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Blood, 15 July 2002, Vol. 100, No. 2, pp. 420-426
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Improved outcome in high-risk childhood acute lymphoblastic
leukemia defined by prednisone-poor response treated with
double Berlin-Frankfurt-Muenster protocol II
Maurizio Aricò,
Maria
Grazia Valsecchi,
Valentino Conter,
Carmelo Rizzari,
Andrea Pession,
Chiara Messina,
Elena Barisone,
Vincenzo Poggi,
Giulio De
Rossi,
Franco Locatelli,
Maria Concetta Micalizzi,
Giuseppe Basso, and
Giuseppe Masera for the Associazione Italiana di Ematologia ed
Oncologia Pediatrica
From Onco-Ematologia Pediatrica, Ospedale dei Bambini
G. Di Cristina, Palermo; Onco-Ematologia Pediatrica, IRCCS Policlinico
San Matteo, Pavia; Clinica Pediatrica and Medical Statistics Section,
University of Milano Bicocca; Clinica Pediatrica, University of
Bologna; Clinica Pediatrica, University of Torino; Oncoematologia
Pediatrica, Ospedale Pausilipon; Ematologia Pediatrica, IRCCS Ospedale
Bambin Gesù of Roma; and Onco-Ematologia Pediatrica, IRCCS G. Gaslini, Genova, Italy.
One hundred ninety-eight children and adolescents were entered in
the Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP)-ALL95 study for high-risk acute lymphoblastic leukemia (ALL).
Inclusion criteria were poor response to initial
prednisone/intrathecal methotrexate (prednisone-poor response [PPR]),
resistance to induction therapy, translocation t(9;22), infants with
the t(4;11), or CD10 ALL. The event-free survival (EFS)
rate at 4 years was 56.5% (SE, 3.9%) for the entire group. The
overall EFS rate in the current study was significantly better
(P = .002) than that obtained in a comparable group
of patients treated in the early 1990s in the AIEOP-ALL91 study. In
particular, patients with PPR had a 4-year EFS of 61.1% (SE, 4.4%)
versus 42.8% (SE, 5.4%) in the ALL 91 study (P = .008).
Among PPR patients, those who were PPR-only (60.1%) that is, they
achieved CR and were negative for t(9;22) and t(4;11)
translocationshad the best outcomes with this intensive treatment,
even when additional adverse features (hyperleukocytosis, T phenotype)
were present (4-year EFS, 70.1%; SE, 4.7%). We attribute this
improvement to the replacement of 6 alternating blocks of non-cross-resistant drugs with an 8-drug reinduction regimen
(Berlin-Frankfurt-Muenster [BFM] protocol II), repeated twice, in the
context of a standard BFM-type intensive chemotherapy for high-risk
ALL. This modified therapy may lead to high cure rates for patients
defined as at high risk for intrinsic resistance to corticosteroids only.
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