CTX Cycles Research Articles

Patient Reported Outcome (PRO) in Patients Receiving High and Moderate Emetogenic Chemotherapy (Ctx) - Results of a German Prospective Non-Interventional Study with Netupitant/Palonosetron Fixed Dose Combination (NEPA)

Introduction:NEPA is a fixed dose combination of the NK1-receptor antagonist (RA) netupitant and 5-HT3-RA palonosetron approved for prevention of chemotherapy-induced nausea and vomiting (CINV) in pts receiving highly emetogenic (HEC) on cisplatin-basis or moderately emetogenic Ctx (MEC). NEPA demonstrated safety and efficacy in platinum, anthracycline and cyclophosphamid based Ctx, These drugs are frequently used in regimens for hematology pts. A German non-interventional study investigated NEPA's efficacy and impact on quality of life in adult cancer pts by patient-related outcomes (PRO) and physicians' personal assessment under real life conditions. Primary objective was the evaluation of quality of life (QoL) in adults receiving NEPA for CINV prevention. Secondary endpoints were efficacy and safety of NEPA.Methods: Open label, non-interventional, prospective, national, multicenter study that evaluates CINV prevention and patients' QoL receiving NEPA in pts with either HEC or MEC on up to 2 consecutive Ctx days for at least consecutive 3 cycles. QoL was evaluated by the validated FLIE questionnaires at the end of each Ctx cycle. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hrs and on 4 additional d after Ctx. Safety, additional medication and physicians' overall satisfaction was reported via eCRF.Results: Between June 2015 and Sept 2017 a total of 2429 pts were enrolled with 1997 pts being eligible for the 2nd interim analysis. 1901 pts were included in the efficacy analysis in the 1st, 1808 pts in the 2nd and 1734 pts in the 3rd cycle. Median age was 58 (range of 28-89). A total of 630 evaluable pts received MEC (53% carboplatin based) and 1185 pts received HEC (88% anthracycline/ cyclophosphamide based), PRO with complete response (CR=no nausea, no vomiting, no rescue medication) was analyzed based on patient diaries. Diaries for PRO in MEC-pts (n=401) reported CR in 94% in cycle 1, 85% in cycle 2 and 86% in cycle 3. Efficacy, assessed by physicians (n=630 pts) on a 4-point scale, was rated very good/good for 91%, 93%, and 94% in cycle 1, 2 and 3, respectively. PRO of 896 pts with HEC reported 81% CR in cycle 1, 82% in cycle 2 and 83% in cycle 3. Efficacy, assessed by physicians (1185 HEC pts), was rated very good/good for 88%, 89%, and 90% in cycle 1, 2 and 3, respectively. A high percentage of patients receiving HEC or MEC did not suffer from any emesis (93%, 93% and 94% in cycle 1-3, respectively). Over 85%of pts reported no impact on daily QoL due to vomiting in all 3 cycles with HEC or MEC.The most common treatment emergent adverse events were constipation and insomnia of mild-moderate intensity.Conclusions: NEPA prevented CINV highly effective in the acute and delayed phase of HEC and MEC with no impact on daily life due to vomiting in >85% of pts. Physicians evaluation was concordant to PRO.Safety profile was good. DisclosuresKarthaus:Riemser: Consultancy. Schilling:Riemser: Honoraria.

Cost Simulation for Febrile Neutropenia Hospitalization in the US Due to Pegfilgrastim on-Body Injector Failure Compared to Single-Injection Pegfilgrastim and Daily Injections with Reference and Biosimilar Filgrastim in Non-Hodgkin Lymphoma

Introduction: Failure rates ranging from 1.7-3.8% of the pegfilgrastim on-body injector (PEG-OBI) device have been reported (Joshi, Curr Med Res Opin 2017; Stuessy, J Clin Onc 2017; Mahler, Clin J Onc Nurs 2017). Failures may increase the risk of chemotherapy-induced febrile neutropenia (FN) and FN-related hospitalizations (FN-HOSP) beyond the FN and FN-HOSP rates for prophylaxis with single-injection pegfilgrastim (PEG) or daily injections of reference (REF-FIL) or Sandoz filgrastim biosimilar (BIOSIM-FIL). We aimed to estimate for a US panel of 10,000 patients with non-Hodgkin lymphoma (NHL) the total incremental costs of PEG-OBI prophylaxis and incremental FN-HOSP costs at different PEG-OBI failure rates versus (vs) assured prophylaxis administration with PEG, REF-FIL, or BIOSIM-FIL.Methods: Simulation analysis from a US payer perspective of the total incremental prophylaxis costs associated with PEG-OBI failure rates of 1-5% compared to assured prophylaxis administration with PEG, REF-FIL, and BIOSIM-FIL in chemotherapy cycle 1 for a panel of 10,000 NHL patients. Filgrastim daily injection regimens included real-world durations of 5 (Gascón, Support Care Cancer 2016) and 6.5 days (Weycker, Ann Pharmacother 2006) and standard 11 days, all clinician-administered. Differential base rates of FN-HOSP (rate of FN-HOSP without colony-stimulating factor [CSF] minus rate with CSF) in NHL patients was computed for two chemotherapy regimens: 1) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) (Chrischilles, Cancer Control 2002; 13.25% with CSF, 23.28% without), and 2) CHOP or cyclophosphamide, mitoxantrone, vincristine and prednisone (CNOP) (Osby, Blood 2003; 33.0% with CSF, 50.0% without). Costs (US$) were based on 1Q2018 average selling price for drugs and 2018 Current Procedural Terminology reimbursement for administration. FN-HOSP costs in 2012 of $25,676 per episode for NHL patients (Tai, J Oncol Pract 2017) were adjusted per the Consumer Price Index for Medical Care to $29,938.63 for 2018.Results: Table 1 (Chrischilles; CHOP) and Table 2 (Osby; CHOP/CNOP) present, for PEG-OBI failures rates of 0.01-0.05, the incremental number of patients at risk for FN-HOSP and associated incremental costs; and total incremental costs of PEG-OBI prophylaxis over the costs of assured prophylaxis administration with other CSFs in CTX cycle 1 for a panel of 10,000 NHL patients. Except for one scenario (savings of $72,916 at 0.1 failure rate due to the lower PEG-OBI administration costs), all scenarios showed incremental costs associated with PEG-OBI prophylaxis and failures of the PEG-OBI device (Tables 1 and 2). Per Chrischilles rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $300,284 (at 0.01 failure rate) to $1,501,422 (at 0.05 failure rate). Total incremental costs of PEG-OBI over PEG ranged from $227,369 to $1,128,222. Total incremental costs of PEG-OBI over REF-FIL ranged from $6,794,984 to $28,859,922; and over BIOSIM-FIL from $19,004,984 to $34,409,922. Per the Osby rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $508,957 to $2,544,784. Total incremental costs of PEG-OBI over PEG ranged from $135,757 to $2,171,584; over REF-FIL from $7,003,657 to $29,903,284; and over BIOSIM-FIL from $19,213,657 to $35,453,284.Conclusions: In this simulation of NHL patients treated with CHOP or CNOP, the total incremental costs of PEG-OBI prophylaxis vs assured prophylaxis administration with other CSFs vary as a function of PEG-OBI failure rates, baseline and failure-associated FN-HOSP risk, and the alternative CSF prophylaxis option. Incremental costs of PEG-OBI prophylaxis and failure are lowest vs PEG and highest vs BIOSIM-FIL at real-world duration of 5 days. [Display omitted] DisclosuresKrendyukov:Sandoz: Employment. Mathieson:Sandoz: Employment. Campbell:Sandoz Inc.: Employment. Balu:Sandoz Inc.: Employment. MacDonald:Sandoz: Consultancy. Abraham:Sandoz: Consultancy.

