Originally published as JCO Early Release 10.1200/JCO.2007.13.4536 on October 9 2007
Journal of Clinical Oncology, Vol 25, No 33 (November 20), 2007: pp. 5313-5318
© 2007 American Society of Clinical Oncology.
American Society of Clinical Oncology Endorsement of the Cancer Care Ontario Practice Guideline on Nonhormonal Therapy for Men With Metastatic Hormone-Refractory (castration-resistant) Prostate Cancer
Ethan M. Basch,
Mark R. Somerfield,
Tomasz M. Beer,
Michael A. Carducci,
Celestia S. Higano,
Maha H.A. Hussain,
Howard I. Scher
From the Memorial Sloan-Kettering Cancer Center, New York, NY; American Society of Clinical Oncology, Alexandria, VA; Oregon Health & Science University, Portland, OR; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Departments of Medicine and Urology, University of Washington, Seattle, WA; and the Ann Arbor Cancer Center, University of Michigan, Ann Arbor, MI
Address reprint requests to ASCO, Cancer Policy and Clinical Affairs, 1900 Duke St, Suite 200, Alexandria, VA 22314; e-mail: guidelines{at}asco.org
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ABSTRACT
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Purpose In 2006, the American Society of Clinical Oncology (ASCO) Board of Directors (BOD) approved a policy and a set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations.
Methods The Cancer Care Ontario (CCO) Guideline on Non-Hormonal Therapy for Men With Metastatic Hormone-Refractory Prostate Cancer (HRPC) was reviewed for developmental rigor by methodologists. An ad hoc prostate cancer guideline review panel consisting of prostate cancer experts reviewed the content.
Results The ASCO ad hoc prostate cancer guideline review panel concurred that the recommendations are clear, thorough, based on the most relevant scientific evidence in this content area, and present options that will be acceptable to patients. The CCO guideline was subsequently endorsed by the ASCO BOD. The guideline recommends the use of docetaxel, prednisone/hydrocortisone, and/or mitoxantrone in specific settings. Docetaxel-based chemotherapy is the only treatment that has demonstrated an overall survival benefit in men with HRPC. The use of estramustine in combination with other cytotoxic agents is not recommended. Continued gonadal androgen suppression and discontinuance of antiandrogens is recommended for men receiving chemotherapy.
Conclusion The review panel agreed with the recommendations as stated in the CCO guideline, with the following qualifications: two of the ASCO content reviewers noted the importance of considering other, nonhormonal therapies in this context that are beyond the scope of this guideline. The review panel notes that CCO has published separate guidelines on radiopharmaceuticals and bisphosphonates in men with castration-resistant (ie, hormone-refractory) metastatic prostate cancer.
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INTRODUCTION
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In 2006, the American Society of Clinical Oncology (ASCO) Board of Directors approved a policy and a set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. The goal of the endorsement policy is to increase the number of high-quality, ASCO-vetted guidelines available to the ASCO membership. Endorsement of guidelines will be considered in selected circumstances, either on request from related professional organizations at the discretion of the ASCO Health Services Committee (HSC), or when ASCO seeks to endorse another organization's guideline in lieu of undertaking its own guideline on the same topic. Of note, any guideline that is being considered for endorsement by ASCO must have been developed based on a systematic review of the literature.
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OVERVIEW OF THE ASCO GUIDELINE ENDORSEMENT PROCESS
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The guideline under endorsement consideration is reviewed and approved by the ASCO HSC and by the ASCO Board. The HSC review includes two parts: methodological review and content review. The methodological review is completed by a member of the HSC's Methodology Subcommittee or by ASCO senior guideline staff using the Rigour of Development subscale of the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. The Rigour subscale consists of seven items that assess the quality of the processes used to gather and synthesize the relevant data, and the methods used to formulate the guideline recommendations (Appendix Fig A1). In addition to this methodological review, ASCO staff conducts literature searches to identify relevant studies and additional systematic reviews, meta-analyses, and guidelines that have been published since the guideline under endorsement was completed.
The content review is completed by an ad hoc review panel (Appendix Table A1). The panel members are asked to complete an eight-item Guideline Endorsement Content Review Form that assesses the perceived clarity and clinical utility of the recommendations, and the degree to which the recommendations are consistent with the content reviewers' interpretation of the available data on the topic in question (Appendix Fig A2). This form was adapted by ASCO from the Cancer Care Ontario (CCO) Program in Evidence-Based Care (PEBC) Practitioner Feedback instrument. Final review and approval is competed by the ASCO Board of Directors pending approval by the ad hoc content review panel and the HSC.
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CANCER CARE ONTARIO GUIDELINE ON NON-HORMONAL THERAPY FOR MEN WITH METASTATIC HORMONE-REFRACTORY PROSTATE CANCER
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The ad hoc content review panel favors the term "metastatic castration-resistant prostate cancer." For the purposes of this guideline review, the term "hormone-resistant prostate cancer" (used in the CCO guideline) and "castration-resistant prostate cancer" should be considered synonymous, meaning prostate cancer that has progressed despite castrate levels of serum testosterone.
