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Annals of Oncology Advance Access published online on November 16, 2006
Annals of Oncology, doi:10.1093/annonc/mdl415
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© 2006 European Society for Medical Oncology
Received May 24, 2006
Revised September 25, 2006
Accepted October 5, 2006

original article

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. Bidoli 1, N. Zilembo 1, D. Cortinovis 1, L. Mariani 2, L. Isa 3, E. Aitini 4, D. Cullurà 3, F. Pari 4, P. Nova 1, M. Mancin 1, B. Formisano 1, and E. Bajetta 1 *

1 Medical Oncology Unit 2, Fondazione IRCCS "Istituto Nazionale dei Tumori" i, Milan, Italy
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

* To whom correspondence should be addressed.
E. Bajetta, E-mail: emilio.bajetta{at}istitutotumori.mi.it


  Abstract

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.

Keywords: first-line chemotherapy; NSCLC; phase II study; platinum analogs.
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