Advanced-stage Hodgkin lymphoma: US/chest radiography for detection of relapse in patients in first complete remission--a randomized trial of routine surveillance imaging procedures.
OBJECTIVE
To compare the use of fluorine 18 fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) with the use of a combination of ultrasonography (US) and chest radiography for systematic follow-up of patients with high-risk Hodgkin lymphoma.


METHODS
Institutional review board approval and informed consent were obtained. In a single center between January 2001 and December 2009, patients with advanced-stage Hodgkin lymphoma who had responded completely to first-line treatment were randomly assigned (1:1) to follow-up with either PET/CT or US/chest radiography. Follow-up included clinical and imaging procedures at 4, 8, 12, 16, 20, 24, 30, 36, 48, 60, 84, and 108 months after treatment discontinuation. When clinical and/or imaging results were positive, recurrence was confirmed histologically. The primary endpoint was to compare the sensitivity of the two follow-up imaging approaches. Secondary endpoints were their specificity, positive and negative predictive values, time to recurrence detection, radiation risks, and costs.


RESULTS
A total of 300 patients were randomized into the two arms. The study was closed after a median follow-up time of 60 months, with a relapse rate of 27%. Sensitivity for detection of Hodgkin lymphoma was similar for the two follow-up approaches. All of the relapses (40 of 40) were identified with FDG PET/CT (100%) and 39 of 40 relapses were identified with US/chest radiography (97.5%; P = .0001 for the equivalence test). US/chest radiography showed significantly higher specificity and positive predictive value than did PET/CT (96% [106 of 110] vs 86% [95 of 110], respectively; P = .02; and 91% [39 of 43] vs 73% [40 of 55], respectively; P = .01). Exposure to ionizing radiation was estimated to be 14.5 mSv for one PET/CT examination versus 0.1 mSv for one chest radiographic examination. Estimated cost per relapse diagnosed with routine PET/CT was 10-fold higher compared with that diagnosed with routine US/chest radiography.


CONCLUSIONS
US and chest radiography are diagnostic tools that enable effective, safe, and low-cost routine surveillance imaging for patients at high risk of Hodgkin lymphoma relapse.
From the Departments of Clinical Medicine and Surgery (M.P., N.P., M.C., C.Q., F.P.), and Advanced Biomedical Science (I.C., G.C., G.P.), Federico II University Medical School, Naples, Italy; Department of Medicine and Surgery, University Medical School, Salerno, Italy (P.Z.); and Department of Economics, Management, Society and Institutions, University of Molise, Campobasso, Italy (C.S.).
Marco
M
Picardi
Novella
N
Pugliese
Michele
M
Cirillo
Pio
P
Zeppa
Imma
I
Cozzolino
Giuseppe
G
Ciancia
Guido
G
Pettinato
Claudia
C
Salvatore
Concetta
C
Quintarelli
Fabrizio
F
Pane
D000293:Adolescent; D000328:Adult; D000368:Aged; D000465:Algorithms; D003131:Combined Modality Therapy; D005260:Female; D019788:Fluorodeoxyglucose F18; D006689:Hodgkin Disease / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography; D011829:Radiation Dosage; D019275:Radiopharmaceuticals; D012680:Sensitivity and Specificity; D014057:Tomography, X-Ray Computed; D018608:Ultrasonography, Doppler
D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18