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1. Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial

Author

Bullock, Andrea J., Schlechter, Benjamin L., Fakih, Marwan G., Tsimberidou, Apostolia M., Grossman, Joseph E., Gordon, Michael S., Wilky, Breelyn A., Pimentel, Agustin, Mahadevan, Daruka, Balmanoukian, Ani S., Sanborn, Rachel E., Schwartz, Gary K., Abou-Alfa, Ghassan K., Segal, Neil H., Bockorny, Bruno, Moser, Justin C., Sharma, Sunil, Patel, Jaymin M., Wu, Wei, Chand, Dhan, Rosenthal, Katherine, Mednick, Gabriel, Delepine, Chloe, Curiel, Tyler J., Stebbing, Justin, Lenz, Heinz-Josef, O’Day, Steven J., and El-Khoueiry, Anthony B.

Published
2024
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2. PI3K/AKT/mTOR signaling transduction pathway and targeted therapies in cancer.

Author

Glaviano, Antonino, Foo, Aaron, Lam, Hiu, Yap, Kenneth, Jacot, William, Jones, Robert, Eng, Huiyan, Nair, Madhumathy, Makvandi, Pooyan, Geoerger, Birgit, Kulke, Matthew, Baird, Richard, Prabhu, Jyothi, Carbone, Daniela, Pecoraro, Camilla, Teh, Daniel, Sethi, Gautam, Cavalieri, Vincenzo, Lin, Kevin, Javidi-Sharifi, Nathalie, Toska, Eneda, Davids, Matthew, Brown, Jennifer, Diana, Patrizia, Stebbing, Justin, Kumar, Alan, and Fruman, David

Subjects
AKT inhibitors, ATP-competitive mTOR inhibitors, Allosteric mTOR inhibitors, Bi-steric mTOR inhibitors, Cancer, Dual PI3K/mTOR inhibitors, Isoform-specific PI3K inhibitors, PDK1 inhibitors, PI3K/AKT/mTORC pathway, Pan PI3K inhibitors, Humans, Phosphatidylinositol 3-Kinases, Proto-Oncogene Proteins c-akt, Signal Transduction, TOR Serine-Threonine Kinases, Neoplasms
Abstract

The PI3K/AKT/mTOR (PAM) signaling pathway is a highly conserved signal transduction network in eukaryotic cells that promotes cell survival, cell growth, and cell cycle progression. Growth factor signalling to transcription factors in the PAM axis is highly regulated by multiple cross-interactions with several other signaling pathways, and dysregulation of signal transduction can predispose to cancer development. The PAM axis is the most frequently activated signaling pathway in human cancer and is often implicated in resistance to anticancer therapies. Dysfunction of components of this pathway such as hyperactivity of PI3K, loss of function of PTEN, and gain-of-function of AKT, are notorious drivers of treatment resistance and disease progression in cancer. In this review we highlight the major dysregulations in the PAM signaling pathway in cancer, and discuss the results of PI3K, AKT and mTOR inhibitors as monotherapy and in co-administation with other antineoplastic agents in clinical trials as a strategy for overcoming treatment resistance. Finally, the major mechanisms of resistance to PAM signaling targeted therapies, including PAM signaling in immunology and immunotherapies are also discussed.

Published
2023

5. The safety and potential efficacy of exosomes overexpressing CD24 (EXO-CD24) in mild-moderate COVID-19 related ARDS

Author

Grigoropoulos, Ioannis, Tsioulos, Georgios, Kastrissianakis, Artemis, Shapira, Shiran, Green, Orr, Rapti, Vasiliki, Tsakona, Maria, Konstantinos, Thomas, Savva, Athina, Kavatha, Dimitra, Boumpas, Dimitrios, Syrigos, Konstantinos, Xynogalas, Ioannis, Leontis, Konstantinos, Ntousopoulos, Vasileios, Sakka, Vissaria, Sardelis, Zafeiris, Fotiadis, Andreas, Vlassi, Lamprini, Kontogianni, Chrysoula, Levounets, Anastasia, Poulakou, Garyfalia, Gaga, Mina, MacLoughlin, Ronan, Stebbing, Justin, Arber, Nadir, Antoniadou, Anastasia, and Tsiodras, Sotirios

