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