A randomized, multicenter clinical trial to determine the efficacy and safety of pegfilgrastim (GEMA BIOTECH) compared to pegfilgrastim (Roche) for prevention of chemotherapy induced neutropenia in patients with breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3113-3113
Author(s):  
Martin Eduardo Richardet ◽  
Ruben Dario Kowalyszyn ◽  
Mirta Susana Varela ◽  
Eduardo Ortiz ◽  
Cristian Micheri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Study Drug ◽  
Severe Neutropenia ◽  
Myelosuppressive Chemotherapy ◽  
Secondary Endpoints ◽  
Study Population ◽  
Efficacy Measures ◽  
The Difference ◽  
To Receive

3113 Background: Peg-Neutropine, GEMA BIOTECH SAU biosimilar Peg-Filgrastim, is the first Peg-Filgrastim approved in LATAM for prevention of febrile neutropenia in patients treated with myelosuppressive chemotherapy. Methods: Study population: women with stage 2, 3 or 4 of breast cancer scheduled to receive 4 or 6 cycles of chemotherapy (with Taxane) at 3 weeks interval. Stratification was based on breast cancer stage. Study drug was administered subcutaneously in a 6 mg dose. The study was blind to the assessors. The primary endpoint was Duration of Severe Neutropenia (DSN, Absolute Neutrophil Count-ANC < 500/mm3) in the first cycle of chemotherapy. Secondary endpoints were incidence of severe neutropenia (SN), other efficacy measures, and incidence of ADRs. The non-inferiority margin for DSN was estimated in less than 1 day. Results: A total of 120 subjects were randomized 1:1, 58 were treated with Peg-Neutropine and 62 with Peg-Filgrastim (Roche). Efficacy: SN was developed in 52/283 (18,4%) cycles with Peg-Neutropine in 27 patients and 48/297 (16,2%) cycles with Peg-Filgrastim (Roche) in 20 patients (p=0,4836). In the first cycle, 16 patients with Peg-Neutropine and 11 patients with Peg-Filgrastim (Roche) developed SN. In per protocol analysis mean DNS in the first cycle was 0,78 ± 1,53 days for Peg-Neutropine group and 0,53±1,25 for Peg-Filgrastim (Roche) group (95% IC for the difference -0,26; 0,76). Per ITT analysis the mean DSN was 0,90±1,79 for Peg- Neutropine group and 0,50±1,21 for Peg-Filgrastim (Roche) group , (95% IC for the difference -0,15; 0,95). For all the efficacy secondary endpoints the differences were not statistically significant. Safety: 7 ADRs were developed by 3 subjects with Peg-Neutropine and 31 ADRs were developed by 10 subjects with Peg-Filgrastim (Roche). The most common reaction was myalgia, and other ADRs were arthralgia, asthenia, bone pain and acid sensitive syndrome. Conclusions: Based on the non-inferiority margin established we conclude that Peg-Neutropine is biosimilar to Peg-Filgrastim (Roche). Clinical trial information: NCT03404752.

The comparative effectiveness of direct oral anti-coagulants and low molecular weight heparins for prevention of recurrent venous thromboembolism in cancer: The CANVAS pragmatic randomized trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12020-12020
Author(s):  
Deborah Schrag ◽  
Hajime Uno ◽  
Rachel Pam Greenerger Rosovsky ◽  
Cynthia Rutherford ◽  
Kristen Marie Sanfilippo ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Comparative Effectiveness ◽  
Pragmatic Trial ◽  
Study Drug ◽  
Recurrent Venous Thromboembolism ◽  
The Us ◽  
Recurrent Vte ◽  
The Difference ◽  
To Receive

