Table 3

Best confirmed hematologic responses to bortezomib in patients treated at the recommended doses on each schedule or at lower doses on either schedule

Recommended dose groups
Lower doses
1.6 mg/m2 QW1.3 mg/m2 BIW
Best confirmed hematologic response, n (%) (95% CI) N = 16 N = 33 N = 18 
    Overall response rate (CR + PR) 11 (68.8) (41.3-89.0) 22 (66.7) (48.2-82.0) 7 (38.9) (17.3-64.3) 
        CR 6 (37.5) (15.2-64.6) 8 (24.2) (11.1-42.3) 2 (11.1) (1.4-34.7) 
    SD 4 (25.0) (7.3-52.4) 10 (30.3) (15.6-48.7) 11 (61.1) (35.7-82.7) 
    PD 1 (6.3) (0.2-30.2) 1 (3.0) (0.1-15.8) 
Median time to hematologic response, mo (range) N = 11 N = 22 N = 7 
    First response 2.1 (0.9-6.9) 0.7 (0.3-4.0) 1.2 (0.6-4.8) 
    Best response 3.2 (0.9-7.2) 1.2 (0.3-7.6) 1.2 (0.6-4.8) 
Duration of response ≥ 1 year, % (95% CI) 78.8 (38.1-94.3) 75.5 (41.6-91.4) 83.3 (27.3-97.5) 
Time to hematologic disease progression N = 18 N = 34 N = 18 
    Median follow-up, mo 17.5 8.4 9.9 
    Patients progressing, n 
    1-year progression-free rate, % (95% CI) 72.2 (48.7-95.7) 74.6 (54.4-94.8) 88.5 (73.6-100) 
Recommended dose groups
Lower doses
1.6 mg/m2 QW1.3 mg/m2 BIW
Best confirmed hematologic response, n (%) (95% CI) N = 16 N = 33 N = 18 
    Overall response rate (CR + PR) 11 (68.8) (41.3-89.0) 22 (66.7) (48.2-82.0) 7 (38.9) (17.3-64.3) 
        CR 6 (37.5) (15.2-64.6) 8 (24.2) (11.1-42.3) 2 (11.1) (1.4-34.7) 
    SD 4 (25.0) (7.3-52.4) 10 (30.3) (15.6-48.7) 11 (61.1) (35.7-82.7) 
    PD 1 (6.3) (0.2-30.2) 1 (3.0) (0.1-15.8) 
Median time to hematologic response, mo (range) N = 11 N = 22 N = 7 
    First response 2.1 (0.9-6.9) 0.7 (0.3-4.0) 1.2 (0.6-4.8) 
    Best response 3.2 (0.9-7.2) 1.2 (0.3-7.6) 1.2 (0.6-4.8) 
Duration of response ≥ 1 year, % (95% CI) 78.8 (38.1-94.3) 75.5 (41.6-91.4) 83.3 (27.3-97.5) 
Time to hematologic disease progression N = 18 N = 34 N = 18 
    Median follow-up, mo 17.5 8.4 9.9 
    Patients progressing, n 
    1-year progression-free rate, % (95% CI) 72.2 (48.7-95.7) 74.6 (54.4-94.8) 88.5 (73.6-100) 

QW indicates once weekly; BIW, twice weekly; CR, complete response; PR, partial response; SD, stable disease; and PD, progressive disease.

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