Table 2.

Baseline patient characteristics

Low dose*Medium dose*High dose*P
≤25% of MTD (n = 170)25-75% of MTD (n = 200)75-100% MTD (exclude patients treated over MTD) n = 218≥75% of MTD (include patients treated over MTD) n = 313Exclude patients over MTDInclude patients over MTD
Age (y; mean ± SD)‡‡55.8 ± 12.955.1 ± 14.056.1 ± 12.956.0 ± 13.80.790.74
Sex (%)0.540.53
    Male58.252.556.055.3
    Female41.847.544.044.7
Race (%)0.690.60
    White77.174.580.380.5
    Black9.411.06.96.4
    Hispanic9.49.06.98.0
    Asian4.14.54.63.8
    Other0.01.01.41.3
Performance status (%; PS)0.550.78
    Patients with PS = 032.930.031.231.6
    Patients with PS = 160.666.063.861.0
    Patients with PS ≥ 26.54.05.07.3
Tumor type (%)§0.320.73
    Breast (n = 61)7.111.58.78.3
    Gastrointestinal (n = 206)37.631.029.425.6
    Genitourinary (n = 63)7.18.09.611.2
    Head and neck (n = 50)7.66.08.38.0
    Melanoma (n = 60)7.69.07.89.3
    Thoracic (n = 54)9.46.56.98.0
    All others (n = 189)23.528.029.429.7
Number of previous treatments (mean ± SD)‡‡0.110.13
    Systemic treatments3.8 ± 2.23.9 ± 2.33.5 ± 2.43.5 ± 2.4
    Radiation treatments0.6 ± 0.80.6 ± 0.80.7 ± 0.80.7 ± 0.9
    Surgical treatments1.2 ± 1.21.4 ± 1.41.3 ± 1.01.3 ± 1.1
    Other treatments0.2 ± 0.60.3 ± 1.00.2 ± 0.50.2 ± 0.5
5.8 ± 2.86.2 ± 2.75.7 ± 2.85.7 ± 2.8
Time from cancer diagnosis to C1D1 of study treatment**3.2 (0.4-26.6)3.5 (0.3-33.1)3.1 (0.1-36.7)3.4 (0.1-36.7)0.790.63
Time from end of last treatment to C1D1 of trial†† (mo; median with range)1.7 (0.3-34.9)2.0 (0.3-67.4)2.1 (0.0-269.9)2.1 (0-269.9)0.100.10
  • *As per Methods, dose percentage is percentage of MTD or percentage of maximum tested dose if the maximum tested dose was not a MTD.

  • P values for analyses of low-, medium-, and high-dose exclude patients over MTD (n = 588).

  • P values for analyses of low-, medium-, and high-dose include patients over MTD (n = 683).

  • §n values include all patients. All others include endocrine, gynecological, lymphoma, myeloma, sarcoma, and other malignancies.

  • Given P values are for the cumulative number of treatments by one way ANOVA.

  • Concurrent chemotherapy and radiation therapy is categorized as other treatments.

  • **C1D1 = cycle 1, day 1 of phase I treatment.

  • ††Two patients (both in the high-dose group) had no therapy before phase I treatment.

  • ‡‡SD = standard deviation.