| General information |
| Database: | DB00445 |
| Objective: | human epidermal growth factor receptor 2 overexpression and/or amplification are present in 938% of gastric or gastroesophageal junction (GEJ) cancers and are correlated to poor outcome. They conducted a multicentrephase II trial to evaluate trastuzumab in combination with cisplatin in patients with untreated human epidermal growth factor receptor 2positive advanced gastric or GEJ cancer. |
| Authors: | Gr¨¢valos C, et al |
| Title: | Phase II study of trastuzumab and cisplatin as firstline therapy in patients with human epidermal growth factor receptor 2positive advanced gastric or gastroesophageal junction cancer. |
| Journal: | Clin Transl Oncol. |
| Year: | 2011 |
| PMID: | 21421462 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | trastuzumab
|
| Target: | Receptor proteintyrosine kinase erbB2
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | human epidermal growth factor receptor 2positive advanced gastric or gastroesophageal junction cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | trastuzumab and cisplatin |
| Study Type: | a phase II study |
| Key Patients Feature: | Chemona ve patients with measurable, nonresectable, advanced or metastatic gastric or GEJ adenocarcinoma, with human epidermal growth factor receptor 2 overexpression and/or amplification (IHC 3+, or IHC 2+ and FISH+), age more than and equal to 18 years, ECOG less than and equal to 2, left ventricle ejection fraction more than and equal to 50% and adequate organ function were eligible. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | Higher baseline HER extracellular domain (ECD) levels were associated with better outcome in terms of response and survival. |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of trastuzumab (8 mg/kg on cycle 1 day 1 as loading; 6 mg/kg in subsequent cycles) and cisplatin (75 mg/m(2)), both intravenously on day 1, every 21 days. |
| Primary End Point: | overall survival |
| Secondary End Point: | NA |
| Patients Number: | 22 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The confirmed ORR was 32% |
| Disease Control Rate: | disease control was achieved in 64% of patients. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Grade 3 adverse events included asthenia (27%), neutropenia (18%), anorexia (14%), diarrhoea (9%) and abdominal pain (9%). There were no grade 4 toxicities or treatmentrelated deaths |
| Conclusions: | Trastuzumab in combination with cisplatin is an active regimen and has a favourable toxicity profile in advanced human epidermal growth factor receptor 2positive gastric or gastroesophageal cancers. |