| General information |
| Database: | DB00409 |
| Objective: | This multicenterphase II trial investigated cetuximab combined with chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC). |
| Authors: | Meng X, et al |
| Title: | Cetuximab in combination with chemoradiotherapy in Chinese patients with nonresectable, locally advanced esophageal squamous cell carcinoma: a prospective, multicenterphase II trail. |
| Journal: | Radiother Oncol. |
| Year: | 2013 |
| PMID: | 24128808 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | advanced esophagogastric cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Cetuximab + chemoradiotherapy |
| Study Type: | prospective, multicenterphase II trail |
| Key Patients Feature: | Patients with locally advanced cervical, upper, or midthoracicESCC (stage II-III) who were medically unfit for surgery, who hadunresectable T4, or who were not eligible for surgery were included in this study. Other eligibility criteria were good performance status (Eastern Cooperative Oncology Group (ECOG) score61) and adequate hematologic, hepatic and renal function (granulocyte count P1500 cells/lL, platelet count P100, 000 cells/lL, bilirubin 61.5 upper limit of normal [ULN], ALT/AST 1.5 ULN, andserum creatinine 61.5 mg/dL). |
| Biomarker: | KRAS status |
| Biomark Analysis: | No KRAS mutations were identified in 50 evaluated samples. |
| Control Group Info: | single arm |
| Treatment Info: | Eligible patients with nonresectable, locallyadvanced ESCC received cetuximab 400mg/m(2) loading dose on day 1; and on day 1 of the 2nd7th weeks: cetuximab 250mg/m(2), paclitaxel 45mg/m(2), and cisplatin 20mg/m(2), concurrent with 59.4Gy/33 fractions of radiation therapy. |
| Primary End Point: | clinical response rate. |
| Secondary End Point: | overall survival (OS), progression free survival (PFS), safety, and KRAS status. |
| Patients Number: | 55 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Fortyfour patients had a clinical response: 29 complete response and 15 partial response. Oneyear PFS and OS of 45 evaluable patients were 84.23% and 93.33%, respectively. |
| Disease Control Rate: | 0.978 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | the 1year PFS rate is 79.06% (95% CI, 65.37-87.82%), and 2year PFS rate is 70.74% (95% CI, 56.15-81.25%) |
| Median OS A vs. C: | the 1year OS rate is 92.55% (95% CI, 81.35-97.14%), and 2year OS rate is 75.20% (95% CI, 61.13-84.78%). |
| Adverse Event(agent arm): | Nonhematologic adverse events were generally grade 1 or 2; primarily rash (92.7%), mucositis (45.5%), fatigue (41.8%), and nausea (38.2%). Grade 3 hematologic adverse events included neutropenia (32.7%) and anemia (1.8%). |
| Conclusions: | Cetuximab can be safely administered with chemoradiotherapy to patients with locallyadvanced ESCC and may improve clinical response rate. |