G-CSF guideline adherence in Germany, an update with a retrospective and representative sample survey

BackgroundCurrent guidelines (GL) recommend neutropenia prophylaxis with G-CSF after chemotherapy (CTX) for patients with high (≥ 20%), or, if additional risk factors are present, intermediate (≥ 10–20%) risk of febrile neutropenia. The first sample survey in 2012 (NP1) showed lack of GL adherence. The aim of this second sample survey was to evaluate if GL adherence and implementation have improved.MethodsThe sample size represented 1.0% of the incidences of lung and 1.1% of breast cancer in Germany in 2010. Data of patients with a febrile neutropenia (FN) risk ≥ 10% who had received at least 2 cycles of chemotherapy between October 2014 and September 2015 was surveyed retrospectively.ResultsData from 573 lung cancer (LC) and 801 breast cancer (BC) patients was collected from 109 hospitals and 83 oncology practices with 222 physicians participating. Compared with the NP1 survey, GL adherence increased in LC and FN high-risk (HR) chemotherapy from 15.4 to 47.8% (p < 0.001), and in FN intermediate-risk (IR) chemotherapy from 38.8 to 44.3% (p = 0.003). In BC and FN-HR chemotherapy, GL adherence was unchanged: 85.6% vs. 85.1% (p = 0.73) but increased in FN-IR from 49.3 to 57.8% (p < 0.001). In all IR CTX cycles, there are also no significant differences in GL adherence between the first (51.3%) and subsequent cycles (51.1%; p = 0.948). In LC patients treated in certified or comprehensive cancer centers, the GL adherence in FN-HR chemotherapy was 53.0% vs. 44.9% in other centers (p = 0.295); in FN-IR chemotherapy, it was 45.1% vs. 43.8% (p = 0.750). In BC with FN-HR chemotherapy, GL adherence in certified or comprehensive centers was 85.4% vs. 84.7% in other institutions (p = 0.869); in FN-IR chemotherapy, it was 60.2% vs. 55.0% (p = 0.139). GL adherence in FN-HR chemotherapy and in FN-IR chemotherapy differed between pulmonologists and hematologist-oncologists (FN-HR: 25.0% vs. 43.6%, p < 0.001; 38.1% vs. 48.6%, p < 0.001). Comparing gynecologists with hematologist-oncologists, GL adherence in FN-HR chemotherapy was 86.2% vs. 82.5%. In FN-IR chemotherapy, GL adherence by gynecologists and hematologist-oncologists was 58.6% and 55.6%, respectively (p = 0.288; p = 0.424). Classification and regression tree analysis split pulmonologists and other specialists, with the latter adhering more to GL (p < 0.001). Hematologist-oncologists and gynecologists with more than 2 years of professional training in medical cancer therapy adhered more closely to GL than others (68.7% vs. 46.2%, p < 0.001). Pulmonologists attending ≥ 2 national congresses annually adhered more to guidelines than other pulmonologists (44.8% vs. 24.3%, p < 0.001).ConclusionsAdherence to G-CSF GL in Germany has increased but is still insufficient. Certified and comprehensive cancer centers show a higher rate of GL implementation. In GL adherence, there is still a disparity between cancer types and between oncology treatment specialists.

1693P - Analysis of parameters to predict the effectiveness of scalp cooling to prevent chemotherapy-induced alopecia in breast cancer patients

Background: Sensor-controlled scalp cooling (SCSC) has been found to be effective to prevent chemotherapy (Ctx)-induced alopecia (CIA). This retrospective study sought to obtain detailed information which clinical parameter is able to predict the success of SCSC in patients (pts) with primary (PBC) or recurrent/metastatic breast cancer (R/MBC) exposed to neoadjuvant (NACT), adjuvant (ACT), or palliative Ctx (PCT) using anthracyclines (A), taxanes (T), both given at different schedules (A+T/A→T, T→A) or none of them (non-A/non-T). Methods: 109 pts who underwent SCSC were included: NACT, 47 (54.6%); ACT, 40 (45.4%); PCT 22; dose-dense (dd) Ctx, 38 (44.2%); non-dd Ctx 48 (55.8%); premenopausal, 48 (55.8%); postmenopausal, 38 (44.2%). Ctx regimens were: A+T/A→T, 41 (37.6%), T→A, 23 (26.7%), T, 34 (31.2%), non-A/non-T, 11 (10.1%). 3 wks after the last Ctx cycle, CIA was quantified according to the Dean score (DS). Data were analyzed in regard to the SCSC completion rate, and the quality of hair preservation (success: DS 0-2, failure: DS 3-4). The following parameters were investigated in regard to the success of SCSC: menopausal status, pretreatment, setting of Ctx, Ctx schedule, Ctx regimen. Results: Success rate was 67.9% with 47 pts (43.1%) experiencing complete (DS 0), and 27 (24.8%) showing partial response (DS 1-2). 30 pts (27.5%) stopped SCSC prematurely with CIA being the reason in 21 pts (19.3%). Effectiveness of SCSC did not differ for most analyzed subgroups. The relative risk (RR) to experience CIA was 1.18 (CI: 0.91-1.53, p=NS) for post- vs premenopausal pts, 1.27 (CI: 0.99-1.64, p=NS) for Ctx-naïve vs pretreated pts, 1.18 (CI: 0.89-1.56, p=NS) for dd Ctx vs non-dd Ctx, 1.42 (CI: 1.03-1.80, p = 0.05) for NACT/ACT vs PCT, and 1.42 (1.11-1.85, 0.012) for A-based Ctx vs non A-based Ctx. Success rates for A+T/A→T, T→A, T, and non-A/non-T were 48.8%, 73.9%, 79.4%, and 90.9% (p = 0.015). Conclusions: SCSC could effectively prevent CIA in a real-world population of pts with PBC or R/MBC with all subgroups of pts benefiting. NACT/ACT and A-based Ctx are associated with lower success rates of SCSC. However, the effectiveness of SCSC associated with A-based Ctx can be as high providing that Ctx does not start with an anthracycline. Legal entity responsible for the study: Christian M. Kurbacher, Gynaecological Centre Bonn-Friedensplatz. Funding: Has not received any funding, Disclosure: All authors have declared no conflicts of interest.

