| General information |
| Database: | DB00804 |
| Objective: | To evaluate the efficacy of cetuximab added to firstline gemcitabine/platinum in chemotherapyna ve patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Butts CA, et al |
| Title: | Randomizedphase II study of gemcitabine plus cisplatin or carboplatin [corrected], with or without cetuximab, as firstline therapy for patients with advanced or metastatic non smallcell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 18089875 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non smallcell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine + cisplatin or carboplatin with cetuximab |
| Study Type: | Randomizedphase II study |
| Key Patients Feature: | chemotherapyna ve patients with recurrent/metastatic non small cell lung cancer (stage IV or stage IIIB with malignant pleural effusion) were eligible. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | chemotherapy alone versus chemotherapy with cetuximab |
| Treatment Info: | Patients received cisplatin (75 mg/m2 i.v., every 3 weeks) or carboplatin (area under the concentrationversustime curve of 5 intravenously [i.v.], every 3 weeks), and gemcitabine (1, 250 or 1, 000 mg/m2 i.v., days 1 and 8) plus cetuximab (400 mg/m2 i.v. day 1, followed by 250 mg/m2 weekly), in arm A, or chemotherapy alone, in arm B. |
| Primary End Point: | Response rate |
| Secondary End Point: | safety, progression free survival, and overall survival were secondary end points. |
| Patients Number: | 65 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 27.7% in the cetuximab arm (95% CI, 17.3 to 40.2) and 18.2% in the platinum/gemcitabine alone arm (95% CI, 9.8 to 29.6). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.09 months for arm A (95% CI, 4.17 to 5.98) and 4.21 months (95% CI, 3.81 to 5.49) in arm B. |
| Median OS A vs. C: | 11.99 months (95% CI, 8.80 to 15.18) and 9.26 months (95% CI, 7.43 to 11.79) in arms A and B, respectively. |
| Adverse Event(agent arm): | Skin toxicity, hypomagnesemia, diarrhea, and fatigue were more frequent in patients on the cetuximab arm. The addition of cetuximab to platinum/gemcitabine did not increase cardiotoxicity. however, serious adverse events related to treatment were more frequent in patients receiving cetuximab than patients treated with platinum/gemcitabine alone (arm A, n = 18; arm B, n = 8). |
| Conclusions: | Firstline treatment with cetuximab plus gemcitabineplatinum is well tolerated and can be administered safely in patients with advanced non small cell lung cancer. Differences in response rate, progression free survival, and overall survival suggest that the addition of cetuximab to platinumgemcitabine may improve clinical outcomes. Larger studies are in progress to address this hypothesis. |