions Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-29 Masuko Katoh, Yohann Loriot, Giovanni Brandi, Simona Tavolari, Zev A. Wainberg, Masaru Katoh
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Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-29 Josep M. Llovet, Roser Pinyol, Mark Yarchoan, Amit G. Singal, Thomas U. Marron, Myron Schwartz, Eli Pikarsky, Masatoshi Kudo, Richard S. Finn
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Regulatory T cell-mediated immunosuppression orchestrated by cancer: towards an immuno-genomic paradigm for precision medicine Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-29 Shogo Kumagai, Kota Itahashi, Hiroyoshi Nishikawa
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Adjuvant chemotherapy improves OS in UTUC Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-22 David Killock
In 2020, adjuvant platinum-based chemotherapy became the standard of care for patients with muscle-invasive or locally advanced upper tract urothelial carcinoma of the ureter or renal pelvis (UTUC) based on disease-free survival (DFS) data from the POUT trial. Now, an update from POUT confirms that adjuvant treatment improves overall survival (OS) in this rare disease. In this phase III trial, 261
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FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-21 Kelly J. Norsworthy, Rosa J. Lee-Alonzo, Richard Pazdur
In 2023, the US FDA approved several new cancer drugs and biologic agents, including seven small-molecule inhibitors, four bispecific T cell engagers, two anti-PD-1 antibodies and one cell therapy product. Regulatory focus areas included analyses of biomarker-positive subgroups that drive efficacy, equipoise in randomized controlled trials and a new authority to require confirmatory trials be underway
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Targeting ATR in patients with cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-20 Natalie Y. L. Ngoi, Patrick G. Pilié, Daniel J. McGrail, Michal Zimmermann, Katharina Schlacher, Timothy A. Yap
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Tabelecleucel is effective in EBV-positive lymphoproliferative disease Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-19 Diana Romero
Epstein–Barr virus (EBV)-positive lymphoproliferative disease can occur following allogeneic haematopoietic stem-cell transplantation (HSCT) or solid organ transplantation (SOT). Several treatment options, including rituximab, are available for patients with this disease, although relapse occurs in ~50% and is associated with a poor prognosis. Now, the results of the phase III ALLELE trial demonstrate
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KN046 shows tolerability and activity in TNBC Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-16 Peter Sidaway
Despite considerable research efforts, patients with advanced-stage triple-negative breast cancer (TNBC) generally receive chemotherapy and have a poor prognosis, with few effective targeted therapy or immunotherapy options available. Now, data from a phase II study demonstrate promising activity of the PD-L1 × CTLA4 bispecific antibody KN046 (a single-domain antibody Fc-fusion protein designed to
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Dendritic cells as orchestrators of anticancer immunity and immunotherapy Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-07 Ignacio Heras-Murillo, Irene Adán-Barrientos, Miguel Galán, Stefanie K. Wculek, David Sancho
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Personalized neoantigen mRNA vaccine mitigates melanoma recurrence Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-01 David Killock
Various immune-checkpoint inhibitors are approved as adjuvant therapies for high-risk melanoma (stage IIB–IV), but disease recurrence remains common. Now, new data indicate that the personalized therapeutic vaccine mRNA-4157 (V940) improves disease control when added to adjuvant pembrolizumab.
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Promising early results with CAR NK cells Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-02-01 Diana Romero
Despite transforming the management of patients with haematological malignancies, autologous chimeric antigen receptor (CAR) T cell therapies have limitations. Now, the results of a phase I/II trial provide evidence of the feasibility, safety and efficacy of allogeneic CD19-directed CAR natural killer (NK) cells in patients with B cell malignancies.
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Sotorasib dosing and incremental cost ineffectiveness — implications and lessons for stakeholders Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-30 Garth W. Strohbehn, Mark J. Ratain
The US FDA Accelerated Approval of sotorasib required the sponsor to conduct a randomized trial that compared the safety and efficacy of the approved dose with a lower dose. These results, recently disclosed, have important implications for patients, payers, oncologists and the pharmaceutical industry.
