title: Moderate dose-intensive chemotherapy for patients with non-small cell lung cancer: randomized trial, can it improve survival of patients with good performance status?
abstract: Advanced non-small cell lung cancer (NSCLC) has proven to be remarkably resistant to standard chemotherapy regimens. One potential alternative approach is the use of dose-intensive chemotherapy with supportive therapy such as granulocyte-colony stimulating factor (G-CSF). We conducted a randomized study of dose-intensive cisplatin/vindesine/mitomycin C chemotherapy (DI-PVM) and standard cisplatin/vindesine/mitomycin C chemotherapy (PVM). A total of one hundred patients with III-IV NSCLC was randomized. The DI-PVM consisted of 3 cycles of cisplatin: 80 mg/m2 (day 1), vindesine: 3 mg/m2 (days 1 and 8) and mitomycin C: 8 mg/m2 (day 1) in 3-week intervals with concurrent G-CSF. The PVM consisted of 2 cycles of the same chemotherapy in 4-week intervals. Blood cell counts were checked twice a week, and G-CSF (2 microgram/kg, SC) was administered when the count was </=2000/microliter. Eligibility criteria for this study were: no previous therapy, no active concomitant malignancy, ECOG PS </=1, age </=75 and adequate hematologic functions. The response rate for DI-PVM (26/50, 52%) was not significantly higher than that for PVM (22/50, 44%, chi2; p=0.423). However, progression-free survival for patients on DI-PVM was significantly longer than that of patients on PVM (23.7 versus 13.9 weeks, log-rank and generalized Wilcoxon test; p=0.006), as was overall median survival (57.0 versus 37.7 weeks, generalized Wilcoxon test; p=0.036). In addition, the difference in survival of patients with metastatic disease was significant (DI-PVM versus PVM; 48.9 weeks versus 23.9; p=0.032). Multivariate analysis showed that only ECOG PS was an independent prognostic variable in predicting response and survival on DI-PVM regimen. Hematological and non-hematological toxicities were equally frequent. The DI-PVM archived a longer survival than the PVM. The DI-PVM regimen should be considered a standard regimen for patients with metastatic NSCLC.
authors.affiliation: First Department of Internal Medicine, Nihon University School of Medicine, Itabashi, Tokyo 173-8610, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Masutani
authors.forename: I
authors.initials: I
authors.lastname: Tsujino
authors.forename: T
authors.initials: T
authors.lastname: Fujie
authors.forename: M
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: K
authors.initials: K
authors.lastname: Miyagi
authors.forename: T
authors.initials: T
authors.lastname: Yano
authors.forename: N
authors.initials: N
authors.lastname: Takahashi
authors.forename: Y
authors.initials: Y
authors.lastname: Koya
authors.forename: T
authors.initials: T
authors.lastname: Horie
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000503:physiopathology; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D016019:Survival Analysis; D014751:Vindesine / Q000008:administration & dosage
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D016685:Mitomycin; D002945:Cisplatin; D014751:Vindesine