12020 Background: Previous randomized trials in cancer patients suggest that DOACs are non-inferior to LMWH for preventing recurrent VTE but have higher risk of bleeding. However, the balance of benefits and burdens remains uncertain. Objective: The CANVAS pragmatic trial compared recurrent VTE, bleeding and death in cancer patients following an initial VTE treated with either DOAC or LMWH therapy. Methods: CANVAS was an unblinded hybrid comparative effectiveness non-inferiority trial, with randomized and preference cohorts. Between 12/16 and 4/20, 671 participants were randomized and followed for 6-months. Between 12/16 and 12/17, 140 participants declined randomization, chose their preferred anticoagulant and were followed for 6-months. The preference cohort was closed when predetermined stopping criteria were met. Final follow-up was 11/30/20. Randomized patients were assigned 1:1 to receive either a DOAC or a LMWH. If assigned to LMWH, transitions to warfarin were allowed. Physicians and patients could choose among any DOAC or LMWH. Doses were suggested based on FDA-approved labeling but not mandated. Patients from 67 practices in the US with any invasive solid tumor, lymphoma, multiple myeloma or CLL and a diagnosis of symptomatic or radiographically detected VTE within 30 days of enrollment were eligible. The 1° analysis was conducted in the randomized modified-into to treat popululation, (all subjects who received study drug). The 1° outcome was recurrent VTE. The aim was to establish noninferiority of anticoagulation with a DOAC as defined by the upper limit of the 2-sided 90% CI for the difference in the event rate at 6 months of < 3%. Secondary outcomes included death and bleeding. Hypothesis testing included only the randomized cohort but propensity score adjusted results for the preference and combined cohorts are also shown. Results: The non-inferiority criteria for recurrent VTE was met. Conclusions: Among adult cancer patients with VTE, the use of a DOAC compared with a LMWH resulted in a noninferior risk of recurrent VTE with no differences in rates of bleeding or death in randomized patients. Clinical trial information: NCT02744092. [Table: see text]

scholarly journals Prospective, Multicentric Phase II Randomized Trial Comparing the Efficacy of Methotrexate or Cyclophosphamide in Large Granular Lymphocytic Leukemia: A French National Study. Report on the Interim Analysis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1545-1545 ◽  
Author(s):  
Thierry Lamy ◽  
Cedric Pastoret ◽  
Roch Houot ◽  
Loic Ysebaert ◽  
Mathilde Hunault ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Funding ◽  
Sequential Analysis ◽  
Severe Neutropenia ◽  
National Study ◽  
Sufficient Information ◽  
Transfusion Requirements ◽  
Stat3 Mutation ◽  
To Receive ◽  
Lgl Leukemia

