TY - JOUR
T1 - A proper schedule of weekly paclitaxel and gemcitabine combination is highly active and very well tolerated in NSCLC patients
AU - De Pas, Tommaso
AU - Putzu, Carlo
AU - Curigliano, Giuseppe
AU - Noberasco, Cristina
AU - Sabrina, Boselli
AU - Catania, Chiara
AU - Orlando, Laura
AU - Milani, Alessandra
AU - Spaggiari, Lorenzo
AU - de Braud, Filippo
PY - 2006/12
Y1 - 2006/12
N2 - 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 1500 mg/m2 and TAX 100 mg/m2 was selected for phase II studies due to its predictable kinetic behaviour and less severe thrombocytopenia. Patients and methods: Fifty-four chemo-naïve patients with advanced NSCLC (53 patients: stage IV) received TAX (100 mg/m2 i.v. infusion over 1 h) followed by GEM 1500 mg/m2 over 30 min) 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 10.4 ms (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-naïve NSCLC patients and confirms the low toxicity profile already observed in a previous phase I study.
AB - 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 1500 mg/m2 and TAX 100 mg/m2 was selected for phase II studies due to its predictable kinetic behaviour and less severe thrombocytopenia. Patients and methods: Fifty-four chemo-naïve patients with advanced NSCLC (53 patients: stage IV) received TAX (100 mg/m2 i.v. infusion over 1 h) followed by GEM 1500 mg/m2 over 30 min) 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 10.4 ms (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-naïve NSCLC patients and confirms the low toxicity profile already observed in a previous phase I study.
KW - Gemcitabine
KW - NSCLC
KW - Paclitaxel
KW - Weekly administration
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U2 - 10.1016/j.lungcan.2006.08.016
DO - 10.1016/j.lungcan.2006.08.016
M3 - Article
C2 - 17028052
AN - SCOPUS:33750368586
VL - 54
SP - 359
EP - 364
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 3
ER -