Intermediate Febrile Neutropenia Risk Research Articles

A prospective, real-world, multinational study of febrile neutropenia (FN) occurrence in oncology patients receiving chemotherapy with intermediate risk of FN: a MASCC Neutropenia, Infection, and Myelosuppression Study Group initiative

PurposeLimited knowledge is available on the incidence of febrile neutropenia (FN) in intermediate-risk patients and the rationale for use of granulocyte colony-stimulating factor (G-CSF) in these patients. We aimed to estimate the rate at which patients associated with intermediate risk (10–20%) of FN would develop ≥ 1 episode of FN with a commonly used chemotherapy regimen in clinical practice.MethodsThis prospective, real-world, observational, multinational, multicenter study (December 2016–October 2019) recruited patients with solid tumors or Hodgkin’s/non-Hodgkin’s lymphoma. Patients receiving chemotherapy with intermediate risk of FN, but not G-CSF as primary prophylaxis were included and observed for the duration of the chemotherapy (≤ 6 cycles and ≤ 30 days after the last chemotherapy administration).ResultsIn total, 364 patients (median age, 56 years) with 1601 cycles of chemotherapy were included in the analysis. The incidence of FN was 5% in cycle 1, 3% in cycles 2–3, and 1% in cycles 4–6. The rate of patients with ≥ 1 episode of FN was 9%, and 59% of FN events were reported during cycle 1. The rate of grade 4 neutropenia in cycle 1 was 11%, and 15% of patients experienced ≥ 1 episode of grade 4 neutropenia.ConclusionsOverall, the incidence of FN was low, with a high incidence in cycle 1 and a decrease in the subsequent cycles. These results provide the real FN risk for common chemotherapy regimens in patients generally excluded from clinical trials. Prophylactic G-CSF in intermediate-risk patients could be considered as per clinician’s judgement.

An exploratory comparative effectiveness analysis of febrile neutropenia incidence among patients with cancer receiving granulocyte colony stimulating factors.

408 Background: We conducted an exploratory comparative effectiveness analysis comparing various G-CSF (pegfilgrastim/filgrastim) products to each other in incidence of febrile neutropenia (FN) among patients with breast, lung, colon, pancreatic, ovarian cancers or non-Hodgkin’s lymphoma (NHL) in the Biologics and Biosimilars Collective Intelligence Consortium’s (BBCIC) Distributed Research Network. Methods: We included patients aged > = 20 years who, in 2015-2019, per insurance claims, received any pegfilgrastim or filgrastim products as febrile neutropenia (FN) prophylaxis during the first cycle of chemotherapy posing a high or intermediate FN risk per National Comprehensive Cancer Network guidelines. We compared the FN risk starting at day 5 following day 1 of chemotherapy receipt between products using Poisson regression model with standardized inverse probability weights and robust variance to estimate the Relative Risk (RR) and 95% Confidence intervals (CI). Results: A total of 15,941 patients received a pegfilgrastim product in cycle 1 of chemotherapy: 15,115 (95%) pegfilgrastim, 484 (3%) pegfilgrastim_cbqv, 342 (2%) pegfilgrastim_jmdb. 565 patients received a filgrastim product: 284 (50%) filgrastim, 201 (36%) filgrastim_sndz, 80 (14%) tbo-filgrastim. FN events by product were: 346 pegfilgrastim (2.3% of users), 11 pegfilgrastim_cbqv (2.3%), 8 pegfilgrastim_jmdb (2.3%), 13 filgrastim (4.6%), 5 filgrastim_sndz (2.5%), 2 tbo-filgrastim (2.5%). We found no difference in FN incidence when comparing pegfilgrastim_cbqv to pegfilgrastim (RR 0.83, 95% CI 0.41-1.69), pegfilgrastim_jmdb to pegfilgrastim (RR 1.03, 95% CI 0.56-1.92), and pegfilgrastim_jmdb to pegfilgrastim_cbqv (RR 1.11, 95% CI 0.45-2.74). Similarly, we found no difference in FN incidence when comparing filgrastim_sndz to filgrastim (RR 0.46, 95% CI 0.17-1.28), tbo-filgrastim to filgrastim (RR = 0.30, 95% CI 0.06-1.36), or tbo-filgrastim to filgrastim_sndz (RR 0.54, 95% CI 0.10-2.77). Adverse events were rare, with similar rates observed among all products. Conclusions: We observed no significant difference in FN incidence among patients when comparing various G-CSF products, including when biosimilars were compared to their reference counterparts.

A pragmatic cluster-randomized trial of a standing physician order entry intervention for colony stimulating factor use among patients at intermediate risk for febrile neutropenia (SWOG S1415CD).

1518 Background: Primary prophylactic colony stimulating factors (PP-CSF) are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia (FN) but their benefit for regimens with intermediate FN risk is uncertain. Within a pragmatic, randomized trial of a standing order entry (SOE) intervention for prescribing PP-CSF, we designed a substudy to evaluate the effectiveness of PP-CSF for patients receiving therapy with intermediate FN risk. Methods: TrACER was a cluster randomized trial where NCI community Oncology Research Program practices were randomized to usual care (UC) or a guideline-based SOE intervention. In the primary study, sites were randomized 3:1 to a SOE of automated PP-CSF orders for NCCN-designated high FN risk chemotherapy regimens and alerts against PP-CSF orders for low FN risk regimens (intervention) versus usual care. A secondary randomization assigned intervention sites to a SOE intervention either to prescribe or not prescribe PP-CSF for patients receiving intermediate FN risk regimens. Clinicians were allowed to override the SOE. Patients age ≥18 with either breast, colorectal or non-small cell lung cancer were enrolled and followed for 12 mo. PP-CSF was defined as initiation within 24-72 hours after systemic chemotherapy. Sample size calculations were based on an FN risk reduction from 15% to 7.5%, and provided 80% power at a planned enrollment of 90 patients per site. Mixed effect logistic regression models were used to test differences between sites randomized to prescribe or not prescribe PP-CSF. Results: Between January 2016 and April 2020, 24 sites (2,287 patients) were randomized to the intervention. Among intervention sites, 12 were randomized to either SOE to prescribe or an alert to not prescribe PP-CSF for the 542 patients receiving intermediate FN risk regimens. Rates of PP-CSF use were higher among sites randomized to prescribe PP-CSF (37.1% vs 9.9%, OR = 5.90 (95% CI 1.72-20.20; p = 0.0048)). Overall, the rates of FN were low and identical between PP-CSF and no PP-CSF arms (3.7% vs 3.7%). Among patients who did not receive PP-CSF, rates of FN were also low and similar between arms (3.8% vs 4.1%). Conclusions: While implementation of a SOE intervention for PP-CSF significantly increased PP-CSF use among patients receiving intermediate risk regimens, FN rates did not differ between arms. Despite SOE, 63% of patients assigned to receive PP-CSF did not receive it. FN rates overall were lower than expected and did not differ between patients that did or did not receive PP-CSF. Although this guideline-informed SOE influenced prescribing, the results suggest that neither the SOE nor PP-CSF itself provide sufficient benefit to justify their use for persons receiving intermediate FN risk regimens. Clinical trial information: NCT02728596.

