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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
9
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pubmed:dateCreated |
1984-10-18
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pubmed:abstractText |
Forty-seven patients with recurrent or metastatic head and neck squamous cancer were entered into a prospectively controlled study comparing high-dose infusion methotrexate with leucovorin against standard-dose methotrexate without leucovorin. Patients were stratified for prior treatment and hematogenous metastases prior to randomization. Patients received either methotrexate (1,500 mg/m2) infused over 24 hours with leucovorin or 40 mg/m2 intramuscularly. Each treatment was given weekly for the first six weeks and followed a dose escalation schedule to toxicity. After six weeks patients received the high-dose regimen every two weeks and the low-dose schedule continued weekly. One patient was ineligible and four had inadequate follow-up to assess response (less than two weeks). Forty-two patients were evaluable for survival and 37 for response. Six of 19 patients (32%) treated with high-dose infusion responded (one complete response) and four of 18 patients (22%) receiving standard dosage responded (P = .52). Treatment with high-dose methotrexate resulted in an improved duration of disease control over standard dosage with the respective median times to progression of 11 weeks and five weeks (P = .04). These differences were most marked in good performance status patients (P = .007) and those without hematogenous dissemination (P = .02). Toxicity, however, was also significantly worse in the high-dose treatment group (P = .01) and survival was identical between treatments (4.2 months). The authors conclude that any treatment advantage to high-dose methotrexate may be attributable to its greater toxicity rather than to a selective therapeutic effect and this regimen does not result in improved patient survival. Good performance status patients may benefit from more aggressive therapy.
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pubmed:grant | |
pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Sep
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pubmed:issn |
0732-183X
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
2
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
1006-11
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pubmed:dateRevised |
2007-11-14
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pubmed:meshHeading |
pubmed-meshheading:6332178-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:6332178-Drug Administration Schedule,
pubmed-meshheading:6332178-Female,
pubmed-meshheading:6332178-Head and Neck Neoplasms,
pubmed-meshheading:6332178-Humans,
pubmed-meshheading:6332178-Infusions, Parenteral,
pubmed-meshheading:6332178-Injections, Intramuscular,
pubmed-meshheading:6332178-Leucovorin,
pubmed-meshheading:6332178-Male,
pubmed-meshheading:6332178-Methotrexate,
pubmed-meshheading:6332178-Middle Aged,
pubmed-meshheading:6332178-Neoplasm Metastasis,
pubmed-meshheading:6332178-Prognosis,
pubmed-meshheading:6332178-Random Allocation
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pubmed:year |
1984
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pubmed:articleTitle |
A randomized comparison of high-dose infusion methotrexate versus standard-dose weekly therapy in head and neck squamous cancer.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Research Support, U.S. Gov't, P.H.S.,
Randomized Controlled Trial
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