Table 2.
Details on therapy, dosing, treatment adjustment, and treatment duration (FAS)
| Details | Pertuzumab n = 126 | Trastuzumab n = 126* | Docetaxel n = 126** | |||
|---|---|---|---|---|---|---|
| Median/no. | Min–max (%) | Median/no. | Min–max (%) | Median dose intensity/no. | Min–max (%) | |
| Initial dose (median) | 840 mg | 420–844 mg | 8.0 mg/kg | 2.0–9.2 mg/kg | 27.2 mg/m2/week | 8.3–499.9 mg/m2/weeka |
| Maintenance dose (median) | 420 mg | 420–840 mg | 6.0 mg/kg | 1.9–8.0 mg/kg | ||
| Relative dose intensity (median) | 96.2% | 67.0%–106.5% | 94.3% | 68.8%–108.3% |
27.2 mg/m2/week |
8.3–499.9 mg/m2/week |
| Dose modification (patients) | 71 | 56.3% | 70 | 55.6% | 79 | 62.7% |
| Reason: AE related to therapy | 12 | 9.5% | 14 | 11.1% | 29 | 23.0% |
| Dose interruption (patients) | 24 | 19.0% | 17 | 13.5% | 17 | 13.5% |
| Reason: AE related to therapy | 6 | 4.8% | 5 | 4.0% | 6 | 4.8% |
| Dose reduction (patients) | 1 | 0.8% | 14 | 11.1% | 29 | 23.0% |
| Reason: AE related to therapy | 0 | 0 | 2 | 1.6% | 16 | 12.7% |
| Therapy delay (patients) | 38 | 30.2% | 45 | 35.7% | 13 | 10.3% |
| Reason: AE related to therapy | 3 | 2.4% | 7 | 5.6% | 4 | 3.2% |
| Premature discontinuation of therapy (patients) | 21 | 16.7% | 17 | 13.5% | 48 | 38.1% |
| Reason: AE related to therapy | 0 | 0 | 1 | 0.8% | 13 | 10.3% |
| Number of treatment cycles (median) | 18 | 1–28 | 19 | 1–28 | 6 | 1–16 |
| Duration of therapy (median, mos) | 13.4 | 11.3–16.3 | 14.3 | 12.2–17.1 | 4.1 | 4.1–4.2 |
AE adverse event, max maximum, min minimum, mos months, no. number
*All patients had intravenous H-therapy, 3 patients received H subcutaneously, 2 of them also intravenously
**Dose intensity could not be estimated for 2 patients due to missing body height/weight. One patient was excluded from the analysis as only paclitaxel and no docetaxel therapy had been documented
aDose range seems wide. As it is part of NIS documentation it might be due to a documentation error, while median dose intensity seems plausible