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The Feasibility and Safety of Surgery in Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Study.

ABSTRACT: Immune checkpoint inhibitors (ICI) are revolutionizing care for cancer patients. The list of malignancies for which the Food and Drug Administration is granting approval is rapidly increasing. Furthermore, there is a concomitant increase in clinical trials incorporating ICI. However, the safety of ICI in patients undergoing surgery remains unclear. Herein, we assessed the safety of ICI in the perioperative setting at a single center. We conducted a retrospective review of patients who underwent planned surgery while receiving ICI in the perioperative setting from 2012 to 2016. We collected 30-day postoperative morbidity and mortality utilizing the Clavien-Dindo classification system. We identified 17 patients who received perioperative ICI in 22 operations. Patients were diagnosed with melanoma (n?=?14), renal cell carcinoma (n?=?2), and urothelial carcinoma (n?=?1). Therapies included pembrolizumab (n?=?10), ipilimumab (n?=?5), atezolizumab (n?=?5), and ipilimumab/nivolumab (n?=?2). Procedures included cutaneous/subcutaneous resection (n?=?6), lymph node resection (n?=?5), small bowel resection (n?=?5), abdominal wall resection (n?=?3), other abdominal surgery (n?=?3), orthopedic surgery (n?=?1), hepatic resection (n?=?1), and neurosurgery (n?=?2). There were no Grade III-IV Clavien-Dindo complications. There was one death secondary to ventricular fibrillation in the setting of coronary artery disease. ICI appear safe in the perioperative setting, involving multiple different types of surgery, and likely do not need to be stopped in the perioperative setting. Further studies are warranted to confirm these findings.

SUBMITTER: Elias AW

PROVIDER: S-EPMC5466999 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The Feasibility and Safety of Surgery in Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Study.

Elias Alexandra W AW Kasi Pashtoon M PM Stauffer John A JA Thiel David D DD Colibaseanu Dorin T DT Mody Kabir K Joseph Richard W RW Bagaria Sanjay P SP

Frontiers in oncology 20170612

Immune checkpoint inhibitors (ICI) are revolutionizing care for cancer patients. The list of malignancies for which the Food and Drug Administration is granting approval is rapidly increasing. Furthermore, there is a concomitant increase in clinical trials incorporating ICI. However, the safety of ICI in patients undergoing surgery remains unclear. Herein, we assessed the safety of ICI in the perioperative setting at a single center. We conducted a retrospective review of patients who underwent ...[more]

PMID: 28660171

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Project description:BACKGROUND:Since 2012, several immune checkpoint inhibitors have been approved by the Taiwan FDA for various types of cancer treatment. However, none of them are covered by Taiwan National Health Insurance due to the fact that they are expensive, and there is a lack of clinical evidence as to their effectiveness. OBJECTIVES:This study was aimed toward an exploration of clinical experiences with use of immune checkpoint inhibitors, including indications, prescription types, drug effectiveness, adverse drug event types, and incidence, all of which shall serve as references for future clinical drug use. METHODS:This is a retrospective study focusing on three immune checkpoint inhibitors (ipilimumab, nivolumab, and pembrolizumab), which are available for cancer treatment in Taiwan. We collected data from medical records for the period from January 1st, 2015 to January 12th, 2017 at National Cheng Kung University Hospital (NCKUH), a medical center in southern Taiwan, and recorded these cases until May 31st, 2017. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method, and adverse drug reaction odds ratios were analyzed using a chi-square analysis. RESULTS:The 50 patients under consideration in this study had used any one of the immune checkpoint inhibitors in NCKUH. Non-small cell lung cancer (n = 24, 48%) accounted for the highest percentage, followed by hepatocellular carcinoma (n = 4, 8%). The median OS was not reached, and the PFS for all immunotherapies was 4.9 months. The median OS period and PFS for non-small cell lung cancer (NSCLC) patients were 13 and 4.9 months, respectively, which were similar to those in many clinical trials. For NSCLC patients, the OS and PFS were only 0.63 and 1.37 months for squamous cell type NSCLC, and for patients who were PD-L1 negative, the OS and PFS were only 11.53 and 2.6 months, respectively. The most common adverse events in this study included fatigue (42%), rashes (22%), nausea (20%), and fever (20%), while one patient developed severe deep venous thrombosis and tissue inflammation, which was not confirmed in previous clinical trials. CONCLUSIONS:The histological subtype, the intensity of the PD-L1 expression, and the timing of treatment affected the NSCLC therapeutic results. It is recommended that clinical tests be conducted in order to enhance therapeutic effectiveness. It is expected that more testing, observation-based studies, and research results will validate their efficacy and the tolerance levels of patients.

