| General information |
| Database: | DB00758 |
| Objective: | The main objective of the current post hoc analysis was to compare patientreported outcomes between crizotinib (N = 172) and chemotherapy subgroups (pemetrexed [N = 99] and docetaxel [N = 72]) in previously treated patients with advanced ALKpositive non small cell lung cancer, in PROFILE 1007 study (Pfizer; NCT0093283). |
| Authors: | Blackhall F, et al |
| Title: | Patientreported outcomes and quality of life in PROFILE 1007: a randomized trial of crizotinib compared with chemotherapy in previously treated patients with ALKpositive advanced non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 25436797 |
| Trial Design |
| Clinical Trial Id: | NCT0093283 |
| Agent: | crizotinib
|
| Target: | Hepatocyte growth factor receptor, ALK, ROS1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced ALKrearranged non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Patientreported outcomes and quality of life in PROFILE I007: a randomized trial |
| Key Patients Feature: | pts in the PROFILE 1007 study(previously treated patients with ALKpositive advanced non small cell lung cancer.) |
| Biomarker: | ALKpositive |
| Biomark Analysis: | NA |
| Control Group Info: | crizotinib compared with chemotherapy |
| Treatment Info: | Patientreported outcomes were assessed at baseline, day 1 of each cycle, and end of treatment. General health status was measured using the EuroQol5D visual analog scale and health utility index scores were assessed using the EuroQol5D descriptive system. Functioning, lung cancer symptoms, and global quality of life (QOL) were assessed using European Organisation for Research and Treatment of Cancer QLQC30 and the QLQLC13 lung cancer module. Repeated measures mixedeffects analyses compared overall scores and change from baseline scores, controlling for baseline scores. |
| Primary End Point: | Patientreported outcomes and quality of life |
| Secondary End Point: | NA |
| Patients Number: | 171 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | The benefits of crizotinib in improving symptoms and QOL are demonstrated regardless of whether the comparator is pemetrexed or docetaxel. |