Phase II study of interim PET-CT-guided response-adapted therapy in advanced Hodgkin's lymphoma.
Ann Oncol
; 26(6): 1170-1174, 2015 Jun.
Article
em En
| MEDLINE
| ID: mdl-25701453
ABSTRACT
BACKGROUND:
Combination chemotherapy ABVD (doxorubicin, bleomycin, vinblastine and dacarabazine) cures â¼70% of patients with advanced Hodgkin's lymphoma (aHL, stages IIB, III and IV) while more toxic escalated BEACOPP (EB, combination of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisolone) increases cure rates to 85%. Patients with a positive interim positron emission tomography-computerized tomography (PET-CT) scan after two cycles (PET-2) of ABVD have very poor outcomes with continued ABVD. Intensifying therapy with EB in PET-2-positive patients ('response-adapted therapy') may improve cure rates, whereas the negative patients can continue ABVD alone. PATIENTS ANDMETHODS:
Eligible patients with newly diagnosed aHL received two cycles of ABVD and underwent PET-2 (scored with semi-quantitative 5-point visual criteria, 'Deauville score'). PET-2-negative patients continued four additional cycles of ABVD, whereas PET-2-positive patients received four cycles of EB. A phase II sample size of 50 was estimated keeping the lower and higher proportion of rejection of the event-free survival (EFS) as 70% and 85%, respectively.RESULTS:
Fifty patients [median age 28 (12-60) years; male female 39 11; stages IIB-3 (6%), III-29 (58%) and IV-18 (36%); International Prognostic Score (IPS) 0-3 34 (68%); 4-7 16 (32%)] were enrolled; 49 underwent PET-2. Eight (16%) were PET-2-positive, whereas 41 (84%) were negative. Forty-seven were evaluable for EFS and all 50 for overall survival (OS). The 2-year EFS was 76% (95% CI 68-83) and OS was 88% (95% CI 82-94). PET-2 was strongly prognostic-2-year EFS, negative versus positive 82% versus 50%; P = 0.013.CONCLUSION:
PET-2 response-adapted strategy could not achieve EFS of 85% in aHL. However, escalated therapy improved outcomes in PET-2-positive patients compared with historical data. TRIAL REGISTRATION CTRI/2012/06/002741 (http//www.ctri.nic.in) and NCT01304849 (http//www.clinicaltrials.gov).Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Doença de Hodgkin
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Protocolos de Quimioterapia Combinada Antineoplásica
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Tomografia Computadorizada por Raios X
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Tomografia por Emissão de Pósitrons
Tipo de estudo:
Etiology_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
País/Região como assunto:
Asia
Idioma:
En
Revista:
Ann Oncol
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2015
Tipo de documento:
Article