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Cancer Res Treat. 2017 Apr;49(2):416-422. doi: 10.4143/crt.2016.121. Epub 2016 Jul 28.

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

Author information

1
Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
2
Department of Internal Medicine, Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.
3
Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.
4
Department of Hematology-Oncology, Inje University Haeundae Paik Hospital, Busan, Korea.
5
Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Korea.
6
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
7
Department of Hematology-Oncology, Keimyung University School of Medicine, Daegu, Korea.
8
Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
9
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.

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.

KEYWORDS:

Cisplatin; Esophageal neoplasms; Irinotecan; Phase II clinical trial

PMID:
27488873
PMCID:
PMC5398400
DOI:
10.4143/crt.2016.121
[Indexed for MEDLINE]
Free PMC Article

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