6MP and MTX

Message: To give 6MP and MTX _concurrently_ before bed is the right thing to do.
  1. E-mails
    Date: Mon, 23 Sep 2002 11:59:03 +1000 (EST)
    From: Jimmy
    Subject: Re: Question re MTX and 6MP
    
    To achieve the best possible result, we have been giving Neuton 6MP and
    MTX _concurrently_ before bed and at least two hours after food (on the
    day when he is due for MTX). Can you please confirm if we have been
    doing the right thing? Would 6MP interfere with the absorption of MTX?
    
    
    Date: Tue, 24 Sep 2002 09:36:05 +1000
    From: Dr P.
    Subject: Re: Question re MTX and 6MP
    
    Jimmy,
    
    The idea behind using 6-MP and MTX togther is that the 2 drugs enhance
    each other.  The crux of these articles was summarised in a lead
    article in the Journal of Clinical Oncology about 10 years ago (Cheson
    BD The Purine analogs - A Therapeutic Beauty Contest. J Clin Oncol 1992
    May 10(5); 861-7)
    
    What it boils down to is that using 6-MP is the best way of treating
    ALL in maintenance, and that the addition of even low dose MTX once a
    week will boost the effect of the 6-MP.  Giving the drugs concuurnetly
    like you have done is fine and the right way to go.  
  2. References
    1: Cancer Chemother Pharmacol 1996;37(5):409-14 Related Articles,  Links
      
    Clinical and experimental pharmacokinetic interaction between
    6-mercaptopurine and methotrexate.
    
    Innocenti F, Danesi R, Di Paolo A, Loru B, Favre C, Nardi M, Bocci G,
    Nardini D, Macchia P, Del Tacca M.
    
    Institute of Medical Pharmacology, University of Pisa, Italy.
    
    Clinical and experimental pharmacokinetic interaction between
    6-mercaptopurine (6-MP) and methotrexate (MTX) was investigated in
    patients as well as in rats and in HL-60 human leukemic cells. Ten
    children affected by acute lymphoblastic leukemia (ALL) in remission
    received daily doses of 6-MP given at 25 mg/m2 and i.v. infusion of
    high-dose MTX at 2 or 5 g/m2 once every other week. When 6-MP was given
    alone, the mean peak plasma concentration (Cmax) and area under the
    curve (AUC) of 6-MP were 72.5 ng/ml and 225.3 h ng ml(-1). Concurrent
    treatment with MTX at 2 or 5 g/m2 resulted in a mean increase of 108%
    and 121% in the Cmax and of 69% and 93% in the AUC, respectively. In
    rats treated with an oral dose of 6-MP at 75 mg/m2, MTX given i.p. at 5
    g/m2 produced mean increases of 110% and 230% in the Cmax and AUC of
    6-MP, respectively. In HL-60 human leukemic cells incubated with 6-MP at
    250 ng/ml, the cumulative intracellular concentration of 6-thioguanine
    and 6-MP nucleotides was not significantly modified by treatment with 20
    micrograms/ml of MTX. The present findings indicate that high-dose MTX
    enhances the bioavailability of 6-MP as evidenced by the observed
    increases in the plasma Cmax and AUC of 6-MP in humans and animals.
    
    PMID: 8599862 [PubMed - indexed for MEDLINE] 
    
    ------
    1: Clin Pharmacol Ther 1987 Apr;41(4):384-7 Related Articles,  Links
    
    The effect of methotrexate on the bioavailability of oral
    6-mercaptopurine.
    
    Balis FM, Holcenberg JS, Zimm S, Tubergen D, Collins JM, Murphy RF,
    Gilchrist GS, Hammond D, Poplack DG.
    
    Fourteen children (aged 3 to 14 years) with average-risk acute
    lymphoblastic leukemia were studied after an oral dose of
    6-mercaptopurine (6-MP) (75 mg/m2) administered alone and, on the next
    day, concurrently with oral methotrexate (20 mg/m2). When 6-MP was
    administered alone, both the peak plasma concentration (15 to 150 ng X
    ml-1) and the AUC (36 to 340 ng X ml-1 X hr) were highly variable.
    Concurrent methotrexate resulted in a 31% increase in the AUC (P less
    than 0.01) and a 26% increase in peak plasma levels (P less than 0.05)
    of 6-MP. The AUC of methotrexate correlated with the degree of increase
    in 6-MP plasma concentrations. These findings are consistent with
    previous in vitro studies demonstrating that methotrexate is an
    inhibitor of xanthine oxidase, the enzyme that catabolizes 6-MP to the
    inactive metabolite thiouric acid. Although the increases in 6-MP AUC
    and peak plasma concentrations resulting from concurrent methotrexate
    administration were statistically significant, this interaction is
    probably not clinically significant at standard low oral doses of
    methotrexate in light of the wide interpatient variability in these
    pharmacokinetic parameters of 6-MP.
    
