Evaluation of high-dose methotrexate serum concentration requirement for discharge.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19204-e19204
Author(s):  
Amulya Yellala ◽  
Prajwal Dhakal ◽  
Brooke Deason ◽  
Susanne Liewer ◽  
Avyakta Kallam ◽  
...  
Keyword(s):  
Sodium Bicarbonate ◽  
Supportive Care ◽  
Metastatic Breast ◽  
Retrospective Chart Review ◽  
Early Discharge ◽  
High Dose ◽  
Discharge Process ◽  
Post Discharge ◽  
Number Of Patients ◽  
Acute Complications

e19204 Background: Methotrexate (MTX) is used in high doses for the treatment of ALL, lymphoma, and metastatic breast cancer with CNS involvement. To avoid drug accumulation and mitigate toxicities caused by delayed clearance, patients (pts) are usually admitted to the hospital and standard supportive care with IV hydration, urinary alkalization, and leucovorin is provided and adjusted based on daily levels. Historically, a serum methotrexate level ≤ 0.05 µmol/L has been used to declare clearance and an ideal level for discharge based on studies conducted in the 1970s. We conducted a retrospective review in 2018 to identify frequency of supportive dose escalations required with MTX levels > 0.05 µmol/L. In 69 pts, 4 patients demonstrated delayed renal clearance and required supportive care escalations but all occurred at MTX levels > 0.3 µmol/L. This led to a proposed pilot discharge process once MTX was < 0.3 µmol/L to confirm the safety of earlier discharge. Methods: A retrospective chart review of pts with baseline CrCl ≥60 who received HD MTX between 07/2018 – 08/2019. Data collection included diagnosis, MTX discharge level, supportive care at discharge including PO Leucovorin and PO sodium bicarbonate and number of days supply, post-discharge complications (AKI, mucositis, fever, others). Primary outcome was the number of patients who required inpatient or outpatient supportive care for acute complications after being discharged with a methotrexate level ≥ 0.1 µmol/L. Descriptive statistics were used. Results: A total of 41 pts were included. Median age was 55 yrs (32-78), 25% were male. 73% were treated for DLBCL, median dose of MTX was 3500 mg/m2. Median MTX level at the time of discharge was 0.16 µmol/L (0.1-0.3 µmol/L). 12 pts were discharged with PO Leucovorin and 15 pts were discharged with both Leucovorin and PO Sodium bicarbonate with an average of 2 day’s supply. 1 acute complication of neutropenic fever requiring admission for inpatient antibiotics occurred which was felt to be unrelated to MTX level at discharge. Conclusions: This pilot suggests that pts can be safely discharged with MTX levels upto 0.3 µmol/L without acute complications. Results of this study will be used to a develop a standardized protocol outlining criteria for early discharge in select pts with MTX levels < 0.3 µmol/L to reduce length of stay, cost of hospitalization and improve patient satisfaction. [Table: see text]

Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer.

1996 ◽  
Vol 14 (6) ◽  
pp. 1858-1867 ◽  
Author(s):  
J M Nabholtz ◽  
K Gelmon ◽  
M Bontenbal ◽  
M Spielmann ◽  
G Catimel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Low Frequency ◽  
Metastatic Breast ◽  
Therapeutic Index ◽  
Complete Response ◽  
Dose Effect ◽  
Clinical Activity ◽  
High Dose ◽  
Number Of Patients