Published
2024
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6. A phase 1/2 clinical trial of invariant natural killer T cell therapy in moderate-severe acute respiratory distress syndrome

Author

Hammond, Terese C., Purbhoo, Marco A., Kadel, Sapana, Ritz, Jerome, Nikiforow, Sarah, Daley, Heather, Shaw, Kit, van Besien, Koen, Gomez-Arteaga, Alexandra, Stevens, Don, Ortuzar, Waldo, Michelet, Xavier, Smith, Rachel, Moskowitz, Darrian, Masakayan, Reed, Yigit, Burcu, Boi, Shannon, Soh, Kah Teong, Chamberland, John, Song, Xin, Qin, Yu, Mishchenko, Ilya, Kirby, Maurice, Nasonenko, Valeriia, Buffa, Alexa, Buell, Jennifer S., Chand, Dhan, van Dijk, Marc, Stebbing, Justin, and Exley, Mark A.

Published
2024
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7. A bile-based microRNA signature for differentiating malignant from benign pancreaticobiliary disease

Author

Mato Prado, Mireia, Puik, Jisce R., Castellano, Leandro, López-Jiménez, Elena, Liu, Daniel S. K., Meijer, Laura L., Le Large, Tessa Y. S., Rees, Eleanor, Funel, Niccola, Sivakumar, Shivan, Pereira, Stephen P., Kazemier, Geert, Zonderhuis, Babs M., Erdmann, Joris I., Swijnenburg, Rutger-Jan, Frilling, Andrea, Jiao, Long R., Stebbing, Justin, Giovannetti, Elisa, Krell, Jonathan, and Frampton, Adam E.

Published
2023
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10. Serial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy

Author

Magbanua, Mark Jesus M, Hendrix, Laura H, Hyslop, Terry, Barry, William T, Winer, Eric P, Hudis, Clifford, Toppmeyer, Deborah, Carey, Lisa Anne, Partridge, Ann H, Pierga, Jean-Yves, Fehm, Tanja, Vidal-Martínez, José, Mavroudis, Dimitrios, Garcia-Saenz, Jose A, Stebbing, Justin, Gazzaniga, Paola, Manso, Luis, Zamarchi, Rita, Antelo, María Luisa, De Mattos-Arruda, Leticia, Generali, Daniele, Caldas, Carlos, Munzone, Elisabetta, Dirix, Luc, Delson, Amy L, Burstein, Harold J, Qadir, Misbah, Ma, Cynthia, Scott, Janet H, Bidard, François-Clément, Park, John W, and Rugo, Hope S

Subjects
Cancer, Prevention, Breast Cancer, Clinical Research, Breast Neoplasms, Female, Humans, Neoplastic Cells, Circulating, Prognosis, Progression-Free Survival, Proportional Hazards Models, Reproducibility of Results, Retrospective Studies, Treatment Outcome, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundWe examined the prognostic significance of circulating tumor cell (CTC) dynamics during treatment in metastatic breast cancer (MBC) patients receiving first-line chemotherapy.MethodsSerial CTC data from 469 patients (2202 samples) were used to build a novel latent mixture model to identify groups with similar CTC trajectory (tCTC) patterns during the course of treatment. Cox regression was used to estimate hazard ratios for progression-free survival (PFS) and overall survival (OS) in groups based on baseline CTCs, combined CTC status at baseline to the end of cycle 1, and tCTC. Akaike information criterion was used to select the model that best predicted PFS and OS.ResultsLatent mixture modeling revealed 4 distinct tCTC patterns: undetectable CTCs (56.9% ), low (23.7%), intermediate (14.5%), or high (4.9%). Patients with low, intermediate, and high tCTC patterns had statistically significant inferior PFS and OS compared with those with undetectable CTCs (P < .001). Akaike Information Criterion indicated that the tCTC model best predicted PFS and OS compared with baseline CTCs and combined CTC status at baseline to the end of cycle 1 models. Validation studies in an independent cohort of 1856 MBC patients confirmed these findings. Further validation using only a single pretreatment CTC measurement confirmed prognostic performance of the tCTC model.ConclusionsWe identified 4 novel prognostic groups in MBC based on similarities in tCTC patterns during chemotherapy. Prognostic groups included patients with very poor outcome (intermediate + high CTCs, 19.4%) who could benefit from more effective treatment. Our novel prognostic classification approach may be used for fine-tuning of CTC-based risk stratification strategies to guide future prospective clinical trials in MBC.

