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2015-6-1

The Thoracic Surgery Department, Graduate School of Medicine, Osaka University is holding clinical trials for evaluating perioperative atrial natriuretic peptide (ANP) for complete resection of non-small cell lung cancer in multicenter randomized controlled trials, JANP study (Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery.)

OKUMURA Meinoshin (Professor, Doctor and Project leader)
NOJIRI Takashi, National Cerebral and Cardiovascular Center Research Institute (Director, Peptide Drug Development Laboratory, Department of Biochemistry; Registered Clinician, Department of Thoracic surgery, Osaka University)
YAMAMOTO Haruko (Manager, Advanced Medical Treatment and Clinical Trial Promotion Department; Specially Appointed Adviser to Director)
KANGAWA Kenji (Director, Research institute)

This JANP study was applied as Advanced Medical Care B by NISHIDA Koji (Professor, Ophthalmology; Manager, Clinical Department Division, Osaka University Hospital) and its notification was announced on May 29 and took effect on June 1. This is the first project under the Advanced Medical Care B using exception of the system for healthcare services provided combining insurance-covered and non-covered services in the National Strategic Economic Growth Areas.

In this project, the effectiveness of prevention of cancer metastases and postoperative recurrence due to ANP's vascular protection effect will be applied to lung cancer surgery. This clinical research targeting 500 lung cancer patients will be conducted at 10 medical facilities all over Japan soon after completing necessary procedures.

Participating institutes include Osaka University Hospital, The University of Tokyo Hospital, Hokkaido University Hospital, Yamagata University Hospital, Kobe University Hospital, Toneyama National Hospital, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Yamagata Prefectural Central Hospital, and National Cancer Center Hospital East.

Abstract

Postoperative cancer recurrence is a major problem following curative cancer
surgery. Perioperative systemic inflammation induces the adhesion of
circulating tumor cells released from the primary tumor to the vascular
endothelium of distant organs, which is the first step in hematogenous
metastasis. We have previously reported that administration of atrial
natriuretic peptide (ANP) during the perioperative period reduces
inflammatory response and has a prophylactic effect on postoperative
cardiopulmonary complications in lung cancer surgery. In addition, we
demonstrate that cancer recurrence after lung cancer surgery was
significantly lower in ANP-treated patients than in control patients
(surgery alone). We show that ANP prevents cancer metastasis by suppressing
the inflammatory reaction of endothelial cells, thereby inhibiting cancer
cell adhesion to vascular endothelial cells (Nojiri et al., Proc Natl Acad
Sci U S A. 112(13):4086-91, 2015).
According to these basic researches, we will perform a clinical trial,
“Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP
study)”, which was designed to clarify whether the addition of
perioperative ANP could improve disease free survival for lung cancer
patients after surgery. “JANP study” was approved by the Ministry of
Health, Labour and Welfare as an advanced medical treatment B. Patients with
non-small-cell lung cancer will be randomized to receive ANP during
perioperative 3 days. Five hundred patients will be enrolled in this study.
This trial will be carried out at Osaka University, Tokyo University,
Hokkaido University, Yamagata University, Kobe University, Toneyama
Hospital, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
Prefectural Medical Center for Respiratory and Allergic Diseases, Yamagata
Prefectural Central Hospital, and National Cancer Center Hospital East.

Figure 1

Effect of ANP treatment on recurrence free survival (RFS) in patients with surgically resected non-small cell lung cancer. (A) Kaplan–Meier curves of the ANP group and control group (surgery alone) in all patients. (B) Kaplan–Meier curves of the above groups in propensity score-matched patients. (Modified from Nojiri et al., Proc Natl Acad Sci U S A. 2015).

Figure 2

We will perform a clinical trial, “Japan Human Atrial Natriuretic Peptide for Lung Cancer Surgery (JANP study)”, which was designed to clarify whether the addition of perioperative ANP could improve disease free survival for lung cancer patients after surgery. Patients with non-small-cell lung cancer will be randomized to receive ANP during perioperative 3 days. Five hundred patients will be enrolled in this study. This trial will be carried out at Osaka University, Tokyo University, Hokkaido University, Yamagata University, Kobe University, Toneyama Hospital, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Yamagata Prefectural Central Hospital, and Japan National Cancer Center East.

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