8599 Background: The goal of salvage chemotherapy in patients with relapsed or primary refractory B-cell non- Hodgkin’s lymphoma (NHL) is to optimize remission status prior to autologous stem cell transplant (ASCT). This study evaluated the efficacy and safety of Paclitaxel (Taxol [T]) and Topotecan plus Rituximab (TTR) as a novel salvage therapy in NHL patients. Methods: 72 eligible patients (pts) with up to 2 previous treatments not containing rituximab, taxane, or topotecan were enrolled. Rituximab 375mg/m2 IV was given on day 1, paclitaxel 200mg/m2 IV on day 2, and topotecan 1mg/m2/day IV on days 2–6 in 3-week cycles with G-CSF support. After 2 to 6 cycles, responding pts were offered ASCT. This single-arm phase II study assessed 70 pts for treatment response and toxicity. 32 (45%) pts were primary refractory, and 20 pts (28%) had received prior platinum-based regimen. Primary endpoints were overall survival (OS) and event- free survival (EFS). Results: Of 70 evaluable pts, 31 (44%) received ASCT. 21 pts (30%) responded but did not receive ASCT. Non-responders were offered additional salvage therapy as tolerated. Initial intent-to-treat analysis was performed in 2003. Median follow- up for current analysis is 70 months (mos). Overall response rate was 70% with 42% complete response (CR). Response was 45% and 80% for pts with and without prior platinum therapy, respectively. EFS for all pts was 16.1 mos (95%CI 7.4, 29.2). EFS was 3.5 mos (CI 2.8, 5.9) for all pts in non-ASCT group; 7.4 mos (CI 5.0, 30.3) for responders. EFS for ASCT group was not reached (NR). OS for all pts was 38.7 mos (CI 19.5, NR). OS was 13.6 mos (CI 10.3, 21.9) for all pts in non-ASCT group; 21.7 mos (CI 13.6, NR) for responders. OS for ASCT group was not reached. The differences in EFS and OS between ASCT and non-ASCT groups were statistically significant (p<0.0001). Grade 3/4 toxicities were neutropenia (62%), thrombocytopenia (53%), and neutropenic fever (30%). Conclusions: Salvage therapy with TTR had significant response rate, even among pts who failed prior platinum-based therapy. This regimen when combined with ASCT is highly effective, as median EFS and OS were not reached in a median follow-up of 70 mos. Hematologic suppression was the most significant toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Berlex Oncology, Millennium Cogenix, Co-Med Communications, Genentech™ BioOncology, Health Sciences Communications, Physicians Education Resource Bayer, Berlex Oncology, BioGen IDEC, Bristol-Myers Squibb, Genentech™ BioOncology, GlaxoSmithKline, Integrated Therapeutics, Millennium, OSI Oncology, Schering-Plough