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Recommendations for the Use of White Blood Cell Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update

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Recommendations for the Use of White Blood Cell Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update Recommendations for the Use of White Blood Cell Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update Table of Contents Data Supplement 1: Evidence tables by clinical question (study design, objectives, population, intervention, and results) Data Supplement 2: Additional Evidence Tables: Quality results for RCTs Data Supplement 3: Search Strategy String and Dates Data Supplement 4: QUOROM Diagram Data Supplement 5: Clinical Questions Data Supplement 1: CSF Evidence Tables Clinical Question 1, Primary Prophylaxis (page 3) Clinical Question 2: Secondary prophylaxis (page 17) Clinical Question 3, Therapeutic CSF (page 18) Clinical Question 4, Dose-Dense (page 20) Clinical Question 5, Stem-cell Transplantation (page 39) Clinical Question 6, Acute leukemia, MDS (no table; not being addressed) Clinical Question 7, Concomitant Chemotherapy and Radiation Therapy (page 53) Clinical Question 8, Older Adults (page 54) Clinical Question 9, Kids (page 56) Clinical Question 10, Administration and Dosing of CSFs (page 62) Clinical Question 11, Comparative Efficacy (page 70) Clinical Question 12, Radiation Injury (page 84) 2 Clinical Question 1, Primary Prophylaxis Author, year Publication Objectives Methods Results Conclusions type 1 NCCN 2014 Guideline To provide Primarily addresses adult patients Process starts with guidelines on the with solid tumors and non-myeloid risk assessment. use of myeloid malignancies Consider disease growth factors. type, chemotherapy regimen, patient risk factors, and treatment intent. Recommends prophylactic CSF if FN risk is ≥20%. Vehreschild Guideline To provide Comprehensive literature search Confirmed many key 20142 evidence-based and expert panel consensus recommendations recommendations given by international for the use of G- guidelines. Evidence CSF, pegylated G- for growth factors CSF, and during acute myeloid biosimilars to leukemia induction prevent infectious chemotherapy complications in and pegfilgrastim use cancer patients in hematological undergoing malignancies was chemotherapy, rated lower compared including those with with other guidelines. hematological malignancies 3 Author, year Publication Objectives Methods Results Conclusions type Lyman Meta- To provide a 59 RCTs with 61 separate RR for mortality All-cause mortality is 3 2013 analysis systematic review comparisons. reduced in patients and evidence Group 1 (same dose receiving summary of the Considered studies of cancer and schedule of chemotherapy with impact of G-CSF patients receiving conventional chemotherapy): primary G-CSF support on dose chemotherapy for solid RR=0.96, 95% CI 0.92 support. The greatest chemotherapydose tumors or malignant lymphoma and to 1.01 impact was observed intensity and randomized to primary G-CSF in RCTs in patients overall mortality. support in one arm versus a control Group 2 (dose-dense receiving dose-dense group without initial G-CSF. chemotherapy in one schedules arm): RR=0.89, 95% CI 0.85 to 0.94 Group 3 (dose- escalated chemotherapy in one arm): RR=0.92, 95% CI 0.85- 0.99 Group 4 (substitution or addition of a drug in one arm): RR=0.94, 95% CI 0.89- 0.99 Overall: RR=0.93, 95% CI 0.90- 0.96 4 Author, year Publication Objectives Methods Results Conclusions type Kirshner RCT To assess an Study population: adults with a Mean AUC for pain Naproxen at a dose 4 2012 intervention for diagnosis of nonmyeloid cancer, Naproxen: 6.04 of 500 mg twice per pegfilgrastim- scheduled for their first dose of Placebo: 7.71 day is effective in induced bone pain. pegfilgrastim on day 2, 3, or 4 of p=0.037 reducing the their chemotherapy cycle incidence and Maximum pain severity of Intervention: Naproxen vs placebo Naproxen: 2.59 pegfilgrastim-induced in patients receiving pegfilgrastim. Placebo: 3.40 bone pain. Naproxen (500 mg two times per p=0.005 day) on the day of pegfilgrastim and continuing for 5 to 8 days after Overall pain incidence pegfilgrastim Naproxen: 61.1% Placebo:71.3% p=0.020 Sample size: Arm 1: 257 Arm 2: 253 Pain duration Naproxen: 1.92 days Placebo: 2.40 days p=0.009 Severe pain incidence Naproxen: 19.2% Placebo:27.0% p=0.048 5 Author, year Publication Objectives Methods Results Conclusions type Renner Meta- To assess the Selected RCTs comparing CSFs Proportion of patients In patients with breast 20125 analysis effect of (any dose) with placebo or no with FN: RR 0.27; 95% cancer receiving prophylactic treatment in patients with breast CI 0.11 to 0.70 (with chemotherapy, CSFs colony-stimulating cancer at any stage, at risk of heterogeneity) have shown evidence factors (CSFs) in developing FN while undergoing of bene fi t in the reducing