Figure 1
Baseline demographic and clinical characteristics of patients in the SERCE subgroup of CompLEEment-1*
| Variable | N = 339 |
|---|---|
| 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) |
Summary of adverse events for patients (N = 339) in the SERCE subgroup of CompLEEment-1_ Safety set in the core phase
| 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) |
| Adverse events by preferred term in ≥ 10% of patients | ||
| 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) |
Disease history for patients in the SERCE subgroup of CompLEEment-1
| Variable | N = 339 No. (%) |
|---|---|
| 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) |
Best overall response according to local assessment for patients in the SERCE subgroup of CompLEEment-1
| No. (%) | All patients (N = 339) | Patients with measurable disease at baseline (N = 230) |
|---|---|---|
| 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) |