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Article ; Online: Is local review of positron emission tomography scans sufficient in diffuse large B-cell lymphoma clinical trials? A CALGB 50303 analysis.

Torka, Pallawi / Pederson, Levi D / Knopp, Michael V / Poon, David / Zhang, Jun / Kahl, Brad S / Higley, Howard R / Kelloff, Gary / Friedberg, Jonathan W / Schwartz, Lawrence H / Wilson, Wyndham H / Leonard, John P / Bartlett, Nancy L / Schöder, Heiko / Ruppert, Amy S

Cancer medicine

2023 Volume 12, Issue 7, Page(s) 8211–8217

Abstract: Background: Quantitative methods of Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) interpretation, including the percent change in FDG uptake from baseline (ΔSUV), are under investigation in lymphoma to overcome challenges associated with ... ...

Abstract	Background: Quantitative methods of Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) interpretation, including the percent change in FDG uptake from baseline (ΔSUV), are under investigation in lymphoma to overcome challenges associated with visual scoring systems (VSS) such as the Deauville 5-point scale (5-PS). Methods: In CALGB 50303, patients with DLBCL received frontline R-CHOP or DA-EPOCH-R, and although there were no significant associations between interim PET responses assessed centrally after cycle 2 (iPET) using 5-PS with progression-free survival (PFS) or overall survival (OS), there were significant associations between central determinations of iPET ∆SUV with PFS/OS. In this patient cohort, we retrospectively compared local vs central iPET readings and evaluated associations between local imaging data and survival outcomes. Results: Agreement between local and central review was moderate (kappa = 0.53) for VSS and high (kappa = 0.81) for ∆SUV categories (<66% vs. ≥66%). ∆SUV ≥66% at iPET was significantly associated with PFS (p = 0.03) and OS (p = 0.002), but VSS was not. Associations with PFS/OS when applying local review vs central review were comparable. Conclusions: These data suggest that local PET interpretation for response determination may be acceptable in clinical trials. Our findings also highlight limitations of VSS and call for incorporation of more objective measures of response assessment in clinical trials.
MeSH term(s)	Humans ; Fluorodeoxyglucose F18 ; Retrospective Studies ; Disease-Free Survival ; Positron-Emission Tomography/methods ; Lymphoma, Large B-Cell, Diffuse/diagnostic imaging ; Lymphoma, Large B-Cell, Diffuse/drug therapy ; Prognosis
Chemical Substances	Fluorodeoxyglucose F18 (0Z5B2CJX4D)
Language	English
Publishing date	2023-02-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2659751-2
ISSN	2045-7634 ; 2045-7634
ISSN (online)	2045-7634
ISSN	2045-7634
DOI	10.1002/cam4.5628
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Article: Perspectives on cancer chemoprevention research and drug development.

Kelloff, G J

Advances in cancer research

2000 Volume 78, Page(s) 199–334

MeSH term(s)	Animals ; Anti-Inflammatory Agents/pharmacology ; Anticarcinogenic Agents/pharmacology ; Anticarcinogenic Agents/therapeutic use ; Antioxidants/pharmacology ; Aromatase Inhibitors ; Clinical Trials as Topic ; ErbB Receptors/antagonists & inhibitors ; Estrogen Receptor Modulators/pharmacology ; Genes, ras ; Humans ; Neoplasms/etiology ; Neoplasms/prevention & control ; Protein Prenylation ; Retinoids/pharmacology ; Signal Transduction/drug effects
Chemical Substances	Anti-Inflammatory Agents ; Anticarcinogenic Agents ; Antioxidants ; Aromatase Inhibitors ; Estrogen Receptor Modulators ; Retinoids ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2000
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	127-2
ISSN	2162-5557 ; 0065-230X
ISSN (online)	2162-5557
ISSN	0065-230X
DOI	10.1016/s0065-230x(08)61026-x
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Article: Modulation of alterations in p53 tumor suppressor gene and its association with activation of ras proto-oncogenes during chemoprevention of colon cancer.

Singh, J / Kelloff, G / Reddy, B

International journal of oncology

2011 Volume 10, Issue 3, Page(s) 449–456

Abstract: Previously, we reported (Carcinogenesis 15: 1317-1323, 1994) a high rate of activating point mutations in I ns proto-oncogenes in azoxymethane (AOM)-induced colon tumors, and a significant suppression of these mutations by dietary administration of ... ...