Efficacy and Safety for the Use of Half-Dosed Pegylated Granulocyte Colony-Stimulating Factors in Preventing Febrile Neutropenia During Chemotherapy in Patients With Malignant Tumors: A Multicenter, Open-Labeled, Single-Arm Phase 2 Trial.

BackgroundProphylactic granulocyte-colony stimulating factor (G-CSF) has been shown to effectively prevent febrile neutropenia (FN) and grade 3/4 neutropenia during myelosuppressive treatment. The present study reports the clinical efficacy and safety of the prophylactic use of G-CSF with a half dose for cancer patients with an intermediate risk of FN combined with ≥1 patient-specific risk during multiple chemotherapy.MethodsThis multicenter, one-arm, and open-label clinical study involved 151 patients [median age, 54 years old (range, 46.0–62.5); 38.4% female] with malignant tumors, including >20 different cancers. These patients underwent a total of 604 cycles of chemotherapy and received a half dose of PEG-rhG-CSF administration prior to each cycle.ResultsThe incidence rate of FN was 3.3% for this cohort during chemotherapy. Chemotherapy delay occurred in 6 (4.0%) patients for 12 (2.0%) cycles. Early termination of cancer treatment occurred in 14 (9.3%) patients. In this cohort, 23 (15.2%) patients required antibiotic use during courses of chemotherapy. A total of 28 (18.5%) patients experienced clear adverse effects during cancer treatment.ConclusionThe prophylactic PEG-rhG-CSF with a half dose can both efficaciously and safely prevent neutropenia for patients of diverse cancers with an intermediate risk of FN combined with ≥1 patient-specific risk during chemotherapy.

Impact of the Oncology Care Model on Use of Supportive Care Medications During Cancer Treatment.

The Oncology Care Model (OCM) is an episode-based alternative payment model for cancer care that seeks to reduce Medicare spending while maintaining care quality. We evaluated the impact of OCM on appropriate use of supportive care medications during cancer treatment. We evaluated chemotherapy episodes assigned to OCM (n = 201) and comparison practices (n = 534) using Medicare claims (2013-2019). We assessed denosumab use for beneficiaries with bone metastases from breast, lung, or prostate cancer; prophylactic WBC growth factor use for beneficiaries receiving chemotherapy for breast, lung, or colorectal cancer; and prophylactic use of neurokinin-1 (NK1) antagonists and long-acting serotonin antagonists for beneficiaries receiving chemotherapy for any cancer type. Analyses used a difference-in-difference approach. After its launch in 2016, OCM led to a relative reduction in the use of denosumab for beneficiaries with bone metastases receiving bone-modifying medications (eg, 5.0 percentage point relative reduction in breast cancer episodes [90% CI, -7.1 to -2.8]). There was no OCM impact on use of prophylactic WBC growth factors during chemotherapy with high or low risk for febrile neutropenia. Among beneficiaries receiving chemotherapy with intermediate febrile neutropenia risk, OCM led to a 7.6 percentage point reduction in the use of prophylactic WBC growth factors during breast cancer episodes (90% CI, -12.6 to -2.7); there was no OCM impact in lung or colorectal cancer episodes. Among beneficiaries receiving chemotherapy with high or moderate emetic risk, OCM led to reductions in the prophylactic use of NK1 antagonists and long-acting serotonin antagonists (eg, 6.0 percentage point reduction in the use of NK1 antagonists during high emetic risk chemotherapy [90% CI, -9.0 to -3.1]). OCM led to the reduced use of some high-cost supportive care medications, suggesting more value-conscious care.

Association of febrile neutropenia (FN) risk factors (RFs) with incident FN in U.S. commercial and Medicare advantage patients receiving intermediate-risk chemotherapy for non-myeloid cancers between 2009 and 2019.

e18607 Background: FN after myelosuppressive chemotherapy may result in significant morbidity/mortality and increase healthcare costs due to interventions such as hospitalization. For patients receiving chemotherapy at intermediate-risk of FN, guidelines recommend assessing patient-specific FN RFs to decide whether to provide primary prophylaxis. However, there is a paucity of real-world data that quantifies the FN risk based on patient RFs when receiving intermediate-risk chemotherapy. Thus, we examined the association of FN RFs with incident FN in the first and subsequent cycles in patients at intermediate-risk of chemotherapy-induced FN within the real-world. Methods: This retrospective cohort study used the Optum Research Database to identify US commercial and Medicare Advantage patients with a non-myeloid malignancy who were treated between 01 Jan 2009 and 31 Dec 2019 with a first-line intermediate-risk chemotherapy regimen. The following FN RFs were identified based on ICD or procedure codes on claims during the 6 months prior to chemotherapy, unless otherwise stated: radiation, neutropenia, liver dysfunction, renal dysfunction, age > 65 years, metastases to the bone, and surgery during the 30 days prior. FN was defined as ICD codes for neutropenia and fever on a claim. Patients without previous FN were followed for FN from five days after index through the earliest of the following: 1) FN, 2) 31 Dec 2019, 3) death, 4) health plan disenrollment, or 5) end of chemotherapy line or cycle (depending on time frame of interest). Cox regression was used to calculate HRs for incident FN. Results: The study included 13,937 patients, and the most common RFs were 1) recent surgery (84%), 2) age > 65 (67%), and 3) liver dysfunction (31%). Compared to patients with no individual RFs, each additional RF was associated with a greater risk of FN during both the first and subsequent cycles, although confidence intervals were large (Table). Conclusions: Among patients at intermediate-risk of chemotherapy-induced FN, patients with more individual RFs for FN had a higher risk of FN during both the first and all cycles. These results underscore the importance of RF analysis in prophylaxis decisions for patients at intermediate-risk of chemotherapy-induced FN.[Table: see text]

Cost-effectiveness of filgrastim-sndz as primary prophylaxis (PP) versus secondary prophylaxis (SP) to prevent chemotherapy-induced febrile neutropenia (FN) in breast cancer patients at intermediate risk.

