| General information |
| Database: | DB00433 |
| Objective: | Clinical data showed promising antitumour activity with feasible tolerability for matuzumab plus epirubicin, cisplatin and capecitabine (ECX) chemotherapy in untreated advanced oesophagogastric (OG) cancer. The aim was to evaluate the efficacy of matuzumab plus ECX versus ECX alone. |
| Authors: | Rao S, et al |
| Title: | Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as firstline treatment in patients with advanced oesophagogastric cancer: a randomised, multicentre openlabelphase II study. |
| Journal: | Ann Oncol. |
| Year: | 2010 |
| PMID: | 20497967 |
| Trial Design |
| Clinical Trial Id: | NCT0021564436 |
| Agent: | matuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer and esophagusgastroesophageal junction cancer |
| Cancer Subtype: | advanced gastric adenocarcinoma or adenocarcinoma of the lower third of the oesophagus |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) |
| Study Type: | randomised, multicentre openlabelphase II study |
| Key Patients Feature: | Patients with histopathologically confirmed metastatic gastricadenocarcinoma or adenocarcinoma of the lotheyr third of the oesophaguswho had not received prior chemotherapy for advanced diseaseunderwent screening for intratumoural EGFR expression after initialwritten informed consent. Only patients with EGFRpositive tumours wereenrolled into the study.Other eligibility requirements included radiologically measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status 0/1, minimum age of 18 years, normal cardiac function (left ventricular ejectionfraction within the institutional normal range), a minimum 12monthinterval from completion of any neoadjuvant or adjuvant chemotherapy, a minimum 4week interval from completion of radiotherapy and adequateliver, bone marrow and renal function as defined by alanineaminotransferase/aspartate aminotransferase no greater than 5. the upperlimit of normal (ULN), bilirubin <1.5. the ULN, neutrophils >1500 mm3, platelets >100 000/ll, haemoglobin >10 g/dl and serum creatinine <1.5. the ULN or glomerular filtration rate (GFR) of 60 ml/min. B |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) B: epirubicin, cisplatin and capecitabine |
| Treatment Info: | 72 patients with metastatic OG cancer were randomly assigned to either 800 mg matuzumab weekly plus epirubicin 50 mg/m2, cisplatin 60 mg/m2 on day 1 and capecitabine 1250 mg/m2 daily in a 21day cycle (ECX) or the same ECX regimen alone. |
| Primary End Point: | objective response. |
| Secondary End Point: | progression free survival (PFS), overall survival (OS), quality of life, safety and tolerability. |
| Patients Number: | 72 |
| Trial Results |
| DLT_MTD: | Grade 3/4 treatmentrelated toxicity was observed in 27 and 25 patients inthe ECX/matuzumab and ECX groups, respectively |
| Objective Response Rate: | The addition of matuzumab to ECX did not improve objective response: 31% for ECX/matuzumab [95% confidence interval (CI) 17-49] compared with 58% for the ECX arm (95% CI 41-74) P = 0.994(one sided). There was no significant difference in median PFS |
| Disease Control Rate: | 60% in ECX/matuzumab and 75% in ECX. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.8 months (95% CI 2.9-8.1) for ECX/matuzumab versus 7.1 months (95% CI 4.4-8.5) for ECX |
| Median OS A vs. C: | 9.4 months (95% CI 7.5-16.2), compared with 12.2 months (95% CI 9.8-13.8 months). |
| Adverse Event(agent arm): | Grade 3/4 treatmentrelated toxicity was observed in 27 and 25 patients in the ECX/matuzumab and ECX groups, respectively. |
| Conclusions: | Matuzumab 800 mg weekly combined with ECX chemotherapy does not increase response or survival for patients with advanced OG cancer. Therefore, ECXmatuzumab should not be examined further inphase III trials. |