Details

Autor(en) / Beteiligte

• Bidoli, P
• Zilembo, N
• Cortinovis, D
• Mariani, L
• Isa, L
• Aitini, E
• Cullurà, D
• Pari, F
• Nova, P
• Mancin, M
• Formisano, B
• Bajetta, E

Titel

Randomized phase II three-arm trial with three platinum-based doublets in metastatic non-small-cell lung cancer. An Italian Trials in Medical Oncology study

Ist Teil von

• Annals of oncology, 2007-03, Vol.18 (3), p.461-467

Ort / Verlag

Oxford: Oxford University Press

Erscheinungsjahr

2007

Quelle

The Electronic Journals Library

Beschreibungen/Notizen

• Background: Many patients with advanced non-small-cell lung cancer (NSCLC) do not tolerate cisplatin-based regimens because of its nonhemathological toxicity. Patients and methods: We evaluated the response rate safety of new platinum analogue regimens, randomizing 147 patients with nonoperable IIIB/IV NSCLC to (i) carboplatin (area under the curve = 5 mg min/ml) on day 1 plus gemcitabine (GEM) (1000 mg/m2) on days 1 and 8 for six cycles; (ii) same regimen for three cycles followed by docetaxel (Taxotere) (40 mg/m2) on days 1 and 8 plus GEM (1250 mg/m2) on days 1 and 8 for three cycles; (iii) oxaliplatin (130 mg/m2) on day 1 plus GEM (1250 mg/m2) on days 1 and 8 for six cycles. Results: Intention-to-treat objective response rates were 25%, 25% and 30.6% in arms A, B and C, respectively. Median survival was 11.9, 9.2 and 11.3 months in arms A, B and C, respectively. Grade 3/4 neutropenia/anemia occurred in 29%/12.5%, 10%/16.5% and 8%/6% of arms A, B and C, respectively; grade 3/4 thrombocytopenia in 20.5%, 16.5% and 6%; grade 1/2 neurological toxicity in 43% of arm C. Conclusions: Oxaliplatin/GEM (arm C) had similar activity to carboplatin/GEM (arm A), but milder hematological toxicity and may be worth testing in a phase III study against carboplatin/GEM in patients not suitable for cisplatin. The sequential regimen gave no additional benefit.