scholarly journals Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy

2021 ◽  
Author(s):  
Ali McBride ◽  
Neda Alrawashdh ◽  
Trace Bartels ◽  
Logan Moore ◽  
Daniel Persky ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Real World ◽  
Single Institution ◽  
Study Results ◽  
Chemotherapy Induced Neutropenia ◽  
Grade 3

Aim: To compare the incidence of febrile neutropenia and related outcomes of prophylactic same-day versus next-day pegfilgrastim/pegfilgrastim-cbqv in patients with lymphoma receiving cyclophosphamide, hydroxydaunorubicin, vincristine, prednisone (CHOP)-like chemotherapy. Methods: Retrospective, real-world, single-institution study. Results: 93 patients received 460 cycles of CHOP-like chemotherapy. The incidence of febrile neutropenia and grade 3/4 chemotherapy-induced neutropenia was 5 and 16.5%, respectively. In 401 cycles pegfilgrastim was administered same-day versus 12 cycles next-day. Febrile neutropenia occurred in 17 cycles versus 0 cycles (p = 1.00) and grade 3/4 chemotherapy-induced neutropenia in 65 cycles (16.2%) versus 1 cycle (16.7%; p = 1.00) with same-day versus next-day pegfilgrastim administration, respectively. Conclusion: Pegfilgrastim may be safely administered on the same day as chemotherapy in patients with lymphoma receiving CHOP-like chemotherapy.

Evaluation of febrile neutropenia and myelosuppression in patients receiving FOLFOX/FOLFIRI in gastrointestinal cancer treated with same-day (SD) pegfilgrastim/pegfilgrastim-CBQV (PFG).

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 311-311
Author(s):  
Basel Shoua ◽  
Mahta Mahmoudieh ◽  
Aaron James Scott ◽  
Jerrelee Hollings ◽  
Rachna T. Shroff ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Study Cohort ◽  
Long Distance ◽  
Gastrointestinal Malignancies ◽  
Nccn Guidelines ◽  
Chemotherapy Administration ◽  
Study Results ◽  
Icd 10 ◽  
Grade 3

311 Background: The National Comprehensive Cancer Network (NCCN) guidelines and the manufacturers of PFG recommend administration at least 24 hours after chemotherapy (CTX). Administering SD PFG carries the potential risk for exacerbation of neutropenia based on analyses in lymphoma and breast cancer regimens; however, little data exists on infusional fluorouracil and SD PFG administration. The availability of biosimilar PFG and increased utilization of growth factors during the COVID-19 pandemic has led to changes in practice for SD PFG administration. This study explored the incidence of febrile neutropenia (FN) and myelosuppression with FOLFOX and FOLFIRI regimens in Gastrointestinal malignancies (GI) to address the safety of SD utilization of PFG. Methods: Patient data was extracted through electronic health records search of ICD-9 and ICD-10 codes for GI malignancies and treated with FOLFOX or FOLFIRI-based regimens from November 2013 to May 2021. SD administration was defined as administration of PFG within 15 minutes after fluorouracil pump disconnect. The primary endpoint of our study was to evaluate the incidence of FN across all CTX cycles for up to four cycles, in SD PFG administration. Secondary outcomes included chemotherapy induced neutropenia (CIN), hospitalizations, and CTX dose reduction or delay. Results: Three hundred and thirty-nine patient charts were reviewed with 55 patients meeting the inclusion criteria. In our study cohort, 72.7% received FOLFOX and 27.2% received FOLFIRI-based regimens. Out of all 194 CTX cycles, 136 (70.1%) cycles received pegfilgrastim and 58 cycles received pegfilgrastim-cbqv (29.9%). Two patients had grade 3/4 CIN (1%), with both cases resulting in FN (1%). Both FN cases resulted in hospitalizations, and dose delays or reductions. Investigation of FN incidences revealed that both patients received CTX with active infections, one case with a urinary tract infection and the other with a chronic gangrene infection. Conclusions: Our study results suggest that SD administration of PFG can be as a safe and effective alternative to 24-hour post-chemotherapy administration in patients receiving FOLFOX or FOLFIRI-based regimens. The incidence of FN was noted to be minimal in our study. Furthermore, no noted increase in myelosuppression was seen in our analysis, as compared to previous studies in breast cancer and lymphoma-based regimens. SD administration not only minimizes travel burdens on long-distance patients but also has allowed for reduction in infusion appointments and therefore possible exposure to the SARS-COV2 virus during the 2020-2021 pandemic. Future prospective studies are warranted in order to elucidate the risk of FN and myelosuppression in patients undergoing chemotherapy for GI malignancies with SD PFG administration.

