Article
Oncology
Aparna Hegde, Priyamvada Jayaprakash, Coline A. Couillault, Sarina Piha-Paul, Daniel Karp, Jordi Rodon, Shubham Pant, Siqing Fu, Ecaterina E. Dumbrava, Timothy A. Yap, Vivek Subbiah, Priya Bhosale, Cristian Coarfa, Jack P. Higgins, Eric T. Williams, Thomas F. Wilson, JoAnn Lim, Funda Meric-Bernstam, Elizabeth Sumner, Hira Zain, Di Nguyen, Ly M. Nguyen, Kimal Rajapakshe, Michael A. Curran, David S. Hong
Summary: The study investigated the combination of hypoxia-alleviating drug evofosfamide with immune checkpoint inhibitor ipilimumab for the treatment of cancers. Results showed partial responses in some patients, with preexisting immune gene signatures predicting treatment response and hypermetabolic tumors predicting disease progression.
CLINICAL CANCER RESEARCH
(2021)
Article
Medicine, Research & Experimental
Helen Barnett, Oliver Boix, Dimitris Kontos, Thomas Jaki
Summary: This article examines the impact of employing backfilling in phase I dose-escalation studies on the estimation of the maximum tolerated dose and the duration of the study. The study finds that backfilling can increase the accuracy of selecting the maximum tolerated dose and reduce the trial duration. However, the use of backfilling comes at the cost of increased sample size.
Article
Oncology
Funda Meric-Bernstam, Randy F. Sweis, F. Stephen Hodi, Wells A. Messersmith, Robert H. Andtbacka, Matthew Ingham, Nancy Lewis, Xinhui Chen, Marc Pelletier, Xueying Chen, Jincheng Wu, Sarah M. McWhirter, Thomas Mueller, Nitya Nair, Jason J. Luke
Summary: This study assessed the safety, pharmacokinetics, and efficacy of MIW815, a novel cyclic dinucleotide, in patients with advanced/metastatic cancers. Results showed that MIW815 was well tolerated, but had limited clinical activity as a single agent. However, evidence of systemic immune activation was observed.
CLINICAL CANCER RESEARCH
(2022)
Article
Oncology
Toshihiko Doi, Nobuaki Matsubara, Yoichi Naito, Yasutoshi Kuboki, Kenichi Harano, Makiko Ono, Tetsuya Urasaki, Akihiro Ohmoto, Tsubasa Kawanai, Takashi Hisai, Hiroki Ikezawa, Sari Shiba, Ken Ito, Taro Semba, Osamu Asano, Shunji Takahashi
Summary: This study reported the dose-escalation part of a first-in-human clinical trial of the synthetic anticancer agent E7130. The results showed that the 480 mu g/m(2) Q3W dose of E7130 had better tolerability and efficacy, and was chosen as the treatment dose for the dose-expansion part.
Article
Oncology
Jun Sato, Toshio Shimizu, Takafumi Koyama, Satoru Iwasa, Akihiko Shimomura, Shunsuke Kondo, Shigehisa Kitano, Kan Yonemori, Yutaka Fujiwara, Kenji Tamura, Takuya Suzuki, Takao Takase, Reiko Nagai, Kohei Yamaguchi, Taro Semba, Zi-Ming Zhao, Min Ren, Noboru Yamamoto
Summary: This study reports the dose-escalation part of a phase I study of liposomal eribulin in Japanese patients with advanced solid tumors. The study found that liposomal eribulin was well tolerated at a dosage of 2.0 mg/m(2) once every three weeks and 1.5 mg/m(2) once every two weeks, and recommended a dosage of 2.0 mg/m(2) once every three weeks.
CLINICAL CANCER RESEARCH
(2022)
Article
Urology & Nephrology
Renee Bultijnck, Benedicte Deforche, Noemi Borrey, Joergen Van Bauwel, Maarten Lievens, Elke Rammant, Valerie Fonteyne, Karel Decaestecker, Adelheid Steyaert, Nicolaas Lumen, Piet Ost
Summary: The study aimed to determine the starting exercise prescription dose in metastatic castrate-resistant prostate cancer patients receiving second-line hormone treatment and recommend phase II exercise prescription. The findings suggest that exercise is perceived to be tolerable in these patients, but caution is needed for safety during the exercises.
