title: A prospective study of P-IMVP-16/CBDCA: a novel salvage chemotherapy for patients with aggressive non-Hodgkin's lymphoma who had previously received CHOP therapy as first-line chemotherapy.
abstract: The purpose of this study was to determine the efficacy of salvage chemotherapy with, P-IMVP-16/CBDCA, consisting of carboplatin (CBDCA), etoposide (VP-16), ifosfamide (IFM), and methotrexate (MTX), for patients with aggressive non-Hodgkin's lymphoma (NHL) who had previously received CHOP [a regimen of cyclophosphamide, hydroxydaunomycin, Oncovin (vincristine), and prednisolone], as first-line chemotherapy. The 45 consecutively enrolled patients received methylprednisolone (mPSL) 1000 mg per body for 3 d (from day 1 to day 3), IFM 1000 mg/m(2) for 5 d (from day 1 to day 5), MTX 30 mg/m(2) on day 3 and day 10, VP-16 80 mg/m(2) for 3 d (from day 1 to day 3), and CBDCA 300 mg/m(2) on day 1, with granulocyte colony-stimulating factor every 21 d. Patients 70 yr of age or older were given 75% of the standard dose. The response rate [complete response (CR) plus partial response (PR)] was 55.6% (25/45), including 12 (26.7%) CR and 13 (28.9%) PR. The overall survival rate for the 45 patients was 31.1% at 1 yr and 17.3% at 2 yr. The failure-free survival rate for the 45 patients was 6.7% at 1 yr and 4.4% at 2 yr. The survival rate for the 25 responders was 48.0% at 1 yr and 24.0% at 2 yr, and the survival rate for the 20 non-responders was 10.0% at 1 yr (P<0.001). Multivariate analysis demonstrated that prior chemotherapy (reduced-dose CHOP for age 70 yr or older) and the number of cases of extranodal involvement (>1) were significant unfavorable factors for overall survival. Although the major toxicity was neutropenia, no patient died of infection related to neutropenia. Non-hematological adverse effects were predominantly mild and tolerable. Unfortunately, the clinical outcome with P-IMVP-16/CBDCA was unfavorable, possibly because the study comprised consecutive patients who had received identified intensive chemotherapy, such as biweekly CHOP. Salvage chemotherapy with P-IMVP-16/CBDCA is not sufficient to cure relapsed or refractory aggressive NHL. Aggressive NHL should be cured by first-line chemotherapy with or without hematopoietic stem cell transplantation.
authors.affiliation: First Department of Internal Medicine, Gifu University School of Medicine, Gifu, Japan.
authors.forename: Michio
authors.initials: M
authors.lastname: Sawada
authors.forename: Hisashi
authors.initials: H
authors.lastname: Tsurumi
authors.forename: Toshiki
authors.initials: T
authors.lastname: Yamada
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hara
authors.forename: Kenji
authors.initials: K
authors.lastname: Fukuno
authors.forename: Hideko
authors.initials: H
authors.lastname: Goto
authors.forename: Masahito
authors.initials: M
authors.lastname: Shimizu
authors.forename: Senji
authors.initials: S
authors.lastname: Kasahara
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Kanemura
authors.forename: Masami
authors.initials: M
authors.lastname: Oyama
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Takami
authors.forename: Hisataka
authors.initials: H
authors.lastname: Moriwaki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008228:Lymphoma, Non-Hodgkin / Q000145:classification / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D013997:Time Factors; D017211:Treatment Failure; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D005047:Etoposide; D004317:Doxorubicin; D003520:Cyclophosphamide; D016190:Carboplatin; D007069:Ifosfamide; D011241:Prednisone; D008775:Methylprednisolone; D008727:Methotrexate