Wyimki z bardzo interesujacego dokumentu opracowanego przez American Urological Association (AUA) dotyczacego postepowania w przypadku raka prostaty opornego na kastracje (CRPC - Castration-Resistant Prostate Cancer).
Autorzy podzielili pacjentow na 6 grup terapeutycznych biorac pod uwage najczesciej wystepujace scenariusze I przedstawili mozliwosci postepowania w zaleznosci od tego czy rak jest przerzutowy czy nie, czy jest symptomatyczny czy asymptomatyczny, czy pacjent byl uprzednio leczony Docetaxelem czy nie
Pod uwage wzieto rowniez stan chorego (ECOG Performance status) oraz podano Evidence Level (A, B lub C).
Zalaczam rowniez pdf. calego dokumentu.
CASTRATION-RESISTANT PROSTATE CANCER: AUA GUIDELINE
Michael S. Cookson, Bruce J. Roth, Philipp Dahm, Christine Engstrom, Stephen J. Freedland, Maha Hussain, Daniel W. Lin, William T. Lowrance, Mohammad Hassan Murad, William K. Oh, David F. Penson and Adam S. Kibel
Approved by the AUA Board of Directors April 2015
Authors’ disclosure of po-tential conflicts of interest and author/staff contributions appear at the end of the article.
© 2015 by the American Urological Association
Note to the Reader:
On July 21, 2014, the FDA issued a recommendation that health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients.
On July 26, 2013, the FDA issued a safety announcement related to the use of ketoconazole in the form of oral tablets. Side effects can include hepatotoxicity, adrenal insufficiency and dangerous drug interactions.
This document was amended in April 2014 and March 2015 to reflect literature that was released since the original publication of this guideline in May 2013. This document will continue to be periodically updated to reflect the growing body of literature related to this disease.
Copyright © 2015 American Urological Association Education and Research, Inc.®
Purpose:
As a direct result of the significant increase in multiple FDA-approved therapeutic agents for use in patients with metastatic castration-resistant prostate cancer (CRPC), clinicians are challenged with a multitude of treatment options and potential sequencing of these agents that, consequently, make clinical decision-making more complex. To assist in clinical decision-making, six index patients were developed representing the most common clinical scenarios that are encountered in clinical practice. With these patients in mind, guideline statements were developed to provide a rational basis for treatment based on currently available published data.
Methodology:
A systematic review and meta-analysis of the published literature was conducted using controlled vocabulary supplemented with keywords relating to the relevant concepts of prostate cancer and castration resistance. The search strategy was developed and executed by reference librarians and methodologists to create a final evidence report limited to English-language, peer-reviewed literature published between January 1996 and February 2013. This review yielded 303 articles, which were used to inform the statements presented in the guideline as Standards, Recommendations or Options. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. In April 2014, the CRPC guideline underwent amendment based on an additional literature search, which retrieved additional studies published between February 2013 and February 2014. Thirty-seven studies from this search provided data relevant to the specific treatment modalities for CRPC. In March 2015, the CRPC guideline underwent a second amendment, which incorporated 10 additional studies into the evidence base published through February 2015.