Published
2021

14. Kinome‐Wide Synthetic Lethal Screen Identifies PANK4 as a Modulator of Temozolomide Resistance in Glioblastoma

Author

Vella, Viviana, primary, Ditsiou, Angeliki, additional, Chalari, Anna, additional, Eravci, Murat, additional, Wooller, Sarah K., additional, Gagliano, Teresa, additional, Bani, Cecilia, additional, Kerschbamer, Emanuela, additional, Karakostas, Christos, additional, Xu, Bin, additional, Zhang, Yongchang, additional, Pearl, Frances M.G., additional, Lopez, Gianluca, additional, Peng, Ling, additional, Stebbing, Justin, additional, Klinakis, Apostolos, additional, and Giamas, Georgios, additional

Published
2024
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19. PIK3C[delta] expression by fibroblasts promotes triple-negative breast cancer progression

Author

Gagliano, Teresa, Shah, Kalpit, Gargani, Sofia, Lao, Liyan, Alsaleem, Mansour, Chen, Jianing, Ntafis, Vasileios, Huang, Penghan, Ditsiou, Angeliki, Vella, Viviana, Yadav, Kritika, Bienkowska, Kamila, Bresciani, Giulia, Kang, Kai, Li, Leping, Carter, Philip, Benstead-Hume, Graeme, OHanlon, Timothy, Dean, Michael, Pearl, Frances M.G., Lee, Soo-Chin, Rakha, Emad A., Green, Andrew R., Kontoyiannis, Dimitris L., Song, Erwei, Stebbing, Justin, and Giamas, Georgios

Subjects
Genetic engineering -- Analysis, Idelalisib -- Analysis, Breast cancer -- Development and progression, Cancer metastasis -- Development and progression, RNA -- Analysis, Health care industry
Abstract

As there is growing evidence for the tumor microenvironment's role in tumorigenesis, we investigated the role of fibroblast-expressed kinases in triple-negative breast cancer (TNBC). Using a high-throughput kinome screen combined with 3D invasion assays, we identified fibroblast-expressed PIK3C[delta] (f- PIK3C[delta]) as a key regulator of cancer progression. Although PIK3C[delta] was expressed in primary fibroblasts derived from TNBC patients, it was barely detectable in breast cancer (BC) cell lines. Genetic and pharmacological gain- and loss-of-function experiments verified the contribution of f-PIK3C[delta] in TNBC cell invasion. Integrated secretomics and transcriptomics analyses revealed a paracrine mechanism via which f-PIK3C[delta] confers its protumorigenic effects. Inhibition of f-PIK3C[delta] promoted the secretion of factors, including PLGF and BDNF, that led to upregulation of NR4A1 in TNBC cells, where it acts as a tumor suppressor. Inhibition of PIK3C[delta] in an orthotopic BC mouse model reduced tumor growth only after inoculation with fibroblasts, indicating a role of f-PIK3C[delta] in cancer progression. Similar results were observed in the MMTV-PyMT transgenic BC mouse model, along with a decrease in tumor metastasis, emphasizing the potential immune-independent effects of PIK3C[delta] inhibition. Finally, analysis of BC patient cohorts and TCGA data sets identified f-PIK3C[delta] (protein and mRNA levels) as an independent prognostic factor for overall and disease-free survival, highlighting it as a therapeutic target for TNBC., Introduction Triple-negative breast cancer (TNBC; [ER.sup.-], [PR.sup.-], [HER2.sup.-]) represents a molecularly diverse and highly heterogeneous subtype of breast cancer (BC) (15%-20%) with a poor prognosis and high rates of recurrence [...]

