An EORTC Randomized Phase III Trial of Three Chemotherapy Regimens in Advanced Non-Small Cell Lung Cancer (NSCLC)

James Metz, MD

University of Pennsylvania Cancer
Last Modified: May 12, 2001

Presenter: J. P. Van Meerbeeck
Affiliation: EORTC


    Combination chemotherapy improves survival in advanced NSCLC based on numerous reports. Cisplatin based chemotherapy has remained the standard regimen used in most studies. This study was designed to compare 3 different chemotherapy regimens, 2 containing cisplatin and one non cisplatin based regimen.

Materials and Methods:

  • 480 patients randomized with 10 patients non- eligle for analysis
  • Patients were randomized between Cisplatin/Paclitaxel (Arm A), Cisplatin/Gemcytabine (Arm B), and Gemcytabine/Paclitaxel (Arm C)
  • Patient characteristics were well balanced between arms


  • There was no difference in response rates between the control arm (A) and experimental arms (B and C).
  • There was no significant difference in median survival between the arms
  • Arm B had an increased incidence of thrombocytopenia and anemia, but no increased incidence of clinical complications.
  • There was no significant difference in non hematologic toxicity

Authors' Conclusions

  • Both experimental arms failed to show superiority over the control arm
  • There was increased hematologic toxicity with the Gemcytabine/Cisplatin combination without increased clinical complications
  • Quality of life analysis is ongoing

Clinical/Scientific Implications:

  • This trial is disappointing for non cisplatin based chemotherapy supporters
  • Future reference regimens should include cisplatin
  • Questions remain if higher doses of paclitaxel will show a benefit than those used in this study

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