Observational Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Respirol. Mar 28, 2016; 6(1): 42-48
Published online Mar 28, 2016. doi: 10.5320/wjr.v6.i1.42
Multicenter cooperative observational study of idiopathic pulmonary fibrosis with non-small cell lung cancer
Noriyuki Ebi, Shoji Tokunaga, Kazunobu Itoh, Isamu Okamoto, Nobutaka Edakuni, Shinji Fujii, Kentaro Watanabe, Shinichiro Hayashi, Takashige Maeyama, Yoichi Nakanishi
Noriyuki Ebi, Department of Respiratory Oncology, Iizuka Hospital, Iizuka 820-8505, Japan
Shoji Tokunaga, Department of Medical Informatics, Kyushu University Hospital, Fukuoka 812-8582, Japan
Kazunobu Itoh, Division of Respiratory Medicine, Shinbeppu Hospital, Beppu 874-0840, Japan
Isamu Okamoto, Takashige Maeyama, Yoichi Nakanishi, Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan
Nobutaka Edakuni, Division of Respirology, Neurology and Rheumatology Department of Medicine, Kurume University School of Medicine, Kurume 830-0011, Japan
Shinji Fujii, Division of Respiratory Disease, Kumamoto Regional Medical Center, Kumamoto 860-0811, Japan
Kentaro Watanabe, Department of Respiratory Medicine, Fukuoka University Hospital, Fukuoka 814-0133, Japan
Shinichiro Hayashi, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga 849-0937, Japan
Author contributions: Ebi N, Tokunaga S and Nakanishi Y designed the study; Ebi N and Tokunaga S acquired patient data, and drafted the manuscript; Tokunaga S performed the statistical analysis; Itoh K, Okamoto I, Edakuni N and Fujii S collected and reviewed patient information; Watanabe K, Hayashi S and Maeyama T contributed to the central review; all authors read and approved the final manuscript.
Supported by The Clinical Research Support Center Kyushu (http://www.cres-kyushu.or.jp/).
Institutional review board statement: This study was performed in accordance with the principles of the Declaration of Helsinki and the good clinical practice guidelines.
Informed consent statement: Written informed consent was obtained from all patients before study entry. This study was approved by our institutional review board and trial document approval was obtained from each participating institution.
Conflict-of-interest statement: All authors declare no conflicts of interest in association with the present study.
Data sharing statement: Technical appendix. The data analyzed in this study will be shared. It is stored as a Stata dataset readable by Stata 11 or later version. Stata is statistical analysis software developed by Stata Corporation at Texas, United States. The codes and labels of the variables were embedded in the dataset. The dataset was stored with a name of “a_b_back_ipf.dta”.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Noriyuki Ebi, MD, Department of Respiratory Oncology, Iizuka Hospital, 3-83, Yoshio-machi, Iizuka 820-8505, Japan. nebi1@aih-net.com
Telephone: +81-948-223800 Fax: +81-948-298747
Received: August 28, 2015
Peer-review started: September 4, 2015
First decision: November 27, 2015
Revised: January 22, 2016
Accepted: February 14, 2016
Article in press: February 16, 2016
Published online: March 28, 2016
Processing time: 210 Days and 0.3 Hours
Abstract

AIM: To research the natural course of idiopathic pulmonary fibrosis (IPF) with advanced non-small cell lung cancer (NSCLC) and the association between acute exacerbation (AE) of IPF and chemotherapy (CT).

METHODS: From May 2007 through April 2011, 17 CT naive patients with IPF and advanced NSCLC were enrolled. Patients were classified into best supportive care (BSC) group or CT group based on the patient’s preference. Patients in the CT group received carboplatin (CBDCA) (AUC 5-6) plus paclitaxel (PTX) (175-200 mg/m2) on day 1 of each 21-d cycle as first-line therapy.

RESULTS: All patients but one chose the CT group. In the CT group, the objective response rate was 38%. The most frequent toxicity ≥ grade 3 was neutropenia (88%). Two patients (12.5%) developed AE-IPF. The median progression-free survival, the median survival time and the 1-year survival rate were 4.1 mo, 8.7 mo and 35%, respectively. Second-line CT-related AE and CT-unrelated AE occurred in 2 and 3 patients (1: BSC group; 2: CT group), respectively. Seven (41%) of all patients developed AE-IPF throughout the clinical course, and 6 of 7 patients with AE-IPF died within one month.

CONCLUSION: The incidence of AE-IPF was higher among IPF patients with advanced NSCLC than among those without NSCLC. CBDCA plus PTX regimen was tolerable and effective. However, AE-IPF has a fatal toxicity with or without CT in IPF patients with advanced NSCLC.

Keywords: Non-small cell lung cancer; Chemotherapy; Idiopathic pulmonary fibrosis; Acute exacerbation; Best supportive care

Core tip: Acute exacerbation (AE) of idiopathic pulmonary fibrosis (IPF) has been generally recognized. Little is known, however, about the natural history of IPF and the frequency of AE-IPF with advanced non-small cell lung cancer (NSCLC). We conducted a prospective observational study of IPF with advanced NSCLC for each group of patients receiving chemotherapy or the best supportive care according to the patient’s preference for the purpose of excluding a potential selection bias by the treating physicians.