title: Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: a North Central Cancer Treatment Group Study.
abstract: Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m2 plus carboplatin 300 mg/m2 vs. cyclophosphamide 600 mg/m2 plus carboplatin 600 mg/m2, each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 micrograms/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
authors.forename: J H
authors.initials: JH
authors.lastname: Edmonson
authors.forename: V J
authors.initials: VJ
authors.lastname: Suman
authors.forename: R J
authors.initials: RJ
authors.lastname: Dalton
authors.forename: W C
authors.initials: WC
authors.lastname: Bro
authors.forename: M M
authors.initials: MM
authors.lastname: Gallenberg
authors.forename: H J
authors.initials: HJ
authors.lastname: Long
authors.forename: R
authors.initials: R
authors.lastname: Levitt
authors.forename: A K
authors.initials: AK
authors.lastname: Hatfield
authors.forename: J E
authors.initials: JE
authors.lastname: Krook
authors.forename: J A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: J B
authors.initials: JB
authors.lastname: Gerstner
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044383:Black People; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D015146:Midwestern United States; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D015996:Survival Rate; D044465:White People; D001741:Black or African American
chemical_list: D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; C082430:molgramostim; D016190:Carboplatin