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Clinical Trial
. 2013 Feb 5;108(2):265-70.
doi: 10.1038/bjc.2012.555. Epub 2013 Jan 17.

A randomised multicentre phase II study with cisplatin/docetaxel vs oxaliplatin/docetaxel as first-line therapy in patients with advanced or metastatic non-small cell lung cancer

A Atmaca  1 , S-E Al-Batran, D Werner, C Pauligk, T Güner, A Koepke, H Bernhard, T Wenzel, A-G Banat, P Brueck, K Caca, N Prasnikar, F Kullmann, H Günther Derigs, M Koenigsmann, G Dingeldein, T Neuhaus, E Jäger
Affiliations
Clinical Trial

A randomised multicentre phase II study with cisplatin/docetaxel vs oxaliplatin/docetaxel as first-line therapy in patients with advanced or metastatic non-small cell lung cancer

A Atmaca et al. Br J Cancer. .

Abstract

Background: This study was designed to compare cisplatin/docetaxel with oxaliplatin/docetaxel in patients with advanced and metastatic non-small lung cancer as a first-line treatment.

Methods: Patients were randomly assigned to receive either cisplatin 75 mg m(-2) and docetaxel 75 mg m(-2) every 3 weeks or oxaliplatin 85 mg m(-2) and docetaxel 50 mg m(-2) every 2 weeks. The primary end point was response rate, and secondary end points were toxicity, time to progression and overall survival.

Results: A total of 88 patients (median age: 65 (39-86) years; stage IV: 93%) were randomly assigned. Response rate (complete and partial response) was 47% (95% CI: 33-61%) in the cisplatin/docetaxel arm and 28% (95% CI: 17-43%) in the oxaliplatin/docetaxel arm (P=0.118). There was no significant difference in time to progression (6.3 vs 4.9 months, P=0.111) and median overall survival (11.6 vs 7.0 months, P=0.102) with cisplatin/docetaxel vs oxaliplatin/docetaxel, although slight trends favouring cisplatin were seen. Oxaliplatin/docetaxel was associated with significantly less (any grade) renal toxicity (56% vs 11%), any grade fatigue (81% vs 59%), complete alopecia (76% vs 27%), any grade leukopenia (84% vs 61%) and grade 3/4 leukopenia (44% vs 14%) and neutropenia (56% vs 27%).

Conclusion: Oxaliplatin/docetaxel has activity in metastatic non-small cell lung cancer, but it seems to be inferior to cisplatin/docetaxel.

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Figures

Figure 1
Figure 1
Survival analysis Kaplan–Meier curves for (A) OS and (B) TTP, assessed in the entire population. Median OS was 11.6 vs 7.0 months and median TTP 6.3 vs 4.9 months with cisplatin/docetaxel vs oxaliplatin/docetaxel, respectively.
See this image and copyright information in PMC

References

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