WORLD JOURNAL OF UROLOGY
(2021)
Article
Health Care Sciences & Services
Burak Kuersad Guenhan, Sebastian Weber, Abdelkader Seroutou, Tim Friede
Summary: The study explores sequential phase I trials in oncology, utilizing information from multiple schedules to inform dose decisions. The adapted TITE-PK model demonstrates improved performance in recommending acceptable doses and avoiding toxicity, with similar patient requirements compared to alternatives. It is recommended for phase I oncology trials with sequential multiple schedules.
BMC MEDICAL RESEARCH METHODOLOGY
(2021)
Article
Radiology, Nuclear Medicine & Medical Imaging
Noemie S. Minczeles, Wouter W. de Herder, Mark W. Konijnenberg, Richard A. Feelders, Tessa Brabander, Johannes Hofland
Summary: Peptide receptor radionuclide therapy (PRRT) can cause dose-limiting toxicities (DLTs) of the bone marrow, liver, and kidneys. It is yet unknown whether women and men are equally at risk of these DLTs. This study found that female neuroendocrine tumor patients more often experienced PRRT-induced toxicities of platelets and hemoglobin than males, but this did not lead to a lower cumulative activity.
CLINICAL NUCLEAR MEDICINE
(2022)
Article
Oncology
Jianming Xu, Jiuwei Cui, Haiping Jiang, Yan Zeng, Xiuyu Cong
Summary: This study determined the MTD, RP2D, pharmacokinetics, safety, and preliminary efficacy of EVER4010001 plus pembrolizumab in patients with advanced solid tumors. The results showed that 80 mg BID was the MTD and RP2D for EVER4010001 plus pembrolizumab.
Article
Medicine, General & Internal
Job P. van Kooten, Michelle Dietz, Niels A. D. Guchelaar, Alexandra R. M. Brandt-Kerkhof, Stijn L. W. Koolen, Jacobus W. A. Burger, Ron H. J. Mathijssen, Cornelis Verhoef, Joachim G. J. Aerts, Eva V. E. Madsen
Summary: Malignant peritoneal mesothelioma (MPM) is a rare and aggressive tumor, and cytoreductive surgery with hyperthermic intraperitoneal chemotherapy is the only potential curative treatment. However, most patients are not eligible for this treatment, highlighting the need for palliative options. This study aims to determine the maximum tolerable dose of intraperitoneal paclitaxel monotherapy in MPM patients and assess its safety and pharmacokinetics.
Article
Oncology
Her-Shyong Shiah, Nai-Jung Chiang, Chia-Chi Lin, Chia-Jui Yen, Hui-Jen Tsai, Shang-Yin Wu, Wu-Chou Su, Kwang-Yu Chang, Ching-Chiung Wang, Jang-Yang Chang, Li-Tzong Chen
Summary: The novel microtubule inhibitor SCB01A has vascular disrupting activity and is safe and tolerable in patients with solid tumors, with a maximum tolerated dose of 24 mg/m(2) every 21 days and a half-life of approximately 2.5 hours. Treatment-related adverse events included anemia, nausea, vomiting, and some patients experienced neurotoxicity.
Article
Oncology
Yangyang Zhang, Lingxiu Zeng, Meng Wang, Zhenwei Yang, Hailin Zhang, Liping Gao, Ranran Zhang, Jialong Liu, Wenqing Shan, Ying Chang, Lan Liu, Qiu Zhao, Yong Li, Jing Liu
Summary: The study found that RIG-I plays an important role in the immunotherapy of colon cancer by maintaining the stability of PD-L1 to promote immune evasion. Silencing RIG-I increases the sensitivity of tumor cells to T cell killing and slows down the growth of colon tumors. High expression of RIG-I promotes tumor progression and enhances the sensitivity to PD-1 therapy.
