Clinical trials provide patients and their physicians with an opportunity to advance the science and treatment options for cancer patients. Accrual is critically important to the success of clinical trials, as slow accrual can lead to closure of the trials and, subsequently, failure to answer important clinical questions. As funding decreases, appropriate accrual is a key element in the success of open trials. Most cancer care is provided in community-based settings; therefore, it is imperative that community cancer centers participate in national clinical trials, and engagement of community cancer surgeons does make a critical difference.
The Alliance for Clinical Trials in Oncology group formed from the merger of the Cancer and Leukemia Group B, the American College of Surgeons Oncology Group, and the North Central Cancer Treatment Group. The Alliance is composed of 137 member networks; 73 are community cancer programs, and 64 are academic institutions. The Alliance includes both community and academic programs that participate in patient enrollment. Even programs that are not members of the Alliance can enroll patients through the Cancer Trials Support Unit (CTSU).
Thomas L. Bauer, Sr., MD, FACS, a co-author of this month’s column, is an example of a community surgeon who has been successful in enrolling patients into national clinical trials. He acknowledges that no one surgeon, radiation oncologist, or medical oncologist can achieve success in this area working alone. Rather, each health care professional should be an advocate for improving the care of our patients by having clinical trial opportunities available for them.
This endeavor requires working with clinical trial coordinators, institutional review board leaders, and cancer registrars to convince the hospital administrators of the importance and need to participate in cancer research through cooperative group clinical trials. The clinical trials coordinators are very important members of the team. They frequently call the oncologists or surgeons when a patient is a candidate for an active trial. Active discussions about trials at cancer conferences keep everyone informed about active or upcoming trials.
Talking to patients
Being able to explain clearly to patients the advantages of participating in a clinical trial is an important skill. Physicians who understand and believe in the trial can explain the value of participation to patients with enthusiasm and assure them they are not being used as “guinea pigs.” When patients understand that a proposed trial may help them in the future or help a family member or friend, they almost always are willing to participate. Increasingly, clinical trials provide patients with treatment options that may otherwise be unavailable to them, such as novel drugs, new technologies, and less invasive surgery.
Having spent more than 40 years treating cancer patients, the last 20 as a full-time breast surgeon, Dr. Bauer has witnessed the advances and changes in the clinical care of breast cancer patients as a result of outcomes from well-designed clinical trials. He discusses with patients how a trial comparing lumpectomy plus radiation with mastectomy proved that the two treatments were essentially equal in outcomes. Illustrating with an example allows patients to better understand the value of trials.
His practice at York Hospital, PA, was invited to be part of the U.S. Department of Defense National Sentinel Node Trial, and by participating in that study, cancer patients entering the trial benefited from the physicians’ early training in and adoption of sentinel lymph node surgery for staging of clinically node-negative breast cancer. York Hospital was fourth out of 53 centers nationally in accrual.
The questions addressed in trials are often the very questions that physicians consider routinely in their clinical practice. For a breast surgeon in community practice, the question and debate regarding the routine use of preoperative magnetic resonance imaging (MRI) is very relevant. Dr. Bauer’s experience over a 10-year period in community practice has shown that MRI discovers additional malignant lesions in one-third of patients, and this finding is in line with the published literature.1 The Alliance recently activated a prospective clinical trial addressing the question regarding preoperative MRI—Alliance A11104.2,3 With all the debate surrounding MRI, the authors encourage community colleagues to enroll as many of their patients as possible to help resolve this controversy.
Another example is the option of breast-conserving operations for women found to have more than one focus of disease in the breast. The Alliance Z11102 study evaluates the option of breast-conserving therapy for women with multiple ipsilateral breast cancers.3,4 This timely question for physicians and patients provides an opportunity for patients to consider breast-conserving therapy, in cases where mastectomy previously may have been recommended.
Other Alliance and cooperative group studies address a multitude of clinically relevant and important questions across multiple disease sites and provide opportunities for physicians and their patients to help advance cancer treatment. Community physicians should play an active role in ensuring the success of these trials.
- Godinez J, Gombos EC, Chikarmane SA, Griffin GK, Birdwell RL. Breast MRI in the evaluation of eligibility for accelerated partial breast irradiation. Am J Roentgenol. 2008;191(1):272-287.
- ClinicalTrials.gov. MRI and mammography before surgery in patients with Stage I-II Breast Cancer. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01805076?term=breast+mri&recr=Open&lead=Alliance+for+Clinical+Trials+in+Oncology&rank=1. Accessed February 2, 2014.
- Boughey JC, Rosenkranz K, Nelson H. Multiple ipsilateral breast cancers: Can the breast be preserved? Bull Am Coll Surg. 2012;97(12):43-45.
- ClinicalTrials.gov. Breast-conserving surgery and radiation therapy in patients with multiple ipsilateral breast cancer. Available at: http://clinicaltrials.gov/ct2/show/NCT01556243?term=multiple+ipsilateral+
breast&rank=1. Accessed February 24, 2014.