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Publications

Journal Article Ahead of print

PubMed: 42527384 DOI: 10.1002/1545-5017.70490

The VIVA Regimen (Vinorelbine, Ifosfamide, Vincristine, and Actinomycin-D) for High-Risk Rhabdomyosarcoma: Feasibility and Outcomes From a Single-Institution Study.

Pediatr Blood Cancer

Authors: Andrea Ferrari, Stefano Chiaravalli, Walter Ferrari Bravo, Sabina Vennarini, Marco Fiore, Carlo Morosi, Roberto Luksch, Monica Terenziani, Filippo Spreafico, Cristina Meazza, Marta Podda, Veronica Biassoni, Elisabetta Schiavello, Nadia Puma, Giovanna Gattuso, Giovanna Sironi, Olga Nigro, Valeria Colombo, Vittoria Hassan, Maura Massimino, Luca Bergamaschi, Michela Casanova

Affiliations

  • Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  • Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy.
  • Pediatric Radiotherapy Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
  • Department of Surgery, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.
  • Radiology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  • Oncology Unit, IRCCS Istituto Giannina Gaslini, Genoa, Italy.

Abstract

INTRODUCTION

Rhabdomyosarcoma is a highly chemosensitive tumor; however, high-risk and metastatic cases require more effective systemic treatments. This study evaluates the feasibility and efficacy of the "VIVA" regimen (vinorelbine-ifosfamide-vincristine-actinomycin D), which incorporates weekly vinorelbine into the induction phase of standard therapy.

METHODS

Between 2020 and 2025, 45 patients (median age 14 years) with high-risk or metastatic rhabdomyosarcoma were treated at the Pediatric Unit of the Istituto Nazionale Tumori in Milan. The VIVA regimen added intravenous vinorelbine (25 mg/m 2) on Days 8 and 15 of the standard 3-week IVA cycle. Treatment included nine induction cycles followed by 6-12 months of maintenance therapy (vinorelbine and oral cyclophosphamide), alongside multidisciplinary local control.

RESULTS

Forty patients (89%) completed the planned nine VIVA cycles; five discontinued early due to disease progression. Among 41 evaluable patients, the overall response rate after three cycles was 95%. The estimated 3-year event-free survival (EFS) and overall survival (OS) rates were 68.0% and 78.6%, respectively. Myelotoxicity was the main side effect: grade ≥ 3 neutropenia, thrombocytopenia, and anemia occurred in 70%, 7%, and 21% of cycles, respectively. Granulocyte-colony-stimulating factor (G-CSF) was administered in 51% of cycles. Overall, 30% of the cycles required either a reduction or the omission of vinorelbine administration. Notably, 68% of patients required either no modifications (24%) or modifications in fewer than 25% of doses (44%).

CONCLUSIONS

Integrating vinorelbine into the intensive induction phase proved feasible with an acceptable toxicity profile and high response rates. Further investigations are needed to define the long-term efficacy of this promising intensive regimen.

MeSH

Rhabdomyosarcoma, Ifosfamide, Neoplasms, Drug Therapy, Vinorelbine, Vincristine, Dactinomycin, Therapeutics, Chemotherapy