Phase II Study of Irinotecan and Cisplatin Combination Chemotherapy in Metastatic, Unresectable Esophageal Cancer.
- Author:
Miso KIM
1
;
Bhumsuk KEAM
;
Tae Min KIM
;
Hoon Gu KIM
;
Jin Soo KIM
;
Sung Sook LEE
;
Seong Hoon SHIN
;
Min Kyoung KIM
;
Keon Uk PARK
;
Dong Wan KIM
;
Hwan Jung YUN
;
Jong Seok LEE
;
Dae Seog HEO
Author Information
- Publication Type:Multicenter Study ; Original Article
- Keywords: Esophageal neoplasms; Irinotecan; Cisplatin; Phase II clinical trial
- MeSH: Asthenia; Cisplatin*; Disease-Free Survival; Drug Therapy, Combination*; Epithelial Cells; Esophageal Neoplasms*; Febrile Neutropenia; Follow-Up Studies; Humans; Neutropenia; Thrombocytopenia
- From:Cancer Research and Treatment 2017;49(2):416-422
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: The objective of this multicenter phase II study was to evaluate the efficacy and safety of irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer. MATERIALS AND METHODS: Patients were treated with irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8 of each 21-day treatment cycle. The primary endpoint was response rate, and secondary endpoints were survival, duration of response, initial metabolic response rate, and toxicity. RESULTS: A total of 27 patients with squamous cell histology were enrolled in the study. The median age of the patients was 61 years. The objective response rate of the 20 patients in the perprotocol group was 30.0% (90% confidence interval [CI], 13.2 to 46.9). The median follow-up duration was 10.0 months, and the median progression-free survival and overall survival were 4.5 months (95% CI, 1.6 to 6.2) and 8.8 months (95% CI, 4.7 to 10.5), respectively. Four of 13 patients (30.8%) evaluated showed initial metabolic response. The median duration of response for partial responders was 5.0 months (range, 3.4 to 8.0 months). The following grade 3/4 treatment-related hematologic toxicities were reported: neutropenia (40.7%), anaemia (22.2%), and thrombocytopenia (7.4%). Two patients experienced febrile neutropenia. The most common grade 3/4 non-hematologic toxicities were asthenia (14.8%) and diarrhoea (11.1%). CONCLUSION: Irinotecan and cisplatin combination chemotherapy showed modest anti-tumour activity and manageable toxicity for patients with metastatic, unresectable esophageal cancer.