JOURNAL FOR IMMUNOTHERAPY OF CANCER
(2023)
Article
Mathematical & Computational Biology
Jieqi Tu, Zhengjia Chen
Summary: This paper proposes a design method, EWOUC-NETS, which integrates escalation with overdose and underdose control (EWOUC) and a normalized equivalent toxicity score (NETS), to control overdose risk and minimize therapeutic effect in cancer Phase I clinical trials. By treating toxicity and efficacy as continuous variables, the design improves trial efficiency and accuracy in identifying the optimized utility dose (OUD) for better therapeutic effects.
BIOMETRICAL JOURNAL
(2023)
Article
Oncology
Jill J. J. Geenen, Gwen M. H. E. Dackus, Philip C. Schouten, Dick Pluim, Serena Marchetti, Gabe S. Sonke, Katarzyna Jozwiak, Alwin D. R. Huitema, Jos H. Beijnen, Jan H. M. Schellens, Sabine C. Linn
Summary: A dose finding study of olaparib tablets bidaily (BID) continuously with carboplatin in advanced cancer patients showed that the combination treatment was feasible and tolerable, with dose-level 3 (olaparib 75 mg BID and carboplatin AUC 4 mg*min/mL) defined as the maximum tolerable dose (MTD). The study also indicated a comparable systemic exposure of the olaparib tablet formulation to the previous capsule formulation. Additionally, the treatment schedule resulted in a partial response in 56% of the patients with common adverse events including nausea and fatigue.
INTERNATIONAL JOURNAL OF CANCER
(2021)
Article
Immunology
Elias A. T. Koch, Niels Schaft, Mirko Kummer, Carola Berking, Gerold Schuler, Kenichiro Hasumi, Jan Doerrie, Beatrice Schuler-Thurner
Summary: Uveal melanoma is a rare disease with poor response to traditional therapies. Researchers designed a trial using personalized dendritic cell vaccines to activate the immune system and potentially improve clinical outcomes.
FRONTIERS IN IMMUNOLOGY
(2022)
Article
Hematology
Anna Dodero, Anna Guidetti, Fabrizio Marino, Alessandra Tucci, Francesco Barretta, Alessandro Re, Monica Balzarotti, Cristiana Carniti, Chiara Monfrini, Annalisa Chiappella, Antonello Cabras, Fabio Facchetti, Martina Pennisi, Daoud Rahal, Valentina Monti, Liliana Devizzi, Rosalba Miceli, Federica Cocito, Lucia Farina, Francesca Ricci, Giuseppe Rossi, Carmelo Carlo-Stella, Paolo Corradini
Summary: This study reports the efficacy of DA-EPOCH-R treatment in patients with DLBCL, including DEL and DH/TH. The study found that TP53 mutations have a negative impact on prognosis, while systemic CNS prophylaxis can improve patient survival.
Article
Critical Care Medicine
Sara Fernandez, Ana B. Moreno-Castano, Marta Palomo, Julia Martinez-Sanchez, Sergi Torramade-Moix, Adrian Tellez, Helena Ventosa, Ferran Segui, Gines Escolar, Enric Carreras, Josep M. Nicolas, Edward Richardson, David Garcia-Bernal, Carmelo Carlo-Stella, Jose M. Moraleda, Paul G. Richardson, Maribel Diaz-Ricart, Pedro Castro
Summary: COVID-19 patients exhibit increased circulating biomarkers of endothelial damage, complement activation, and fibrinolytic dysregulation, associated with disease severity. COVID-19 endotheliopathy differs from sepsis syndrome, in which endothelial damage is also a critical feature of pathobiology.
Article
Oncology
Elena Ortona, Silvia L. Locatelli, Maria Teresa Pagano, Barbara Ascione, Giuseppa Careddu, Maria Luisa Dupuis, Matteo Marconi, Carmelo Carlo-Stella, Walter Malorni, Paola Matarrese, Marina Pierdominici
Summary: This study evaluated the anticancer activity of the phytoestrogen silibinin on DLBCL growth and its potential cardioprotective effect. The results showed that silibinin induced apoptosis and autophagy, blocked tumor cell proliferation, and protected cardiomyocytes from doxorubicin-induced toxicity.