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Combination strategies for advanced-stage urothelial carcinoma: a paradigm shift Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-26 Nimira Alimohamed, Srikala S. Sridhar
Durable responses with first-line platinum-based chemotherapy for advanced-stage urothelial carcinoma are rare, and patient outcomes are poor. Recently, CheckMate 901 became the first phase III trial to establish a significant overall survival benefit from a combined chemoimmunotherapy approach in this disease setting. Herein, we discuss key findings from CheckMate 901 and their implications in the
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Repotrectinib effective in ROS1-fusion-positive NSCLC Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-26 Peter Sidaway
Patients with advanced-stage non-small-cell lung cancer (NSCLC) harbouring ROS1 fusions (~1–2% of all patients) can derive benefit from ROS1 tyrosine-kinase inhibitors (TKIs), such as entrectinib or crizotinib. Nonetheless, acquired resistance to these agents is common, and CNS activity is often limited. Now, data from TRIDENT-1, a large-cohort phase I/II trial, demonstrate the safety and efficacy
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BRAF — a tumour-agnostic drug target with lineage-specific dependencies Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-26 Aphrothiti J. Hanrahan, Ziyu Chen, Neal Rosen, David B. Solit
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Harnessing neoantigen-specific T cells for precision cancer immunotherapy Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-19 Marco Donia, Inge Marie Svane
Several novel personalized therapies focus on targeting neoantigens. Such strategies require the identification of suitable vaccine neoepitopes or neoantigen-specific T cell receptor (TCR) clonotypes. Herein, we discuss a recently published report that describes a combined transcriptional and phenotype signature, NeoTCRPBL, that enables the minimally invasive identification of rare neoantigen-specific
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Lung cancer in patients who have never smoked — an emerging disease Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-09 Jaclyn LoPiccolo, Alexander Gusev, David C. Christiani, Pasi A. Jänne
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Tumour-infiltrating lymphocyte therapy for patients with advanced-stage melanoma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-08 Sebastian Klobuch, Tom T. P. Seijkens, Ton N. Schumacher, John B. A. G. Haanen
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Myeloid-derived suppressor cells in cancer and cancer therapy Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-08 Samantha A. Lasser, Feyza G. Ozbay Kurt, Ihor Arkhypov, Jochen Utikal, Viktor Umansky
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Exploring the next generation of antibody–drug conjugates Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-08 Kyoji Tsuchikama, Yasuaki Anami, Summer Y. Y. Ha, Chisato M. Yamazaki
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Management of patients with advanced-stage HER2-positive breast cancer: current evidence and future perspectives Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-08 Antonio Marra, Sarat Chandarlapaty, Shanu Modi
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‘Contribution of component’ and the perioperative immune-checkpoint inhibitor precedent Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-05 Garth W. Strohbehn, Bishal Gyawali
The FDA approval of perioperative pembrolizumab, an approach that combines neoadjuvant and adjuvant therapy with this agent, for patients with early stage non-small-cell lung cancer (NSCLC) contradicts its own stated standard for combination therapies. Given the large population of patients with early stage NSCLC and the high costs of pembrolizumab, whether the adjuvant component provides incremental
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Benefit with MRD-guided treatment in CLL Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2024-01-02 Diana Romero
Patients with chronic lymphocytic leukaemia (CLL) typically receive first-line treatment with fludarabine, cyclophosphamide and rituximab (FCR), although other agents have shown promising efficacy over the past decade. These treatments include the combination of the BTK inhibitor ibrutinib and the BCL2 antagonist venetoclax. Now, results from the phase III FLAIR trial demonstrate the superiority of
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Pyrotinib in combination with first-line trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer: a new therapeutic option? Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-19 Pier Paolo M. Berton Giachetti, Giuseppe Curigliano
