| General information |
| Database: | DB00777 |
| Objective: | Overexpression of COX2 correlates with advanced stage and worse outcomes in non small cell lung cancer (non small cell lung cancer), possibly as a result of elevated levels of COX2dependent prostaglandin E2 (PGE2). Exploratory analyses of studies that used COX2 inhibitors have demonstrated potentially superior outcome in patients in whom the urinary metabolite of PGE2 (PGEM) is suppressed. they hypothesized that patients with disease defined by PGEM suppression would benefit from the addition of apricoxib to secondline docetaxel or pemetrexed |
| Authors: | Edelman MJ, et al |
| Title: | Randomized, doubleblind, placebocontrolled, multicenterphase II study of the efficacy and safety of apricoxib in combination with either docetaxel or pemetrexed in patients with biomarkerselected non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 25452446 |
| Trial Design |
| Clinical Trial Id: | NCT00771953 |
| Agent: | apricoxib
|
| Target: | Prostaglandin G/H synthase 2
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | apricoxib + either docetaxel or pemetrexed |
| Study Type: | Randomized, doubleblind, placebocontrolled, multicenterphase II study |
| Key Patients Feature: | Patients with non small cell lung cancer who had disease progression after one line of platinumbased therapy, performance status of 0 to 2, and normal organ function were potentially eligible. Only patients with a more than and equal to 50% decrease in urinary PGEM after 5 days of treatment with apricoxib could enroll. |
| Biomarker: | baseline urinary PGEM |
| Biomark Analysis: | Apricoxib did not improve PFS, despite biomarkerdriven patient selection |
| Control Group Info: | single arm |
| Treatment Info: | Docetaxel 75 mg/m(2) or pemetrexed 500 mg/m(2) once every 21 days per the investigator was administered with apricoxib or placebo 400 mg once per day. |
| Primary End Point: | progression free survival (PFS). Exploratory analysis was performed regarding baseline urinary PGEM and outcomes. |
| Secondary End Point: | NA |
| Patients Number: | 101 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | the control arm was 97 days (95% CI, 52 to 193 days) versus 85 days (95% CI, 67 to 142 days) for the experimental arm (P = .91). |
| Median OS A vs. C: | The OS for the entire population was 245 days (95% CI, 202 to 344 days). For the control arm, OS was 287 days (95% CI, 206 to 384 days) versus 233 days (95% CI, 151 to 365 days; HR, 0.96; P = .87) for the experimental arm. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Apricoxib did not improve PFS, despite biomarkerdriven patient selection. |