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J.A. García-Marco et al.
of 0-1. Overall, 53.7% (n=45) of the trial population had B symptoms.
Table 1 summarizes the biological and genetic abnor- malities assessed at baseline that were considered to be prognostic for outcome. Overall, 57.14% (n=48) of patients had unmutated IGHV, 47.6% (n=39) were CD38+ and 57.3% (n=43) were ZAP70+. Forty-two (50.0%) patients had a 13q14 deletion, 22 (26.1%) had a 11q22-q23 deletion, 13 (15.4%) harbored trisomy 12, four (4.7%) patients had a 17p deletion, and three (3.5%) had a 6q deletion.
Overall, 12 patients (14%) ended treatment induction prematurely. The reasons for discontinuation included toxicity (n=6), progressive disease (n=1), ineligibility (n=2), and investigators’ decision (n=3: 1 patient with ischemic cerebrovascular disease, 1 patient with concomi- tant idiopathic thrombocytopenic purpura and 1 patient with a karyotype with chromosomal random losses). The median number of FCR cycles was six, and complete treatment was administered to 80% of the patients.
Response and treatment outcomes
Induction
Of 84 evaluable patients in an intent-to-treat analysis of the effects of FCR induction treatment, 80 patients had a CR/CR with incomplete hematologic recovery (CRi), PR or nPR for an overall response rate of 95.2% (75.0% CR/CRi(2), n=63; 7.1% nPR, n=6; 13.1% PR, n=11) while four patients failed to respond to FCR. Of the 80 patients evaluable for BM-MRD status, 44.1% (n=37) had unde- tectable MRD at 3 months after induction, of whom 35 (41.7%) had a CR and two (2.4%) had a PR, while 43 had detectable MRD, of whom 28 (35.0%) had a CR, eight (10.0%) had a nPR, and seven (8.8%) had a PR.
Rituximab maintenance
Of the 80 patients with CR or PR after FCR induction, 74 entered the maintenance study. At the end of the main- tenance phase, 52 patients had a CR and seven had a PR (2 nPR; 5 PR). At cycle 12 of treatment, 29 patients had a CR and four patients had attained a PR. At cycle 9, 42 patients had a CR and five had a PR. Reasons for discon-
Table 1. Patients’ baseline characteristics. Patients’ characteristics
Median age (range)
Sex (n; %) Men
Women
ECOG performance status (n; %) PS-0
59.5 years (37,1-70,9)
57 (67.9)
27 (32.1)
55 (70.5) 23 (29.4)
14 (16.7) 53 (63.1) 17 (20.2)
42 (50.0) 22 (26.1) 13 (15.4) 4 (4.7)
3 (3.5)
48 (57.1) 3 (3.6) 27 (32.1) 6 (7.1)
53 (64,6) 39 (47,6) 43 (57,3) 30 (37,0)
63 (75.0) 11 (13.1) 6 (7.1)
60 (71.4)
37 (44.0)
PS-≥1
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) diagram. ITT: intention-to-treat.
Binet stage (n; %) A
B
C
FISH cytogenetic status (n; %) del(13q)
del(11q)
trisomy 12
del(17p) del(6q)
IGHV status (n; %) unmutated
IGHV 3-21 mutated inconclusive
Immunophenotyping (n; %). >10% CD38 positive
>30% CD38 positive
>20% ZAP70 positive >20% CD49d positive
Response (n; %) Complete response Partial response Nodular partial response
Undetectable MRD status post-induction Peripheral blood
Bone marrow
ECOG: Eastern Cooperative Oncology Group; PS: Performance Status; FISH: fluores- cence in-situ hybridization; MRD; measurable residual disease.
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