ANTICANCER RESEARCH
(2022)
Article
Oncology
Carmelo Carlo-Stella, Pier Luigi Zinzani, Anna Sureda, Luis Araujo, Olivier Casasnovas, Cecilia Carpio, Su-Peng Yeh, Krimo Bouabdallah, Guillaume Cartron, Won Seog Kim, Raul Cordoba, Youngil Koh, Alessandro Re, Daniela Alves, Martine Chamuleau, Steven Le Gouill, Armando Lopez-Guillermo, Ilidia Moreira, Marjolein W. M. van der Poel, Giovanni Abbadessa, Robin Meng, Ran Ji, Lucie Lepine, Rao Saleem, Vincent Ribrag
Summary: This study evaluated the safety, efficacy, and pharmacokinetics of a combination treatment of Cemi (anti-PD-1 receptor antibody) and Isa (anti-CD38 antibody) in patients with relapsed or refractory lymphoma. The results showed that the combination treatment had manageable safety and modest clinical efficacy in patients with cHL, DLBCL, and PTCL.
HEMATOLOGICAL ONCOLOGY
(2023)
Meeting Abstract
Hematology
Vittorio Montefusco, Anna Maria Cafro, Gloria Margiotta Casaluci, Francesca Patriarca, Roberto Mina, Mattia D'Agostino, Andrea Capra, Claudia Priola, Anna Benedetta Dalla Palma, Rita Rizzi, Angelo Genua, Maria Teresa Petrucci, Laura Paris, Angelo Belotti, Michele Cavo, Concetta Conticello, Carmelo Carlo-Stella, Mario Boccadoro
Editorial Material
Hematology
Lydia Scarfo, Antonio Cuneo
Meeting Abstract
Hematology
Michael Dickinson, Giuseppe Gritti, Carmelo Carlo-Stella, Harriet S. Walter, David Carlile, Nicole Getzmann, Samira Curdt, Emma Harrop, Abiraj Keelara, Koorosh Korfi, Remi Labatut, Francesca Michielin, Sarah Louise Mycroft, Tom Moore, Robert Nutbrown, Giuseppe Palldino, Matt Whayman, Johannes Sam, Martin Weisser, Katharina E. Lechner, Franck Morschhauser, Martin Hutchings
Meeting Abstract
Hematology
Paolo F. Caimi, Mehdi Hamadani, Carmelo Carlo-Stella, Masoud Nickaeen, Eric Jordie, Kiersten Utsey, Tim Knab, Francesca Zammarchi, Serafino Pantano, Karin Havenith, Ying Wang, Joseph Boni
Article
Oncology
Alexander Lesokhin, Richard LeBlanc, Meletios A. Dimopoulos, Marcelo Capra, Carmelo Carlo-Stella, Lionel Karlin, Jean-Francois Castilloux, Peter Forsberg, Gurdeep Parmar, Axel Tosikyan, Ludek Pour, Vincent Ribrag, Rossella Ribolla, Al-Ola Abdallah, Nadia Le Roux, Liyan Dong, Helgi van de Velde, Laurent Mayrargue, Lucie Lepine, Sandrine Mace, Philippe Moreau
Summary: This study aimed to determine whether cemiplimab enhances the anti-myeloma activity of isatuximab in RRMM patients and evaluate its safety. The results showed that although the combination of cemiplimab and isatuximab had a certain effect in patients, the differences were not statistically significant and did not improve progression-free or overall survival. Therefore, adding cemiplimab to the isatuximab treatment regimen only has marginal benefits.