Recent results from the phase III PHILA trial demonstrate a benefit in terms of progression-free survival derived from the addition of pyrotinib to first-line chemotherapy plus trastuzumab in patients with metastatic HER2-positive breast cancer. Dual HER2 blockade with pyrotinib and trastuzumab is an effective therapeutic strategy but might increase the risk of gastrointestinal toxicity; therefore
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Neoadjuvant chemoimmunotherapy is effective in locally advanced cervical cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-18 Diana Romero
Chemoradiotherapy is the standard of care for women with locally advanced cervical cancer, although a substantial proportion will subsequently have disease recurrence. The addition of immune-checkpoint inhibitors (ICIs) to chemotherapy improves outcomes in the advanced-stage disease setting. Now, data from the single-arm phase II NACI trial demonstrate that neoadjuvant therapy with the ICI camrelizumab
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Optimizing the FDA’s Project Optimus: opportunities and challenges Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-21 Simon Rodney, Udai Banerji
Through Project Optimus, the FDA calls for radical changes in the design of early phase trials to identify the optimal doses of oncology drugs to achieve maximal efficacy with better tolerability and patient acceptability. Herein, we discuss approaches that will enable the implementation of this initiative as well as some concerns that the draft guidance has raised in the oncology community.
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PERSEUS triumphs — efficacy of daratumumab confirmed in transplant-eligible NDMM Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-20 David Killock
The standard-of-care treatment for patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplantation includes four initial induction cycles and two further post-transplant consolidation cycles of bortezomib, lenalidomide and dexamethasone (VRd), followed by maintenance lenalidomide. Adding the anti-CD38 antibody daratumumab throughout such treatment improved disease
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Mirvetuximab soravtansine superior to chemotherapy in platinum-resistant epithelial ovarian cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-19 Peter Sidaway
Despite an initial response, most patients with epithelial ovarian cancer will develop acquired resistance to platinum-based chemotherapy. Later-line options typically involve non-platinum-based chemotherapy with or without bevacizumab, although these usually provide only limited benefit. Now, data from the phase III MIRASOL trial demonstrate the activity of the antibody–drug conjugate mirvetuximab
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Pharmacological reactivation of p53 in the era of precision anticancer medicine Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-15 Amos Tuval, Charlotte Strandgren, Angelos Heldin, Mireia Palomar-Siles, Klas G. Wiman
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The CDK4/6 inhibitor revolution — a game-changing era for breast cancer treatment Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-11 Laura Morrison, Sibylle Loibl, Nicholas C. Turner
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Tovorafenib effective against low-grade gliomas harbouring BRAF fusions Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-11 Peter Sidaway
The FDA approval of dabrafenib plus trametinib in March 2023 provided a much-needed targeted therapy option for patients with BRAFV600E-mutant low-grade glioma (LGG). Nonetheless, as a type I kinase inhibitor, dabrafenib is ineffective in patients with BRAF fusions, including KIAA1549–BRAF, which has been detected in ~35% of paediatric patients with LGG. Now, data from the phase II FIREFLY-1 trial
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Patients with uncommon EGFR mutations also benefit from first-line osimertinib Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-06 Diana Romero
Around one-third of non-small-cell lung cancers (NSCLCs) are driven by mutations in EGFR. The most common of these alterations (in ~85% of patients) are exon 19 deletions and exon 21 L858R; the remaining alterations are referred to as uncommon. Osimertinib is the standard-of-care first-line therapy for patients with metastatic EGFR-mutated NSCLC, although limited evidence is available on efficacy in
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Chemotherapy in EGFR-mutated NSCLC: optimizing combinations with TKIs and amivantamab Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-12-06 Rafael Rosell, María González-Cao
Recent results from the FLAURA2 and MARIPOSA-2 trials underline the continued role of chemotherapy in the treatment of patients with EGFR-mutated non-small-cell lung cancer in the era of targeted therapies. Herein, we argue that the most appropriate and rational sequence and/or combination of therapies remains a matter of discussion.
