More efficient clinical trials in pancreatic cancer: develop better treatment options, faster

被引:1
作者
Rosenzweig, Allison [1 ]
Moravek, Cassadie [1 ]
Matrisian, Lynn M. [1 ]
机构
[1] Pancreat Canc Action Network, Sci & Med Affairs, 1500 Rosecrans Ave,Suite 200, Manhattan Beach, CA 90266 USA
关键词
Pancreatic ductal adenocarcinoma; clinical trials; master protocols; platform trials; PHASE-III TRIAL; SOLID TUMORS; GEMCITABINE; SURVIVAL; FOLFIRINOX; THERAPIES; ERLOTINIB;
D O I
10.20517/2394-4722.2022.58
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Clinical development of new treatment options for patients with pancreatic cancer has been slow and expensive and resulted in few effective therapies. With a dismal five-year survival rate of 11% in the U.S., pancreatic cancer remains the third leading cause of cancer- related deaths and is poised to move to second by 2030. Standard clinical trials typically compare one investigational treatment to one standard of care, encompass one phase of clinical investigation at a time, and treat one patient population. Accrual and data analysis are often very slow, and unfortunately, the vast majority of clinical trials targeting pancreatic cancer patients are unsuccessful. More efficient clinical trial designs can include combining phases I and II or phases II and III, and trials that involve a master protocol approach can also answer multiple clinical questions simultaneously. These modern clinical trial designs can allow a faster, more efficient and cost-effective approach to testing investigational therapies in patients with pancreatic cancer and, most importantly, fewer patients may be required to determine the efficacy of treatment. Herein we summarize some of the recent innovative clinical trials in pancreatic cancer to provide meaningful data toward developing new treatment options to benefit patients with a dismal disease like pancreatic cancer.
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页数:9
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共 38 条
[1]   Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE [J].
Alexander, Brian M. ;
Ba, Sujuan ;
Berger, Mitchel S. ;
Berry, Donald A. ;
Cavenee, Webster K. ;
Chang, Susan M. ;
Cloughesy, Timothy F. ;
Jiang, Tao ;
Khasraw, Mustafa ;
Li, Wenbin ;
Mittman, Robert ;
Poste, George H. ;
Wen, Patrick Y. ;
Yung, W. K. Alfred ;
Barker, Anna D. .
CLINICAL CANCER RESEARCH, 2018, 24 (04) :737-743
[2]  
[Anonymous], 2021, FDA Grants Accelerated Approval for Alzheimer's Drug
[3]   Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial [J].
Aung, Kyaw L. ;
Fischer, Sandra E. ;
Denroche, Robert E. ;
Jang, Gun-Ho ;
Dodd, Anna ;
Creighton, Sean ;
Southwood, Bernadette ;
Liang, Sheng-Ben ;
Chadwick, Dianne ;
Zhang, Amy ;
O'Kane, Grainne M. ;
Albaba, Hamzeh ;
Moura, Shari ;
Grant, Robert C. ;
Miller, Jessica K. ;
Mbabaali, Faridah ;
Pasternack, Danielle ;
Lungu, Ilinca M. ;
Bartlett, John M. S. ;
Ghai, Sangeet ;
Lemire, Mathieu ;
Holter, Spring ;
Connor, Ashton A. ;
Moffitt, Richard A. ;
Yeh, Jen Jen ;
Timms, Lee ;
Krzyzanowski, Paul M. ;
Dhani, Neesha ;
Hedley, David ;
Notta, Faiyaz ;
Wilson, Julie M. ;
Moore, Malcolm J. ;
Gallinger, Steven ;
Knox, Jennifer J. .
CLINICAL CANCER RESEARCH, 2018, 24 (06) :1344-1354
[4]   I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy [J].
Barker, A. D. ;
Sigman, C. C. ;
Kelloff, G. J. ;
Hylton, N. M. ;
Berry, D. A. ;
Esserman, L. J. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 86 (01) :97-100
[5]   Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial [J].
Burris, HA ;
Moore, MJ ;
Andersen, J ;
Green, MR ;
Rothenberg, ML ;
Madiano, MR ;
Cripps, MC ;
Portenoy, RK ;
Storniolo, AM ;
Tarassoff, P ;
Nelson, R ;
Dorr, FA ;
Stephens, CD ;
VanHoff, DD .
JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (06) :2403-2413
[6]   Integrated Genomic Characterization of Pancreatic Ductal Adenocarcinoma [J].
Aguirre, Andrew J. ;
Hruban, Ralph H. ;
Raphael, Benjamin J. .
