Phase I study of ifosfamide plus high-dose epirubicin in advanced non-small-cell lung cancer.
The present phase I study was designed to determine the maximum tolerated dose (MTD) of epirubicin given in combination with ifosfamide at a dose of 3 g/m2, recycled every 4 weeks, in patients with advanced non-small-cell lung cancer (NSCLC). A total of 18 patients entered the study; they received the following four dose levels of epirubicin (i.v., day 1): 75 (6 patients), 90 (3 patients), 105 (3 patients, and 120 mg/m2 (6 patients). The MTD of epirubicin was 120 mg/m2, neutropenia being the dose-limiting toxicity. We observed 1/6, 1/3 1/3, and 2/6 partial responses (PRs) at epirubicin dose levels of 75, 90, 104, and 120 mg/m2, respectively. A phase II study of epirubicin given at a dose of 120 mg/m2, in association with conventional-dose ifosfamide in advanced NSCLC is in order.
Gridelli
C
C
Divisione di Oncologia Medica B Instituto Nazionale Tumori, Napoli, Italy.
Rossi
A
A
Incoronato
P
P
Bruni
G S
GS
Scognamiglio
F
F
Ruffolo
P
P
Rinaldi
L
L
Bianco
A R
AR
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D015251:Epirubicin; D007069:Ifosfamide