Guideline Statements
Index Patient 1 (Asymptomatic non-metastatic CRPC)
1. Clinicians should recommend observation with continued androgen deprivation to patients with non-metastatic CRPC. (Recommendation; Evidence Level Grade C)
2. Clinicians may offer treatment with first- generation anti-androgens (flutamide, bicalutamide and nilutamide) or first generation androgen synthesis inhibitors (ketoconazole+steroid) to select patients with non-metastatic CRPC who are unwilling to accept observation. (Option; Evidence Level Grade C)
3. Clinicians should not offer systemic chemotherapy or immunotherapy to patients with non-metastatic CRPC outside the context of a clinical trial. (Recommendation; Evidence Level Grade C)
Index Patient 2 (Asymptomatic or minimally-symptomatic, mCRPC without prior docetaxel chemotherapy)
4. Clinicians should offer abiraterone + prednisone, enzalutamide, docetaxel, or sipuleucel-T to patients with asymptomatic or minimally symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy. [Standard; Evidence Level Grade A (abiraterone + prednisone and enzalutamide)/B (docetaxel and sipuleucel-T)]
5. Clinicians may offer first- generation anti-androgen therapy, ketoconazole + steroid or observation to patients with asymptomatic or minimally symptomatic mCRPC with good performance status and no prior docetaxel chemotherapy who do not want or cannot have one of the standard therapies. (Option; Evidence Level Grade C)
Index Patient 3 (Symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy)
6. Clinicians should offer abiraterone + prednisone, enzalutamide or docetaxel to patients with symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy. [Standard; Evidence Level Grade A (abiraterone + prednisone and enzalutamide/ B (docetaxel)]
7. Clinicians may offer ketoconazole + steroid, mitoxantrone or radionuclide therapy to patients with symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy who do not want or cannot have one of the standard therapies. [Option; Evidence Level Grade C (ketoconazole) /B (mitoxantrone) / C (radionuclide therapy)]
8. Clinicians should offer radium-223 to patients with symptoms from bony metastases from mCRPC with good performance status and no prior docetaxel chemotherapy and without known visceral disease. (Standard; Evidence Level Grade B)
9. Clinicians should not offer treatment with either estramustine or sipuleucel-T to patients with symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy. (Recommendation; Evidence Level Grade C)
Index Patient 4 (Symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy)
10. Clinicians may offer treatment with abiraterone + prednisone or enzalutamide to patients with symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy. (Option; Evidence Level Grade C)
11. Clinicians may offer treatment with ketoconazole+ steroid or radionuclide therapy to patients with symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy who are unable or unwilling to receive abiraterone + prednisone or enzalutamide. (Option; Evidence Level Grade C)
12. Clinicians may offer docetaxel or mitoxantrone chemotherapy to patients with symptomatic mCRPC with poor performance status and no prior docetaxel chemotherapy in select cases, specifically when the performance status is directly related to the cancer. (Expert Opinion)
13. Clinicians may offer radium-223 to patients with symptoms from bony metastases from mCRPC with poor performance status and no prior docetaxel chemotherapy and without known visceral disease in select cases, specifically when the performance status is directly related to symptoms related to bone metastases. (Expert Opinion)
14. Clinicians should not offer sipuleucel-T to patients with symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy. (Recommendation; Evidence Level Grade C)
Index Patient 5 (Symptomatic, mCRPC with good performance status and prior docetaxel chemotherapy)
15. Clinicians should offer treatment with abiraterone + prednisone, cabazitaxel or enzalutamide to patients with mCRPC with good performance status who received prior docetaxel chemotherapy. If the patient received abiraterone + prednisone prior to docetaxel chemotherapy, they should be offered cabazitaxel or enzalutamide. [Standard; Evidence Level Grade A (abiraterone) / B (cabazitaxel)/ A (enzalutamide)]
16. Clinicians may offer ketoconazole + steroid to patients with mCRPC with good performance status who received prior docetaxel if abiraterone + prednisone, cabazitaxel or enzalutamide is unavailable. (Option; Evidence Level Grade C)
17. Clinicians may offer retreatment with docetaxel to patients with mCRPC with good performance status who were benefitting at the time of discontinuation (due to reversible side effects) of docetaxel chemotherapy. (Option; Evidence Level Grade C)
18. Clinicians should offer radium-223 to patients with symptoms from bony metastases from mCRPC with good performance status who received prior docetaxel chemotherapy and without known visceral disease. (Standard; Evidence Level Grade B)
Index Patient 6 (Symptomatic, mCRPC with poor performance status and prior docetaxel chemotherapy)
19. Clinicians should offer palliative care to patients with mCRPC with poor performance status who received prior docetaxel chemotherapy. Alternatively, for selected patients, clinicians may offer treatment with abiraterone + prednisone, enzalutamide, ketoconazole + steroid or radionuclide therapy. (Expert Opinion)
20. Clinicians should not offer systemic chemotherapy or immunotherapy to patients with mCRPC with poor performance status who received prior docetaxel chemotherapy. (Expert Opinion)
Bone Health
21. Clinicians should offer preventative treatment (e.g. supplemental calcium, vitamin D) for fractures and skeletal related events to CRPC patients. (Recommendation; Evidence Level Grade C)
22. Clinicians may choose either denosumab or zoledronic acid when selecting a preventative treatment for skeletal related events for mCRPC patients with bony metastases. (Option; Evidence Level Grade C)