Introduction Large granular lymphocyte (LGL) leukemia is characterized by a clonal expansion of CD3+ cytotoxic T or CD3- NK cells. Prominent clinical features include neutropenia, anemia and autoimmune-associated diseases such as rheumatoid arthritis (RA). Although the disease is usually chronic and indolent, some patients may be symptomatic and require treatment. No standard therapy has been established due to the absence of prospective clinical trials. So far, low dose methotrexate, oral cyclophosphamide, and cyclosporine represent the 3 main options for initial therapy. In 2014, we launched a prospective clinical trial comparing methotrexate to cyclophosphamide in previously-untreated patients with LGL leukemia in need of treatment. Patients and methods The study was designed as a multicentric, national, open label, randomized, controlled trial on two parallel groups, comparing methotrexate and cyclophosphamide. Patients were included if they had at least one of the following indications of treatment: isolated severe neutropenia (ANC &lt;0.5x109/L) or neutropenia (ANC &lt;1.5x109/L) with infections, anemia requiring transfusions or symptomatic anemia, associated complications such as systemic diseases or auto-immune diseases resistant to steroids and/or immunomodulating agents (colchicin, disulone, hydrochloroquine). They were randomly assigned to receive either methotrexate (10 mg/m²/w) or cyclophosphamide (100 mg/d) for 4 months. Responders at M4 continued with the same treatment until M12 (cyclophosphamide was then delivered at 50 mg/d). Non-responders at M4 were randomly assigned to receive either cyclosporine (3 mg/kg/d) or the drug which had not been administered at the first randomization (methotrexate or cyclophosphamide). Response was assessed using previously published criteria (Lamy T, Blood 123:1182, 2014). Complete response (CR) was defined as a normalization of clinical exam (disappearance of splenomegaly or associated autoimmune symptoms) and a complete normalization of blood counts. Partial response (PR) was defined as an improvement in blood counts which did not meet criteria for complete remission (e.g., ANC &gt;0.5x109/L or decrease of transfusion requirements). Treatment failure was defined as no response or any response which did not meet the above-mentioned criteria within four months after the beginning of treatment. To stop the trial as soon as sufficient information was collected, a sequential analysis was planned each time 20 patients were included and evaluated using the triangular test (Sébille V, Bellissant E. Fundam Clin Pharmacol. 2003;17(5):505-16). The primary endpoint was the hematological CR rate evaluated at M4 (binary endpoint). Secondary endpoints were overall response rate (ORR) at M4, M8 and M12, time to relapse. For non-responders at M4, cyclosporine was compared to the treatment which had not been administered during the first phase. Results From Nov 2013 to July 2019, 99 patients met inclusion criteria among which 96 were randomized. The baseline characteristics of these patients are shown in Table1. STAT3 mutation was observed 52% of cases. After the 4th sequential analysis performed on the first 80 patients evaluable for response at M4, the sample path remained in the continuation region of the triangular test. Thus, the trial has to be continued. At M4, 13 patients were in CR (16.3%) and 29 patients were in PR (36.3%), ORR was 52.6%, 36 patients were considered as refractory and underwent a second randomization: 18 patients received cyclosporine and 17 received methotrexate or cyclophosphamide. Conclusions This first prospective randomized clinical trial in LGL leukemia shows that the CR after first line therapy using either methotrexate or cyclophosphamide is relatively low (&lt; 20%). Recruitment is still ongoing to assess if there is a difference in terms of response between the two drugs. Predictive biomarkers of response will be presented at the meeting. Regarding a 52% of incidence of Stat3 mutation (higher than that previously published), Jak/Stat targeted therapy should be prospectively evaluated in this disease. Disclosures Houot: Bristol Myers Squibb: Honoraria; Merck Sharp Dohme: Honoraria. Gyan:Pfizer: Honoraria. Feugier:janssen: Honoraria, Research Funding, Speakers Bureau; abbvie: Honoraria, Research Funding, Speakers Bureau; gilead: Honoraria, Research Funding, Speakers Bureau; roche: Honoraria, Research Funding, Speakers Bureau.

A phase III, randomized, double-blind, multicenter, active control study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC): CONSOLE.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12099-12099
Author(s):  
Yoshimasa Shiraishi ◽  
Akito Hata ◽  
Naoki Inui ◽  
Morihito Okada ◽  
Masahiro Morise ◽  
...  
Keyword(s):  
Study Drug ◽  
Incidence Rates ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Secondary Endpoints ◽  
To Receive ◽  
Age Category