73 Background: According to clinical practice guidelines, the threshold for routine myeloid growth factor (MGF) PP is a high risk (>20%) of developing FN. However, in response to the COVID-19 pandemic, a recent recommendation expands this threshold for using MGF PP to include patients at intermediate risk (10-20%) of developing FN, with the goal of reducing emergency room and hospital visits. Patients with breast cancer receiving potentially curative chemotherapy consisting of docetaxel or paclitaxel (every 21 days) are at an intermediate risk (10-20%) of developing FN. This study evaluates the cost-effectiveness of PP vs. SP using a biosimilar MGF, filgrastim-sndz, in early-stage breast cancer patients at intermediate risk of FN. Methods: A Markov model with a lifetime horizon was constructed to evaluate the total costs and clinical outcomes when using filgrastim-sndz as PP vs. SP in 56 year old early-stage breast cancer patients receiving adjuvant docetaxel (following doxorubicin/cyclophosphamide) every 3 weeks for 4 cycles. Patients had ≥1 FN risk factor (i.e., recent surgery) without the receipt of anti-HER2 therapy, representing a 16% baseline FN risk. Average Sales Price (ASP) calculated from the Centers for Medicare & Medicaid Services July 2020 ASP Drug Pricing File was used as the filgrastim-sndz cost. Incremental cost-effectiveness ratios (ICERs) were calculated for cost per FN event avoided, life-year saved (LYS), and quality-adjusted life-year (QALY) gained from a United States payer perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. Results: Filgrastim-sndz as PP vs. SP provided an additional 0.102 FN events avoided, 0.065 LYS, and 0.056 QALYs at an incremental cost of $2,106. The ICERs were $20,656, $32,624 and $37,333 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. In the PSA, the likelihood of cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per QALY gained was 71.3%. Conclusions: For early-stage breast cancer patients at intermediate risk of FN receiving adjuvant docetaxel with 1 or more risk factors, PP with filgrastim-sndz compared to SP is cost-effective based on a WTP threshold of $50,000/QALY. [Table: see text]

1715P Plinabulin (Plin) is a more favorable option for the prevention of chemotherapy induced neutropenia (CIN) than pegfilgrastim (Peg) during the COVID-19 pandemic

Due to COVID-19, the NCCN Myeloid Growth Factor Panel expanded prophylactic G-CSF use to chemotherapy with Intermediate Risk (10%-20% risk) of Febrile Neutropenia (FN), and to Low Risk FN patients (pts) who previously developed FN. Preservation of resources for COVID-19 pts by reducing hospitalizations and emergency room visits by cancer chemotherapy pts is the intent of these changed recommendations. Other recommendations include use of self-injecting or on-body injector Peg, to minimize COVID-19 exposure at outpatient center by cancer pts and limiting prophylactic platelet transfusion to preserve blood product supply. Plin is an attractive alternative: it is a novel, non-G-CSF small molecule with CIN protection comparable to Peg, is given once 30 minutes after Chemo, and avoids the need for healthcare system touches on Day 1-3 for G-CSF administration. In contrast to Peg, Plin does not cause bone pain and thrombocytopenia and maintains quality of life. We compared the combined CIN data with single agent (SA) Plin 20 mg/m2 (n=29) vs. SA Peg 6mg (n=35) from 2 different phase II CIN studies over 4 cycles: 1. Study 105 in NSCLC pts given Intermediate FN Risk Docetaxel 75 mg/m2 (Doc) pts with risk factors), and 2. Study 106 in Breast cancer pts given High FN Risk Doc +Doxorubicin 50 mg/m2 + Cyclophosphamide 50mg/m2 (TAC). Plin was given as a single IV infusion on Day (D)1, 30 min after the last Chemo, and Peg 6mg given on D2 by SC injection. Grade 4 Neutropenia (Gr 4 N), Hospitalizations (Hosp), Infection rate (Inf), Sepsis (Sep), all Grade Thrombocytopenia (T) or Gr 2/3 T and Bone Pain (BoP) is summarized for SA Plin and SA Peg. (NS= non-significant). Table: 1715PGr 4 NHospInfSepAll Gr TGr 2/3 TGr 3 TBoPPegfilgrastim42.9%11.4%5.71%0%68.6%20%8.57%YesPlinabulin44.8%13.8%6.90%3.44%24.1%3.4%0%Nop-valueNSNSNSNS0.00020.0250.06- Open table in a new tab . Plin requires at least 50% fewer touches to the health care system and is equally effective as Peg for prevention of CIN and its clinical sequelae. Plin causes less thrombopenia and bone pain. Plin (given as a 40 mg fixed dose) is currently in two phase III trials for CIN.

Cost-effectiveness of filgrastim-sndz as primary prophylaxis (PP) versus secondary prophylaxis (SP) to prevent chemotherapy-induced febrile neutropenia (FN) in non-small cell lung cancer (NSCLC) patients at intermediate risk.

e19401 Background: Patients with nonmetastatic NSCLC receiving platinum-based chemotherapy are at an intermediate risk (10-20%) of developing FN; clinical practice guidelines recommend assessing whether these patients have FN risk factors before considering myeloid growth factor (MGF) prophylaxis. Most NSCLC patients receiving chemotherapy have ≥1 FN risk factors, and while PP leads to lower rates of FN across all cycles, it is more costly compared to SP. This study evaluates the cost-effectiveness of PP vs. SP using a biosimilar MGF, filgrastim-sndz, in NSCLC patients at intermediate risk of FN. Methods: A Markov model with a lifetime horizon was constructed to evaluate the total costs and clinical outcomes of using filgrastim-sndz as PP vs. SP in NSCLC patients 61 years old receiving adjuvant carboplatin/paclitaxel every 3 weeks for 4 cycles. Separate analyses were conducted for patients with 0 FN risk factors (0RF) and with ≥1 FN risk factors (1+RF), representing 11.3% and 18% baseline FN risk, respectively. Incremental cost-effectiveness ratios (ICERs) were calculated for cost per FN event avoided, life-year saved (LYS), and quality-adjusted life-year (QALY) gained from a United States payer perspective. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. Results: For patients with 0RF, use of filgrastim-sndz as PP vs. SP provided an additional 0.056 QALYs (0.079 LYS) at an incremental cost of $3,266. The ICERs were $46,815, $41,555, and $58,531 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. For patients with 1+RF, PP vs. SP added 0.090 QALYs (0.127 LYS) at an incremental cost of $1,605. The ICERs were $13,970, $12,644, and $17,805 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. In the PSA, the likelihood of cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per QALY gained was 31.7% for patients with 0RF and 96.6% for 1+RF. Conclusions: For NSCLC patients at intermediate risk of FN receiving adjuvant carboplatin/paclitaxel with 1+RF, PP with filgrastim-sndz compared to SP is cost-effective based on a WTP threshold of $50,000/QALY. [Table: see text]

