Prospective Study
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World J Gastroenterol. Dec 28, 2014; 20(48): 18452-18457
Published online Dec 28, 2014. doi: 10.3748/wjg.v20.i48.18452
Treatment outcomes of chemotherapy between unresectable and recurrent biliary tract cancer
Takashi Sasaki, Hiroyuki Isayama, Yousuke Nakai, Yukiko Ito, Ichiro Yasuda, Nobuo Toda, Hiroshi Yagioka, Saburo Matsubara, Keiji Hanada, Hiroyuki Maguchi, Hideki Kamada, Osamu Hasebe, Tsuyoshi Mukai, Yoshihiro Okabe, Iruru Maetani, Kazuhiko Koike
Takashi Sasaki, Hiroyuki Isayama, Yousuke Nakai, Kazuhiko Koike, Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo, Tokyo 113-8655, Japan
Yukiko Ito, Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo 150-8935, Japan
Ichiro Yasuda, First Department of Internal Medicine, Gifu University Hospital, Gifu 501-1194, Japan
Nobuo Toda, Department of Gastroenterology, Mitsui Memorial Hospital, Tokyo 101-8643, Japan
Hiroshi Yagioka, Department of Gastroenterology, JR Tokyo General Hospital, Tokyo 151-8528, Japan
Saburo Matsubara, Department of Gastroenterology, Kanto Central Hospital, Tokyo 158-8531, Japan
Keiji Hanada, Center for Gastroendoscopy, Onomichi General Hospital, Hiroshima 722-8508, Japan
Hiroyuki Maguchi, Center for Gastroenterology, Teine-Keijinkai Hospital, Hokkaido 006-8555, Japan
Hideki Kamada, Department of Gastroenterology and Neurology Faculty of Medicine, Kagawa University, Kagawa 761-0793, Japan
Osamu Hasebe, Department of Gastroenterology, Nagano Municipal Hospital, Nagano 381-8551, Japan
Tsuyoshi Mukai, Department of Gastroenterology, Gifu Municipal Hospital, Gifu 500-8513, Japan
Yoshihiro Okabe, Department of Gastroenterology, Osaka Red Cross Hospital, Osaka 543-8555, Japan
Iruru Maetani, Division of Gastroenterology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo 153-8515, Japan
Author contributions: Sasaki T designed the study, analyzed the data, and worked on the manuscript; Isayama H designed the study concept; Nakai Y analyzed the data and worked on the manuscript; Ito Y, Yasuda I, Toda N, Yagioka H, Matsubara S, Hanada K, Maguchi H, Kamada H, Hasebe O, Mukai T, Okabe Y and Maetani I collected the clinical data; and Koike K supervised and overviewed the study.
Correspondence to: Hiroyuki Isayama MD, PhD, Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan. isayama-2im@h.u-tokyo.ac.jp
Telephone: +81-3-38155411-33056 Fax: +81-3-38140021
Received: April 22, 2014
Revised: June 9, 2014
Accepted: July 15, 2014
Published online: December 28, 2014
Processing time: 258 Days and 10.3 Hours
Abstract

AIM: To evaluate the differences in the treatment outcomes between the unresectable and recurrent biliary tract cancer patients who received chemotherapy.

METHODS: Patients who were treated with gemcitabine and S-1 combination therapy in the previous prospective studies were divided into groups of unresectable and recurrent cases. The tumor response, time-to-progression, overall survival, toxicity, and dose intensity were compared between these two groups.

RESULTS: Response rate of the recurrent group was higher than that of the unresectable group (40.0% vs 25.5%; P = 0.34). Median time-to-progression of the recurrent and unresectable groups were 8.7 mo (95%CI), 1.2 mo, not reached) and 5.7 mo (95%CI: 4.0-7.0 mo), respectively (P = 0.14). Median overall survival of the recurrent and the unresectable groups were 16.1 mo (95%CI: 2.0 mo-not reached) and 9.6 mo (95%CI: 7.1-11.7 mo), respectively (P = 0.10). Dose intensities were significantly lower in the recurrent groups (gemcitabine: recurrent group 83.5% vs unresectable group 96.8%; P < 0.01, S-1: Recurrent group 75.9% vs unresectable group 91.8%; P < 0.01). Neutropenia occurred more frequently in recurrent group (recurrent group 90% vs unresectable group 55%; P = 0.04).

CONCLUSION: Not only the efficacy but also the toxicity and dose intensity were significantly different between unresectable and recurrent biliary tract cancer.

Keywords: Biliary tract cancer; Unresectable; Recurrent; Pooled analysis; Chemotherapy

Core tip: Many chemotherapeutic studies of advanced biliary tract cancer include both unresectable and recurrent cases. However, the treatment outcomes of these two conditions might be different. We therefore conducted a pooled analysis of two prospective studies to evaluate the differences in the treatment outcomes between the unresectable and recurrent cases in patients with advanced biliary tract cancer patients who received chemotherapy. From our pooled analysis, not only the efficacy but also the toxicity and dose intensity were significantly different between these two conditions. Therefore, it is better to evaluate the unresectable and recurrent cases separately in future prospective studies.