Risk Factors Associated With Chemotherapy-Induced Nausea in the Week Before the Next Cycle and Impact of Nausea on Quality of Life Outcomes

ContextDespite current advances in antiemetic treatments, between 19% and 58% of oncology patients experience chemotherapy-induced nausea (CIN). ObjectivesAims of this post hoc exploratory analysis were to determine occurrence, severity, and distress of CIN and evaluate for differences in demographic and clinical characteristics, symptom severity, stress; and quality of life (QOL) outcomes between oncology patients who did and did not report CIN in the week before chemotherapy (CTX). Demographic, clinical, symptom, and stress characteristics associated with CIN occurrence were determined. MethodsPatients (n = 1296) completed questionnaires that provided information on demographic and clinical characteristics, symptom severity, stress, and QOL. Univariate analyses evaluated for differences in demographic and clinical characteristics, symptom severity, stress, and QOL scores between the two patient groups. Multiple logistic regression analysis was used to evaluate for factors associated with nausea group membership. ResultsOf the 1296 patients, 47.5% reported CIN. In the CIN group, 15% rated CIN as severe and 23% reported high distress. Factors associated with CIN included less education; having childcare responsibilities; poorer functional status; higher levels of depression, sleep disturbance, evening fatigue, and intrusive thoughts; as well as receipt of CTX on a 14-day CTX cycle and receipt of an antiemetic regimen that contained serotonin receptor antagonist and steroid. Patients in the CIN group experienced clinically meaningful decrements in QOL. ConclusionThis study identified new factors (e.g., poorer functional status, stress) associated with CIN occurrence. CIN negatively impacted patients' QOL. Pre-emptive and ongoing interventions may alleviate CIN occurrence in high-risk patients.

Quality of life of patients with gastrointestinal cancers undergoing chemotherapy.

Findings regarding changes in the quality of life (QOL) of patients with gastrointestinal cancers (GI) undergoing chemotherapy (CTX) are inconclusive. Purpose was to evaluate for changes in QOL scores of patients with GI cancers over two cycles of CTX. Patients (n = 397) completed disease-specific [i.e., Quality of Life-Scale-Patient Version (QOL-PV)] and generic [12-item Medical Outcomes Study Short Form Survey (SF-12)] measures of QOL a total of six times over two cycles of CTX. Changes in these QOL scores were evaluated using bootstrapped multilevel regression with full information maximum likelihood estimation. Treatment group (i.e., with or without targeted therapy), age, number of metastatic sites, time from cancer diagnosis, number of prior cancer treatments, GI cancer diagnosis (i.e., colon/rectum/anal vs. other), and CTX regimen were evaluated as covariates in the conditional models for each of the QOL scores. During the second cycle of CTX, QOL-PV scores decreased in the week following CTX administration, and then increased the following week. For both cycles of CTX, the physical component summary and mental component summary scores of the SF-12 decreased in the week following CTX administration and then increased the following week. Increased time from cancer diagnosis and a higher number of prior cancer treatments resulted in worse QOL-PV and SF-12 scores at enrollment. While changes in QOL scores over the two CTX cycles were statistically significant, the differences were not clinically meaningful. Future studies need to determine the optimal timing of QOL assessments to assess changes associated with cancer treatments.

Abstract P6-11-14: Safety and effectiveness of sensor-controlled scalp cooling to prevent alopecia in primary breast cancer patients receiving neoadjuvant or adjuvant epirubicin, taxanes, or both

Abstract Background: Chemotherapy (Ctx)-induced alopecia (CIA), produces a deep psychological distress in many women involved. Sensor-controlled scalp cooling (SCSC) is now approved by the FDA due to both its effectiveness and safety to prevent CIA demonstrated in two randomized trials in patients (pts) with primary breast cancer (PBC). However, SCSC is still infrequently used in many countries due to physicians´ concerns regarding both its safety and feasibility, in particular regarding anthracycline-based Ctx [Nangia et al., 2017]. This retrospective analysis was initiated to obtain more detailed information on the effectiveness and safety of SCSC using the Paxman system (Paxman, Huddersfield, UK) in PBC pts exposed to CIA-inducing neoadjuvant (NACT) or adjuvant Ctx (ACT) based on epirubicin (E), taxanes (T), or both (ET) in the clinical routine. Methods: 79 pts who underwent SCSC alongside with Ctx for PBC from 2014-2017 were identified from our database: NACT, 41 (51.9%); ACT, 38 (48.1%); dose-dense (dd) Ctx, 56 (70.9%); non-dd Ctx 23 (29.1%); premenopausal, 44 (55.7%); postmenopausal, 35 (44.3%). The following Ctx regimens were used: E, 1 (1.3%); T, 23 (29.1%); ET, 55 (69.6%). Pts were subjected to SCSC during each Ctx cycle. CIA was quantified according to the Dean score (DS) determined 3 wks after the last Ctx cycle. Data were analyzed regarding feasibility indicated by the SCSC completion rate, quality of hair preservation (success: DS 0-2, failure: DS 3-4), reasons of SCSC discontinuation, and safety. Moreover, the following parameters were investigated in regard to the success of SCSC: menopausal status (pre- vs postpenopausal), NACT vs ACT, dd Ctx vs non-dd Ctx, E- or ET-based Ctx vs T-based Ctx. Results: 55 pts (69.6%) completed SCSC, with 36 (45.6%) experiencing complete hair preservation (DS 0), and 19 (22.8%) showing partial success (DS 1-2). 24 pts (30.4%) discontinued SCSC, with CIA being the main reason in 18 pts (22.8%). Headache or earache was reported in 2 pts (1.3%) each, and local discomfort in another 4 pts (5.1%). Side effects were all not severe and resolved quickly after cessation of SCSC. SCSC was equally effective in most analyzed subgroups. The relative risk (RR) to experience CIA was 1.11 (CI: 0.82-1.54) for post- vs premenopausal pts, 1.11 (CI: 0.83-1.53) for ACT vs NACT, and 0.99 (CI: 0.72-1.43) for dd Ctx vs non-dd Ctx. Pts receiving E or ET had a significantly higher RR for SCSC failure: 1.39 (CI: 1.04-1.81, p=0.035). However, the success rate in this group was still 62.5%, thus clearly indicating a clinically meaningful benefit. Conclusions: In our study, SCSC was feasible, safe and effective in order to prevent CIA in pts with PBC. All therapeutic subgroups benefited from SCSC. Although patients on E or ET are at higher risk for CIA, the success rate in this subgroup indicates that SCSC can be reasonably offered to patients subjected to NACT or ACT with epirubicin-containing regimens. Citation Format: Kurbacher CM, Kurbacher AT, Herz S, Kolberg G, Kettelhoit N, Schweitzer C, Kurbacher JA, Eichler C. Safety and effectiveness of sensor-controlled scalp cooling to prevent alopecia in primary breast cancer patients receiving neoadjuvant or adjuvant epirubicin, taxanes, or both [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-14.