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Personalizing adjuvant therapy for patients with colorectal cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-24 Li Yang, Jinlin Yang, Andreas Kleppe, Håvard E. Danielsen, David J. Kerr
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Combination neoadjuvant therapies are paving the way for bladder preservation to become the standard for selected patients Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-17 Jakob Klemm, Ekaterina Laukhtina, Shahrokh F. Shariat
Neoadjuvant cisplatin-based combination chemotherapy followed by radical cystectomy with pelvic lymphadenectomy is the current standard therapy for cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC). A phase II trial testing treatment intensification by adding the immune-checkpoint inhibitor nivolumab to chemotherapy has yielded promising complete response rates, which suggests
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Progress in systemic therapy for advanced-stage urothelial carcinoma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-09 Rosa Nadal, Begoña P. Valderrama, Joaquim Bellmunt
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From ESMO 2023: advances in lung cancer Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-03 Peter Sidaway
Among the many transformative developments reported at this year’s ESMO Congress, advances in the management of patients with lung cancer were particularly prominent and encompassed several different disease stages and settings.
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From CHRYSALIS to PAPILLON: the metamorphosis of amivantamab into frontline therapy for NSCLC Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-03 David Killock
In 2021, data from the phase I CHRYSALIS trial supported the FDA Accelerated Approval of amivantamab, an EGFR–MET bispecific antibody, for the treatment of advanced-stage non-small-cell lung cancer (NSCLC) harbouring non-classical EGFR exon 20 insertion mutations after disease progression on platinum-based chemotherapy. Now, new data from the phase III PAPILLON trial demonstrate the efficacy of combining
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THOR provides new data on the efficacy of erdafitinib Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-02 Diana Romero
The outcomes of patients with metastatic urothelial carcinoma (mUC) and non-muscle invasive urothelial carcinoma (NMIBC) following disease progression on standard-of-care therapy remain poor. Approximately 20% and 30% of such cancers, respectively, harbour FGFR alterations. Now, the results of three comparative trials in various disease settings provide insight into the role of the FGFR inhibitor erdafitinib
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Activity of selpercatinib confirmed in phase III trials Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-11-02 Diana Romero
In May 2020, the FDA granted Accelerated Approval to the RET kinase inhibitor selpercatinib for patients with metastatic non-small-cell lung cancer (NSCLC) harbouring RET fusions and for those with metastatic medullary thyroid cancer (MTC) harbouring RET mutations. In September 2022, the approval of selpercatinib for NSCLC was converted into a regular approval. These regulatory decisions were all based
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Computational immunogenomic approaches to predict response to cancer immunotherapies Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-31 Venkateswar Addala, Felicity Newell, John V. Pearson, Alec Redwood, Bruce W. Robinson, Jenette Creaney, Nicola Waddell
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From the ESMO Congress 2023 Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-31 David Killock
As in 2017, this year’s ESMO Congress brought many members of the oncology community together in Madrid, this time with >33,000 delegates attending in person or online. Even the uncharacteristically wet weather could not dampen the enthusiasm raised by the ground-breaking results presented. ESMO 2023 will probably be remembered mostly for featuring many high-impact studies involving patients with non-small-cell
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CAR T cell therapy for patients with solid tumours: key lessons to learn and unlearn Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-30 Steven M. Albelda
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Global trends in hepatocellular carcinoma epidemiology: implications for screening, prevention and therapy Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-26 Amit G. Singal, Fasiha Kanwal, Josep M. Llovet
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Digital symptom assessment tools: the next frontier in financial toxicity screening Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-25 Christopher T. Su, Veena Shankaran