PURPOSE AND METHODS The objective of this multicenter study was to compare the therapeutic index of two different doses of paclitaxel given as a 3-hour infusion in patients with metastatic breast cancer (MBC), who had failed to respond to previous chemotherapy. A total of 471 patients with MBC were randomized to receive intravenous paclitaxel at a dose of 175 or 135 mg/m2 every 3 weeks. RESULTS Better treatment results were achieved with high-dose (HD) versus low-dose (LD) paclitaxel: overall response rate, 29% versus 22% (P = .108); complete response (CR) rate, 5% versus 2% (P = .088); median time to disease progression, 4.2 versus 3.0 months (P = .027); and median survival time, 11.7 versus 10.5 months (P = .321). Patients previously exposed or resistant to anthracyclines were as likely to respond as those without such prior exposure. Treatment was well tolerated, as documented by the number of administered treatment courses (median, six v five; range, one 17 v one to 18), the low frequency of dose reductions (14% v 7%, P = .024), and the small number of patients (n = 9 or 4% vn = 5 or 2%) who required treatment discontinuation for adverse reactions. The incidence and severity of neutropenia and peripheral neuropathy were dose-related. After quality-of-life-adjusted time-to-progression analysis, the HD arm (175 mg/m2) retained its advantage over the LD arm (135 mg/m2). CONCLUSION The results of this trial substantiate the activity of paclitaxel in the treatment of MBC. The observed superior efficacy with a dose of 175 mg/m2 over 135 mg/m2 suggests a dose-effect relationship. The clinical activity in anthracycline-resistant patients is particularly noteworthy. Paclitaxel in breast cancer needs further evaluation in large trials that use combination chemotherapy and involve earlier disease stages.

NCMP-18. FIXED PTOSIS AS A SYMPTOM OF MYOSITIS SECONDARY TO CHECKPOINT INHIBITION

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi150-vi150
Author(s):  
Ashley Aaroe ◽  
Sudhakar Tummala
Keyword(s):  
Myasthenia Gravis ◽  
Striated Muscle ◽  
Rapid Onset ◽  
Cancer Center ◽  
High Dose ◽  
Post Discharge ◽  
Institutional Review ◽  
Number Of Patients ◽  
Average Maximum

Abstract BACKGROUND A growing number of patients with cancer receive checkpoint inhibitor (CPI) based immunotherapy. Peripheral nervous system toxicities including myositis, myasthenia gravis and inflammatory neuropathy are distinct from their non immunotherapy-related equivalents, with unique clinical presentations and therapeutic considerations. METHODS Patients with CPI myositis and non-fatigable ptosis were identified, and clinical data was retrospectively extracted from the electronic medical record in compliance with MD Anderson Cancer Center Institutional Review Board guidelines. RESULTS 14 patients were identified. Average maximum creatine kinase (CK) was 3571 U/L (range 20-19,794). 9 patients had electromyography and nerve conduction studies documented in our system; all had electrodiagnostic evidence of myopathy and two had evidence of concomitant myasthenia gravis by electrodecrement. Two muscle biopsies revealed myositis with inflammatory T-cell infiltrate. 6 had positive anti-striated muscle antibody titers, 9/14 had concomitant myocarditis, 2 had hepatitis, 2 had pneumonitis and 1 had thyroiditis. All received high dose steroids, 11 received plasma exchange, 4 received rituximab, 4 received tacrolimus and 2 received tocilizumab. 7/14 patients died (50%). Mean time from initial neurology consultation for symptoms to death was 6.46 months (range .3-24). 5 patients had documented clinical stabilization or mild improvement on post-discharge follow-up. CONCLUSIONS While ptosis in patients receiving CPI can initially suggest myasthenia gravis, in patients with rapid onset and ultimately fixed deficits there should be a high index of suspicion for immunotherapy related restricted localized myositis. Myositis may coincide with other toxicities, such as myocarditis and pneumonitis, and can be fatal despite aggressive treatment. Deficits persist on post-discharge follow-up, suggesting protracted recovery for patients who survive.

Minimal toxicity and mortality in high-risk breast cancer patients receiving high-dose cyclophosphamide, thiotepa, and carboplatin plus autologous marrow/stem-cell transplantation and comprehensive supportive care.

