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* * * * * * The efficacy of a standard Plat.-based therapy with the convenience of CBDCA Attention ph III et ph II * * * * In conclusion, this study showed that substitution of i.v. vinorelbine by its oral formulation on days 1 and 8 in combination with cisplatin, based on a 3-week schedule, maintains the efficacy and the safety of the standard well-known i.v. regimen. As previously emphasized, the safety profile of such combination regimen used for the treatment of elderly patients, presenting significant co-morbidities, should be carefully weighed. The possible occurrence of grade 3-neutropenia, albeit brief and uncomplicated in most instances, suggests it is best to use a starting dose of 60 mg/m2 and neutrophils monitoring, before increasing dosage [9]. The administration of the oral formulation increases the patient comfort by reducing the time spent in hospital for the follow-up of cancer therapy. A desirable approach would be a fully oral vinorelbine regimen, in combination with another active oral agent. Such ambulatory administered regimen would be clearly a very welcome development in the palliative setting of NSCLC, provided its safety and efficacy are similar to standard i.v. combinations. * * * NVB Oral: 60 mg/m2/w x3 then 80 mg/m2/w versus NVB I.V.: 30 mg/m2/w Stage IIIB-IV PS 0-1 No history of malabsorption Jassem, Ann Oncol 2001 NAVELBINE I.V. versus ORAL RANDOMISED PHASE II STUDY NAVELBINE I.V. versus ORAL Regimen mg/m2 weekly I.V. 30 Oral 60 /80 n 30 76 OR (%) 11 12 Disease control 48 52 PFS (months) 2.1 3.2 MS (months) 7.9 9.3 Neutropenia G3/4(%) 62 46 Jassem, Ann Oncol 2001 Single agent Gridelli et al JNCI 1999, p = 0.04 6.2 4.7 0 2 4 6 8 10 12 CHEMOTHERAPY REGIMEN MEDIAN SURVIVAL IN MONTHS: Vinorelbine Supportive Care Kelly J Clin Oncol 2001; Survival: 1 YR 36%/38%, 2 YR 15%/16%; Resp Rate: 28%/25% 8 8 0 2 4 6 8 10 12 CHEMOTHERAPY REGIMEN MEDIAN SURVIVAL IN MONTHS: Vinorelbine + DDP Paclitaxel + Carbo Kelly J Clin Oncol 2001. (N
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