title: Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma.
abstract: Multidrug chemotherapy increases responses in advanced soft tissues sarcoma. Can a 20% increase of relative dose intensity of the MAID regimen, more improve responses? From 1994 to 1997, 162 patients were randomized in a phase III study to the conventional drug combination (6 cycles of MAID: 60, 7,500, 900 mg/m(2) for doxorubicin, ifosfamide and dacarbazine respectively), or at doses 20-33% higher per cycle (5 cycles of intensified MAID for similar cumulative doses) with systematic G-CSF. Primary endpoint was response rate; secondary were toxicity, event-free and overall survival. The objective response rate in assessable patients was 38% with intensified MAID and 35% with MAID (p = 0.72). Event-free and overall survivals were similar in both arms. Only grade 3-4 thrombocytopenia and anemia were significantly higher in intensified arm. Treatment with intensified MAID did not improve response rate neither survival and cannot be recommended for advanced or metastatic soft tissue sarcoma.
authors.affiliation: Centre Léon Bérard, Département de Médecine & Inserm U590, Université de Lyon, 28 rue Laennëc, 69008, Lyon, France. fayette@lyon.fnclcc.fr
authors.forename: Jérôme
authors.initials: J
authors.lastname: Fayette
authors.forename: Nicolas
authors.initials: N
authors.lastname: Penel
authors.forename: Christine
authors.initials: C
authors.lastname: Chevreau
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Blay
authors.forename: Didier
authors.initials: D
authors.lastname: Cupissol
authors.forename: Antoine
authors.initials: A
authors.lastname: Thyss
authors.forename: Cécile
authors.initials: C
authors.lastname: Guillemet
authors.forename: Maria
authors.initials: M
authors.lastname: Rios
authors.forename: Frédéric
authors.initials: F
authors.lastname: Rolland
authors.forename: Pierre
authors.initials: P
authors.lastname: Fargeot
authors.forename: Jacques Olivier
authors.initials: JO
authors.lastname: Bay
authors.forename: Simone
authors.initials: S
authors.lastname: Mathoulin-Pelissier
authors.forename: Jean Michel
authors.initials: JM
authors.lastname: Coindre
authors.forename: Binh
authors.initials: B
authors.lastname: Bui-Nguyen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D007890:Leiomyosarcoma / Q000188:drug therapy* / Q000473:pathology; D008080:Liposarcoma / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011379:Prognosis; D012208:Rhabdomyosarcoma / Q000188:drug therapy* / Q000473:pathology; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003606:Dacarbazine; D004317:Doxorubicin; D007069:Ifosfamide