PRO-TECT is a randomized trial that innovatively integrated financial toxicity screening into a pre-existing digital symptom-monitoring programme, enabling longitudinal detection of financial toxicity. Such a strategy provides an unobtrusive and cost-effective method for early detection and mitigation of financial toxicity by aligning the needs of patients and carers with the resources available in
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Dose-reduction trials in oncology — aiming for less toxicity and better quality of life at lower costs Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-16 Kim Theilgaard-Mönch, Lars Holger Ehlers
Projected increases of cancer-attributable health-care costs, accompanied by staff shortages, will impose future economic and operational challenges on national health-care systems. Herein, we highlight a series of clinical and health economic rationales in support of publicly funded clinical trial teams that conduct real-world dose-reduction trials aiming for adjustment of cancer drug label doses
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Molecular tumour boards — current and future considerations for precision oncology Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-16 Apostolia M. Tsimberidou, Michael Kahle, Henry Hiep Vo, Mehmet A. Baysal, Amber Johnson, Funda Meric-Bernstam
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Progression-free survival, disease-free survival and other composite end points in oncology: improved reporting is needed Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-12 Anushka Walia, Jordan Tuia, Vinay Prasad
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Dabrafenib–trametinib moves to the first line in low-grade glioma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-10 Diana Romero
Approximately 15–20% of paediatric low-grade gliomas harbour the BRAFV600E mutation. The combination of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib is approved for previously treated patients ≥6 years of age with solid tumours harbouring this mutation, including low-grade gliomas. Now, data from a phase II trial demonstrate that first-line treatment with this combination improves
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Irradiation of asymptomatic bone metastases improves outcomes Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-06 David Killock
Bone metastases are associated with considerable morbidity, and radiotherapy is widely used for palliation of symptomatic bone lesions. Now, data from a phase II trial performed at three US centres indicate that irradiation of asymptomatic bone metastases not only mitigates skeletal-related events (SREs), but also reduces the risk of death.
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Nasopharyngeal cancer screening with an anti-BNLF2b antibody: a new arrow in the quiver? Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-04 W. K. Jacky Lam, Anthony T. C. Chan
Epstein–Barr virus (EBV)-based biomarkers are used for nasopharyngeal carcinoma (NPC) screening in endemic regions. A recent prospective study describes the use of a new serological biomarker, antibodies targeting the EBV protein BNLF2b, for NPC screening in >20,000 participants. This biomarker yielded both higher sensitivity and specificity for NPC detection in the screening cohort compared with the
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Heterogeneity and treatment landscape of ovarian carcinoma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-10-02 Ana C. Veneziani, Eduardo Gonzalez-Ochoa, Husam Alqaisi, Ainhoa Madariaga, Gita Bhat, Marjan Rouzbahman, Suku Sneha, Amit M. Oza
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Patritumab deruxtecan shows activity in EGFR-mutant NSCLC Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-09-25 Peter Sidaway
Patients with advanced-stage EGFR-mutant non-small-cell lung cancer (NSCLC) usually receive an EGFR-targeted therapy, followed by platinum-based chemotherapy with or without an immune-checkpoint inhibitor. However, those with disease progression on both of these treatments or regimens have limited options and often poor survival outcomes. Now, data from the phase II HERTHENA-Lung01 study demonstrate
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Drug-tolerant persister cells in cancer: the cutting edges and future directions Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-09-25 Yi Pu, Lu Li, Haoning Peng, Lunxu Liu, Dominique Heymann, Caroline Robert, François Vallette, Shensi Shen
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Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma Nat. Rev. Clin. Oncol. (IF 78.8) Pub Date : 2023-09-21 Edward R. Scheffer Cliff, Talal Hilal, Aaron S. Kesselheim
In 2023, a decade after granting Accelerated Approval to the first-in-class BTK inhibitor ibrutinib for the treatment of mantle cell lymphoma, the FDA requested this indication be withdrawn. Herein, we discuss the seemingly inconsistent results from the SHINE and TRIANGLE trials, which relate to the distinct patient populations of these trials, and posit that regulatory approaches should take these