1996 ◽  
Vol 14 (4) ◽  
pp. 1156-1164 ◽  
Author(s):  
H K Holland ◽  
S P Dix ◽  
R B Geller ◽  
S M Devine ◽  
L T Heffner ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Bone Marrow ◽  
Metastatic Breast Cancer ◽  
Supportive Care ◽  
Metastatic Breast ◽  
High Dose ◽  
Care Approach ◽  
Risk Breast Cancer ◽  
Treatment Related Mortality ◽  
Related Mortality

PURPOSE To assess the clinical toxicity and outcome associated with a comprehensive supportive care approach in poor-risk breast cancer (BrCA) patients with high-dose chemotherapy (HDC). PATIENTS AND METHODS One hundred twenty-five consecutive patients with stages II, III or metastatic breast cancer received HDC between February 1992 and June 1994. Recipients received 4 days of continuous infusion of cyclophosphamide 1.5 g/m2/d, thiotepa 125 mg/m2/d, and carboplatin 200 mg/m2/d followed by infusion of bone marrow or peripheral-blood stem cells (PBSC) and recombinant human growth factor (rhu-GF) support. Patients received similar supportive care that included administration of prophylactic antibiotics, management of neutropenic fevers, and transfusion support. RESULTS There were 38 women with stage II or III (27 patients with > or = 10 lymph nodes), four with stage IIIB, and 83 with metastatic breast cancer. The median age was 44 years (range, 27 to 61). Grade II or greater nonhematologic toxicities included diarrhea (66%), stomatitis (33%), hepatic venoocclusive disease (VOD) (5%), and pulmonary toxicity (4%). Myeloid and platelet engraftment was comparable between bone marrow and PBSC recipients (P > .1). Infectious complications were rare and consisted of gram-negative bacteremia (1.6%), gram-positive bacteremia (1.6%), fungemia (1.6%), and documented or suspected aspergillosis infection (3%). There was one treatment-related death secondary to severe VOD. CONCLUSION A comprehensive supportive care approach was associated with a low treatment-related mortality rate of less than 1%. With the observed reduction in treatment-related mortality, it is reasonable to evaluate the efficacy of HDC in women with less than 10 positive nodes and stage II disease in well-designed clinical trials.

Safety and efficacy of a urine alkalinization protocol developed for high-dose methotrexate patients during intravenous bicarbonate shortage

2019 ◽  
Vol 25 (8) ◽  
pp. 1860-1866 ◽  
Author(s):  
Amanda M Roy ◽  
Matthew Lei ◽  
Uvette Lou
Keyword(s):  
Sodium Bicarbonate ◽  
Creatinine Clearance ◽  
Urine Output ◽  
Retrospective Chart Review ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Urine Ph ◽  
Dose Methotrexate ◽  
Mean Time ◽  
Intravenous Sodium

Purpose Urinary alkalinization with intravenous sodium bicarbonate is standard during high-dose methotrexate administration. Due to a national intravenous sodium bicarbonate shortage, a urinary alkalinization protocol involving hyperhydration with intravenous fluids, oral bicarbonate, and intravenous or oral acetazolamide was utilized from 10 April to 30 May 2017 (“shortage protocol”). This study compared outcomes between protocols. Methods A single-center, retrospective chart review was conducted for adults who received methotrexate ≥500 mg/m2 on ≥ two occasions, at least once during each protocol, between 19 February and 19 July 2017. Results Eighteen patients (50% male), median age 65 years, received 76 total high-dose methotrexate cycles. Shortage protocol was used in 37 cycles (48.7%). Mean time to methotrexate clearance did not differ between groups (p = ns). Mean time to urinary alkalinization and duration of hospitalization were not statistically different (p = 0.49 and 0.23, respectively). Average total bicarbonate administered per 24 hours was higher in standard protocol (p < 0.05), but hydration rates were similar (p = 0.73). Creatinine clearance and urine output on days 1 and 2 post-high-dose methotrexate did not significantly differ (creatinine clearance day 1, p = 0.27; creatinine clearance day 2, p = 0.55; urine output day 1, p = 0.62; urine output day 2, p = 0.60). Interruptions in alkalinization were significantly higher during shortage (0.41 ± 0.75 instances of urine pH < 7 during standard vs. 1.3 ± 1.7 under shortage, p < 0.05).

scholarly journals SUN-201 Adrenal Insufficiency After Treatment for Vaping Associated Pulmonary Injury

