Titre
Outcome after reduced chemotherapy for intermediate-risk neuroblastoma.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Baker, D.L.
Auteure/Auteur
Schmidt, M.L.
Auteure/Auteur
Cohn, S.L.
Auteure/Auteur
Maris, J.M.
Auteure/Auteur
London, W.B.
Auteure/Auteur
Buxton, A.
Auteure/Auteur
Stram, D.
Auteure/Auteur
Castleberry, R.P.
Auteure/Auteur
Shimada, H.
Auteure/Auteur
Sandler, A.
Auteure/Auteur
Shamberger, R.C.
Auteure/Auteur
Look, A.T.
Auteure/Auteur
Reynolds, C.P.
Auteure/Auteur
Seeger, R.C.
Auteure/Auteur
Matthay, K.K.
Auteure/Auteur
Contributrices/contributeurs
Greenwood, M.
Salvi, S.
Kanwar, V.
Strother, D.
Frantz, C.
Daghistani, D.
Grewal, S.
Kretschmar, C.
Bond, M.
Mody, R.
Yanofsky, R.
Ferguson, W.
Atkinson, M.
McMahon, D.
Michon, B.
Yu, L.
Feusner, J.
Crouse, V.
Kuerbitz, S.
Halton, J.
Ravindranath, Y.
Broxson, E.
Dome, J.
Mascarenhas, L.
Shen, V.
Balis, F.
Lowe, E.
Bostrom, B.
Walterhouse, D.
Perentesis, J.
Tekautz, T.
Lee, A.
Isakoff, M.
Granger, M.
Prasannan, L.
Rodriguez-Galindo, C.
Chaffee, S.
Lockhart, S.
Johnson, MC.
Kreissman, S.
Pais, R.
Katzenstein, H.
Selsky, C.
Taylor, J.
Shad, A.
Stroud, C.
Appel, B.
Finklestein, J.
Dickens, D.
Samson, Y.
Grant, R.
Fallon, R.
Schorin, M.
Hand, J.
Arceci, R.
Kiley, V.
Lobel, J.
Silva, M.
Bertolone, S.
Salman, E.
Olson, J.
Bedros, A.
Kwon, JH.
Larsen, E.
McManus, M.
Louie, R.
Weinstein, H.
Arndt, C.
Portwine, C.
Lenarsky, C.
McDonough, C.
Kraveka, J.
Johnston, J.
Hanif, I.
Jasty, R.
Kobrinsky, N.
Estrada, J.
Gera, R.
Kelly, M.
Ricafort, R.
Chang, E.
Kirkpatrick, G.
Termuhlen, A.
Sandler, E.
Bernstein, J.
Ozkaynak, M.
Kamalakar, P.
Neely, J.
Boklan, J.
Bryant, P.
Barnette, P.
Cole, C.
Roberts, W.
Matloub, YJ.
Mitchell, T.
Schwartz, C.
Brecher, M.
Ashley, D.
Irving, H.
Felgenhauer, J.
Chatchawin, A.
Cameron, T.
John, H.
Bassem, R.
Luis, C.
Daniel, G.
Christopher, M.
Arlene, R.
Douglas, H.
Joseph, W.
Furman, W.
Smith, S.
Gowda, N.
Marina, N.
Desai, SJ.
Cherrick, I.
Lee, Y.
Ammann, R.
Beck Popovic, M.
Bomgaars, L.
Turner, C.
Maloney, K.
McCowage, G.
Hetherington, M.
Cohn, S.
Stein, D.
Scher, C.
Fu, C.
Drachtman, R.
Reddy, A.
Wittman, B.
Becton, D.
Goldsby, R.
Ducore, J.
Smith, A.
Schmidt, M.
Tannous, R.
Kumar, M.
York, T.
Keuker, C.
Neglia, J.
Megason, G.
Loew, T.
Winter, S.
Gold, S.
McNall-Knapp, R.
Ritchey, A.
Hackney, L.
Thomas, P.
Homans, A.
De Santes, K.
Winick, N.
Kuttesch, J.
Cairney, A.
Godder, K.
McLean, T.
Hayashi, R.
Chauvenet, A.
Main, C.
Weinblatt, M.
Kupfer, G.
