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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
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
- 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
- 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
OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen