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Blood, 15 August 2000, Vol. 96, No. 4, pp. 1247-1253
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Definition of relapse risk and role of nonanthracycline drugs for
consolidation in patients with acute promyelocytic leukemia: a joint
study of the PETHEMA and GIMEMA cooperative groups
Miguel A. Sanz,
Francesco
Lo Coco,
Guillermo Martín,
Giuseppe Avvisati,
Consuelo Rayón,
Tiziano Barbui,
Joaquín Díaz-Mediavilla,
Giuseppe Fioritoni,
José David González,
Vincenzo Liso,
Jordi Esteve,
Felicetto Ferrara,
Pascual Bolufer,
Carlo Bernasconi,
Marcos Gonzalez,
Francesco Rodeghiero,
Dolors Colomer,
Maria C. Petti,
José M. Ribera, and
Franco Mandelli for the Spanish
PETHEMA and the Italian GIMEMA Cooperative Groups
From the Hospital Universitario La Fe, Valencia, Spain;
University "La Sapienza," Rome, Italy; Hospital Central de
Asturias, Oviedo, Spain; Ospedali Riuniti di Bergamo, Bergamo, Italy;
Hospital Clínico San Carlos, Madrid, Spain; Ospedale "Civile
Spirito Santo"; Pescara, Italy; Hospital Insular de Las Palmas, Las
Palmas, Spain; University of Bari, Bari, Italy; Hospital Clinic,
Barcelona, Spain; Ospedale Cardarelli, Napoli, Italy; Policlinico S. Matteo, Pavia, Italy; Hospital Universitario, Salamanca, Spain; S. Bartolo Hospital, Vicenza, Italy; Hospital U. Germans Trias i Pujol,
Badalona, Spain.
Preliminary independent reports of the Italian GIMEMA and the
Spanish PETHEMA trials for newly diagnosed acute promyelocytic leukemia
(APL) indicated a similarly high antileukemic efficacy in terms of
complete remission and disease-free survival rates. To better
investigate these studies and the prognostic factors influencing
relapse risk, this study analyzed the updated results of 217 patients
with PML/RAR -positive APL enrolled in GIMEMA (n = 108) and PETHEMA
(n = 109). All patients received identical induction (AIDA schedule)
and maintenance. For consolidation, GIMEMA patients received 3 courses
including idarubicin/cytarabine, mitoxantrone/etoposide, and
idarubicin/cytarabine/thioguanine, whereas PETHEMA patients received
the same drugs and dose schedule of idarubicin and mitoxantrone with
the omission of nonintercalating agents. Depending on whether molecular
relapses were classified as censored or uncensored events, the 3-year
Kaplan-Meier estimates of relapse-free survival (RFS) for the combined
series were 90 ± 2% and 86 ± 2%, respectively. Minor
differences observed between the 2 patient cohorts were negligible.
Multivariate regression analysis of RFS showed that initial leukocyte
(WBC) and platelet counts were the only variables with
independent prognostic value. The resulting predictive model for RFS
demonstrated its capability of segregating patients into low-risk
(WBC count  10 × 109/L, platelet count > 40 × 109/L), intermediate-risk (WBC count 10 × 109/L, platelets 40 × 109/L), and high-risk
(WBC count > 10 × 109/L) groups, with distinctive RFS
curves (P < .0001). The conclusions are that omission of
nonanthracycline drugs from the AIDA regimen is not associated with
reduced antileukemic efficacy and a simple predictive model may be used
for risk-adapted therapy in this disease.
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