Thalidomide Dosing in Patients with Relapsed or Refractory Multiple Myeloma

Jennifer L Thompson; Lea Ann Hansen

doi:10.1345/aph.1a155

Thalidomide Dosing in Patients with Relapsed or Refractory Multiple Myeloma

Annals of Pharmacotherapy ◽

10.1345/aph.1a155 ◽

2003 ◽

Vol 37 (4) ◽

pp. 571-576 ◽

Cited By ~ 3

Author(s):

Jennifer L Thompson ◽

Lea Ann Hansen

Keyword(s):

Multiple Myeloma ◽

Data Synthesis ◽

Medline Search ◽

Prognostic Features ◽

Refractory Multiple Myeloma ◽

Search Terms ◽

Promising Agent ◽

Pertinent Data ◽

Reasonable Approach ◽

Gradual Dose

OBJECTIVE: To evaluate the literature regarding the dosing of thalidomide in multiple myeloma. DATA SOURCES: A MEDLINE search (1990–February 2003) using the search terms thalidomide and multiple myeloma was performed to identify clinical trials and abstracts. Identified literature was then cross-referenced for further pertinent data. DATA SYNTHESIS: Patients with relapsed or refractory multiple myeloma have few therapeutic options. Thalidomide is a promising agent, although many dose-related issues are still in question. Starting doses studied ranged from 50 to 200 mg/d, usually given at bedtime. Gradual dose escalation up to 800 mg/d has been studied, with some evidence of improved outcome with doses of 400–600 mg/d, while thalidomide appears to be best tolerated at doses ≤400 mg/d. CONCLUSIONS: A reasonable approach for use of thalidomide in multiple myeloma is to initiate therapy at 50–100 mg nightly and escalate every 2 weeks in 50-to 100-mg increments as tolerated. Efforts should be made to titrate the dose to 400–600 mg/d, especially in patients with poor prognostic features. Efficacy should be assessed at approximately 8 weeks and the dose maintained if desired response is achieved.

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Dexrazoxane: A New Cardioprotective Agent

Journal of Pharmacy Technology ◽

10.1177/875512259801400505 ◽

1998 ◽

Vol 14 (5) ◽

pp. 182-190 ◽

Cited By ~ 1

Author(s):

Beverly D Abbott ◽

Cindy M Ippoliti

Keyword(s):

Supportive Care ◽

English Language ◽

Bolus Dose ◽

Cardiac Tissue ◽

Data Extraction ◽

Data Synthesis ◽

Medline Search ◽

Search Terms ◽

Study Selection ◽

Clinically Significant

Objective: To review the literature discussing the use of dexrazoxane (e.g., Zinecard, ICRF-187) to prevent doxorubicin-induced cardiotoxicity. Data Sources: Pertinent English-language reports of studies in humans were retrieved from a MEDLINE search (January 1980-January 1997); search terms included chelating agents, razoxane, dexrazoxane, Zinecard, ICRF-187, ADR-529, and ICRF-159. Study Selection: Representative articles discussing the chemistry, pharmacology, pharmacokinetics, dosing, and administration of dexrazoxane and those discussing clinical trials were selected. Data Extraction: Data were extracted and analyzed if the information was relevant and consistent. Studies were selected for review in the text on the basis of study design and clinical end points. Data Synthesis: Dexrazoxane is a chemoprotective agent developed to prevent cardiac tissue toxicity. Dexrazoxane exerts a cardioprotective effect with some clinically significant toxicities; it may also interfere with the antitumor activity of doxorubicin. Until there are sufficient data to support its use in first-line supportive care therapy, dexrazoxane should be reserved for use in patients responding to doxorubicin-based chemotherapy but who have risk factors for cardiac toxicity or have received a cumulative doxorubicin bolus dose of 300 mg/m2. Conclusions: The management of doxorubicin-induced cardiotoxicity has led to the development of supportive care drugs that specifically counteract the dose-limiting toxicities. Dexrazoxane may not completely eliminate the concern about doxorubicin-induced cardiotoxicity, but it may open new avenues for continuing doxorubicin-based chemotherapy.

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Safety and Efficacy of Influenza Vaccine in Children

Annals of Pharmacotherapy ◽

10.1345/aph.1d009 ◽

2003 ◽

Vol 37 (11) ◽

pp. 1712-1715 ◽

Cited By ~ 5

Author(s):

Leslie GB Goldstein

Keyword(s):

Influenza Vaccine ◽

Asthma Exacerbation ◽

Data Sources ◽

Influenza Vaccines ◽

Data Synthesis ◽

Safety And Efficacy ◽

Medline Search ◽

Asthmatic Children ◽

Search Terms

OBJECTIVE: To describe the safety and efficacy of influenza vaccines in asthmatic children. DATA SOURCES: Literature was identified by a MEDLINE search (2002–March 2003). Key search terms included asthma, exacerbation, children, vaccine, and influenza. DATA SYNTHESIS: Concerns that the influenza vaccine may exacerbate asthma attacks have kept many asthmatic children from receiving this immunization. Researchers have conducted studies to determine the burden of influenza on asthmatic children, the safety of influenza vaccines, and their benefit in the presence of glucocorticoid burst therapy in the same population. CONCLUSIONS: Influenza vaccines tested are safe and efficacious in asthmatic children.