Project description:BACKGROUND:Influenza vaccination (FV) is recommended for patients with cancer. Recent data suggested that the administration of the FV was associated with an increase in immune-related adverse events (irAEs) among patients on immune checkpoint inhibitors (ICIs). Myocarditis is an uncommon but serious complication of ICIs and may also result from infection with influenza. There are no data testing the relationship between FV and the development of myocarditis on ICIs. METHODS:Patients on ICIs who developed myocarditis (n?=?101) (cases) were compared to ICI-treated patients (n?=?201) without myocarditis (controls). A patient was defined as having the FV if they were administered the FV from 6?months prior to start of ICI to anytime during ICI therapy. Alternate thresholds for FV status were also tested. The primary comparison of interest was the rate of FV between cases and controls. Patients with myocarditis were followed for major adverse cardiac events (MACE), defined as the composite of cardiogenic shock, cardiac arrest, hemodynamically significant complete heart block and cardiovascular death. RESULTS:The FV was administered to 25% of the myocarditis cases compared to 40% of the non-myocarditis ICI-treated controls (p?=?0.01). Similar findings of lower rates of FV administration were noted among myocarditis cases when alternate thresholds were tested. Among the myocarditis cases, those who were vaccinated had 3-fold lower troponin levels when compared to unvaccinated cases (FV vs. No FV: 0.12 [0.02, 0.47] vs. 0.40 [0.11, 1.26] ng/ml, p?=?0.02). Within myocarditis cases, those administered the FV also had a lower rate of other irAEs when compared to unvaccinated cases (36 vs. 55% p?=?0.10) including lower rates of pneumonitis (12 vs. 36%, p?=?0.03). During follow-up (175 [IQR 89, 363] days), 47% of myocarditis cases experienced a MACE. Myocarditis cases who received the FV were at a lower risk of cumulative MACE when compared to unvaccinated cases (24 vs. 59%, p?=?0.002). CONCLUSION:The rate of FV among ICI-related myocarditis cases was lower than controls on ICIs who did not develop myocarditis. In those who developed myocarditis related to an ICI, there was less myocardial injury and a lower risk of MACE among those who were administered the FV.

Project description:BackgroundAt present, there is no accurate biomarker for immune checkpoint inhibitors (ICIs). Since the efficacy of ICIs is associated with a variety of indicators, establishing a model to predict its efficacy is more clinically significant and in line with clinical needs.MethodsWe collected and retrospectively analyzed the relationship between immunotherapy efficacy and clinicopathologic features in lung adenocarcinoma patients treated with ICIs. Progression-free survival (PFS) and overall survival (OS) were analyzed. Univariate and multivariate Cox proportional hazards regression analyses were conducted to identify prognostic factors associated with PFS. Besides, a clinical prediction model was established based on the results of the multivariate Cox regression analyses to predict PFS.ResultsA total of 201 lung adenocarcinoma patients treated with ICIs were assessed. Univariate analysis showed that male gender [hazard ratio (HR) =0.521, 95% confidence interval (CI): 0.356-0.761, P=0.001], smoking (HR =0.595, 95% CI: 0.420-0.843, P=0.003), epidermal growth factor receptor (EGFR) wild type (HR =2.766, 95% CI: 1.719-4.452, P<0.001), Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (HR =0.449, 95% CI: 0.271-0.743, P=0.001), positive programmed death ligand 1 (PD-L1) expression (HR =0.527, 95% CI: 0.336-0.825, P=0.004), early tumor node metastasis (TNM) stage (HR =0.581, 95% CI: 0.344-0.983, P=0.039), no liver metastasis (HR =1.801, 95% CI: 1.046-3.102, P=0.031), ICIs combined with chemotherapy (HR =0.560, 95% CI: 0.384-0.815, P=0.002), having immune-related adverse effects (HR =0.354, 95% CI: 0.228-0.511, P<0.001) and first-line immunotherapy (HR =0.596, 95% CI: 0.420-0.845, P=0.003) were significantly associated with better PFS in patients with lung adenocarcinoma receiving immunotherapy. Multivariate analysis showed that smoking status, KRAS mutation, PD-L1 expression, line of immunotherapy and immune-related adverse effects were independent prognostic factors affecting PFS. A clinical prediction model was established to predict the PFS of lung adenocarcinoma patients treated with ICIs. The model showed good predictive ability via C-index, calibration curve and receiver operating characteristic (ROC) curve validation.ConclusionsThe clinical prediction model developed in this study can be used to some extent to predict PFS after immunotherapy in lung adenocarcinoma patients. However, the model still needs to be validated in studies with large sample size.

Project description:BackgroundHyponatremia due to endocrinopathies such as adrenal insufficiency and hypothyroidism has been reported in patients receiving immune checkpoint inhibitors (ICIs). We determined the risk and predictors of hyponatremia and other electrolyte abnormalities in a 'real-world' sample of patients receiving ICIs to treat advanced malignancies.MethodsThis was a retrospective observational study of all patients who received ICIs from a single cancer center between 2011 and 2018. Patients were followed for 12 months after initiation of ICIs or until death. Common Terminology for Cancer Adverse Events version 5.0 criteria were used to grade the severity of hyponatremia and other electrolyte abnormalities. The predictors of severe (Grade 3 or 4) hyponatremia were determined using a multivariable logistic regression model. The etiology of Grade 3 or 4 hyponatremia was determined by chart review.ResultsA total of 2458 patients were included. Their average age was 64 years [standard deviation (SD) 13], 58% were male and 90% were white. In the first year after starting ICIs, 62% experienced hyponatremia (sodium <134 mEq/L) and 136 (6%) experienced severe hyponatremia (<124 mEq/L). Severe hyponatremia occurred on average 164 days (SD 100) after drug initiation. Only nine cases of severe hyponatremia were due to endocrinopathies (0.3% overall incidence). Risk factors for severe hyponatremia included ipilimumab (a cytotoxic T lymphocyte antigen-4 inhibitor) use, diuretic use and non-White race. Other severe electrolyte abnormalities were also commonly observed: severe hypokalemia (potassium <3.0 mEq/L) occurred in 6%, severe hyperkalemia (potassium ≥6.1 mEq/L) occurred in 0.6%, severe hypophosphatemia (phosphorus <2 mg/dL) occurred in 17% and severe hypocalcemia (corrected calcium <7.0 mg/dL) occurred in 0.2%.ConclusionsHyponatremia is common in cancer patients receiving ICIs. However, endocrinopathies are an uncommon cause of severe hyponatremia.

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The Feasibility and Safety of Surgery in Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Study.

Publications

The Feasibility and Safety of Surgery in Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Study.

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