Abstract	Previously, we reported (Carcinogenesis 15: 1317-1323, 1994) a high rate of activating point mutations in I ns proto-oncogenes in azoxymethane (AOM)-induced colon tumors, and a significant suppression of these mutations by dietary administration of chemopreventive agents, D,L-alpha-difluoromethylornithine (DFMO) and piroxicam. To understand the role of p53 tumor suppressor gene in chemoprevention of colon cancer and to study the association of p53 gene alterations with activation of ras genes, we determined point mutations in conserved regions (exons 5-9) of p53 gene and analyzed the occurrence of double event of ms activation acid p53 mutation. Groups of male F344 rats were fed the modified AIN-76A diet containing 0, 4000 ppm DFMO, or 150 ppm piroxicam and administered s.c. AOM at a dose rate of 15 mg/kg body wt, once weekly, for 4 weeks. Vehicle controls received s.c. equal volume of normal saline. Animals were sacrificed 32 weeks after the last AOM or saline injection and their grossly visible colon tumors were analyzed to determine p53 mutations by PCR amplification based single strand conformation polymorphism (SSCP) and direct DNA sequencing. Our results demonstrate that about 57% tumors from animals fed the control diet contained predominantly missense but also nonsense mutations, whereas only 30% tumors from animals on piroxicam diet, and none (0%) from animals fed the DFMO diet had similar mutations. Analysis of data revealed that about half of the tumors from animals on control diet possessed both ms and p53 mutations together, only 27% of colon tumors from animals on piroxicam diet and none of the tumors from animals on DFMO diet exhibited both ms and p53 mutations. These results indicate that the administration of piroxicam, a non-steroidal anti-inflammatory drug, and DFMO, a irreversible inhibitor of ornithine decarboxylase, may inhibit selective proliferation of initiated cells containing activated las and/or mutant p53. Dietary DFMO exerted more pronounced inhibition of selective amplification of initiated cells containing mutated ras and/or p53.
Language	English
Publishing date	2011-05-02
Publishing country	Greece
Document type	Journal Article
ZDB-ID	1154403-x
ISSN	1019-6439
ISSN	1019-6439
DOI	10.3892/ijo.10.3.449
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Zs.A 3690: Show issues

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Article ; Online: State of the Science and Future Directions for Liquid Biopsies in Drug Development.

Narayan, Preeti / Ghosh, Soma / Philip, Reena / Barrett, J Carl / McCormack, Robert T / Odegaard, Justin I / R Oxnard, Geoffrey / Pracht, Laurel J / Williams, P Mickey / Kelloff, Gary J / Beaver, Julia A

The oncologist

2020 Volume 25, Issue 9, Page(s) 730–732

MeSH term(s)	Biomarkers, Tumor ; Drug Development ; Humans ; Liquid Biopsy
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2020-06-29
Publishing country	United States
Document type	Editorial
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2020-0246
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 494: Show issues

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Article ; Online: Case Studies for Overcoming Challenges in Using Big Data in Cancer.

Sweeney, Shawn M / Hamadeh, Hisham K / Abrams, Natalie / Adam, Stacey J / Brenner, Sara / Connors, Dana E / Davis, Gerard J / Fiore, Louis D / Gawel, Susan H / Grossman, Robert L / Hanlon, Sean E / Hsu, Karl / Kelloff, Gary J / Kirsch, Ilan R / Louv, Bill / McGraw, Deven / Meng, Frank / Milgram, Daniel / Miller, Robert S /

Morgan, Emily / Mukundan, Lata / O'Brien, Thomas / Robbins, Paul / Rubin, Eric H / Rubinstein, Wendy S / Salmi, Liz / Schaller, Teilo H / Shi, George / Sigman, Caroline C / Srivastava, Sudhir

Cancer research

2023 Volume 83, Issue 8, Page(s) 1183–1190

Abstract: The analysis of big healthcare data has enormous potential as a tool for advancing oncology drug development and patient treatment, particularly in the context of precision medicine. However, there are challenges in organizing, sharing, integrating, and ... ...

