Pediatric blood & cancer · 2026
The VIVA Regimen (Vinorelbine, Ifosfamide, Vincristine, and Actinomycin-D) for High-Risk Rhabdomyosarcoma: Feasibility and Outcomes From a Single-Institution Study.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Ferrari Andrea, Chiaravalli Stefano, Ferrari Bravo Walter, Vennarini Sabina, Fiore Marco, Morosi Carlo, Luksch Roberto, Terenziani Monica, Spreafico Filippo, Meazza Cristina, Podda Marta, Biassoni Veronica, Schiavello Elisabetta, Puma Nadia, Gattuso Giovanna, Sironi Giovanna, Nigro Olga, Colombo Valeria, Hassan Vittoria, Massimino Maura, Bergamaschi Luca, Casanova Michela
Аннотация
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/m2) 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.
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/m2) 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.