Cancer Chemotherapy and Pharmacology

, Volume 47, Supplement 1, pp S38–S44 | Cite as

Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma

  • Adriena Sakalová
  • Paul R. Bock
  • Ladislav Dedík
  • Jürgen Hanisch
  • Wilfried Schiess
  • Slávka Gažová
  • Irena Chabroňová
  • Dagmar Holomanova
  • Martin Mistrík
  • Mikuláš Hrubiško
ORIGINAL ARTICLE

Abstract

Purpose: To evaluate the impact of an additive therapy with an oral enzyme (OE) preparation given for more than 6 months additionally to standard combination chemotherapy (vincristine/melphalan/cyclophosphamide/prednisone (VMCP)- or methylprednisolone/vincristine/CCNU/cyclophosphamide/melphalan (MOCCA)-regimen) in the primary treatment of patients with multiple myeloma stages I–III. Methods: A cohort of 265 patients with multiple myeloma stages I–III was consecutively treated at our institution in two parallel groups (control group (n=99): chemotherapy ±OE for less than 6 months; OE-group (n=166): chemotherapy + OE for more than 6 months). The median follow-up time in the stages I, II, and III for the OE-group was 61, 37, and 46.5 months, respectively; for the control group the respective values were 33, 51.5, and 31.5 months. The primary endpoint of the study was disease-specific survival. Secondary endpoints were response to therapy, duration of first response and side effects. The chosen method for evaluation was the technique of a retrolective cohort analysis with a concurrent control group. Survival analysis was performed by the Kaplan-Meier method and multivariate analysis was done with the Cox proportional hazards model. Results: Significantly higher overall response rates and longer duration of remissions were observed in the OE-group. Primary responders showed a longer mean survival time than non-responders. Additive therapy with OE given for more than 6 months decreased the hazard of death for patients at all stages of disease by approximately 60%. Observation time was not long enough to estimate the median survival for patients at stages I and II; for stage III patients it was 47 months in the control group versus 83 months for the patients treated with OE (P=0.0014) which means a 3-year gain of survival time. Significant prognostic factors for survival, in the Cox regression analysis, were stage of disease and therapy with OE. The OE-therapy was generally well tolerated (3.6% of patients with mild to moderate gastrointestinal symptoms). Conclusion: OEs represent a promising new additive therapy in multiple myeloma which will be further evaluated in a randomized phase III trial in the USA.

Key words Retrolective cohort study Additive treatment Multiple myeloma Oral enzyme preparation Survival 

Copyright information

© Springer-Verlag Berlin Heidelberg 2001

Authors and Affiliations

  • Adriena Sakalová
    • 1
  • Paul R. Bock
    • 3
  • Ladislav Dedík
    • 2
  • Jürgen Hanisch
    • 3
  • Wilfried Schiess
    • 4
  • Slávka Gažová
    • 1
  • Irena Chabroňová
    • 1
  • Dagmar Holomanova
    • 1
  • Martin Mistrík
    • 1
  • Mikuláš Hrubiško
    • 1
  1. 1.Clinic of Haematology and Transfusion Medicine, University of Brastislava, Partizánzka ul. 4, 81103 Bratislava, Slovak Republic Tel.:  + 421-7-54413080; Fax: + 421-7-54413085SK
  2. 2.Institute for Experimental Pharmacology, Slovak Technical University, Bratislava, Slovak RepublicSK
  3. 3.IFAG Basle, Rümlingen (BL), SwitzerlandCH
  4. 4.Clinical Research, Mucos Pharma, Geretsried, GermanyDE

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