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Ipilimumab Combination Dosing: Less is More.

ABSTRACT: Ipilimumab with and without anti-Programmed Death 1 (PD-1) improved overall survival (OS) in melanoma. Despite this, the optimal dose and therapeutic mechanism of ipilimumab in patients remains unclear. KEYNOTE-029 and other studies suggest that low-dose ipilimumab with anti-PD1 maintains efficacy while decreasing toxicity, emphasizing T-cell trafficking and reinvigoration as likely mechanisms. See related article by Long et al., p. 5280.

SUBMITTER: Jameson-Lee M

PROVIDER: S-EPMC8807780 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Ipilimumab Combination Dosing: Less is More.

Jameson-Lee Max M Luke Jason J JJ

Clinical cancer research : an official journal of the American Association for Cancer Research 20211001 19

Ipilimumab with and without anti-Programmed Death 1 (PD-1) improved overall survival (OS) in melanoma. Despite this, the optimal dose and therapeutic mechanism of ipilimumab in patients remains unclear. KEYNOTE-029 and other studies suggest that low-dose ipilimumab with anti-PD1 maintains efficacy while decreasing toxicity, emphasizing T-cell trafficking and reinvigoration as likely mechanisms. See related article by Long et al., p. 5280. ...[more]

PMID: 34341015

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Project description:Implantable chemoport is a very useful device for long-term venous access for infusion of chemotherapeutic drugs and other agents. There are few studies from resource poor countries reporting complications of chemoport. The aim of the present study is to evaluate the feasibility of chemoport insertion without image guidance and by closed technique without direct visualisation of a major vein (mainly IJV) and to study the complications associated with the procedure. This was a prospective observational study which analysed 263 patients who underwent chemoport insertion. The medical records of these patients were analysed for the patient characteristics, diagnosis, port-related complications, and their management. A total of 263 patients who were harbouring either locoregionally advanced or metastatic tumour requiring either chemotherapy or targeted treatment or both were included in the study. In total, 133 (50.57%) were female patients and 130 were male patients (49.43%). A total of 236 patients (89.73%) underwent port insertion procedures under local anaesthesia. None of the patients had any major intra-operative complications. Postoperatively, 4 patients (1.52%) were found to have port catheter malposition; 3 out of this 4 were corrected under IITV guidance as a second procedure under local anaesthesia only. One patient (0.38%) required formal removal and replacement of port. Four patients (1.52%) developed IJV thrombosis requiring port removal and anti-coagulation. One patient (0.38%) developed thrombus in the right atrium. There were 2 port site infections (0.74%) requiring port removal (SSI cat. 5). Low complication rates of port insertion were observed in the present, large, prospective study. Complication rates may be further reduced by using a well-designed procedure, experienced surgeons, an aseptic environment, ultrasound-guided puncture, and fluoroscopy with contrast media.Supplementary informationThe online version contains supplementary material available at 10.1007/s13193-020-01265-6.

Project description:BackgroundNo meta-analysis has assessed the pooled frequencies of adverse events (AEs) induced by concomitant nivolumab plus ipilimumab regimen for anticancer-medications-naïve malignancies. Furthermore, no meta-analysis has compared detailed safety profiles between four doses of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks (N3I1) and four doses of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks (N1I3). Objectives of this study was estimating AE frequencies, and comparison of AE frequencies between N3I1 and N1I3 regimens.MethodsFour major electronic databases were searched; both interventional and observational studies were included. All primary cancer types were permitted. Patients should not have been previously treated with any anti-cancer medications. The frequency of AEs was pooled using a random-model meta-analysis using the generic inverse variance method. Protocol registration: UMIN000044090.ResultsForty articles representing 48 populations with 4,677 patients were included in the study. The pooled frequencies for key indicators were as follows: any AE, 81.3% (95% confidence interval (CI) 77.5-85.1); grade 3 or higher AE, 40.6% (95% CI: 35.7-45.5); serious AE, 32.7% (95% CI: 22.4-43.1); AE leading to discontinuation, 28.3% (95% CI: 23.7-32.8); and treatment-related death, 0.7% (95% CI: 0.4-1.1). AEs with the highest incidence were fatigue (27.9%, 95% CI: 22.6-33.3), followed by diarrhea (26.0%, 95% CI: 21.5-30.5), pruritus (24.6%, 95% CI: 20.3-28.8), rash (24.0% 95% CI: 19.3-28.7), and elevated aspartate aminotransferase (21.2%, 95% CI: 14.9-27.5). Subgroup analyses demonstrated that N3I1, compared to N1I3, less frequently induced any AE (N1I3 95.7%, N3I1 84.5%, p = 0.003), grade 3 or higher AE (N1I3 64.3%, N3I1 35.7%, p < 0.001), and serious AE (N1I3 61.4%, N3I1 47.8%, p = 0.004).ConclusionsApproximately 40% of patients had grade 3 or higher AE. The N3I1 regimen was substantiated to trigger fewer any AEs, high grade AEs, and serious AE than the N1I3 regimen.

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Ipilimumab Combination Dosing: Less is More.

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Ipilimumab Combination Dosing: Less is More.

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