| General information |
| Database: | DB00413 |
| Objective: | To determine the efficacy and toxicity of weekly neoadjuvant cetuximab combined with irinotecan, cisplatin, and radiation therapy in patients with locally advanced esophageal or gastroesophageal junction cancer. |
| Authors: | Lee MS, et al |
| Title: | Preoperative cetuximab, irinotecan, cisplatin, and radiation therapy for patients with locally advanced esophageal cancer. |
| Journal: | Oncologist |
| Year: | 2013 |
| PMID: | 23429739 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer and esophagusgastroesophageal junction cancer |
| Cancer Subtype: | advanced adenocarcinoma of the gastroesophageal junction and esophagus. |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | Preoperative cetuximab, irinotecan, cisplatin, and radiation therapy |
| Study Type: | a Simon twostage design, prospective, phase IIstudy |
| Key Patients Feature: | Patients aged 18 years with pathologically confirmed stageIIA, IIB, orIIIcarcinomaoftheesophagusorgastroesophagealjunction(asdefinedbytheAmericanJointCommitteeonCancer [AJCC Cancer Staging Manual, 5th ed., http://www.cancerstaging.org/products/pasteditions.html])andpatientswith stage IVA lotheyr esophageal or gastroesophageal junction carcinoma with involved regional lymph nodes encompassed by the radiation field were eligible for this trial. Theseparticipants also had Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1. Required laboratory parameters for inclusion were an absolute neutrophilcount (ANC) 1, 500/ L, a platelet count 100, 000/ L, a total bilirubin level 1.5 mg/dL, creatinine 1.5 mg/dL, serumglutamic oxaloacetic transaminase 2.5 the upper limit ofnormal(ULN), andalkalinephosphatase 5 theULN.Exclusion criteria included any prior radiation therapy or chemotherapy, anypriorsurgeryforesophagealcarcinoma, andanyprior treatment targeting the EGFR pathway. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received weekly cetuximab on weeks 08 and irinotecan and cisplatin on weeks 1, 2, 4, and 5, with concurrent radiotherapy (50.4 Gy on weeks 16), followed by surgical resection. |
| Primary End Point: | the pCR rate and toxicity with this regimen. |
| Secondary End Point: | median progression free survival (PFS) and median OS times. |
| Patients Number: | 17 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Three patients (16%) had a pCR. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9 months (range, 2 months to 88 months) |
| Median OS A vs. C: | 19.5 months (range, 2 months to 88 months) |
| Adverse Event(agent arm): | The most common hematologic grade 3 or 4 adverse event preoperatively was neutropenia (47%), including febrile neutropenia in 26% of patients. The most common nonhematologic grade 3 or 4 adverse events were diarrhea (47%), dehydration (31%), dysphagia or esophagitis (31%), nausea (31%), anorexia (26%), and vomiting (21%). |
| Conclusions: | This schedule of cetuximab in combination with irinotecan, cisplatin, and radiation therapy was toxic and did not achieve a sufficient pCR rate in patients with localized esophageal adenocarcinoma to undergo further evaluation. |