A Comparison of Same Day Versus Next Day Administration of Pegfilgrastim in Lymphoma Patients Receiving CHOP Chemotherapy

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 11-11
Author(s):  
Trace Bartels ◽  
Logan Moore ◽  
Neda Alrawashdh ◽  
Abhijeet Kumar ◽  
Ivo Abraham ◽  
...  

Background Febrile neutropenia (FN) is a potentially life-threatening complication of myelotoxic chemotherapy, with increased incidence in patients with high risk chemotherapy or with patients with predisposing comorbidities in intermediate risk regimens. Prophylactic pegfilgrastim has been shown to decrease the incidence, duration, and severity of neutropenia, fever, and infection. Current guidelines recommend at least a 24-hour time lapse from chemotherapy to administration of growth factor; however, many cancer centers give same day growth factor due to convivence. Here, we explored lymphoma patients treated with CHOP+/-R (cyclophosphamide, doxorubicin, vincristine, prednisone, with or without rituximab) and received either same-day (within 24 hours of chemotherapy) or next-day (≥24 hours post chemotherapy) pegfilgrastim to address the safety and efficacy of administration timing in the real-world setting. Methods A retrospective, single center, cohort study was conducted between October 1, 2013 and October 1, 2016 to evaluate lymphoma patients who were treated with CHOP+/-R and given pegfilgrastim for prophylaxis at the University of Arizona Cancer Center. Patients were followed up to six cycles of chemotherapy. In the first cycle, 39 patients were identified: 33 patients received same-day pegfilgrastim and 6 patients received next-day pegfilgrastim. Primary data collected included the incidence of FN, neutropenia, dose reductions, antibiotic administration, and hospitalization rate. Results Two hundred and fourteen R-CHOP (0.90) or CHOP (0.10) chemotherapy cycles (187 cycles for the same-day and 27 cycles for the next-day) were evaluated in 39 patients. Among the first cycles (33 patients in the same-day and 6 patients in the next-day), there were no significant differences in the incidence of FN (0.21 vs. 0.00, P= 0.57), grade 3/4 neutropenia (0.39 vs. 0.33, P= 0.99) and hospitalizations (0.39 vs. 0.00, P= 0.08) between the same day and the next day groups. Among cycle two to six (154 cycles for the same-day and 21 for the next-day), there were no statistically significant differences in the incidence of FN (0.07 vs 0.05, P=0.99)grade 3/4 neutropenia (0.30 vs. 0.24, P= 0.80) and hospitalizations (0.11 vs 0.10, P= 0.99) between the same-day and next-day. The same-day group, had 33% percent of patients received reduced doses of CHOP or R-CHOP (median age= 80.0 yr). The incidence of FN was 0.11 in these patients and 0.06 in patients who received the usual doses (median age=65.5 yr) (P= 0.27). The incidence of grade 3/4 neutropenia was (0.34 vs 0.29, P=0.53) and hospitalizations (0.20 and 0.08, P=0.07) between patients who received reduced doses of chemotherapy because of age versus normal dosing respectively in the same-day arm. Conclusion In our analysis, we have shown that same-day was as safe and effective as next-day pegfilgrastim administration in lymphoma patients receiving CHOP+/-R. There was not a significant increase in FN in either group. Future prospective studies are warranted to investigate the practical benefits of same-day pegfilgrastim or its biosimilar. Potential future study directions could include addressing outcomes, side effects, patient satisfaction, and reduced healthcare costs associated with same-day administration of pegfilgrastim for the prophylaxis of FN. Table Disclosures Abraham: Coherus BioSciences: Research Funding, Speakers Bureau; Celgene: Consultancy; Terumo: Consultancy; Rockwell Medical: Consultancy; Janssen: Consultancy; Mylan: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy. McBride:Coherus BioSciences: Consultancy, Speakers Bureau; Merck: Speakers Bureau; Pfizer: Consultancy; Sandoz: Consultancy; MorphoSys: Consultancy; Bristol-Myers Squibb: Consultancy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19541-e19541
Author(s):  
Ali McBride ◽  
Neda AlRawashdh ◽  
Trace Bartels ◽  
Logan Moore ◽  
Daniel O Persky ◽  
...  