Outcomes of Primary and Secondary Prophylaxis of Chemotherapy Induced and Febrile Neutropenia (CIN/FN) in Bendamustine Plus Rituximab (BR) Regimens in Patients with Lymphoma and Chronic Lymphocytic Leukemia (CLL): Real-World, Single-Center Experience

Introduction: Granulocyte stimulating growth factors (G-CSF) such as filgrastim or pegfilgrastim are indicated as prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). BR regimen is considered an intermediate FN risk (10-20%) per National Comprehensive Cancer Network guidelines. Therefore, patients receiving BR need to be assessed using patient specific risk factors to evaluate the need for primary prophylaxis. This study evaluates real-world patterns and outcomes associated with primary and secondary G-CSF prophylaxis in patients with B-cell lymphoma and CLL treated with BR. Methods: Retrospective chart review of all lymphoma or CLL patients treated with BR from 11/2013 through 6/2019 at the University of Arizona Cancer Center was conducted. Baseline demographic and chemotherapy cycle data was analyzed through Chi-Squared test and Unpaired t-test with a-priori p-value of 0.05 being considered statistically significant. Results: Eighty-five patients met inclusion criteria. Of these, 48 received G-CSF during all chemotherapy cycles for primary prophylaxis while 37 received G-CSF only for secondary prophylaxis. Same-day pegfilgrastim compared to next-day pegfilgrastim or filgrastim was the most common G-CSF dosing utilized with primary and secondary prophylaxis patients receiving it (87.5%, 94.6%) respectively. As shown in Table, primary and secondary prophylaxis groups were similar on baseline characteristics (p>0.05); the primary outcome of FN (p>0.05); all secondary outcomes (p>0.05) except for a higher frequency of dose delays in secondary (37.8%) vs primary prophylaxis patients (14.6%; p=0.01); and mean absolute neutrophil counts (ANC) in all cycles (p>0.05) except for cycles 3 and 5. Higher ANC levels were found in primary prophylaxis patients (4.06+0.43) vs secondary prophylaxis (3.03+0.30; p=0.03) for cycle 3 and (3.57+0.25) vs (2.88+0.26; p=0.03) for cycle 5. Conclusion: In this single-center retrospective study, BR-treated lymphoma and CLL patients receiving primary vs secondary with G-CSF showed similar outcomes except, notably, for chemotherapy dose delays that may put secondary patients at risk for poor treatment outcomes. Further research is needed to evaluate the impact of primary vs secondary prophylaxis on chemotherapy treatment outcomes. Table Disclosures Persky: Sandoz: Consultancy; Debiopharm: Other: Member, Independent Data Monitoring Committee; Bayer: Consultancy; Morphosys: Other: Member, Independent Data Monitoring Committee. McBride:Sanofi Genzyme: Consultancy; Sandoz: Consultancy; teva: Consultancy.

Appropriateness of using granulocyte colony-stimulating factor (G-CSF) for primary prophylaxis of febrile neutropenia in solid tumors.

Febrile neutropenia (FN) is one of the dose-limiting adverse effects of chemotherapy. Granulocyte-Colony Stimulating Factors (G-CSFs) minimize the incidence of FN and reduce the risk of neutropenia complications. This study was conducted to address the prescription pattern of G-CSF for primary prophylaxis of FN during the first cycle of chemotherapy in solid tumors. This prospective observational study was done to investigate the G-CSF prescription pattern in patients receiving the first cycle of chemotherapy for solid tumors and compare it with the NCCN guideline recommendations. Based on the guideline, prophylactic G-CSF administration was indicated in 26 of the 96 patients (27.1%) and all of them received G-CSF. On the other hand, 70 patients (72.9%) did not meet the guideline criteria for prophylaxis, but 60 (62.5%) of them received G-CSF. Seven doses of pegfilgrastim and 165 doses of filgrastim were used inappropriately in the study population, which was associated with an economic burden of about 224.7 million IRR (5350 USD). Taken together, inconsistencies with the guideline were observed in this prospective evaluation, suggesting that submitting rationalized policies to decrease G-CSF prescription, especially in patients with a lower or intermediate FN risk, yields substantial cost savings.

The financial impact of physician practice patterns: An analysis of as-needed filgrastim versus prophylactic pegfilgrastim in patients with prostate cancer receiving docetaxel.

6506 Background: Docetaxel improves survival in metastatic prostate cancer. Patients receiving docetaxel are at an intermediate risk of febrile neutropenia (FN). Granulocyte-colony stimulating factor (G-CSF) reduces the incidence of neutropenia and infection. There is no consensus among physicians on G-CSF use with docetaxel in prostate cancer, and physician preference may significantly impact healthcare costs. The purpose of this study is to assess physician practice patterns by comparing efficacy and cost of as-needed filgrastim (ANF) to prophylactic pegfilgrastim (PPF) for neutropenia in patients with prostate cancer receiving docetaxel. Methods: This retrospective cohort study included patients with prostate cancer that received standard docetaxel and G-CSF, either ANF or PPF, from February 2016 to October 2018 at our institution. In the ANF arm, patients with an ANC less than 1000 cells/µL on day 8 of the cycle received filgrastim. In the PPF arm, patients received pegfilgrastim on day 2 for primary prophylaxis. Patient characteristics, chemotherapy dose intensity, delays, and reductions, and incidence of FN were collected. Results: Of the 65 patients included in this study, 32 received ANF and 33 received PPF. Patients in the ANF arm received an average of 6.0 cycles versus 4.8 cycles in the PPF arm (p = 0.013). The completion rate of planned cycles differed, with 93.8% completion in the ANF arm versus 66.7% in the PPF arm (p = 0.001). Average total drug exposure per patient was greater in the ANF arm than the PPF arm (437.5 mg/m2 versus 343.4 mg/m2; p = 0.007). In both groups, there was no significant difference in dose delays or reductions, or incidence of FN. However, there was a significant difference in cost, with an average of $740.26 per cycle per patient for filgrastim, versus $7327.72 per cycle per patient for pegfilgrastim, based on current average wholesale price. Conclusions: In our study, use of ANF was safe, and did not impact planned dose, intensity, or duration when compared to PPF. In addition, the administration of ANF was associated with significant cost savings. Analysis of G-CSF use in patients with prostate cancer receiving docetaxel at our institution has identified an opportunity for substantial healthcare cost savings.

