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Feasibility of implementing molecular-guided therapy for the treatment of patients with relapsed or refractory neuroblastoma.

Saulnier Sholler GL, Bond JP, Bergendahl G, Dutta A, Dragon J, Neville K, Ferguson W, Roberts W, Eslin D, Kraveka J, Kaplan J, Mitchell D, Parikh N, Merchant M, Ashikaga T, Hanna G, Lescault PJ, Siniard A, Corneveaux J, Huentelman M, Trent J - Cancer Med (2015)

Bottom Line: Current treatment options for recurrent neuroblastoma are limited and ineffective, with a survival rate of <10%.Clinical benefit was seen in 64% of patients as stabilization of disease for at least one cycle of therapy or partial response.This study demonstrates the feasibility and safety of performing real-time genomic profiling to guide treatment decision making for pediatric neuroblastoma patients.

View Article: PubMed Central - PubMed

Affiliation: Helen DeVos Children's Hospital, Grand Rapids, Michigan.

No MeSH data available.


Related in: MedlinePlus

Box-and-whisker representation of the completion times (Days) for each step in the study process relative to the date of biopsy. The median, interquartile range, and range are represented by the central band, box, and whiskers, respectively.
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fig02: Box-and-whisker representation of the completion times (Days) for each step in the study process relative to the date of biopsy. The median, interquartile range, and range are represented by the central band, box, and whiskers, respectively.

Mentions: There were 16 subjects enrolled with multiply relapsed or refractory neuroblastoma of which 14 were eligible: eight males and six females with a median age of 10.1 years (see Table 1A). Subjects were between 1–11 years post diagnosis. The patients presented with actively progressing neuroblastoma and had exhausted relapse therapies (see Table S1). All subjects had soft tissue disease in which biopsy was possible. All biopsies were adequate by pathology evaluation (>75% viable tumor) and RNA quality (>6.5 RIN). Two subjects were deemed ineligible due to benign tumor type after biopsy, therefore 14 subjects were eligible to remain on study. Gene chips were completed in 3–8 days (95% CI: 3.8–6.8), report generation took 0–3 days (95% CI: 0.0–1.5), tumor board took 1–6 days (95% CI: 1.6–4.2), medical monitor sign off took 1–2 days (95% CI: 0.8–1.4). The total time from date of biopsy to tumor board was 6–11 days (95% CI: 7.5–10.2) for all subjects and 7–20 days to treatment (95% CI: 8.9–16.1) (Fig. 2). The tumor board successfully created individualized therapy regimens for all subjects. Patients received between 2–4 drugs chosen from the predicted list. All patients completed at least one cycle of therapy, resulting in 100% feasibility.


Feasibility of implementing molecular-guided therapy for the treatment of patients with relapsed or refractory neuroblastoma.

Saulnier Sholler GL, Bond JP, Bergendahl G, Dutta A, Dragon J, Neville K, Ferguson W, Roberts W, Eslin D, Kraveka J, Kaplan J, Mitchell D, Parikh N, Merchant M, Ashikaga T, Hanna G, Lescault PJ, Siniard A, Corneveaux J, Huentelman M, Trent J - Cancer Med (2015)

Box-and-whisker representation of the completion times (Days) for each step in the study process relative to the date of biopsy. The median, interquartile range, and range are represented by the central band, box, and whiskers, respectively.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4472210&req=5

fig02: Box-and-whisker representation of the completion times (Days) for each step in the study process relative to the date of biopsy. The median, interquartile range, and range are represented by the central band, box, and whiskers, respectively.
Mentions: There were 16 subjects enrolled with multiply relapsed or refractory neuroblastoma of which 14 were eligible: eight males and six females with a median age of 10.1 years (see Table 1A). Subjects were between 1–11 years post diagnosis. The patients presented with actively progressing neuroblastoma and had exhausted relapse therapies (see Table S1). All subjects had soft tissue disease in which biopsy was possible. All biopsies were adequate by pathology evaluation (>75% viable tumor) and RNA quality (>6.5 RIN). Two subjects were deemed ineligible due to benign tumor type after biopsy, therefore 14 subjects were eligible to remain on study. Gene chips were completed in 3–8 days (95% CI: 3.8–6.8), report generation took 0–3 days (95% CI: 0.0–1.5), tumor board took 1–6 days (95% CI: 1.6–4.2), medical monitor sign off took 1–2 days (95% CI: 0.8–1.4). The total time from date of biopsy to tumor board was 6–11 days (95% CI: 7.5–10.2) for all subjects and 7–20 days to treatment (95% CI: 8.9–16.1) (Fig. 2). The tumor board successfully created individualized therapy regimens for all subjects. Patients received between 2–4 drugs chosen from the predicted list. All patients completed at least one cycle of therapy, resulting in 100% feasibility.

Bottom Line: Current treatment options for recurrent neuroblastoma are limited and ineffective, with a survival rate of <10%.Clinical benefit was seen in 64% of patients as stabilization of disease for at least one cycle of therapy or partial response.This study demonstrates the feasibility and safety of performing real-time genomic profiling to guide treatment decision making for pediatric neuroblastoma patients.

View Article: PubMed Central - PubMed

Affiliation: Helen DeVos Children's Hospital, Grand Rapids, Michigan.

No MeSH data available.


Related in: MedlinePlus