| General information |
| Database: | DB00407 |
| Objective: | The aim of this study was to evaluate the efficacy and toxicity of cetuximab and pemetrexed as the secondline treatment for advanced esophageal cancer patients, who had undergone treatment with the standard cisplatin and 5FU regimens. |
| Authors: | Tian J, et al |
| Title: | Cetuximab plus pemetrexed as secondline therapy for fluorouracilbased pretreated metastatic esophageal squamous cell carcinoma. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2015 |
| PMID: | 26330330 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | EGFR
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | advanced esophageal squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Cetuximab plus pemetrexed |
| Study Type: | phase II study |
| Key Patients Feature: | All the patients who participated in this study had histologically proven squamous cell carcinoma and beenpreviously treated with other chemotherapeutic agentsbased upon the standard cisplatin and 5FU.All thepatients received cetuximab plus pemetrexed betweenSeptember 2011 and August 2013 at Shandong TumorHospital, after firstline treatment failure. The patientselection criteria were: age, 18-75 years old; ECOGperformance status (PS) less than and equal to 2; adequate hematological, hepatic function adrenal functions (white blood cellcount more than and equal to 4.0 ¡Á 109/l; neutrophil count more than and equal to 1.5 ¡Á 109/l;platelet count more than and equal to 100 ¡Á 109/l and hemoglobin more than and equal to 10 g/dl; ALT and AST less than and equal to 2.5 ¡Á upper limits of normal; totalbilirubin less than and equal to 1.5 ¡Á upper limits of normal; creatinineclearance more than and equal to 60 ml/min or creatinine less than and equal to upper limits ofnormal); and life expectancy greater than 3 months |
| Biomarker: | NA |
| Biomark Analysis: | The expression levels of serum miR335 were determined, and the subsequent analysis suggested that PFS was significantly different between the patients with higher level of serum miR335 and those with low level of serum miR335. The former had a PFS of 4.9 months (95 % CI 4.25.7) and the latter 4.1 months (95 % CI 3.74.5) (log rank = 0.025). |
| Control Group Info: | single arm |
| Treatment Info: | A total of 29 patients accepted this treatment. Cetuximab was administered at an initial dose of 400 mg/m(2) IV followed by weekly doses of 250 mg/m(2) IV, whereas pemetrexed 500 mg/m(2) was administered on day 1 every 3 weeks. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 12 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 12 patients (41.4 %) presented PR, ten (34.5 %) had SD, and seven (24.1 %) had PD. The response rate was 41.4 %. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.5 months (95 % CI 4.14.9) |
| Median OS A vs. C: | 9.4 months (95 % CI 8.410.5) |
| Adverse Event(agent arm): | None of the patients experienced grade 4 toxicity. Twentyfour patients presented rash. |
| Conclusions: | A combination of cetuximab plus pemetrexed was marginally effective and well tolerated in patients with advanced esophageal squamous cell carcinoma as the secondline treatment. |