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Stereotactic Body Radiation Therapy
Comparative Effectiveness Technical Briefs, No. 6
Investigators: Kelley N Tipton, MPH, Nancy Sullivan, BA, Wendy Bruening, PhD, Rohit Inamdar, MSc, DABR, Jason Launders, MSc, Stacey Uhl, MSS, and Karen M Schoelles, MD, SM, FACP.
Author Information and AffiliationsStructured Abstract
Objectives:
Conduct a systematic literature scan for published data for the treatment of stereotactic body radiation therapy (SBRT) and provide a broad overview of the current state of SBRT for solid malignant tumors.
Data Sources:
Ovid, MEDLINE, EMBASE, the Cochrane Database, and the Health Technology Assessment Database from January 2000 to December 2010. We also searched www.ClinicalTrials.gov, www.fda.gov, and gray literature within Windhover, Current HC News, Gray Sheet, The Wall Street Journal, Clinica, and the Google search engine.
Review Methods:
Clinical studies of any design, published in English that delivered SBRT in 10 or fewer fractions, and enrolled at least three patients with solid malignant tumors in the body (excluding head and spine) were included. Two reviewers abstracted information on study design, patients, and reported outcomes. We synthesized the following variables if reported: cancer type, patient inclusion criteria, type of radiation, instrumentation, and algorithms used, study design and size, comparators, concurrent and/or prior treatments, length of followup, outcomes measured, and adverse events.
Results:
Our searches identified a total of 124 relevant prospective and retrospective single group studies. The bulk of the studies examined SBRT for tumors of the lung/thorax (k = 68). We found 27 studies of tumors located in the pancreas, liver, colon, and fewer than 10 studies each for sites within uterus, pelvis, sacrum, kidney, prostate, and thyroid. There were 10 studies that included multiple treatment sites within the study. Study designs for SBRT include prospective and retrospective single group studies. Study size varied from 3 (minimum acceptable for inclusion in this review) to 398 patients. None of the published trials were comparative studies. Reported patient inclusion criteria include inoperable tumors, patients refusing surgery, biopsy proven disease, life expectancy, no prior radiation therapy (RT) or prior RT received in a particular time frame prior to SBRT, and required performance levels on the Karnofsky or World Health Organization/Eastern Cooperative Oncology Group scales. Several studies reported the use of modified linacs(k = 47), CyberKnife (k = 39), Novalis Shaped Beam or Clinac (k = 16), Body GammaKnife (k=1), Tomotherapy Hi-Art(k = 2), FOCAL unit(k = 1), and Synergy systems(k = 6). Typically, inverse treatment planning algorithms; pencil beam algorithms for dose calculation; and tissue maximum ratio calculation algorithms were reported. Prior treatments reported include surgery, radiation therapy (e.g., intensity-modulated radiation therapy (IMRT), brachytherapy), pharmaceuticals (e.g., tamoxifen), and/or chemotherapy. We calculated an overall mean and median for the length of followup for each cancer type. The shortest mean and median followup was within the multiple site category (12.9 and 8.2 months [1–95 months] respectively). Studies of the tumors involving the pelvis, sacrum, and uterus had the longest mean/median followup (31 and 33 months [range 2–77 months]). The reported outcomes include tumor control/response, toxicity, and overall survival. Most studies used four criteria to measure tumor control/tumor response: complete response, partial response, stable disease, and progression of disease. The most frequently reported adverse events include pain, fatigue, nausea, bleeding, and diarrhea.
Conclusions:
In brief, SBRT appears to be widely disseminated for treatment of a variety of cancer types, although a majority of studies have only focused on treatment of thoracic tumors. None of the currently available studies include comparison groups. Comparative studies are needed to provide evidence that the theoretical advantages of SBRT over other radiotherapies actually occur in the clinical setting. Currently, there is only one small ongoing trial doing so. Consequently, a full systematic review of the current literature cannot answer questions on the effectiveness and safety of SBRT compared to other radiotherapy interventions.
Contents
- Preface
- Acknowledgments
- Peer Reviewers
- Executive Summary
- Introduction
- Statement of Work
- Methods
- Results
- Guiding Question 1. 1a For which cancers has stereotactic body radiation therapy been used?
- 1b What are the theoretical advantages and disadvantages of stereotactic body radiation therapy compared to other radiation therapies that are currently used for cancer treatment?
- 1c What are the potential safety issues and harms of the use of stereotactic body radiation therapy?
- Guiding Question 2. 2a What specialized instrumentation is needed for stereotactic body radiation therapy and what is the FDA status of this instrumentation?
- 2b What is an estimate of the number of hospitals that currently have the capability for stereotactic body radiation therapy in the United States?
- 2c What instrumentation technologies are in development?
- Guiding Question 3 Evidence Base
- Discussion
- Conclusion
- References
- Glossary
- Abbreviations
- Appendixes
- Appendix A Literature Search Methods
- Appendix B Included Studies
- Appendix C Excluded Studies
- Appendix D Personnel Qualifications
- Appendix E Recommendations
- Appendix F Currently Marketed Devices for SBRT
- Appendix G Linac-Based SBRT Accessories
- Appendix H Applicants’ FDA 510K Information
- Appendix I Manufacturer Web Sites
- Appendix J Facilities Performing SBRT for Solid Tumors
- Appendix K Ongoing Clinical Trials
- Appendix L Results for Guiding Question 3
- Appendix M Literature Results Device Specifications
- Appendix N Responses From Device Manufacturers on Device Specifications and Compatible Accessories (January 2010)
- Appendix O References Cited in Appendixes
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1. Contract No. 290-02-0019. Prepared by: ECRI Institute Evidence-based Practice Center.
Suggested citation:
Tipton KN, Sullivan N, Bruening W, Inamdar R, Launders J, Uhl S, Schoelles K. Stereotactic Body Radiation Therapy. Technical Brief No. 6. (Prepared by ECRI Institute Evidence-based Practice Center under Contract No. HHSA-290-02-0019.)AHRQ Publication No. 10 (11)-EHC058-EF. Rockville, MD:Agency for Healthcare Research and Quality. May2011. Available at www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the ECRI Institute under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0019). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decision-makers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators has any affiliations or financial involvement related to the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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