Variable | |
---|---|
Age, years | 58.0 (24-88) |
< 65 | 228 (67.3) |
≥ 65 | 111 (32.7) |
Gender | |
Female | 335 (98.8) |
Male | 4 (1.2) |
Child-bearing status | |
Able to bear children | 80 (23.6) |
Postmenopausal | 241 (71.1) |
Sterile – of child-bearing age | 14 (4.1) |
Unknown | 4 (1.2) |
Race | |
Caucasian | 330 (97.3) |
Black | 2 (0.6) |
Other | 4 (1.2) |
Unknown | 3 (0.9) |
ECOG performance status | |
0 | 208 (61.4) |
1 | 119 (35.1) |
2 | 12 (3.5) |
3 or 4 | 0 |
BMI, kg/m2 | 26.0 (16.1–48.4) |
Event | All grades No. (%) | Grade ≥ 3 No. (%) |
---|---|---|
Any adverse event | 332 (97.9) | 238 (70.2) |
Treatment-related | 322 (95.0) | 211 (62.2) |
Serious adverse event | 62 (18.3) | 50 (14.79) |
Treatment-related | 24 (7.1) | 18 (5.3) |
Adverse discontinuation event leading to treatment | 44 (13.0) | 30 (8.8) |
Treatment-related | 36 (10.6) | 22 (6.6) |
Adverse adjustment/event interruption leading to dose | 233 (68.7) | 205 (60.5) |
Treatment-related | 214 (63.1) | 192 (56.6) |
Adverse therapy events requiring additional | 248 (73.2) | 96 (28.3) |
Treatment-related | 149 (44.0) | 59 (17.4) |
Neutropenia | 239 (70.5) | 176 (51.9) |
Treatment-related | 234 (69.0) | 175 (51.6) |
Nausea | 81 (23.9) | 1 (0.3) |
Treatment-related | 71 (20.9) | 1 (0.3) |
Leucopenia | 88 (26.0) | 26 (7.7) |
Treatment-related | 86 (25.4) | 26 (7.7) |
Fatigue | 65 (19.2) | 9 (2.7) |
Treatment-related | 53 (15.6) | 5 (1.5) |
Anemia | 61 (18.0) | 12 (3.5) |
Treatment-related | 53 (15.6) | 6 (1.8) |
Alanine aminotransferase increase | 54 (15.9) | 21 (6.2) |
Treatment-related | 45 (13.3) | 18 (5.3) |
Alopecia | 49 (14.5) | 0 (0) |
Treatment-related | 39 (11.5) | 0 (0) |
Vomiting | 46 (13.6) | 3 (0.9) |
Treatment-related | 32 (9.4) | 2 (0.6) |
Aspartate aminotransferase increase | 45 (13.3) | 11 (3.2) |
Treatment-related | 37 (10.9) | 7 (2.1) |
Back pain | 45 (13.3) | 3 (0.9) |
Diarrhea | 39 (11.5) | 2 (0.6) |
Treatment-related | 21 (6.2) | 1 (0.3) |
Headache | 39 (11.5) | 1 (0.3) |
Arthralgia | 36 (10.6) | 2 (0.6) |
Treatment-related | 23 (6.8) | 2 (0.6) |
Pruritis | 36 (10.6) | 2 (0.6) |
Treatment-related | 30 (8.8) | 2 (0.6) |
Rash | 34 (10.0) | 2 (0.6) |
Treatment-related | 21 (6.2) | 2 (0.6) |
Variable | |
---|---|
Histological grade | |
Well-differentiated | 29 (8.6) |
Moderately differentiated | 165 (48.7) |
Poorly differentiated | 76 (22.4) |
Undifferentiated | 5 (1.5) |
Unknown | 64 (18.9) |
Disease stage at study entry | |
II | 1 (0.3) |
III | 5 (1.5) |
IV | 333 (98.2) |
Time median since (range) diagnosis months of primary site, | 33.7 (0.3-401.9) |
≤ 3 | 72 (21.2) |
> 3 and ≤ 12 | 53 (15.6) |
> 12 | 213 (62.8) |
Missing | 1 (0.3) |
Disease-free interval | |
Newly-diagnosed disease | 110 (32.4) |
Existing disease | 228 (67.3) |
≤ 12 months | 26 (7.7) |
> 12 to ≤ 24 months | 19 (5.6) |
> 24 months | 183 (54.0) |
Missing | 1 (0.3) |
Types of lesions at baseline | |
Target only | 27 (8.0) |
Non-target only | 106 (31.3) |
Both target and non-target | 206 (60.8) |
Extent of metastatic disease | |
Bone | 254 (74.9) |
Bone only | 75 (22.1) |
Breast | 23 (6.8) |
Central nervous system | 2 (0.6) |
Visceral | 214 (63.1) |
Skin | 14 (4.1) |
Lymph nodes | 108 (31.9) |
Other | 13 (3.8) |
Number of metastatic sites | |
1 | 103 (30.4) |
2 | 105 (31.0) |
≥ 3 | 131 (38.7) |
No. (%) | All patients ( |
Patients with measurable disease at baseline ( |
---|---|---|
Complete response | 2 (0.6) | 0 (0) |
Partial response | 91 (26.8) | 91 (39.6) |
Non-CR / Non-PD | 90 (26.5) | – |
Stable disease | 108 (31.9) | 106 (46.1) |
Progressive disease | 14 (4.1) | 11 (4.8) |
Unknown | 34 (10.0) | 22 (9.6) |
Overall response rate (CR + PR) | 93 (27.4) | 91 (39.6) |
Clinical benefit ratea | 253 (74.6) | 170 (73.9) |