e19541 Background: BR and CHOP+/-R regimens are considered an intermediate FN risk (10-20%) per guidelines. Patients (pts) receiving these regimens need to be assessed for FN prophylaxis using specific risk factors. Current guidelines suggest waiting 24 hours post chemotherapy (CTX) to administer PFG due to an increased FN risk. Studies have shown equivocal outcomes between same day (D1) and next day (D2) administration. We evaluated real-world outcomes associated with D1 and D2 PFG administration in pts with lymphoma and CLL treated with these two regimens. Methods: Retrospective chart review of lymphoma or CLL pts treated with CHOP+/-R or BR and PFG or a biosimilar from 11/2013 through 11/2020 at the University of Arizona Cancer Center was conducted. Two pt cohorts were analyzed based on D1 vs D2 PFG administration timing. Outcomes of interest were the incidence of FN across all CTX cycles and after cycle 1, CIN grade 3/4, hospitalizations, antibiotics administration, and CTX dose reduction or delay. A secondary analysis compared the incidence of FN in pts receiving CHOP+/-R in our study with published studies (Burris et al, 2010 and Cheng et al, 2014) of D1 PFG in lymphoma pts. Results: Of the 116 pts meeting inclusion criteria, 103 received PFG on D1 and 13 on D2 of CTX. As shown in the Table, the incidence of 1st cycle FN was 6% vs 8% (P>0.05), FN across all cycles was 4% vs 5% (P>0.05), CIN grade 3/4, hospitalization, anti-biotic administration and dose delays/reductions incidences were 11% vs 16% (P>0.05), 8% vs 11% (P>0.05), 6% vs 32% (P=0.001), 11% vs 5% (P>0.05) for D1 vs D2, respectively. The incidence of 1st cycle FN in D1 cohort was 6% vs 19% (P=0.15) and 11% (P=0.67) in our study vs Burris et al and Cheng et al, respectively. While the incidence of FN across all cycles in D1 group was 5% vs 9% (P=0.03) and 17% (P=0.001) in our study vs Burris et al and Cheng et al, respectively. Conclusions: This data provides evidence that D1 PFG/PFG-cbqv does not increase FN or delayed engraftment risk as compared to previously published studies in lymphoma and may be safe to use after CTX has been administered.[Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19542-e19542
Author(s):  
Trace Bartels ◽  
Ali McBride ◽  
Neda AlRawashdh ◽  
Logan Moore ◽  
Daniel O Persky ◽  
...  

e19542 Background: Non-Hodgkin’s lymphoma, specifically, diffuse large B-cell lymphoma (DLBCL) is most frequently diagnosed among older patients. The utilization of a reduced dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (miniCHOP) chemotherapy-based regimen has an improved tolerance and toxicity profile in select patient populations. Prophylaxis with pegfilgrastim or its biosimilar pegfilgrastim-cbqv is administration on the same day of chemotherapy in all patients with MiniCHOP at The University of Arizona Cancer Center (UACC). We report here on the first study to address the safety and efficacy of same day pegfilgrastim administration in lymphoma patients receiving MiniCHOP. Methods: A retrospective, single center, cohort study was conducted at UACC between October 1, 2013 and October 2020 to evaluate lymphoma patients who were treated with miniR-CHOP and given pegfilgrastim or its biosimilar (pegfilgrastim-cbqv) for FN prophylaxis. The primary objective was to compare the incidence of FN across all cycles of chemotherapy and after the first cycle of chemotherapy in DLBCL patients on miniR-CHOP and provided with next-day versus same-day pegfilgrastim administration. Our secondary outcomes of interests were incidence of chemotherapy-induced neutropenia (CIN) grade 3/4; hospitalization; anti-biotics administration; and chemotherapy dose-reduction or delays. Results: A total of 100 cycles of miniR-CHOP were received, of these pegfilgrastim was administered on same-day of chemotherapy in 95 cycles and five cycles on the next-day of chemotherapy. Among all cycles the incidence of FN was 5.3% vs. 0.0 ( P= 1.00); CIN 3/4 was 10.5% vs. 0.0 ( P= 1.00); hospitalization was 10.5% vs. 20.0% ( P= 0.45), anti-biotics administration was 6.3% vs. 40.0% ( P= 0.05) and the chemotherapy dose delays or reductions was 16.8% vs. 0.0% ( P= 0.99). In the first cycle of chemotherapy, the incidence of FN was 14.3% vs. 0.0% ( P= 1.00), CIN 3/4 was 21.4% vs. 0.0 ( P= 1.00), hospitalization 28.6% vs. 25.0% ( P= 0.99), and the anti-biotics administration was 21.4% vs. 50.0% ( P= 0.53) for same-day vs. next-day study groups. Conclusions: In our analysis, we have shown that same-day pegfilgrastim or pegfilgrastim-cbqv was safe and effective in lymphoma patients receiving miniR-CHOP. There was no significant increase in FN or delayed engraftment in either group. Future prospective studies are warranted to address the safety and efficacy profile of same day pegfilgrastim or a pegfilgrastim biosimilars in elderly lymphoma patients.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 71-71
Author(s):  
Briana Choi ◽  
Neda Alrawashdh ◽  
Jamie Vraney ◽  
Ali McBride ◽  
Ivo Abraham