Clinical characterization of febrile neutropenia episodes in patients with testicular germ cell tumors.

e16038 Background: Febrile neutropenia (FN) is a serious complication of chemotherapy (CTX). Here, we aim to characterize the clinical course of FN in patients (pts) with testicular germ cell tumors (TGCT). Methods: 413 TGCT patients who underwent at least one cycle of CTX in adjuvant or curative intent were studied within this single-center observational cohort study. Baseline characteristics of the subpopulation with FN are reported in Table 1. Results: During a total number of 1,196 CTX cycles in 413 patients, we observed 70 episodes of febrile neutropenia (16.9%). 55 (79%) of these episodes occurred during the 1stcycle of CTX. The median time between CTX start and FN onset was 14 days [IQR: 12-15, range: 7-18]. One (1%) FN episode was fatal, and 56 patients (80%) had to be hospitalized. Median time in hospital was 7 days [IQR: 6-8, range: 3-12], and the median number of days with an absolute neutrophil count below 0.5G/L was 2 [IQR: 2-3, range: 1-7]. Twelve (20%) FN episodes occurred in the 60 pts who received primary G-CSF support. There was very little treatment delay due to FN (median: 0 days [IQR: 0-0, range: 0-7]. 3 patients (4%) developed a second FN episodes. Conclusions: This study supports prior reports that FN is a relatively frequent complication of CTX in TGCT. However, the case-fatality-rate of FN in TGCT appears to be very low. [Table: see text]

UGT1A1 gene polymorphisms and clinical outcomes in small cell lung cancer (SCLC) patients treated with irinotecan-platinum chemotherapy: The first study from north India.

e20024 Background: Irinotecan(CPT11) is an important drug for SCLC chemotherapy(CTx). UDP-glucuronosyl-transferase1A1(UGT1A1) polymorphisms can influence CPT11-related toxicity. This study aimed to assess incidence of UGT1A1 polymorphisms and their association with clinical outcomes in SCLC patients on CPT11-CTx. Methods: Observational cohort of treatment-naïve SCLC patients given CPT11-platinum doublet at a referral centre in North India over 3-yrs(January 2013-December 2015). Clinical outcomes assessed were hematological &amp; gastrointestinal toxicity(CTC-AE v3.0), response rates by RECIST &amp; overall survival(OS). Peripheral blood was drawn from all enrolled patients just prior to CPT11-CTx initiation &amp; genomic DNA isolated. Genotyping was done by PCR-RFLP for UGT1A1*7, UGT1A1*6 &amp; UGT1A1*27 &amp; by PCR-DNA sequencing for UGT1A1*28. Patients were classified as homozygous wild-type(WT/WT), heterozygous-mutant(WT/M) or homozygous-mutant(M/M) for each polymorphism assessed. Results: Of 140 patients enrolled, no mutant alleles were found for UGT1A1*27 or UGT1A1*7. Frequency of UGT1A1*6 polymorphisms(n = 111) was 89.2% WT/WT, 8.1% WT/M &amp; 2.7% M/M. For UGT1A1*28(n = 102), this was 41.2% WT/WT, 43.1% WT/M &amp; 15.7% M/M. For UGT1A1*6, 60% WT/WT patients tolerated &gt; 95% predicted CPT11 dose (vs. 25% in WT/M-M/M combined group;p = 0.026). Severe(grade≥3) diarrhea was more common in WT/M-M/M group (44.4% vs. 17.9% in WT/WT,p = 0.06) as was any grade mucositis (55.6% vs. 9.5% in WT/WT,p = 0.002). On multivariate logistic regression analysis, UGT1A1*6 WT/M-M/M status was the only variable associated with(a/w) occurrence of both mucositis[OR = 10.4] &amp; severe(grade≥3) diarrhea[OR = 4.8]. UGT1A1*28 WT/M-M/M patients had better OS[338 days(95% CI = 190-486) vs. 216 days(95% CI = 136-296) in WT/WT group;p = 0.045]. On multivariate Cox proportional hazards analysis, better OS was independently a/w number of CTx cycles, UGT1A1*28 WT/M-M/M status, maximum % dose of CPT11 delivered &amp; inversely with age. Conclusions: UGT1A1*6 &amp; UGT1A1*28 polymorphisms are a/w increased toxicity &amp; improved OS respectively in North Indian SCLC patients receiving CPT11-CTx.

The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

IntroductionWhile some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom...

A multidisciplinary effort to decrease time from admission to chemotherapy on an inpatient oncology unit.