Published
2020
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20. The clinical use of circulating tumor cells (CTCs) enumeration for staging of metastatic breast cancer (MBC): International expert consensus paper

Author

Cristofanilli, Massimo, Pierga, Jean-Yves, Reuben, James, Rademaker, Alfred, Davis, Andrew A., Peeters, Dieter J., Fehm, Tanja, Nolé, Franco, Gisbert-Criado, Rafael, Mavroudis, Dimitrios, Grisanti, Salvatore, Giuliano, Mario, Garcia-Saenz, Jose A., Stebbing, Justin, Caldas, Carlos, Gazzaniga, Paola, Manso, Luis, Zamarchi, Rita, de Lascoiti, Angela Fernandez, De Mattos-Arruda, Leticia, Ignatiadis, Michail, Cabel, Luc, van Laere, Steven J., Meier-Stiegen, Franziska, Sandri, Maria-Teresa, Vidal-Martinez, Jose, Politaki, Eleni, Consoli, Francesca, Generali, Daniele, Cappelletti, Maria Rosa, Diaz-Rubio, Eduardo, Krell, Jonathan, Dawson, Sarah-Jane, Raimondi, Cristina, Rutten, Annemie, Janni, Wolfgang, Munzone, Elisabetta, Carañana, Vicente, Agelaki, Sofia, Almici, Camillo, Dirix, Luc, Solomayer, Erich-Franz, Zorzino, Laura, Darrigues, Lauren, Reis-Filho, Jorge S., Gerratana, Lorenzo, Michiels, Stefan, Bidard, François-Clément, and Pantel, Klaus

Published
2019
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21. Afatinib treatment in a lung adenocarcinoma patient harboring a rare EGFR L747P mutation

Author

Li, Jisheng, Zhu, Liping, Stebbing, Justin, and Peng, Ling

Subjects
Gene mutations -- Case studies, Lung cancer, Non-small cell -- Genetic aspects -- Drug therapy -- Case studies, Health
Abstract

Byline: Jisheng. Li, Liping. Zhu, Justin. Stebbing, Ling. Peng Classical activating alterations including exon 19 deletions and exon 21 L858R point mutations comprise the majority of epidermal growth factor receptor [...]

Published
2022

23. The renin angiotensin system (RAS) mediates bifunctional growth regulation in melanoma and is a novel target for therapeutic intervention

Author

Renziehausen, Alexander, Wang, Hexiao, Rao, Bhavya, Weir, Lynda, Nigro, Cristiana Lo, Lattanzio, Laura, Merlano, Marco, Vega-Rioja, Antonio, del Carmen Fernandez-Carranco, Maria, Hajji, Nabil, Matin, Rubeta, Harwood, Catherine, Li, Su, Sim, Van Ren, O’Neill, Kevin, Evans, Alan, Thompson, Alastair, Szlosarek, Peter, Fleming, Colin, Stebbing, Justin, Proby, Charlotte, Tzakos, Andreas G., Syed, Nelofer, and Crook, Tim

Published
2019
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25. LMTK3 confers chemo-resistance in breast cancer

Author

Stebbing, Justin, Shah, Kalpit, Lit, Lei Cheng, Gagliano, Teresa, Ditsiou, Angeliki, Wang, Tingting, Wendler, Franz, Simon, Thomas, Szabó, Krisztina Sára, O’Hanlon, Timothy, Dean, Michael, Roslani, April Camilla, Cheah, Swee Hung, Lee, Soo-Chin, and Giamas, Georgios

Published
2018
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29. The Inhibitory Properties of a Novel, Selective LMTK3 Kinase Inhibitor

