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Complications of Cancer Chemotherapy

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Complications of Cancer Chemotherapy BHS TRAINING COURSE AND SEMINARS Seminar 4 – Supportive care in Hematology February 20, 2016 Philippe Lewalle Hematopoietic Growth Factors I. Granulocyte colony stimulating factors: G-CSFs II. Epoietins: synthetic erythropoietin's III. Synthetic platelets growth factor: Thrombopoeitin analog I. Granulocyte colony stimulating factors: G-CSFs Complications of Chemotherapy induced Neutropenia Myelosuppressive chemotherapy Neutropenia Febrile neutropenia (FN) Chemotherapy dose delays and dose reductions Complicated life- threatening infection and Decreased relative dose prolonged hospitalization intensity (RDI) Reduced survival Kuderer NM et al. Cancer 2006;106:2258–2266 Chirivella I et al. J Clin Oncol 2006;24;abstract 668 Bosly A et al. Ann Hematol 2007, advance access published 20 October 2007; doi:10.1007/s00277-007-0399-y Granulocyte Colony Stimulating Factors G-CSF effect on Neutrophils Controls proliferation of committed progenitor cells Acts to increase the influences their maturation into mature neutrophils. phagocytic activity Stimulates the release of neutrophils from bone marrow of mature storage pools and reduces their maturation time. neutrophils. Dexter TM, 1994. - Dexter TM. Eur J Cancer 1994;30A(3):S15-19. Different innovative recombinant G-CSF molecules ● Neupogen ® (Filgrastim) is an Escherichia coli- derived modified recombinant human granulocyte colony stimulating factor (G-CSF) protein, non- glycosylated and having an extra methionine group at the N-terminal end of the peptide chain. ● Granocyte ® (lenograstrim) is a Chinese hamster ovary-derived G-CSF consisting of 174 amino acids with 4% carbohydrate, indistinguishable from native G-CSF. ● Neulasta® (pegfilgrastim) is a pegylated version of Neupogen™ ● Lonquex ® (lipegfilgrastrim) is also a pegylated filgrastim but with a different site of pegylation Filgrastim Daily injection Mean 12 injections (11-16) Variation of neutrophils count Clinical practice : 5-6 injections between injections Pegfilgrastim Clearance is Neutrophil count dependant 1 injection per cycle = 12 injections of filgrastim Neulasta® Pharmacokinetics ●Renal impairment had no influence on PK ●Maximum Neulasta® concentration was achieved approximately 30 hours after SC administration ●Volume of distribution at steady state approximated plasma volume/central compartment ●Elimination is primarily via a neutrophil- mediated clearance mechanism ●Half-life variable: chemotherapy setting 33 hrs compared to 3.37 hours for filgrastim Pediatric Aspects of the Neulasta® Label The safety and effectiveness of Neulasta™ in pediatric patients have not been established. The 6 mg fixed dose single-use syringe formulation should not be used in infants, children, and smaller adolescents weighing less than 45 kg. Adverse Effects of G-CSFs ► Injection site disconfort ► Bone pain (20 to 30%): no difference for filgastrim or Pegfilgastrim. ► AML/MDS ? Meta-analysis : 12000 patients 43 versus 22 AML/MDS (RR 1.92) ► Splenic rupture ► Increase Bleomycin-related pulmonry toxicity (26% vs 9%) Meta-analysis of Randomized Controlled Trials Relative risk of FN Pegfilgrastim (Neulasta) 73% Filgastrim (Neupogen) 57% Lenogastrim (Granocyte) 63% Pegfilgrastim (NF 11%) > Filgastrim (NF19%) Lipegfilgrastim (Lonquex) 52 % Pegfilgrastim = Lipegfilgrastim Li Wang et al : Support Care Cancer. 2015; 23(11): 3131–3140. Efficacy of primary prophylactic G-CSF ( pegfilgrastim, filgrastim or lenograstim versus placebo ) Aapro: Support Care Cancer. 2010 May; 18(5): 529–541. Efficacy of G-CSFs in preventing infection-related mortality, early mortality and febrile neutropenia 3,493 patients treated with chemotherapy for solid tumours or lymphoma. Aapro: Support Care Cancer. 2010 May; 18(5): 529–541. Overview of the 6 EORTC recommendations (2010) ► Recommendation 1: Patient-related risk factors for increased incidence of FN and complications of FN* ► Recommendation 2: Chemotherapy regimens associated with increased risk of FN ► Recommendation 3: G-CSF to support intensive chemotherapy regimens** ► Recommendation 4: Impact of the overall FN risk on G-CSF use ► Recommendation 5: G-CSF in patients with existing FN ► Recommendation 6: Choice of formulation * Note that this title has changed compared to the 2006 guidelines (patient- related risk factors for increased incidence of FN ) ** Note that this title has changed compared to the 2006 guidelines (G-CSF to support chemotherapy) Recommendation 1 Patient-related risk factors for increased incidence of FN and complications of FN THE PATIENT: patient-related factors that may increase the risk of FN should be assessed before each chemotherapy cycle ► Age >65 years, advanced disease, previous episodes of FN or lack of G-CSF