Cancer Res Treat.  2017 Apr;49(2):416-422. 10.4143/crt.2016.121.

Phase II Study of Irinotecan and Cisplatin Combination Chemotherapy in Metastatic, Unresectable Esophageal Cancer

• Kim M
• Keam B
• Kim TM
• Kim HG
• Kim JS
• Lee SS
• Shin SH
• Kim MK
• Park KU
• Kim DW
• Yun HJ
• Lee JS
• Heo DS

• KMID: 2378113
• DOI: http://doi.org/10.4143/crt.2016.121

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.

Keyword

Esophageal neoplasms; Irinotecan; Cisplatin; Phase II clinical trial

MeSH Terms

Asthenia
Cisplatin*
Disease-Free Survival
Drug Therapy, Combination*
Epithelial Cells
Esophageal Neoplasms*
Febrile Neutropenia
Follow-Up Studies
Humans
Neutropenia
Thrombocytopenia
Cisplatin

Figure

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  Fig. 1. Progression-free survival for the per protocol population.

• 

  Fig. 2. Overall survival for the per protocol population.

Reference

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