71 Background: Pegfilgrastim administration is recommended at least 24 hours after the end of chemotherapy (CTX) treatment for prevention of chemotherapy-induced (febrile) neutropenia (CIN/FN). Published studies have found no differences in the risk of FN between same-day and next-day pegfilgrastim administrations in certain cancers. To evaluate the efficacy and safety of same-day compared to next-day pegfilgrastim administration in SCLC patients, we evaluated our own institutional data. Methods: Using ICD-9 and ICD-10 codes for SCLC, electronic health records were reviewed retrospectivey for the period 11/1/2013-8/31/2018 at the University of Arizona Cancer Center (UACC). Inclusion criteria were age 18 or older, biopsy confirmed SCLC diagnosis, treated at UACC, and pegfilgrastim administration on the same day as CTX. Outcomes collected in the first cycle and all cycles of CTX were: FN incidence, CIN grade 3/4, and treatment delay or hospitalizations due to CIN/FN. Results: Out of 1,181 patient records, 34 patients met inclusion criteria. The median age was 67.5 years, 23.5% of patients had stage 3 or 4 SCLC while 50% had 0-1 ECOG status. 44.1% of patients had a risk based on the type of CTX. Average baseline absolute neutrophil count was 5.55x109cells/L (SD=1.27x109cells/L). A total of 104 CTX cycles were given. Outcomes are summarized in the Table below. After the first cycle, the incidence rate of CIN grade 3/4 was 5.88%, but 0% for all other outcomes. Conclusions: After the first cycle, there were s of FN and no patients experienced treatment delays or hospitalizations related to CIN/FN; only two cases for CIN grade 3/4 were observed. Across all cycles, CIN grade 3/4 was observed in 17 cycles. In only two cycles, treatment was delayed or patient was hospitalized due to CIN/FN, not involving same patients. FN was observed in only 3/104 cycles. All observed rate were comparable or lower than known rates for next-day pegfilgrastim administration. Future studies including randomized trials should be further evaluated.[Table: see text]


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Haipeng Chen ◽  
Sicheng Zhou ◽  
Jianjun Bi ◽  
Qiang Feng ◽  
Zheng Jiang ◽  
...  

