What is the EWALL PH+ protocol with dosing for an adult patient, especially those aged 70 years or older?

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Last updated: July 1, 2026 • View editorial policy

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Protocolo EWALL PH+ com Doses

O protocolo EWALL PH+ para pacientes idosos (≥55 anos) com LLA Ph+ utiliza dasatinibe 140 mg/dia (100 mg/dia se >70 anos) combinado com quimioterapia de baixa intensidade, conforme estabelecido no estudo EWALL-PH-01. 1

Esquema de Tratamento Detalhado

Fase de Indução

  • Dasatinibe: 140 mg/dia via oral (reduzir para 100 mg/dia em pacientes >70 anos)
  • Vincristina: dose padrão
  • Dexametasona: dose padrão
  • Quimioterapia intratecal: profilaxia do SNC

Fase de Consolidação (6 meses)

Pacientes em remissão completa continuam com:

  • Dasatinibe: dose contínua (140 mg/dia ou 100 mg/dia conforme idade)
  • Citarabina: administração sequencial
  • Asparaginase: administração sequencial
  • Metotrexato: administração sequencial

Fase de Manutenção (18 meses)

  • Dasatinibe: dose contínua
  • Vincristina/Dexametasona: ciclos de reindução
  • Seguido por dasatinibe isolado até recidiva ou óbito

Resultados e Considerações Importantes

Este protocolo demonstrou 1:

  • Taxa de remissão completa: 96%
  • Sobrevida global em 5 anos: 36% (até 45% considerando mortes não relacionadas à doença)
  • Apenas 7 pacientes realizaram transplante alogênico de células-tronco
  • 65% dos pacientes alcançaram redução de 3-log nos níveis de transcritos BCR-ABL1 durante consolidação

Armadilhas Críticas

Monitoramento obrigatório da mutação T315I: 1

  • 75% das recidivas testadas foram T315I-positivas
  • 23% dos pacientes eram positivos para BCR-ABL1(T315I) antes de qualquer terapia
  • Detecção precoce identifica pacientes com alto risco de recidiva precoce
  • Recomenda-se teste por RT-qPCR com oligonucleotídeo alelo-específico desde o diagnóstico

Comorbidades relevantes: 2

  • Dasatinibe contraindicado em doença pulmonar significativa
  • 77% dos pacientes do estudo EWALL-PH-01 tinham alto escore de comorbidade, demonstrando tolerabilidade do protocolo

Alternativas Modernas

As diretrizes ELN 2024 2 e ESMO 2024 3 reconhecem que protocolos mais recentes com inibidores de tirosina quinase de terceira geração (ponatinibe) ou combinações com imunoterapia (blinatumomab) mostram resultados superiores, mas o protocolo EWALL PH+ permanece como opção validada para pacientes idosos com múltiplas comorbidades que não toleram regimes mais intensivos.

References

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