Cetuximab use without chronic antihistamine premedication

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]

2019 ◽  
pp. 1-3
Author(s):  
Yukihiro Hama ◽  
Yukihiro Hama

Objective: Daily hospital visits for radiation therapy during working hours, five days a week, are sometimes burdensome to cancer patients who are working or studying. The purpose of this study was to evaluate the feasibility and safety of night-time radiation therapy for physically independent patients. Methods: This retrospective study consisted of 100 consecutive patients with various types of malignancies treated by helical tomotherapy at night (6:00 PM or later). The safety and feasibility of nighttime radiation therapy were evaluated. Results: Among the 100 patients, 20 (20%) developed mild (Grade 1) or moderate (Grade 2) radiationinduced side effects during the treatment. No patient developed severe (Grade 3) or life-threatening (Grade 4) adverse events during, immediately after, or three months after radiation therapy. There were no physical or mental disadvantages caused by night-time radiation therapy. Conclusion: Night-time radiation therapy is feasible and acceptable for physically independent patients.


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.


Breast Care ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. 129-134
Author(s):  
Anna Hester ◽  
Franziska Henze ◽  
Christiane Travi ◽  
Nadia Harbeck ◽  
Rachel Wuerstlein

<b><i>Introduction:</i></b> The phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib is the only approved agent for treating ­<i>PIK3CA</i>-mutated, hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC). Trials have reported hyperglycemia, diarrhea, and rash as the main grade 3 side effects. <b><i>Methods:</i></b> In a managed access program (ClinicalTrials.gov ID: NCT03706573; start: 06/2019), 8 HR+ HER2– ABC patients with a median 4.5 prior therapy lines were treated with alpelisib at the Breast Center of the Ludwig-Maximilian University (LMU) Hospital, Munich, based on the results of a new-generation sequencing (NGS) panel and <i>PIK3CA</i> mutation analysis by the Molecular Tumor Board of the Comprehensive Cancer Center, Munich. <b><i>Results:</i></b> Median therapy duration was 3.42 months for patients who discontinued and 3.95 months for those still on alpelisib (4 pts). Five had hyperglycemia (1 with grade 3) with fasting glucose levels of up to 450 mg/dL that required hospitalization and insulin therapy. Two experienced rash (grades 1 and 3) and 2 reported grade 3 diarrhea. Supportive therapy as well as interruption and/or dose reduction were necessary to control treatment-associated side effects. <b><i>Conclusion:</i></b> Patient education and a well-trained, interdisciplinary team including diabetologists, from the initiation of alpelisib treatment onwards, are essential to safely treat ABC patients with this new drug and to maintain their quality of life and ensure their survival.


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 ◽  
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.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4830-4830
Author(s):  
Farhad Ravandi-Kashani ◽  
Zeev Estrov ◽  
Alessandra Ferrajoli ◽  
Gautam Borthakur ◽  
Miloslav Beran ◽  
...  

