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 1500 mg/m(2) and TAX 100 mg/m(2) was selected for phase II studies due to its predictable kinetic behaviour and less severe thrombocytopenia.


METHODS
Fifty-four chemo-naïve patients with advanced NSCLC (53 patients: stage IV) received TAX (100mg/m(2) i.v. infusion over 1h) followed by GEM 1500 mg/m(2) 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.
De Pas
Tommaso
T
New Drugs Development Unit, Italy. tommaso.de-pas@ieo.it <tommaso.de-pas@ieo.it>
Putzu
Carlo
C
Curigliano
Giuseppe
G
Noberasco
Cristina
C
Boselli
Sabrina
S
Sabrina
Boselli
B
Catania
Chiara
C
Orlando
Laura
L
Milani
Alessandra
A
Spaggiari
Lorenzo
L
de Braud
Filippo
F
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D017211:Treatment Failure; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine