Table 2.
Baseline characteristics and T-DXd treatment
| N = 1150 | |
|---|---|
| Age, median (range), years ≥65 years, n (%) |
60.0 (20-96) 396 (34.4) |
| Female, n (%) | 755 (65.7) |
| Country, n (%) | |
| Japan | 506 (44.0) |
| Non-Japan | 644 (56.0) |
| ECOG PS, n (%) | |
| 0 | 583 (50.7) |
| 1/2 | 565 (49.1)/2 (0.2) |
| Tumor type, n (%)a | |
| Breast cancer | 510 (44.3) |
| Gastric cancer | 294 (25.6) |
| Lung cancer | 203 (17.7) |
| Colorectal cancer | 107 (9.3) |
| Other cancer | 34 (3.0) |
| HER2 expression, n (%)b | |
| Breast cancer | |
| HER2 overexpressing | 398 (34.6) |
| HER2 low expressing | 110 (9.6) |
| Missing | 2 (0.2) |
| Gastric cancer | |
| HER2 overexpressing | 199 (17.3) |
| HER2 low expressing | 44 (3.8) |
| Missing | 51 (4.4) |
| Lung cancer | |
| IHC 3+ | 38 (3.3) |
| IHC 2+ | 89 (7.7) |
| IHC 1+ | 13 (1.1) |
| Missing | 63 (5.5) |
| Colorectal cancer | |
| IHC 3+ | 43 (3.7) |
| IHC 2+ | 30 (2.6) |
| IHC 1+ | 15 (1.3) |
| Missing | 19 (1.7) |
| Any HER2 mutation, n (%) | |
| Breast cancer | 5 (0.4) |
| Gastric cancer | 0 |
| Lung cancer | 75 (6.5) |
| Colorectal cancer | 6 (0.5) |
| Age by tumor type, median (range), yearsa | |
| Breast cancer (n = 510) | 56 (28-96) |
| Gastric cancer (n = 294) | 65 (20-82) |
| Lung cancer (n = 203) | 62 (23-88) |
| Colorectal cancer (n = 107) | 59 (27-79) |
| Other cancer (n = 34) | 58 (31-76) |
| Lung cancer or lung metastasis/lymphangitis carcinomatosis at baseline, n (%) | 738 (64.2) |
| Lung comorbidities, n (%)c | 81 (7.0) |
| Prior chest/lung radiotherapy, n (%) | 190 (16.5) |
| Time since disease diagnosis, median (range), yearsd | 2.98 (<0.1-30.9) |
| 0 to ≤4 years, n (%) | 624 (54.3) |
| >4 years, n (%) | 403 (35.0) |
| No. of prior regimens, median (range)d | 4.0 (1-27) |
| Lines of therapy in locally advanced/metastatic setting, n (%)d | |
| 1-2 | 405 (35.2) |
| 3-10 | 674 (58.6) |
| >10 | 40 (3.5) |
| Time from end date of last anticancer therapy to first infusion of T-DXd, median (range), monthsd | 1.41 (0.3-54.5) |
| <Median (1.41 months), n (%) | 518 (45.0) |
| ≥Median (1.41 months), n (%) | 531 (46.2) |
| T-DXd dose, n (%) | |
| 5.4 mg/kg q3w | 315 (27.4) |
| 6.4 mg/kg q3w | 808 (70.3) |
| >6.4 mg/kg q3w | 27 (2.3) |
| Duration of treatment, median (range), months | 5.81 (0.7-56.3) |
| 0-6 months, n (%) | 583 (50.7) |
| >6-12 months, n (%) | 290 (25.2) |
| >12-24 months, n (%) | 188 (16.3) |
| >24 months, n (%) | 89 (7.7) |
| No. of treatment cycles, median (range) | 8.0 (1-76) |
| WBC count, median (range), ×109/ld | 5.88 (0.9-77.5) |
| Weight, median (range), kg | 59.70 (27.3-265.8) |
| Renal function, n (%)e | |
| Normal (serum creatinine clearance ≥90 ml/min) | 470 (40.9) |
| Mild impairment (serum creatinine clearance ≥60 to <90 ml/min) | 458 (39.8) |
| Moderate impairment (serum creatinine clearance ≥30 to <60 ml/min) | 193 (16.8) |
| Severe impairment (serum creatinine clearance <30 ml/min) | 3 (0.3) |
| Missing | 26 (2.3) |
| Baseline albumin, median (range), g/l | 39.0 (22-55) |
| Normal (≥3.5 g/dl), n (%) | 937 (81.5) |
| Mild (≥3.0 to <3.5 g/dl), n (%) | 151 (13.1) |
| Moderate (≥2.5 to <3.0 g/dl), n (%) | 46 (4.0) |
| Severe (<2.5 g/dl), n (%) | 3 (0.3) |
| Missing, n (%) | 13 (1.1) |
| SpO2, n (%) | |
| ≥95% | 1080 (93.9) |
| <95% | 57 (5.0) |
| Missing | 13 (1.1) |
ECOG PS, Eastern Cooperative Oncology Group performance status; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; q3w, every 3 weeks; SpO2, oxygen saturation; T-DXd, trastuzumab deruxtecan; WBC, white blood cell.
Tumor type was missing for two patients.
HER2 expression is evaluated using either central or local results according to the protocol defined enrollment criteria. Overexpressing was defined as IHC 3+ or in situ hybridization (ISH) positive for breast cancer, IHC 3+ or IHC 2+/ISH-positive for gastric cancer. Low expressing was defined as IHC 2+/ISH-negative or IHC 1+/not ISH-positive for breast cancer, or IHC 2+/ISH-negative or IHC 1+ for gastric cancer.
Includes asthma, chronic obstructive pulmonary disease, prior interstitial lung disease/pneumonitis, pulmonary fibrosis, pulmonary emphysema, and radiation pneumonitis.
Due to differences in data collection among the studies, some data were not collected for all patients; thus, the number of patients and percentages may not add up to 100% of the population.
Renal function calculated based on creatinine clearance using the Cockcroft–Gault formula.