and absence of antibiotic prophylaxis ,Medical history, Disease characteristic • Recommendation grade: B •Addition: ‘Please note that the indiscriminate use of antibiotic prophylaxis for patients undergoing treatment for solid tumours or lymphoma is not recommended…’ FN Cumulative risk probability regarding the number of independant risk factors Age>65 years Renal disease Cardio-vascular disease Hb< 12gr/dl Planing Dose IDR ≥ 80% No GCSF prophylaxis Lyman GH et al. Oncol 2005;10:427-437 Primary Prophylactic CSF Administration: Special Circumstances ► When the following clinical factors are present, primary prophylaxis with CSF is often appropriate even with regimens with FN rates of <20% : ● Age >65 years ● Poor performance status ● Previous FN ● Poor nutritional status ● Open wounds or active infections ● More advanced cancer ● Extensive prior treatment, including large XRT ports ● Administration of combined chemoradiotherapy ● Cytopenias due to bone marrow involvement by tumor ● Other serious comorbidities Recommendation 2 Chemotherapy regimens associated with increased risk of FN THE TREATMENT: consideration should be given to the elevated risk of FN when using certain chemotherapy regimens G- CSF should be administered after autologous stem-cell transplantation • Recommendation grade: A/B (varies per regimen) Common chemotherapy regimens associated with intermediate or high risk of FN added in 2010 Malignancy FN risk category (%) Chemo regimen FN risk (%) NHL/CLL >20 R-ESHAP as salvage 33.5 after prior rituximab (R) NHL/CLL >20 Hyper CVAD + 11.5-24 with PP rituximab (Burkitt’s Lymphoma) ICE/R-ICE Stanford V Grade 3-4 neutrop 25% MOPPEB-VCAD Grade 3-4 neutrop 49% FC 35 FC 10% despite PP FCR Grade 3-4 neutrop 33.7% Common chemotherapy regimens associated with intermediate or high risk of FN added in 2010 Malignancy FN risk category (%) Chemo regimen FN risk (%) NHL/CLL 10-20 Dose adjusted 19% of cycles EPOCH 51 Mega CHOP-R- 15 Ara-C cyclophos- phamide (mantle cell) RGemP 61% grade 3/4 neutrop RGemOx (elderly) 43% grade 3/4 neutrop Hodgkin’s >20 BEACOPP >90% grade 4 Disease leukopenia 54% grade 3/4 neutrop 10% septic deaths Common chemotherapy regimens associated with intermediate or high risk of FN added / in 2010 Malignancy FN risk category (%) Chemo regimen FN risk (%) Hodgkin’s >20 ABVD (Hodgkin’s 4 Disease Lymphoma) CEC 48% grade 3/4 neutrop IGEV 28% grade 3/4 neutrop NHL R-CHOP/CHOP DA-EPOCH RICE/ICE HD IGEV Recommendation 3 G-CSF to support intensive chemotherapy regimens THE PURPOSE OF THE TREATMENT: prophylactic G-CSF should be used to support chemotherapy: ► When dose-dense or dose-intense chemotherapy strategies have survival benefits : No other equally effective and safe regimen that does not require CSFs is available. ► If reductions in chemotherapy dose intensity or density are known to be associated with a poor prognosis • Recommendation grade: A Recommendation 4 Impact of the overall FN risk on G-CSF use FROM RECOMMENDATIONS 1, 2 AND 3 ONE CONCLUDES: Prophylactic G-CSF is recommended if the risk of FN associated with chemotherapy is ≥20% ● Patient characteristics that may increase FN risk should be assessed in those receiving regimens associated with a 10–20% risk of FN • Recommendation grade: A Secondary Prophylactic CSF ► Secondary prophylaxis with a CSF is recommended for patients who experienced a neutropenic complication from a prior cycle of chemotherapy (for which primary prophylaxis was not received), in which a reduced dose or treatment delay may compromise disease-free or overall survival or treatment outcome. In many clinical situations, dose reduction or delay may be a reasonable alternative. ► Dose-dense regimens with CSF support should only be used if supported by convincing efficacy data or within a clinical trial. (There are limited and conflicting data on the value of dose-dense regimens with CSF support in non- Hodgkin lymphoma, and it cannot routinely be recommended.) ► CSFs should not be routinely used for patients with neutropenia who are afebrile. Recommendation 5: Treatment G-CSF in patients with existing FN EXISTING FN: G-CSF treatment should be considered for patients with ongoing FN who do not respond to expert antibiotics management ● This may reduce the risk of infection-related mortality/morbidity in patients at impending risk of FN-related life-threatening infections, such as severe sepsis or septic shock ● CSFs should not be routinely used as adjunctive treatment with antibiotic therapy for patients with fever and neutropenia. Only if high risk for infection-associated complications or prognostic factors predictive of poor clinical outcomes. • Recommendation grade: B Recommendation 6 Choice of formulation WHICH G-CSF?: The use of filgrastim, lenograstim or pegfilgrastim is recommended to prevent FN or FN-related complications,
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