Evaluation of febrile neutropenic episodes in adult patients with solid tumors

Yapici, Oktay; Günseren, Filiz; Yapici, Hafize; Merdin, Alparslan; Yaylali, Ülkü Üser; Merdin, Fatma Avci

doi:10.3892/mco.2015.722

Cited by 10 publications

(7 citation statements)

References 19 publications

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“…The patient died due to this event, considered not related to ARGX-110 by the investigator. In patients with advanced malignancies, infections are of concern and frequently occur, mainly because of bone marrow suppression and neutropenia from cytotoxic chemotherapies (34). The infectious complications of patients with CTCL are of importance since they are involved in over 50% of deaths in patients with CTCL (35)(36)(37).…”

Section: Discussionmentioning

confidence: 99%

Phase I Dose-Escalation Study of the Anti-CD70 Antibody ARGX-110 in Advanced Malignancies

Aftimos

Rolfo

Rottey

et al. 2017

Clinical Cancer Research

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The purpose of this study was to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of ARGX-110, a glyco-engineered monoclonal antibody, targeting CD70, in patients with CD70 expressing advanced malignancies. Dose escalation with a sequential 3+3 design was performed in five steps at the 0.1, 1, 2, 5, and 10 mg/kg dose levels ( = 26). ARGX-110 was administered intravenously every 3 weeks until progression or intolerable toxicity. Dose-limiting toxicity was evaluated in the 21 days following the first ARGX-110 administration (Cycle 1). Samples for pharmacokinetics and pharmacodynamics were collected. Dose-limiting toxicity was not observed and the maximum tolerated dose was not reached. ARGX-110 was generally well tolerated, with no dose-related increase in treatment-emergent adverse events (TEAE). The most common TEAE were fatigue and drug related infusion-related reactions (IRR). Of the 20 SAEs reported, five events, all IRRs, were considered related to ARGX-110. ARGX-110 demonstrates dose proportionality over the dose range 1 to 10 mg/kg, but not at 0.1 mg/kg and a terminal half-life of 10 to 13 days. The best overall response was stable disease (14/26) in all 26 evaluable patients with various malignancies and the mean duration of treatment was 15 weeks. No dose-response related antitumor activity was observed, but biomarker readouts provided signs of biological activity, particularly in patients with hematologic malignancies. This dose-escalation phase I trial provides evidence of good tolerability of ARGX-110, pharmacokinetics, and preliminary antitumor activity at all dose levels in generally heavily pretreated patients with advanced CD70-positive malignancies. .

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Section: Discussionmentioning

confidence: 99%

Phase I Dose-Escalation Study of the Anti-CD70 Antibody ARGX-110 in Advanced Malignancies

Aftimos

Rolfo

Rottey

et al. 2017

Clinical Cancer Research

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“…Most infections in patients with solid tumors are caused by the individual patients’ resident microflora. Consequently, the distribution of causative organisms mirrors the normal microflora at a particular site of infection [ 4 , 21 ]. Acquisition of nosocomial or healthcare-associated pathogens generally occurs several days after hospitalization, although, in recent years, the site of care has shifted to a great extent to clinics and out-patient oncology centers, wherein healthcare-associated infections are also commonplace.…”

Section: Current Microbiology Of Infectionmentioning

confidence: 99%

Infections in Cancer Patients with Solid Tumors: A Review

2017

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Solid tumors are much more common than hematologic malignancies. Although severe and prolonged neutropenia is uncommon, several factors increase the risk of infection in patients with solid tumors, and the presence of multiple risk factors in the same patient is not uncommon. These include obstruction (most often caused by progression of the tumor), disruption of natural anatomic barriers such as the skin and mucosal surfaces, and treatment-related factors such as chemotherapy, radiation, diagnostic and/or therapeutic surgical procedures, and the increasing use of medical devices such as various catheters, stents, and prostheses. Common sites of infection include the skin and skin structures (including surgical site infections), the bloodstream (including infections associated with central venous catheters), the lungs, the hepato-biliary and intestinal tracts, and the urinary tract, and include distinct clinical syndromes such as post-obstructive pneumonia, obstructive uropathy, and neutropenic enterocolitis. The epidemiology of most of these infections is changing with resistant organisms [MRSA, Pseudomonas aeruginosa, extended spectrum beta-lactamase (ESBL)-producing organisms] being isolated more often than in the past. Polymicrobial infections now predominate when deep tissue sites are involved. Conservative management of most of these infections (antibiotics, fluid and electrolyte replacement, bowel rest when needed) is generally effective, with surgical intervention being reserved for the drainage of deep abscesses, or to deal with complications such as intestinal obstruction or hemorrhage. Infected prostheses often need to be removed. Reactivation of certain viral infections (HBV, HCV, and occasionally CMV) has become an important issue, and screening, prevention and treatment strategies are being developed. Infection prevention, infection control, and antimicrobial stewardship are important strategies in the overall management of infections in patients with solid tumors. Occasionally, infections mimic solid tumors and cause diagnostic and therapeutic challenges.

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“…2 Affecting 10% to 50% of patients with solid tumors and greater than 80% of those with hematologic malignancies, neutropenic fever is a frequent emergency department (ED) chief complaint. 3 Admission for these immunocompromised patients is not without serious risk of hospital-acquired infections, highlighting the need to weigh the risks and benefits of early discharge and outpatient management for low-risk patients.…”

Section: Commentarymentioning

confidence: 99%