Table 1.
Renal cell carcinoma-directed imaging using radiolabeled G250
| Study | Year | Trial design | Primary outcomes | Patients n (n final) | Imaging agent | RCC stage | Accuracy (primary/mRCC) | Adverse events† |
|---|---|---|---|---|---|---|---|---|
| Oosterwijk et al91 | 1993 | I* | Imaging and biodistribution characteristics | 16 (15) | 131I-mG250 | All | 12/12 ccRCC 1/3 non-ccRCC >90% of primary and mRCC lesions |
None |
| Steffens et al79 | 1997 | I* | Pharmacokinetics, biodistribution, immunogenicity, and imaging characteristics | 16 | 131I-cG250 | All | 13/13 ccRCC 0/3 non-ccRCC 5/5 mRCC |
HACA 2/16 |
| Divgi et al78 | 1998 | I/II | Maximum tolerated dose and therapeutic efficacy (RIT) | 33 | 131I-mG250 | IV | 100% lesions > 2 cm | None |
| Steffens et al99 | 1999 | I | Maximum tolerated dose (RIT) | 12 | 131I-cG250 | IV | Metastases visualized in 9/12 patients | None |
| Brouwers et al92 | 2002 | Open, nonrandomized | Diagnostic efficacy (intrapatient comparison) | 20 | 131I-cG250 vs 18F-FDG | IV | Metastases visualized in 77/112 18F-FDG 34/112 131I-cG250 |
None |
| Brouwers et al95 | 2003 | Subanalysis of phase I/II trial | Diagnostic efficacy (intrapatient comparison) | 5 | 131I-cG250 vs 111In-cG250 | IV |
111In-cG250 47 lesions 131I-cG250 30 lesions |
None |
| Divgi et al100 | 2004 | I | Maximum tolerated dose (fractionated RIT) | 15 | 131I-cG250 | IV | 100% lesions > 2 cm | 2/15 HACA 1/15 G2 allergic reaction |
| Brouwers et al94 | 2005 | I/II | Safety and therapeutic efficacy (RIT) | 29 | 131I-cG250 | IV | CT/MRI 92 lesions 131I-cG250 138 lesions |
None |
| Divgi et al20 | 2007 | I* | Characterization of tumor histology | 26 (25) | 124I-cG250 | All | 15/16 ccRCC 0/9 non-ccRCC Sensitivity 94% NPV 90%, PPV 100% |
None |
| Uzzo et al108 | 2010 | III* | Characterization of tumor histology, comparison of diagnostic efficacy with CECT | 204 (195) | 124I-cG250 | All | 86% sensitivity 87% specificity 95% PPV |
13.3% transient AEs 1/204 G3 hepatic dysfunction 56/198 HACA |
Notes:
*
Presurgical imaging;
†
only adverse events related to the use of G250 for diagnostic or pretreatment purposes were reported.
Abbreviations: RCC, renal cell carcinoma; ccRCC, clear-cell RCC; mRCC, metastatic RCC; m, murine; c, chimeric; HACA, human antichimeric antibodies; CECT, contrast-enhanced computed tomography; RIT, radioimmunotherapy; G, grade; NPV, negative predictive value; PPV, positive predictive value; AE, adverse event.