12099 Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity for the neurokinin-1 (NK-1) receptor and a long half-life of 70 h. This phase 3 study is the first head-to-head study to compare two NK-1 receptor antagonists, FN and fosaprepitant (FA), in combination with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (JapicCTI-194611). Methods: Patients scheduled to receive cisplatin (≥70 mg/m2) -based chemotherapy were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg, in combination with palonosetron 0.75 mg and dexamethasone (9.9 mg on day 1, 6.6 mg on days 2-4). The stratification factors were sex, age category (<55 vs. ≥55 years), and site. The primary endpoint was the complete response (CR; no emetic events and no rescue medication) rate, stratified by sex and age category, during the overall phase (0-120 h) to show the non-inferiority (margin, -10%) of FN to FA. The secondary endpoints were: CR rate, complete protection rate, total control rate, no nausea rate, no emetic events rate in each period [i.e., acute (0-24 h), delayed (24-120 h), overall, 0-168 h and 120-168 h], time to treatment failure, and safety, including injection site reactions (ISRs). Assessment of efficacy was continued until 168 h after the initiation of cisplatin. Some eligible patients were evaluated for safety and efficacy of FN for up to four cycles. Results: Between February 2019 and March 2020, total 795 patients were enrolled in the study. The study drug was administered to 785 patients (n=392 in FN vs. n=393 in FA), and all of them were evaluated for efficacy and safety. Baseline characteristics were generally balanced between the two groups. The adjusted overall CR rate was 75.2% in FN vs. 71.0% in FA [MH common risk difference, 4.1%; 95% CI, -2.1% to 10.3%), thus demonstrating non-inferiority of FN to FA. Regarding the other secondary endpoints of efficacy until 168 h, FN was favorable against FA, especially the CR rate during 0-168 h (73.2% in FN vs. 66.9% in FA) (Table). The incidence rates of treatment-related adverse events were 22.2% in FN vs. 25.4% in FA, whereas those of ISRs with any cause or with treatment-related were 11.0% or 0.3% in FN vs 20.6% or 3.6% in FA, respectively ( p<0.001). Conclusions: FN demonstrated non-inferiority to FA, with a favorable safety profile and lower risk for ISRs. For the period beyond 120 h after initiation of chemotherapy, FN may have the potential to improve the prevention of “beyond delayed” CINV. Clinical trial information: JapicCTI-194611. [Table: see text]

A randomized clinical efficacy study targeting mPGES1 or EP4 in dogs with spontaneous osteoarthritis

2019 ◽  
Vol 11 (516) ◽  
pp. eaaw9993
Author(s):  
Carol Robertson-Plouch ◽  
John R. Stille ◽  
Peng Liu ◽  
Claire Smith ◽  
Dorothy Brown ◽  
...  
Keyword(s):  
Posterior Probability ◽  
Brief Pain Inventory ◽  
Repeated Measure ◽  
Controlled Study ◽  
Prostaglandin E ◽  
Double Blind ◽  
Mixed Effect ◽  
Secondary Endpoints ◽  
Efficacy Measures ◽  
The Difference

Canine studies of spontaneous osteoarthritis (OA) pain add valuable data supporting drug treatment mechanisms that may translate to humans. A multicenter, randomized, double-blind, placebo- and active-controlled study was conducted in client-owned dogs with moderate OA pain to evaluate efficacy of LYA, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES1), an EP4 antagonist (LYB), and carprofen, versus placebo. Of 255 dogs screened, 163 were randomized (placebo/LYA/LYB/carprofen: n = 43/39/42/39) and 158 completed treatment. Efficacy versus placebo was assessed using Bayesian mixed-effect model for repeated measure analyses of the Canine Brief Pain Inventory (CBPI) pain interference score (PIS; primary endpoint), pain severity score, and overall impression, as well as the Liverpool Osteoarthritis in Dogs (LOAD) mobility score. The posterior probability that the difference to placebo was <0 at week 2 was 80% for LYA and 54% for LYB for CBPI PIS (both <95% predefined threshold). For secondary endpoints, the posterior probability that the difference to placebo was <0 at week 2 ranged from 89 to 96% for LYA and from 56 to 89% for LYB. The posterior probabilities comparing carprofen to placebo groups were ≥90% for all efficacy endpoints. The proportion of dogs with one or more adverse event was not significantly different from placebo (32.6%) for LYA (35.9%) or carprofen (25.6%), but the rate for LYB (59.5%) was higher versus placebo (P = 0.017). LYA treatment demonstrated consistent improvement in all efficacy measures, suggesting that inhibition of mPGES1 may be an effective treatment for chronic pain associated with OA.

scholarly journals Transnasal Humidified Rapid Insufflation Ventilatory Exchange With Nasopharyngeal Airway Facilitates Apneic Oxygenation: A Randomized Clinical Noninferiority Trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Lingke Chen ◽  
Liu Yang ◽  
Weitian Tian ◽  
Xiao Zhang ◽  
Yanhua Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lower Boundary ◽  
Clinical Trial Registration ◽  
Apneic Oxygenation ◽  
Nasopharyngeal Airway ◽  
Airway Opening ◽  
The Difference ◽  
To Receive ◽  
Noninferiority Margin ◽  
Upper Boundary

