Nimotuzumab Plus Paclitaxel and Cisplatin as a 1^st-Line Treatment for Esophageal Cancer: Long Term Follow-up of a Phase II Study

Abstract

The effect of anti-epidermal growth factor receptor targeted treatment in esophageal squamous cell carcinoma (ESCC) is still unclear. We conducted a prospective phase II study of paclitaxel, cisplatin, and nimotuzumab (TPN) as a first-line treatment for unresectable or metastatic ESCC and the objective response rate was 51.8%. Here, we report the long-term follow-up results of the initial trial. Fifty-nine patients were enrolled from Mar 2011 to Apr 2013 and were treated with the TPN regimen. Palliative sequential radiotherapy was given if all tumor lesions were confined to 1-2 radiation fields. Fifty-six patients were eligible for evaluation. After a median follow-up of 32.2months, the median progression-free survival (PFS) and the overall survival (OS) time were 18.1±4.2 months (95% CI: 9.8-26.4) and 26.2±10.0 months (95% CI: 6.6-45.8), respectively, in 29 patients with unresectable local-regional disease, while they were 6.6±0.4 months (95% CI: 5.8-7.5) and 11.5±3.7 months (95% CI: 4.2-18.8), respectively, in 27 patients with metastatic disease. Patients who were male, those with multiple station lymph node metastases, those with visceral metastasis, those who did not response to TPN treatment, and those who did not receive radiotherapy, had a worse OS. In 6 patients with multiple station lymph node metastasis and in 3 patients with recurrent disease and oligo-metastasis (local lymph nodes), TPN with sequential radiation resulted in a mean OS of 17.67±9.50 months and a mean OS of over 40 months, respectively. In conclusion, TPN is effective as a first-line treatment for patients with unresectable and metastatic ESCC. In addition, TPN treatment with sequential radiation might improve survival in patients with limited or oligo lymph node metastases.

CSMD1 Mutation Related to Immunity Can Be Used as a Marker to Evaluate the Clinical Therapeutic Effect and Prognosis of Patients with Esophageal Cancer

“…Given the high incidence of severe gastrointestinal toxicity, leukopenia, radiation dermatitis and radiation pneumonitis caused by paclitaxel chemotherapy, the screening for sensitive populations is particularly important. 46 , 47 Our analysis shows that CSMD1 mutation status can be used as a biomarker to screen ESCA patients sensitive to paclitaxel chemotherapy.…”

The Anti-PD-1/PD-L1 Immunotherapy for Gastric Esophageal Cancer: A Systematic Review and Meta-Analysis and Literature Review

“…EGFR has been shown to be up-regulated in 30-90% of esophageal cancer patients 9 and 27%-64% of gastric cancer patients, 10 respectively. However, all the clinical trials of monoclonal antibody and tyrosine kinase inhibitors targeted to EGFR did not gave us the positive outcome, such as cetuximab, 11 , 12 panitumumab, 13 nimotuzumab, 14 gefitinib and erlotinib. 15 , 16 Trastuzumab and ramulizumab have clear efficacy in adenocarcinoma, but lack of clinical evidence in esophageal squamous cell carcinoma.…”

Effectiveness and Safety of Targeted Agents Combined With Chemoradiotherapy for the Treatment of Esophageal Cancer: A Network Meta-Analysis

“…Previous studies have concluded that cetuximab is not beneficial in patients with low EGFR expression ( 32 ), and whether the high expression of EGFR is associated with larger tumors or T stage 3-4 is the reason why cetuximab is more effective can be further confirmed. In addition, sex was an independent predictor of OS in EC patients ( 33 ). The sex subgroup results showed that cetuximab combined with CRT was relatively superior to the control in female EC patients but inferior to the control in male EC patients.…”