96 Background: Patients with established cancer diagnoses often experience delays in starting scheduled inpatient chemotherapy (CTX) after arrival on the University of Virginia (UVA) Medical Center oncology unit. These delays negatively impact hospital resource utilization. We formed a multidisciplinary team of physicians, nurses, and pharmacists to investigate these delays. We aim to decrease time-to-CTX (TTC) by 30% from baseline. Methods: From 340 planned inpatient CTX encounters in calendar year 2015, 100 were randomly reviewed to establish baseline retrospective data. The following were collected for each encounter: patient demographics; oncologic diagnosis; admitting team; CTX regimen and cycle; procedures and urinary parameters required prior to CTX start; times of lab orders and results, CTX signature and release, and start of intravenous fluid (IVF), premedications, and CTX; unit census data; available nursing staff; and length of stay. With guidance from ASCO’s Quality Training Program, we constructed a process map of the current state, an Ishikawa cause-and-effect diagram, a Pareto chart to assess causes of delays, and a priority matrix of potential interventions. XmR charts compared baseline and post-intervention data. Results: Baseline median TTC was 6.7 hours (range 1.5-105.3 h). Patients with pre-admission outpatient appointments started CTX 2.4 h earlier than those without appointments. Patients without urine parameters for treatment started CTX 3 h earlier than those with parameters. The Pareto chart indicated the longest delays occurred in pre-medicating patients, starting IVF, and signing CTX orders. In the first Plan-Do-Study-Act (PDSA) cycle, the CTX consent process was reformed. Post-intervention data showed no change in median TTC (7.2 h). Other PDSA cycles (setting patient arrival times and pre-admission pharmacy review of treatment plans) are ongoing; prospective data collection is pending. Conclusions: Retrospective data validate concerns that delays in starting inpatient CTX are longer than acceptable. They affect hospital length of stay, cost, and patient satisfaction. Our first PDSA cycle showed no change in TTC but additional interventions are ongoing.

Common and Distinct Characteristics Associated With Trajectories of Morning and Evening Energy in Oncology Patients Receiving Chemotherapy

ContextAlthough energy conservation strategies are recommended in clinical practice guidelines, little is known about changes in energy levels in oncology patients undergoing cancer treatment. ObjectivesThe objective of this study was to identify variations in the trajectories of morning and evening energy levels and determine which characteristics predicted initial levels and the trajectories of morning and evening energy. MethodsOutpatients receiving chemotherapy (CTX) completed demographic and symptom questionnaires six times over two CTX cycles. Energy was assessed using the Lee Fatigue Scale. Hierarchical linear modeling was used to analyze the data. ResultsA large amount of interindividual variability was found in the morning and evening energy trajectories. Patients who lived alone, had childcare responsibilities, had a lower functional status, did not exercise on a regular basis, had lower hemoglobin levels, had lower attentional function, higher trait anxiety, and higher sleep disturbance reported lower morning energy levels at enrollment. Variations in the trajectories of morning energy were associated with a higher body mass index and higher levels of morning energy and higher sleep disturbance scores. For evening energy, patients who were female, white, had lower functional status, and had lower attentional function and higher sleep disturbance reported lower evening energy levels at enrollment. Evening energy levels at enrollment were associated with changes in evening energy over time. ConclusionPatients undergoing CTX experience decrements in both morning and evening energy. The modifiable characteristics associated with these decrements can be used to design intervention studies to increase energy levels in these patients.

Chemotherapy-Induced Nausea and Vomiting (CINV) - First Results of a German Non-Interventional Study with NEPA - a Netupitant/Palonosetron Fixed Dose Combination

Introduction: Platinum and anthracyclin chemotherapy regimens are frequently used in hematology pts and compromised by severe acute and delayed CINV. NEPA, a fixed dose combination of the long lasting NK1-receptor antagonist (RA) netupitant and the pharmacological distinct 5HT3-RA palonosetron, has been approved by FDA and EMA for the prevention of acute and delayed CINV receiving highly emetogenic cisplatin- and AC-based as well as moderately emetogenic chemotherapy. A German non-interventional study is currently investigating NEPA's efficacy and impact on quality of life in adult cancer patients by PRO and physicians' personal assessment under real life conditions.Objectives: Primary objective is to evaluate quality of life (QoL) in adult patients receiving NEPA for CINV prevention. Secondary endpoints are efficacy and safety of NEPA.Methods: This open label, non-interventional, prospective, national, multicenter study evaluates CINV prevention and patients' QoL with NEPA in 2,500 pts receiving either highly or moderately emetogenic cytostatics on up to 2 consecutive days. NEPA is prescribed in accordance with the EU marketing authorization. QoL is evaluated by the validated FLIE questionnaire for 3 chemotherapy cycles 24 hours before, within 24 hours after and additional 4 days after chemotherapy. Efficacy is documented via patient diaries for the same time period. Safety and physicians' overall satisfaction is reported via eCRF. The interim analysis reports on the first 20% of the pre-planned number of patients.Results: Between June 2015 and July 2016 a total of 583 patients were enrolled. Median age was 56 (range of 28-88) with 521 out of 583 patients that completed documentation. A total of 291 patients (56%) received AC-based chemotherapy. Efficacy, evaluated by physicians’ personal assessment on a 4-point scale, was rated very good or good for 486 (90.7%), 409 (93.4%) and 350 (92.9%) patients in cycle 1, 2 and 3, respectively. Complete response was analyzed based on 87 completed patient diaries. Here, 88.5% reported no emesis and no rescue medication in the acute phase (0-24h post chemotherapy), while 85.1% and 79.3% reported complete response in the delayed (>24-120h post chemotherapy) and overall phase (0-120h post chemotherapy). A high percentage of patients did not suffer from any emesis (94%, 99% and 93% in acute, delayed and overall phase). The study is ongoing.Conclusions: NEPA proved to be highly effective for prevention of chemotherapy-induced emesis and nausea. Patient reported outcome was rated very good or good in more than 90% of Ctx cycles in the acute as the delayed phase of highly and moderately emetogenic Ctx including cisplatin or anthracyclin based therapy. DisclosuresKarthaus:HELSINN: Honoraria; RIEMSER: Honoraria. Schilling:RIEMSER: Honoraria.

