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1.  Comparison of 123I-Metaiodobenzylguanidine (MIBG) and 131I-MIBG Semi-Quantitative Scores in Predicting Survival in Patients With Stage 4 Neuroblastoma: A Report From the Children’s Oncology Group 
Pediatric blood & cancer  2011;56(7):1041-1045.
123I-metaiodobenzylguanidine (MIBG) scans are preferable to 131I-MIBG for neuroblastoma imaging as they deliver less patient radiation yet have greater sensitivity in disease detection. Both 123I-MIBG and 131I-MIBG scans were used for disease assessments of neuroblastoma patients enrolled on Children’s Oncology Group (COG) high-risk study A3973. The hypothesis was that 123I-MIBG and 131I-MIBG scans were sufficiently similar for clinical purposes in terms of ability to predict survival.
Patients enrolled on COG A3973 with stage 4 disease who completed 123I-MIBG or 131I-MIBG scans at diagnosis, post-induction, post-transplant, or post-biotherapy were analyzed. The performance of the Curie score for each MIBG scan type in predicting survival was evaluated. At each time point, survival curves for 123I-MIBG versus 131I-MIBG were compared using the log-rank test.
Of the 413 patients on A3973 with at least one MIBG scan, 350 were stage 4. The 5-year event-free survival (EFS) and overall survival (OS) rates were 33.4 ± 3.6% and 45.6 ± 4.0% (N = 350). At post-induction, EFS (P = 0.3501) and OS (P = 0.5337) for 123I-MIBG versus 131I-MIBG were not significantly different. Similarly, comparisons at the three other time points were non-significant.
We found no evidence of a statistically significant difference in outcome by type of scan. For future survival analyses of MIBG Curie scores, 123I-MIBG and 131I-MIBG results may be combined and analyzed overall, without adjustment for scan type.
PMCID: PMC4581540  PMID: 21328522
COG A3973; Curie score
2.  Phase II study of oral capsular 4-hydroxyphenylretinamide (4-HPR/fenretinide) in pediatric patients with refractory or recurrent neuroblastoma: A report from the Children’s Oncology Group NSC #374551; IND# 40294 
To determine the response rate to oral capsular fenretinide in children with recurrent or biopsy proven refractory high-risk neuroblastoma.
Experimental Design
Patients received 7 days of fenretinide: 2475 mg/m2/day divided TID (<18 years) or 1800 mg/m2/day divided BID (≥18 years) every 21 days for a maximum of 30 courses. Patients with stable or responding disease after course 30 could request additional compassionate courses. Best response by course 8 was evaluated in Stratum 1 (measurable disease on CT/MRI +/− bone marrow and/or MIBG avid sites) and Stratum 2 (bone marrow and/or MIBG avid sites only).
Sixty-two eligible patients, median age 5 years (range 0.6–19.9), were treated in Stratum 1 (n=38) and Stratum 2 (n=24). One partial response (PR) was seen in Stratum 2 (n=24 evaluable). No responses were seen in Stratum 1 (n=35 evaluable). Prolonged stable disease (SD) was seen in 7 patients in Stratum 1 and 6 patients in Stratum 2 for 4–45+ (median 15) courses. Median time to progression was 40 days (range 17–506) for Stratum 1 and 48 days (range 17–892) for Stratum 2. Mean 4-HPR steady state trough plasma concentrations were 7.25 µM (coefficient of variation 40–56%) at day 7 course 1. Toxicities were mild and reversible.
Although neither stratum met protocol criteria for efficacy, 1 PR + 13 prolonged SD occurred in 14/59 (24%) of evaluable patients. Low bioavailability may have limited fenretinide activity. Novel fenretinide formulations with improved bioavailability are currently in pediatric Phase I studies.
PMCID: PMC3207022  PMID: 21908574
fenretinide; neuroblastoma; Phase II; ANBL0321

Results 1-2 (2)