Phase II trial of dose intensification with cisplatin and carboplatin plus vindesine in patients with inoperable non-small cell lung cancer.
We conducted a phase II trial of a regimen that combined cisplatin (CDDP), carboplatin (CBDCA), and vindesine (VDS) in previously untreated patients with non-small cell lung cancer (NSCLC) to evaluate the efficacy and safety of the regimen. Thirty-five patients with inoperable NSCLC entered the study. Cisplatin (CDDP 80 mg/m2) was administered on day 1, and CBDCA 100 mg/m2 and VDS 2 mg/m2) were administered on days 2, 3, and 8. We observed one complete response (CR) and 16 partial responses (PR), with a total response rate of 49% [95% confidence interval (CI) 31-66%]. The overall median survival was 58 weeks; the 1-year survival rate was 60%, and the 2-year survival rate was 23%. Major toxicities were hematologic; leukopenia of grades 3 and 4 occurred in 66% patients, and thrombocytopenia occurred in 23%. Therefore, the dose-intensified regimen of CDDP, CBDCA, and VDS was active in treating patients with inoperable NSCLC, with demonstration of a favorable median survival time.
Nakanishi
Y
Y
Research Institute for Diseases of the Chest, Faculty of Medicine, Kyushu University, Fukuoka, Japan.
Takayama
K
K
Kawasaki
M
M
Yatsunami
J
J
Inutsuka
S
S
Wakamatsu
K
K
Tsuruta
N
N
Hara
N
N
D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011994:Recombinant Proteins; D012074:Remission Induction; D012449:Safety; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced; D014751:Vindesine / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced
D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D016190:Carboplatin; D002945:Cisplatin; D014751:Vindesine