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1.
Blood ; 138(SUPPL 1):3525, 2021.
Article in English | EMBASE | ID: covidwho-1770434

ABSTRACT

Background - The WINDOW-1 regimen introduced first-line ibrutinib with rituximab (IR) followed by 4 cycles of R-HCVAD for younger mantle cell lymphoma (MCL) patients (pts) demonstrating 90% CR on IR alone and we aimed to improve the CR rate with the addition of venetoclax. We therefore investigated the efficacy and safety of IR and venetoclax (IRV) followed by risk-stratified observation or short course R-HCVAD/MTX-ARA-C as consolidation in previously untreated young patients with mantle cell lymphoma (MCL). Our aim was to use a triplet chemotherapy-free induction to reduce the toxicity, complications and minimize chemotherapy exposure in MCL pts. Methods - We enrolled 50 previously untreated pts in this single institution, single arm, phase II clinical trial - NCT03710772. Pts received IR induction (Part-1) for initial 4 cycles. Pts were restaged at cycle 4 and received IRV for up to eight cycles (Cycle 5 to Cycle 12) starting with ramp up venetoclax dosing in Cycle 5. All pts who achieved CR prior to cycle 12 continued to receive IRV for 4 cycles (maximum 12 cycles) and then moved to part 2. Pts were stratified into three disease risk groups: high, moderate and low risk categories from the baseline data for assignment to R-HCVAD/MTX-ARA-C as consolidation in part 2 (4 cycles, 2 cycles, or no chemotherapy for high, medium and low risk pts respectively). Briefly, low risk pts were those with Ki-67 ≤30%, largest tumor mass <3 cm, low MIPI score and no features of high risk disease (Ki-67 ≥50%, mutations in the TP53, NSD2 or in NOTCH genes, complex karyotype or del17p, MYC positive, or largest tumor diameter >5 cm or blastoid/pleomorphic histology or if they remain in PR after 12 cycles of part 1. Medium risk are pts which did not belong to low or high-risk category. Those who experienced progression on part 1 went to part 2 and get 4 cycles of part 2. Patient were taken off protocol but not off study, if they remained in PR after 4 cycles of chemotherapy, these patients were followed up for time to next treatment and progression free survival on subsequent therapies. After part 2 consolidation, all pts received 2 years of IRV maintenance. The primary objective was to assess CR rates after IRV induction. Adverse events were coded as per CTCAE version 4. Molecular studies are being performed. Results - Among the 50 pts, the median age was 57 years (range - 35-65). There were 20 pts in high-risk group, 20 pts in intermediate-risk group and 10 pts in low-risk group. High Ki-67 (≥30%) in 18/50 (36%) pts. Eighteen (36%) had high and intermediate risk simplified MIPI scores. Six (12%) pts had aggressive MCL (blastoid/pleomorphic). Among the 24 TP53 evaluable pts, eight pts (33%) had TP53 aberrations (mutated and/or TP53 deletion by FISH). Forty-eight pts received IRV. Best response to IRV was 96% and CR of 92%. After part 2, the best ORR remained unaltered, 96% (92% CR and 4% PR). The median number of cycles of triplet IRV to reach best response was 8 cycles (range 2-12). Fifteen pts (30%) did not receive part 2 chemotherapy, two pts (4%) received 1 cycle, 16 pts (32%) 2 cycles and 13 pts (26%) got 4 cycles of chemotherapy. With a median follow up of 24 months, the median PFS and OS were not reached (2 year 92% and 90% respectively). The median PFS and OS was not reached and not significantly different in pts with high and low Ki-67% or with/without TP53 aberrations or among pts with low, medium or high-risk categories. The median PFS and OS was inferior in blastoid/pleomorphic MCL pts compared to classic MCL pts (p=0.01 and 0.03 respectively). Thirteen pts (26%) came off study - 5 for adverse events, 3 for on study deaths, and 2 for patient choice, 2 patients lost to follow up and one for disease progression. Overall, 5 pts died (3 on trial and 2 pts died off study, one due to progressive disease and another due to COVID pneumonia). Grade 3-4 toxicities on part 1 were 10% myelosuppression and 10% each with fatigue, myalgia and rashes and 3% mucositis. One pt developed grade 3 atrial flutter on part 1. None had grade 3-4 bleeding/bruising. Conclusions - Chemotherapy-free induction with IRV induced durable and deep responses in young MCL pts in the frontline setting. WINDOW-2 approach suggests that pts with low risk MCL do not need chemotherapy but further follow up is warranted. This combined modality treatment approach significantly improves outcomes of young MCL pts across all risk groups. Detailed molecular analyses will be reported. (Figure Presented).