CANCER CELL, 2017, 32 (02) :185-+
[7]   Transcription phenotypes of pancreatic cancer are driven by genomic events during tumor evolution [J].
Chan-Seng-Yue, Michelle ;
Kim, Jaeseung C. ;
Wilson, Gavin W. ;
Ng, Karen ;
Figueroa, Eugenia Flores ;
O'Kane, Grainne M. ;
Connor, Ashton A. ;
Denroche, Robert E. ;
Grant, Robert C. ;
McLeod, Jessica ;
Wilson, Julie M. ;
Jang, Gun Ho ;
Zhang, Amy ;
Liang, Sheng-Ben ;
Borgida, Ayelet ;
Chadwick, Dianne ;
Kalimuthu, Sangeetha ;
Lungu, Ilinca ;
Bartlett, John M. S. ;
Krzyzanowski, Paul M. ;
Sandhu, Vandana ;
Tiriac, Herve ;
Froeling, Fieke E. M. ;
Karasinska, Joanna M. ;
Topham, James T. ;
Renouf, Daniel J. ;
Schaeffer, David F. ;
Jones, Steven J. M. ;
Marra, Marco A. ;
Laskin, Janessa ;
Chetty, Runjan ;
Stein, Lincoln D. ;
Zogopoulos, George ;
Haibe-Kains, Benjamin ;
Campbell, Peter J. ;
Tuveson, David A. ;
Knox, Jennifer J. ;
Fischer, Sandra E. ;
Gallinger, Steven ;
Notta, Faiyaz .
NATURE GENETICS, 2020, 52 (02) :231-+
[8]   FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer [J].
Conroy, T. ;
Hammel, P. ;
Hebbar, M. ;
Ben Abdelghani, M. ;
Wei, A. C. ;
Raoul, J. -L. ;
Chone, L. ;
Francois, E. ;
Artru, P. ;
Biagi, J. J. ;
Lecomte, T. ;
Assenat, E. ;
Faroux, R. ;
Ychou, M. ;
Volet, J. ;
Sauvanet, A. ;
Breysacher, G. ;
Di Fiore, F. ;
Cripps, C. ;
Kavan, P. ;
Texereau, P. ;
Bouhier-Leporrier, K. ;
Khemissa-Akouz, F. ;
Legoux, J. -L. ;
Juzyna, B. ;
Gourgou, S. ;
O'Callaghan, C. J. ;
Jouffroy-Zeller, C. ;
Rat, P. ;
Malka, D. ;
Castan, F. ;
Bachet, J. -B. .
NEW ENGLAND JOURNAL OF MEDICINE, 2018, 379 (25) :2395-2406
[9]   FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer [J].
Conroy, Thierry ;
Desseigne, Francoise ;
Ychou, Marc ;
Bouche, Olivier ;
Guimbaud, Rosine ;
Becouarn, Yves ;
Adenis, Antoine ;
Raoul, Jean-Luc ;
Gourgou-Bourgade, Sophie ;
de la Fouchardiere, Christelle ;
Bennouna, Jaafar ;
Bachet, Jean-Baptiste ;
Khemissa-Akouz, Faiza ;
Pere-Verge, Denis ;
Delbaldo, Catherine ;
Assenat, Eric ;
Chauffert, Bruno ;
Michel, Pierre ;
Montoto-Grillot, Christine ;
Ducreux, Michel .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (19) :1817-1825
[10]   Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials [J].
Doebele, Robert C. ;
Drilon, Alexander ;
Paz-Ares, Luis ;
Siena, Salvatore ;
Shaw, Alice T. ;
Farago, Anna F. ;
Blakely, Collin M. ;
Seto, Takashi ;
Cho, Byung Chul ;
Tosi, Diego ;
Besse, Benjamin ;
Chawla, Sant P. ;
Bazhenova, Lyudmila ;
Krauss, John C. ;
Chae, Young Kwang ;
Barve, Minal ;
Garrido-Laguna, Ignacio ;
Liu, Stephen V. ;
Conkling, Paul ;
John, Thomas ;
Fakih, Marwan ;
Sigal, Darren ;
Loong, Herbert H. ;
Buchschacher, Gary L., Jr. ;
Garrido, Pilar ;
Nieva, Jorge ;
Steuer, Conor ;
Overbeck, Tobias R. ;
Bowles, Daniel W. ;
Fox, Elizabeth ;
Riehl, Todd ;
Chow-Maneval, Edna ;
Simmons, Brian ;
Cui, Na ;
Johnson, Ann ;
Eng, Susan ;
Wilson, Timothy R. ;
Demetri, George D. .
LANCET ONCOLOGY, 2020, 21 (02) :271-282