CDDP+NVB association chemotherapy in stage III-IV NSCLC. Results of a phase-2 study

North Milan Group presents a phase II study, including CDDP+NVB combination therapy, conducted between April 1992 and September 1994 on 115 patients (pts) with NSCLC. Pts characteristics are: Stage IIIa: 21, IIIb: 54, IV: 40; Median age: 63 (range: 40–74); PS: ECOG 0– 1 (Karnofsky 100–80): Male/Female: 103/12; Squamous Cell Carcinoma; 61, Adenocarcinoma: 42, Large Cell Carcinoma: 12; No Weight loss ≥ 10%. All pts were previously untreated and showed measurable disease. Cisplatin (CDDP) 80 mg/mg on day 1 + Vinorelbine (NVB) 25 mg/mg on day 1 and 8 were administered intravenously every 21 days, for 3 standard courses in all. Toxicities were evaluated after every course, responses after 3 cycles. Pts evaluable for response were 111/115 (2 pts died before the last cycle of chemotherapy, 2 pts were lost at follow-up). Objective responses (CR+PR) were documented in 58 pts (overall response rate 52.2%): 29 NC (26.3%), 24 P (21.8%). Among stage-III pts, 33 PR and 12 NC received radiotherapy on the chest; 8 pts in all received palliative radiotherapy on methastatic bone lesions. Ten pts (6 IlIA and 4 IIIB) were reconducted to surgical treatment: 7 pneumonectomies, 2 lobectomies and 1 segmentectomy were performed. Medical time to progression (TTP) was 7 months (ms). Medical survival time (MST) ranged from 4 to 30 ms: in particular it was 14 ms for PR, 7 ms for NC, 6 ms for P pts. Median survival rate is 10 ms. 34 pts are now alive: 26 pts at 12 ms or more, 4 pts at 24 ms or more. Cycles administrated in all were 353; 17 cycles (5%) were postponed because of intercurrent neutropenia 10% was ever recorded. Quality of life was reported as obtimal during all the treatment. We conclude this CDDP+NVB trial shows evident validity in terms of activity, efficacy, tolerability and applicability in out patients. Survival increment and III-stages surgical reconduction are still modest, yet our results are totally comparable to others including Vinorelbine in two-three drugs association chemotherapy on NSCLC.