Author

Agnarelli, Alessandro, primary, Lauer Betrán, Andrea, additional, Papakyriakou, Athanasios, additional, Vella, Viviana, additional, Samuels, Mark, additional, Papanastasopoulos, Panagiotis, additional, Giamas, Christina, additional, Mancini, Erika J., additional, Stebbing, Justin, additional, Spencer, John, additional, Cilibrasi, Chiara, additional, Ditsiou, Angeliki, additional, and Giamas, Georgios, additional

Published
2023
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38. A novel platform for attenuating immune hyperactivity using EXO‐CD24 in COVID‐19 and beyond

Author

Shapira, Shiran, primary, Ben Shimon, Marina, additional, Hay‐Levi, Mori, additional, Shenberg, Gil, additional, Choshen, Guy, additional, Bannon, Lian, additional, Tepper, Michael, additional, Kazanov, Dina, additional, Seni, Jonathan, additional, Lev‐Ari, Shahar, additional, Peer, Michael, additional, Boubas, Dimitrios, additional, Stebbing, Justin, additional, Tsiodras, Sotirios, additional, and Arber, Nadir, additional

Published
2022
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42. Modeling the Prognostic Impact of Circulating Tumor Cells Enumeration in Metastatic Breast Cancer for Clinical Trial Design Simulation

Author

Gerratana, Lorenzo, Pierga, Jean Yves Ves J.Y., Reuben, James, Davis, Andrew Adam, Wehbe, Firas F.H., Dirix, Luc Y, Fehm, Tanja Natascha T., Nolé, Franco, Gisbert-Criado, Rafael, Mavroudis, Dimitrios, Grisanti, Salvatore, García Sáenz, José Ángel J.A., Stebbing, Justin, Caldas, Carlos, Gazzaniga, Paola, Manso, Luis, Zamarchi, Rita, Bonotto, Marta, Fernandez de Lascoiti, Angela, de Mattos-Arruda, Letícia, Ignatiadis, Michail, Sandri, Maria Teresa, Generali, Daniele, De Angelis, Carmine, Dawson, Sarah Jane, Janni, Wolfgang, Carañana, Vicente, Riethdorf, Sabine, Solomayer, Erich-Franz, Puglisi, Fabio, Giuliano, Mario, Pantel, Klaus, Bidard, François-Clément, Cristofanilli, Massimo, Gerratana, Lorenzo, Pierga, Jean Yves Ves J.Y., Reuben, James, Davis, Andrew Adam, Wehbe, Firas F.H., Dirix, Luc Y, Fehm, Tanja Natascha T., Nolé, Franco, Gisbert-Criado, Rafael, Mavroudis, Dimitrios, Grisanti, Salvatore, García Sáenz, José Ángel J.A., Stebbing, Justin, Caldas, Carlos, Gazzaniga, Paola, Manso, Luis, Zamarchi, Rita, Bonotto, Marta, Fernandez de Lascoiti, Angela, de Mattos-Arruda, Letícia, Ignatiadis, Michail, Sandri, Maria Teresa, Generali, Daniele, De Angelis, Carmine, Dawson, Sarah Jane, Janni, Wolfgang, Carañana, Vicente, Riethdorf, Sabine, Solomayer, Erich-Franz, Puglisi, Fabio, Giuliano, Mario, Pantel, Klaus, Bidard, François-Clément, and Cristofanilli, Massimo