Abstract Background The impact of primary tumour location on the prognosis of patients with peritoneal metastasis (PM) arising from colorectal cancer (CRC) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is rarely discussed, and the evidence is still limited. Methods Patients with PM arising from CRC treated with CRS and HIPEC at the China National Cancer Center and Huanxing Cancer Hospital between June 2017 and June 2019 were systematically reviewed. Clinical characteristics, pathological features, perioperative parameters, and prognostic data were collected and analysed. Results A total of 70 patients were divided into two groups according to either colonic or rectal origin (18 patients in the rectum group and 52 patients in the colon group). Patients with PM of a colonic origin were more likely to develop grade 3–4 postoperative complications after CRS+HIPEC (38.9% vs 19.2%, P = 0.094), but this difference was not statistically significant. Patients with colon cancer had a longer median overall survival (OS) than patients with rectal cancer (27.0 vs 15.0 months, P = 0.011). In the multivariate analysis, the independent prognostic factors of reduced OS were a rectal origin (HR 2.15, 95% CI 1.15–4.93, P = 0.035) and incomplete cytoreduction (HR 1.99, 95% CI 1.06–4.17, P = 0.047). Conclusion CRS is a complex and potentially life-threatening procedure, and we suggest that the indications for CRS+HIPEC in patients with PM of rectal origin be more restrictive and that clinicians approach these cases with caution.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18591-e18591
Author(s):  
Jamie Vraney ◽  
Neda AlRawashdh ◽  
Briana Choi ◽  
Ivo Abraham ◽  
Ali McBride

e18591 Background: Pegfilgrastim is recommended to be administered 24 hours after myelosuppressive chemotherapy (CTX) as prophylaxis for chemotherapy-induced (febrile) neutropenia (CIN/FN). Recent studies have yielded equivocal data on same day versus next day administration of pegfilgrastim. There has been limited real world evidence addressing lung cancer (LC) patients and the use of same day pegfilgrastim. We evaluated our own institutional data on the safety of same day pegfilgrastim administration in LC patients. Methods: A retrospective chart review was performed by searching electronic health records using ICD-9 and ICD-10 codes corresponding with a lung cancer diagnosis between November 1, 2013 and August 31, 2018 at The University of Arizona Cancer Center (UACC). Patients included in the study were 18 years of age or older, diagnosed with biopsy-confirmed lung cancer, treated at UACC, and receiving chemotherapy and pegfilgrastim on the same day. The outcomes of interest included FN incidence after the first cycle and across all cycles of CTX, CIN grade 3/4 and CTX dose delays or hospitalizations due to CIN/FN after first cycle and across all cycles of CTX. Results: 1,181 patient records were reviewed and 114 patients met the inclusion criteria; 87 (76%) patients had non-small cell LC and 27 (24%) patients had small cell LC. The median age was 68 years, 52% of patients had cancer stage of 3 to 4, and 63% of patients had 0-1 ECOG status. The FN risk assessment was mild in 72% of patients. The mean (SD) of baseline absolute neutrophil count was 5.68 (3.09). In total 384 CTX cycles were received. The table shows the results of all intended outcomes. One patient experienced FN after the first cycle of CTX of irinotecan and 5 patients developed 6 FN episodes across all cycles; 2 patients were on carboplatin etoposide; 1 patient on cisplatin etoposide; 1 patient on vinorelbine and 1 patient was on pemetrexed and then on irinotecan CTX when the two FN episodes were developed. Conclusions: This study showing that same day administration of pegfilgrastim was as effective as next day administration in LC patients, without warranting any concerns for febrile neutropenia or delayed engraftment. Utilization of same day pegfilgrastim, in light of biosimilars and COVID, provides a unique opportunity for cancer care without concerns for FN as stated in previous studies.[Table: see text]


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13521-13521 ◽  
Author(s):  
J. Timoney ◽  
K. Y. Chung ◽  
V. Park ◽  
R. Trocola ◽  
C. Peake ◽  
...  