scholarly journals Pooled Analysis on the Effectiveness and Safety of Lipegfilgrastim in Patients With Urological Malignancies in the Real-World Setting

2021 ◽  
Vol 11 ◽  
Author(s):  
Axel S. Merseburger ◽  
Götz Geiges ◽  
Jörg Klier ◽  
Martin Wiesholzer ◽  
Petra Pichler
Keyword(s):  
Febrile Neutropenia ◽  
Real World ◽  
Pooled Analysis ◽  
Two Phase ◽  
The Real ◽  
Real World Setting ◽  
Urological Malignancies ◽  
Chemotherapy Induced Neutropenia ◽  
Prophylactic Use ◽  
Long Acting

Lipegfilgrastim is a long-acting glycopegylated granulocyte-colony stimulating factor (G-CSF) approved for the management of chemotherapy-induced neutropenia. In general, there is little information on the use of any G-CSFs specifically in patients with urological malignancies receiving chemotherapy. This report combines information from two prospective non-interventional studies on the prophylactic use of lipegfilgrastim in urological cancer patients receiving chemotherapy in the real-world setting. Data were derived from two phase IV studies (NADIR and LEOS) with similar protocols conducted in nine European countries. Analysis included 228 patients (142 prostate, 50 testicular, 27 bladder, and 9 other urological cancers). Chemotherapy-induced febrile neutropenia risk was classified as high (43.0%), intermediate (49.1%), or low (7.5%). Lipegfilgrastim was administered as primary (n=180, 78.9%) or secondary (n=29, 12.7%) prophylaxis. The incidence of febrile neutropenia over all chemotherapy cycles (n=998) and first cycles (n=228) for which lipegfilgrastim was administered for prophylaxis was 2.6% and 1.3%, respectively. Corresponding results for Grade 3/4 neutropenia were 2.2% and 0.9%, respectively. Adverse drug reactions occurred in 24 patients (10.5%): those in more than one patient were bone pain (n=6, 2.6%) and pyrexia (n=3, 1.3%). The use of lipegfilgrastim for the prophylaxis of chemotherapy-induced neutropenia was effective and well tolerated in patients with urological malignancies in the real-world setting.

Efficacy and Safety of Lipegfilgrastim in Lung Cancer Patients Receiving Myelosuppressive Chemotherapy in a Real-World Setting: Results of an Analysis of Pooled Data from Two Non-Interventional European Studies

2021 ◽  
pp. 1-9
Author(s):  
Christian Gessner ◽  
Karin Potthoff ◽  
Nikolaj Frost
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Adverse Drug Reactions ◽  
Real World ◽  
Secondary Prophylaxis ◽  
Drug Reactions ◽  
Myelosuppressive Chemotherapy ◽  
Lung Cancer Patients ◽  
Chemotherapy Induced Neutropenia

<b><i>Background/Aim:</i></b> Chemotherapy-induced neutropenia is a common and serious complication in cancer patients receiving myelosuppressive chemotherapy. This analysis was undertaken to evaluate the effectiveness and safety of prophylaxis with lipegfilgrastim, a glycoPEGylated granulocyte colony-stimulating factor, in lung cancer patients undergoing chemotherapy in real-world clinical practice. <b><i>Methods:</i></b> Data from two European non-interventional studies (NIS NADIR and NIS LEOS) investigating lipegfilgrastim for primary and secondary prophylaxis were pooled. Outcomes included the incidence of chemotherapy-induced neutropenia and febrile neutropenia (FN), use of anti-infectives and antimycotics, and adverse events and their relationship to lipegfilgrastim. <b><i>Results:</i></b> The safety population included 361 patients with lung cancer (median age, 66 years [range, 36–88]), of whom 322 had received 2 or more consecutive cycles of lipegfilgrastim (efficacy population [primary prophylaxis, 75.5%; secondary prophylaxis, 16.5%]). Almost 40% of the patients were considered to have a high risk (&#x3e;20%) of FN, and around 60% had an intermediate risk (10–20%). For all cycles, FN was reported in 3 patients (0.9%), neutropenia in 14 (4.3%), and grade 4 neutropenia in 9 (2.8%). Anti-infectives were used in 27 patients (8.4%) and antimycotics in 6 (1.9%). The incidence rates were lower for the patients’ first cycle (FN, 0.4%; neutropenia, 0.8%; grade 4 neutropenia, 0.8%; anti-infectives, 0.6%; antimycotics, 0.6%). Adverse drug reactions considered lipegfilgrastim related were reported in 35 patients (9.7%), and serious adverse drug reactions in 10 (2.8%). None of the fatal events reported in 28 patients (7.8%) were lipegfilgrastim related. <b><i>Conclusion:</i></b> Lipegfilgrastim administered to patients with lung cancer undergoing chemotherapy in real-world clinical practice showed similar effectiveness and safety to that reported in published pivotal trials.

