Home



ZADAXIN
(thymosin alpha 1)



ZADAXIN
Bibliography &
Presentations



Medical
Conferences



Contact



Site Map



International
Language Support
   

<< Previous Section Table of Contents Next Section >>

Cancer

Non–Small-Cell Lung Cancer

Zadaxin has been used to treat NSCLC in several different trials. This cancer accounts for approximately 75% of lung cancer cases, and current therapies such as radiation therapy and chemotherapy give disappointing results, with 5-year survival for stage III tumors ranging from 0% to 12% after a combination of radiation and chemotherapy. (144-146)

George Washington University trial (147)
This was a double-blind, randomized trial.

Patients and protocol:
• 42 patients with localized, unresectable NSCLC
• Treatment after radiation therapy up to 1 year or until relapse
– Placebo biweekly
– Zadaxin 0.9 mg/m2 biweekly
– Zadaxin 0.9 mg/m2 daily for 14 days followed by biweekly maintenance treatments

Results:
• Improvement of absolute T-cell levels that had been depleted by radiation in Zadaxin-treated patients
• Increase in the percentage of lymphocytes expressing the pre–T-cell and helper–/inducer–T-cell
– Zadaxin treated patients: 90% retention of both OKT3- and OKT4-positive cells surface markers in Zadaxin-treated patients
– Placebo-treated patients: OKT3-positive cells decreased to 78% of original value; OKT4-positive cells decreased to 64% of original value)
• Statistically significant improvement in relapse-free survival in both Zadaxin-treated groups (P = 0.04)
• Statistically significant improvement in overall survival in both Zadaxin-treated groups (P = 0.009)

Italian trials

Trial #1 (148)
• 60 patients
• Zadaxin in combination with chemotherapy (cisplatin and etoposide) and IFNα
• 55 evaluable patients
• 2 complete responses
• 22 partial responses
• Overall response rate of 44%
•
 Median survival was 12.6 months

Trial #2 (25)
• 22 patients
 
– 10 patients randomized to chemotherapy (ifosfamide)
– 12 patients randomized to chemotherapy followed by Zadaxin (1 mg) and low-dose IFNα (3 MIU)
• Enhanced response rate of 33% in Zadaxintreated patients
• 10% response rate with chemotherapy alone
• Increased time to progression in Zadaxintreated patients
 
– Zadaxin-treated patients: 18 weeks, range 9-53 weeks
– Ifosfamide alone: 9 weeks, range 6-18 weeks
– P = 0.006
• CD4 and CD8 cell counts significantly depressed after 2 cycles of chemotherapy alone
• No difference in cell count in Zadaxin group
• 50% of patients treated with ifosfamide alone presenting with grade 3 or 4 myelosuppression
• 0% of Zadaxin patients presenting with grade 3 or 4 myelosuppression

Back to top

<< Previous Section Table of Contents Next Section >>


  Home | Zadaxin | Scientific Papers | Conferences | Contact | Site Map
Copyright © 2003-2004 SciClone Pharmaceuticals International