13521 Background: Cetuximab is a human-murine chimeric monoclonal antibody against EGFR with approximately a 3% reported incidence of severe (≥ grade 3) anaphylactoid reactions. The overwhelming majority of such reactions have been reported with the initial dose of cetuximab. Diphenhydramine (Benedryl)or a related antihistamine is often given as a premedication for cetuximab, however this may cause fatigue or other side effects. Most early clinical trials of cetuximab permitted investigator discretion in use of premedication beyond the initial cetuximab dose. Methods: We obtained an IRB waiver of authorization to review the records of patients treated with cetuximab at Memorial Sloan Kettering Cancer Center for the first year of commercial availability of cetuximb (Feb, 2004 through Feb, 2005). Computerized pharmacy records were reviewed to identify all patients who were treated with cetuximab (outside of a clinical trial) and use of premedication was then evaluated. Records of institutional adverse event reports regarding chemotherapy administration were reviewed, and, any moderate or severe/life-threatening reactions were evaluated for presence or absence of concurrent premedication. Results: As per our institutional guidelines, all patients received 50 mg of diphenhydramine prior to the initial loading dose of cetuximab, and 25 mg of diphenhydramine prior to the second dose. While there was inconsistency in terms of cessation of diphenhydramine, overall a total of 115 patients received one or more doses of cetuximab without premedication. A total of 746 doses of cetuxmab without diphenhydramine premedication were given over this time period. No severe/life-threatening reactions to cetuximab occurred during these doses given without premedication. Conclusions: Omission of diphenhydramine premedication after the initial two doses of cetuximab is our current institutional practice, and appears not to alter the safety profile of cetuximab. Considering the side effects of diphenhydramine, routine long tern use of antihistamine premedication with cetuximab administration does not appear to be warranted. [Table: see text]


2007 ◽  
Vol 14 (4) ◽  
pp. 125-125
Author(s):  
M. McLean

We are delighted to inform the readership of Current Oncology that Dr. Richard J. Ablin, from the University of Arizona College of Medicine and the Arizona Cancer Center, has agreed to join Dr. Phil Gold as co-deputy editor. [...]


2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A304-A304
Author(s):  
Eric Singhi ◽  
Frank Mott ◽  
Michelle Worst ◽  
Cheuk Hong Leung ◽  
Jack Lee ◽  
...  

BackgroundWhile the clinical outcomes of immune checkpoint inhibitor (ICI) use in older adults with advanced-stage non-small cell lung cancer (NSCLC) have been described, the role of ICI use continued beyond disease progression (BDP) remains to be well defined for this population. This retrospective single-center study explored the clinical outcomes of continuing ICIs BDP among older adult patients with advanced NSCLC.MethodsUsing MD Anderson’s Gemini Lung Cancer database, we retrospectively reviewed the clinical outcomes of older adults (≥70 years) diagnosed with advanced-stage NSCLC treated with anti-PD-(L)1 monotherapy from March 2015 through April 2019 to correlate clinicopathologic features with clinical outcomes. Clinical therapy responses were evaluated by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). Toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE), version 5. Patients treated BDP were defined as individuals receiving ICIs for ≥8 weeks prior to documentation of progression who subsequently remained on ICIs for ≥6 weeks.ResultsOf the 159 older adults meeting the inclusion criteria, 33 (21%) received ICIs BDP (64% male, median age 74.9 years (70.1–82.0) at the start of ICI treatment, 3 received first-line ICI therapy). Most patients were former (85%) or current (6%) smokers. 79% had adenocarcinoma histology. The median duration of immunotherapy continued BDP was 7.1 months (95% CI: 3.0–8.2). After a follow-up of 30.1 months, the median overall survival (mOS) was 31.5 months (95% CI: 16.5-not reached). Eight (24%) received local consolidative radiotherapy with a median duration of ICI BDP of 8.2 months (95% CI: 1.9–13.3). Twenty-five (76%) did not receive local consolidative therapy and achieved a median duration of ICI BDP of 4.1 months (95% CI: 2.3–7.8). Six (18%) exhibited pseudo-progression (i.e. delayed response to immunotherapy with decreased tumor burden on subsequent radiologic studies), with 4 achieving ”stable disease” as best response and 2 achieving a partial response. The median duration of immunotherapy continued beyond pseudo-progression was 11.7 months (95% CI: 7.1–35.7), and the mOS was 26.2 months (95% CI: 16.5–40.0). Patients treated with ICI BDP most commonly experienced fatigue (18%), pneumonitis (12%), rash (9%), and hypothyroidism (9%). Three patients (9%) experienced grade 3 or higher toxicities (one grade 3 arthralgias and two grade 3 pneumonitis).ConclusionsICI-use BDP in older adults with advanced NSCLC may benefit a subset of patients. Additionally, local consolidative therapy with radiation may offer prolonged duration of ICI treatment.AcknowledgementsSupported by the generous philanthropic contributions to The University of Texas MD Anderson Lung Moon Shot Program and the MD Anderson Cancer Center Support Grant P30 CA01667. Special acknowledgment to the GEMINI team.Ethics ApprovalThis study was approved and conducted in accordance with the institutional review board at the University of Texas MD Anderson Cancer Center; approval number (PA13-0589).


