REVIEWS
“[M]eticulously researched and precisely written. . . . Keating and Cambrosio’s incredibly detailed and technical account of the development of medical oncology in the United States and Europe is written for historians of science and medicine as well as for the oncology community. Scholars in these fields will recognize this book as an important addition to the literature on clinical trials, biomedicine, and technology studies.”
— Rebecca M. Kluchin, California State University, Sacramento, American Historical Review
“Keating and Cambrosio have made a major contribution to this area and scholars of any stripe working on cancer or biomedicine, and even the further-flung fields of statistics and molecular biology, will benefit from reckoning with its insights.”
— Robin Wolfe Scheffler, Yale University, Medical History
“Cancer on Trial is a substantial contribution to our historical and sociological understanding of clinical cancer research and is highly recommended for anyone interested in the actual emergence of bioscience in clinical settings. This excellent book treats the meteoric rise of cancer research and treatment across the globe since the mid-twentieth century by focusing explicitly on transnational cooperative clinical trials as the hub through which oncology emerged as a new form of medical and scientific practice.”
— Stephen Pemberton, Metascience
“Cancer on Trial is a landmark study in historical and social studies of clinical research. Keating and Cambrosio brilliantly analyze the apparatus through which oncology trials are conducted. Through detailed examinations of specific trials in three periods, they show how tightly coupled epistemic, institutional, and technical changes constituted a new form of clinical research practice. This carefully argued and meticulously documented book will be immensely interesting not only to scholars in science and technology studies, but also to cancer researchers interested in the origins of their experimental practices.”
— Stephen Hilgartner, Cornell University
“This innovative book is more than a history of cancer research and clinical trials in the twentieth century, it’s a history of contemporary biomedicine all together. Whereas most previous scholarly accounts have placed the laboratory at center stage, Cancer on Trial finally gives the clinic the attention it deserves. Clinical trials might seem less glamorous than ‘eureka moments’ in the laboratory, but they are certainly more representative of the workings of today’s biomedical research. By focusing on cancer clinical trials as a ‘style of practice,’ rather than as the routine testing of new treatments, Keating and Cambrosio show compellingly how biomedicine has evolved into a specific kind of research enterprise redefining at the same time treatments, diseases, patients, and researchers. Cancer on Trial offers to its readers powerful intellectual tools to understand current debates about the successes and failures of cancer therapies, the role of public and private research, and the promises and perils of personalized medicine. Anyone interested in current biomedical research will benefit immensely from reading this book.”
— Bruno J. Strasser, University of Geneva and Yale University
“This remarkable book charts the emergence of a clinical field—medical oncology—for which experimental protocols have become routinized as a form of normal practice. Cancer on Trial will make a lasting contribution to the sociology of scientific knowledge, the history of clinical practice, and the understanding of the networked basis of biomedical research.”
— Jeremy A. Greene, Harvard University
“Today’s cancer patient inhabits a bewildering chemo-world of trials and protocols, risks and probabilities, toxic chemicals and noxious side effects. What brought this new world into being? With a powerful grasp of historical and technical detail, Keating and Cambrosio tell the important story of the rise of the organizational forms of modern ‘oncopolitics,’ and they deftly capture the unique character of a new style of scientific practice.”
— Steven Epstein, Northwestern University
TABLE OF CONTENTS
Foreword
Acknowledgments
Introduction
From “Nonentity” to Global Network - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0010
[cancer treatment research, Pierre Band, clinical cancer research, ECOG, EORTC, clinical trials, cancer therapy]
This chapter discusses the rise of cancer treatment research. It begins by discussing Dr. Pierre Band's career as a chemotherapist and a cancer clinical trial specialist. It then describes briefly the growth of clinical cancer research and the establishment of institutions such as the Eastern Cooperative Oncology Group (ECOG) and the European Organization for Research and Treatment of Cancer (EORTC). The chapter also provides a historical background of cancer clinical trials and the institutions that performed them. Finally, the chapter provides background information of the field of cancer therapy prior to the emergence of clinical cancer research. (pages 3 - 32)
This chapter is available at:
https://academic.oup.com/chica...
prelude Before There Were Trials - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0018
This chapter is available at:
https://academic.oup.com/chica...