Trends in Neutropenia-Related Hospitalization in Older Patients with Non-Hodgkin Lymphoma (NHL) Receiving Myelosuppressive Chemotherapy in the United States: 1995-2015

Introduction: Febrile neutropenia (FN) is a serious complication among patients receiving myelosuppressive chemotherapy (MC). Clinical trials have shown efficacy of primary prophylaxis with granulocyte colony-stimulating factor (PP-GCSF) in reducing FN risk, but few population-based studies have examined trends in PP-GCSF use and FN incidence in older patients over the past 20 years. We describe trends in MC regimens by FN risk category, PP-GCSF use, and risk of neutropenia (NP)-related hospitalization focusing on older NHL patients initiating MC.Methods: We identified patients (age ≥ 66 years) diagnosed with NHL and initiating MC each year 1995-2015 using Medicare 5% (1994-2007) and 20% (2007-2015) sample data. We required patients to be continuously enrolled in Medicare Part A and B for 12 months before MC initiation (first MC treatment in the year with no claims for MC agents in the preceding 12 months) and to survive ≥ 6 days after initiation. The first MC cycle started on the MC initiation date (day 1) and ended at the next administration at least 6 days, but no more than 35 days, after initiation. If no second cycle started before day 35, the first cycle was considered completed at the earliest of day 35 after initiation, the day before regimen change, death, disenrollment from Part A or B, or September 30, 2015.Chemotherapy regimen was defined based on MC agents on Part A outpatient (OP) or Part B (PB) claims from day 1-day 6 of the first cycle and, on the same claims, an ICD-9-CM diagnosis code for NHL. Based on the National Comprehensive Cancer Network guidelines, regimens with FN risk >20% and 10%-20% were classified as high and intermediate FN risk categories, respectively. Patients receiving MC agents but not high or intermediate FN risk regimens were classified as “Other” FN risk category. PP-GCSF use was defined as an administration of pegfilgrastim or any short-acting CSF (filgrastim, tbo-filgrastim, filgrastim-sndz, or sargramostim) in OP/PB claims up to 5 days after first cycle chemotherapy completion. NP-related hospitalization was identified from Part A inpatient claims with ICD-9-CM diagnosis code 288.0X in the first five positions between day 7 and the last day of the cycle. We describe trends in proportions of patients receiving MC regimens by FN risk category, with PP-GCSF use, and with NP-related hospitalization in the first cycle. Trends in NP-related hospitalization rates were further evaluated using a logistic regression model with calendar year treated as a continuous variable and functional form estimated by a penalized spline after adjusting for age, race, baseline hospital length of stay, baseline NP-related hospitalization, number of comorbid conditions, and MC FN risk category.Results: Yearly cohorts included 538-717 eligible patients, 1995-2007, and 1877-2640, 2008-2015. Proportions of patients aged ≥80 years increased from 39% in 1995 to 44% in 2015. Proportions receiving high/intermediate FN risk regimens were <20% before 1997, 36% in 1997, and 40%-46% 1998-2015 (Figure 1). Most patients receiving high/intermediate risk regimens (88%-96%) received CHOP-21 (cyclophosphamide, doxorubicin, and vincristine every 21 days with or without rituximab).Overall, PP-GCSF use increased from 8% in 1995 to 60% in 2015, mainly due to introduction of pegfilgrastim in 2002 (Figure 2). PP-GCSF use was more common in patients receiving high/intermediate FN risk regimens than in patients receiving other regimens (Figure 3). Overall, unadjusted incidence of NP-related hospitalization decreased from 7% in 1995 to 4% in 2015 (Figure 4). Change point in trend was detected at 2010; incidence of NP-related hospitalization decreased, on average, 6% each year before 2010 (p<0.0001) and was flat from 2010 (p=0.6) after adjustment for changed patient characteristics.Conclusions: Among older patients diagnosed with NHL receiving MC, 1995-2015, PP-GCSF use increased substantially after 2002. Over the same 20-year period, incidence of NP-related hospitalization in the first cycle decreased, on average, 6% each year before 2010 and was flat from 2010. Further studies are needed to understand overall decreasing trends in NP-related hospitalization and effects of changes in chemotherapy and FN management. [Display omitted] DisclosuresLiu:FibroGen Inc.: Consultancy. Gawade:Amgen: Employment, Equity Ownership. Kim:Amgen: Employment, Equity Ownership. Bensink:Amgen: Employment, Equity Ownership. Chandler:Amgen: Employment, Equity Ownership.

Abstract 2767: Consistency of standing orders for primary prophylactic CSF within a national network of community oncology practices: SWOG intergroup trial S1415CD

