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Particular caution should be exercised in the use of ESAs concomitant with treatment strategies and diseases where risk of thromboembolic complications is increased (see Recommendations 4 and 6). In patients with MDS, one RCT evaluated the addition of epoetin beta to lenalidomide in 131 patients with RBC transfusion-dependent, low, or intermediate-1 risk (according to the International Prognostic Scoring System), ESA refractory, nondel(5q) MDS.26 The combination of lenalidomide and epoetin beta increased the frequency of erythroid response relative to lenalidomide alone (39% v 23%; P = .04), but did not significantly affect duration of erythroid response (15 v 18 months; P = .64) or likelihood of transfusion independence (24% v 14%; P = .13). This clinical practice guideline addresses 10 clinical questions: (1) To reduce the need for RBC transfusions, should ESAs be offered to patients who have chemotherapy-associated anemia? BioDrugs 32:129-135, 2018 [Erratum: BioDrugs 32:137-138, 2018].

Evaluation of individual cases must be based on the intent of treatment and the life expectancy for each patient.

0000005061 00000 n ASCO and ASH specifically disclaim any warranties of merchantability or fitness for a particular use or purpose. The biosimilar literature review suggested that biosimilars of epoetin alfa have similar efficacy and safety to reference products, although evidence in cancer remains limited. endstream endobj 128 0 obj <> endobj 129 0 obj <> endobj 130 0 obj <>/Encoding<>>>>> endobj 131 0 obj <> endobj 132 0 obj <>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>>/Type/Page>> endobj 133 0 obj <>/Border[0 0 0]/Type/Annot>> endobj 134 0 obj <> endobj 135 0 obj <> endobj 136 0 obj <> endobj 137 0 obj <>/Border[0 0 0]/Type/Annot>> endobj 138 0 obj <>/Border[0 0 0]/Type/Annot>> endobj 139 0 obj <> endobj 140 0 obj <> endobj 141 0 obj <> endobj 142 0 obj [/ICCBased 167 0 R] endobj 143 0 obj <> endobj 144 0 obj <> endobj 145 0 obj <> endobj 146 0 obj <> endobj 147 0 obj <>stream The Expert Panel wishes to thank Bryan Schneider, MD, Charles Shapiro, MD, the ASCO Clinical Practice Guidelines Committee, the ASH Guideline Oversight Subcommittee, the ASH Committee on Quality, and ASH Officers for their thoughtful reviews of this guideline. 0000041549 00000 n

����a� � Be aware that their healthcare professional has received special training about the use of ESAs in patients with cancer. Be aware that they will be asked to sign an acknowledgment form that says they have talked with their healthcare professional about the risks of ESAs. One exception to this was reported in the 2012 Cochrane review by Tonia et al.2 Epoetin was associated with a larger improvement in fatigue than darbepoetin, but these results may have been confounded by three darbepoetin trials without anticancer treatment. Enter words / phrases / DOI / ISBN / authors / keywords / etc. The recommendations were developed using a systematic review of the literature from January 31, 2010, through May 14, 2018, and clinical experience. Finally, it should be noted that there is little to no information regarding the risks and benefits of the concurrent use of ESAs and newer agents, such as monoclonal antibodies and targeted and cellular therapies, and therefore, no recommendations can be issued in this regard. ESAs should be discontinued in patients who do not respond within 6 to 8 weeks. Other meta-analyses also evaluated subgroups of patients with hematologic malignancies, but only in relation to a single outcome: overall survival (nonsignificantly associated with ESA use based on a single study of 60 patients with lymphoma),21 thromboembolism (increased risk with ESA use),16 or fatigue (decreased risk with ESA use).14. Specific dose-reduction recommendations are provided in Table 2. Relationships are self-held unless noted. 0000041054 00000 n

As a result of the Department for Work and Pensions changes, people who are awaiting, receiving, or … The .gov means it’s official.Federal government websites often end in .gov or .mil. For the question on biosimilars, PubMed and the Cochrane Library were searched for RCTs and meta-analyses of RCTs in patients with cancer or chronic kidney disease (CKD), or cohort studies in patients with cancer. The information herein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care.

In the remaining two meta-analyses, baseline HgB did not significantly modify the association between ESA use and fatigue14 or overall survival.21 In the 2016 RCT by Leyland-Jones et al,6 the HRs for progression-free survival were similar in patients with lower and higher baseline HgB levels (HR, 1.11; 95% CI, 0.92 to 1.33, for patients with baseline HgB < 10 g/dL; HR, 1.08; 95% CI, 0.96 to 1.21, for patients with baseline HgB ≥ 10 g/dL); a test for interaction was not reported, but 95% CIs are widely overlapping.

New York, NY, The Commonwealth Fund, 2008.

0 U.S. Food and Drug Administration: FDA approves Retacrit as a biosimilar to Epogen/Procrit. 0000013590 00000 n 0000015664 00000 n ESAs are not recommended for patients with cancer who are not receiving chemotherapy, except in the case of patients with lower risk MDS.