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Melinda Pierce ◽  
Anne Griffiths
Keyword(s):  
Adrenal Insufficiency ◽  
High Dose ◽  
Pediatric Endocrinology ◽  
Acth Stimulation ◽  
Post Discharge ◽  
Prednisone Therapy ◽  
Number Of Patients ◽  
First Time ◽  
Dose Prednisone

Abstract Background: In 2019 a record number of patients were admitted to our children’s hospital with e-cigarette or vaping-associated lung injury (EVALI). The majority of patients were treated with high-dose prednisone therapy including 3 days of 1000 mg daily followed by a 4 week wean. Because of the concern for iatrogenic adrenal insufficiency, all patients were then placed on a 3-4 weak hydrocortisone taper followed by ACTH stimulation testing. The purpose of this study is to document the incidence of iatrogenic adrenal insufficiency following a 2 months glucocorticoid wean. Methods: All patients seen by the Pulmonary team for EVALI who also received high dose prednisone therapy were referred to Pediatric Endocrinology for ACTH testing. A low dose (1 mcg) ACTH stimulation test was performed with cortisol measurements at baseline, 30 minutes, and 60 minutes. A passing result was any cortisol over 18 ug/dl. Results: An anticipated 20-25 patients will have had ACTH stimulation testing by the time of abstract presentation. Of those that have already completed testing, three of four patients failed the first time. Discussion: High-dose prednisone therapy for EVALI is associated with significant rates of iatrogenic adrenal insufficiency, even after slow hydrocortisone wean. Structures need to be implemented to teach patients about adrenal insufficiency prior to hospital discharge and organize adequate post-discharge follow-up until HPA function returns.

Implementation and evaluation of high-dose methotrexate administration guidelines

2018 ◽  
Vol 25 (7) ◽  
pp. 1675-1681 ◽  
Author(s):  
Thomas J Nowak ◽  
Aaron H Lorge ◽  
Lisa E Rein ◽  
Angela M Canadeo ◽  
Joel P Frank ◽  
...  
Keyword(s):  
Sodium Bicarbonate ◽  
Supportive Care ◽  
Primary Endpoint ◽  
Guideline Implementation ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Prospective Group ◽  
Dose Methotrexate ◽  
Bicarbonate Infusion ◽  
Sodium Bicarbonate Infusion

BackgroundHigh-dose methotrexate is used to treat a variety of malignancies. Methotrexate-associated supportive care and the threshold methotrexate level for the discontinuation of supportive care are not consistent among studies. We evaluated the implementation of high-dose methotrexate administration guidelines, which raised the standard threshold methotrexate level for the discontinuation of supportive care from <0.05 to <0.1 µmol.MethodsA single-center, observational analysis of patients receiving high-dose methotrexate from 1 January 2015 to 31 May 2017 was conducted. The primary endpoint was time from the start of the methotrexate infusion until the discontinuation of the sodium bicarbonate infusion, before and after guideline implementation.ResultsFifty-two patients met the inclusion criteria, which comprised of a total of 136 individual methotrexate doses and were included in the retrospective analysis. Twenty-four patients were included in the prospective analysis, which comprised a total of 46 individual methotrexate doses. The primary endpoint, time until discontinuation of the sodium bicarbonate infusion, was a median of 97.7 h in the retrospective group versus 73.2 h in the prospective group (p = 0.098). Secondary endpoints also favored patients in the prospective group, including hours of hospitalization, number of methotrexate levels checked, weight gained during admission, and adherence to the guideline.ConclusionAmong patients who received high-dose methotrexate, implementation of a guideline using a methotrexate threshold of <0.1 µmol was able to significantly decrease the time to discontinuation of supportive care and subsequently may lead to early hospital discharge given that we did not show a statistical significance.

scholarly journals Evaluation of an Oral Sodium Bicarbonate Protocol for High-Dose Methotrexate Urine Alkalinization

2021 ◽  
Author(s):  
Rachel Heisler ◽  
Jordan Kelly ◽  
Sara Abedinzadegan Abdi ◽  
Jennifer Hawker ◽  
Leanne Fong ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Sodium Bicarbonate ◽  
Retrospective Chart Review ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Dose Methotrexate ◽  
Urine Alkalinization ◽  
Nausea And Emesis ◽  
Alberta Health ◽  
Oral Sodium

