July 2004
What is a Technology Assessment?
To help doctors give their patients the best possible care, the American Society of Clinical Oncology (ASCO) asks its medical experts to review the latest literature and provide recommendations on the use of medical procedures, devices, or tests in diagnosing or treating cancer. This technology assessment is a patient-friendly version of ASCO's original technology assessment for clinicians.
As you read this technology assessment, which summarizes a process for determining whether a procedure, treatment, or practice is appropriate for widespread, conventional use in clinical practice, please keep in mind that every person treated for cancer is different. These recommendations are not meant to replace your or your doctors' judgment. The final decisions you and your doctors make will be based on your individual circumstances.
Information in ASCO's patient education materials is not intended as medical advice or as a substitute for the treating doctor's own professional judgment; nor does it imply ASCO endorsement of any product or company.
What is a Chemotherapy Sensitivity and Resistance Assay?
A chemotherapy sensitivity assay is a laboratory test that can be performed on samples of a patient's tumor to determine if a chemotherapy drug will be effective in killing tumor cells.
All clinical oncologists want to make chemotherapy recommendations that are tailored specifically to the unique characteristics of a particular patient's tumor. Therefore, the idea of testing chemotherapy drugs outside the body to see which ones will work has tremendous appeal. These tests of tumor sensitivity to chemotherapy drugs are called chemotherapy sensitivity assays. In some cases, these assays are called chemotherapy resistance assays because the laboratory analyses identify agents that do not influence tumor growth. In this technology assessment, we refer to both types of analyses as a chemotherapy sensitivity and resistance assay (CSRA).
In theory, by determining which treatments do not work in the laboratory, patients could be spared the use of ineffective therapy.
What is the Purpose of This Technology Assessment?
ASCO brought together a panel of cancer experts, called a Working Group, to conduct this technology assessment. This overview offers a brief summary of the Working Group's recommendations on the use of CSRAs.
This technology assessment evaluates the effectiveness of CSRAs in predicting which chemotherapy medications will best stop tumor growth, when compared with a chemotherapy regimen that is chosen based on the results of research published from clinical trials. This technology assessment focuses only on CSRAs performed on living tumor tissue, versus other assays that are performed on nonliving tumor tissue.
Which Assays Were Evaluated?
| Assay Name |
Primary Target Tumor Types* |
| Sub-renal Capsule Assay (SRCA) |
Epithelial Ovarian Cancers |
| Human Tumor Cloning Assay (HTCA) and Capillary Cloning System (CCS) |
Multiple Tumor Types |
| Differential Staining Cytotoxicity (DiSC) |
Lung Cancer (Small and Non-small Cell) |
| Methylthiazolyl-diphenyltetrazolium bromide (MTT) |
Breast Cancer |
| Adenosine Triphosphate Bioluminescence (ATP) |
Epithelial Ovarian Cancer |
| Extreme Drug Resistance (EDR) Assay |
Epithelial Ovarian Cancer |
*See original technology assessment for clinicians for more information on the assays that were included in this study. Most assays can be used on multiple tumor types, and are not limited to the tumor types represented here.
Available technology for predicting tumor response to chemotherapy agents has developed dramatically in the decades since the first efforts to use CSRAs. It is important for researchers to continue to develop and refine additional methods to select treatments based on an individual's tumor characteristics.
Recommendations
The ASCO Working Group suggests the following:
1. Based on the current research, CSRAs should not be used outside of clinical trials.
Although there is some appeal to using CSRAs to potentially select cancer treatments based on tumor responsiveness, at this time, the available research on the use of CSRAs does not support the use of this technology outside of a clinical research trial. This, in part, is a result of limitations in the literature about CSRAs, including small sample sizes, the lack of prospective studies, low yield of assays, and newer chemotherapy drugs that continue to be developed.
2. There is no single assay that is ready for routine use in the clinical setting.
Although the concept behind CSRAs is compelling, unfortunately, there does not appear to be a single assay that is ready for routine use in a clinical setting. This is likely due to problems in the technical success and yield of the assays, the lack of adequate prospective evaluation of CSRAs in clinical trials, and the tendency of CSRAs to "recommend" treatments that would have been given based on the results of research published from clinical trials.
