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    Wyświetlanie 1-9 z 9
    Tytuł:
    Response-adapted omission of radiotherapy in children and adolescents with early-stage classical Hodgkin lymphoma and an adequate response to vincristine, etoposide, prednisone, and doxorubicin (EuroNet-PHL-C1) : a titration study
    Autorzy:
    Ramsay, Alan D.
    Mauz-Körholz, Christine
    Vordermark, Dirk
    Gattenlöhner, Stefan
    Mann, Georg
    Daw, Stephen
    Wallace, William H.
    Rajić, Vladan
    Claviez, Alexander
    Georgi, Thomas
    Leblanc, Thierry
    Stoevesandt, Dietrich
    Montravers, Francoise
    Fernández-Teijeiro, Ana
    Hraskova, Andrea
    Dieckmann, Karin
    Pears, Jane
    Karlen, Jonas
    Pelz, Tanja
    Kluge, Regine
    Kurch, Lars
    Balwierz, Walentyna
    Boudjemaa, Sabah
    Fossa, Alexander
    Körholz, Dieter
    Uyttebroeck, Anne
    Hasenclever, Dirk
    Attarbaschi, Andishe
    Cepelova, Michaela
    Ceppi, Francesco
    Landman-Parker, Judith
    Hjalgrim, Lisa L.
    Bartelt, Jörg M.
    Beishuizen, Auke
    Opis:
    Background: Children and adolescents with early-stage classical Hodgkin lymphoma have a 5-year event-free survival of 90% or more with vincristine, etoposide, prednisone, and doxorubicin (OEPA) plus radiotherapy, but late complications of treatment affect survival and quality of life. We investigated whether radiotherapy can be omitted in patients with adequate morphological and metabolic responses to OEPA. Methods: The EuroNet-PHL-C1 trial was designed as a titration study and recruited patients at 186 hospital sites across 16 European countries. Children and adolescents with newly diagnosed stage IA, IB, and IIA classical Hodgkin lymphoma younger than 18 years of age were assigned to treatment group 1 to be treated with two cycles of OEPA (vincristine 1·5 mg/m2 intravenously, capped at 2 mg, on days 1, 8, and 15; etoposide 125 mg/m2 intravenously, on days 1–5; prednisone 60 mg/m2 orally on days 1–15; and doxorubicin 40 mg/m2 intravenously on days 1 and 15). If no adequate response (a partial morphological remission or greater and PET negativity) had been achieved after two cycles of OEPA, involved-field radiotherapy was administered at a total dose of 19·8 Gy (usually in 11 fractions of 1·8 Gy per day). The primary endpoint was event-free survival. The primary objective was maintaining a 5-year event-free survival rate of 90% in patients with an adequate response to OEPA without radiotherapy. We performed intention-to-treat and per-protocol analyses. The trial was registered at ClinicalTrials.gov (NCT00433459) and with EUDRACT, (2006–000995-33) and is completed. Findings: Between Jan 31, 2007, and Jan 30, 2013, 2131 patients were registered and 2102 patients were enrolled onto EuroNet-PHL-C1. Of these 2102 patients, 738 with early-stage disease were allocated to treatment group 1. Median follow-up was 63·3 months (IQR 60·1–69·8). We report on 714 patients assigned to and treated on treatment group 1; the intention-to-treat population comprised 713 patients with 323 (45%) male and 390 (55%) female patients. In 440 of 713 patients in the intention-to-treat group who had an adequate response and did not receive radiotherapy, 5-year event-free survival was 86·5% (95% CI 83·3–89·8), which was less than the 90% target rate. In 273 patients with an inadequate response who received radiotherapy, 5-year event-free survival was 88·6% (95% CI 84·8–92·5), for which the 95% CI included the 90% target rate. The most common grade 3–4 adverse events were neutropenia (in 597 [88%] of 680 patients) and leukopenia (437 [61%] of 712). There were no treatment-related deaths. Interpretation: On the basis of all the evidence, radiotherapy could be omitted in patients with early-stage classical Hodgkin lymphoma and an adequate response to OEPA, but patients with risk factors might need more intensive treatment.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    Response-adapted omission of radiotherapy and comparison of consolidation chemotherapy in children and adolescents with intermediate-stage and advanced-stage classical Hodgkin lymphoma (EuroNet-PHL-C1) : a titration study with an open-label, embedded, multinational, non-inferiority, randomised controlled trial
    Autorzy:
    Hjalgrim, Lisa L.
