mistletoe and osteosarcoma

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A randomized study with adjuvant mistletoe versus oral Etoposide on post relapse

disease-free survival in osteosarcoma patients

Alessandra Longhia, Erminia nib, Jürgen J. Kuehnc

Received 28 December 2008; received in revised form 29 January 2009; accepted 2

February 2009.

Abstract

Background

Osteosarcoma is a highly malignant bone tumor affecting mainly adolescents.

While it can be cured in approximately 60% of cases with the recommended

neoadjuvant chemotherapy, few experimental target drugs are currently available

through phases I and II trials for relapsed and inoperable patients. We know

from historical controls that the risk to relapse increases after the second

relapse. Relapse-free survival then decreases to <20% at 12 months. Oral

Etoposide is often used in clinical practice but outside any protocol or

evidence of improved survival.

Methods and Materials

Viscum album fermentatum Pini (Viscum) is a highly popular phytocompound across

central Europe with immunomodulatory activity. Encouraged by the preliminary

findings of a pilot study that showed a prolonged disease-free survival (DFS) of

more than 12 months in four of our five osteosarcoma patients after their second

relapse, we started a two-arm randomized study comparing Viscum album

fermentatum Pini s.c. to oral Etoposide for patients free from disease after

their second metastatic relapse. Our aim is to compare the disease-free survival

to a historical group of patients at 12 months.

Results

To date, the median follow-up is 9.5 months while the study is in progress. The

median DFS is currently 3 months for Etoposide and 8.5 months for Viscum.

Patients on Viscum report a higher quality of life due to lower toxicity,

compared to Etoposide.

Conclusion

In-depth study of the immunomodulatory mechanisms of Viscum in osteosarcoma

patients is required. Viscum shows promise as adjuvant treatment in prolonging

DFS after a second relapse, while Etoposide does not seem to prolong the DFS in

patients after their second relapse. A larger multi-center trial is required to

determine efficacy of therapy in osteosarcoma patients. Preliminary data are

reported.

Keywords: Mistletoe, Viscum album, Etoposide, Osteosarcoma, Disease-free

survival

a Chemotherapy Division, Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136

Bologna, Italy

b Immunology and Genetics Laboratory, Istituto Ortopedico Rizzoli, Bologna,

Italy

c Lukas Clinic, Arlesheim, Switzerland

Corresponding author. Tel.: +390516366374; fax: +390516366277.

PII: S1876-3820(09)00009-2

doi:10.1016/j.eujim.2009.02.005

© 2009 Elsevier GmbH. All rights reserved.

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