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Levodopa Therapy and the Risk of Malignant Melanoma

Annals of Pharmacotherapy ◽

10.1345/aph.19150 ◽

2000 ◽

Vol 34 (3) ◽

pp. 382-385 ◽

Cited By ~ 29

Author(s):

Jolene F Siple ◽

Diana C Schneider ◽

Wendy A Wanlass ◽

Burton K Rosenblatt

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Malignant Melanoma ◽

English Language ◽

Case Reports ◽

Levodopa Therapy ◽

Data Sources ◽

Data Synthesis ◽

Medline Search ◽

Search Terms

OBJECTIVE: To evaluate the use of levodopa therapy in patients with Parkinson's disease and malignant melanoma. DATA SOURCES: A MEDLINE search (January 1966–September 1999) of English-language articles was conducted. Key search terms included levodopa, melanoma, and Parkinson's disease; 34 case reports were identified. DATA SYNTHESIS: Carbidopa/levodopa continues to be a mainstay in the treatment of Parkinson's disease. Since the late 1970s, a warning has appeared in the prescribing literature for levodopa regarding the risk of activating malignant melanoma. An evaluation was conducted of the case reports in which a causal relationship between levodopa and melanoma was suggested. CONCLUSIONS: There is an unlikely association between levodopa and induction or exacerbation of malignant melanoma.

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Fomepizole as an Antidote for Ethylene Glycol Poisoning

Annals of Pharmacotherapy ◽

10.1345/aph.1a397 ◽

2002 ◽

Vol 36 (6) ◽

pp. 1085-1089 ◽

Cited By ~ 16

Author(s):

Marisa Battistella

Keyword(s):

Ethylene Glycol ◽

English Language ◽

Case Reports ◽

Controlled Trial ◽

Prospective Trial ◽

Data Synthesis ◽

Medline Search ◽

Randomized Controlled ◽

Search Terms ◽

Ethylene Glycol Poisoning

OBJECTIVE: To assess the use of fomepizole in the treatment of ethylene glycol poisoning in the absence of hemodialysis. DATA SOURCES: A MEDLINE search (1966–May 2001) of English-language literature pertaining to the use of fomepizole in ethylene glycol poisoning was performed. Key search terms included fomepizole, ethylene glycol poisoning, and hemodialysis. References cited in those articles were also evaluated. DATA SYNTHESIS: Results from a number of case reports and a prospective trial suggest that fomepizole is a safe and effective antidote in the treatment of ethylene glycol poisoning. CONCLUSIONS: Case reports and 1 prospective trial have shown that, in the absence of both renal dysfunction and significant metabolic acidosis, the use of fomepizole should obviate the need for hemodialysis. However, the decision to add hemodialysis in the treatment of ethylene glycol poisoning based on plasma ethylene glycol concentrations is still debatable. A randomized, controlled trial is needed to determine the exact criteria for adding hemodialysis.

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Antibiotic and Oral Contraceptive Drug Interactions: Is There a Need for Concern?

Canadian Journal of Infectious Diseases ◽

10.1155/1999/539376 ◽

1999 ◽

Vol 10 (6) ◽

pp. 429-433 ◽

Cited By ~ 9

Author(s):

George G Zhanel ◽

Shannon Siemens ◽

Kathryn Slayter ◽

Lionell Mandell

Keyword(s):

Oral Contraceptive ◽

Drug Interactions ◽

Birth Control ◽

Oral Contraceptives ◽

Data Extraction ◽

Data Synthesis ◽

Contraceptive Failure ◽

Medline Search ◽

Search Terms ◽

Clinical Consequences

OBJECTIVE: To assess the clinical significant of antibiotic and oral contraceptive drug interactions.DATA SELECTION: MEDLINE search from 1975 to 1998 (September) inclusive. Search terms ‘antitiobic’, ‘oral contraceptive’ and ‘pregnancy’ were included. Published papers as well as references from these papers were reviewed. Papers documenting mechanistic interactions between antibiotics and oral contraceptives were included.DATA EXTRACTION: Studies reporting oral contraceptive pharmacokinetics, mechanisms, incidence, implicated antibiotics and clinical consequences of antibiotic/oral contraceptive drug interactions.DATA SYNTHESIS: Reports of oral contraceptive failure seem to be most numerous in women using preparations containing 30 μg of ethinylestradiol and 150 μ g of levonorgestrel. Rifampin is the only antibiotic that has been reported to reduce plasma estrogen concentrations. When taking rifampin, oral contraceptives cannot be relied upon and a second method of contraception is mandatory. Amoxicillin, ampicillin, griseofulvin, metronidazole and tetracycline have been associated with contraceptive failure in three or more clinical cases. When these agents are used, the clinician should discuss the available data with the patient and suggest a second form of birth control. Other antibiotics are most likely safe to use concomitantly with oral contraceptives.CONCLUSIONS: Rifampin is the only antibiotic to date that has been reported to reduce plasma estrogen concentrations. Oral contraceptives cannot be relied upon for birth control while taking rifampin.

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Randomized Controlled Trials versus Single Cohort Studies in Relapse Refractory Multiple Myeloma

Medical Research Archives ◽

10.18103/mra.v9i7.2452 ◽

2021 ◽

Vol 9 (7) ◽

Author(s):

John Sampalis ◽

Dimitrios Tomaras ◽

Christopher Zuraik ◽

Catherine Silotch ◽

Richard Trachy ◽

...

Keyword(s):

Multiple Myeloma ◽

Cohort Studies ◽

Controlled Trial ◽

Treatment Protocols ◽

Medline Search ◽

Refractory Multiple Myeloma ◽

Randomized Controlled ◽

Number Of Patients ◽

New Treatment ◽

Single Cohort

Background: The Randomized Controlled Trial (RCT) is considered the gold-standard for the evaluation of treatment efficacy. For rare or end stage cancers for which there are no effective treatments, or the number of patients is sparse, the use of RCTs for the assessment of efficacy and safety may be difficult. In these circumstances the single cohort study (SC) can be considered as an alternative to the RCT. Purpose: The purpose of this study was to compare the measures of efficacy as assessed with estimates of the Overall Response Rate (ORR) or Overall Survival (OS) obtained in RCT and SC studies that evaluate the same treatments for Relapse Refractory Multiple Myeloma (RRMM). The study also compared the estimates of ORR and OS ratios between treatments estimated in RCTs and extrapolated in SCs for the same treatments of RRMM. Methods: The study utilized data from 42 RCTs and 47 SCs assessing 18 different treatment protocols for RRMM that were identified through a MEDLINE search. Results: The results showed that there were no material differences in the demographics of patients enrolled in RCTs and SCs. The estimates of ORR and OS obtained in RCTs and SCs were comparable. Statistically significant Intra-Class Correlation Coefficient (ICC = 0.618, P = 0.027) was observed for ORR and for OS (ICC = 0.734; P = 0.014) indicating good agreement between RCTs and SCs. Treatment effect size as measured by the ORR and OS ratios (new treatment / control) was ascertained directly from RCTs and extrapolated for SCs based on the control ORR and OS observed in RCTs. There was agreement between RCTs and SCs with respect to the magnitude and direction of the ORR ratios (91% of the studies) and the OS ratios (75% of the studies). With respect to the conclusion regarding the relative efficacy of the new treatment versus the control, there was agreement between RCTs and SCs for 8/11 treatments based on ORR ratios and for 6 / 8 based on OS ratios. Conclusions: The results of this study have shown that for RRMM single cohort studies can be used to assess the efficacy of new treatments, given that sufficient data are available on controls treatments used as standard of care. The results may have implications for the evaluation of treatments of rare and advanced cancers as well as other conditions.

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Effect of Cyclobenzaprine on Tricyclic Antidepressant Assays

Annals of Pharmacotherapy ◽

10.1345/aph.1e632 ◽

2005 ◽

Vol 39 (7-8) ◽

pp. 1314-1317 ◽

Cited By ~ 14

Author(s):

Nicole M Van Hoey

Keyword(s):

Tricyclic Antidepressants ◽

Tricyclic Antidepressant ◽

Ultraviolet Absorption ◽

Data Sources ◽

Charge Ratio ◽

Data Synthesis ◽

Medline Search ◽

Search Terms ◽

History Of ◽

Unique Mass

OBJECTIVE To evaluate cyclobenzaprine interference on tricyclic antidepressant assays. DATA SOURCES Literature was identified through a MEDLINE search (1966–August 2004) using the search terms cyclobenzaprine, tricyclic antidepressant, toxicology, and assay. DATA SYNTHESIS Cyclobenzaprine is structurally similar to tricyclic antidepressants and is often identified as a tricyclic antidepressant on toxicology assays. Older chromatographic assays demonstrate retention time differences of only seconds and nearly identical color stains between cyclobenzaprine and individual tricyclic antidepressants. In comparison, ultraviolet absorption ratios of 4.18 for amitriptyline and 1.85 for cyclobenzaprine are easily distinguished. Spectroscopy also consistently identifies cyclobenzaprine's unique mass-to-charge ratio peaks of 275 and 215 compared with those of amitriptyline. Available bioanalytic techniques are reviewed for their ability to correctly identify cyclobenzaprine and differentiate the drug from tricyclic antidepressants. CONCLUSIONS When assays are positive for tricyclic antidepressants without a history of their use, an attempt should be made to identify confounders, such as cyclobenzaprine. Newer bioanalytic techniques, such as ultraviolet absorption and mass spectroscopy, accurately identify cyclobenzaprine in such instances.

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