| General information |
| Database: | DB00419 |
| Objective: | Preoperative chemoradiotherapy (CRT) improves the survival of patients with oesophageal cancer when compared with surgery alone. |
| Authors: | De Vita F, et al |
| Title: | A multicenterphase II study of induction chemotherapy with FOLFOX4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer. |
| Journal: | Br J Cancer. |
| Year: | 2011 |
| PMID: | 21245865 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | adenocarcinoma or squamous cell carcinoma of the oesophagus |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | induction chemotherapy with FOLFOX4 and cetuximab followed by radiation and cetuximab |
| Study Type: | phase II study |
| Key Patients Feature: | Patients 18 years of age or older with locally advanced (T3- 4, N0 or any T, N t ) and biopsyconfirmed adenocarcinoma orsquamous cell carcinoma of the oesophagus were enroled. Othereligibility criteria included Eastern Cooperative Oncology Groupperformance status of 0-2, no significant concomitant comorbidities; adequate organ function (absolute neutrophil count X1500cells 0 ml 1, platelet count 4100 000 ml 1, estimated creatinineclearance 460 ml min 1, normal bilirubin, aspartate aminotransferase and alanine aminotransferase o1.5 the institutionalupper limit of normal (ULN), and alkaline phosphatase o2.5 ULN. |
| Biomarker: | Cytokines levels potentially related to cetuximab efficacy |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Cytokines levels potentially related to cetuximab efficacy were assessed using multiplexbead assays and enzymelinked immunosorbent assay at baseline, at week 8 and at week 17. |
| Primary End Point: | complete pathological response rate (pCR). |
| Secondary End Point: | NA |
| Patients Number: | 41 |
| Trial Results |
| DLT_MTD: | The most frequent grade 3/4 toxicity was skin (30%) and neutropenia (30%). |
| Objective Response Rate: | Among 30 patients who underwent surgery, a pCR was observed in 8 patients correspondingto a rate of 27%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | the 3years survival was 57% for squamous histology vs 41% for adenocarcinoma. |
| Adverse Event(agent arm): | The most frequent grade 3/4 toxicity was skin (30%) and neutropenia (30%). |
| Conclusions: | Incorporating cetuximab into a preoperative regimen for LAEC is feasible; no correlation bettheyen cytokines changes and patient outcome was observed. Positron emission tomographycomputed tomography study even if influenced by the small number of patients appears to be able to predict patients outcome both as early and late metabolic response. |