Guideline Clinical Questions and Target Population
The CCO guideline asked "Which nonhormonal systemic therapies are most beneficial and should be recommended for the treatment of hormone-refractory prostate cancer (HRPC)?"1 The target population included men with progressive hormone-refractory prostate cancer with evidence of metastases.
Summary of Guideline Development Methodology and the Key Evidence
The CCO guideline was developed under the auspices of CCO's PEBC by five members of the PEBC's Genitourinary Cancer Disease Site Group and methodologists. The literature search of MEDLINE spanned 1966 to February 2005. Additional databases searched included the Cochrane Library databases (through 2004, issue 4), ASCO Annual Meeting proceedings, the Canadian Medical Association Infobase, EMBASE (1980 to 2005), and the National Guideline Clearinghouse.2 Details of the search strategies and the study inclusion criteria are available at http://www.cancercare.on.ca/pdf/pebc3-15f.pdf.
The searches identified 83 unique randomized clinical trials (RCTs), 28 of which satisfied the inclusion criteria. These 28 trials, published between 1979 and 2004 and representing a total of 7,627 eligible men, formed the basis for the guideline. A qualitative versus a quantitative (meta-analytic) synthesis of the data was done by the Genitourinary Cancer Disease Site Group given the high degree of heterogeneity among trials in terms of study design, patient populations, and interventions.
Major Guideline Recommendations and Qualifying Statements
The CCO guideline recommendations for nonhormonal therapy in men with castration-resistant (ie, hormone-refractory) prostate cancer are as follows, and are taken verbatim from the CCO guideline: - For men with clinical or biochemical evidence of progression and evidence of metastases, treatment with docetaxel 75 mg/m2 administered intravenously every 3 weeks with 5 mg oral prednisone twice daily should be offered to improve overall survival, disease control, symptom palliation, and quality of life.
- Alternative therapies that have not demonstrated improvement in overall survival but can provide disease control, palliation, and improve quality of life include weekly docetaxel plus prednisone, and mitoxantrone plus prednisone (or hydrocortisone).
The CCO guideline also included the following qualifying statements, which are taken verbatim from the CCO guideline: - Docetaxel-based chemotherapy is the only treatment that has demonstrated an overall survival benefit in men with hormone-refractory prostate cancer.
- The timing of docetaxel therapy in men with evidence of metastases but without symptoms should be discussed with patients and individualized based on their clinical status and preferences.
- In the largest clinical trials reviewed for this guideline, the men enrolled continued on gonadal androgen suppression and discontinued the use of antiandrogens. These maneuvers are recommended for men with hormone-refractory prostate cancer who receive chemotherapy.
- Men with hormone-refractory prostate cancer should have symptom control optimized.
- Use of estramustine in combination with other cytotoxic agents is not recommended due to the increased risk of clinically important toxicities without evidence of improved survival or palliation.
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RESULTS OF THE ASCO METHODOLOGICAL REVIEW
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The methodological review of the CCO guideline was completed independently by three ASCO guideline staff members using the Rigour of Development subscale from the AGREE instrument, as discussed. The score for the Rigour of Development domain is calculated by summing the scores across individual items in the domain and standardizing the total score as a proportion of the maximum possible score. Detailed results of the scoring for this guideline are available on request from guidelines@asco.org. Overall, the CCO guideline scored very high (86%) in terms of methodological quality, with only minor deviations from the ideal (eg, lack of stated exclusion criteria for study selection) as reflected in the AGREE items.
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METHODS AND RESULTS OF THE ASCO UPDATED LITERATURE SEARCH
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A search for new evidence was conducted by ASCO guidelines staff to identify relevant RCTs, systematic reviews, meta-analyses, and guidelines that have been published since the CCO guideline was completed. Following the strategies described in the CCO guideline, MEDLINE, and the Cochrane Library databases were searched from 2004 to April 2007. The search was restricted to papers published in English and the CCO guideline inclusion criteria were applied to review of the literature search results. Table 1 provides a summary of the relevant evidence identified by the updated search.
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Table 1. Summary of Articles From the ASCO Updated Search of the Literature on Nonhormonal Systemic Therapy for Metastatic Hormone-Refractory Prostate Cancer
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RESULTS OF THE ASCO CONTENT REVIEW
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The ASCO ad hoc prostate cancer guideline review panel has reviewed the guideline in question and concurs that the recommendations are clear, thorough, are based on the most relevant scientific evidence in this content area, and present options that will be acceptable to patients. Overall, the ad hoc review panel agrees with the recommendations as stated in the CCO guideline, with the following qualifications: - Two of the ASCO content reviewers noted the importance of considering other, nonhormonal therapies in this context that are beyond the scope of this guideline. The ad hoc review panel notes that CCO has published separate guidelines on radiopharmaceuticals and bisphosphonates in men with castration-resistant (ie, hormone-refractory) metastatic prostate cancer, which are available at www.cancercare.on.ca/pdf/pebc14-1f.pdf and www.cancercare.on.ca/pdf/pebc3-14f.pdf, respectively.