Article
Oncology
Damiano Dei, Nicola Lambri, Sara Stefanini, Veronica Vernier, Ricardo Coimbra Brioso, Leonardo Crespi, Elena Clerici, Luisa Bellu, Chiara De Philippis, Daniele Loiacono, Pierina Navarria, Giacomo Reggiori, Stefania Bramanti, Marcello Rodari, Stefano Tomatis, Arturo Chiti, Carmelo Carlo-Stella, Marta Scorsetti, Pietro Mancosu
Summary: The contouring of lymph node clinical target volume (CTV_LN) in total marrow and lymph node irradiation (TMLI) is complex and time-consuming. The introduction of internal guidelines reduced inter- and intraobserver variability in CTV_LN delineation. The guidelines improved the consistency of contouring in TMLI treatments.
Article
Hematology
Carol Moreno, Isabelle G. Solman, Constantine S. Tam, Andrew Grigg, Lydia Scarfo, Thomas J. Kipps, Srimathi Srinivasan, Raghuveer Singh Mali, Cathy Zhou, James P. Dean, Edith Szafer-Glusman, Michael Choi
Summary: This study evaluated immune cell subsets in patients with CLL who received different treatments. The results demonstrated successful elimination of CLL cells and restoration of normal immune cells in some patients.
Article
Hematology
Andrea Visentin, Thomas Chatzikonstantinou, Lydia Scarfo, Anargyros Kapetanakis, Christos Demosthenous, Georgios Karakatsoulis
Summary: In this retrospective international multicenter study, the clinical characteristics and outcomes of patients with chronic lymphocytic leukemia (CLL) and related disorders infected by SARS-CoV-2 were described. The study also investigated the development of post-COVID condition. The data showed that patients infected in the most recent phases of the pandemic had lower hospitalization rates, ICU admission rates, and mortality compared to those infected in the initial phases. Overall survival improved throughout the phases. Age, comorbidity, and CLL-directed treatment were identified as risk factors for mortality. A significant number of patients developed post-COVID condition, characterized by fatigue, dyspnea, lasting cough, and impaired concentration. The severity of infection was the only risk factor for developing post-COVID. Further investigations are warranted to understand the impact of COVID-19 on CLL patients.
AMERICAN JOURNAL OF HEMATOLOGY
(2023)
Article
Oncology
Gian Matteo Rigolin, Pier Paolo Olimpieri, Valentina Summa, Simone Celant, Lydia Scarfo, Lucia Tognolo, Maria Pia Ballardini, Antonio Urso, Mariarosaria Sessa, Silvia Gambara, Francesca Cura, Monica Fortini, Paolo Ghia, Antonio Cuneo, Pierluigi Russo
Summary: This analysis evaluates the effectiveness of first-line ibrutinib in 747 CLL patients with TP53 aberrations. The study found a treatment persistence rate of 63.4% and a survival rate of 82.6% at 24 months. Disease progression or death were the main reasons for treatment discontinuation. The study also identified factors associated with an increased risk of discontinuation and death.
BLOOD CANCER JOURNAL
(2023)
Article
Oncology
Nicola Lambri, Simone Leopoldo Antonetti, Damiano Dei, Luisa Bellu, Stefania Bramanti, Ricardo Coimbra Brioso, Carmelo Carlo-Stella, Isabella Castiglioni, Elena Clerici, Leonardo Crespi, Chiara De Philippis, Carmela Galdieri, Daniele Loiacono, Pierina Navarria, Giacomo Reggiori, Roberto Rusconi, Stefano Tomatis, Marta Scorsetti, Pietro Mancosu
Summary: Delivery of total marrow (lymph node) irradiation (TMI/TMLI) takes longer than standard radiotherapy treatments due to patient's extremity movements. The study evaluated the reproducibility of TMI/TMLI patient's extremities in order to find the best positioning and minimize unwanted movements.
Meeting Abstract
Radiology, Nuclear Medicine & Medical Imaging
M. Sollini, L. Cavinato, N. Gozzi, M. Kirienko, C. Carlo-Stella, M. Biroli, C. Rusconi, P. Corradini, E. Seregni, F. Ieva, A. Chiti
EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING
(2022)