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Gemcitabine - vinorelbine regimen
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Lung Cancer News |
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Lung Cancer |
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Abstract: Phase I/II study of gemcitabine plus vinorelbine as first-line
chemotherapy of non-small-cell lung cancer.
PURPOSE: To determine the maximum-tolerated dose of gemcitabine when
combined with a fixed dose of vinorelbine in the treatment of non-small-cell
lung cancer (NSCLC) and to evaluate in a phase II trial the activity of
this combination. PATIENTS AND METHODS: Sixty-eight patients with stage
IIIB/IV NSCLC were treated with vinorelbine at fixed dose of 30 mg/m(2)
intravenously and gemcitabine at increasing dose levels from 800 to 1,500
mg/m(2) intravenously on days 1 and 8 every 3 weeks. RESULTS: In phase I,
dose-limiting toxicity occurred at the dosage of 1,500 mg/m(2) gemcitabine,
with three of five patients developing grade 4 thrombocytopenia. In phase
II, with gemcitabine at 1,200 mg/m(2), 19 (36%) of 52 assessable patients
responded. Objective response was observed in 11 (39%) of 28 patients with
stage IIIB disease and in eight (33%) of 24 patients with stage IV. The
median time to progression was 29 weeks (range, 2 to 41 weeks; 35 weeks
and 16 weeks for stages IIIB and IV, respectively), and median survival
was 54 weeks (range, 2 to 84+ weeks; 63 weeks and 42 weeks for stages IIIB
and IV, respectively). One-year survival was 64% for patients with stage
IIIB disease and 29% for those with stage IV. Clinical benefit response
was observed in 29 (59%) of 49 assessable patients. Grade 4 leukopenia and
thrombocytopenia were uncommon (6% and 8% of cases, respectively); however,
grade 3/4 leukothrombocytopenia occurred more frequently in patients aged
more than 70 years (52% and 24%, respectively). CONCLUSION: The combination
of vinorelbine and gemcitabine is effective and tolerable in the treatment
of NSCLC, thus deserving randomized trials with cisplatin combination regimens.
References
Lorusso V, Carpagnano F, Frasci G, Panza N, Di Rienzo G, Cisternino ML,
Napoli G, Orlando S, Cinieri S, Brunetti C, Palazzo S, De Lena M. Phase
I/II study of gemcitabine plus vinorelbine as first-line chemotherapy of
non-small-cell lung cancer. J Clin Oncol. 2000 Jan;18(2):405-11.

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Gemcitabine....... 1200 mg / M2 IV days 1, 8
Vinorelbine....... 30 mg / M2 IV days 1, 8
FREQUENCY every 21 days
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