Table 2.
Selected Grade 3 or 4 treatment-related adverse events in advanced, first-line, and neoadjuvant breast cancer settings.
| Advanced BC | First-line | Neoadjuvant BC | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ixa alone | Ixa + C | C | Ixa + Carb + T | Ixa alone | Ixa + B | Ixa + B | P + B | Ixa + C | C | Ixa alone | |||||
|
| |||||||||||||||
| Reference | [36] | [51] | [38] | [44] | [50] | [41] | [39] | [54] | |||||||
|
| |||||||||||||||
| Patient population | A-, T-, C-resistant | T-resistant | A- and T-resistant | HER2+ confirmed by IHC [3+] or FISH | A-resistant | No prior chemo for MBC | No prior chemo for MBC | No prior chemo/radiation | |||||||
|
| |||||||||||||||
| Patient number | 126 | 49 | 375 | 377 | 39 | 65 | 46 | 45 | 32 | 149 | 144 | 161 | |||
|
| |||||||||||||||
| Dose | PI* | PI* | Ixa (PI*) + C: 2000 mg/m2 on days 1–14 of a 21-day cycle | C: 2500 mg/m2 on days 1–14 of a 21-day cycle | [A] | PI* | [B] | [C] | [D] | [E] | [F] | PI*, for 4 or fewer cycles | |||
|
| |||||||||||||||
| Grade 3/4 hematologic adverse events (%) | |||||||||||||||
|
| |||||||||||||||
| Febrile neutropenia | 3 | 10 | 5 | <1 | 0 | 6 | 0 | 2.2 | 0 | 5 | 1 | 3 | |||
| Neutropenia | 54 | 53 | 68 | 11 | 49 | 58 | 16 | 60 | 22 | 74 | 9 | 14 | |||
|
| |||||||||||||||
| Grade 3/4 nonhematologic adverse events (%) | |||||||||||||||
|
| |||||||||||||||
| PN sensory | 14 | 12† | 21 | 0 | 4 | 20 | 18 | 24 | 25 | 23 | 0 | 1 | |||
| PN motor | 1 | 0 | 5 | 0 | 0 | 5 | NP | NP | NP | 1 | |||||
[A] Ixa 15 mg/m2 IV and carboplatin AUC = 2 IV on days 1, 8, and 15 every 28 days + weekly trastuzumab (4 mg/kg loading dose, then 2 mg/kg IV) during chemotherapy then 6 mg/kg IV every-3-weeks; [B] Ixa 16 mg/m2 IV on days 1, 8, and 15 every 28 days + bevacizumab 10 mg/kg IV every 2 weeks; [C] Ixa (per the PI*) + bevacizumab 15 mg/kg IV every 3 weeks; [D] paclitaxel 90 mg/m2 IV every 2 weeks + bevacizumab 10 mg/kg IV every 2 weeks; [E] Ixa (per the PI) + oral capecitabine 1000 mg/m2 on day 14 every 3 weeks; [F] capecitabine 1250 mg/m2 alone on day 14 every 3 weeks.
*The recommended dosage of ixabepilone is 40 mg/m2 administered intravenously over 3 hours every 3 weeks. Doses for patients with body surface area greater than 2.2 m2 should be calculated based on 2.2 m2.
†Sensory neuropathy was assessed and graded according to symptoms as reported by the patient; neurosensory studies were not performed.
B: bevacizumab; BC: breast cancer; C: capecitabine; Carb: carboplatin; FISH: fluorescent in situ hybridization; IHC: immunohistochemistry; Ixa: Ixabepilone; NP: not provided; MBC: metastatic breast cancer; P: paclitaxel; PI: prescribing information; PN: peripheral neuropathy; T: trastuzumab.