Part 1: The Emergence of Clinical Cancer Research (1955–66)
A Landmark Clinical Trial - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0039
[VAMP trial, anticancer drugs, acute lymphocytic leukemia, vincristine, amethopterin, mercaptopurine, prednisone]
This chapter discusses the VAMP trial, the clinical trial to test a combination of anticancer drugs on children with acute lymphocytic leukemia (ALL). Four different drugs with different mechanisms of action were used: vincristine (V), amethopterin (A), mercaptopurine (M) and prednisone (P). The results of the VAMP protocol were quite spectacular. Of the sixteen patients treated, thirteen achieved complete remission. (pages 55 - 83)
This chapter is available at:
https://academic.oup.com/chica...
The Collective Turn - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0053
[cooperative program, NCI, cooperative research, CCNSC, CALGB, ECOG, Surgery-Adjuvant-Lung Group]
This chapter provides an overview of the groups established by the cooperative program between 1955 and the mid-1970s. It visualizes the rise and decline of numerous groups bearing witness to the NCI's continued experimentation with different forms of cooperative research. It also describes the establishment of the US Cancer Chemotherapy National Service Center (CCNSC). The chapter also identifies three categories of cooperative group research: Cancer and Leukemia Group B (CALGB), Eastern Cooperative Oncology Group (ECOG) and Surgery-Adjuvant-Lung Group. The chapter ends by discussing the notion of a random sample and the concept of statistical significance. (pages 85 - 116)
This chapter is available at:
https://academic.oup.com/chica...
first interlude Clinical Trial Statistics - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0063
This chapter is available at:
https://academic.oup.com/chica...
Statisticians, Statistics, and Early Cooperative Clinical Trials - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0069
[statisticians, NIH, CCNSC, clinical trials, National Hygiene Institute, Gustave-Roussy Institute, sequential analysis, phase system]
This chapter discusses the statisticians at the NIH and their role in the establishment of the different components of the Cancer Chemotherapy National Service Center (CCNSC). It also discusses the French statistical approach to clinical trials at the National Hygiene Institute and the Gustave-Roussy Institute. The development of the sequential analysis and the phase system is also examined. (pages 133 - 159)
This chapter is available at:
https://academic.oup.com/chica...
Criticism and the Redefinition of Clinical Cancer Trials as an Autonomous Form of Research - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0080
[clinical trials, CCNSC, clinical research, screening, cooperative cancer research, surgery, radiotherapy, clinical cancer research]
This chapter discusses how clinical cancer trials ceased to be seen as a mere extension of the Cancer Chemotherapy National Service Center (CCNSC) and became an autonomous form of clinical research. First, it discusses the reorganization of screening and clinical trials in the United States. It also discusses the emergence of cooperative cancer research and then examines how surgery and radiotherapy participated in clinical cancer research. (pages 161 - 184)
This chapter is available at:
https://academic.oup.com/chica...
Part 2: An Avalanche of Numbers from the New Style of Practice (1965–89)
A Web of Trials - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0090
[breast cancer trials, ECOG 0971, ECOG/NSABP B-05, breast cancer, combination therapy, chemotherapeutic substances]
This chapter examines the relationships between clinical trials such as ECOG 0971, ECOG/NSABP B-05 and other breast cancer protocols. It also discusses some of the techniques that analyze censored data and estimate the survival times for all patients in the breast cancer trials. The chapter also discusses combination therapy or the use of combinations of chemotherapeutic substances in the treatment of advanced breast cancer. (pages 187 - 210)
This chapter is available at:
https://academic.oup.com/chica...
