The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.
Alterations in tretinoin pharmacokinetics following administration of liposomal all-trans retinoic acid
Abstract
We administered liposome-encapsulated all-trans retinoic acid (L-ATRA) to 48 patients with refractory hematologic malignancies using an every- other-day schedule for 28 days and doses of 15 to 175 mg/m2. In 19 patients, pharmacology studies were conducted after the first (day 1) and seventh (day 15) doses. In contrast to the decline in tretinoin concentration seen within 3 to 4 days of administration of daily oral ATRA, there were no differences between the area under the curve (AUC) of tretinoin concentration versus time on day 1 and day 15 (P = .98, Wilcoxon signed-rank test). Peak day 1 concentrations after 15 mg/m2 were higher than those reported after 45 mg/m2 oral ATRA. Six patients with relapsed acute promyelocytic leukemia (APL) were treated. Three, each in first relapse and at least year from the last exposure to oral ATRA, achieved a complete response (CR). Disease recurred in two (one at 3 months despite maintenance L-ATRA and similarity in tretinoin AUC on days 1 and 85, and the other at 5 months, 2 months after discontinuation of L-ATRA) and the third was transplanted 1 month into CR. The three nonresponders were in at least a second relapse and failed to respond to oral ATRA before or immediately after receiving L- ATRA. Severe toxicity developed in three of eight patients treated at 175 mg/m2 (joint pains in two, skin in one). The maximum tolerated dose (MTD) was determined to be 140 mg/m2, at which dose grade 2 toxicity (primarily headache and skin) occurred in eight of eight patients, but grade 3 to 4 toxicity in none. Compared with oral ATRA, L-ATRA apparently results in greater exposure to tretinoin and for a longer time.
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“In the last application, the remission rate (67% clinical remission) was lower than that obtained using a combinatorial therapy (77% clinical remission), which included oral administration of ATRA plus idarubicin and thus the liposomal formulation was not further evaluated.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [70]
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“For example, a liposomal-based formulation of RA (monotherapy) was successfully tested in patients with facial acne71 and refractory hematological malignancies in a phase II clinical trial70.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [70]
In the citing paper
“In vivo tests showed that rats49 or human patients70 treated with ATRA-containing liposomes by intravenous administration had no decrease in plasma ATRA levels while animals/humans treated with oral formulation of ATRA (nonliposomal) had a significant decrease in plasma ATRA levels41,49.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [70]
In the citing paper
“Both formulations were safe in human trials.”
From Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine (2020) · cites this paper as [70]
Citations
Cites
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Clinical pharmacology of oral all-trans retinoic acid in patients with acute promyelocytic leukemia.
Muindi, J. R., Frankel, S. R., Huselton, C. A., DeGrazia, F., Garland, W., Young, C. W., & Warrell, R. P. (1992) · PubMed · Cited by 286
All-trans Retinoic Acid for Acute Promyelocytic Leukemia: Results of the New York Study
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A Comparison of Some Approximate Confidence Intervals for the Binomial Parameter
Ghosh, B. K. (1979) · Journal of the American Statistical Association · doi:10.1080/01621459.1979.10481051 · Cited by 130
Pharmacokinetics of oral all-trans retinoic acid in patients with acute promyelocytic leukemia.
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Drach, J. W., Lopez‐Berestein, G., McQueen, T., Andreeff, M., & Mehta, K. (1993) · PubMed · Cited by 70
Self-citationLiposome encapsulation circumvents the hepatic clearance mechanisms of all-trans-retinoic acid
Mehta, K., Sadeghi, T., McQueen, T., & Lopez-Berestein, G. (1994) · Leukemia Research · doi:10.1016/0145-2126(94)90040-x · Cited by 67
Self-citationAll-Trans-Retinoic Acid Treatment for Patients with Acute Promyelocytic Leukemia
Degos, L., Chomienne, C., Daniel, M., Berger, R., & Castaigné, S. (2015) · KARGER eBooks · doi:10.1159/000420332 · Cited by 64
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Use of arsenic trioxide (As2O3) in the treatment of patients with acute promyelocytic leukemia
Lazo, G., Kantarjian, H. M., Estey, E. H., Thomas, D. A., O'Brien, S. M., & Cortes, J. E. (2003) · Cancer · doi:10.1002/cncr.11314 · Cited by 493
Self-citationNew trends in encapsulation of liposoluble vitamins
Gonnet, M., Lethuaut, L., & Boury, F. (2010) · Journal of Controlled Release · doi:10.1016/j.jconrel.2010.01.037 · Cited by 351
Retinoids and their receptors in cancer development and chemoprevention
Sun, S., & Lotan, R. (2002) · Critical Reviews in Oncology/Hematology · doi:10.1016/s1040-8428(01)00144-5 · Cited by 324
Solid lipid nanoparticles (SLNs) to improve oral bioavailability of poorly soluble drugs
Hu, L., Tang, X., & Cui, F. (2004) · Journal of Pharmacy and Pharmacology · doi:10.1211/0022357044959 · Cited by 281
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Metadata
- Authors
- Estey, E., Thall, P., Mehta, K., Rosenblum, M., Brewer, T. J., Simmons, V, Cabanillas, F., Kurzrock, R., & Lopez-Berestein, G.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Department of Hematology, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 1996-05-01
- Volume
- 87
- Issue
- 9
- Pages
- 3650-3654
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- OpenAlex
- W2413626681
- Cited by
- 66
- References
- 16
- Citations by year
- 2023: 1 · 2021: 1 · 2020: 1 · 2018: 2 · 2015: 2 · 2013: 2 · 2012: 1
- FWCI
- 1.39
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Blood (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Food and Drug Administration (FDA-01-000923)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Retinoids in leukemia and cellular processes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Keywords
- all-trans retinoic acid, pharmacokinetics, refractory hematologic malignancies, acute promyelocytic leukemia, relapsed APL, dose escalation, maximum tolerated dose, drug toxicity, drug exposure
- MeSH terms
- Drug Carriers, Hematologic Diseases, Humans, Liposomes, Neoplasms, Recurrence, Tretinoin, Leukemia, Myeloid, Acute
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