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

Abstract

7328 Background: Oral vinorelbine (O-VNR), administered weekly until PD, has shown good activity as 1st-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 2nd-line setting of NSCLC elderly pts relapsed after front-line treatment. Methods: From Aug 2003 till Oct 2004, 18 consecutive elderly pts (>70y) with advanced NSCLC progressing after first-line therapy received O-VNR 60 mg/m2 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. Results: 47 cy...