Abstract	The analysis of big healthcare data has enormous potential as a tool for advancing oncology drug development and patient treatment, particularly in the context of precision medicine. However, there are challenges in organizing, sharing, integrating, and making these data readily accessible to the research community. This review presents five case studies illustrating various successful approaches to addressing such challenges. These efforts are CancerLinQ, the American Association for Cancer Research Project GENIE, Project Data Sphere, the National Cancer Institute Genomic Data Commons, and the Veterans Health Administration Clinical Data Initiative. Critical factors in the development of these systems include attention to the use of robust pipelines for data aggregation, common data models, data deidentification to enable multiple uses, integration of data collection into physician workflows, terminology standardization and attention to interoperability, extensive quality assurance and quality control activity, incorporation of multiple data types, and understanding how data resources can be best applied. By describing some of the emerging resources, we hope to inspire consideration of the secondary use of such data at the earliest possible step to ensure the proper sharing of data in order to generate insights that advance the understanding and the treatment of cancer.
MeSH term(s)	Humans ; United States/epidemiology ; Big Data ; Neoplasms/genetics ; Neoplasms/therapy ; Medical Oncology ; Delivery of Health Care
Language	English
Publishing date	2023-01-06
Publishing country	United States
Document type	Review ; Journal Article
ZDB-ID	1432-1
ISSN	1538-7445 ; 0008-5472
ISSN (online)	1538-7445
ISSN	0008-5472
DOI	10.1158/0008-5472.CAN-22-1277
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Article ; Online: Vol-PACT: A Foundation for the NIH Public-Private Partnership That Supports Sharing of Clinical Trial Data for the Development of Improved Imaging Biomarkers in Oncology.

Dercle, Laurent / Connors, Dana E / Tang, Ying / Adam, Stacey J / Gönen, Mithat / Hilden, Patrick / Karovic, Sanja / Maitland, Michael / Moskowitz, Chaya S / Kelloff, Gary / Zhao, Binsheng / Oxnard, Geoffrey R / Schwartz, Lawrence H

JCO clinical cancer informatics

2019 Volume 2, Page(s) 1–12

Abstract: Purpose: To develop a public-private partnership to study the feasibility of a new approach in collecting and analyzing clinically annotated imaging data from landmark phase III trials in advanced solid tumors.: Patients and methods: The collection ... ...

Abstract	Purpose: To develop a public-private partnership to study the feasibility of a new approach in collecting and analyzing clinically annotated imaging data from landmark phase III trials in advanced solid tumors. Patients and methods: The collection of clinical trials fulfilled the following inclusion criteria: completed randomized trials of > 300 patients, highly measurable solid tumors (non-small-cell lung cancer, colorectal cancer, renal cell cancer, and melanoma), and required sponsor and institutional review board sign-offs. The new approach in analyzing computed tomography scans was to transfer to an academic image analysis laboratory, draw contours semi-automatically by using in-house-developed algorithms integrated into the open source imaging platform Weasis, and perform serial volumetric measurement. Results: The median duration of contracting with five sponsors was 12 months. Ten trials in 7,085 patients that covered 12 treatment regimens across 20 trial arms were collected. To date, four trials in 3,954 patients were analyzed. Source imaging data were transferred to the academic core from 97% of trial patients (n = 3,837). Tumor imaging measurements were extracted from 82% of transferred computed tomography scans (n = 3,162). Causes of extraction failure were nonmeasurable disease (n = 392), single imaging time point (n = 224), and secondary captured images (n = 59). Overall, clinically annotated imaging data were extracted in 79% of patients (n = 3,055), and the primary trial end point analysis in each trial remained representative of each original trial end point. Conclusion: The sharing and analysis of source imaging data from large randomized trials is feasible and offer a rich and reusable, but largely untapped, resource for future research on novel trial-level response and progression imaging metrics.
MeSH term(s)	Algorithms ; Clinical Trials, Phase III as Topic ; Data Curation ; Disease Progression ; Endpoint Determination ; Feasibility Studies ; Female ; Humans ; Information Dissemination ; Male ; Neoplasms/diagnostic imaging ; Neoplasms/drug therapy ; Public-Private Sector Partnerships/organization & administration ; Radiographic Image Interpretation, Computer-Assisted ; Randomized Controlled Trials as Topic ; Tomography, X-Ray Computed/methods ; Treatment Outcome
Language	English
Publishing date	2019-01-16
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2473-4276
ISSN (online)	2473-4276
DOI	10.1200/CCI.17.00137
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Article ; Online: Enhanced Detection of Treatment Effects on Metastatic Colorectal Cancer with Volumetric CT Measurements for Tumor Burden Growth Rate Evaluation.

Maitland, Michael L / Wilkerson, Julia / Karovic, Sanja / Zhao, Binsheng / Flynn, Jessica / Zhou, Mengxi / Hilden, Patrick / Ahmed, Firas S / Dercle, Laurent / Moskowitz, Chaya S / Tang, Ying / Connors, Dana E / Adam, Stacey J / Kelloff, Gary / Gonen, Mithat / Fojo, Tito / Schwartz, Lawrence H / Oxnard, Geoffrey R

Clinical cancer research : an official journal of the American Association for Cancer Research

2020 Volume 26, Issue 24, Page(s) 6464–6474

Abstract: Purpose: Mathematical models combined with new imaging technologies could improve clinical oncology studies. To improve detection of therapeutic effect in patients with cancer, we assessed volumetric measurement of target lesions to estimate the rates ... ...

