| General information |
| Database: | DB00861 |
| Objective: | Sunitinib plus erlotinib may enhance antitumor activity compared with either agent alone in non small cell lung cancer (non small cell lung cancer), based on the importance of the signaling pathways involved in tumor growth, angiogenesis, and metastasis. Thisphase III trial investigated overall survival (OS) for sunitinib plus erlotinib versus placebo plus erlotinib in patients with refractory non small cell lung cancer. |
| Authors: | Scagliotti GV, et al |
| Title: | Sunitinib plus erlotinib versus placebo plus erlotinib in patients with previously treated advanced non small cell lung cancer: a phase III trial. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22564989 |
| Trial Design |
| Clinical Trial Id: | NCT00457392 |
| Agent: | Sunitinib erlotinib
|
| Target: | NA
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Sunitinib+ erlotinib |
| Study Type: | a phase III trial |
| Key Patients Feature: | Patients previously treated with one to two chemotherapy regimens (including one platinumbased regimen) for recurrent non small cell lung cancer, and for whom erlotinib was indicated |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Sunitinib+erlotinib versus placebo+erlotinib |
| Treatment Info: | patients were randomly assigned (1:1) to sunitinib 37.5 mg/d plus erlotinib 150 mg/d or to placebo plus erlotinib 150 mg/d, stratified by prior bevacizumab use, smoking history, and epidermal growth factor receptor expression. |
| Primary End Point: | OS. |
| Secondary End Point: | progression free survival (PFS), objective response rate (ORR), and safety. |
| Patients Number: | 960 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 10.6% versus 6.9% (twosided stratified logrank P = .0471), respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.6 months versus 2.0 months (HR, 0.807; 95% CI, 0.695 to 0.937; onesided stratified logrank P = .0023), |
| Median OS A vs. C: | 9.0 months for sunitinib plus erlotinib versus 8.5 months for erlotinib alone (hazard ratio [HR], 0.922; 95% CI, 0.797 to 1.067; onesided stratified logrank P = .1388). |
| Adverse Event(agent arm): | Treatmentrelated hemoptysis occurred in 4.0% versus 2.5% of patients in the sunitinib plus erlotinib versus erlotinib alone arms, and treatmentrelated pulmonary hemorrhage occurred in 0.4% versus 0.4% of patients, respectively. The most frequent treatmentrelated serious AEs were diarrhea (4.4% v 0.6%), vomiting (1.5% v 0.6%), and dehydration (1.3% v 0.2%) in the sunitinib plus erlotinib and erlotinib arms, respectively. The most common AEs associated with discontinuation of sunitinib and erlotinib (either arm) were diarrhea, fatigue, rash, and dyspnea, each in approximately 5% or fetheyr patients. |
| Conclusions: | In patients with refractory non small cell lung cancer, sunitinib plus erlotinib did not improve OS compared with erlotinib alone, but the combination was associated with a statistically significantly longer PFS and greater ORR. The incidence of grade 3 or higher toxicities was greater with combination therapy. |