Abstract BACKGROUND Among the 400,000 individuals undergoing chemotherapy for breast, colorectal and lung cancer in the US, many are at risk of febrile neutropenia (FN). Prophylactic colony stimulating factor (CSF) use reduces the risk of FN, yet studies show that 55%-95% of CSF prescribing is inconsistent with clinical practice guidelines. There is lack of evidence and ambiguous guidelines for CSF use in regimens with an intermediate risk of FN. To address these issues, we are conducting a pragmatic trial to assess CSF prescribing and to generate evidence about CSF efficacy with intermediate risk regimens. To inform the design and sample size needs, we conducted a survey of current CSF order system use within a large network of community oncology practices. METHODS The study setting are sites within the NCI Community Oncology Research Program (NCORP), a national network across the U.S. and Puerto Rico that conducts multi-site cancer clinical trials. Between January-September 2016, 58 NCORP practices were surveyed on their existing systems for prescribing CSF prophylaxis. RESULTS 8 clinics (14%) reported that their sites do not use any standing orders for CSF prophylaxis prescribing. Standing order set characteristics for the remaining 50 practices are shown in Table 1. Table 1Summary of CSF standing order implementation in 50 surveyed NCORP clinicsBreast Cancer RegimensNon-Small Cell Lung Cancer RegimensColorectal Cancer RegimensOrder Set CharacteristicDose DenseHigh RiskIntermediate RiskLow RiskIntermediate RiskLow RiskIntermediate RiskLow RiskN (%)N (%)N (%)N (%)N (%)N (%)N (%)N (%)Automatically Included in Order Set (Standing Orders)46 (82%)31 (62%)7 (14%)08 (16%)07 (14%)0Automatically Excluded in Order Set 006 (12%)19 (38%)5 (10%)19 (38%)8 (16%)19 (38%)No automatic ordering- up to physician discretion to add or exclude orders4 (8%)19 (38%)37 (74%)31 (62%)37 (74%)31 (62%)35 (670%)31 (62%) CONCLUSIONS We observed wide variation in the current application of standing orders. Intermediate risk regimens had the most inconsistent practices, with a near equal number of clinics choosing either actively including or excluding CSF order sets. The majority of clinics using standing orders included CSF for dose dense and high risk regimens but only 19 (38%) actively excluded CSF for low risk regimens. These results support the need for more evidence to inform clearer guidelines on CSF use in intermediate risk regimens and studies that evaluate the effects of existing CSF standing orders on guideline adherence and patient outcomes. Funding:PCORI (PCS-1402-09988) and NCORP grant (5UG1CA189974) Citation Format: Scott Ramsey, Dawn Hershman, Ari Bell-Brown, Kate Watabayashi, Karma Kreizenbeck, Sean Sullivan, Aasthaa Bansal, William Barlow, Kathryn Arnold, Gary Lyman. Consistency of standing orders for primary prophylactic CSF within a national network of community oncology practices: SWOG intergroup trial S1415CD [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 2767. doi:10.1158/1538-7445.AM2017-2767

Risk of Febrile Neutropenia (FN) in Select Myelosuppressive Chemotherapy Regimens

IntroductionFebrile neutropenia (FN) is a serious adverse effect of myelosuppressive chemotherapy, which often results in hospitalization and chemotherapy dose modification. FN risk depends on patient characteristics and chemotherapy regimen risk. Understanding the FN risk associated with individual chemotherapy regimens can help guide the use of prophylactic granulocyte colony-stimulating factor (G-CSF) and patient monitoring. To this end, the NCCN has classified regimens into high (≥20%), intermediate (10%-20%), or low (<10%) FN risk based primarily on clinical trial data. However, even for the same regimen, the FN risk is often higher in clinical practice than in clinical trials. In this study, we assessed the FN risk associated with several regimens for which FN risk has not been determined or has shown substantial variability outside of a clinical trial setting, using data from Kaiser Permanente Southern California (KPSC), a large, community-based practice.MethodsIncluded were patients diagnosed with incident non-Hodgkin's lymphoma (NHL), breast cancer (BC), or multiple myeloma (MM) between 2008 and 2013 at KPSC who initiated the following chemotherapy regimens: bendamustine ± rituximab for NHL; docetaxel, carboplatin, and trastuzumab (TCH) or docetaxel and cyclophosphamide (TC) for BC; or Q4W lenalidomide 25 mg/dexamethasone for MM. Bendamustine ± rituximab, TCH, and lenalidomide are not classified by NCCN; TC is classified as intermediate FN risk but has shown considerable variability of FN incidence when used in clinical practice. Data on cancer diagnosis, chemotherapy use, G-CSF use, neutrophil count, and infections were obtained from KPSC's electronic medical records to estimate the incidence proportions of FN and grade 3 and 4 neutropenia. FN was defined as (1) hospitalization with absolute neutrophil count (ANC) <1000/µL or (2) hospitalization with primary or secondary diagnosis codes of neutropenia (ICD-9 288.0x) and fever (ICD-9 780.6), diagnosis code for bacterial/fungal infection, or antibiotic use. Grade 3 neutropenia was defined as ANC ≥500/µL to <1000/µL; grade 4 neutropenia as ANC <500/µL. Patients who received prophylactic G-CSF within 5 days of chemotherapy initiation were excluded from analysis.ResultsOverall, 40 (12%) NHL patients; 149 (24%) and 340 (28%) BC patients who received TCH and TC, respectively; and 0 (0%) MM patients were excluded due to prophylactic G-CSF. Over the first 6 cycles of bendamustine (median 338.4 mg/m2) ± rituximab for NHL patients (n = 307), 7.2% experienced FN, 4.2% grade 3 neutropenia, and 17.6% grade 4 neutropenia. Over the first 6 cycles of TCH for BC patients (n = 462), 24.2% experienced FN, 10.6% grade 3 neutropenia, and 44.6% grade 4 neutropenia. Over the first 6 cycles of TC for BC patients (n = 859), 20.5% experienced FN, 9.5% grade 3 neutropenia, and 37.5% grade 4 neutropenia. Over the first 4 cycles of lenalidomide/dexamethasone for MM patients (n = 186), 3.8% experienced FN, 5.9% grade 3 neutropenia, and 18.3% grade 4 neutropenia (Table 1).ConclusionsUsing NCCN criteria, bendamustine ± rituximab for NHL and lenalidomide/dexamethasone for MM would be classified as low-FN-risk regimens (<10%). By contrast, BC regimens TCH and TC would be classified as high-FN-risk regimens (>20%) based on our data. These results could help inform prophylactic G-CSF use for the selected regimens in clinical practice.Table 1Number and Incidence Proportion of Neutropenic Outcomes Overall and by CycleCancer: RegimenCyclePatients nFN Events n (%)Grade 3 Neutropenia Events n (%)Grade 4 Neutropenia Events n (%)NHL: Bendamustine ± rituximabOverall30722 (7.2)13 (4.2)54 (17.6)130712 (3.9)5 (1.6)28 (9.1)22253 (1.3)4 (1.8)21 (9.3)31732 (1.2)4 (2.3)15 (8.7)41302 (1.5)4 (3.1)10 (7.7)5924 (4.4)4 (4.4)8 (8.7)6692 (2.9)2 (2.9)0 (0)BC: TCHOverall462112 (24.2)49 (10.6)206 (44.6)146270 (15.2)39 (8.4)138 (29.9)232613 (4.0)15 (4.6)42 (12.9)328217 (6.0)9 (3.2)39 (13.8)42476 (2.4)8 (3.2)31 (12.6)51994 (2.0)6 (3.0)25 (12.6)61698 (4.7)3 (1.8)12 (7.1)BC: TCOverall859176 (20.5)82 (9.5)322 (37.5)1859126 (14.7)51 (5.9)266 (30.9)264921 (3.2)42 (6.5)82 (12.6)357119 (3.3)23 (4.0)62 (10.9)451114 (2.7)22 (4.3)45 (8.8)5941 (1.1)3 (3.2)9 (9.6)6842 (2.4)1 (1.2)2 (2.4)MM: Lenalidomide / dexamethasoneOverall1867 (3.8)11 (5.9)34 (18.3)11862 (1.1)8 (4.3)17 (9.1)21013 (3.0)5 (5.0)14 (13.9)3632 (3.2)2 (3.2)8 (12.7)4370 (0)0 (0)4 (10.8) DisclosuresFamily:Amgen Inc.: Research Funding. Klippel:Amgen Inc.: Employment, Equity Ownership. Li:Amgen Inc.: Employment, Equity Ownership. Page:Amgen Inc.: Employment, Equity Ownership.

Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia.

Febrile neutropenia (FN) is a potentially fatal complication of chemotherapy. This prospective, observational study describes physicians' approaches toward assessing FN risk in patients receiving chemotherapy regimens with an intermediate (10-20%) FN risk. In the baseline investigator assessment, physicians selected factors considered important when assessing overall FN risk and deciding on granulocyte colony-stimulating factor (G-CSF) primary prophylaxis (PP). Physicians then completed patient assessments using the same lists of factors. The final FN risk scores and whether G-CSF PP was planned were reported. The final analysis included 165 physicians and 944 patients. The most frequently considered factor in both assessments was chemotherapy agents in the backbone (88% of investigator and 93% of patient assessments). History of FN (83%), baseline laboratory values (76%) and age (73%) were commonly selected at baseline, whereas tumor type (72%), guidelines (62%) and tumor stage (43%) were selected most during patient assessments. Median investigator-reported FN risk threshold for G-CSF PP was 20% (range 10-85%). G-CSF PP was planned in 82% of patients with an FN risk at or above this threshold; therefore, almost one-fifth of qualifying patients would not receive G-CSF PP. Physicians generally follow guidelines, but also consider individual patient characteristics when assessing FN risk and deciding on G-CSF PP. A standardized FN risk assessment may optimize the use of G-CSF PP, which may minimize the incidence of FN in patients undergoing chemotherapy with an intermediate FN risk. ClinicalTrials.gov Identifier: NCT01813721.

Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk?

This study evaluated the correlation between the risk of febrile neutropenia (FN) estimated by physicians and the risk of severe neutropenia or FN predicted by a validated multivariate model in patients with nonmyeloid malignancies receiving chemotherapy. Before patient enrollment, physician and site characteristics were recorded, and physicians self-reported the FN risk at which they would typically consider granulocyte colony-stimulating factor (G-CSF) primary prophylaxis (FN risk intervention threshold). For each patient, physicians electronically recorded their estimated FN risk, orders for G-CSF primary prophylaxis (yes/no), and patient characteristics for model predictions. Correlations between physician-assessed FN risk and model-predicted risk (primary endpoints) and between physician-assessed FN risk and G-CSF orders were calculated. Overall, 124 community-based oncologists registered; 944 patients initiating chemotherapy with intermediate FN risk enrolled. Median physician-assessed FN risk over all chemotherapy cycles was 20.0%, and median model-predicted risk was 17.9%; the correlation was 0.249 (95% CI, 0.179−0.316). The correlation between physician-assessed FN risk and subsequent orders for G-CSF primary prophylaxis (n = 634) was 0.313 (95% CI, 0.135−0.472). Among patients with a physician-assessed FN risk ≥20%, 14% did not receive G-CSF orders. G-CSF was not ordered for 16% of patients at or above their physician’s self-reported FN risk intervention threshold (median, 20.0%) and was ordered for 21% below the threshold. Physician-assessed FN risk and model-predicted risk correlated weakly; however, there was moderate correlation between physician-assessed FN risk and orders for G-CSF primary prophylaxis. Further research and education on FN risk factors and appropriate G-CSF use are needed.

Attitudes of Physicians Toward Risk Assessment and Use of Granulocyte-Colony Stimulating Factor (G-Csf) As Primary Prophylaxis (Pp) in Patients (Pts) Receiving Chemotherapy with an Intermediate Risk of Febrile Neutropenia (Fn)

ABSTRACT Aim: For chemotherapy regimens with intermediate FN risk (10–20%), physicians should assess patient risk factors to determine whether overall risk is >20% and G-CSF PP is indicated1. This study described factors considered important by physicians when assessing FN risk and deciding to use G-CSF PP in pts receiving intermediate-FN-risk chemotherapy. Methods: This prospective observational study (NCT01813721) was conducted in Europe, Australia and Canada. Before pt enrolment, investigators reported their own FN risk threshold at which they usually give G-CSF PP, and selected and ranked factors they considered important when assessing overall FN risk and deciding to give G-CSF PP (investigator baseline assessment). For each enrolled pt, their overall FN risk score and the same factors were assessed before starting chemotherapy (patient assessment), and whether G-CSF PP was planned was reported. Results: The final analysis included 165 investigators (67% medical oncologists) and 944 pts (median age 61 years, range 20–94) with breast cancer (42%), lung cancer (39%) or NHL (19%). Stage IV disease was reported in 34% of pts; 1% had a history of FN. Table 1 lists factors most often ranked for FN risk assessment and G-CSF PP decision. The median investigator-reported FN risk threshold was 20% and the pt median overall FN risk score was 18%. G-CSF PP was planned in 82% pts with an overall FN risk score≥the investigator's threshold and in 19% pts with an overall risk score Top 5 most frequently listed factors deemed important by investigators in the overall FN risk assessment and the G-CSF PP decision, at baseline and for each individual patient Factors considered in overall FN risk assessment, % (95% CI) Factors considered in G-CSF PP decision, % (95% CI) Investigator assessment (n = 165) Patient assessment (n = 944) Investigator assessment (n = 165) Patient assessment (n = 944) Chemotherapy agents in the backbone 88 (82–93) Chemotherapy agents in the backbone 93 (88–96) Outcome of FN risk assessment 89 (83–93) Outcome of FN risk assessment 79 (71–84) Prior history of FN 83 (76–89) Tumour type 72 (61–82) Age 80 (71–87) Guidelines 67 (53–79) Baseline laboratory values 76 (68–83) Guidelines 62 (48–74) Baseline laboratory values 74 (64–82) Treatment intent 67 (59–74) Age 73 (64–81) Tumour stage 43 (34–53) Guidelines 71 (61–78) Age 51 (43–60) Prior chemotherapy 71 (62–78) Age 39 (32–48) Treatment intent 69 (61–77) ECOG/Karnofsky performance status 36 (28–45) CI, confidence interval; ECOG, Eastern Cooperative Oncology Group. Conclusions: The most frequently considered factors were chemotherapy regimen for assessing FN risk and FN risk assessment outcome for decision to initiate G-CSF PP. Other factors were selected less consistently at the investigator and pt level. A standardised approach to risk factor assessment may improve guideline adherence and G-CSF use. 1Aapro et al. (2011) Eur J Cancer;47:8–32 Disclosure: G. Freyer: Consultant for Amgen France; E. Kalinka-Warzocha: Received honoraria from Amgen for clinical trials. Given lectures for Amgen; M. Marinca: Has spoken in speaker bureaus for Amgen Romania; L. Decosta: Employed by Amgen and holds stock; Z. Szabo: Employed by Amgen and holds stock. All other authors have declared no conflicts of interest.

