Abstract | BACKGROUND: METHODS: Chemo-naive patients with stages III and IV NSCLC and Karnofsky performance status >70 were assigned to receive either (a) gemcitabine 1000mg/m(2) plus vinorelbine 25mg/m(2) on days 1 and 8 for 2 cycles, followed by gemcitabine 1000mg/m(2) on days 1 and 8 plus ifosfamide 2000mg/m(2) on day 1 (GV-GI arm) for 2 cycles or (b) gemcitabine 1250mg/m(2) on days 1 and 8 with cisplatin 70mg/m(2) on day 1 (GC arm) for 4 cycles. RESULTS: Between July 2001 and January 2003, 102 patients were enrolled (50 on the GV-GI arm and 52 on the GC arm). Patient characteristics were balanced between arms (GV-GI arm: median age 59 years, 84% male, 22 stage IIIB, 24 stage IV, 4 stage IIIA; GC arm: median age 56 years, 87% male, 27 stage IIIB, 23 stage IV, 2 stage IIIA). Of the 101 patients evaluable for response, ORR was significantly higher on the GC arm than on the GV-GI arm (25% versus 6%, respectively; p=0.007). No complete responses occurred. TTP was longer on the GC arm than on the GV-GI arm (median 135 and 79 days, respectively), although this difference was not statistically significant (p=0.065). Survival was not significantly different between the arms (median 293 and 197 days, respectively; p=0.16). Although significantly more thrombocytopenia was reported on the GC arm (22% and 4%, respectively; p=0.02), it did not lead to more transfusions (15 transfusions in 5 patients versus 14 transfusions in 6 patients, respectively). There was no significant difference in other safety parameters between treatment arms. CONCLUSIONS: GC appears to produce better response in advanced NSCLC than GV-GI, with a trend towards longer TTP. Except for more thrombocytopenia with GC, similar toxicity profiles were observed.
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Authors | Alexandru Grigorescu, Tudor Ciuleanu, Elena Firoiu, Delia Ruta Muresan, Gabriela Teodorescu, Bruce R Basson |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 57
Issue 2
Pg. 168-74
(Aug 2007)
ISSN: 0169-5002 [Print] Ireland |
PMID | 17467848
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Deoxycytidine
- Vinblastine
- Cisplatin
- Vinorelbine
- Ifosfamide
- Gemcitabine
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Topics |
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology)
- Cisplatin
(administration & dosage)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Female
- Humans
- Ifosfamide
(administration & dosage)
- Male
- Middle Aged
- Neoplasm Staging
- Survival Analysis
- Treatment Outcome
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
- Gemcitabine
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