Article
Hematology
Jesse G. Dixon, Natalie Dimier, Tina Nielsen, Jamie Zheng, Robert Marcus, Franck Morschhauser, Andrew M. Evens, Massimo Federico, Kristie A. Blum, Qian Shi
Summary: This study aimed to evaluate the surrogate role of PET-CR measured at the end of the induction period as a predictor of PFS in first-line follicular lymphoma treatment. The results showed that although EoI-PET-CR demonstrated strong predictive ability for PFS at a prognostic level, the trial-level assessment did not show a strong correlation. The high uncertainty in estimation was possibly due to the small number of trials and limited availability of PET data. Maintenance therapy may have influenced the association between treatment effects. Further evaluation of PET-CR as a surrogate endpoint is still warranted.
BRITISH JOURNAL OF HAEMATOLOGY
(2022)
Article
Hematology
Tommy Etekal, Kelly Koehn, Douglas W. Sborov, Brian McClune, Vinay Prasad, Alyson Haslam, Katherine Berger, Christopher Booth, Samer Al Hadidi, Al-Ola Abdallah, Aaron Goodman, Ghulam Rehman Mohyuddin
Summary: This systematic review examines the use of surrogate end-points in multiple myeloma clinical trials and assesses the strength of PFS as a surrogate for overall survival. The results suggest that PFS is a poor surrogate for OS in MM.
BRITISH JOURNAL OF HAEMATOLOGY
(2023)
Article
Oncology
Shai Gilboa, Yarden Pras, Aviv Mataraso, David Bomze, Gal Markel, Tomer Meirson
Summary: This study analyzed the patterns of censoring in surrogate endpoints in oncology RCTs between 2010 and 2020. Results showed that censoring imbalance between study arms could potentially affect the validity of the results, especially in trials where new treatments failed to demonstrate survival benefit.
EUROPEAN JOURNAL OF CANCER
(2021)
Article
Urology & Nephrology
Hiddo J. L. A. Heerspink, Lesley Inker, Hocine H. Tighiouart, Willem Collier, Benjamin Haaland, Jiyu B. Luo, Gerald Appel, Tak Mao O. Chan, Raymond Estacio, Fernando Fervenza, Juergen Floege, Enyu H. Imai, Tazeen B. Jafar, Julia Lewis, Philip Kam-Tao Li, Francesco D. Locatelli, Bart Maes, Annalisa D. Perna, Ronald Perrone, Manuel P. Praga, Francesco Schena, Christoph Wanner, Di Xie, Tom Greene, CKD EPI CT
Summary: This study aims to develop a conceptual framework that combines albuminuria and GFR slope to better predict treatment effects on clinical endpoints in Phase 2 trials. The results demonstrate that combining the treatment effects on albuminuria and GFR slope improves the prediction of treatment effects on clinical endpoints. These findings may help inform the design of clinical trials for interventions aimed at slowing CKD progression.
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
(2023)
Article
Oncology
Sarah C. Rutherford, Jun Yin, Levi Pederson, Gabriela Perez Burbano, Betsy LaPlant, Mazyar Shadman, Hongli Li, Michael L. LeBlanc, Vaishalee P. Kenkre, Fangxin Hong, Kristie A. Blum, Travis Dockter, Peter Martin, Sin-Ho Jung, Barbara Grant, Cara Rosenbaum, Chaitra Ujjani, Paul M. Barr, Joseph M. Unger, Bruce D. Cheson, Nancy L. Bartlett, Brad Kahl, Jonathan W. Friedberg, Sumithra J. Mandrekar, John P. Leonard
Summary: The study aimed to determine the value of bone marrow biopsies (BMB) in assessing response and predicting survival outcomes in follicular lymphoma (FL) patients. The results showed that BMB had little impact on treatment response in FL patients, with only 1-1.3% of patients showing BMB affecting response assessment.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Medicine, General & Internal
Hideki Maeda, Riko Shingai, Kentaro Takeda, Asuka Hara, Yuna Murai, Momoka Ofuchi
Summary: This study found that the use of OS as an endpoint in clinical trials supporting the approval of anticancer drugs in Japan has increased since 2005, but approximately two-thirds of these approvals are still based on surrogates. Therefore, postmarketing surveillance studies of true endpoints are needed to validate the use of surrogates.
Article
Oncology
Rachel G. Woodford, Deborah D. X. Zhou, Peey-Sei Kok, Sally J. Lord, Michael Friedlander, Ian C. Marschner, R. John Simes, Chee Khoon Lee
Summary: Overall survival (OS) is the gold standard endpoint for oncology trials, but progression-free survival 2 (PFS-2) has been proposed as a surrogate endpoint due to delays in OS data maturation. A meta-analysis found that PFS-2 had a moderate correlation with OS across diverse tumors and therapies, performing consistently better than PFS-1 and objective response rate (ORR). PFS-2 should be included as a key endpoint in future randomized trials of solid tumors.
Article
Immunology
Stephen M. Bart, Sumathi Nambiar, Ramya Gopinath, Daniel Rubin, John J. Farley
Summary: In analyzing participant-level data from recent CABP trials submitted to the FDA, it was found that 85.6% of participants had concordant early and late end-point outcomes. Early end-point response was highly predictive of late end-point success, with certain factors like obesity, specific infections, prior antibacterial therapy, and baseline chest pain associated with discordance between early and late outcomes.
CLINICAL INFECTIOUS DISEASES
(2021)
Article
Oncology
Yucai Wang, Shouhao Zhou, Xinyue Qi, Fang Yang, Matthew J. Maurer, Thomas M. Habermann, Thomas E. Witzig, Michael L. Wang, Grzegorz S. Nowakowski
Summary: This study conducted a network meta-analysis to compare the efficacy of different treatment regimens for follicular lymphoma. The results showed that G-Benda-G had the best progression-free survival, indicating that bendamustine is a better chemotherapy backbone for follicular lymphoma.
BLOOD CANCER JOURNAL
(2022)
Article
Hematology
Carla Casulo, Jesse G. Dixon, Fang-Shu Ou, Eva Hoster, Bruce A. Peterson, Howard S. Hochster, Pauline Brice, Marco Ladetto, Wolfgang Hiddemann, Robert Marcus, Eva Kimby, Michael Herold, Tina Nielsen, Franck Morschhauser, Mathias Rummel, Anton Hagenbeek, Umberto Vitolo, Gilles A. Salles, Qian Shi, Christopher R. Flowers
Summary: Limited data exists on the clinical features and outcomes of elderly patients with follicular lymphoma (FL). In a pooled analysis of individual patient data from first-line randomized controlled trials, age over 70 was a significant predictor of overall survival and progression-free survival in FL patients. However, age alone should not exclude elderly patients from standard treatments or clinical trials.
Article
Oncology
Mixue Xie, Lulu Wang, Qi Jiang, Xuxia Luo, Xin Zhao, Xueying Li, Jie Jin, Xiujin Ye, Kui Zhao
Summary: This study investigated the predictive values of pre-transformation SUVmax for the risk of transformation in FL patients. Results showed that SUVbaseline and SUVend were significant predictors for HT, suggesting that quantitative assessment using SUVmax at pre-treatment and end-of-treatment PET/CT scan may help in early screening high-risk patients and guiding treatment decisions.
CANCER CELL INTERNATIONAL
(2021)
Article
Multidisciplinary Sciences
Gaetano Paone, Mariana Raditchkova-Sarnelli, Teresa Ruberto-Macchi, Marco Cuzzocrea, Emanuele Zucca, Luca Ceriani, Luca Giovanella
Summary: The study aimed to compare the diagnostic performance of PET/ldCT and PET/ceCT in evaluating FL patients at the end of treatment, showing no differences in metabolic response classification, but PET/ceCT identified additional FDG-negative nodal lesions in some patients. Relapse rate and Event-Free Survival were comparable between concordant and discordant imaging groups, with both PET imaging methods predicting EFS better than ceCT in FL patients.
SCIENTIFIC REPORTS
(2021)
Article
Hematology
David A. Russler-Germain, Kilannin Krysiak, Cody Ramirez, Matthew Mosior, Marcus P. Watkins, Felicia Gomez, Zachary L. Skidmore, Lee Trani, Feng Gao, Susan Geyer, Amanda F. Cashen, Neha Mehta-Shah, Brad S. Kahl, Nancy L. Bartlett, Juan P. Alderuccio, Izidore S. Lossos, Sarah L. Ondrejka, Eric D. Hsi, Peter Martin, John P. Leonard, Malachi Griffith, Obi L. Griffith, Todd A. Fehniger
Summary: This study conducted a clinicogenomic analysis of follicular lymphoma (FL) patients and identified specific gene mutations associated with patient outcomes. They defined a mutations associated with progression (MAP) signature that can predict the progression risk of FL, providing insights for identifying high-risk subsets of patients.