    Pelz, Tanja
    Claviez, Alexander
    Mauz-Korholz, Christine
    Rajic, Vladan
    Cepelova, Michaela
    Wallace, William Hamish
    Daw, Stephen
    Karlen, Jonas
    Kurch, Lars
    Gattenlohner, Stefan
    Ramsay, Alan D.
    Stoevesandt, Dietrich
    Dieckmann, Karin
    Bartelt, Jorg M.
    Balwierz, Walentyna
    Montravers, Francoise
    Hasenclever, Dirk
    Beishuizen, Auke
    Attarbaschi, Andishe
    Anderson, Richard A.
    Ammann, Roland A.
    Vordermark, Dirk
    Landman-Parker, Judith
    Korholz, Dieter
    Boudjemaa, Sabah
    Mann, Georg
    Uyttebroeck, Anne
    Fernandez-Teijeiro, Ana
    Fossa, Alexander
    Kluge, Regine
    Leblanc, Thiery
    Georgi, Thomas
    Pears, Jean
    Hraskova, Andrea
    Opis:
    Background: Children and adolescents with intermediate-stage and advanced-stage classical Hodgkin lymphoma achieve an event-free survival at 5 years of about 90% after treatment with vincristine, etoposide, prednisone, and doxorubicin (OEPA) followed by cyclophosphamide, vincristine, prednisone, and procarbazine (COPP) and radiotherapy, but long-term treatment effects affect survival and quality of life. We aimed to investigate whether radiotherapy can be omitted in patients with morphological and metabolic adequate response to OEPA and whether modified consolidation chemotherapy reduces gonadotoxicity. Methods: Our study was designed as a titration study with an open-label, embedded, multinational, non-inferiority, randomised controlled trial, and was carried out at 186 hospital sites across 16 European countries. Children and adolescents with newly diagnosed intermediate-stage (treatment group 2) and advanced-stage (treatment group 3) classical Hodgkin lymphoma who were younger than 18 years and stratified according to risk using Ann Arbor disease stages IIAE, IIB, IIBE, IIIA, IIIAE, IIIB, IIIBE, and all stages IV (A, B, AE, and BE) were included in the study. Patients with early disease (treatment group 1) were excluded from this analysis. All patients were treated with two cycles of OEPA (1·5 mg/m2 vincristine taken intravenously capped at 2 mg, on days 1, 8, and 15; 125 mg/m2 etoposide taken intravenously on days 1–5; 60 mg/m2 prednisone taken orally on days 1–15; and 40 mg/m2 doxorubicin taken intravenously on days 1 and 15). Patients were randomly assigned to two (treatment group 2) or four (treatment group 3) cycles of COPP (500 mg/m2 cyclophosphamide taken intravenously on days 1 and 8; 1·5 mg/m2 vincristine taken intravenously capped at 2 mg, on days 1 and 8; 40 mg/m2 prednisone taken orally on days 1 to 15; and 100 mg/m2 procarbazine taken orally on days 1 to 15) or COPDAC, which was identical to COPP except that 250 mg/m2 dacarbazine administered intravenously on days 1 to 3 replaced procarbazine. The method of randomisation (1:1) was minimisation with stochastic component and was centrally stratified by treatment group, country, trial sites, and sex. The primary endpoint was event-free survival, defined as time from treatment start until the first of the following events: death from any cause, progression or relapse of classical Hodgkin lymphoma, or occurrence of secondary malignancy. The primary objectives were maintaining 90% event-free survival at 5 years in patients with adequate response to OEPA treated without radiotherapy and to exclude a decrease of 8% in event-free survival at 5 years in the embedded COPDAC versus COPP randomisation to show non-inferiority of COPDAC. Efficacy analyses are reported per protocol and safety in the intention-to-treat population. The trial is registered with ClinicalTrials.gov (trial number NCT00433459) and EUDRACT (trial number 2006-000995-33), and is closed to recruitment. Findings: Between Jan 31, 2007, and Jan 30, 2013, 2102 patients were recruited. 