Time to disease progression in children with relapsed or refractory neuroblastoma treated with ABT-751: A report from the Children's Oncology Group (ANBL0621)

Background ABT‐751, an orally bioavailable sulfonamide binds the colchicine site of beta‐tubulin and inhibits microtubule polymerizaton. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m2 PO daily × 7 days every 21 days and subjects with neuroblastoma e...

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Published inPediatric blood & cancer Vol. 61; no. 6; pp. 990 - 996
Main Authors Fox, Elizabeth, Mosse', Yael P., Meany, Holly M., Gurney, James G., Khanna, Geetika, Jackson, Hollie A., Gordon, Gary, Shusterman, Suzanne, Park, Julie R., Cohn, Susan L., Adamson, Peter C., London, Wendy B., Maris, John M., Balis, Frank M.
Format Journal Article
LanguageEnglish
Published United States Blackwell Publishing Ltd 01.06.2014
Wiley Subscription Services, Inc
Subjects
Adolescent
Antineoplastic Agents - adverse effects
Antineoplastic Agents - pharmacokinetics
Antineoplastic Agents - therapeutic use
Biomarkers
Capsules
Child
Child, Preschool
childhood cancer
clinical trial
Combined Modality Therapy
Disease Progression
Disease-Free Survival
Female
Gastrointestinal Diseases - chemically induced
Hematologic Diseases - chemically induced
Hematology
Humans
Male
microtubule inhibitor
Nervous System Diseases - chemically induced
neuroblastoma
Neuroblastoma - drug therapy
Neuroblastoma - therapy
Oncology
Pediatrics
Quality of Life
Recurrence
Salvage Therapy
Sulfonamides - adverse effects
Sulfonamides - pharmacokinetics
Sulfonamides - therapeutic use
Suspensions
time to progression
Treatment Failure
Tubulin Modulators - therapeutic use
clinical trial
neuroblastoma
childhood cancer
time to progression
microtubule inhibitor
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Abstract Background ABT‐751, an orally bioavailable sulfonamide binds the colchicine site of beta‐tubulin and inhibits microtubule polymerizaton. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m2 PO daily × 7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT‐751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population. Procedure Children and adolescents (n = 91) with a median (range) age 7.7 (2.3–21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n = 47) or disease assessable by 123I‐metaiodobenzylguanine scintigraphy (MIBG, n = 44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG‐avid disease. Results ABT‐751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG‐avid disease stratum. TTP was similar to the historical control group (n = 136, median TTP 42 days). For the combined strata (n = 91), 1‐year progression free survival (PFS) was 13 ± 4% and overall survival (OS) was 48 ± 5%. Conclusions The low objective response rate and failure to prolong TTP indicate that ABT‐751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma. Pediatr Blood Cancer 2014;61:990–996. © 2013 Wiley Periodicals, Inc.
AbstractList ABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerization. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m(2) PO daily × 7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT-751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population.BACKGROUNDABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerization. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m(2) PO daily × 7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT-751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population.Children and adolescents (n = 91) with a median (range) age 7.7 (2.3-21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n = 47) or disease assessable by (123) I-metaiodobenzylguanine scintigraphy (MIBG, n = 44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG-avid disease.PROCEDUREChildren and adolescents (n = 91) with a median (range) age 7.7 (2.3-21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n = 47) or disease assessable by (123) I-metaiodobenzylguanine scintigraphy (MIBG, n = 44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG-avid disease.ABT-751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG-avid disease stratum. TTP was similar to the historical control group (n = 136, median TTP 42 days). For the combined strata (n = 91), 1-year progression free survival (PFS) was 13 ± 4% and overall survival (OS) was 48 ± 5%.RESULTSABT-751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG-avid disease stratum. TTP was similar to the historical control group (n = 136, median TTP 42 days). For the combined strata (n = 91), 1-year progression free survival (PFS) was 13 ± 4% and overall survival (OS) was 48 ± 5%.The low objective response rate and failure to prolong TTP indicate that ABT-751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma.CONCLUSIONSThe low objective response rate and failure to prolong TTP indicate that ABT-751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma.
ABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerization. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m(2) PO daily × 7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT-751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population. Children and adolescents (n = 91) with a median (range) age 7.7 (2.3-21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n = 47) or disease assessable by (123) I-metaiodobenzylguanine scintigraphy (MIBG, n = 44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG-avid disease. ABT-751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG-avid disease stratum. TTP was similar to the historical control group (n = 136, median TTP 42 days). For the combined strata (n = 91), 1-year progression free survival (PFS) was 13 ± 4% and overall survival (OS) was 48 ± 5%. The low objective response rate and failure to prolong TTP indicate that ABT-751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma.
Background ABT‐751, an orally bioavailable sulfonamide binds the colchicine site of beta‐tubulin and inhibits microtubule polymerizaton. Prior phase I studies established the recommended dose in children with solid tumors as 200 mg/m2 PO daily × 7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT‐751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population. Procedure Children and adolescents (n = 91) with a median (range) age 7.7 (2.3–21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n = 47) or disease assessable by 123I‐metaiodobenzylguanine scintigraphy (MIBG, n = 44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG‐avid disease. Results ABT‐751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG‐avid disease stratum. TTP was similar to the historical control group (n = 136, median TTP 42 days). For the combined strata (n = 91), 1‐year progression free survival (PFS) was 13 ± 4% and overall survival (OS) was 48 ± 5%. Conclusions The low objective response rate and failure to prolong TTP indicate that ABT‐751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma. Pediatr Blood Cancer 2014;61:990–996. © 2013 Wiley Periodicals, Inc.
Background ABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerizaton. Prior phase I studies established the recommended dose in children with solid tumors as 200mg/m2 PO daily×7 days every 21 days and subjects with neuroblastoma experienced prolonged stable disease. We conducted a phase 2 study (NCT00436852) in children and adolescents with progressive neuroblastoma to determine if ABT-751 prolonged the time to progression (TTP) compared to a hypothesized standard based on a historical control population. Procedure Children and adolescents (n=91) with a median (range) age 7.7 (2.3-21.5) years and progressive neuroblastoma were enrolled and stratified by disease status into disease measureable by CT/MRI (n=47) or disease assessable by 123I-metaiodobenzylguanine scintigraphy (MIBG, n=44). Response was evaluated using RECIST for measureable disease and the Curie score for MIBG-avid disease. Results ABT-751 was well tolerated. The objective response rate was 7%. The median TTP was 42 days (95% CI: 36, 56) in the measureable disease stratum and 45 days (95% CI: 42, 85) in the MIBG-avid disease stratum. TTP was similar to the historical control group (n=136, median TTP 42 days). For the combined strata (n=91), 1-year progression free survival (PFS) was 13±4% and overall survival (OS) was 48±5%. Conclusions The low objective response rate and failure to prolong TTP indicate that ABT-751 is not sufficiently active to warrant further development for neuroblastoma. However, this trial demonstrates the utility of TTP as the primary endpoint in phase 2 trials in children and adolescents with neuroblastoma. Pediatr Blood Cancer 2014;61:990-996. © 2013 Wiley Periodicals, Inc. [PUBLICATION ABSTRACT]
Author Mosse', Yael P.
Gordon, Gary
Meany, Holly M.
Jackson, Hollie A.
London, Wendy B.
Cohn, Susan L.
Gurney, James G.
Khanna, Geetika
Fox, Elizabeth
Maris, John M.
Park, Julie R.
Adamson, Peter C.
Shusterman, Suzanne
Balis, Frank M.
AuthorAffiliation 6 Abbott Laboratories, Abbott Park, IL
3 Saint Jude Children's Research Hospital, Memphis, TN
1 The Children's Hospital of Philadelphia, Philadelphia, PA
2 Children's National Medical Center, Washington, DC
4 Washington University School of Medicine, St Louis. MO
9 University of Chicago, Chicago, IL
7 Boston Children's Hospital and Dana-Farber Harvard Cancer Center, Boston, MA
8 Seattle Children's Hospital, Seattle, WA
5 Children's Hospital of Los Angeles, Los Angeles, CA
10 Children Oncology Group Statistics and Data Center, Gainesville, FL
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  email: Correspondence to: Elizabeth Fox, The Children's Hospital of Philadelphia, CTRB4016, 3501 Civic Center Blvd, Philadelphia, PA 19104., foxe@email.chop.edu
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Keywords clinical trial
neuroblastoma
childhood cancer
time to progression
microtubule inhibitor
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2013 Wiley Periodicals, Inc.
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PublicationTitle Pediatric blood & cancer
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Fox E, Maris JM, Cohn SL, et al. Pharmacokinetics of orally administered ABT-751 in children with neuroblastoma and other solid tumors. Cancer Chemother Pharmacol 2010; 66:737-743.
