A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients

Background. Osteosarcoma is a highly malignant bone tumour. After the second relapse, the 12-month postrelapse disease-free survival (PRDFS) rate decreases below 20%. Oral Etoposide is often used in clinical practice after surgery as an “adjuvant” outside any protocol and with only limited evidence...

Full description

Bibliographic Details
Main Authors: Alessandra Longhi, Marcus Reif, Erminia Mariani, Stefano Ferrari
Format: Article
Language:English
Published: Hindawi Limited 2014-01-01
Series:Evidence-Based Complementary and Alternative Medicine
Online Access:http://dx.doi.org/10.1155/2014/210198
id doaj-45aa988b10f8453e93d5a96f06bb5035
record_format Article
spelling doaj-45aa988b10f8453e93d5a96f06bb50352020-11-24T22:01:59ZengHindawi LimitedEvidence-Based Complementary and Alternative Medicine1741-427X1741-42882014-01-01201410.1155/2014/210198210198A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma PatientsAlessandra Longhi0Marcus Reif1Erminia Mariani2Stefano Ferrari3Musculoskeletal Oncology Department, Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, ItalyInstitute for Clinical Research, Hardenbergstraße 20, 10623 Berlin, GermanyImmunorheumatology and Tissue Regeneration Laboratory, Istituto Ortopedico Rizzoli, Via Barbiano 1/10, 40136 Bologna, ItalyMusculoskeletal Oncology Department, Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, ItalyBackground. Osteosarcoma is a highly malignant bone tumour. After the second relapse, the 12-month postrelapse disease-free survival (PRDFS) rate decreases below 20%. Oral Etoposide is often used in clinical practice after surgery as an “adjuvant” outside any protocol and with only limited evidence of improved survival. Viscum album fermentatum Pini (Viscum) is an extract of mistletoe plants grown on pine trees for subcutaneous (sc) injection with immunomodulatory activity. Methods. Encouraged by preliminary findings, we conducted a study where osteosarcoma patients free from disease after second metastatic relapse were randomly assigned to Viscum sc or Oral Etoposide. Our goal was to compare 12-month PRDFS rates with an equivalent historical control group. Results. Twenty patients have been enrolled, with a median age of 34 years (range 11–65) and a median follow-up time of 38.5 months (3–73). The median PRDSF is currently 4 months (1–47) in the Etoposide and 39 months (2–73) in the Viscum group. Patients getting Viscum reported a higher quality of life due to lower toxicity. Conclusion. Viscum shows promise as adjuvant treatment in prolonging PRDFS after second relapse in osteosarcoma patients. A larger study is required to conclusively determine efficacy and immunomodulatory mechanisms of Viscum therapy in osteosarcoma patients.http://dx.doi.org/10.1155/2014/210198
collection DOAJ
language English
format Article
sources DOAJ
author Alessandra Longhi
Marcus Reif
Erminia Mariani
Stefano Ferrari
spellingShingle Alessandra Longhi
Marcus Reif
Erminia Mariani
Stefano Ferrari
A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
Evidence-Based Complementary and Alternative Medicine
author_facet Alessandra Longhi
Marcus Reif
Erminia Mariani
Stefano Ferrari
author_sort Alessandra Longhi
title A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
title_short A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
title_full A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
title_fullStr A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
title_full_unstemmed A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients
title_sort randomized study on postrelapse disease-free survival with adjuvant mistletoe versus oral etoposide in osteosarcoma patients
publisher Hindawi Limited
series Evidence-Based Complementary and Alternative Medicine
issn 1741-427X
1741-4288
publishDate 2014-01-01
description Background. Osteosarcoma is a highly malignant bone tumour. After the second relapse, the 12-month postrelapse disease-free survival (PRDFS) rate decreases below 20%. Oral Etoposide is often used in clinical practice after surgery as an “adjuvant” outside any protocol and with only limited evidence of improved survival. Viscum album fermentatum Pini (Viscum) is an extract of mistletoe plants grown on pine trees for subcutaneous (sc) injection with immunomodulatory activity. Methods. Encouraged by preliminary findings, we conducted a study where osteosarcoma patients free from disease after second metastatic relapse were randomly assigned to Viscum sc or Oral Etoposide. Our goal was to compare 12-month PRDFS rates with an equivalent historical control group. Results. Twenty patients have been enrolled, with a median age of 34 years (range 11–65) and a median follow-up time of 38.5 months (3–73). The median PRDSF is currently 4 months (1–47) in the Etoposide and 39 months (2–73) in the Viscum group. Patients getting Viscum reported a higher quality of life due to lower toxicity. Conclusion. Viscum shows promise as adjuvant treatment in prolonging PRDFS after second relapse in osteosarcoma patients. A larger study is required to conclusively determine efficacy and immunomodulatory mechanisms of Viscum therapy in osteosarcoma patients.
url http://dx.doi.org/10.1155/2014/210198
work_keys_str_mv AT alessandralonghi arandomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT marcusreif arandomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT erminiamariani arandomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT stefanoferrari arandomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT alessandralonghi randomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT marcusreif randomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT erminiamariani randomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
AT stefanoferrari randomizedstudyonpostrelapsediseasefreesurvivalwithadjuvantmistletoeversusoraletoposideinosteosarcomapatients
_version_ 1725837543820230656