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FDA approves Abraxane for metastatic NSCLC
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The FDA has approved paclitaxel protein-bound particles for injectable suspension, also known as nab-paclitaxel, for use combined with carboplatin for the preliminary treatment of patients with non–small cell lung cancer who are not candidates for radiation therapy or surgery.
The FDA relied on the prior approval of paclitaxel (Taxol, Corden Pharma) injection for this indication, supported by an additional trial establishing that nab-paclitaxel (Abraxane, Abraxis Bioscience) was no less active — determined by overall response rate — than paclitaxel when both agents are used in combination with carboplatin.
Mark A. Socinski
The additional trial (Protocol CA031) was a randomized, open-label, multinational trial that enrolled 1,052 patients with locally advanced or metastatic NSCLC. Patients were randomly assigned to receive nab-paclitaxel at a dose of 100 mg/m² as a weekly infusion (n=521) or paclitaxel injection at a dose of 200 mg/m² as an IV infusion every 3 weeks (n=531).
Patients in both treatment groups also received identical doses of carboplatin at the same schedule (area under the curve [AUC], 6 mg per min/mL) every 3 weeks. All patients receiving paclitaxel were obligated to be premedicated with corticosteroids and an antihistamine, whereas those in the nab-paclitaxel group were administered premedication at the investigator’s discretion.
The primary endpoint was to demonstrate that patients receiving nab-paclitaxel plus carboplatin exhibited a significantly higher overall response rate with no evidence of a significant impairment in OS compared with patients who were receiving paclitaxel plus carboplatin. The primary endpoint of overall response rate, defined as percentage of patients who achieved a durable complete or partial response, was determined by a radiological review committee masked to treatment assignment.
The trial met its primary endpoint demonstrating a statistically significantly higher overall response rate for patients in the nab-paclitaxel group of 33% (95% CI, 29- 37) vs. 25% (95% CI, 21-28) for patients in the paclitaxel-containing group (P=.005, chi square test).
The absolute increase was in overall response rate was 8% (95% CI, 2-8). The durability of responses was comparable for responding patients in the two treatment groups, with median response durations of 6.9 for the nab-paclitaxel group vs. 6 months for the paclitaxel group. There was no statistically significant difference in OS reported between the two groups.
“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” Mark A. Socinski, MD, director of the lung cancer section in the division of hematology/oncology at the
The most common (≥10% incidence) grade 1 to grade 4 adverse drug reactions reported in the nab-paclitaxel group consisted of: anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, fatigue, vomiting, dyspnea, peripheral edema, rash, decreased appetite, asthenia, constipation, diarrhea, arthralgia and myalgia. The most common (≥5%) grade 3 to grade 4 adverse reactions were neutropenia, anemia and thrombocytopenia.
Serious adverse reactions were reported in 18% of patients in both groups, with the nab-paclitaxel group citing anemia (4%) and thrombocytopenia (3%) as the most common reactions.
The recommended dose and schedule for initial treatment of patients with locally advanced or metastatic NSCLC is 100 mg/m² of nab-paclitaxel administered as an IV infusion over 30 minutes, on days 1, 8 and 15 of each 21-day cycle. The recommended dose of carboplatin is AUC of 6 mg per min/mL on day 1 of each 21-day cycle after the completion of nab-paclitaxel.