1492P - Prevention of chemotherapy-induced alopecia in patients with breast or female genital tract cancer using sensor-controlled scalp-cooling

Chemotherapy (Ctx)-induced alopecia (CIA), produces a deep psychological impact in many women involved. Although sensor-controlled scalp cooling (SCSC) is effective in preventing CIA, it is infrequently used in many countries due to physicianś concerns regarding both safety and feasibility. This retrospective analysis was initiated to obtain detailed information about the effectiveness and safety of SCSC using the Paxman system (Paxman, Huddersfield, UK) in female patients (pts) exposed to CIA-inducing Ctx for breast cancer (BC) or genital tract malignancies in the clinical routine. 87 pts who underwent SCSC alongside Ctx from 2014-2016 were identified from our database: BC, 68; epithelial ovarian carcinoma, 14; others, 5; premenopausal, 42; postmenopausal, 45. 63 pts were treated in a curative intent, 24 were treated in a palliative setting; 57 pts were Ctx-naïve, 30 pts had a history of prior Ctx. The following Ctx regimens were used: anthracycline-based (A), 4; taxane-based (T), 21; AT-based, 48; others, 14. Pts were subjected to SCSC during each Ctx cycle. CIA was quantified according to the Dean score (DS) determined 3 wks after the last Ctx cycle. Data were analyzed regarding feasibility indicated by the SCSC completion rate, quality of hair preservation (success: DS 0-2, failure: DS 3-4), reasons of SCSC discontinuation, and safety. 57 pts (64.5%) completed SCSC, with 47 (53.0%) experiencing complete hair preservation (DS 0), and 10 (11.5%) showing partial success (DS 1-2). 30 pts (35.5%) discontinued SCSC, with CIA being the main reason in 21 pts (24.1%). Headache was reported in 4 (5.0%), and local discomfort ("feeling cold") in 3 pts (3.4%). In 2 pts (2.3%), the reason of discontinuation remained unclear. Side effects were all not severe and resolved completely after cessation of SCSC. In the clinical routine, SCSC using the Paxman system is feasible, safe and effective in order to prevent CIA in pts with BC and female genital tract carcinomas. The treatment success rate in our study is in good agreement with previous reports on SCSC although more pts in the palliative setting or with a history of prior Ctx have been included.

868P - Direct effects of platinum-based chemotherapy ± bevacizumab on the bone metabolism of patients with primary and platinum-sensitive recurrent tuboovarian carcinoma

Data regarding direct effects of antineoplastic chemotherapy (Ctx) on the bone metabolism of patients (pts) with epithelial tuboovarian carcinoma (ETOC) are largely lacking. The present translational project sought to gain detailed information on the influence of platinum-based Ctx ± bevacizumab (Bev) on the expression of various bone markers in pts with primary or platinum-sensitive recurrent ETOC. 85 ETOC pts receiving platinum-based Ctx apart from a clinical trial were analyzed. 16 pts also received Bev. The following bone markers were determined at baseline and prior to every subsequent Ctx cycle (C1-C6): C-terminal telopeptide of type I collagen (ICTP) as a marker of osteoclast function, N-terminal propeptide of type I collagen (P1NP) as a marker of osteoblast function, and alkaline phosphatase (AP). Results for C2-6 were calculated as percent of baseline values prior to C1. Changes of bone markers over time were analyzed using repeated measures analysis of variance (ANOVA) with p < 0.05 indicating statistical significance. 350 Ctx cycles without and 87 with Bev were evaluated. In both groups of pts, ICTP showed a constant decline beyond C2 to 76 percent of the baseline value without and 56 percent of the baseline value with Bev at C6. For Ctx alone, P1NP decreased immediately after C1 showing a plateau effect beyond C3 with 85 percent of the baseline level at minimum. For Ctx + Bev, P1NP values declined during the whole course of Ctx reaching 66 percent of the baseline level at C6 without any plateau effect. Adding Bev to Ctx resulted in a significantly stronger effect on both parameters (ICTP: p = 0.043, P1NP: p = 0.002). For AP, no significant changes were detected for both Ctx and Ctx + Bev, respectively. Platinum-based Ctx for primary and platinum-sensitive recurrent ETOC resulted in a significant inhibition of osteoblast and (secondarily) osteoclast activity. This is the first study demonstrating that addition of Bev is likely to both increase and accelerate the negative effect of platinum-based Ctx on bone metabolism of pts with ETOC. Prospective clinical trials adding osteoprotective agents to Ctx for ETOC are strongly recommended.

Sensor-controlled scalp cooling to prevent chemotherapy-induced alopecia in women treated for either breast or female genital tract cancer: A German experience using the Paxman system.

10118 Background: Chemotherapy (Ctx)-induced alopecia (CIA), produces a deep emotional impact in many female cancer patients (pts). Sensor-controlled scalp cooling (SCSC) has been found to be effective in preventing CIA, However, this technique is infrequently used in many countries due to concerns regarding both safety and feasibility. This prospective non-interventional study was initiated to gain detailed information about the effectiveness and reasons of discontinuation of SCSC using the Paxman system (Paxman, Huddersfield, UK) in German women exposed to CIA-inducing Ctx due to breast cancer (BC) or genital tract malignancies. Methods: 72 pts were included: BC, 54; epithelial ovarian carcinoma, 14; others, 4; premenopausal, 38; postmenopausal, 34. 51 pts were treated in a curative intent, 21 were treated in a palliative setting; 49 pts were Ctx-naïve, 23 pts had a history of prior Ctx. The following Ctx regimens were used: anthracycline-based (A), n = 4; taxane-based (T), n = 18; AT-based, n = 39; non-AT-based, n = 11. Pts were subjected to SCSC during each Ctx cycle. CIA was quantified according to the Dean score (DS) determined 3 wks after the end of Ctx. The primary endpoint was feasibility indicated by the treatment completion rate. Secondary endpoints were the degree of hair preservation (success: DS 0-2, failure: DS 3-4, or discontinuation of SCSC), and safety. Results: 46 pts (63.9%) completed SCSC, with 38 (52.8%) experiencing complete hair preservation (DS 0), and 8 (11.1%) showing partial success (DS 1-2). 26 pts (36.1%) discontinued CTCS, with CIA being the main reason in 18 pts (25%). Headache was reported in 4 (5.6%), and discomfort in 2 pts (2.8%). In the remaining 2 pts (2.8%), the reason for discontinuation was unclear. Side effects were not severe and resolved completely after cessation of SCSC. Conclusions: CTCS using the Paxman system is feasible, safe and effective in order to prevent CIA in pts with BC and female genital tract carcinomas in the clinical routine. Our study is in good agreement with previous reports on CTCS although including a higher proportion of pts in the palliative setting or with a history of prior Ctx.

