| General information |
| Database: | DB00763 |
| Objective: | the phase III BEYOND trial was undertaken to confirm in a Chinese patient population the efficacy seen with firstline bevacizumab plus platinum doublet chemotherapy in globally conducted studies. |
| Authors: | Zhou C, et al |
| Title: | BEYOND: A Randomized, DoubleBlind, PlaceboControlled, Multicenter, phase III Study of FirstLine Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous non small cell Lung Cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 26014294 |
| Trial Design |
| Clinical Trial Id: | NCT01364012 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | nonsquamous non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Carboplatin/Paclitaxel + Bevacizumab |
| Study Type: | A Randomized, DoubleBlind, PlaceboControlled, Multicenter, phase III Study |
| Key Patients Feature: | Patients age more than and equal to 18 years with locally advanced, metastatic, or recurrent advanced nonsquamous non small cell lung cancer (non small cell lung cancer) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Carboplatin/Paclitaxel Plus Bevacizumab versus Carboplatin/Paclitaxel Plus Placebo |
| Treatment Info: | patients were randomly assigned to receive carboplatin (area under the curve, 6) intravenously and paclitaxel (175 mg/m(2)) intravenously (CP) on day 1 of each 3week cycle, for less than and equal to six cycles, plus placebo (Pl+CP) or bevacizumab (B+CP) 15 mg/kg intravenously, on day 1 of each cycle, until progression, unacceptable toxicity, or death. |
| Primary End Point: | progression free survival (PFS) |
| Secondary End Point: | objective response rate, overall survival, exploratory biomarkers, safety. |
| Patients Number: | 276 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Objective response rate was improved with B+CP compared with Pl+CP (54% v 26%, respectively). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | PFS was prolonged with B+CP versus Pl+CP (median, 9.2 v 6.5 months, respectively; hazard ratio [HR], 0.40; 95% CI, 0.29 to 0.54; P < .001). Median PFS was 12.4 months with B+CP and 7.9 months with Pl+CP (HR, 0.27; 95% CI, 0.12 to 0.63) in EGFR mutationpositive tumors and 8.3 and 5.6 months, respectively (HR, 0.33; 95% CI, 0.21 to 0.53), in wildtype tumors. |
| Median OS A vs. C: | B+CP compared with Pl+CP (median, 24.3 v 17.7 months, respectively; HR, 0.68; 95% CI, 0.50 to 0.93; P = .0154). |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition to bevacizumab to carboplatinpaclitaxel was well tolerated and resulted in a clinically meaningful treatment benefit in Chinese patients with advanced nonsquamous non small cell lung cancer. |