ARCII: A phase II trial of the HIV protease inhibitor Nelfinavir in combination with chemoradiation for locally advanced inoperable pancreatic cancer.
Radiother Oncol
; 119(2): 306-11, 2016 05.
Article
em En
| MEDLINE
| ID: mdl-27117177
ABSTRACT
BACKGROUND AND PURPOSE:
Nelfinavir can enhance intrinsic radiosensitivity, reduce hypoxia and improve vascularity. We conducted a phase II trial combining nelfinavir with chemoradiotherapy (CRT) for locally advanced inoperable pancreatic cancer (LAPC). MATERIALS ANDMETHODS:
Radiotherapy (50.4Gy/28 fractions; boost to 59.4Gy/33 fractions) was administered with weekly gemcitabine and cisplatin. Nelfinavir started 3-10days before and was continued during CRT. The primary end-point was 1-year overall survival (OS). Secondary end-points included histological downstaging, radiological response, 1-year progression free survival (PFS), overall survival (OS) and treatment toxicity. An imaging sub-study (n=6) evaluated hypoxia ((18)F-Fluoromisonidazole-PET) and perfusion (perfusion CT) during induction nelfinavir.RESULTS:
The study closed after recruiting 23 patients, due to non-availability of Nelfinavir in Europe. The 1-year OS was 73.4% (90% CI 54.5-85.5%) and median OS was 17.4months (90% CI 12.8-18.8). The 1-year PFS was 21.8% (90% CI 8.9-38.3%) and median PFS was 5.5months (90% CI 4.1-8.3). All patients experienced Grade 3/4 toxicity, but many were asymptomatic laboratory abnormalities. Four of 6 patients on the imaging sub-study demonstrated reduced hypoxia and increased perfusion post-nelfinavir.CONCLUSIONS:
CRT combined with nelfinavir showed acceptable toxicity and promising survival in pancreatic cancer.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Pancreáticas
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Inibidores da Protease de HIV
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Nelfinavir
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Quimiorradioterapia
Limite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Radiother Oncol
Ano de publicação:
2016
Tipo de documento:
Article