2.
American Journal of Kidney Diseases ; 77(4):666, 2021.
Article in English | EMBASE | ID: covidwho-1768928

ABSTRACT

We present the case of a patient with acute kidney injury (AKI) associated with star fruit consumption, a very popular food in the tropics. A 69 year old male with a PMH of HTN, gout and stage 2 CKD presented to the Miami VA the day after visiting the Puerto Rico VA for hiccups and abdominal discomfort. He had been found to have an AKI but decided to seek care to the Miami VA instead of being admitted. He denied recent use of NSAIDs or antibiotics and had no changes in medication regimen. He had one self-limited episode of loose stools 2 days prior with no vomiting and had no urinary or neurologic complaints. His physical exam was normal for his age. Labs showed a Cr 4.5 (eGFR 13), a bland urinalysis, mild proteinuria, FeNa 4.1% (in context of chronic HCTZ use) and FeUrea: 52.2%. Further testing showed negative SARS-CoV-2, hepatitis and HIV serologies, ANA(-), SPEP(-), UPEP(-), and normal complement levels. Imaging revealed normal appearance and size of kidneys, no hydronephrosis, and no urolithiasis. Given negative work-up, a kidney biopsy was performed revealing acute tubular injury with increased intratubular oxalate, mild to moderate interstitial fibrosis, moderate to marked arteriosclerosis, FSGS (likely secondary). Upon further questioning he reported consuming a large amount of star fruit the day before developing GI symptoms. He was discharged with close follow up, no renal replacement therapy was needed. Star fruit induced nephrotoxicity is a rare cause of AKI, however it should be suspected in patients with AKI and a recent consumption of large amounts of this fruit. Initial presentation includes nausea, vomiting, abdominal pain and hiccups. After ingestion, circulating free oxalates are filtered through the kidney where they can precipitate into calcium oxalate crystals and cause tubular obstruction. Demonstration of this through biopsy is diagnostic for this type of nephrotoxicity. Many patients need early renal replacement therapy, at least temporarily, but fortunately that wasn't the case in our patient. Oxalate nephrotoxicity should be suspected in patients presenting with AKI and recent consumption of starfruit.

4.
Journal of the American Society of Nephrology ; 31:224-225, 2020.
Article in English | EMBASE | ID: covidwho-984133

ABSTRACT

Background: Chronic kidney disease (CKD) affects 37 million adults in the United States. Since 2013 our Nephrology section has carried out a telenephrology clinic and implemented electronic consults (E-consults). During the COVID-19 pandemic, we implemented changes to evaluate patients with kidney disease. The aim of this study is to report our experience. Methods: This is a single-center, retrospective chart review study, which evaluated the effect of our telenephrology clinic (video-on-demand and telemedicine clinic visits), as well as E-consults. Between January 2013 and 2020, 410 patients were seen at telemedicine clinic visits, and 1020 E-consults were evaluated. During the COVID-19 pandemic, between March 2020 and May 2020, 40 patients were assessed through videoon-demand. Results: For telemedicine, a total of 169 patients were included, 99.4% were males, and 87% were white. The mean age was 66 ± 10 years, 92% had hypertension, and 41% diabetes mellitus. The baseline eGFR was 45 ± 14 ml/min/1.73m2. A one-way analysis of variance was conducted showing a statistically significant reduction on the systolic (SBP) and diastolic (DBP) blood pressure (p-value = 0.000), and improvement in potassium and bicarbonate levels (p-value = 0.000). Phosphorus levels did not show a significant difference (p-value 0.37). There was a significant association between attendance to >;3 telenephrology visits and SBP control (p-value=0.027), DBP control (p-value=0.002) and potassium improvement (p-value=0.013). The overall decrease in GFR was 1.2 ± 11.1 ml/ min/1.73 m2 (95% CI-0.41 to 2.95), lower than the reported natural progression of CKD (1.03 ml/min/1.73 m2/year). A survey for the video-on-demand patients showed 100% satisfaction, reflecting that patients felt their renal care needs were fulfilled. E-consults were answered in less than 24 hours, with 100% satisfaction from primary care physicians. Conclusions: This is the first study evaluating the use of telenephrology in patients with kidney disease during the COVID-19 pandemic. In our cohort, telenephrology interventions improved SBP, DBP, bicarbonate, and potassium control. All three options improved health outcomes and guaranteed safety during the COVID-19 pandemic, at a reduced cost for the patient and the institution.

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