Follow-up investigations. Omgo E. Nieweg

Transcription

1 Follow-up investigations Omgo E. Nieweg

2 Systematic literature review follow-up investigations identify few patients with recurrence frequent false positive findings impact on survival unclear Nieweg, Surg Oncol Clin N Am 2006;15:

3 British and Dutch guidelines stage III-IV No follow-up investigations NICE 2015

4 German guidelines stage III-IV first three years every 3 months ultrasound of nodal basin serum S-100 every six months whole body CT or whole body MRI or whole body PET/CT with brain MRI Pflugfelder, J Deutschen Dermatol Gesellschaft, 2013;11:

5 Is it worthwhile to detect relapse at an early stage? Corrected for lead-time bias, early detection of melanoma metastasis during surveillance is associated with a survival benefit in stage I-III patients. Diagnostic techniques have been refined. Effective systemic therapy Leiter, Melanoma Res 2010;20: 240-6

6 Laboratory tests blood cell counts blood chemistry screen serum lactate dehydrogenase S-100B

7 S-100B 88 patients undergoing sentinel node biopsy three-monthly follow-up with S-100B median follow-up 41 months 18 patients recurred 8 of these patients had elevated S-100B (sensitivity 44%) in 2 patients recurrence detected because of elevated S-100B no S-100B elevation in patients without recurrence Smit, J Surg Oncol 2005;90: 66-9

8 Ultrasound 181 patients lymphoscintigraphy without sentinel node biopsy focused ultrasound 33% of nodal recurrence detected focused ultrasound acceptable management Ipenburg, Ann Surg Oncol, in press

9 Follow-up imaging Whole body PET/CT MRI of the brain

10 PET in the follow-up of melanoma patients: a systematic review Danielsen, Am J Nucl Med Mol Imaging 2014;4: 17-28

11 Patients and methods 6 studies 415 patients studies grade B 4 studies grade C prospective studies retrospective studies patients without symptoms patients with symptoms stage II and III PET or PET/CT hot spots confirmed normal scans not confirmed Danielsen, Am J Nucl Med Mol Imaging 2014;4: 17-28

12 Results % sensitivity 96 false negative rate 4 specificity 92 false positive rate 8 Danielsen, Am J Nucl Med Mol Imaging 2014; 4: 17-28

13 Patients and methods 6 studies 415 patients studies grade B 4 studies grade C prospective studies retrospective studies patients without symptoms patients with symptoms stage II and III PET or PET/CT hot spots confirmed normal scans not confirmed Danielsen, Am J Nucl Med Mol Imaging 2014;4: 17-28

14 Conclusions. the true evidence of PET s role in routine follow-up of asymptomatic melanoma patients has yet to be properly clarified. Danielsen, Am J Nucl Med Mol Imaging 2014; 4: 17-28

15 Follow-up investigations PET/CT whole body MRI brain CT lungs MRI liver S-100B

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17 Recommendations Danielson et al value of PET/CT should be tested asymptomatic patients randomised study survival benefit should be clarified cost-effectiveness analysis Danielsen, Am J Nucl Med Mol Imaging 2014; 4: 17-28

18 Grade A methodological quality of diagnostic studies 35 patients with disease 35 patients without disease patients drawn from a clinically relevant sample clinical symptoms appropriately described diagnoses defined by an appropriate reference standard high quality imaging images evaluated independently of reference Flynn, MDRC Technology Assessment Program - PET report, 1996

19 Danielsen, Am J Nucl Med Mol Imaging 2014; 4: 17-28

20 Grades for quality assessment A - Body of evidence can be trusted to guide practice B - Body of evidence can be trusted to guide practice in most situations C - Body of evidence provides some support for recommendation(s) but care should be taken in its application D - Body of evidence is weak and recommendations must be applied with caution

21 Study population : high risk technique : whole body PET/CT, brain MRI frequency : 3, 4, 6 monthly? endpoints : sensitivity specificity treatment initiated? what treatment? outcome false positive rate false positive consequences

22 Primary endpoints frequency of suspicious findings sensitivity specificity treatment initiated? nature of treatment resource use and costs quality adjusted survival cost-effectiveness

23 Secondary endpoints frequency of recurrence time to recurrence location of recurrence how often recurrence detected by patient, doctor, imaging? how presence/absence of disease confirmed (gold standard) change in stage of disease? what other lesions were found? doctor s visits, examinations and procedures required to confirm a recurrence additional tests and procedures in false positive cases? circulating tumour DNA?

24 Questions what stage? MRI of brain? LDH? circulating tumour DNA? How long should patients be in the study? frequency of imaging? include symptomatic patients?

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