Moderate dose-intensive chemotherapy for patients with non-small cell lungcancer: Randomized trial, can it improve survival of patients with good performance status?

Advanced non-small cell lung cancer (NSCLC) has proven to be remarkably res istant to standard chemotherapy regimens. One potential alternative approac h is the use of dose-intensive chemotherapy with supportive therapy such as granulocyte-colony stimulating factor (G-CSF). We conducted a randomized s tudy of dose-intensive cisplatin/vindesine/ mitomycin C chemotherapy (DI-PV M) and standard cisplatin/ vindesine/mitomycin C chemotherapy (PVM). A tota l of one hundred patients with III-IV NSCLC was randomized. The DI-PVM cons isted of 3 cycles of cisplatin: 80 mg/m(2) (day 1), vindesine: 3 mg/m2 (day s 1 and 8) and mitomycin C: 8 mg/m(2) (day 1) in 3-week intervals with conc urrent G-CSF. The PVM consisted of 2 cycles of the same chemotherapy in 4-w eek intervals. Blood cell counts were checked twice a week, and G-CSF (2 mu g/kg, SC) was administered when the count was less than or equal to 2000/m u l. Eligibility criteria for this study were: no previous therapy, no acti ve concomitant malignancy, ECOG PS < 1, age less than or equal to 75 and ad equate hematologic functions. The response rate for DI-PVM (26/50, 52%) was not significantly higher than that for PVM (22/50, 44%, chi(2); 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 v ersus 37.7 weeks, generalized Wilcoxon test; p=0.036). In addition, the dif ference in survival of patients with metastatic disease was significant (DI -PVM versus PVM) 48.9 weeks versus 23.9; p=0.032). Multivariate analysis sh owed that only ECOG PS was an independent prognostic variable in predicting response:and survival on DI-PVM regimen. Hematological and non-hematologic al toxicities were equally frequent. The DI-PVM archived a longer survival than the PVM. The DI-PVM regimen should be considered a standard regimen fo r patients with metastatic NSCLC.