0000002033 00000 n Expert Panel members reviewed comments from all sources and determined whether to maintain original draft recommendations, revise with minor language changes, or consider major recommendation revisions. Lower pretreatment RBC transfusion dependence (< 2 units per month) has also been associated with a higher likelihood of ESA response in patients with MDS.39 Among the potential benefits of ESA therapy in patients with MDS is avoidance of secondary hemochromatosis, particularly for lower risk patients who may have years of survival.

0000004122 00000 n In all cases, blood transfusion is a treatment option that should be considered (Type: informal consensus; Evidence quality: low; Strength of recommendation: moderate). Categories for disclosure include employment; leadership; stock or other ownership; honoraria, consulting or advisory role; speaker's bureau; research funding; patents, royalties, other intellectual property; expert testimony; travel, accommodations, expenses; and other relationships. Increasingly, individuals with cancer are required to pay a larger proportion of their treatment costs through deductibles and coinsurance.50,51 Higher patient out-of-pocket costs have been shown to be a barrier to initiating and adhering to recommended cancer treatments.52,53, Discussion of cost can be an important part of shared decision making.54 Clinicians should discuss with patients the use of less expensive alternatives when it is practical and feasible for treatment of the patient’s disease and there are two or more treatment options that are comparable in terms of benefits and harms.54. The ESAs that are part of the REMS are marketed under the names Epogen, Procrit, and Aranesp. Because these malignancies recur in most patients but multiple treatments are currently available for this situation, determining the treatment intent and the expected survival requires clinical judgment of an individual patient’s circumstances.

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ASCO and the ASH believe that cancer clinical trials are vital to inform medical decisions and improve cancer care, and that all patients should have the opportunity to participate. %PDF-1.7 %���� 37, no. Consulting or Advisory Role: Tempus, PledPharma, Hologic/Cynosure, Consulting or Advisory Role: Italfarmaco, Kyowa Hakko Kirin, Teva, Sandoz-Novartis, Amgen, Takeda, Travel, Accommodations, Expenses: Takeda, Janssen-Cilag, Celgene, Sanofi, Honoraria: Roche, Boehringer Ingelheim, AstraZeneca, Merck Sharp & Dohme, Astra Zeneca Greece, Travel, Accommodations, Expenses: AstraZeneca, Ipsen, Consulting or Advisory Role: Bayer, Novartis, Servier, Sandoz-Novartis, Ipsen, Sanofi, Grünenthal Group, Otsuka, Biogen, Research Funding: Amgen (Inst), Daiichi Sankyo (Inst), IBSA (Inst), AstraZeneca (Inst), Research Funding: Alexion Pharmaceuticals (Inst), Bayer (Inst), Daiichi Sankyo (Inst), Pfizer (Inst), Bristol-Myers Squibb (Inst). Therefore, in consideration of recommended care for the target index condition, clinicians should review all other chronic conditions present in the patient and take those conditions into account when formulating the treatment and follow-up plan. This used to be called contribution-based ESA. No publications in the updated literature review addressed ESA continuation in nonresponders. Clinicians are urged to exercise caution in considering ESA use in patients with malignancy being treated with curative intent. Patients with a baseline HgB level of 10 to 12 g/dL had the greatest reduction in risk of RBC transfusion with ESA use. 0000002406 00000 n Ultimately, the choice of a particular agent will depend on cost, availability, convenience, and personal considerations or preference.40,41. ESAs should be discontinued following completion of a chemotherapy course of treatment. Changes to the work capability assessment which aim to improve the way it assesses the effect of cancer treatment are being introduced today, meaning many people will no longer be forced to work or look for work while dealing with the effects of the disease. Reprint requests: 2318 Mill Rd, Ste 800, Alexandria, VA 22314; [email protected], Conception and design: Julia Bohlius, Benjamin Djulbegovic, Massimo Martino, Laura Porter, Gianluca Trifirò, Alejandro Lazo-Langner, Collection and assembly of data: Julia Bohlius, Massimo Martino, Giannis Mountzios, Namrata Peswani, Laura Porter, Tiffany N. Tanaka, Gianluca Trifirò, Hushan Yang, Alejandro Lazo-Langner, Data analysis and interpretation: Julia Bohlius, Kari Bohlke, Roberto Castelli, Benjamin Djulbegovic, Maryam B. Lustberg, Massimo Martino, Giannis Mountzios, Laura Porter, Tiffany N. Tanaka, Gianluca Trifirò, Hushan Yang, Alejandro Lazo-Langner, Final approval of manuscript: All authors, Accountable for all aspects of the work: All authors.

Biosimilar and originator epoetin alfa had similar safety and efficacy in both CKD and cancer with one exception: among patients with cancer, biosimilar epoetin alfa was associated with lower overall mortality than the originator (HR, 0.82; 95% CI, 0.70 to 0.97), but this finding is not conclusive because residual confounding could not be excluded since more patients in the originator group died of cancer activity. ASCO and ASH convened an Expert Panel to review the evidence and revise previous recommendations as needed. RBC transfusion is also an option, depending on the severity of the anemia or clinical circumstances (Type: evidence based; Evidence quality: high; Strength of recommendation: strong). The ESA APPRISE Oncology program requires that all healthcare professionals who prescribe ESAs for patients with cancer do the following: Complete a training module that covers the use of ESAs.

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