Background: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) was used to extend the safe apnea time. However, THRIVE is only effective in patients with airway opening. Nasopharyngeal airway (NPA) is a simple device that can help to keep airway opening. This study aimed to investigate the noninferiority of NPA to jaw thrust for airway opening during anesthesia-induced apnea.Methods: This was a prospective randomized single-blinded noninferiority clinical trial on the use of THRIVE in patients with anesthesia-induced apnea. The participants were randomly allocated to receive NPA or jaw thrust. The primary outcomes were PaO2 and PaCO2 at 20 min after apnea, with noninferiority margin criteria of −6.67 and 0.67 kPa, respectively.Results: A total of 123 patients completed the trial: 61 in the NPA group and 62 in the jaw thrust group. PaO2 at 20 min after apnea was 42.9 ± 14.0 kPa in the NPA group and 42.7 ± 13.6 kPa in the jaw thrust group. The difference between these two means was 0.25 kPa (95% CI, −3.87 to 4.37 kPa). Since the lower boundary of the 95% CI was &gt; −6.67 kPa, noninferiority was established because higher PO2 is better. PaCO2 at 20 min after apnea was 10.74 ± 1.09 kPa in the NPA group and 10.54 ± 1.18 kPa in the jaw thrust group. The difference between the two means was 0.19 kPa (95% CI, −0.14 to 0.53 kPa). Since the upper boundary of the 95% CI was &lt;0.67 kPa, noninferiority was established because lower PCO2 is better. No patient had a SpO2 &lt; 90% during apnea.Conclusion: When THRIVE was applied during anesthesia-induced apnea, NPA placement kept airway opening and was noninferior to jaw thrust in terms of its effects on PaO2 and PaCO2 at 20 min after apnea.Clinical Trial Registration:ClinicalTrials.gov (NCT03741998).

Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol

2020 ◽  
Vol 29 (LatAm sup 1) ◽  
pp. 18-26
Author(s):  
Fernanda Mateus Queiróz Schmidt ◽  
Carol V. Serna González ◽  
Rodrigo Calixto Mattar ◽  
Luciana Biagini Lopes ◽  
Marinilce Fagundes dos Santos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Vitamin E ◽  
Controlled Study ◽  
Trial Protocol ◽  
Clinical Trial Protocol ◽  
Primary Endpoints ◽  
Hospital Patients ◽  
Secondary Endpoints ◽  
Group B

Objective: Little is known about the efficacy of products aiming to prevent radiodermatitis, which affects between 90–95% of women with breast cancer. The use of antioxidants is promising, however, there is a lack of evidenceon their effectiveness. Here, the authors present a clinical trial protocol to evaluate the effects of applying a cream containing nanoparticles with vitamin E to prevent radiodermatitis in patients with breast cancer. Method: The protocol recommends that 108 women with breast cancer, receiving radiotherapy, are included in this triple-blinded, randomized, controlled study at an oncology hospital. Patients will be divided in three groups of 36 individuals each: group A will receive a cream with lipid nanoparticles and vitamin E, group B will receive a cream without nanoparticles nor vitamin E, and group C will receive a cream with nanoparticles without vitamin E. The primary endpoints will evaluate the incidence, degree, and time of onset of radiodermatitis. The secondary endpoints will focus on the quality of life, symptoms, and local temperature. Patients will be assessed three times a week, from the start of their radiotherapy treatment to two weeks after the last session. This protocol was approved by the research ethics committee of the institutions involved and registered on an international trials database.

