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37 Patients with Treatment-Emergent Grade 3-4 Neuropathy

37 Patients with Treatment-Emergent Grade 3-4 Neuropathy. 10 patients had simultaneous PD Of the 27 patients remaining: 11 patients withdrew for neuropathy (7) or withdrew consent (4) 16 patients continued with VSLI

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37 Patients with Treatment-Emergent Grade 3-4 Neuropathy

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  1. 37 Patients with Treatment-Emergent Grade 3-4 Neuropathy • 10 patients had simultaneous PD Of the 27 patients remaining: • 11 patients withdrew for neuropathy (7) or withdrew consent (4) • 16 patients continued with VSLI • Therefore, 16/27 patients (59%) chose to continue therapy despite Grade 3-4 neuropathy in the absence of PD EB-739

  2. Additional Doses Beyond First Treatment-Emergent Grade 3-4 Neuropathy EB-740

  3. Duration of Response Duration of response Start of treatment Documented progression Lost to follow-up when still in response First documented response (6-8 weeks after first treatment) Additional data to be collected EB-266

  4. Duration of Response – IRP Review EB-270

  5. Duration of Response – INV Review (updated) EB-275

  6. Infusional VCR in humans(Jackson et al; Cancer 53:2601-2606, 1984) • 25 pts with a variety of NHL • 5-day continuous IV VCR 0.25 mg/m2/day after initial 0.5 mg I.V. bolus • Repeat course q 3 wks EB-802

  7. Infusional VCR in Humans - Safety • Principal complication = mild to mod neurotoxicity (48%) • GI toxicity included severe ileus • Hematological toxicity was minimal EB-803

  8. Dr. Jackson’s Comments onClinical Results for VSLI • Ability to deliver such high cumulative dose of vincristine with low GI toxicity and no ileus is highly unusual • Ability to proceed to transplant following monotherapy is also highly unusual EB-804

  9. Objective Response Rate by IRP EB-429

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