| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Ann Thorac Surg 1999;68:2-3
© 1999 The Society of Thoracic Surgeons
a Thoracic Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA
Address reprint requests to Dr Rusch, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, Rm C-867, New York, NY 10021
e-mail: ruschv{at}mskcc.org
The article by Dr Krasna and colleagues in this issue of The Annals [1], describing surgical guidelines in Cancer and Leukemia Group B lung cancer trials addresses many topics, including the importance of careful staging and the need for a standard approach to preoperative evaluation and pulmonary resection. The authors present an algorithm by which patients with non–small cell lung cancer can be entered into clinical trials according to tumor stage. They also allude to efforts to increase the number of patients entered on trials and to fostering collaboration across the cooperative groups.
It is helpful to place this review in a broader historic context. The importance of codifying standards for staging and resection in cooperative group trials is well recognized. The Gynecologic Oncology Group, for example, has had such guidelines for many years. The Lung Cancer Study Group developed guidelines for preoperative evaluation, staging, and resection for thoracic malignancies, which were subsequently revised and published as a Thoracic Surgical Handbook for Clinical Trials [2]. However, when funding by the National Cancer Institute for the Lung Cancer Study Group was discontinued in 1989, thoracic surgical expertise diffused into the larger cooperative groups that study a broad spectrum of malignancies. These groups, which include the Cancer and Leukemia Group B, the Eastern Cooperative Oncology Group, the North Central Cancer Therapy Group, the Radiation Therapy Oncology Group, and the Southwest Oncology Group, are dominated by medical and radiation oncologists and focus their efforts on the treatment of hematologic malignancies and advanced inoperable solid tumors [3, 4]. During the past decade, thoracic surgeons have worked hard to develop a presence in each of these groups, to redefine surgical guidelines, and to collaborate on intergroup trials [5]. The guidelines established by the Cancer and Leukemia Group B represent an updated version of the Lung Cancer Study Group’s handbook and are very similar to those used in the eligibility and surgical treatment sections of other cooperative group trials. In the future, formal acceptance of a single set of such guidelines across all of the cooperative groups would facilitate protocol development.
In spite of the efforts of thoracic surgeons in various cooperative groups, many deficits remain. The proportion of eligible patients being entered on trials remains small. For example, approximately 30,000 patients per year have stage III non–small cell lung cancer at diagnosis, yet only 60 to 70 patients per year have been enrolled in the single most important trial (intergroup 0139) for this group of patients. There are many factors responsible for the low accrual rate to important trials such as intergroup 0139, but chief among these are surgeon awareness and interest, easy universal access to clinical trials, and financial and practical support of surgical investigators. Solutions to these problems must be sought. To ensure success as we enter the next millennium, these solutions must be innovative and broad-ranging.
The awareness and interest of surgeons in clinical trials will only increase if this becomes an intrinsic part of surgical education and practice from the moment physicians enter general surgical residency. In this regard, the recently funded American College of Surgeons Oncology Group has the greatest opportunity of shifting the paradigm of surgical education [6]. This can occur through the development of surgical trials in every subspecialty and the development of educational programs relating to clinical trials at annual college meetings. As suggested by Dr Krasna, the American College of Surgeons Oncology Group has the opportunity for improving access to key multidisciplinary clinical trials, in addition to sponsoring trials that ask purely surgical questions. Funding for data management for the American College of Surgeons Oncology Group trials will occur on a capitation basis, enabling surgeons who enter large numbers of patients to be reimbursed directly and appropriately for their efforts. This is not currently the case for surgeons in many of the cooperative groups, in which the funding is distributed through institutional grant applications to investigators who are usually medical or radiation oncologists.
During the past few years, the National Cancer Institute has undertaken a comprehensive review of the clinical trials program to define ways in which trials could be performed more rapidly and efficiently. To this end, new initiatives include developing a "concept evaluation panel," similar in design to the traditional National Institutes of Health study section, that would score proposals for new trials so that the most scientifically meritorious protocols can be performed rapidly through an intergroup mechanism, rather than as slowly accruing, competing trials in individual groups. In addition, the National Cancer Institute is considering an "open menu" of clinical trials that would be available to all qualified physicians across the United States, even if they are not members of the cooperative groups. Patients could be entered through a central data managementsystem located at the National Cancer Institute. Finally, the National Cancer Institute is focusing on unifying and streamlining data forms, toxicity coding, and grant application and cooperative group review.
The efforts of Cancer and Leukemia Group B thoracic surgeons, described by Dr Krasna and his colleagues, are commendable. They are part of a broader historic effort by thoracic surgeons that fortunately will be expanded by large national initiatives now under way, which will change how clinical trials are performed. In an era when thoracic surgeons are increasingly constrained by administrative demands and decreasing reimbursement rates, such national efforts are critical to the future of clinical trials, which in turn are essential to solving the clinical problems that affect the well-being of our patients.
References
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| ANN THORAC SURG | ASIAN CARDIOVASC THORAC ANN | EUR J CARDIOTHORAC SURG |
| J THORAC CARDIOVASC SURG | ICVTS | ALL CTSNet JOURNALS |