737 (35%) of the 2102 recruited patients were in treatment group 1 (early-stage disease) and were not included in our analysis. 1365 (65%) of the 2102 patients were in treatment group 2 (intermediate-stage disease; n=455) and treatment group 3 (advanced-stage disease; n=910). Of these 1365, 1287 (94%) patients (435 [34%] of 1287 in treatment group 2 and 852 [66%] of 1287 in treatment group 3) were included in the titration trial per-protocol analysis. 937 (69%) of 1365 patients were randomly assigned to COPP (n=471) or COPDAC (n=466) in the embedded trial. Median follow-up was 66·5 months (IQR 62·7–71·7). Of 1287 patients in the per-protocol group, 514 (40%) had an adequate response to treatment and were not treated with radiotherapy (215 [49%] of 435 in treatment group 2 and 299 [35%] of 852 in treatment group 3). 773 (60%) of 1287 patients with inadequate response were scheduled for radiotherapy (220 [51%] of 435 in the treatment group 2 and 553 [65%] of 852 in treatment group 3. In patients who responded adequately, event-free survival rates at 5 years were 90·1% (95% CI 87·5–92·7). event-free survival rates at 5 years in 892 patients who were randomly assigned to treatment and analysed per protocol were 89·9% (95% CI 87·1–92·8) for COPP (n=444) versus 86·1% (82·9–89·4) for COPDAC (n=448). The COPDAC minus COPP difference in event-free survival at 5 years was −3·7% (−8·0 to 0·6). The most common grade 3–4 adverse events (intention-to-treat population) were decreased haemoglobin (205 [15%] of 1365 patients during OEPA vs 37 [7%] of 528 treated with COPP vs 20 [2%] of 819 treated with COPDAC), decreased white blood cells (815 [60%] vs 231 [44%] vs 84 [10%]), and decreased neutrophils (1160 [85%] vs 223 [42%] vs 174 [21%]). One patient in treatment group 2 died of sepsis after the first cycle of OEPA; no other treatment-related deaths occurred. Interpretation: Our results show that radiotherapy can be omitted in patients who adequately respond to treatment, when consolidated with COPP or COPDAC. COPDAC might be less effective, but is substantially less gonadotoxic than COPP. A high proportion of patients could therefore be spared radiotherapy, eventually reducing the late effects of treatment. With more refined criteria for response assessment, the number of patients who receive radiotherapy will be further decreased. Funding: Deutsche Krebshilfe, Elternverein für Krebs-und leukämiekranke Kinder Gießen, Kinderkrebsstiftung Mainz, Tour der Hoffnung, Menschen für Kinder, Programme Hospitalier de Recherche Clinique, and Cancer Research UK.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    An extensive quality control and quality assurance (QC/QA) program significantly improves inter-laboratory concordance rates of flow-cytometric minimal residual disease assessment in acute lymphoblastic leukemia : an I-BFM-FLOW-Network report
    Autorzy:
    Scarparo, Pamela
    Groeneveld-Krentz, Stefanie
    Dubravcic, Klara
    Moller, Claudia
    Ratei, Richard
    Rodriguez, Cecilia
    Kloboves Prevodnik, Veronika
    Popov, Alexander
    Giordano, Hugo
    Svec, Peter
    Palazzi, Jorge
    Anastasiou-Grenzelia, Theodora
    Mejstrikova, Ester
    Hrusak, Ondrej
    Barcala, Virna
    Szczepański, Tomasz
    Deniz, Gunnur
    Malusardi, Cecilia
    Kiss, Csongor
    Buldini, Barbara
    Martin, Bibiana Maria
    Gaipa, Giuseppe
    Batinic, Drago
    Campbell, Myriam
    Paterakis, Georgios
    Varotto, Elena
    Barna, Gabor
    Biondi, Andrea
    Bruggemann, Monika
    Dworzak, Michael N.