Abstract P3-15-08: A multicenter observational study to investigate the relationship between physician-assessed febrile neutropenia (FN) risk and prediction model FN or SN (severe neutropenia) risk in patients with breast cancer

Abstract Background: A prediction model was previously developed to estimate the risk of SN or FN during the first cycle of chemotherapy, taking into account both the myelotoxicity of the chemotherapy regimen and the interplay of specific tumor and patient characteristics (Lyman, 2011). This model may potentially be useful for predicting which patients are at greatest risk for developing neutropenic complications, particularly among those patients receiving intermediate FN risk chemotherapy regimens, where the influence of patient characteristics becomes a critical consideration. To assess the clinical utility of this model, physicians assessed FN risk in patients with non-myeloid malignancies, and then physician-assessed FN risk was compared to prediction model risk. Methods: This was a prospective, multicenter, observational study (124 community-based oncologists, 944 patients). Analysis of a breast cancer subgroup (93 oncologists, 364 patients) is reported here. Patients were eligible if they were: ≥18 years old, newly diagnosed, and candidates for initiating a new course of chemotherapy using an NCCN intermediate (10-20%) FN risk chemotherapy regimen. Oncologists entered clinical data about the patient into the model; they also made a clinical prediction of FN risk. Oncologists were blinded to both the data elements collected by the model and the risk predicted by the model. Data were only collected until the chemotherapy order was written; no outcome data were collected. The primary objective was to investigate the relationship between physician-assessed FN risk and prediction model SN or FN risk. As an exploratory endpoint, physicians were asked to estimate FN risk on the same set of four hypothetical case studies with varying FN risk factors. The correlation between risk probability scores was estimated as well as a 95% confidence interval accounting for intra-physician correlation. A smooth spline curve was fit to show the average relationship between physician-assessed and prediction model risk probability scores. Results: Most patients were planning to receive TC (54%) and most had stage I-II disease (71%). Median (min, max) age was 58 years (23, 83). Physician-assessed FN risk correlated weakly with prediction model FN or SN risk: correlation 0.166 (95% CI: 0.027, 0.298). There was wide variability among all 124 physicians in their assessment of FN risk for the four case studies (Q1, Q3 case study 1: 20%, 40%; case study 2: 10%, 18%; case study 3: 20%, 40%; case study 4: 25%, 60%). Conclusions: This study suggests that community oncologists would benefit from the use of an automated system for assessing FN risk among those receiving intermediate risk chemotherapy regimens. Such a system would help oncologists identify the patients who would benefit most from clinical intervention and help improve practice efficiency and quality of care. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-15-08.

Pegfilgrastim Use and Outcomes In Non-Hodgkin-Lymphoma Patients Receiving Chemotherapy In Clinical Practice: Combined Analysis Of The Austrian and Swiss E-Avare Studies

BackgroundE-AVARE were observational studies in Austria and Switzerland investigating febrile neutropenia (FN) risk assessment and granulocyte colony-stimulating factor (G-CSF) guideline implementation in real life Non-Hodgkin-lymphoma (NHL) treatment. A combined analysis of both studies was performed to better understand the characteristics of NHL patients who receive pegfilgrastim and the outcomes of these patients in everyday clinical practice. MethodsEligible patients had NHL, were eligible to receive G-CSF, and were planned to receive ≥3 chemotherapy (CT) cycles. The Austrian study included pegfilgrastim treated patients only, while the Swiss study included all G-CSF formulations used. To evaluate pegfilgrastim-related outcomes, only data from patients who completed ≥3 CT cycles and who received pegfilgrastim in ≥1 cycle were included (primary analysis set). Primary outcome: proportion of patients with investigator-assessed high (≥20%) overall FN risk in cycle 1 receiving pegfilgrastim as primary prophylaxis (PP). Other outcomes: investigator-assessed CT-related FN risk, overall incidence of FN and unplanned hospitalizations. Exploratory analysis: description of age cohorts (<65 or ≥65 years [yrs]). Results277 patients fulfilled the inclusion criteria for the primary analysis set. Table 1 shows patient characteristics and outcomes. In cycle 1, 237 patients had an investigator-assessed ≥20% overall FN risk and of these 219 (92%) received pegfilgrastim as PP. Among all 277 patients, pegfilgrastim was administered as PP in 236 (85%); pegfilgrastim was first administered in the second or later cycle in 41 patients, of these 8 (3%) received daily G-CSF and 33 (12%) received no G-CSF in cycle 1. Older patients were less likely to receive chemotherapy with curative intent or with high FN risk; FN incidence was similar between age groups but older patients had a greater duration of hospitalization for FN. No serious adverse drug reactions were reported. ConclusionsIn patients with NHL pegfilgrastim was used predominantly as PP in patients assessed at an overall high risk of FN, in accordance with guidelines. Older patients who received CT with intermediate FN risk were more likely than younger patients to be assessed as high overall FN risk. FN risk seemed well managed with pegfilgrastim use in both older and younger patients, but FN may carry a greater burden in patients aged ≥65 yrs, although less intensive therapies were used in this subset of patients.Medical Writer: Margit Hemetsberger (Amgen-sponsored) Disclosures:Willenbacher:Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Jaeger:Amgen: Employment, Equity Ownership. Bast:Amgen: Employment, Equity Ownership. Renner:Amgen: Consultancy, Honoraria, Speakers Bureau.