Review
Health Care Sciences & Services
Anthony Muchai Manyara, Philippa Davies, Derek Stewart, Christopher J. Weir, Amber E. Young, Valerie Wells, Jane Blazeby, Nancy J. Butcher, Sylwia Bujkiewicz, An-Wen Chan, Gary S. Collins, Dalia Dawoud, Martin Offringa, Mario Ouwens, Joseph S. Ross, Rod S. Taylor, Oriana Ciani
Summary: This study synthesized the current literature on the use of surrogate end points, including definitions, acceptability, limitations, and guidance, into trial reporting items. A total of 90 documents were included, and data were thematically analyzed and synthesized into 17 potential trial reporting items.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2023)
Review
Medicine, Research & Experimental
Emmanuel Bachy, Kaspar Rufibach, Joana Parreira, Aino Launonen, Tina Nielsen, Allan Hackshaw
Summary: The improved outcomes in first-line treatment of FL have made it challenging to demonstrate further treatment benefits in trials. New endpoints are needed to reflect long remission times, low relapse rates, and the impact of subsequent therapies in FL.
ADVANCES IN THERAPY
(2021)
Review
Hematology
David Sermer, Pavania Elavalakanar, Jeremy S. Abramson, M. Lia Palomba, Gilles Salles, Jon Arnason
Summary: CD19 is widely present on B-lymphocytes and B-cell malignancies. CD19-directed CAR T cells have improved outcomes in B-cell malignancies, but there are limitations. CD19 can also be targeted by other drugs, but optimal patient selection and sequencing are not established. This review focuses on CD19 as a target for DLBCL treatment, discussing clinical trials of tafasitamab, loncastuximab tesirine, and blinatumo-mab, and the potential of re-challenging with anti-CD19 therapies post-CAR T cells.
Article
Oncology
Justin C. C. Brown, Chao Ma, Qian Shi, Charles S. S. Fuchs, Jeffrey Meyer, Donna Niedzwiecki, Tyler Zemla, Felix Couture, Philip Kuebler, Pankaj Kumar, DeQuincy Lewis, Benjamin Tan, Smitha Krishnamurthi, Eileen M. M. O'Reilly, Anthony F. F. Shields, Jeffrey A. A. Meyerhardt
Summary: The purpose of this study was to determine the specific types, durations, and intensities of recreational physical activity that are associated with the greatest improvements in disease-free survival (DFS) for patients with colon cancer. The study found that engaging in larger volumes of recreational physical activity, longer durations of light-to-moderate-intensity aerobic exercise, or any vigorous-intensity aerobic exercise were significantly associated with improved DFS.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Oncology
Peter Martin, Jonathon B. Cohen, Michael Wang, Anita Kumar, Brian Hill, Diego Villa, Jeffrey M. Switchenko, Brad Kahl, Kami Maddocks, Natalie S. Grover, Keqin Qi, Lori Parisi, Katherine Daly, Angeline Zhu, Gilles Salles
Summary: This study analyzed the data of 4,216 patients with mantle cell lymphoma and found that only one in four young patients received high-dose cytarabine-based induction and autologous stem-cell transplant (ASCT) consolidation in the US community setting, indicating the need for effective treatments in routine clinical practice. Additionally, maintenance rituximab (MR) after bendamustine plus rituximab (BR) was associated with longer time to next treatment and overall survival.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Radiology, Nuclear Medicine & Medical Imaging
Fabien Ricard, Sally Barrington, Ron Korn, Guenther Brueggenwerth, Judith Trotman, Bruce Cheson, Gilles Salles, Larry Schwartz, Greg Goldmacher, Rudresh Jarecha, Jayant Narang, Florence Broussais, Paul Galette, Min Liu, Surabhi Bajpai, Eric Perlman, Julie Gillis, Ira Smalberg, Pierre Terve, Gudrun Zahlmann, Annette Schmid
Summary: The aim of this initiative was to provide consensus recommendations for the consistent application of imaging assessment with the Lugano classification in the field of lymphoma and imaging. Consensus was obtained through a series of sponsored meetings, resulting in recommendations to clarify technical considerations and provide guidance on the role of imaging and clinical reviewers in the classification. An example template of an imaging case report form is also provided to support efficient data collection. These consensus recommendations address technical and imaging areas of inconsistency and ambiguity in the classification encountered by end users.