Toxicity of epirubicin and cyclophosphamide (EC) vs. docetaxel (D) followed by EC in the adjuvant (adj) treatment of node positive breast cancer. A multicenter randomized phase III study (GOIM9902)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10526-10526
Author(s):  
M. Lopez ◽  
M. Brandi ◽  
P. Foggi ◽  
F. Giotta ◽  
N. Gebbia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cardiac Toxicity ◽  
Phase Iii ◽  
Cross Resistance ◽  
Secondary Endpoints ◽  
Phase Iii Study ◽  
Sequential Trials ◽  
To Receive ◽  
Hormonal Receptor Status ◽  
Normal Cardiac Function

10526 Background: Due to high activity of taxanes (T) and anthracyclines (A) in advanced breast cancer (BC) and to the lack of cross-resistance between them, several adjuvant (adj) trials have been performed to test the efficacy of combination or sequential schedules of T and A adjuvant. In most of the sequential trials A followed T. The sequence T->A was proven active in metastatic BC, but no data are available in the adj setting. This multicenter randomized phase III study was designed to evaluate the efficacy of the sequence T->A vs an A containing regimen Methods: Pts with pT1–3 pN1 M0 (UICC1997) BC, age 18–70, PS(ECOG) 0–1, normal cardiac function, adequate bone marrow, hepatic and renal function were eligible for the study. Pts were stratified according to institution, age (≤ 50 vs > 50), hormonal receptor status and number of involved nodes (≤ 3, 4–9, ≥ 10) and were randomized to receive either 4 cycles of EC (Epirubicin 120 mg/m2 + Cyclophosphamide 600 mg/m2 on day 1 q21) in arm A or 4 cycles of D (100 mg/m2 on day 1 q21) followed by 4 cycles of EC in arm B. Primary endpoint was DFS. Secondary endpoints OS and toxicity. Results: Between april 1999 and october 2005, 750 pts were enrolled (374 in arm A and 376 in arm B) in 25 Italian institutions. Pts characteristics are as follows: Arm A: age ≤ 50 yrs 185/374; ≤ 3 nodes 182/374, 4–9 nodes 129/374, ≥ 10 nodes 63/374; positive HR 287/374 Arm B: age ≤ 50 yrs 197/376; ≤ 3 nodes 184/376, 4–9 nodes 131/376, ≥ 10 nodes 61/376; positive HR 289/376 Toxicity data (Arm A vs Arm B) of the first 495(241/254) pts are the following: Neutropenia G3 (29% vs 21.3%), neutropenia G4 (32.7% vs 48.8%), febrile neutropenia G3–4 (3.7% vs 9.5%), thrombocytopenia G3–4 (3.3% vs 1.6%), anemia G3 (0% vs 2.4%), N/V G3–4 (6.2% vs 3.1%), mucositis G3–4 (3.7% vs 3.9%), diarrhea G3–4 (0.4% vs 2.8%), peripheral neuropathy G1–3 (0% vs 9.9%), hypersensitivity reactions G3–4 (0% vs 4.3%), cardiac toxicity G3 (0.4% vs 0%) Conclusions: Treatment was generally well tollerated in both arms with a higher incidence of neutropenia, usually short lasting, in arm B. The use of prophylactic G-CSF in those patients experiencing neutropenia G3–4 may be advisable. There were no significant differences in cardiac toxicity. No significant financial relationships to disclose.

Cost of chemotherapy-related febrile neutropenia

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6068-6068 ◽  
Author(s):  
D. Weycker ◽  
J. Malin ◽  
A. Glass ◽  
G. Oster
Keyword(s):  
Febrile Neutropenia ◽  
Source Population ◽  
Tumor Type ◽  
Type Number ◽  
Myelosuppressive Chemotherapy ◽  
Study Population ◽  
Baseline Characteristics ◽  
The Difference ◽  
Initial Hospitalization ◽  
Number Of Cycles

