Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
9
pubmed:dateCreated
1989-9-27
pubmed:abstractText
In this phase II trial, 105 eligible patients with no prior chemotherapy and advanced sarcoma received doxorubicin, ifosfamide, and dacarbazine (DTIC) with mesna uroprotection (MAID). Starting doses of these drugs were 60, 7,500, and 900 mg/m2 divided over 72 hours by continuous infusion, respectively. Mesna was given for 84 to 96 hours at 2,500 mg/m2/d. Myelosuppression was dose limiting, causing the only toxic death (sepsis). Nonhematologic toxicity consisted predominantly of anorexia and vomiting. Severe mucositis, macroscopic hematuria, renal tubular acidosis, renal failure, and CNS toxicity occurred in less than 5% of cycles. No cardiotoxicity was detected. The overall response rate (10% complete response [CR]) was 47% (95% confidence intervals, 5% to 18% and 37% to 57%, respectively). Most responses (approximately 70%) were observed within two cycles. Median times to progression were 10 and 9 months, respectively. Histologic high tumor grade, lesions less than 5 cm, and less than 1 year from diagnosis to study entry correlated with the probability of response. The median survival was 16 months. Time from diagnosis to study entry, performance status, and extent of disease, but not histologic grade, correlated with survival. Following CR, two patients remain disease-free at 32 and 16 months. Of the 15 additional patients rendered disease-free with surgery, two remain disease-free at 30 and 18 months with no further therapy. While most relapses occurred in sites of prior involvement, death from CNS metastases occurred in 11 of the 80 patients with high-grade sarcomas, of whom seven were still responding systematically (three complete responders). Because of its substantial response in this phase II trial, the MAID regimen is being compared with doxorubicin and DTIC alone in advanced sarcomas and to observation in the adjuvant treatment of high-grade sarcomas in randomized trials.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
0732-183X
pubmed:author
pubmed:issnType
Print
pubmed:volume
7
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1208-16
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed-meshheading:2504890-Actuarial Analysis, pubmed-meshheading:2504890-Adult, pubmed-meshheading:2504890-Aged, pubmed-meshheading:2504890-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:2504890-Bone Neoplasms, pubmed-meshheading:2504890-Brain Neoplasms, pubmed-meshheading:2504890-Clinical Trials as Topic, pubmed-meshheading:2504890-Dacarbazine, pubmed-meshheading:2504890-Doxorubicin, pubmed-meshheading:2504890-Drug Administration Schedule, pubmed-meshheading:2504890-Drug Evaluation, pubmed-meshheading:2504890-Female, pubmed-meshheading:2504890-Humans, pubmed-meshheading:2504890-Ifosfamide, pubmed-meshheading:2504890-Male, pubmed-meshheading:2504890-Mesna, pubmed-meshheading:2504890-Middle Aged, pubmed-meshheading:2504890-Remission Induction, pubmed-meshheading:2504890-Sarcoma, pubmed-meshheading:2504890-Soft Tissue Neoplasms, pubmed-meshheading:2504890-Spinal Cord Neoplasms
pubmed:year
1989
pubmed:articleTitle
Response to mesna, doxorubicin, ifosfamide, and dacarbazine in 108 patients with metastatic or unresectable sarcoma and no prior chemotherapy.
pubmed:affiliation
Division of Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't