First line oral vinorelbine in elderly patients with advanced non-small-cell lung cancer

Purpouse: The activity of vinorelbine (VRL) as single agent in treatment-naive inoperable non small cell cancer (NSCLC) patients (pts) has been assessed in several published studies. Oral and intravenous formulation have a linearity of VRL pharmacokinetics with both routes of administration. This is a study with oral VRL in first line advanced NSCLC in elderly pts. Patients and methods: A total of 12 chemonaive elderly pts ≥ 70 years were recruited from October 2005 through to June 2006. Principal inclusion criteria included histologically confirmed advanced NSCLC, performance status ≤ 2, measurable disease, appropriate bone marrow and organ function. The dosage schedule was 60 mg/m 2 once a week for three weeks (first cycle), followed if not toxicity by 80 mg/m 2 once a week, until disease progression or development of unacceptable toxicity. Results: The mean age was 74 years (range: 71 to 79), all males, and all pts stage IV. Histology subtypes: adenocarcinoma in 5 pts, largo cell carcinoma in 1 pts and squamous cell carcinoma in 6 pts. PS (ECOG) distribution was: 3 pts with PS 1, and 9 pts with PS 2. The median weekly VRL doses was 13 (range 3-23). Out of 11 pts receiving the second cycle, 7 patients went a dose escalation to 80 mg/m 2 . The other 4 pts remained at the 60 mg/m2 dose level. There were no complete responses (CR). Two (13%) of 12 patients achieved partial response (PR). There were 6 (50%) stable disease (SD) and 4 (34%) progressive disease (PD). Respect survival, the median follow-up was 4 months (range 1-9 months). Until date, the median survival time (MST) and median progression-free survival had not been reached; and survival and progression-free survival was 66% in both. Treatment with oral VRL in elderly patients was well tolerated, and there were no toxic deaths. No grade 4 toxicities were observed, and grade 3 toxicities were infrequent, exclusively neutropenia in 2 patients and asthenia in other 2 patients. Rest of toxicities were grade 1 or 2. Conclusions: Oral VRL appears to be a reasonable alternative intravenous VRL, both in terms of activity and tolerability in advanced, elderly NSCLC patients.