6068 Background: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy that typically necessitates hospitalization. While the costs of FN have been reported to be substantial, previous studies may have underestimated these costs due to failure to account for follow-on care. Methods: A retrospective cohort study was undertaken using a US healthcare claims database. The source population included adult cancer patients who received a course of chemotherapy between 2001 and 2003. For each such patient, each unique cycle of chemotherapy was identified, and patients who developed FN within these cycles were further identified based on hospitalization for neutropenia, fever, and/or infection. Patients with FN in a given cycle (“cases”), starting with the first, were matched–on tumor type, number of cycles, chemotherapy characteristics, and propensity score–to those not experiencing FN in that cycle (“controls”), regardless of occurrence of FN in subsequent cycles; once matched, patients were removed from their respective pools. FN-related healthcare charges–including inpatient, outpatient, and drug treatment for neutropenia, fever, and infection–were tallied for each such pair of patients from the cycle day on which cases developed FN through the last chemotherapy cycle. Healthcare charges were used as a proxy for costs, as the latter were unavailable. Results are reported as means and 95% confidence intervals. Results: The study population consisted of 746 patients; 38% had breast cancer, 21% had lung cancer, and 11% had non-Hodgkin’s lymphoma. Cases and controls were similar in terms of baseline characteristics. FN-related charges totaled $40,928 (95%CI $28,783-$62,586) among cases versus $3,933 ($2,890-$5,119) for controls, a difference of $36,995 ($25,283-$58,776). Non-FN-related charges were similar in the two groups ($32,774 [$28,587-$36,061] vs. $32,253 [$29,248-$36,066]). Care subsequent to initial hospitalization accounted for $9,872 (or 27%) of the higher FN-related charges among cases. Conclusions: Costs of care during chemotherapy are twofold higher among patients who develop FN; follow-on care represents more than one-quarter of the difference. [Table: see text]

Efficacy and safety of balugrastim in chemotherapy-induced neutropenia: Integrated analysis of two randomized phase III studies.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17572-e17572
Author(s):  
Oleg Gladkov ◽  
Constantin D. Volovat ◽  
Steven Barash ◽  
Anton Buchner ◽  
Noa Avisar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Medical Condition ◽  
Phase Iii ◽  
Severe Neutropenia ◽  
Integrated Analysis ◽  
Efficacy And Safety ◽  
Breast Cancer Patients ◽  
Myelosuppressive Chemotherapy ◽  
Phase Iii Studies

e17572 Background: Balugrastim is a recombinant fusion protein composed of human serum albumin and human granulocyte colony-stimulating factor, which allows for once-per-chemotherapy cycle administration. We present a combined analysis of two double-blind, randomized Phase III studies comparing efficacy and safety of balugrastim vs pegfilgrastim in breast cancer patients receiving myelosuppressive chemotherapy (CTx). Methods: All patients were treated with doxorubicin 60 mg/m2 followed by docetaxel 75 mg/m2 administered by i.v. infusion on Day 1 of a 21-day cycle for up to 4 cycles. For each cycle, patients received a single s.c. injection of balugrastim approximately 24 hours after administration of CTx. The primary endpoint for both studies was duration of severe neutropenia (DSN) in Cycle 1. Safety of balugrastim was assessed by evaluating the type, frequency, and severity of adverse events (AEs); changes in laboratory parameters and vital signs, and immunogenicity over time. Analyses were performed in the per-protocol population. Results: A total of 469 patients were randomized to receive balugrastim 40 mg (N=235) or pegfilgrastim 6 mg (N=234). Mean DSN in Cycle 1 was 1.1±1.11 days in patients receiving balugrastim (n=236) and 1.0±1.14 days in patients receiving pegfilgrastim (n=234). Non-inferiority was demonstrated by statistical analysis for balugrastim vs pegfilgrastim for reduction in DSN across studies. Patients treated with balugrastim had a significantly shorter time to ANC recovery in Cycle 1 vs pegfilgrastim (2.0 vs 2.3 days; P=0.015). No other significant differences were seen between treatment groups in either study for any other secondary endpoints in Cycles 1–4. The safety profile was similar for both drugs, with the incidence of AEs consistent with the underlying medical condition and administration of myelosuppressive CTx. Conclusions: In both Phase III studies, non-inferiority was clearly demonstrated for balugrastim 40 mg vs pegfilgrastim 6 mg. Balugrastim is a safe and effective alternative to long-acting pegfilgrastim for reducing DSN in breast cancer patients receiving myelosuppressive chemotherapy. Clinical trial information: 2010-019001-42.

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