An alternative schedule of oral vinorelbine tested as 2-line treatment on elderly patients with advanced non-small cell lung cancer (NSCLC): A phase I feasibility trial.

7328 Background: Oral vinorelbine (O-VNR), administered weekly until PD, has shown good activity as 1-line treatment in elderly pts (RR:11%, MST 8.2 mos), though G3-4 neutropenia and G1-2 diarrhea were reported in 50% and 33% of pts respectively (Gridelli, Eur J Cancer 2004). Therefore, in the attempt to reduce toxicity, we performed this phase I study to test an alternative schedule of O-VNR, administered 2 weeks out of 3, in 2-line setting of NSCLC elderly pts relapsed after front-line treatment.,From Aug 2003 till Oct 2004, 18 consecutive elderly pts (>70y) with advanced NSCLC progressing after first-line therapy received O-VNR 60 mg/m dd 1,8 every 3 wks. Pts' characteristics were as follows: median age 74 y (range 70-79), gender M/F 83%/17%, histology adeno/squamous/undiff. 33%/50%/17%, ECOG PS 0/1/2 5%/72%/22%. First-line chemotherapy: carboplatin-based doublets in fit pts (73%), single agent gemcitabine in frail pts (27%). Response was assessed after 3 cycles of therapy.,47 cycles of O-VNR were administered (median 3 cycles). Grade 3-4 neutropenia was recorded in 1 pt (5%), G3 paresthesias in 1 pt (5%). Serious adverse events requiring hospitalization were reported in 2 pts (G3 diarrhea, arrhythmia). Other toxicities were mild (G1-2): anemia (16%), diarrhea (11%), constipation (5%). No PR was observed. SD was maintained in 33% of pts, while 66% of pts. underwent PD. Median TTP: 2.5 mos; actuarial median OS (events:61%): 4 mos. Evaluation of clinical benefit is ongoing.,The weekly schedule of O-VNB is not convenient for elderly patients with advanced NSCLC. Tested in this 2-line setting, O-VNR administered 2 weeks out of 3, was a feasible treatment. If compared to other schedules toxicity is remarkably reduced, though activity is poor. An evaluation in 1-line setting on advanced NSCLC elderly patients is thus required. No significant financial relationships to disclose.