Allowing patients with non-squamous non-small cell lung cancer (NSCLC) to cross over from a study arm in which they received weekly docetaxel to 1 in which they received weekly paclitaxel and bevacizumab demonstrated a progression-free survival (PFS) benefit, according to results presented at the International Association for the Study of Lung Cancer (IASLC) 17th Annual World Conference on Lung Cancer in Austria.1
The phase 3 ULTIMATE (ClinicalTrials.gov Identifier: NCT01763671) clinical trial compared docetaxel (Arm A) to paclitaxel plus bevacizumab, an angiogenesis inhibitor (Arm B), as second- and third-line therapy for patients with non-squamous NSCLC. At progression, patients were given the option to cross from 1 study arm to the other. Patients who did not cross over received a post-discontinuation treatment within 60 days of progression. PFS and overall survival (OS) were calculated from day 1 of post-discontinuation treatment.
PFS was significantly improved in Arm B (5.4 months vs 3.9 months in Arm A). Of the patients in Arm A (55), those who crossed over to Arm B (21, 38.2%) had a median PFS of 4.9 months and a median OS of 12.5 months post-discontinuation. Those who did not cross over, but received a post-discontinuation treatment, had a median PFS of 1.7 months and OS of 4.1 months post-discontinuation.
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Of the patients in Arm B (111), those who crossed over to Arm A (9, 8.3%), median PFS was 1.9 months post-discontinuation. Those who did not cross over, but received a post-discontinuation treatment, had a median PFS of 1.9 months and median OS of 5.0 months post-discontinuation.
- Cortot AB, Audigier Valette C, Molinier O, et al. Prolonged OS of patients exposed to weekly paclitaxel and bevacizumab: impact of the cross-over in the IFCT-1103 ULTIMATE study. Paper presented at: International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer; December 2016; Vienna, Austria.