Abstract Purpose: Intravenous (IV) sodium bicarbonate is considered standard therapy for high-dose methotrexate (HDMTX) urine alkalinization. Due to a national IV sodium bicarbonate shortage, an oral (PO) sodium bicarbonate protocol was implemented by Alberta Health Services (AHS) for HDMTX urine alkalinization. This study aims to evaluate the efficacy and safety of the PO sodium bicarbonate protocol compared to IV sodium bicarbonate for HDMTX urine alkalinization. Methods: A retrospective chart review of adult patients who received HDMTX (>500 mg/m2) with sodium bicarbonate for urine alkalinization at 4 hospitals in Alberta was conducted. Patients who received IV sodium bicarbonate between January-June 2017 and PO sodium bicarbonate between July-December 2017 were compared for the primary outcome of time to methotrexate clearance. Results: A total of 84 and 78 HDMTX cycles were included in the IV and PO cohorts, respectively. No difference in time to methotrexate clearance was seen between the IV and PO cohorts, 91.6 (± 35.4) hours and 95.2 (± 44) hours respectively; p=0.5. The proportion of HDMTX cycles that experienced a >25% increase in serum creatinine was not statistically significant, IV protocol 12% and PO protocol 5%; p=0.13. Nausea and emesis occurred more frequently in the PO cohort than the IV cohort, though rarely resulted in refused doses or change to alternate sodium bicarbonate formulations.Conclusions: The results of this study indicate that the AHS PO sodium bicarbonate protocol was no different in time to methotrexate clearance or rates of increased serum creatinine when compared to IV sodium bicarbonate.

Oral sodium bicarbonate protocol for high-dose methotrexate urine alkalinization: A pediatric experience

2020 ◽  
pp. 107815522091576
Author(s):  
Mark Diachinsky ◽  
Tracey Tran ◽  
Jennifer Jupp ◽  
Krista McKinnon
Keyword(s):  
Adverse Effects ◽  
Sodium Bicarbonate ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
High Dose ◽  
Children's Hospital ◽  
Children’S Hospital ◽  
Urine Alkalinization ◽  
Feasible Alternative ◽  
Oral Sodium

Introduction Methotrexate (MTX) is a cytotoxic antimetabolite. Intravenous (IV) hydration and urine alkalinization with sodium bicarbonate (NaHCO3) can mitigate nephrotoxicity associated with high-dose MTX (HDMTX, doses ≥500 mg/m2). A shortage of IV NaHCO3 in 2017 prompted Alberta Children’s Hospital (ACH) and Stollery Children’s Hospital (SCH) to adopt an alternative protocol including oral NaHCO3 and IV hydration with Lactated Ringer’s (LR). Methods A retrospective chart review was conducted for ACH and SCH inpatients who received HDMTX between January and December 2017. The primary outcome was the proportion of cycles with delayed HDMTX clearance within the IV and oral cohorts. Secondary outcomes include NaHCO3 administered until clearance, NaHCO3 required to reach pH ≥7, time to reach pH ≥7, incidence of pH <7, time to clearance, and time to discharge. Adverse effects associated with delayed clearance or NaHCO3 administration were also reported. Results 112 MTX cycles were included, 50 and 62 from the IV and oral cohorts, respectively. Clearance delays beyond protocol expectations occurred in 10 cycles (8.9%), 5 from each cohort ( p = 0.72). Differences between cohorts were not statistically significant, except the amounts of NaHCO3 required until clearance (383 vs. 277 mmol/m2, p = 0.005) and to reach pH ≥7 (52 vs. 40 mmol/m2, p = 0.004) were lower in the oral cohort. Incidences of adverse effects were not different. Conclusions Oral NaHCO3 with LR is a feasible alternative for urine alkalinization. The total dose of NaHCO3 utilized was lower in the oral cohort, with no additional delays in clearance.

