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Annals of Oncology Advance Access originally published online on November 16, 2006
Annals of Oncology 2007 18(3):461-467; doi:10.1093/annonc/mdl415
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© 2006 European Society for Medical Oncology

lung cancer

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

P Bidoli1, N Zilembo1, D Cortinovis1, L Mariani2, L Isa3, E Aitini4, D Cullurà3, F Pari4, P Nova1, M Mancin1, B Formisano1 and E Bajetta1,*

1 Medical Oncology Unit 2
2 Medical Statistics and Biometry Unit, Fondazione IRCCS "Istituto Nazionale dei Tumori" i, Milan, Italy
3 Department of Oncology, H. Serbelloni, Gorgonzola (MI), Italy
4 Department of Medical Oncology, H.C. Poma, Mantova, Italy

* Correspondence to: Dr E. Bajetta, S.C. Oncologia Medica 2, Fondazione IRCCS "Istituto Nazionale dei Tumori", Via Venezian 1, 20133 Milano, Italy. Tel: +39 02 23902500; Fax: +39 02 23902149; E-mail: emilio.bajetta{at}istitutotumori.mi.it

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.

Key words: first-line chemotherapy, NSCLC, phase II study, platinum analogs

Received for publication May 24, 2006. Revision received September 25, 2006. Accepted for publication October 5, 2006.


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