    PMID: 3470165 [PubMed - indexed for MEDLINE]
    
    ------
    1: J Pediatr Hematol Oncol 1997 Mar-Apr;19(2):102-9 Related Articles,
    Books, LinkOut  
    
    Impact of morning versus evening schedule for oral methotrexate and
    6-mercaptopurine on relapse risk for children with acute lymphoblastic
    leukemia. Nordic Society for Pediatric Hematology and Oncology (NOPHO).
    
    Schmiegelow K, Glomstein A, Kristinsson J, Salmi T, Schroder H, Bjork O.
    
    Section of Clinical Hematology and Oncology, Juliane Marie Center,
    University Hospital, Copenhagen, Denmark.
    
    PURPOSE: To study the risk of non-B-cell acute lymphoblastic leukemia
    (ALL) relapse in relation to the routines of administration of oral
    methotrexate (MTX) and 6-mercaptopurine (6MP) and to the erythrocyte (E)
    levels of the intracellular cytotoxic metabolites, that is, MTX
    polyglutamates and 6-thioguanine nucleotides (E-MTX and E-6TGN).
    PATIENTS AND METHODS: E-MTX and E-6TGN levels were measured at least
    three times (medians, eight and nine) in 294 children with non-B-cell
    ALL during oral MTX and 6MP therapy. For each patient, we registered (a)
    the individual circadian schedule of drug administration and (b) the
    coadministration of food, and (c) calculated a mean (m) of all E-MTX and
    E-6TGN measurements and (d) the product of mE-MTX and mE-6TGN
    (mE-MTX*6TGN), due to their synergistic action. RESULTS: A total of 42
    patients were on a morning schedule, 219 were on an evening schedule,
    and 33 had miscellaneous routines. A total of 149 patients took the
    drugs with meals, 106 took the drugs between meals, and 39 had varying
    routines. With a median follow-up of 78 months, ALL has recurred in 66
    patients. The patients on an evening schedule had a superior outcome
    [probability of event-free survival (pEFS) = 0.82 +/- 0.03 vs. 0.57 +/-
    0.08; p = 0.0002], whereas the coadministration of food did not
    significantly influence outcome. Patients with a mE-MTX*6TGN < 813
    [product of median mE-MTX (4.7 nmol/mmol Hb) and mE-6TGN (173 nmol/mmol
    Hb)] had an inferior outcome (pEFS = 0.70 +/- 0.04 vs. 0.85 +/- 0.03; p
    = 0.003), even if only patients on an evening schedule were analyzed.
    Thus, 109 patients on the MTX/6MP evening schedule with an mE-MTX*6TGN <
    or = 813 (nmol/mmol Hb)2 had a pEFS of 0.89 +/- 0.03 and a probability
    of continuous hematopoietic remission of 0.91 +/- 0.03. CONCLUSIONS: An
    evening schedule should be recommended for oral MTX/6MP maintenance
    therapy. The value of individual dose adjustments by E-MTX and E-6TGN
    remains to be determined in prospective randomized trials.
    
    PMID: 9149738 [PubMed - indexed for MEDLINE] 
    
    ------
    1: Gen Pharmacol 1999 Oct;33(4):341-6 Related Articles,  Links  
      
    The interaction of 6-mercaptopurine (6-MP) and methotrexate (MTX).
    
    Giverhaug T, Loennechen T, Aarbakke J.
    
    Department of Pharmacology, Institute of Pharmacy, University of
    Tromso, Norway. trudeg@farmasi.uit.no
    
    The antimetabolites 6-mercaptopurine (6-MP) and methotrexate (MTX)
    are the cornerstones in the maintenance treatment of children's
    acute lymphoblastic leukemia (ALL). The biochemical mechanisms
    underlying the increased therapeutic efficacy of the combination of
    these drugs have not yet been elucidated. However, both drugs
    interact with important pathways. such as purine de novo synthesis
    (PDNS), purine salvage, and methylation reactions. A review of the
    mechanistic aspects of the interactions between 6-MP and MTX is
    given.
    
    Publication Types: 
    Review 
    Review, Tutorial 
    
    PMID: 10523073 [PubMed - indexed for MEDLINE]
    
    
JLI@IEEE.ORG. Sept 2002