JOURNAL OF NUCLEAR MEDICINE
(2023)
Article
Radiology, Nuclear Medicine & Medical Imaging
Fabien Ricard, Bruce Cheson, Sally Barrington, Judith Trotman, Annette Schmid, Guenther Brueggenwerth, Gilles Salles, Larry Schwartz, Greg Goldmacher, Rudresh Jarecha, Jayant Narang, Florence Broussais, Paul Galette, Min Liu, Surabhi Bajpai, Eric Perlman, Julie Gillis, Ira Smalberg, Pierre Terve, Gudrun Zahlmann, Ron Korn
Summary: This article presents consensus recommendations on the consistent application of the Lugano classification in the field of lymphoma and imaging. The recommendations were obtained through meetings involving academic and industry experts and provide updates and clarifications on the technical considerations and scoring guidelines of the Lugano classification. These consensus recommendations aim to address inconsistencies and ambiguities encountered by end users during response evaluation and should be used alongside the 2014 Lugano classification as a companion guide.
JOURNAL OF NUCLEAR MEDICINE
(2023)
Article
Oncology
Claire Gallois, Qian Shi, Jeffrey P. Meyers, Timothy Iveson, Steven R. Alberts, Aimery de Gramont, Alberto F. Sobrero, Daniel G. Haller, Eiji Oki, Anthony Frank Shields, Richard M. Goldberg, Rachel Kerr, Sara Lonardi, Greg Yothers, Caroline Kelly, Ioannis Boukovinas, Roberto Labianca, Frank A. Sinicrope, Ioannis Souglakos, Takayuki Yoshino, Jeffrey A. Meyerhardt, Thierry Andre, Demetris Papamichael, Julien Taieb
Summary: Whether early discontinuation of all treatment or early discontinuation of oxaliplatin could worsen the prognosis in patients with stage III CC remains unknown.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Oncology
Seohyuk Lee, Chao Ma, Qian Shi, Pankaj Kumar, Felix Couture, Philip Kuebler, Smitha Krishnamurthi, DeQuincy Lewis, Benjamin Tan, Richard M. Goldberg, Alan Venook, Charles Blanke, Eileen M. O'Reilly, Anthony F. Shields, Jeffrey A. Meyerhardt
Summary: This study aimed to evaluate the independent and interactive associations of planned treatment duration, celecoxib use, physical activity, BMI, diabetes, and vitamin B6 with Oxaliplatin-induced peripheral neuropathy (OIPN). The results showed that longer treatment cycles, lower physical activity, higher BMI, and diabetes were significantly associated with increased OIPN severity.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Letter
Oncology
David Qualls, Ariela Noy, David Straus, Matthew Matasar, Craig Moskowitz, Venkatraman Seshan, Ahmet Dogan, Gilles Salles, Anas Younes, Andrew D. Zelenetz, Connie Lee Batlevi
LEUKEMIA & LYMPHOMA
(2023)
Article
Oncology
Qiao-Li Wang, Chao Ma, Chen Yuan, Qian Shi, Brian M. Wolpin, Yin Zhang, Charles S. Fuchs, Jeffrey Meyer, Tyler Zemla, En Cheng, Priya Kumthekar, Katherine A. Guthrie, Felix Couture, Philip Kuebler, Pankaj Kumar, Benjamin Tan, Smitha Krishnamurthi, Richard M. Goldberg, Alan Venook, Charles Blanke, Anthony F. Shields, Eileen M. O'Reilly, Jeffrey A. Meyerhardt, Kimmie Ng
Summary: The purpose of this study was to assess the association between plasma 25-hydroxyvitamin D (25(OH)D) levels and outcomes in colon cancer patients and to determine whether circulating inflammatory cytokines mediate this association. The results showed that nondeficient vitamin D status was significantly associated with improved disease-free survival, overall survival, and time to recurrence in patients with stage III colon cancer. The mediation analysis revealed that sTNF-R2 played a mediating role, while CRP and IL6 did not.
CLINICAL CANCER RESEARCH
(2023)
Article
Oncology
Sri Harsha Tella, Nathan Foster, Shi Qian, Tran Nguyen, Mitesh J. Borad, Robert R. McWilliams, Steven R. Alberts, Wen Wee Ma, Sakti Chakrabarti, Briant Fruth, Jaclynn Wessling, Mindy Hartgers, Leslie Washburn, Martin E. Fernandez-Zapico, Tara L. Hogenson, Henry Pitot, Zhaohui Jin, Amit Mahipal
Summary: This study investigated the safety and efficacy of trifluridine/tipiracil in combination with irinotecan for refractory, advanced unresectable biliary tract carcinoma. The combination treatment showed promising results in terms of progression-free and overall survival. Adverse events were observed, but the genetic mutation status did not affect treatment response. Larger randomized trials are needed to confirm these findings.