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ENDORSEMENT RECOMMENDATION
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The ASCO ad hoc prostate cancer guideline review panel has reviewed the CCO guideline and endorses the adoption of the guideline.
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AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
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Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Employment or Leadership Position: None Consultant or Advisory Role: Tomasz M. Beer, Aegera Therapeutics Inc (C), Novacea (C), Syndax (C); Michael A. Carducci, Sanofi-aventis (C), Abbott Laboratories (C), Methylgene (C), GlaxoSmithKline (C), Dendreon (C), Cougar Biotech (C), MGI Pharma (C), Merck (C), Boerhinger Ingelheim (C) Stock Ownership: Tomasz M. Beer, Novacea; Maha H.A. Hussain, Sanofi-Aventis Honoraria: Tomasz M. Beer, Novacea, Sanofi-Aventis; Michael A. Carducci, Sanofi-Aventis, Abbott Laboratories Research Funding: Tomasz M. Beer, Attenuon, Berlex, Cell Therapeutics Inc, Dendreon, Genaera, GlaxoSmithKline, Medarex, Medivation, Novacea, Novartis, Pfizer, Sanofi-aventis; Maha H.A. Hussain, Pfizer, Pharma Mar, Lilly, Sanofi-aventis, Merck KGA Expert Testimony: None Other Remuneration: None
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AUTHOR CONTRIBUTIONS
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Conception and design: Ethan M. Basch, Tomasz M. Beer, Michael A. Carducci, Celestia S. Higano, Maha H.A. Hussain, Howard I. Scher
Administrative support: Mark R. Somerfield
Collection and assembly of data: Mark R. Somerfield
Data analysis and interpretation: Ethan M. Basch, Mark R. Somerfield, Tomasz M. Beer, Michael A. Carducci, Celestia S. Higano, Maha H.A. Hussain, Howard I. Scher
Manuscript writing: Ethan M. Basch, Mark R. Somerfield, Tomasz M. Beer, Michael A. Carducci, Celestia S. Higano, Maha H.A. Hussain, Howard I. Scher
Final approval of manuscript: Ethan M. Basch, Tomasz M. Beer, Michael A. Carducci, Celestia S. Higano, Maha H.A. Hussain, Howard I. Scher
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Appendix
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ACKNOWLEDGMENTS
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The authors are grateful to Bruce Roth, MD, and to members of the ASCO Health Services Committee for their thoughtful reviews of earlier drafts. Also, special thanks to Kaitlin Einhaus and Karen Hagerty for completing methodological reviews of the Cancer Care Ontario guideline.
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NOTES
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published online ahead of print at www.jco.org on October 9, 2007.
Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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REFERENCES
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1. Winquist E, Waldron T, Berry S, et al: Non-hormonal systemic therapy in men with metastatic hormone-refractory prostate cancer: A Clinical Practice Guideline, 2005. http://www.cancercare.on.ca/pdf/pebc3-15s.pdf2. Winquist E, Waldron T, Berry S, et al: Non-hormonal systemic therapy in men with hormone-refractory prostate cancer and metastases: A systematic review from the Cancer Care Ontario Program in Evidence-Based Care's Genitourinary Cancer Disease Site Group. BMC Cancer 6:112, 2006[CrossRef][Medline] 3. Beer TM, Ryan CW, Venner PM, et al: Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: A report from the ASCENT Investigators. J Clin Oncol 25:669-674, 2007[Abstract/Free Full Text] 4. Berry DL, Moinpour CM, Jiang CS, et al: Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. J Clin Oncol 24:2828-2835, 2006[Abstract/Free Full Text] 5. Collins R, Trowman R, Norman G, et al: A systematic review of the effectiveness of docetaxel and mitoxantrone for the treatment of metastatic hormone-refractory prostate cancer. Br J Cancer 95:457-462, 2006[CrossRef][Medline] 6. Fizazi K, Hudes GR, Berry WR, et al: A meta-analysis of individual patient data from randomized trials assessing chemotherapy with and without estramustine in patients with castration-refractory prostate cancer. J Clin Oncol 24:231s, 2006 (suppl; abstr 4561) 7. Shelley M, Harrison C, Coles B, et al: Chemotherapy for hormone-refractory prostate cancer. Oxford, United Kingdom, Cochrane Library, CD005247, 1, 2007
Submitted July 19, 2007;
accepted August 17, 2007.
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ABSTRACT
INTRODUCTION