Abstract	Purpose: Mathematical models combined with new imaging technologies could improve clinical oncology studies. To improve detection of therapeutic effect in patients with cancer, we assessed volumetric measurement of target lesions to estimate the rates of exponential tumor growth and regression as treatment is administered. Experimental design: Two completed phase III trials were studied (988 patients) of aflibercept or panitumumab added to standard chemotherapy for advanced colorectal cancer. Retrospectively, radiologists performed semiautomated measurements of all metastatic lesions on CT images. Using exponential growth modeling, tumor regression ( Results: Exponential growth modeling of volumetric measurements detected different empiric mechanisms of effect for each drug: panitumumab marginally augmented the decay rate [tumor half-life; Conclusions: Combined tumor volume measurement and estimation of tumor regression and growth rate has potential to enhance assessment of treatment effects in clinical studies of colorectal cancer that would not be achieved with conventional, RECIST-based unidimensional measurements.
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Clinical Trials, Phase III as Topic/statistics & numerical data ; Colorectal Neoplasms/diagnostic imaging ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/pathology ; Cone-Beam Computed Tomography/methods ; Follow-Up Studies ; Humans ; Neoplasm Metastasis ; Prognosis ; Response Evaluation Criteria in Solid Tumors ; Retrospective Studies ; Survival Rate ; Tomography, X-Ray Computed/methods
Language	English
Publishing date	2020-09-28
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-20-1493
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Zs.A 4223: Show issues

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Article ; Online: International liquid biopsy standardization alliance white paper.

Connors, Dana / Allen, Jeff / Alvarez, J D / Boyle, Jennifer / Cristofanilli, Massimo / Hiller, Carolyn / Keating, Susan / Kelloff, Gary / Leiman, Lauren / McCormack, Robert / Merino, Diana / Morgan, Emily / Pantel, Klaus / Rolfo, Christian / Serrano, Maria Jose / Pia Sanzone, A / Schlange, Thomas / Sigman, Caroline / Stewart, Mark

Critical reviews in oncology/hematology

2020 Volume 156, Page(s) 103112

Abstract: The promise of precision medicine as a model to customize health care to the individual patient is heavily dependent upon new genetic tools to classify and characterize diseases and their hosts. Liquid biopsies serve as a safe alternative to solid ... ...

Abstract	The promise of precision medicine as a model to customize health care to the individual patient is heavily dependent upon new genetic tools to classify and characterize diseases and their hosts. Liquid biopsies serve as a safe alternative to solid biopsies and are thus a useful and critical component to fully realizing personalized medicine. The International Liquid Biopsy Standardization Alliance (ILSA) comprises organizations and foundations that recognize the importance of working towards the global use of liquid biopsy in oncology practice to support clinical decision making and regulatory considerations and seek to promote it in their communities. This manuscript provides an overview of the independent liquid biopsy- and standardization-based programs engaged with ILSA, their objectives and progress to date, and the tools and resources each is developing to contribute to the field. It also describes the unique areas of effort as well as synergy found within the group.
MeSH term(s)	Biomarkers, Tumor ; Biopsy ; Humans ; Liquid Biopsy ; Neoplastic Cells, Circulating ; Precision Medicine
Chemical Substances	Biomarkers, Tumor
Language	English
Publishing date	2020-09-30
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2020.103112
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Article: New science-based endpoints to accelerate oncology drug development.

Kelloff, Gary J / Sigman, Caroline C

European journal of cancer (Oxford, England : 1990)

2005 Volume 41, Issue 4, Page(s) 491–501

Abstract: ... direct visualisation by microscopy (e.g., confocal microscopy and computer-assisted image analysis ... of cellular features), nanotechnologies, and direct and remote imaging (e.g., fluorescence endoscopy and ...