Abstract Standard therapy of aplastic anemia (AA) involves the use of equine anti-thymocyte globulin (ATG) in combination with cyclosporine. Hematological responses occur in 40% to 50% of patients treated with ATG alone. The addition of cyclosporine to ATG has improved response and survival; response rates have been up to 65%, and the 5-year survival rate in the responding patients has been over 80%. Several lines of observation have also implicated an autoimmune mechanism in at least a subset of patients with myelodysplastic syndrome (MDS) whose disease process may overlap AA. The rationale for treating refractory or relapsing patients with ATG from a different animal has been the lower risk of potentially life-threatening allergic reactions. In a recent study, most patients who received rabbit ATG (Thymoglobulin) after unsuccessful treatment with ATG became transfusion independent (Di bonna E, Br J Haematol, 1999). Another study has reported high responses to Thymoglobulin in patients with relapsed AA (Scheinberg P, Br J Haematol, 2006). We are conducting a clinical trial of Thymoglobulin in combination with cyclosporin and GCSF in the first line therapy of patients with AA or low-risk MDS. Patients receive Thymoglobulin 3.5 or 2.5 (if they were 55 years or older) mg/kg/day IV for 4 days, methyl prednisone 1 mg/kg/day IV for 4 days followed by a tapering dose of oral prednisone, cyclosporine 5 mg/kg orally, and G-CSF 5 μg/kg daily for up to 3 months at the discretion of the treating physician. All patients receive prophylactic broad-spectrum antibiotics. We have enrolled 13 patients in the study including 7 patients with AA and 6 patients with MDS. The median age for AA patients was 61 years (range 45 – 73 years), and for MDS patients 60 years (range, 41 – 71 years). The median absolute neutrophil count (ANC) for AA patients was 0.74 × 109/L (range, 0.1 – 1.0 × 109/L) and for MDS patients 2.0 × 109/L (range, 1.1 – 8.1 × 109/L). The median Hgb for AA patients was 6.9 g/dL (range, 3.9 – 7.9 g/dL) and for MDS patients 8.1 g/dL (range 6.4 – 10.7 g/dL). The median platelet count for AA patients was 8 × 109/L (range, 0 – 153 × 109/L) and for MDS patients 10 × 109/L (range, 6 – 16 × 109/L). Flow cytometry for a PNH clone was negative in all patients. Seven patients (4 AA, 3 MDS) were positive for HLA-DR15. So far, 6 patients with AA have responded including 3 CRs, 2 PRs and 1 HI. One patient with MDS had a PR. Toxicity has been acceptable with no grade 3 or 4 side effects. Other side effects (grade 1 and 2) included infusion-related reactions, hypomagnesemia, elevation of serum creatinine, and hyperbilirubinemia. We conclude that Thymoglobulin can be administered safely in combination with cyclosporin and GCSF to treat patients with untreated AA and MDS.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9562-9562
Author(s):  
Bjørn Henning Grønberg ◽  
Sveinung Sørhaug ◽  
Harald Harris Hjelde ◽  
Guro Birgitte Stene ◽  
Tore Amundsen

9562 Background: Physicians might overestimate benefits and underestimate toxicity of cancer therapy. Thus, patient reported HRQoL is an important part of evaluating treatment effect and assessing side effects. HRQoL is commonly reported once per chemotherapy cycle and just prior to administration of the next course (day 0). Several studies have not detected differences in HRQoL despite differences in physician-observed toxicity. We hypothesized that HRQoL varies during chemotherapy cycles; that side effects are most pronounced the first week after chemotherapy administration; and that repeated assessments improve the ability to detect differences in HRQoL. Methods: Patients were randomized to receive 3 courses of either vinorelbine/carboplatin (VC) or gemcitabine/carboplatin (GC) every 3 weeks. They reported HRQoL on the EORTC QLQ C30 + LC13 on day 0, 3, 8, 11, 15 and 22 of each cycle. A difference in mean scores of > 5 points is considered clinically detectable. Results: 52 pts (VC: 25, GC: 27); median age 65; 56 % men; 85 % stage IV; 93 % performance status 0-1; 75 % completed 3 cycles; 32 % response-rate; 71 % grade 3-4 toxicity. Baseline characteristics; treatment administered and outcomes of therapy were similar between treatment arms. Completion rates of QLQs were 96-64 %. There were significant variations in mean scores during cycles for several domains (mean scores during cycle 1 for some domains are listed in the table). For several domains, there were differences of > 5 points between the treatments arms at day 3-15 that were not detectable on day 22 (day 0 of next cycle). In general, treatment related symptoms were most pronounced on day 3 in every cycle. Conclusions: Our results suggest that timing and number of assessments influence the likelihood of detecting differences in HRQoL during chemotherapy. Day 3 was the best time point for assessing reduced function and side effects of the regimens administered in our trial. [Table: see text]


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 58-58
Author(s):  
Daniel Mulkerin ◽  
Mary Mably ◽  
Jason Bergsbaken ◽  
Kari Schuhmacher ◽  
Chris Nemergut ◽  
...  

