| General information |
| Database: | DB00425 |
| Objective: | This study assessed the activity of the mAb cetuximab in combination with cisplatin and 5fluorouracil (5FU) in advanced esophageal squamous cell carcinoma. |
| Authors: | Lorenzen S, et al |
| Title: | Cetuximab plus cisplatin5fluorouracil versus cisplatin5fluorouracil alone in firstline metastatic squamous cell carcinoma of the esophagus: a randomizedphase II study of the Arbeitsgemeinschaft Internistische Onkologie. |
| Journal: | Ann Oncol. |
| Year: | 2009 |
| PMID: | 19549707 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the esophagus |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Cetuximab plus cisplatin5fluorouracil versus cisplatin5fluorouracil alone |
| Study Type: | multicenter, openlabel, noncomparative randomizedphase II study |
| Key Patients Feature: | Patients aged 18 years, with histologically confirmed, EGFRexpressing, nonresectable, advanced ESCC, who had not received (neo)adjuvantchemotherapy within 6 months of study entry or prior chemotherapy forrecurrent or metastatic disease were eligible. They required an EasternCooperative Oncology Group performance status (ECOG PS) of one orless, creatinine clearance >70 ml/min, an adequate hepatic and bonemarrow function and a unidimensionally measurable lesion 1 cm indiameter detected by computed tomography (CT) scan. A secondmalignancy, uncontrolled infection, neuropathy grade >1 and pregnancy orlactation excluded participation. |
| Biomarker: | KRAS mutation status |
| Biomark Analysis: | No KRAS codon 12/13 tumor mutations were identified in 37 evaluated samples. |
| Control Group Info: | A:Cetuximab plus cisplatin5fluorouracil B: cisplatin5fluorouracil alone |
| Treatment Info: | For a maximum of six 29day cycles, patients received cisplatin 100 mg/m(2), day 1, plus 5FU 1000 mg/m(2), days 15 (CF), either alone or in combination with cetuximab (CETCF; 400 mg/m(2) initial dose followed by 250 mg/m(2) weekly thereafter). |
| Primary End Point: | tumor response. |
| Secondary End Point: | overall survival (OS), progression freesurvival (PFS), duration of response, time to treatment failure (TTF) and safety. |
| Patients Number: | 62 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The overall response rate according to RECIST criteria was 19% and 13% |
| Disease Control Rate: | the disease control rate was 75% and 57% for the CETCF and CF arms, respectively. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.9 and 3.6 months for CETCF and CF |
| Median OS A vs. C: | 9.5 and 5.5 months for CETCF and CF |
| Adverse Event(agent arm): | Cetuximab did not exacerbate grade 3/4 toxicity, except for rash (6% versus 0%) and diarrhea (16% versus 0%). |
| Conclusions: | Cetuximab can be safely combined with CF chemotherapy and may increase the efficacy of standard CF chemotherapy. |