Statisticians, Data Centers, and the Organization of Large-Scale Clinical Trials - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0102
[data centers, statisticians, data managers, cooperative oncology groups, clinical cancer trials, multicenter trials, computerized techniques]
This chapter examines data centers, statisticians, data managers, and collaborators within cooperative oncology groups who took over the management of clinical trials and their results. It also discusses the applications of statistics in clinical cancer trials, the design of multicenter trials, the stratification of treatment randomization by institutions, the advent of computerized techniques, and the introduction of organizational innovations by statisticians. (pages 211 - 246)
This chapter is available at:
https://academic.oup.com/chica...
A Relational Space of Substances and Regimens - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0113
[clinical trials, Phase III, drugs, chemotherapeutic substances, anticancer drugs, animals]
This chapter discusses the clinical trials from the 1970s to the 1990s, a period dominated by large Phase III clinical trials that compared numerous combinations of a small number of drugs. It begins by discussing the nature of chemotherapeutic substances, taking into account their clinical use. It shows a number of articles listed in PubMed that reported the results of clinical trials using a number of anticancer drugs. The chapter also discusses the screening of the chemotherapeutic substances in animals. (pages 247 - 276)
This chapter is available at:
https://academic.oup.com/chica...
Oncopolitics? Reshaping Collaborative Research - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0127
[cooperative oncology groups, Cancer Therapy Evaluation Program, Division of Cancer Treatment, cooperative group]
This chapter focuses on the debates concerning the relations between the US cooperative oncology groups and the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment (DCT). It also describes the emergence of an autonomous form of research when the cooperative group program was implicitly recognized as an independent research enterprise. (pages 277 - 300)
This chapter is available at:
https://academic.oup.com/chica...
Part 3: Targeted Therapy, Targeted Trials (1990–2006)
second interlude Molecular Biology and Oncogenes - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0136
This chapter is available at:
https://academic.oup.com/chica...
Magic Bullets? The Gleevec Trials - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0144
[clinical trials, Gleevec, imatinib, targeted cancer therapies, chronic myelogenous leukemia]
This chapter discusses the series of clinical trials conducted between 1998 and 2001 to test the efficacy of a compound known as Gleevec. Gleevec (imatinib), one of the first targeted cancer therapies to gain FDA approval, has revolutionized the treatment of chronic myelogenous leukemia. (pages 315 - 346)
This chapter is available at:
https://academic.oup.com/chica...
Targeted Therapy and Clinical Cancer Research - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0154
[oncogenes, clinical cancer trials, molecular biology, cooperative groups, National Cancer Institute, target therapy, OODP]
This chapter discusses the major turning points in the clinical trial process and examines the consequences of the oncogene revolution for the conduct of clinical cancer trials. It begins with the introduction of molecular biology into the US cooperative groups. The reorganization of the drug discovery process and the transformation of the National Cancer Institute (NCI) screen are then discussed. This is followed by a discussion on the redesigning of clinical trials and how target therapy is changing clinical cancer trials as a system. Finally, the chapter discusses the establishment of the Office of Oncology Drug Products (OODP). (pages 347 - 370)
This chapter is available at:
https://academic.oup.com/chica...
Conclusion
Looking Back and Looking Forward - Peter Keating, Alberto Cambrosio
DOI: 10.7208/chicago/9780226428932.003.0163
[molecular practices, comparative effectiveness research, clinical cancer trials, health technology assessment, medicine, medical decision-making]
This concluding chapter discusses the evolution of the new style of practice, for instance, its incorporation of molecular practices via comparative effectiveness research (CER). It considers the observational alternative to clinical cancer trials and the current interest in CER. CER involves a set of technologies that include health technology assessment, evidence-based medicine, and clinical guidelines designed to evaluate competing medical interventions and guide medical decision-making. (pages 373 - 382)
This chapter is available at:
https://academic.oup.com/chica...
References
Index