Abstract

Despite the strong prognostic stratification of circulating tumor cells (CTCs) enumeration in metastatic breast cancer (MBC), current clinical trials usually do not include a baseline CTCs in their design. This study aimed to generate a classifier for CTCs prognostic simulation in existing datasets for hypothesis generation in patients with MBC. A K-nearest neighbor machine learning algorithm was trained on a pooled dataset comprising 2436 individual MBC patients from the European Pooled Analysis Consortium and the MD Anderson Cancer Center to identify patients likely to have CTCs ≥ 5/7 mL blood (StageIVaggressive vs StageIVindolent). The model had a 65.1% accuracy and its prognostic impact resulted in a hazard ratio (HR) of 1.89 (Simulatedaggressive vs SimulatedindolentP < .001), similar to patients with actual CTCs enumeration (HR 2.76; P < .001). The classifier's performance was then tested on an independent retrospective database comprising 446 consecutive hormone receptor (HR)-positive HER2-negative MBC patients. The model further stratified clinical subgroups usually considered prognostically homogeneous such as patients with bone-only or liver metastases. Bone-only disease classified as Simulatedaggressive had a significantly worse overall survival (OS; P < .0001), while patients with liver metastases classified as Simulatedindolent had a significantly better prognosis (P < .0001). Consistent results were observed for patients who had undergone CTCs enumeration in the pooled population. The differential prognostic impact of endocrine- (ET) and chemotherapy (CT) was explored across the simulated subgroups. No significant differences were observed between ET and CT in the overall population, both in terms of progression-free survival (PFS) and OS. In contrast, a statistically significant difference, favoring CT over ET was observed among Simulatedaggressive patients (HR: 0.62; P = .030 and HR: 0.60; P = .037, respectively, for PFS and OS)., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2022

43. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC)

Author

Zamorano, Jose Luis, Lancellotti, Patrizio, Aboyans, Victor, Asteggiano, Riccardo, Galderisi, Maurizio, Habib, Gilbert, Lenihan, Daniel J., Muñoz, Daniel Rodriguez, Lip, Gregory Y. H., Lyon, Alexander R., Fernandez, Teresa Lopez, Mohty, Dania, Piepoli, Massimo F., Tamargo, Juan, Torbicki, Adam, Suter, Thomas M., Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Barón-Esquivias, Gonzalo, Baumgartner, Helmut, Bax, Jeroen J., Bueno, Héctor, Carerj, Scipione, Dean, Veronica, Erol, Çetin, Fitzsimons, Donna, Gaemperli, Oliver, Kirchhof, Paulus, Kolh, Philippe, Lancellotti, Patrizio, Nihoyannopoulos, Petros, Ponikowski, Piotr, Roffi, Marco, Vaz Carneiro, António, Windecker, Stephan, Achenbach, Stephan, Minotti, Giorgio, Cardinale, Daniela, Curigliano, Giuseppe, de Azambuja, Evandro, Dent, Susan, Erol, Cetin, Ewer, Michael S., Farmakis, Dimitrios, Fietkau, Rainer, Kirchhof, Paulus, Kohl, Philippe, McGale, Paul, Ringwald, Juergen, Schulz-Menger, Jeanette, Stebbing, Justin, Steiner, Rudolf K., Szmit, Sebastian, and Vaz Carneiro, Antonio

Published
2017
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44. A pyroptosis‐related lncRNA signature in bladder cancer.

Author

Wang, Peng, Wang, Zhiqiang, Zhu, Liping, Sun, Yilan, Castellano, Leandro, Stebbing, Justin, Yu, Zhentao, and Peng, Ling

Subjects
RECEIVER operating characteristic curves, LINCRNA, APOPTOSIS, DISEASE risk factors, BLADDER cancer, CANCER prognosis
Abstract

Purpose: Pyroptosis, a type of programmed cell death, is implicated in the tumorigenesis, development and migration of cancer, which can be regulated by long non‐coding RNAs (lncRNAs). Our research aimed to investigate the prognostic role of pyroptosis‐related lncRNAs and the relationship to the tumor immune microenvironment through bioinformatics analysis. Methods: The clinical and RNA‐sequencing data of bladder cancer patients were downloaded from The Cancer Genome Atlas (TCGA). And 412 bladder cancer subjects with clinical information were divided into training and testing cohort. And 52 reported pyroptosis‐related genes were used to screen pyroptosis‐related lncRNAs. A pyroptosis‐related lncRNA signature was constructed based on Cox regression analyses. Results: A 9‐pyroptosis‐related‐lncRNA signature was identified to separate patients with bladder cancer into two groups. The prognosis of bladder cancer patients in the high‐risk group was significantly inferior compared with those in the low‐risk group. Risk scores were validated to develop an independent prognostic indicator based on multivariate Cox regression analysis. Receiver operating characteristic curve (ROC) analysis examined the signature on overall survival. The area under time‐dependent ROC curve (AUC) at 1‐, 3, and 5‐years measured 0.747, 0.783, and 0.768, respectively. Analysis of the immune landscape and PD‐L1 expression showed that PD‐L1 is upregulated in the high‐risk group. The immunocyte subtypes of the two groups were different. Conclusion: A novel pyroptosis‐related lncRNA signature was identified with prognostic value for bladder cancer patients. Pyroptosis‐related lncRNAs have a potential role in cancer immunology and may serve as prognostic or therapeutic targets. [ABSTRACT FROM AUTHOR]

