Chronic myeloid leukemia: a prospective comparison of interphase fluorescence in situ hybridization and chromosome banding analysis for the definition of complete cytogenetic response: a study of the GIMEMA CML WP.
In chronic myeloid leukemia, different methods are available to monitor the response to therapy: chromosome banding analysis (CBA), interphase fluorescence in situ hybridization (I-FISH), and real-time quantitative polymerase chain reaction (RT-Q-PCR). The GIMEMA CML WP (Gruppo Italiano Malattie Ematologiche Adulto Chronic Myeloid Leukemia Working Party) has performed a prospective study to compare CBA and I-FISH for the definition of complete cytogenetic response (CCgR). Samples (n = 664) were evaluated simultaneously by CBA and I-FISH. Of 537 cases in CCgR, the number of positive nuclei by I-FISH was less than 1% in 444 cases (82.7%). Of 451 cases with less than 1% positive nuclei by I-FISH, 444 (98.4%) were classified as CCgR by CBA. The major molecular response rate was significantly greater in cases with I-FISH less than 1% than in those with I-FISH 1% to 5% (66.8% vs 51.6%, P < .001) and in cases with CCgR and I-FISH less than 1% than in cases with CCgR and I-FISH 1% to 5% (66.1% vs 49.4%, P = .004). I-FISH is more sensitive than CBA and can be used to monitor CCgR. With appropriate probes, the cutoff value of I-FISH may be established at 1%. These trials are registered at http://www.clinicaltrials.gov as NCT00514488 and NCT00510926.
Department of Hematology-Oncology, L and A Seràgnoli, University of Bologna and S Orsola-Malpighi University Hospital, Bologna, Italy.
Nicoletta
N
Testoni
Giulia
G
Marzocchi
Simona
S
Luatti
Marilina
M
Amabile
Carmen
C
Baldazzi
Monica
M
Stacchini
Mauro
M
Nanni
Giovanna
G
Rege-Cambrin
Emilia
E
Giugliano
Ursula
U
Giussani
Elisabetta
E
Abruzzese
Simonetta
S
Kerim
Maria Grazia
MG
Grimoldi
Alessandro
A
Gozzetti
Barbara
B
Crescenzi
Carlo
C
Carcassi
Paolo
P
Bernasconi
Antonio
A
Cuneo
Francesco
F
Albano
Giuseppina
G
Fugazza
Alfonso
A
Zaccaria
Giovanni
G
Martinelli
Fabrizio
F
Pane
Gianantonio
G
Rosti
Michele
M
Baccarani
D000970:Antineoplastic Agents / Q000627:therapeutic use; D002871:Chromosome Banding; D002986:Clinical Trials as Topic; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy / Q000235:genetics*; D012074:Remission Induction; D020133:Reverse Transcriptase Polymerase Chain Reaction; D016896:Treatment Outcome
D000970:Antineoplastic Agents