| Background:Esophageal cancer(EC)is a common malignancy of the digestive system,china has the largest number of both newly diagnosed EC cases and EC cancer-related deaths in the world,and the vast majority are patients with esophageal squamous cell cancer Because the clinical symptoms of early esophageal cancer are insidious and non-specific,most of the patients with esophageal cancer are in the middle or late stages when diagnosed Despite the evolution of multidisciplinary treatments,the prognosis of EC has not improved much,especially for patients with esophageal squamous cell cancer refractory to previous regimens of chemotherapy.Currently,there is no standard second-line or later-line treatments recommended for advanced recurrent metastatic esophageal squamous cell cancer.This study retrospectively assessed the efficacy and safety of irinotecan plus raltitrexed in esophageal squamous cell cancer patients who had been previously treated with multiple systemic therapies.Patients and methods:Between January 2016 to December 2018,a total of 38 esophageal squamous cell cancer patients with complete pretreatment and evaluation data were collected from Northern Jiangsu People’s Hospital affiliated to Yangzhou University,who were progressing after at least standard first-line chemotherapy.And then the efficacy and safety of irinotecan plus raltitrexed in treatment of the 38 patients were retrospectively assessed.The patients received irinotecan as a 90-min infusion on day 1 and raltitrexed as a 30-min infusion on day 2 every 3 weeks up to a maximum of 6 cycles or until either unacceptable toxicity or progressive disease.And administration of 5-hydroxytryptamine type 3 receptor antagonist and proton pump inhibitor 30 minutes prior to chemotherapy prophylactic reduced the incidence of gastrointestinal side effects such as nausea and vomiting.Efficacy was evaluated every two cycles according to the Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1),and safety was evaluated for each chemotherapy cycle according to the National Cancer Institute Common Toxicity Criteria(NCI-CTC).Results:A total of 95 cycles of chemotherapy were administered to all 38 patients,and the median course was 3(range 2-6).The patients received the median dose of irinotecan was 178 mg/m2(118-217 mg/m2)and the median dose of raltitrexed was 2.7 mg/m2(2.17-3.07 mg/m2).Among all 38 patients,there was no treatment related death.Nine patients had partial response(PR),21 had stable disease(SD)and 8 had progressive disease(PD).The overall objective response rate(ORR)was 23.68%(9/38)and the disease control rate(DCR)was78.94%(30/38).After a median follow-up of 18.5 months(2-32 months),the median progression-free survival(PFS)and overall survival(OS)were 105 days(25 to 357 days)and 221 days(32 to 632 days)respectively.The objective response rates(ORRs)were 35.00%and 11.11%respectively in patients who had received non 5-Fu prior treatment and received 5-Fu prior treatment,which was almost statistically significant(P=0.08).The ORRs were 37.50%and 20.00%respectively in patients who had received prior only chemotherapy and received prior chemoradiotherapy,which showed no statistical difference(P=0.27).The ORRs were 31.82%and 12.50%respectively in patients who had received only first line prior treatment and at least two lines of prior treatment,which also showed no statistical difference(P=0.16).There were 5 patients(13.15%)with grade 3/4 leukopenia,3 patients(7.89%)with grade 3/4 neutropenia and 1 patient(2.63%)with grade 3/4 diarrhea.Conclusions:The combination of irinotecan plus raltitrexed was a new treatment for advanced and refractory esophageal squamous cell cancer patients with considerable efficacy and acceptable toxicity.This study provides a safe and effective new option for clinical selection of second-line or later line treatment for esophageal squamous cell cancer. |
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