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.
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.
Fayette
Jérôme
J
Centre Léon Bérard, Département de Médecine & Inserm U590, Université de Lyon, 28 rue Laennëc, 69008, Lyon, France. fayette@lyon.fnclcc.fr
Penel
Nicolas
N
Chevreau
Christine
C
Blay
Jean-Yves
JY
Cupissol
Didier
D
Thyss
Antoine
A
Guillemet
Cécile
C
Rios
Maria
M
Rolland
Frédéric
F
Fargeot
Pierre
P
Bay
Jacques Olivier
JO
Mathoulin-Pelissier
Simone
S
Coindre
Jean Michel
JM
Bui-Nguyen
Binh
B
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
D003606:Dacarbazine; D004317:Doxorubicin; D007069:Ifosfamide