Outcome of Infants Younger Than 1 Year With Acute Lymphoblastic Leukemia Treated With the Interfant-06 Protocol: Results From an International Phase III Randomized Study.

Autor:	Pieters R; Dutch Childhood Oncology Group, Utrecht, the Netherlands.; Princess Maxima Center for Pediatric Oncology, Utrecht, the Netherlands., De Lorenzo P; University of Milano-Bicocca, Monza, Italy., Ancliffe P; United Kingdom Children Cancer Study Group, London, United Kingdom., Aversa LA; GATLA, Buenos Aires, Argentina., Brethon B; French Acute Lymphoblastic Leukemia Study Group, Paris, France., Biondi A; University of Milano-Bicocca, Monza, Italy.; Istituto di Ricovero e Cura a Carattere Scientifico Bambino Gesù Children's Hospital, Rome, Italy.; University of Pavia, Pavia, Italy., Campbell M; Chilean National Pediatric Oncology Group, Santiago, Chile., Escherich G; German Cooperative Study Group for Childhood Acute Lymphoblastic Leukemia, Hamburg, Germany., Ferster A; European Organisation for Research and Treatment of Cancer Children Leukemia Group, Brussels, Belgium., Gardner RA; Seattle Children's Hospital and Research Institute, Seattle, WA., Kotecha RS; Australian and New Zealand Children's Haematology/Oncology Group, Perth, Australia.; University of Western Australia, Perth, Western Australia, Australia., Lausen B; Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Li CK; The Chinese University of Hong Kong, Shatin, Hong Kong, Special Administrative Region, People's Republic of China., Locatelli F; University of Milano-Bicocca, Monza, Italy.; Istituto di Ricovero e Cura a Carattere Scientifico Bambino Gesù Children's Hospital, Rome, Italy.; University of Pavia, Pavia, Italy., Attarbaschi A; St Anna Children's Hospital, Medical University of Vienna, Vienna, Austria., Peters C; Children Cancer Research Institute, Vienna, Austria., Rubnitz JE; St Jude Children's Research Hospital, Memphis, TN., Silverman LB; Dana-Farber Cancer Institute, Boston, MA., Stary J; Czech Working Group for Pediatric Hematology, Prague, Czech Republic., Szczepanski T; Polish Pediatric Leukemia/Lymphoma Study Group, Zabrze, Medical University of Silesia, Katowice, Poland., Vora A; United Kingdom Children Cancer Study Group, London, United Kingdom., Schrappe M; Berlin-Frankfurt-Münster Group Germany, Kiel, Germany., Valsecchi MG; University of Milano-Bicocca, Monza, Italy.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 Sep 01; Vol. 37 (25), pp. 2246-2256. Date of Electronic Publication: 2019 Jul 08.
DOI:	10.1200/JCO.19.00261
Abstrakt:	Purpose: Infant acute lymphoblastic leukemia (ALL) is characterized by KMT2A ( MLL ) gene rearrangements and coexpression of myeloid markers. The Interfant-06 study, comprising 18 national and international study groups, tested whether myeloid-style consolidation chemotherapy is superior to lymphoid style, the role of stem-cell transplantation (SCT), and which factors had independent prognostic value. Materials and Methods: Three risk groups were defined: low risk (LR): KMT2A germline; high risk (HR): KMT2A -rearranged and older than 6 months with WBC count 300 × 10 9 /L or more or a poor prednisone response; and medium risk (MR): all other KMT2A -rearranged cases. Patients in the MR and HR groups were randomly assigned to receive the lymphoid course low-dose cytosine arabinoside [araC], 6-mercaptopurine, cyclophosphamide (IB) or experimental myeloid courses, namely araC, daunorubicin, etoposide (ADE) and mitoxantrone, araC, etoposide (MAE). Results: A total of 651 infants were included, with 6-year event-free survival (EFS) and overall survival of 46.1% (SE, 2.1) and 58.2% (SE, 2.0). In West European/North American groups, 6-year EFS and overall survival were 49.4% (SE, 2.5) and 62.1% (SE, 2.4), which were 10% to 12% higher than in other countries. The 6-year probability of disease-free survival was comparable for the randomized arms (ADE+MAE 39.3% [SE 4.0; n = 169] v IB 36.8% [SE, 3.9; n = 161]; log-rank P = .47). The 6-year EFS rate of patients in the HR group was 20.9% (SE, 3.4) with the intention to undergo SCT; only 46% of them received SCT, because many had early events. KMT2A rearrangement was the strongest prognostic factor for EFS, followed by age, WBC count, and prednisone response. Conclusion: Early intensification with postinduction myeloid-type chemotherapy courses did not significantly improve outcome for infant ALL compared with the lymphoid-type course IB. Outcome for infant ALL in Interfant-06 did not improve compared with that in Interfant-99.
Databáze:	MEDLINE
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