Viscum album fermentatum Pini versus oral Etoposide as adjuvant treatment in osteosarcoma patients after second relapse.
Background: Osteosarcoma is a highly malignant bone tumor affecting mainly adolescents. With the recommended neoadjuvant chemotherapy it can be cured in approximately 60% of cases. Few experimental drugs are currently tested in phase I/I I trials for relapsed and inoperable patients. We know from historical controls that the risk of relapse increases after the second relapse. Relapse-free survival then decreases to <20% after 12 months. Oral Etoposide is often used in clinical practice but outside any protocol or evidence of improved survival. Interferon alpha and Mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; Mepact[R]) have been tried as adjuvants in treatment of osteosarcoma with encouraging results of improved DFS disease-free survival (DFS) of 7%.
Methods and materials: Viscum alburn fermentatum Pini (Vis-cum) is a highly popular herbal medicinal product across central Europe with immunomodulatory activity. Encouraged by the preliminary findings of a pilot study that showed a prolonged DFS of more than 12 months in four out of five with Viscum album treated osteosarcoma patients after their second relapse, we started a two-arm randomized study comparing Viscum album fermentatum Pini s.c. to oral Etoposide in patients free from disease after their second metastatic relapse. Primary end point is the DFS at 12 months compared to an historical group of patients.
Results: To date, we have enrolled 17 patients: 8 patients were enrolled in the Viscum arm and 9 patients in the Etoposide arm, 8 female and 9 male, median age 35 years (11-65), median follow up 19 months (1-42). Median DFS is currently 17.5 months (5-42) for the Viscum album arm and 4 months (1-12) for the Etoposide arm. Viscum patients had lower toxicity symptoms compared to patients treated with Etoposide. An interim analysis will be done once we have 20 treated study patients (10 for each arm).
Conclusion: Viscum album showed promising results as adjuvant treatment in prolonging DFS after a second relapse. It seems to have the same advantages compared to other immunostimulants (IFN, MTP) at lower costs. A larger multi-center trial is required to determine efficacy of Viscum therapy in osteosarcoma patients compared to other immunostimulants currently approved in osteosarcoma treatment like Mifamurtide.
Keywords: Osteosarcoma; Two-arm randomized study; Treatment with Viscum album versus Etoposide; Disease-free survival (DFS)
A. Longhi (a), * E. Mariani (a), J. Kuehn (b), M. Reif (c)
(a) Musculoskeletal Oncology Dept, 1st. Ortopedico Rizzoli, Bologna, Italy (1)
(b) Lukasklinik Arlesheim, Switzerland
(c) Institutfiir klinische Forschung (IKF) Berlin, Germany
* Corresponding author. Tel: +41 91 811 86 66; fax: +41 91 811 80 56.
E-mail address: alessandra.longhi[congruent to]eoc.ch (A. Longhi).
(1.) From 1st of July 2011: Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.
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|Author:||Longhi, A.; Mariani, E.; Kuehn, J.; Reif, M.|
|Publication:||Phytomedicine: International Journal of Phytotherapy & Phytopharmacology|
|Date:||Oct 15, 2011|
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