Immunomodulatory drugs like thalidomide and lenalidomide are being increasingly used for the treatment of patients with multiple myeloma and myelodysplastic syndromes. In contrast to thalidomide, which undergoes nonenzymatic hydrolysis in the plasma, approximately two-thirds of lenalidomide is eliminated unchanged through the kidneys in healthy volunteers. The risk of adverse reactions is expected to be greater in lenalidomide-treated patients with impaired renal function. 1,2 We would like to alert clinicians to the possibility of lenalidomide-induced hepatotoxicity when the drug is given in the setting of mild renal impairment after observing this rare side effect in a patient with multiple myeloma.A He began treatment with thalidomide (200 mg daily) and dexamethasone for 2 cycles but subsequently developed peripheral neuropathy and fatigue. His disease remained refractory to treatments including vincristine, adriamycin, and dexamethasone (VAD); bortezomib; and autologous stem cell transplantation. He was hospitalized for hypercalcemia, which improved from 0.45 mM to 0.275 mM (1.8 mg/dL to 1.1 mg/dL) after conservative management, and renal insufficiency. The patient was started on lenalidomide 25 mg orally daily and dexamethasone 40 mg orally on days 1 to 4, with warfarin 1 mg and aspirin 325 mg as venous thromboembolism prophylaxis. He was not receiving any hepatotoxic medications. One week later, he developed significant fatigue and hyperbilirubinemia (Figure 1). Lenalidomide was considered as a potential source of the liver function test abnormalities and discontinued. Further evaluation included an abdominal sonogram that showed mild hepatomegaly (16.5 cm) and 2 incidental hemangiomas (Ͻ 2 cm) but no bile duct dilatation or thrombi in hepatic veins. An abdominal magnetic resonance imaging (MRI) confirmed the hemangiomas but did not reveal any other specific pathology. He had complete normalization of his liver function profile 16 days following discontinuation of lenalidomide.In a review of lenalidomide toxicities by Hussein, 3 grade 2 liver enzyme elevations were described in 1 patient in a single-agent lenalidomide study. There was a similar association with fatigue, and a liver biopsy showed no specific pathology. Elevations in liver enzymes recurred after the patient was rechallenged with a lower dose.It is possible that our patient's reduced renal function played a role in the development of hepatotoxicity. The development of hepatotoxicity in this patient and its subsequent improvement coincided with the initiation and discontinuation of lenalidomide. This provides a temporal relationship and the basis for a strong association of hepatotoxicity induced by lenalidomide. As use of this drug expands, clinicians must recognize hepatotoxicity as a rare but potential complication of lenalidomide therapy. Since the drug is excreted mainly via the kidney as unchanged drug, higher caution would be warranted in patients with preexisting liver or kidney disease.
e18073 Background: Immune checkpoint inhibitors have changed the treatment paradigm for metastatic LC. Minority populations are under-represented in large IO clinical trials. Among 989 pts with newly diagnosed LC at Montefiore Medical Center - a community-based academic center from 2014-2015, 330 (33%) were AA and 195 (20%) were H. In line with practice-changing clinical studies, PD-L1 expression testing and IO have been incorporated into LC treatment. Methods: Pts receiving IO and/or had PD-L1 testing between 1/1/14-12/31/16 were identified from records obtained from pathology, pharmacy, oncology clinics and Clinical Looking Glass. Retrospective chart review was conducted. PD-L1 testing was performed using 22C3pharmDx IHC. Results: We identified 111 pts with LC who received IO and/or had PD-L1 testing, with a median age of 66. 55% were female. Based on race, 52 (47%) were AA, 24 (22%) were White, 26 (24%) were Other, and 9 (8%) were race unknown. Based on ethnicity, 30 (27%) were H, 73 (66%) were non-H and 8 (7%) were ethnicity unknown. 82% were former/current smokers. Adenocarcinoma was the dominant histology (60%). The majority were EGFR WT (91%) and ALK neg (98%). PD-L1 testing was performed in 67 (60%), including 32 (29%) AAs and 20 (18%) Hs. Archival tissue was used in 63%. PD-L1 TPS > 50% was found in 30%, 1-49% in 24%, < 1% in 37%. 62 pts received IO, including 26 (42%) AAs and 18 (29%) Hs. Nivolumab was the most commonly used agent (77%). In AAs, 8 (31%) received IO as 1st line, 13 (50%) as 2nd line, 5 (19%) as 3rd line and above. In Hs, 1 (5%) received IO as 1st line, 10 (56%) as 2nd line, 7 (39%) as 3rd line and above. Immune-related adverse events (IRAEs) were reported in 31% of AAs and 39% of Hs. Data analysis on survival is ongoing. Conclusions: Unlike the low numbers of minority pts in large clinical trials, we found no significant difference in PD-L1 testing and IO across racial and ethnic groups treated at our center. Compared to large clinical trials, we observed lower rates of IRAEs in our cohort. Our current and ongoing observations in these populations may have future implications in narrowing health disparities based on race/ethnicity.
120 Background: At our institution, we observed that 86% (n = 25) of patients admitted for elective chemotherapy experienced a delay (greater than 6 hours) in initiating their treatment. Methods: We measured time from admission to chemotherapy administration (Defined from time of vital signs taken at admission until time of chemotherapy administration) in patients admitted for elective chemotherapy. Key process measures were identified and monitored (i.e, time from admission to laboratory exam results, time from admission to chemotherapy signed, time from chemotherapy signed to chemotherapy released by nurse from the EMR). We collected data every two weeks. After collecting data and utilizing performance improvement tools such as a pareto chart and PICK chart, we developed multiple PDSA cycles as described in Table 1. Results: At the time of interim analysis, we observed a median decrease in time to chemotherapy administration from 25 hours to 8.85 hours. Median time to lab draws decreased from 2.33 hours to -0.63 hours. There was no change in time from signature to nurse releasing the chemotherapy. We noticed more providers were signing the chemotherapy prior to patient admission and more patients were receiving pre-admission alkalinization strategies. Conclusions: By implementing new admission workflows, optimizing our use of the EMR to communicate among providers, and improving pre-admission planning we were able to reduce our time to chemotherapy for elective admissions by 64.6%. Improvement still needed to meet our goals and fully standardize the processes as part of our daily workflow.[Table: see text]
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