    Gaillard, Marie Isabel
    Slavkovic, Bojana
    Basso, Giuseppe
    Sala, Simona
    Kohlscheen, Saskia
    Sartor, Mary
    Sędek, Łukasz
    Burnusuzov, Hasan
    Vernitsky, Helly
    Bourquin, Jean-Pierre
    Conter, Valentino
    Felice, Marisa
    Nikulshin, Sergey
    Schumich, Angela
    Rossi, Jorge
    Suzan, Adin Cinar
    Gonzalez, Alejandro
    Torrebadell, Montserrat
    Attarbaschi, Andishe
    Bukowska-Straková, Karolina
    Iarossi, Maria Belen
    Feuerstein, Tamar
    Tzanoudaki, Marianna
    Kappelmayer, Janos
    Kreminska, Elena
    Solari, Liliana
    Carelli, Daniela
    Schrappe, Martin
    Jakso, Pal
    Agriello, Evangelina
    Maglia, Oscar
    Karawajew, Leonid
    Galeano, Adriana
    Marinov, Neda
    Samardzija, Gordana
    Taparkou, Anna
    Maurer-Granofszky, Margarita
    Sajaroff, Elisa Olga
    Hevessy, Zsuzsanna
    Opis:
    Monitoring of minimal residual disease (MRD) by flow cytometry (FCM) is a powerful prognostic tool for predicting outcomes in acute lymphoblastic leukemia (ALL). To apply FCM-MRD in large, collaborative trials, dedicated laboratory staff must be educated to concordantly high levels of expertise and their performance quality should be continuously monitored. We sought to install a unique and comprehensive training and quality control (QC) program involving a large number of reference laboratories within the international Berlin-Frankfurt-Münster (I-BFM) consortium, in order to complement the standardization of the methodology with an educational component and persistent quality control measures. Our QC and quality assurance (QA) program is based on four major cornerstones: (i) a twinning maturation program, (ii) obligatory participation in external QA programs (spiked sample send around, United Kingdom National External Quality Assessment Service (UK NEQAS)), (iii) regular participation in list-mode-data (LMD) file ring trials (FCM data file send arounds), and (iv) surveys of independent data derived from trial results. We demonstrate that the training of laboratories using experienced twinning partners, along with continuous educational feedback significantly improves the performance of laboratories in detecting and quantifying MRD in pediatric ALL patients. Overall, our extensive education and quality control program improved inter-laboratory concordance rates of FCM-MRD assessments and ultimately led to a very high conformity of risk estimates in independent patient cohorts.
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
    Tytuł:
    Biologic and clinical analysis of childhood Gamma Delta T-ALL identifies LMO2/STAG2 rearrangements as extremely high risk
    Autorzy:
    Caldwell, Kenneth J.
    Cheng, Zhongshan
    Takita, Junko
    Chen, Chelsey
    Inaba, Hiroto
    Zhou, Yinmei
    Paietta, Elisabeth M.
    Deguchi, Takao
    Gu, Zhaohui
    Reyes, Noemi
    Crews, Kristine R.
    Kimura, Shunsuke
    Roberts, Kathryn G.
    Khan, Tanya
    Tang, Yanjing
    Buldini, Barbara
    Köhrer, Stefan
    Sato, Atsushi
    Pawińska-Wąsikowska, Katarzyna
    Li, Chi-Kong
    Rowe, Jacob M.
    Horibe, Keizo
    Kornblau, Steven M.
    Park, Chun Shik
    Varotto, Elena
    Masetti, Riccardo
    Chiew, Kean H.
    Yang, Jun J.
    Kotecha, Rishi S.
    Gao, Qingsong
    Kicinski, Michal
    Moore, Andrew S.
    Meijerink, Jules P.P.
    Mazilier, Pauline
    Schmiegelow, Kjeld
    Oshima, Koichi
    Choi, John
    Kato, Motohiro
    de Groot-Kruseman, Hester A.
    Iacobucci, Ilaria
    Arnold, Elizabeth D.
    Marquart, Hanne V.
    Yeoh, Allen E.J.
    Takagi, Masatoshi
    Trka, Jan
    Pui, Ching-Hon
    Miyamura, Takako
    Elitzur, Sarah
    Chang, Yunchao
    Svaton, Michael
    Montefiori, Lindsey E.
    Escherich, Gabriele
    Jeha, Sima
    Brown, Anthony
    Pölönen, Petri
    Luger, Selina M.
    Pieters, Rob
    Tomizawa, Daisuke
    Schrappe, Martin
    Imamura, Toshihiko
    Reiterova, Michaela
    Skoczeń, Szymon
    Attarbaschi, Andishe
    Spinelli, Orietta
    Shen, Shuhong
    Stary, Jan
    Cheng, Cheng
    Han, Katie
    Zimmermann, Martin
    Vincent, Tiffaney L.
    Teachey, David T.
    Maybury, Mellissa
    Freeman, Burgess B.
    Thomas, Paul G.
    Muhle, Hannah E.
    Liu, Yen-Chun
    Manabe, Atsushi
    Mullighan, Charles G.
    Qu, Chunxu
    Eguchi, Mariko
    Prater, Mollie S.
    Locatelli, Franco
    Pruett-Miller, Shondra M.
    Mitchell, Sharnise
    Conter, Valentino
    Dostawca treści:
    Repozytorium Uniwersytetu Jagiellońskiego
    Artykuł
      Wyświetlanie 1-9 z 9

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