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De Pas, T. et al.

De Pas, Putzu, Curigliano, Noberasco, Sabrina, Catania, Orlando, Milani, Spaggiari, de Braud,

A proper schedule of weekly paclitaxel and gemcitabine combination is highly active and very well tolerated in NSCLC patients.

BACKGROUND: In a previous phase I dose-escalation study, we showed a weekly administration of paclitaxel (TAX) and gemcitabine (GEM) to be active and very well tolerated in non-small-cell lung cancer (NSCLC) patients, with the lack of interaction between drugs. The dose of GEM 1500mg/m(2) and TAX 100mg/m(2) was selected for phase II studies due to its predictable kinetic behaviour and less severe thrombocytopenia. PATIENTS AND METHODS: Fifty-four chemo-na??ve patients with advanced NSCLC (53 patients: stage IV) received TAX (100mg/m(2) i.v. infusion over 1h) followed by GEM 1500mg/m(2) over 30min) on days 1, 8, 15 and 21 of a 28-day cycle. RESULTS: The objective response rate was 46% (95% CI 32-61), median OS of 10.4ms (95% CI 6.5-4.3), and a 1-year survival rate of 53%. Grades 3 and 4 haematological toxicity consisted of non-febrile neutropenia and thrombocytopenia in 13 and 4% of the cycles, respectively. Grade 3 non-haematological toxicities were observed in three patients (asthenia, diarrhoea and neuropathy), and were always reversible. CONCLUSIONS: This weekly schedule of TAX and GEM is highly active in chemo-na??ve NSCLC patients and confirms the low toxicity profile already observed in a previous phase I study.[1]

References

A proper schedule of weekly paclitaxel and gemcitabine combination is highly active and very well tolerated in NSCLC patients. De Pas, T., Putzu, C., Curigliano, G., Noberasco, C., Sabrina, B., Catania, C., Orlando, L., Milani, A., Spaggiari, L., de Braud, F. Lung Cancer (2006) [Pubmed]

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