Decreased Opioid doses used on a Palliative Care Unit

1996 ◽  
Vol 12 (4) ◽  
pp. 6-9 ◽  
Author(s):  
Robin L. Fainsinger ◽  
Karen Louie ◽  
Michelle Belzile ◽  
Eduardo Bruera ◽  
John Hanson
Keyword(s):  
Palliative Care ◽  
Rapid Development ◽  
Retrospective Chart Review ◽  
Palliative Care Unit ◽  
Published Data ◽  
High Dose ◽  
Opioid Use ◽  
Cross Tolerance ◽  
Opioid Dose ◽  
Number Of Patients

We have previously published data on our use of opioids in the last week of life. A change in our pattern of opioid use, i.e. switching opioids more frequently and using high-dose methadone suppositories, appears to have resulted in a decrease in the number of patients requiring high-dose opioids. A retrospective chart review of 100 consecutive patients treated on our palliative care unit during 1992 was completed and compared to the original data from 1990. Results confirmed a decrease in the range of opioids used, as well as a statistically significant decrease in the daily opioid dose in the last week of life. We believe that this difference is most likely due to the use of methadone in patients showing either a poor response to other opioids or a rapid development of tolerance, as well as switching opioids more frequently to take advantage of incomplete cross-tolerance.

Abstract 105: A 360 Degree Perspective on the Timing of Patient Discharge: A Multidisciplinary Survey of Patients, Physicians, and Nurses on Discharge Practices Within a Cardiovascular Service Line at a Tertiary Academic Institution

2016 ◽  
Vol 9 (suppl_2) ◽  
Author(s):  
Harshith Avula ◽  
Srinath Adusumalli ◽  
Kartik Telukuntla ◽  
Daniel M Kolansky ◽  
Leah Moran ◽  
...  
Keyword(s):  
Transitional Care ◽  
Healthcare Providers ◽  
Patient Discharge ◽  
Early Discharge ◽  
Optimal Time ◽  
Discharge Process ◽  
Discharge Time ◽  
Post Discharge ◽  
Survey Period ◽  
Provider Perspectives

Background: Early hospital discharge for patients has been linked to improved post-discharge outcomes. Health systems continue to struggle with early discharges and past interventions have centered around provider perspectives of the discharge process, with no identifiable studies focusing on patient perspectives. We sought to examine the discharge process from a comprehensive perspective, obtaining simultaneous patient and healthcare provider beliefs to improve our institution’s discharge process. Methods: Our study was approved by the Institutional Review Board at the University of Pennsylvania and all participants provided informed consent. Physicians and nurses who took part in discharges from our inpatient cardiology services participated in an electronic survey regarding discharge processes over a six-month period. Patients being discharged from these services also completed anonymous surveys at the time of discharge from the hospital. Results: The survey was completed by 476 patients, 47 nurses, and 44 physicians. Approximately 54% of physicians and 43% of nurses reported that the ideal time of discharge is between 8:00 AM and 12:00 PM. A vast majority (85%) of patients reported that discharges before 2:00 PM are best, with 60% of patients reporting that discharges should ideally occur before 12:00 PM. Nearly half (46%) of patients, 64% of physicians, and 75% of nurses reported that the discharges they participated in occurred after 2:00 PM, which was consistent with the mean discharge times reported by institutional data taken during the survey period. Less than half (40%) of patients also reported that they were informed of their discharge before 12:00 PM on their day of discharge. The majority of healthcare providers reported that they do not believe early discharges would reduce the rate of 30-day readmissions (physicians 87%, nurses 88%) or lead to safer discharges (physicians 78%, nurses 69%). More than one-third (36%) of patients reported that a delay in coordination of transitional care (e.g. medication delivery, transportation issues, and inadequate communication with primary team) contributed to a later discharge time. Conclusion: Our data reveal that both patients and providers believe that the optimal time for discharge is prior to 12:00 PM, despite the fact that most discharges occur after 2:00 PM. Patients cite delays in coordination of transitional care as the most common reason for delayed discharge times, and were typically informed of their formal discharge after noon on the day of discharge. Although most healthcare providers do not believe that early discharge improves outcomes, additional studies are needed to investigate outcomes associated with early discharge time.

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