1271P - 5-ALA administration for photodynamic diagnosis of peritoneal metastases due to advanced gastric cancer: A randomised, double-blind, multicentre ph...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancer in Adolescents
Gastric Cancer
Diagnostics
Translational Research
Presenter Tsuyoshi Takahashi
Citation Annals of Oncology (2017) 28 (suppl_5): v449-v452. 10.1093/annonc/mdx378
Authors T. Takahashi1, K. Fujitani2, T. Omori3, K. Nishikawa4, T. Hayashi5, T. Namikawa6, E. Otsuji7, S. Takiguchi8, Y. Doki1
  • 1Department Of Gatroenterological Surgery, Osaka university hospoital, 5650871 - Suita/JP
  • 2Department Of Surgery, Osaka General Medical Center, 558-8558 - Osaka/JP
  • 3Department Of Surgery, Osaka International Cancer Institute, osaka/JP
  • 4Surgery, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP
  • 5Surgery, Saito yukoukai hospital, ibaraki/JP
  • 6Surgery, Kochi university hospital, Nankoku/JP
  • 7Surgery, Kyoto prefectural university hospital, Kyoto/JP
  • 8Surgery, Nagoya city university hospital, Nagoya/JP

Abstract

Background

For advanced gastric cancer, diagnosis of peritoneal dissemination is mandatory prior to the decision of therapy; therefore, staging laparoscopy (SL) has gained wider clinical acceptance. We have reported the efficacy of SL with photodynamic diagnosis (PDD) using 5-aminolevulinic acid (5-ALA). In this study, the safety and effectiveness of oral administration of 5-ALA PDD compared with that of conventional white-light laparoscopic diagnosis is assessed in a phase I/II study. This research also used a randomised double-blind comparison to explore the optimum dose of 5-ALA to be followed by a confirmatory study.

Methods

Subjects were patients with type 3 or 4 gastric cancer. A total of 20 or 40 mg/kg 5-ALA was administered orally 180–300 minutes before SL. The primary endpoint was safety; the secondary endpoints were sensitivity, specificity, positive predictive value, negative predictive value, and the proportion of patients with peritoneal dissemination.

Results

Thirty-one patients, comprising 19 men and 12 women, were enrolled. Fourteen patients were allocated to the 20 mg/kg group and 17 to the 40 mg/kg group. The median age was 70 years. The proportions of adverse events were 53.8% and 41.2% in the 20 and 40 mg/kg groups, respectively. Hypotension was noted as serious adverse event in 1 patient. The sensitivities of PDD in the 20 and 40 mg/kg groups were higher (95.7% and 100%, respectively) than those of conventional diagnosis (73.9% and 67.8%) (p = 0.0625 and p = 0.0313). In terms of precision, the evaluation values of diagnosis through conventional imaging compared with PDD were as follows: sensitivity, 83.5% vs. 98.6%; specificity, 75.5% vs. 38.8%; positive predictive value, 82.2% vs. 69.6%; and negative predictive value, 75.5% vs. 95.0%, respectively. In addition, one more patient was found positive for dissemination via PDD.

Conclusions

This investigator-initiated clinical trial confirmed the safety and effectiveness of 5-ALA administration in PDD for peritoneal metastases in gastric cancer. Results indicated that both doses of 5-ALA may be clinically applicable. Thus, we are now conducting a confirmatory study to apply for pharmaceutical approval of 5-ALA.

Clinical trial identification

JMA-IIA00225

Legal entity responsible for the study

Prof. Yuichiro Doki

Funding

This work was supported by the clinical trial promotion pro-gram subsidized by the Japan Medical Association with theMinistry of Health, Labour and Welfare Research Grant

Disclosure

All authors have declared no conflicts of interest.