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Clinical Trials

The Effects of Neoadjuvant Anastrozole (Arimidex) on Tumor Volume in Postmenopausal Women with Breast Cancer: A Randomized, Double-Blind, Single-Center Study

J. Michael Dixon, Lorna Renshaw, Chris Bellamy, Mary Stuart, Guido Hoctin-Boes and William R. Miller
J. Michael Dixon
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Lorna Renshaw
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Chris Bellamy
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Mary Stuart
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Guido Hoctin-Boes
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William R. Miller
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DOI:  Published June 2000
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    Fig. 1.

    The reduction from baseline in tumor volume at week 12 as measured by calipers, ultrasound, and mammography in patients administered either (a) 1 mg/day or (b) 10 mg/day of anastrozole.

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    Fig. 2.

    Relationship between pathological and calliper (left), mammography (middle), and ultrasound (right) tumor volumes (mm3) for all of the patients.

Tables

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  • Table 1

    Patient demographics and baseline tumor characteristics

    Anastrozole
    1 mg/day (n = 12)10 mg/day (n = 12)
    Age (yr)a74.1 ± 8.768.8 ± 8.9
    Weight (kg)a69.6 ± 9.677.5 ± 14.2
    Height (cm)a156.3 ± 12.2157.8 ± 11.7
    Tumor stageb
    T211(91.7)10(83.3)
    T3 0 (0) 2(16.7)
    T4B 1 (8.3) 0 (0)
    Lymph node metastases 2(16.7) 1 (8.3)
    Tumor volume assessment (cm3)
    Caliper
    Median23.7 27.3
    Maximum42.4161.0
    Minimum12.4 10.9
    Ultrasound
    Median 4.8  4.9
    Maximum 9.9 14.3
    Minimum 2.4  1.4
    Mammography
    Median 7.3  8.4
    Maximum25.5 47.7
    Minimum 1.4  0.7
    • a Mean ± SD.

    • b No. of patients, with percentage in parens.

  • Table 2

    Tumor volume after 12 weeks of anastrozole treatment

    Assessment methodAnastrozole
    1 mg/day10 mg/day
    Tumor volume (cm3)% Reduction from baselineTumor volume (cm3)% Reduction from baseline
    Caliper
    n 12121111
    Median2.089.30.199.6
    Maximum7.9100.050.1100.0
    Minimum0.074.00.0−8.8
    Ultrasound
    n 12121111
    Median0.980.51.469.6
    Maximum2.595.75.197.6
    Minimum0.36.30.1−16.8
    Mammography
    n 12121111
    Median1.873.65.669.3
    Maximum5.698.822.5100.0
    Minimum0.137.00.08.1
  • Table 3

    Tumor shrinkage in response to treatment with anastrozole treatment for 12 weeks

    Change from baseline after 12 weeks of treatmentCaliperUltrasoundMammogram
    Anastrozole, 1 mg/day (n = 12)Anastrozole, 10 mg/day (n = 11)Anastrozole, 1 mg/day (n = 12)Anastrozole, 10 mg/day (n = 11)Anastrozole, 1 mg/day (n = 12)Anastrozole, 10 mg/day (n = 11)
    100% decrease (i.e., lesions disappeared)230002
    >75 to <100% decrease958453
    50–75% decrease123331
    <50% decrease to 25% increase011445
    >25% increase000000
  • Table 4

    Difference between assessment and surgical specimen tumor volumes for all of the patients who had a measurable 12-week assessment (measured at 12 weeks), treated with anastrozole, irrespective of dose

    CaliperUltrasoundMammography
    n 232323
    Median−0.24−0.12−1.33
    Q1a−4.88−0.67−2.80
    Q30.440.79−0.35
    Maximum6.154.395.69
    Minimum−42.60−1.89−14.91
    • a Q1, lower quartile (25% of data); Q3, upper quartile (75% of data).

  • Table 5

    Bidimensional measurements

    Change from baseline in product of bidimensional measurementsClinicalUltrasoundMammogram
    Anastrozole, 1 mg/day (n = 12)Anastrozole, 10 mg/day (n = 11)Anastrozole, 1 mg/day (n = 12)Anastrozole, 10 mg/day (n = 11)Anastrozole, 1 mg/day (n = 12)Anastrozole, 10 mg/day (n = 11)
    100% decrease230002
    >50% decrease1069784
    <50% decrease to 25% increase023445
  • Table 6

    TNM clinical stage before and after treatment and pathological nodal status

    Patient no.TNMa stage before treatmentTNM stage after treatmentNodal status (pathology assessment)
    1T2N0M0T1N0M00 /5
    2T2N0M0T1N0M01 /4
    3T2N0M0T1N0M04 /5
    4T3N0M0T2N0M02 /5
    5T2N1M0T1N0M01 /7
    6T2N0M0T1N0M00 /5
    9T2N0M0T2N1M00 /4
    11T2N0M0T1N0M02 /3
    12T2N0M0T1N0M00 /4
    13T2N0M0T1N0M00 /2
    14T2N0M0T1N0M02 /7
    15T2N0M0T2N0M00 /5
    16T2N0M0T1N0M00 /5
    17T2N0M0T1N0M00 /4
    18T2N0M0T1N0M00 /7
    19T2N0M0T2N0M01 /18b
    20T3N1M0T2N1M017 /22b
    21T2N0M0T0N0M03 /6
    22T2N0M0T1N0M00 /4
    23T2N0M0T0N0M00 /5
    24T2N0M0T2N0M00 /4
    25T4bN1M0cT2N1M03 /4
    26T2N0M0T0N0M00 /3
    • a TNM, tumor, node, metastasis.

    • b Patients underwent mastectomy plus axillary clearance (all of the other patients had wide local excision and axillary node sampling).

    • c Peau d’orange.

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June 2000
Volume 6, Issue 6
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The Effects of Neoadjuvant Anastrozole (Arimidex) on Tumor Volume in Postmenopausal Women with Breast Cancer: A Randomized, Double-Blind, Single-Center Study
J. Michael Dixon, Lorna Renshaw, Chris Bellamy, Mary Stuart, Guido Hoctin-Boes and William R. Miller
Clin Cancer Res June 1 2000 (6) (6) 2229-2235;

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The Effects of Neoadjuvant Anastrozole (Arimidex) on Tumor Volume in Postmenopausal Women with Breast Cancer: A Randomized, Double-Blind, Single-Center Study
J. Michael Dixon, Lorna Renshaw, Chris Bellamy, Mary Stuart, Guido Hoctin-Boes and William R. Miller
Clin Cancer Res June 1 2000 (6) (6) 2229-2235;
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