| General information |
| Database: | DB00864 |
| Objective: | This is a phase II randomized study to evaluate the efficacy and safety of bortezomib and pemetrexed alone or in combination, in patients with previously treated advanced non small cell lung cancer (non small cell lung cancer). The primary end point was assessment of response rate. |
| Authors: | Scagliotti GV, et al |
| Title: | A randomizedphase II study of bortezomib and pemetrexed, in combination or alone, in patients with previously treated advanced non small cell lung cancer. |
| Journal: | Lung Cancer. |
| Year: | 2010 |
| PMID: | 19692142 |
| Trial Design |
| Clinical Trial Id: | NCT00343720 |
| Agent: | bortezomib
|
| Target: | 26S proteasome
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | pemetrexed+ bortezomib |
| Study Type: | A randomizedphase II study |
| Key Patients Feature: | patients with previously treated advanced non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | pemetrexed+ bortezomib(arm A)verus pemetrexed(arm B)verus bortezomib(arm C) |
| Treatment Info: | patients were randomized (1:1:1) to pemetrexed (500mg/m(2)) on day 1 plus bortezomib (1.6mg/m(2)) on days 1 and 8 (Arm A) or pemetrexed (500mg/m(2)) on day 1 (Arm B) or bortezomib (1.6mg/m(2)) on days 1 and 8 (Arm C) of a 21 day cycle. |
| Primary End Point: | assessment of response rate |
| Secondary End Point: | NA |
| Patients Number: | 155 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 7% in Arm A, 4% in Arm B, and 0% in Arm C; |
| Disease Control Rate: | 73%, 62%, and 43% |
| Median Time to Progression: | 4.0 months, 2.9 months, and 1.4 months, respectively. |
| Median PFS A vs. C: | 8.6 months in Arm A, 12.7 months in Arm B, and 7.8 months in Arm C |
| Median OS A vs. C: | in Arm A was 8.6 months (95% CI: 6.2-11.7), 12.7 months (95% CI: 8.2-15.6) for Arm B, and 7.8 months (95% CI: 4.9-10.2) for Arm C |
| Adverse Event(agent arm): | The most commonly reported AEs were: thrombocytopenia (31%), dyspnea (27%), and fatigue (27%) in Arm A; nausea (35%), asthenia (27%), and fatigue (22%) in Arm B; and fatigue (25%) and dyspnea (23%) in Arm C. |
| Conclusions: | previously treated non small cell lung cancer the addition of bortezomib to pemetrexed was well tolerated but offered no statistically significant response or survival advantage versus pemetrexed alone, while bortezomib alone showed no clinically significant activity. |