2021 ◽  
Author(s):  
Haipeng Chen ◽  
Sicheng Zhou ◽  
Jianjun Bi ◽  
Qiang Feng ◽  
Zheng Jiang ◽  
...  

Abstract Background The impact of primary tumour location on the prognosis of patients with peritoneal metastasis (PM) arising from colorectal cancer (CRC) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is rarely discussed, and the evidence is still limited.Methods Patients with PM arising from CRC treated with CRS and HIPEC at the China National Cancer Center and Huanxing Cancer Hospital between June 2017 and June 2019 were systematically reviewed. Clinical characteristics, pathological features, perioperative parameters, and prognostic data were collected and analysed.Results A total of 70 patients were divided into two groups according to colonic or rectal origin (18 patients in the rectum group and 52 patients in the colon group). Patients with PM of colonic origin were more likely to develop grade 3-4 postoperative complications after CRS+HIPEC (38.9% vs 19.2%, P=0.094), but this difference was not statistically significant. Patients with colon cancer had a longer median overall survival (OS) than patients with rectal cancer (27.0 vs 15.0 months, P=0.011). On the multivariate analysis, independent prognostic factors of reduced OS were rectal origin (HR 2.03, 95% CI 1.02–4.24, P = 0.044) and incomplete cytoreduction (HR 2.33, 95% CI 1.05-5.28, P = 0.039).Conclusion CRS is an originally complex and potentially life-threatening procedure, and we suggest that the indications for CRS+HIPEC in patients with PM of rectal origin be more restrictive and cautious.


2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 41-41
Author(s):  
Krishna Bilas Ghimire ◽  
Po-Hung Lin ◽  
Irum Khan ◽  
Kasandra Cadman ◽  
LeeAnn Valero ◽  
...  

41 Background: Current ASCO guidelines for management of febrile neutropenia (FN) recommend initial antibiotic administration within one hour of triage, and initial assessment within 15 minutes of triage for patients presenting with FN within 6 weeks of chemotherapy. The University of Illinois Cancer Center (UICC) implemented an early identification and management strategy in the ambulatory setting for FN in 2017, with success in increasing the percentage of FN patients receiving antibiotics within 2 hours from 50% to 92% over a 6 months (05/2017-11/2017) period. Given updated joint ASCO/IDSA guidelines, we aimed to increase percentage of FN patients receiving antibiotics within 1 hour from 56% to more than 90% over 16 months. Methods: A multidisciplinary team involving oncology, hematology (attendings and fellows), pharmacy, and nursing met quarterly to review FN cases including time to antibiotic administration and documentation of prompt assessment. Two Plan-Do-Study-Act (PDSA) cycles were completed, including development and deployment of an electronic medical record automated order set and targeted education for fellows and nurses. Results: Between 12/17 and 04/19, of 7 patients with FN, 100% (N = 7) received antibiotics in clinic. The percentage of FN patients receiving antibiotics within 1 hour of triage post first and second interventions was as follows: 25% (N = 1), 100% (N = 4). 100% (N = 7) of FN patients had documentation of prompt assessment, but time from triage was not specified. Conclusions: We were successful in improving the percentage of FN patients receiving antibiotics from 56% to more than 90% over 16 months. We are targeting our next PDSA cycle to increase assessments within 15 minutes of triage. Additional future interventions include tailoring antibiotics based on FN with low or high risk of complication via focus group and root case analyses discussion with our attendings, fellows, and nurses, and collaborating with ED on a standard care pathway for FN management.


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