Article
Oncology
Serena Zheng, Kanika Gupta, Piyush Goyal, Reiko Nakajima, Laure Michaud, Connie Lee Batlevi, Paul A. Hamlin, Steven Horwitz, Anita Kumar, Matthew J. Matasar, Alison J. Moskowitz, Craig H. Moskowitz, Ariela Noy, M. Lia Palomba, David J. Straus, Gottfried Von Keudell, Lorenzo Falchi, Joachim Yahalom, Andrew D. Zelenetz, Anas Younes, Gilles Salles, Heiko Schoeder, Erel Joffe
Summary: This study discusses the limitations of using interim PET for decision-making and prognosis in the frontline management of Hodgkin's lymphoma. It presents data suggesting that patients who continue treatment with ABVD despite not achieving a complete metabolic response on interim PET may have better outcomes than previously thought. The study also compares the performance of different methods for evaluating PET positivity. Overall, the results indicate that a subset of patients can continue ABVD treatment without a poor outcome, regardless of the criteria for PET2 positivity.
Letter
Biochemistry & Molecular Biology
Takayuki Yoshino, Qian Shi, Toshihiro Misumi, Hideaki Bando, Masashi Wakabayashi, Morteza Raeisi, Thierry Andre, Aimery de Gramont
Article
Oncology
Fang-Shu Ou, Daniel H. Ahn, Jesse G. Dixon, Axel Grothey, Yiyue Lou, Pashtoon M. Kasi, Joleen M. Hubbard, Eric Van Cutsem, Leonard B. Saltz, Hans-Joachim Schmoll, Richard M. Goldberg, Alan P. Venook, Paulo Hoff, Jean-Yves Douillard, J. Randolph Hecht, Herbert Hurwitz, Cornelis J. A. Punt, Miriam Koopman, Carsten Bokemeyer, Charles S. Fuchs, Eduardo Diaz-Rubio, Niall C. Tebbutt, Chiara Cremolini, Fairooz F. Kabbinavar, Tanios Bekaii-Saab, Benoist Chibaudel, Takayuki Yoshino, John Zalcberg, Richard A. Adams, Aimery de Gramont, Qian Shi
Summary: Metastatic colorectal cancer (mCRC) is a complex disease that can exhibit different responses to treatment in different lesions within the same patient. The current response evaluation criteria (RECIST) do not account for this heterogeneity. This study developed lesion-based response criteria and found that they had a prognostic effect on overall survival (OS), suggesting their potential importance in treatment decision-making and patient outcomes. Overall, the study highlights the need for more comprehensive and personalized assessment tools for mCRC.
Article
Hematology
Veit Buecklein, Ariel Perez, Kai Rejeski, Gloria Iacoboni, Vindi Jurinovic, Udo Holtick, Olaf Penack, Soraya Kharboutli, Viktoria Blumenberg, Josephine Ackermann, Lisa Froelich, Grace Johnson, Kedar Patel, Brian Arciola, Rahul Mhaskar, Anthony Wood, Christian Schmidt, Omar Albanyan, Philipp Goedel, Eva Hoster, Lars Bullinger, Andreas Mackensen, Frederick Locke, Michael von Bergwelt, Pere Barba, Marion Subklewe, Michael D. Jain
Summary: Real-world evidence shows that patients receiving CD19 chimeric antigen receptor (CAR) T-cell therapy in Europe and with tisagenlecleucel have inferior survival outcomes. The reasons for these discrepancies are poorly understood.
Article
Hematology
Veit Buecklein, Ariel Perez, Kai Rejeski, Gloria Iacoboni, Vindi Jurinovic, Udo Holtick, Olaf Penack, Soraya Kharboutli, Viktoria Blumenberg, Josephine Ackermann, Lisa Froelich, Grace Johnson, Kedar Patel, Brian Arciola, Rahul Mhaskar, Anthony Wood, Christian Schmidt, Omar Albanyan, Philipp Goedel, Eva Hoster, Lars Bullinger, Andreas Mackensen, Frederick Locke, Michael Von Bergwelt, Pere Barba, Marion Subklewe, Michael D. Jain
Summary: Real-world evidence shows that patients receiving CD19 chimeric antigen receptor (CAR) T-cell therapy in Europe and with tisagenlecleucel have lower survival rates. The reasons for these discrepancies, including logistic and patient-and disease-related factors, are not well understood.