Gemcitabine-oxaliplatin combination for ovarian cancer resistant to taxane-platinum treatment: a phase II study from the GINECO group.
Advanced ovarian carcinoma in early progression (<6 months) (AOCEP) is considered resistant to most cytotoxic drugs. Gemcitabine (GE) and oxaliplatin (OXA) have shown single-agent activity in relapsed ovarian cancer. Their combination was tested in patients with AOCEP in phase II study. Fifty patients pre-treated with platinum-taxane received q3w administration of OXA (100 mg m(-2), d1) and GE (1000 mg m(-2), d1, d8, 100-min infusion). Patient characteristics were a : median age 64 years (range 46-79),and 1 (84%) or 2 (16%) earlier lines of treatment. Haematological toxicity included grade 3-4 neutropaenia (33%), anaemia (8%), and thrombocytopaenia (19%). Febrile neutropaenia occurred in 3%. Non-haematological toxicity included grade 2-3 nausea or vomiting (34%), grade 3 fatigue (25%),and grade 2 alopecia (24%). Eighteen (37%) patients experienced response. Median progression-free (PF) and overall survivals (OS) were 4.6 and 11.4 months, respectively. The OXA-GE combination has high activity and acceptable toxicity in AOCEP patients. A comparison of the doublet OXA-GE with single-agent treatment is warranted.
Ray-Coquard
I
I
Centre Léon Bérard, 28 rue Laennec, 69008 Lyon, France. ray@lyon.fnclcc.fr
Weber
B
B
Cretin
J
J
Haddad-Guichard
Z
Z
Lévy
E
E
Hardy-Bessard
A C
AC
Gouttebel
M C
MC
Geay
J-F
JF
Aleba
A
A
Orfeuvre
H
H
Agostini
C
C
Provencal
J
J
Ferrero
J M
JM
Fric
D
D
Dohollou
N
N
Paraiso
D
D
Salvat
J
J
Pujade-Lauraine
E
E
D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D000077150:Oxaliplatin; D010984:Platinum / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D003841:Deoxycytidine; C080625:taxane; D010984:Platinum; D000093542:Gemcitabine