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Morton CL, Favours EG, Mercer KS, et al. Evaluation of ABT-751 against childhood cancer models in vivo. Invest New Drugs 2007; 25:285-295.
Varni JW, Burwinkle TM, Katz ER, et al. The PedsQL in pediatric cancer: Reliability and validity of the pediatric quality of life inventory generic core scales, multidimensional fatigue scale, and cancer module. Cancer 2002; 94:2090-2106.
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References_xml – reference: Fox E, Maris JM, Widemann BC, et al. A phase I study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 21 days every 28 days in pediatric patients with solid tumors. Clin Cancer Res 2008; 14:1111-1115.
– reference: Varni JW, Burwinkle TM, Seid M, et al. The Peds QL™ as a pediatric population health measure: Feasibility, reliability, and validity. Ambul Pediatr 2003; 3:329-341.
– reference: Meany HJ, Sackett DL, Maris JM, et al. Clinical outcome in children with recurrent neuroblastoma treated with ABT-751 and effect of ABT-751 on proliferation of neuroblastoma cell lines and on tubulin polymerization in vitro. Pediatr Blood Cancer 2010; 54:47-54.
– reference: Morton CL, Favours EG, Mercer KS, et al. Evaluation of ABT-751 against childhood cancer models in vivo. Invest New Drugs 2007; 25:285-295.
– reference: Fox E, Maris JM, Widemann BC, et al. A phase 1 study of ABT-751, an orally bioavailable tubulin inhibitor, administered daily for 7 days every 21 days in pediatric patients with solid tumors. Clin Cancer Res 2006; 12:4882-4887.
– reference: Fox E, Maris JM, Cohn SL, et al. Pharmacokinetics of orally administered ABT-751 in children with neuroblastoma and other solid tumors. Cancer Chemother Pharmacol 2010; 66:737-743.
– reference: Varni JW, Burwinkle TM, Seid M, et al. The PedsQL 4.0 as a pediatric population health measure: Feasibility, reliability, and validity. Ambul Pediatr 2003; 3:329-341.
– reference: Yu AL, Gilman AL, Ozkaynak MF, et al. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med 2010; 363:1324-1334.
– reference: Maris JM, Hogarty MD, Bagatell R, et al. Neuroblastoma. Lancet 2007; 369:2106-2120.
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– reference: Woolson R. Rank tests and a one sample logrank test for comparing observed survival data to a standard population. Biometrics 1981; 37:687-696.
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Snippet Background ABT‐751, an orally bioavailable sulfonamide binds the colchicine site of beta‐tubulin and inhibits microtubule polymerizaton. Prior phase I studies...
ABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerization. Prior phase I studies...
Background ABT-751, an orally bioavailable sulfonamide binds the colchicine site of beta-tubulin and inhibits microtubule polymerizaton. Prior phase I studies...
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StartPage 990
SubjectTerms Adolescent
Antineoplastic Agents - adverse effects
Antineoplastic Agents - pharmacokinetics
Antineoplastic Agents - therapeutic use
Biomarkers
Capsules
Child
Child, Preschool
childhood cancer
clinical trial
Combined Modality Therapy
Disease Progression
Disease-Free Survival
Female
Gastrointestinal Diseases - chemically induced
Hematologic Diseases - chemically induced
Hematology
Humans
Male
microtubule inhibitor
Nervous System Diseases - chemically induced
neuroblastoma
Neuroblastoma - drug therapy
Neuroblastoma - therapy
Oncology
Pediatrics
Quality of Life
Recurrence
Salvage Therapy
Sulfonamides - adverse effects
Sulfonamides - pharmacokinetics
Sulfonamides - therapeutic use
Suspensions
time to progression
Treatment Failure
Tubulin Modulators - therapeutic use
Title Time to disease progression in children with relapsed or refractory neuroblastoma treated with ABT-751: A report from the Children's Oncology Group (ANBL0621)
URI https://api.istex.fr/ark:/67375/WNG-2RNL93G5-9/fulltext.pdf
https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fpbc.24900
https://www.ncbi.nlm.nih.gov/pubmed/24347462
https://www.proquest.com/docview/1516397167
https://www.proquest.com/docview/1517398260
https://pubmed.ncbi.nlm.nih.gov/PMC5127168
Volume 61
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