Published
2023
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45. Design and reporting of phase III oncology trials with prospective biomarker validation.

Author

Liang, Fei, Peng, Ling, Wu, Zhengyu, Giamas, Georgios, and Stebbing, Justin

Subjects
CLINICAL trials, BIOMARKERS, CRIME & the press
Abstract

Background: Phase III trials with prospective biomarker validation are essential to drug development in the era of personalized oncology. However, concerns have emerged regarding the design and reporting of phase III trials with prospective biomarker validation.Methods: We searched MEDLINE for phase III oncology trials with prospective biomarker validation published in high-impact medical journals from 2011 to 2020. Information regarding trial design and reporting were extracted. Descriptive methods were used to summarize the results.Results: We identified 45 phase III trials with prospective biomarker validation. There was a trend for increasing use of biomarker validation phase III trials (from 1 trial in 2011 to 12 trials in 2020). For 39 (86.7%) trials, results in biomarker-negative population were either listed as an exploratory subgroup analysis (62.2%) or not mentioned in the methods (24.4%). Twenty-one (46.7%) trials were originally designed without biomarker validation but were then apparently modified to incorporate prospective biomarker validation after trial commencement, albeit only 15 (33.3%) trials reported this change. Treatment effect and primary outcome values in biomarker-negative patients were not reported in 24.4% and 40.0% trials, respectively. For 18 trials with statistically significant results in the overall population, only 7 trials reported a hazard ratio less than 0.8 in the biomarker-negative population.Conclusion: Although biomarker validation in phase III trials have been increasingly used in the past decade, issues regarding changes in trial design after commencement without disclosure, under-reporting of results in biomarker-negative groups and recommending treatment in biomarker negative groups despite modest effects, require substantial improvement. [ABSTRACT FROM AUTHOR]

Published
2023
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48. Modeling the Prognostic Impact of Circulating Tumor Cells Enumeration in Metastatic Breast Cancer for Clinical Trial Design Simulation

Author

Gerratana, Lorenzo, primary, Pierga, Jean-Yves, additional, Reuben, James M, additional, Davis, Andrew A, additional, Wehbe, Firas H, additional, Dirix, Luc, additional, Fehm, Tanja, additional, Nolé, Franco, additional, Gisbert-Criado, Rafael, additional, Mavroudis, Dimitrios, additional, Grisanti, Salvatore, additional, Garcia-Saenz, Jose A, additional, Stebbing, Justin, additional, Caldas, Carlos, additional, Gazzaniga, Paola, additional, Manso, Luis, additional, Zamarchi, Rita, additional, Bonotto, Marta, additional, Fernandez de Lascoiti, Angela, additional, De Mattos-Arruda, Leticia, additional, Ignatiadis, Michail, additional, Sandri, Maria-Teresa, additional, Generali, Daniele, additional, De Angelis, Carmine, additional, Dawson, Sarah-Jane, additional, Janni, Wolfgang, additional, Carañana, Vicente, additional, Riethdorf, Sabine, additional, Solomayer, Erich-Franz, additional, Puglisi, Fabio, additional, Giuliano, Mario, additional, Pantel, Klaus, additional, Bidard, François-Clément, additional, and Cristofanilli, Massimo, additional

Published
2022
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