Groupes de travail
Children's Oncology Group
Liens vers les personnes
Liens vers les unités
ISSN
1533-4406
Statut éditorial
Publié
Date de publication
2010
Volume
363
Numéro
14
Première page
1313
Dernière page/numéro d’article
1323
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Research Support, N.I.H., Extramural
Publication Status: ppublish
Publication Status: ppublish
Résumé
BACKGROUND: The survival rate among patients with intermediate-risk neuroblastoma who receive dose-intensive chemotherapy is excellent, but the survival rate among patients who receive reduced doses of chemotherapy for shorter periods of time is not known.
METHODS: We conducted a prospective, phase 3, nonrandomized trial to determine whether a 3-year estimated overall survival of more than 90% could be maintained with reductions in the duration of therapy and drug doses, using a tumor biology-based therapy assignment. Eligible patients had newly diagnosed, intermediate-risk neuroblastoma without MYCN amplification; these patients included infants (<365 days of age) who had stage 3 or 4 disease, children (≥365 days of age) who had stage 3 tumors with favorable histopathological features, and infants who had stage 4S disease with a diploid DNA index or unfavorable histopathological features. Patients who had disease with favorable histopathological features and hyperdiploidy were assigned to four cycles of chemotherapy, and those with an incomplete response or either unfavorable feature were assigned to eight cycles.
RESULTS: Between 1997 and 2005, a total of 479 eligible patients were enrolled in this trial (270 patients with stage 3 disease, 178 with stage 4 disease, and 31 with stage 4S disease). A total of 323 patients had tumors with favorable biologic features, and 141 had tumors with unfavorable biologic features. Ploidy, but not histopathological features, was significantly predictive of the outcome. Severe adverse events without disease progression occurred in 10 patients (2.1%), including secondary leukemia (in 3 patients), death from infection (in 3 patients), and death at surgery (in 4 patients). The 3-year estimate (±SE) of overall survival for the entire group was 96±1%, with an overall survival rate of 98±1% among patients who had tumors with favorable biologic features and 93±2% among patients who had tumors with unfavorable biologic features.
CONCLUSIONS: A very high rate of survival among patients with intermediate-risk neuroblastoma was achieved with a biologically based treatment assignment involving a substantially reduced duration of chemotherapy and reduced doses of chemotherapeutic agents as compared with the regimens used in earlier trials. These data provide support for further reduction in chemotherapy with more refined risk stratification. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003093.)
METHODS: We conducted a prospective, phase 3, nonrandomized trial to determine whether a 3-year estimated overall survival of more than 90% could be maintained with reductions in the duration of therapy and drug doses, using a tumor biology-based therapy assignment. Eligible patients had newly diagnosed, intermediate-risk neuroblastoma without MYCN amplification; these patients included infants (<365 days of age) who had stage 3 or 4 disease, children (≥365 days of age) who had stage 3 tumors with favorable histopathological features, and infants who had stage 4S disease with a diploid DNA index or unfavorable histopathological features. Patients who had disease with favorable histopathological features and hyperdiploidy were assigned to four cycles of chemotherapy, and those with an incomplete response or either unfavorable feature were assigned to eight cycles.
RESULTS: Between 1997 and 2005, a total of 479 eligible patients were enrolled in this trial (270 patients with stage 3 disease, 178 with stage 4 disease, and 31 with stage 4S disease). A total of 323 patients had tumors with favorable biologic features, and 141 had tumors with unfavorable biologic features. Ploidy, but not histopathological features, was significantly predictive of the outcome. Severe adverse events without disease progression occurred in 10 patients (2.1%), including secondary leukemia (in 3 patients), death from infection (in 3 patients), and death at surgery (in 4 patients). The 3-year estimate (±SE) of overall survival for the entire group was 96±1%, with an overall survival rate of 98±1% among patients who had tumors with favorable biologic features and 93±2% among patients who had tumors with unfavorable biologic features.
CONCLUSIONS: A very high rate of survival among patients with intermediate-risk neuroblastoma was achieved with a biologically based treatment assignment involving a substantially reduced duration of chemotherapy and reduced doses of chemotherapeutic agents as compared with the regimens used in earlier trials. These data provide support for further reduction in chemotherapy with more refined risk stratification. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00003093.)
Sujets
PID Serval
serval:BIB_2F4F92F42E1C
PMID
Open Access
Oui
Date de création
2014-10-17T09:38:36.097Z
Date de création dans IRIS
2025-05-20T15:54:32Z