Abstract P4-10-17: Changes of bone turnover markers during perioperative anthracycline- and/or taxane-based chemotherapy in pre- and postmenopausal patients with primary breast cancer

Abstract Background: Loss of bone mineral density (BMD) is among the well known sequelae of pharmacological therapy of patients (pts) with primary breast cancer (PBC). Cancer therapy induced bone loss (CTIBL) progresses more rapidly as compared to normal age-related changes of BMD and is best known to be associated with aromatase inhibitors in postmenopausal pts. Chemotherapy (Ctx) may also lead to a deterioration of BMD but in contast to endocrine Tx, this phenomenon is by far less elucidated and, at least in younger pts, mostly interpreted as a secondary effect following Ctx induced ovarian failure. Previous investigations focused on the classical CMF scheme, whereas conclusive data regarding direct effects of more recent Ctx protocols on the bone metabolism of PBC pts are still lacking. This translational project was initiated to gain detailed insights into the influence of anthracycline (A)- and/or taxane (T)-based Ctx on bone turnover of both pre- and postmenopausal PBC pts in the clinical routine. Methods: Data of 109 pts (premenopausal: 49; postmenopausal: 60) with non-metastatic Ctx-naïve PBC exposed to neoadjuvant or adjuvant Ctx were analyzed. 84 pts (75%) had estrogen receptor-positive (ER+) disease, HER2- overexpression was found in 18 pts (17%). 16 pts (15%) received A-based Ctx, 34 pts (31%) received T-based Ctx, and 59 pts (54%) received A/T-based Ctx. Trastuzumab was given to 17 pts (16%) with HER2-positive disease. Serum bone markers including the C-telopeptide of type I collagen (ICTP) indicating osteoclast activity, the N-propeptide of type I collagen (P1NP) measuring osteoblast activity, and alkaline phosphatase (AP) were determined at baseline and prior to each subsequent Ctx cycle (C) up to C6. Changes of ICTP, P1NP, and AP over time were analyzed by repeated-measure ANOVA. Results: 600 Ctx cycles were analyzed. Baseline levels of ICTP (p = 0.0027), P1NP (p = 0.0063), and AP (p = 0.0007) were significantly higher in post- versus premenopausal pts. AP levels remained largely unchanged during Ctx. Trends showing an increase of ICTP from baseline until C6 in premenopausal pts and a decrease in postmenopausal pts did not reach statistical significance. In contrast, P1NP significantly declined in postmenopausal pts from baseline to C6 (p = 0.0152). In premenopausal pts, P1NP declined from baseline to C3 and thereafter increased to C6. These changes were highly significant (p = 0.0024). Conclusions: Our study represents one of the first systematic evaluations of bone turnover in pts exposed to modern A- and/or T-based Ctx for PBC in the clinical routine. Postmenopausal pts presented with higher baseline levels of all three markers which may be attributable to an enhanced bone turnover related to the loss of ovarian function prior to the initiation of Ctx. In postmenopausal pts, Ctx was associated with a sustained suppression of osteoblast activity whereas osteoblast suppression recovered until the end of Ctx in premenopausal pts. Whether these effects will translate into an increased risk of CTIBL remains a matter of further investigations which should clearly focus on the individual menopausal status. Citation Format: Kurbacher CM, Rauschenbach N, Kurbacher AT, Sperling S, Herz S, Monreal K, Kurbacher JA. Changes of bone turnover markers during perioperative anthracycline- and/or taxane-based chemotherapy in pre- and postmenopausal patients with primary breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-10-17.

4P - Influence of anthracycline- and/or taxane-based chemotherapy on bone metabolism of patients with primary breast cancer

Background: Cancer therapy-induced bone loss (CTIBL) is well-known sequela of adjuvant endocrine therapy in postmenopausal patients (pts) with primary breast cancer (PBC). Pts exposed to chemotherapy (Ctx) with alkylators for lymphoma/leukemia own a high risk of premature CTIBL which as in premenopausal PBC pts may be mainly an indirect endocrine effect of Ctx. In contrast, data on direct effects of modern perioperative Ctx on bone metabolism are limited. This retrospective study was initiated to gain more detailed insights into the influence of perioperative anthracycline (A)- and/or taxane (T)-based Ctx on bone turnover of pts with pre- and postmenopausal PBC.Methods: A total of 109 pts (premenopausal: 49; postmenopausal: 60) receiving neoadjuvant or adjuvant A- and/or T-based Ctx were included. Serum markers of bone metabolism including C-telopeptide of type I collagen (ICTP) indicating the osteoclast activity, N-propeptide of type I collagen (P1NP) indicating the osteoblast activity, and bone alkaline phosphatase (BALP) were determined at baseline and prior to each subsequent Ctx cycle (C) up to C6. Changes of ICTP, P1NP, and BALP over time were analyzed by repeated-measure ANOVA.Results: A total of 600 Ctx cycles were analyzed. Baseline levels of ICTP, P1NP, and BALP were significantly higher in post- versus premenopausal pts. ICTP and BALP did not significantly change during Ctx. Both an increase of ICTP from baseline until C6 in premenopausal pts and a decrease in postmenopausal pts did not reach statistical significance. In contrast, P1NP significantly declined in postmenopausal pts from baseline to C6 (p = 0.0152). In premenopausal pts, P1NP declined from baseline to C3 and then increased until C6. These changes were highly significant (p = 0.0024).Conclusion: Our study demonstrates that A- and/or T-based Ctx for PBC exhibits direct effects on bone metabolism. In postmenopausal pts, Ctx was associated with a sustained suppression of osteoblast activity. In premenopausal pts, early osteoclast suppression completely recovered during C4-6. Whether these effects will translate into an increased risk to further develop CTIBL needs to be clarified by long-term observations.Disclosure: All authors have declared no conflicts of interest. Background: Cancer therapy-induced bone loss (CTIBL) is well-known sequela of adjuvant endocrine therapy in postmenopausal patients (pts) with primary breast cancer (PBC). Pts exposed to chemotherapy (Ctx) with alkylators for lymphoma/leukemia own a high risk of premature CTIBL which as in premenopausal PBC pts may be mainly an indirect endocrine effect of Ctx. In contrast, data on direct effects of modern perioperative Ctx on bone metabolism are limited. This retrospective study was initiated to gain more detailed insights into the influence of perioperative anthracycline (A)- and/or taxane (T)-based Ctx on bone turnover of pts with pre- and postmenopausal PBC. Methods: A total of 109 pts (premenopausal: 49; postmenopausal: 60) receiving neoadjuvant or adjuvant A- and/or T-based Ctx were included. Serum markers of bone metabolism including C-telopeptide of type I collagen (ICTP) indicating the osteoclast activity, N-propeptide of type I collagen (P1NP) indicating the osteoblast activity, and bone alkaline phosphatase (BALP) were determined at baseline and prior to each subsequent Ctx cycle (C) up to C6. Changes of ICTP, P1NP, and BALP over time were analyzed by repeated-measure ANOVA. Results: A total of 600 Ctx cycles were analyzed. Baseline levels of ICTP, P1NP, and BALP were significantly higher in post- versus premenopausal pts. ICTP and BALP did not significantly change during Ctx. Both an increase of ICTP from baseline until C6 in premenopausal pts and a decrease in postmenopausal pts did not reach statistical significance. In contrast, P1NP significantly declined in postmenopausal pts from baseline to C6 (p = 0.0152). In premenopausal pts, P1NP declined from baseline to C3 and then increased until C6. These changes were highly significant (p = 0.0024). Conclusion: Our study demonstrates that A- and/or T-based Ctx for PBC exhibits direct effects on bone metabolism. In postmenopausal pts, Ctx was associated with a sustained suppression of osteoblast activity. In premenopausal pts, early osteoclast suppression completely recovered during C4-6. Whether these effects will translate into an increased risk to further develop CTIBL needs to be clarified by long-term observations. Disclosure: All authors have declared no conflicts of interest.