the any type of chemotherapy. Infection-related prevention of FN. incidence and mortality: There is evidence, duration of FN, and RR 0.14; 95% CI 0.02 though less reliable, all-cause and to 1.29 of a decrease of all- Included eight RCTs, involving 2156 infection-related cause mortality during participants, carried out between mortality during Risk for hospitalization: chemotherapy and a 1995 and 2008. chemotherapy in RR 0.14; 95% CI 0.06 reduced need for patients with breast to 0.30 hospital care. No cancer reliable evidence was IV antibiotics: found for a reduction RR 0.35; 95% CI 0.22 of infection-related to 0.55 mortality, a higher dose intensity of chemotherapy with CSFs or diminished rates of severe neutropenia and infections. The majority of adverse events reported from CSF use were bone pain and injection-site reactions but no conclusions could be drawn regarding late- term side effects. 6 Author, year Publication Objectives Methods Results Conclusions type Aapro 20116 Guideline To update EORTC Systematic literature review up to Recommends that patient-related adverse risk guidelines for the July 2009. factors, such as elderly age (>/=65 years) and use of granulocyte- neutrophil count be evaluated in the overall colony stimulating assessment of FN risk before administering factor to reduce the each cycle of chemotherapy. It is important that Excluded studies of children, cost incidence of after a previous episode of FN, patients receive analyses, studies of leukemia. chemotherapy- prophylactic administration of G-CSF in induced febrile subsequent cycles. neutropenia in adult patients with Prophylactic G-CSF continues to be lymphoproliferative recommended in patients receiving a disorders and solid chemotherapy regimen with high risk of FN. tumors When using a chemotherapy regimen associated with FN in 10-20% of patients, particular attention should be given to patient- related risk factors that may increase the overall risk of FN. In situations where dose-dense or dose-intense chemotherapy strategies have survival benefits, prophylactic G-CSF support is recommended. Similarly, if reductions in chemotherapy dose intensity or density are known to be associated with a poor prognosis, primary G-CSF prophylaxis may be used to maintain chemotherapy. Clinical evidence shows that filgrastim, lenograstim and pegfilgrastim have clinical efficacy and we recommend the use of any of these agents to prevent FN and FN-related complications where indicated. Filgrastim biosimilars are also approved for use in Europe. 7 Author, year Publication Objectives Methods Results Conclusions type Cooper Meta- To assessed the Assessed 20 studies of primary G- Reduction in FN Primary prophylaxis 20117 analysis effectiveness of G- CSF prophylaxis with no primary G- incidence with primary with G-CSFs CSFs pegfilgrastim, CSF prophylaxis: five studies of versus no primary G- significantly reduces filgrastim or pegfilgrastim; ten of filgrastim; and CSF FN incidence in lenograstim) in five of lenograstim. adults undergoing reducing FN Pegfilgrastim: chemotherapy for incidence in adults Five studies compared pegfilgrastim RR 0.30, 95% CI 0.14 solid tumors or undergoing with filgrastim to 0.65 lymphoma. chemotherapy for Pegfilgrastim reduces solid tumors or Filgrastim: FN incidence to a lymphoma. RR 0.57, 95% 0.48 to significantly greater 0.69 extent than filgrastim. Lenograstim: RR 0.62, 95% CI 0.44 to 0.88 Pegfilgrastim vs filgrastim RR 0.66, 95% CI 0.44 to 0.98 8 Author, year Publication Objectives Methods Results Conclusions type Kuderer Meta- To assess primary 17 RCTs Febrile neutropenia Confirmed that 20118 analysis prophylaxis with G- G-CSF: 22.4% primary prophylaxis CSF in adults with Control: 39.5% with G-CSF a solid tumor or RR=0.54, 95% CI 0.43 significantly reduces malignant to 0.67 the risk of FN in lymphoma patients undergoing Infection-related conventional mortality chemotherapy across G-CSF: 1.5% a broad range of Control: 2.8% baseline risk. RR=0.55, 95% CI 0.34- 0.90 There was a reduction in infection- Early all-cause mortality related and all-cause G-CSF: 3.4% early mortality in Control: 5.7% patients randomized RR=0.60, 95% CI 0.43- to receive primary 0.83 prophylaxis with G- CSF. Relative dose intensity G-CSF: median 95.5% Control: median 88.5% Bone and musculoskeletal pain G-CSF: 19.6% Control: 10.4% RR=4.02, 95% CI 1.56- 7.52 9 Author, year Publication Objectives Methods Results Conclusions type Wildiers Systematic To help define the English-language publications Many breast cancer 20119 review impact of relative between 1995 and 2008 evaluating patients do not dose intensity (RDI) standard 3- or 4-weekly achieve planned RDI. and the role of chemotherapy regimens. Older age, obesity growth factor and febrile support on 30 breast cancer studies and 15 neutropenia are outcomes in breast lymphoma studies. associated with cancer and reduced
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