58 Background: Use of oral chemotherapy is expanding and offers advantages but introduces unique safety challenges. ASCO and ONS addressed these issues with inclusion of oral chemotherapy in published chemotherapy administration safety standards. Methods: The updated ASCO/ONS standards offered a framework for the University of Wisconsin Carbone Cancer Center to evaluate and improve our practice with the goal of full compliance with these standards. Gap analysis revealed noncompliance with five and partial compliance with eleven standards. We divided areas for improvement into three foci: patient education, workflow, and information technology. Multidisciplinary groups addressed each area generating twenty-five recommendations. Important changes included: defining chemotherapy, standardization of patient and caregiver education, mandated use of standardized electronic order sets incorporating safety checks, and standardizing dose modification documentation. The revised electronic process allows for prospective order review of all oral chemotherapy by pharmacists and supports automated processes for assessing adherence and toxicities utilizing a library of scripted drug specific materials. Results: Prior to implementation of new processes we estimated that only 39% of our oral chemotherapy was delivered with potential demonstrable compliance with ASCO/ONS standards. Audit of oral chemotherapy orders from February to July 2015 now shows compliance with use of electronic chemotherapy plans in 244/251 (97.5%) of cases. Prospective pharmacist order review resulted in one or more interventions in 24% of these cases.Identification of patients to receive adherence and toxicity monitoring calls is 100%. Conclusions: Closure of significant gaps between institutional practice and published standards was accomplished for our oral chemotherapy practice. Key elements of success included: multidisciplinary approach, defining chemotherapy, leveraging our electronic health record with mandated use of standardized order sets, and standardization of clinical and educational processes. We are disseminating this approach across our regional network and we believe our tools are broadly applicable.


2020 ◽  
Vol 8 (4) ◽  
pp. 204-205
Author(s):  
Susanne M. Lang

Introduction: Predicting the factors that increase the risk of immune-related pneumonitis, a potentially life-threatening complication of treatment with immune checkpoint inhibitors for cancer, is a clinical challenge. Baseline clinical factors such as asthma may portend the development of pneumonitis due to pre-existing airway inflammation prior to immunotherapy. Objective: The purpose of the study was to investigate whether a prior diagnosis of asthma is associated with an increased risk of immune-related pneumonitis in patients undergoing cancer immunotherapy. Methods: Patients at the Moores Cancer Center at UC San Diego Health undergoing immunotherapy were identified on an IRB-approved protocol. Clinical charts were reviewed for asthma documented in the medical records and CT scans were reviewed during and after treatment. Pneumonitis was defined as the onset of new pulmonary symptoms with characteristic imaging findings during or after a patient’s first course of immunotherapy that could not be readily explained as infection or a progression of malignancy. It was graded according to the Common Terminology Criteria for Adverse Events. Results: A total of 187 patients were included. A diagnosis of asthma was found in the records of 26 cases (13.9%). Pneumonitis was found in 10 cases (5.35%); 50% were grade 2 and 50% were grade 3–4. Two of the grade 3–4 cases (40%) occurred in patients with non-small-cell lung cancer. Three patients with asthma developed pneumonitis (11.5% of patients with asthma), all grade 3–4. Only 28.6% of the non-asthma-pneumonitis cases were grade 3–4. All (100%) of the asthma-pneumonitis patients were former smokers, while 71.4% of the non-asthma-pneumonitis patients were former smokers. Conclusion: A history of asthma may be associated with a higher grade of pneumonitis if it develops, and a history of smoking may augment this relationship.


2019 ◽  
Vol 14 (1) ◽  
pp. 14-20 ◽  
Author(s):  
Kerasia-Maria Plachouri ◽  
Eleftheria Vryzaki ◽  
Sophia Georgiou

Background:The introduction of Immune Checkpoint Inhibitors in the recent years has resulted in high response rates and extended survival in patients with metastatic/advanced malignancies. Their mechanism of action is the indirect activation of cytotoxic T-cells through the blockade of inhibitory receptors of immunomodulatory pathways, such as cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), programmed cell death protein-1 (PD-1) and its ligand (PD-L1). Despite their impressive therapeutic results, they can also induce immune-related toxicity, affecting various organs, including the skin.Objective:To provide an updated summarized overview of the most common immune-mediated cutaneous side effects and their management.Method:English articles derived from the databases PubMed and SCOPUS and published between 2009 and 2018, were analyzed for this narrative review.Results:The most common adverse cutaneous reactions include maculopapular rash, lichenoid reactions, vitiligo and pruritus, with severity Grade 1 or 2. Less frequent but eventually life-threatening skin side effects, including Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms and Toxic Epidermal necrolysis, have also been reported.Conclusion:Basic knowledge of the Immune-Checkpoint-Inhibitors-induced skin toxicity is necessary in order to recognize these treatment-related complications. The most frequent skin side effects, such as maculopapular rash, vitiligo and pruritus, tend to subside under symptomatic treatment so that permanent discontinuation of therapy is not commonly necessary. In the case of life-threatening side effects, apart from the necessary symptomatic treatment, the immunotherapy should be permanently stopped. Information concerning the management of ICIs-mediated skin toxicity can be obtained from the literature as well as from the Summary of Product Characteristics of each agent.


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