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Intensification treatment based on early FDG ‐ PET in patients with high‐risk diffuse large B‐cell lymphoma: a phase II GELTAMO trial
Author(s) -
Pardal Emilia,
Coronado Mónica,
Martín Alejandro,
Grande Carlos,
MarínNiebla Ana,
Panizo Carlos,
Bello José Luis,
Conde Eulogio,
Hernández Miguel T.,
Arranz Reyes,
Bargay Joan,
GonzálezBarca Eva,
PérezCeballos Elena,
MontesMoreno Santiago,
Caballero María Dolores
Publication year - 2014
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.13036
Subject(s) - medicine , hazard ratio , diffuse large b cell lymphoma , rituximab , etoposide , progression free survival , vincristine , autologous stem cell transplantation , oncology , transplantation , nuclear medicine , confidence interval , surgery , lymphoma , cyclophosphamide , chemotherapy
Summary We conducted a multicentre, phase II study of interim positron emission tomography ( PET ) as a guide to risk‐adapted therapy in high‐risk patients with newly diagnosed diffuse large B‐cell lymphoma ( DLBCL ). Patients achieving negative fluorodeoxyglucose ( FDG )‐ PET after three courses of R‐Mega CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) received three additional courses, whereas PET ‐positive patients received two courses of R‐ IFE (rituximab, ifosfamide, etoposide) followed by BEAM ( BCNU , etoposide, cytarabine, melphalan) and autologous stem‐cell transplantation. The primary endpoint was progression‐free survival ( PFS ). 71 patients (median age 55 years, range 25–69) were enrolled. With a median follow‐up of 42·8 months (range 7·2–58·4), the estimated 4‐year PFS and overall survival ( OS ) were 67% and 78%, respectively, for the global series. Patients in complete remission after interim PET ( N = 36) had significantly better 3‐year PFS than those with partial response ( N = 30) [81% vs. 57%, Hazard ratio (HR) = 2·6, 95% confidence interval (CI) = 1·02–6·65] but not a statistically significant longer OS . A retrospective PET central review was done for 51 patients. According to semiquantitative analysis, 3‐year PFS (81% vs. 33%; HR = 6·9, 95% CI = 2·35–20·6) and OS (95% vs. 33%, HR = 19·4, 95% CI = 3·89–97·0) were significantly better for negative than for positive interim PET patients. Early PET assessment is valuable for risk stratification in DLBCL ; for this purpose semiquantitative evaluation is a better predictor than visual criteria.