scholarly journals Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review

2019 ◽  
Vol 11 ◽  
pp. 175883591985036 ◽  
Author(s):  
Elena Gabriela Chiorean ◽  
Winson Y. Cheung ◽  
Guido Giordano ◽  
George Kim ◽  
Salah-Eddin Al-Batran
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Real World ◽  
Controlled Trial ◽  
Safety Data ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Eligibility Criteria ◽  
Grade 3

Background: No clinical trial has directly compared nab-paclitaxel/gemcitabine (nab-P/G) with FOLFIRINOX (fluorouracil/leucovorin/oxaliplatin/irinotecan) in metastatic or advanced pancreatic cancer (mPC or aPC). We conducted a systematic review of real-world studies comparing these regimens in the first-line setting. Methods: Embase and MEDLINE databases through 22 January 2019, and Gastrointestinal Cancers Symposium 2019 abstracts were searched for real-world, retrospective studies comparing first-line nab-P/G versus FOLFIRINOX in mPC or aPC that met specific parameters. Studies with radiotherapy were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Results: Of 818 records initially identified, 35 were duplicates and 749 did not meet the eligibility criteria, mostly because they were either not comparative ( n = 356) or not first line ( n = 245). The remaining 34 studies (21 mPC; 13 aPC) assessed >6915 patients who received nab-P/G or FOLFIRINOX. In the studies identified, the median overall survival (OS) reached 14.4 and 15.9 months with nab-P/G and FOLFIRINOX, respectively, and median progression-free survival reached 8.5 and 11.7 months, respectively. Safety data were reported in 14 studies (2205 patients), including 8 single-institutional studies. In most single-institutional studies that reported safety data, rates were higher with FOLFIRINOX versus nab-P/G for grade 3/4 neutropenia (five of six studies) and febrile neutropenia (all three studies), while rates of grade 3/4 peripheral neuropathy were higher with nab-P/G in four of seven studies. Conclusions: Although FOLFIRINOX was associated with slightly longer median OS in more studies, the differences, when available, were not statistically significant. Therefore, a randomized, controlled trial is warranted. Toxicity profile differences represent key considerations for treatment decisions.

Unresectable hepatocellular carcinoma: prospects for drug therapy with lenvatinib

2022 ◽  
Vol 11 (3) ◽  
pp. 45-52
Author(s):  
V.  V. Breder ◽  
D.  T. Abdurakhmanov ◽  
V.  V. Petkau ◽  
P.  V. Balakhnin ◽  
M.  V. Volkonsky ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Drug Therapy ◽  
Liver Function ◽  
Real World ◽  
Systemic Therapy ◽  
Efficacy And Safety ◽  
Study Results ◽  
Class B ◽  
Pugh Class ◽  
Positive Results

There is a number of unresolved issues regarding the systemic therapy administration for hepatocellular carcinoma (HCC). Their solution is facilitated by accumulating real‑world study results. Lenvatinib therapy is a recognized drug with a good efficacy and safety profile for the treatment of HCC. Subanalyses of the REFLECT study showed that the absence of stratification by baseline AFP and baseline liver function, as well as the lack of options for subsequent drug therapy after lenvatinib, also affects the outcomes. Once these factors are taken into account, the hypothesis of superiority of lenvatinib to sorafenib and other drugs can be tested. Real‑world clinical studies have demonstrated positive results of lenvatinib therapy in patients with Child‑Pugh class B liver function, provided recommendations on the sequence of systemic therapy after lenvatinib and on the use of lenvatinib in patients with BCLC stage B, along with considering the possibility of lenvatinib monotherapy and the prospects for its use in patients with nHCC. Further real‑world studies of lenvatinib for HCC in the Russian population are required.

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