3. The concept behind CSRAs is very appealing and research in this area should continue.
The Working Group does not find any opportunity, outside of a clinical research trial, in which CSRAs should be obtained to make treatment recommendations in routine clinical practice. However, as laboratory procedures become increasingly advanced, better assays will be developed. Also, as additional chemotherapy drugs become available and treatment choices for oncologists become more complex, the rationale for developing CSRAs becomes even more compelling. Studying tumor tissue response in a laboratory may potentially spare patients from undergoing unnecessary chemotherapy treatments.
In conclusion, based on the evidence that is currently available, ASCO's Working Group does not recommend the use of assay-guided chemotherapy outside of the clinical trial setting. Oncologists should make chemotherapy treatment recommendations based on published reports of clinical trials and a patient's health status and treatment preferences.
However, the Working Group supports continued research in this area and encourages patients to participate in clinical trials to further evaluate the potential importance of CSRAs.
What Does This Mean for Patients?
Decisions about which chemotherapy regimen you receive should be based on discussions with your oncologist about how the results of clinical trials pertain to your situation. At this time, CSRAs should not be used to select the choice of chemotherapy. Because the concept of customizing chemotherapy is important, participation in research studies that evaluate the accuracy of laboratory testing of tumor specimens to predict chemotherapy response is encouraged.
More About the Working Group
ASCO established a Working Group that included individuals with expertise in laboratory and clinical aspects of chemotherapy sensitivity and resistance assay development, clinical trial methodology, and guideline development to conduct the technology assessment. The Working Group collaborated with the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center. The Working Group developed independent criteria for selecting articles for inclusion in the ASCO assessment, and developed a structured data abstraction tool to facilitate review of selected manuscripts.
For More Information
For a copy of the original technology assessment, please visit www.asco.org or call 703-299-0150.
For more information about cancer, visit People Living With Cancer at www.plwc.org. People Living With Cancer, ASCO's patient information website, provides oncologist-approved information on more than 50 types of cancer and their treatments, clinical trials, coping, and side effects. Additional resources include a Find an Oncologist database, live chats, message boards, a drug database, and links to patient support organizations. The site is designed to help people with cancer make informed health-care decisions.
Also on People Living With Cancer, you can find:
Patient Guides. Adapted from the recommendations in ASCO's Clinical Practice Guidelines, these guides offer easy to understand information and helpful resources. View the following guides:
- Adjuvant Chemotherapy for Stage II Colon Cancer
- Advanced Lung Cancer Treatment
- Bisphosphonates for Breast Cancer
- Bisphosphonates for Multiple Myeloma
- Epoetin Treatment
- Follow-Up Care for Breast Cancer
- Follow-Up Care for Colorectal Cancer
- Hormone Therapy for Advanced Prostate Cancer
- Preventing and Treating Nausea and Vomiting Caused by Cancer Treatment
- Understanding Tumor Markers for Breast and Colorectal Cancers
Cancer Advances. This series provides summaries of important research presented at ASCO's Annual Meeting and Meet the Experts sessions, and published in the Journal of Clinical Oncology (JCO).
Links to abstracts presented at ASCO's Annual Meetings and other educational meetings.
The American Society of Clinical Oncology (ASCO) is the world's leading professional society of multidisciplinary physicians who treat people with cancer. ASCO's more than 20,000 members from the United States and abroad set the standard for patient care worldwide and lead the fight for more effective cancer treatments, increased funding for clinical and translational research, and, ultimately, cures for the many different types of cancer that strike an estimated 10 million people worldwide each year. ASCO publishes the Journal of Clinical Oncology (JCO), the preeminent, peer-reviewed, medical journal on clinical cancer research, and produces Cancer.net (www.cancer.net), an award-winning website providing oncologist-vetted cancer information to help patients and families make informed healthcare decisions.
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Copyright © 2004 American Society of Clinical Oncology. All rights reserved. For permissions information, contact ASCO's Intellectual Property Rights Manager at permissions@asco.org.
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