Abstract	Although several new oncology drugs have reached the market, more than 80% of drugs for all indications entering clinical development do not get marketing approval, with many failing late in development often in Phase III trials, because of unexpected safety issues or difficulty determining efficacy, including confounded outcomes. These factors contribute to the high costs of oncology drug development and clearly show the need for faster, more cost-effective strategies for evaluating oncology drugs and better definition of patients who will benefit from treatment. Remarkable advances in the understanding of neoplastic progression at the cellular and molecular levels have spurred the discovery of molecularly targeted drugs. This progress along with advances in imaging and bioassay technologies are the basis for describing and evaluating new biomarker endpoints as well as for defining other biomarkers for identifying patient populations, potential toxicity, and providing evidence of drug effect and efficacy. Definitions and classifications of these biomarkers for use in oncology drug development are presented in this paper. Science-based and practical criteria for validating biomarkers have been developed including considerations of mechanistic plausibility, available methods and technology, and clinical feasibility. New promising tools for measuring biomarkers have also been developed and are based on genomics and proteomics, direct visualisation by microscopy (e.g., confocal microscopy and computer-assisted image analysis of cellular features), nanotechnologies, and direct and remote imaging (e.g., fluorescence endoscopy and anatomical, functional and molecular imaging techniques). The identification and evaluation of potential surrogate endpoints and other biomarkers require access to and analysis of large amounts of data, new technologies and extensive research resources. Further, there is a requirement for a convergence of research, regulatory and drug developer thinking - an effort that will not be accomplished by individual scientists or research institutions. Research collaborations are needed to foster development of these new endpoints and other biomarkers and, in the United States (US), include ongoing efforts among the Food and Drug Administration (FDA), National Cancer Institute (NCI), academia, and industry.
MeSH term(s)	Antineoplastic Agents/economics ; Antineoplastic Agents/therapeutic use ; Biomarkers, Tumor/analysis ; Costs and Cost Analysis ; Drug Design ; Forecasting ; Humans ; Neoplasms/drug therapy ; Prognosis
Chemical Substances	Antineoplastic Agents ; Biomarkers, Tumor
Language	English
Publishing date	2005-03
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	82061-1
ISSN	1879-0852 ; 0959-8049 ; 0277-5379 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0959-8049 ; 0277-5379 ; 0964-1947
DOI	10.1016/j.ejca.2004.12.006
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Zs.A 456: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Effects of dietary supplementation of N-acetylcysteine on cigarette smoke-related DNA adducts in rat tissues.

Arif, J / Gairola, C / Glauert, H / Kelloff, G / Lubet, R / Gupta, R

International journal of oncology

2011 Volume 11, Issue 6, Page(s) 1227–1233

Abstract: Cigarette smoking plays a major role in the etiology of several human cancers. It is believed that formation of DNA adducts is an initial step in the carcinogenic process. In this study, we have examined the ability of dietary N-acetylcysteine (NAG) to ... ...

Abstract	Cigarette smoking plays a major role in the etiology of several human cancers. It is believed that formation of DNA adducts is an initial step in the carcinogenic process. In this study, we have examined the ability of dietary N-acetylcysteine (NAG) to inhibit the formation of cigarette smoke-related DNA adducts in various tissues of rats. Female Sprague-Dawley rats were exposed to cigarette smoke (10 mg TPM/m(3)) in a whole-body exposure chamber for 6 h per day, seven days a week for four weeks. The smoke-exposed groups were provided either an unrefined diet or diets supplemented with low (5,000 ppm) or high (20,000 ppm) dose of NAG. A sham group was given control diet and maintained on filtered ambient air. Tissue DNA analysis of smoke-exposed rats by nuclease P1-version of the P-32-postlabeling assay showed up to 6 adducts in the following descending order expressed as total adducts/10(10) nucleotides: 1 predominant (no. 5) and 4 (no. 1-no. 4) minor adducts in the (219 +/- 36), 6 minor adducts in the heart (93 +/- 11), 5 adducts in the trachea (50 +/- 16), and 4 adducts in the bladder (50 +/- 3.5); sham-treated animals showed 2 or 3 adducts in each tissue but at 4-20-fold lower levels. Dietary intervention with either high or low dose of NAC did not affect the levels of most adducts, except for the following: a 30-40% increase (P<0.05) for adducts 3 and 4 in the lung; a 40-50% decrease (P<0.05) for adduct 2 in the trachea; and a 30% increase (P<0.05) for adduct 2 in the bladder. In a second experiment conducted under identical conditions, most major and minor adducts remained unaffected with NAC intervention, except for adduct 2 in the trachea which was somewhat diminished. These results suggest that dietary NAC intervention does not significantly influence the levels of most major and minor adducts. However, some minor adducts in the lung, trachea and bladder were modulated differentially.
Language	English
Publishing date	2011-04-28
Publishing country	Greece
Document type	Journal Article
ZDB-ID	1154403-x
ISSN	1019-6439
ISSN	1019-6439
DOI	10.3892/ijo.11.6.1227
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