Efficacy of Lipegfilgrastim (Lipeg) and Pegfilgrastim (Peg) in Breast Cancer Patients Receiving Chemotherapy (Ctx) Stratified By Status, Age, and Disease Stageby Status, Age, and Disease Stage

ABSTRACT Aim: Lipegfilgrastim is a once-per-cycle, glycoPEGylated recombinant human granulocyte colony-stimulating factor approved by the European Medicines Agency to reduce the duration of severe neutropenia (DSN) and incidence of febrile neutropenia in adult patients receiving CTx. Methods: Breast cancer patients scheduled for CTx (doxorubicin 60 mg/m2+docetaxel 75 mg/m2 on Day 1 for up to 4 cycles) were randomized to 6-mg subcutaneous injections of Lipeg (n = 101) or Peg (n = 101) on Day 2 of each cycle. Post-hoc analyses compared efficacy outcomes during CTx cycle 1 within treatment groups stratified by Eastern Cooperative Oncology Group (ECOG) status, age (≤50 and >50 years of age [y]), and disease stage at baseline. Results: The DSN within treatment groups was comparable regardless of ECOG status (0.7 vs 0.7 days [d] for Lipeg and 0.8 vs 0.9 d for Peg, status 0 vs 1, respectively) or age (0.6 vs 0.7 d for Lipeg and 0.8 vs 0.9 d for Peg, ages ≤50 y vs >50 y, respectively), but shorter in stage IV Lipeg-treated patients (0.7, 0.7, 0.4 d for Lipeg and 0.7, 0.9, 0.9 d for Peg, stages II, III, IV, respectively). The incidence of severe neutropenia (SN) was comparable regardless of ECOG status (45.5% vs 42.0% for Lipeg and 50.0% vs 52.1% for Peg, status 0 vs 1, respectively), higher in patients >50 y within both treatments (40.7% vs 47.5% for Lipeg and 47.7% vs 54.0% for Peg, ≤50 y vs >50 y, respectively), and lower within both treatment groups in stage IV patients (44.7%, 45.7%, 30.0% for Lipeg and 51.4%, 52.3%, 46.7% for Peg, stages II, III, IV, respectively). Time to ANC recovery was similar regardless of ECOG status (5.9 vs 5.8 d for Lipeg and 7.1 vs 7.7 d for Peg, status 0 vs 1, respectively), shorter in Lipeg patients ≤50 y (5.5 vs 6.4 d for Lipeg and 7.5 vs 7.3 d for Peg, ≤50 y vs >50 y, respectively), and similar regardless of disease stage (5.6, 6.0, 6.0 d for Lipeg and 7.0, 7.6, 7.7 d for Peg, stages II, III, IV, respectively). Conclusions: Within treatment groups, ECOG status did not affect DSN, incidence of SN, or time to ANC recovery. Age did not influence DSN or time to ANC recovery; however, more patients >50 y had SN vs those ≤50 y. DSN was shorter and SN was lower in stage IV patients. Disclosure: P. Bias: TEVA employee and receives stock options; U. Muller: TEVA employee and receives stock options; A. Buchner: TEVA employee and receives stock options. All other authors have declared no conflicts of interest.

Lipegfilgrastim: A long-acting, once-per-cycle, glycopegylated recombinant human filgrastim.

e13548 Background: Lipegfilgrastim is a once-per-cycle fixed-dose glycoPEGylated granulocyte-colony stimulating factor (G-CSF) under development for the prevention of severe neutropenia in cancer patients receiving chemotherapy (CTx). PEGylation of a molecule extends its half-life in the body, requiring less frequent dosing and allowing for administration of G-CSF once per CTx cycle, making treatment potentially less expensive and enhancing patient compliance and safety. Briefly, traditional PEGylation methods use chemical conjugation through reactive groups on amino acids, which may reduce protein activity and result in non-uniform chemical and pharmaceutical properties. Here, we describe a highly site-specific GlycoPEGylation technology for site-directed PEGylation and summarize preclinical findings compared with pegfilgrastim (Neulasta). Methods: Glycosylation sequon scanning was used to identify the glycoPEGylation site with least impact on protein activity. E. coli-expressed G-CSF was selectively glycosylated at natural O-glycosylation sites and a polyethylene glycol (PEG) sialic acid derivative attached using a sialyltransferase (glycoPEGylation technology). Ligand binding affinity was assessed using the BIACORE 3000 system. Biologic activity of lipegfilgrastim was assessed in an NFS-60 cell line proliferation assay vs filgrastim and pegfilgrastim. PK and PD properties were studied in healthy and neutropenic animal models. Results: GlycoPEGylation produces long-acting G-CSF with improved PK profiles. In vitro, lipegfilgrastim had binding affinity and specific activity comparable to pegfilgrastim, and both were lower than non-PEGylated filgrastim. Comparable increases in leukocytes, neutrophilic granulocytes, and monocytes were seen with lipegfilgrastim and pegfilgrastim in rats and monkeys and were consistent with the effects expected for a long-lasting G-CSF. Conclusions: GlycoPEGylation technology platform is used to produce lipegfilgrastim – a novel, biologically active G-CSF with greater structural homogeneity and comparable pharmacologic properties to conventionally PEGylated G-CSFs.