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Nab-paclitaxel demonstrated superiority over paclitaxel in early breast cancer
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SAN ANTONIO — Neoadjuvant chemotherapy with nab-paclitaxel was associated with a higher rate of complete pathologic response compared with paclitaxel among women with early-stage breast cancer, according to phase 3 study results presented at the San Antonio Breast Cancer Symposium.
Supporting evidence provided three reasons for the design of the current analysis, researcher Michael Untch, MD, PhD, chief physician at Helios Hospital Berlin-Buch in Germany, said during his presentation.
Michael Untch
“Nab-paclitaxel has shown superiority in patients with metastatic breast compared to solvent-based paclitaxel,” Untch said. “We used a reversed sequence, starting with the taxane followed by the anthracycline, based on the findings of the Neo-Tango trial. Lastly, the Neosphere study showed higher pathologic complete response rate in patients with HER-2–overexpressing tumors with the double antibody combination trastuzumab and pertuzumab.”
The analysis included 1,204 patients (median age, 49 years). About one-third (32.8%) of patients had HER-2–positive disease and the median tumor size was 30 mm (range, 4-150).
Researchers assigned patients 125 mg/m2 nab-paclitaxel (n=606) — a solvent-free formulation of paclitaxel — or 80 mg/m2 paclitaxel (n=598) weekly for 12 weeks. All patients then received four cycles of 90mg/m2 epirubicin and 600 mg/m2 cyclophosphamide every 3 weeks.
Patients with HER-2–positive disease received trastuzumab (Herceptin, Genentech) plus pertuzumab (Perjeta, Genentech) every 3 weeks concomitantly.
A majority of patients in both arms completed taxane therapy (paclitaxel, 86.3%; nab-paclitaxel, 79%). The most common reasons for taxane discontinuation were adverse events (paclitaxel, 6.2%; nab-paclitaxel, 17%) and disease progression (paclitaxel, 5%; nab-paclitaxel 1.7%).
Overall, significantly more patients in the nab-paclitaxel arm achieved the study’s primary endpoint of pathologic complete response, defined by the lack of residual disease in situ in the breast and no invasive tumor in lymph nodes and the breast (34% vs. 29%; P=.001).
The pathologic complete response rate was higher with nab-paclitaxel across disease subtypes, particularly for patients with triple-negative disease (48% vs. 25%; OR=2.69), HER-2–positive and HR-negative disease (75% vs. 66%), and patients with high baseline Ki67.
The benefit of nab-paclitaxel persisted when researchers used definitions of pathologic complete response that allowed for residual in situ in the breast (43% vs. 34%; P=.004) and were irrespective of nodal status (49% vs. 40%; P=.002).
Rates of any-grade anemia (92.4% vs. 88.3%), febrile neutropenia (4.6% vs. 4.2%), fatigue (82.8% vs. 77.8%) and diarrhea (51.2% vs. 44.1%) occurred in comparable proportions of patients assigned nab-paclitaxel and paclitaxel.
Significantly more patients in the nab-paclitaxel arm experienced any-grade neutropenia (87.3% vs. 81.5%; P=.007), rash (33.2% vs. 23.1%; P˂.001), hand–foot syndrome (27.7% vs. 17.6%; P˂.001) and peripheral sensory neuropathy (84.3% vs. 65.2%; P˂.001).
“The primary study endpoint was met,” Untch said. “Nab-paclitaxel significantly increased the pathological complete rate compared with paclitaxel … and this effect was seen in all subgroups, especially in patients with triple-negative tumors. Obviously, we have to wait for long-term follow-up to validate whether this increase in pathological complete response will translate to a better DFS and OS.”
For more information:
Untch M. Abstract #S2-07. Presented at: San Antonio Breast Cancer Symposium; Dec. 9-13, 2014; San Antonio.
Disclosure: The researchers report research funding from Celgene and Roche; consultant roles with Celgene, Novartis, Pfizer and Roche; and advisory board roles with Celgene.