Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 7071
© 2004 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Rigas, J. R. Articles by Dragnev, K. Search for Related Content PubMed Articles by Rigas, J. R. Articles by Dragnev, K.

Abstract

Multicenter Web-based phase III study to test the survival equivalence of non-platinum-based (NPB) vs platinum-based (PB) therapy for advanced non-small cell lung cancer (NSCLC): The Dartmouth NPB Chemotherapy Trial (D0112)

Dartmouth Medical School, Hanover, NH; Norris Cotton Cancer Center, Lebanon, NH; PPD Development, Wilmington, NC; Texas Cancer Care, Fort Worth, TX; University of Tennessee, Memphis, TN; Florida Cancer Specialist, Bonita Springs, FL; Appalachian Clinical Research, Pikeville, KY; Dartmouth Hitchcock Medical Center, Lebanon, NH

7071

Background: For patients (pts) with advanced disease and a good performance status (PS) PB therapy is recommended. To date, the survival benefit of a NPB remains unanswered. This trial is designed to compare the overall survival (OS) of NPB vs PB therapy for advanced NSCLC testing for equivalence. Methods: Pt eligibility: pathological stage IIIB/IV NSCLC, PS 0–2, and no prior chemotherapy. Randomized pts were stratified by stage and PS to arm A: carboplatin AUC = 6 + docetaxel 75 mg/m² every 3 wks (PB) or arm B: gemcitabine 1 gm/m² + docetaxel 40 mg/m² days 1 and 8 every 3 wks (NPB). The primary endpoint is OS. Relative risk (RR) and log-rank will be used to establish therapeutic equivalence (RR 0.8–1.2). Planned sample size 928 pts. This trial is monitored by an independent SDMC and source documentation (SD) for all web-based entries is sought. Results: As of December 2003, 732 pts (367 pts arm A vs 365 pts arm B) are enrolled at 87 sites. Pt characteristics are balanced for gender (38% female), age (median 65, range 36–90), PS (14% PS2), stage (76% stage IV) and histology (51% adenocarcinoma, 20% squamous cell). Arm A received 1,538 cycles and 1,335 cycles in arm B. Serious adverse events (SAEs) occurred 135 pts in arm A and 184 in arm B. Only 30% of all SAEs are attributed to therapy. There were 2 treatment-related deaths, one on each arm. In July 2003 at a predefined interim analysis with 97% of the data SD, 250 deaths occurred among 620 randomized pts. The OS yielded p = 0.38. The 1-year survival rate was 45% for PB and 42% for NPB. The pre-specified stopping rule for superiority was p = 0.01. The SDMC recommended continuation. We anticipate completion by May 2004 and presentation of the final data sets in June 2004. Conclusions: At the predefined interim analysis, there appears to be no statistical survival advantage for platinum or non-platinum-based therapy. At present, there appear to be qualitative and quantitative differences in SAEs. Upon completion, we will definitively comment on the equivalence of a non-platinum-based treatment for this disease.

Author Disclosure

Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Aventis Abbott; Amgen; Aventis; Bristol-Myers Squibb; Genentech; GlaxoSmithKline; Ortho Biotech; Ligand; Merck; Pfizer; OSI; Roche

Abstract presentation from the 2004 ASCO Annual Meeting