18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group.

2.50
Hdl Handle:
http://hdl.handle.net/10541/94300
Title:
18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group.
Authors:
Huddart, Robert A; O'Doherty, Michael J; Padhani, Anwar; Rustin, Gordon J S; Mead, Graham M; Joffe, Johnathan K; Vasey, Paul; Harland, Stephen J; Logue, John P; Daugaard, Gedske; Hain, Sharon F; Kirk, Sarah J; MacKewn, Jane E; Stenning, Sally P
Abstract:
PURPOSE: There are several management options for patients with clinical stage I (CS1) nonseminomatous germ cell tumors (NSGCT); this study examined whether an 18fluorodeoxyglucose positron emission tomography (18FDG PET) scan could identify patients without occult metastatic disease for whom surveillance is an attractive option. METHODS: High-risk (lymphovascular invasion positive) patients with CS1 NSGCT underwent 18FDG PET scanning within 8 weeks of orchidectomy or marker normalization. PET-positive patients went off study; PET-negative patients were observed on a surveillance program. The primary outcome measure was the 2-year relapse-free rate (RFR) in patients with a negative PET scan (the negative predictive value). Assuming an RFR of 90% to exclude an RFR less than 80% with approximately 90% power, 100 PET-negative patients were required; 135 scanned patients were anticipated. RESULTS: Patients were registered between May 2002 and January 2005, when the trial was stopped by the independent data monitoring committee due to an unacceptably high relapse rate in the PET-negative patients. Of 116 registered patients, 111 underwent PET scans, and 88 (79%) were PET-negative (61% of preorchidectomy marker-negative patients v 88% of marker-positive patients; P = .002); 87 proceeded to surveillance, and one requested adjuvant chemotherapy. With a median follow-up of 12 months, 33 of 87 patients on surveillance relapsed (1-year RFR, 63%; 90% CI, 54% to 72%). CONCLUSION: Though PET identified some patients with disease not detected by computed tomography scan, the relapse rate among PET negative patients remains high. The results show that 18FDG PET scanning is not sufficiently sensitive to identify patients at low risk of relapse in this setting.
Affiliation:
Academic Radiotherapy, Institute of Cancer Research and Royal Marsden Hospital, Sutton, Surrey, UK. Robert.Huddart@icr.ac.uk
Citation:
18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. 2007, 25 (21):3090-5 J. Clin. Oncol.
Journal:
Journal of Clinical Oncology
Issue Date:
20-Jul-2007
URI:
http://hdl.handle.net/10541/94300
DOI:
10.1200/JCO.2006.09.3831
PubMed ID:
17634488
Type:
Article
Language:
en
ISSN:
1527-7755
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorHuddart, Robert Aen
dc.contributor.authorO'Doherty, Michael Jen
dc.contributor.authorPadhani, Anwaren
dc.contributor.authorRustin, Gordon J Sen
dc.contributor.authorMead, Graham Men
dc.contributor.authorJoffe, Johnathan Ken
dc.contributor.authorVasey, Paulen
dc.contributor.authorHarland, Stephen Jen
dc.contributor.authorLogue, John Pen
dc.contributor.authorDaugaard, Gedskeen
dc.contributor.authorHain, Sharon Fen
dc.contributor.authorKirk, Sarah Jen
dc.contributor.authorMacKewn, Jane Een
dc.contributor.authorStenning, Sally Pen
dc.date.accessioned2010-03-15T17:00:45Z-
dc.date.available2010-03-15T17:00:45Z-
dc.date.issued2007-07-20-
dc.identifier.citation18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. 2007, 25 (21):3090-5 J. Clin. Oncol.en
dc.identifier.issn1527-7755-
dc.identifier.pmid17634488-
dc.identifier.doi10.1200/JCO.2006.09.3831-
dc.identifier.urihttp://hdl.handle.net/10541/94300-
dc.description.abstractPURPOSE: There are several management options for patients with clinical stage I (CS1) nonseminomatous germ cell tumors (NSGCT); this study examined whether an 18fluorodeoxyglucose positron emission tomography (18FDG PET) scan could identify patients without occult metastatic disease for whom surveillance is an attractive option. METHODS: High-risk (lymphovascular invasion positive) patients with CS1 NSGCT underwent 18FDG PET scanning within 8 weeks of orchidectomy or marker normalization. PET-positive patients went off study; PET-negative patients were observed on a surveillance program. The primary outcome measure was the 2-year relapse-free rate (RFR) in patients with a negative PET scan (the negative predictive value). Assuming an RFR of 90% to exclude an RFR less than 80% with approximately 90% power, 100 PET-negative patients were required; 135 scanned patients were anticipated. RESULTS: Patients were registered between May 2002 and January 2005, when the trial was stopped by the independent data monitoring committee due to an unacceptably high relapse rate in the PET-negative patients. Of 116 registered patients, 111 underwent PET scans, and 88 (79%) were PET-negative (61% of preorchidectomy marker-negative patients v 88% of marker-positive patients; P = .002); 87 proceeded to surveillance, and one requested adjuvant chemotherapy. With a median follow-up of 12 months, 33 of 87 patients on surveillance relapsed (1-year RFR, 63%; 90% CI, 54% to 72%). CONCLUSION: Though PET identified some patients with disease not detected by computed tomography scan, the relapse rate among PET negative patients remains high. The results show that 18FDG PET scanning is not sufficiently sensitive to identify patients at low risk of relapse in this setting.en
dc.language.isoenen
dc.subjectCancer Recurrenceen
dc.subjectCancer Stagingen
dc.subjectTesticular Canceren
dc.subject.meshAdolescent-
dc.subject.meshAdult-
dc.subject.meshBiopsy, Needle-
dc.subject.meshChemotherapy, Adjuvant-
dc.subject.meshCombined Modality Therapy-
dc.subject.meshDisease-Free Survival-
dc.subject.meshFluorodeoxyglucose F18-
dc.subject.meshGerminoma-
dc.subject.meshHumans-
dc.subject.meshMale-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Recurrence, Local-
dc.subject.meshNeoplasm Staging-
dc.subject.meshOrchiectomy-
dc.subject.meshPositron-Emission Tomography-
dc.subject.meshPredictive Value of Tests-
dc.subject.meshPrognosis-
dc.subject.meshRisk Assessment-
dc.subject.meshSalvage Therapy-
dc.subject.meshSensitivity and Specificity-
dc.subject.meshSurvival Analysis-
dc.subject.meshTesticular Neoplasms-
dc.title18fluorodeoxyglucose positron emission tomography in the prediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group.en
dc.typeArticleen
dc.contributor.departmentAcademic Radiotherapy, Institute of Cancer Research and Royal Marsden Hospital, Sutton, Surrey, UK. Robert.Huddart@icr.ac.uken
dc.identifier.journalJournal of Clinical Oncologyen

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