William T. DeRosa, DO, from Carol G. Simon Cancer Center at Morristown Memorial Hospital, discusses subset analyses from the phase III CA031 trial that examined nab-paclitaxel in non-small cell lung cancer.
William T. DeRosa, DO, medical oncologist, Carol G. Simon Cancer Center at Morristown Memorial Hospital, discusses subset analyses from the phase III CA031 trial that examined nab-paclitaxel (Abraxane) in non-small cell lung cancer (NSCLC).
In the trial, 1052 previously untreated patients with NSCLC were randomized 1:1 to receive carboplatin every 3 weeks at AUC6 mg/mL/min combined with either 100 mg/m2 of weekly nab-paclitaxel or 200 mg/m2 of solvent-based (sb)-paclitaxel every 3 weeks.
Overall, results from the trial were positive and lead to an FDA approval for nab-paclitaxel. The nab-paclitaxel arm demonstrated a significantly higher ORR than sb-paclitaxel (33% versus 25%; response rate ratio, 1.313; 95% CI, 1.082-1.593; P = .005).
In a subset analysis of this trial, patients with squamous histology who received nab-paclitaxel experienced more than a doubling in response rate when compared with sb-paclitaxel (41% versus 24%; response rate ratio, 1.680; 95% CI, 1.271-2.221; P < .001). DeRosa notes that patients with squamous NSCLC are an underserved population with few available treatment options.
DeRosa notes that the trial found a 10% nonsignficant improvement in both progression-free survival and overall survival (OS). However, in patients enrolled exclusively in North America there was a significant improvement in OS of 12.7 months with nab-paclitaxel compared to 9.8 months. For patients older than 70, OS was 19.9 compared to 10.4 months for sb-paclitaxel.
These results are highly intriguing, DeRosa believes, because a majority of patients diagnosed with NSCLC are over the age of 70. One of the benefits of nab-paclitaxel is that it is fairly well tolerated, which is preferable in an elderly population. In the trial, most neurotoxicity in the nab-paclitaxel arm resolved in 38 days compared to those with sb-paclitaxel, which took 104 days to resolve.
DeRosa believes these results are very intriguing and warrant further trials looking specifically at patients with squamous NSCLC.