Large scale clinical trial for Neuroendocrine Carcinoma (NEC), a rare and refractory cancer establishes current chemotherapy for advanced and recurrent cancer as standard therapymore effective new treatments anticipated

August 24, 2022
National Cancer Center Kanagawa Cancer Center
Japan Clinical Oncology Group
In Jaspanese

Highlights

• A randomized Phase 3 clinical trial, a world first of the kind, was conducted on patients at advanced/recurrent stages of a rare and refractory cancer originating from the digestive tract, Neuroendocrine carcinoma (NEC)
• 3 groups from Japan Clinical Oncology Group (hepatobiliary/pancreatic, gastric, esophageal), jointly conducted the research on 170 patients at 50 sites nationwide, a significant scale for rare cancer research
• As a result, both combinations of etoposide and cisplatin (EP) and irinotecan with cisplatin (IP) regimens were established as effective standard treatments for NEC
• The results are anticipated to provide a basis for, and instigate further treatment developments for NEC and other rare cancers

Summary

Japan Clinical Oncology Group (JCOG), to which the National Cancer Center Hospital serves as secretariat and datacenter, conducts multi-site clinical trials nationwide by specialty groups, to establish standard treatments and best diagnostic methods underpinned by scientific evidence.

TOPIC-NEC trials, a randomized Phase 3 study with 170 patients with advanced stage/recurrent cancers were conducted by three groups (hepatobiliary/pancreatic, gastric, esophageal) at JCOG. The objective was to compare the efficacy of first-line combination treatments, etoposide and cisplatin (EP) against irinotecan with cisplatin (IP) regimens.

Neuroendocrine carcinoma is rare, it is difficult to conduct clinical trials to develop new treatments. Currently, standard treatment for a similar cancer, non-small cell lung cancers, EP or IP regimens are given, however, previously it was unknown as to which treatment was more effective for NEC patients.

The study demonstrated similar results for both treatments, underpinning the recommendation for both as standard treatments.

The results were published on August 18, 2022, in JAMA Oncology.

Further development of NEC treatments and other rare cancers are anticipated, building on the new findings.

Publication

Journal

JAMA Oncology

Title

Etoposide+cisplatin versus irinotecan+cisplatin therapy for advanced neuroendocrine carcinoma of the digestive system: The TOPIC-NEC (JCOG1213) randomized phase III clinical trial

Authors

Chigusa Morizane*4 M.D., Ph.D., Nozomu Machida*5 M.D., Ph.D., Yoshitaka Honma*7 M.D., Takuji Okusaka*1 M.D., Ph.D., Narikazu Boku*2 M.D., Ph.D., Ken Kato*3・6 M.D., Ph.D., Shogo Nomura Ph.D., Nobuyoshi Hiraoka M.D., Ph.D., Shigeki Sekine M.D., Ph.D., Hirokazu Taniguchi MD. PhD, Naohiro Okano M.D., Ph.D., Kensei Yamaguchi M.D., Takuji Sato M.D., Ph.D., Masafumi Ikeda M.D., Ph.D, Nobumasa Mizuno M.D., Ph.D., Masato Ozaka M.D., Tomoko Kataoka DDS, Ph.D., Makoto Ueno M.D., Ph.D., Yuko Kitagawa M.D., Ph.D., Masanori Terashima M.D., PhD, Junji Furuse M.D., Ph.D., Japan Clinical Oncology Group (JCOG)

*1：Hepatobiliary PI, NCC Hospital, Takuji Okusaka
*2：Gastric PI, IMSUT Hospital, Narukazu Boku
*3：Esophageal PI, NCC Hospital, Ken Kato
*4：Hepatobiliary Research Secretariat, NCC Hospital, Chigusa Morizane
*5：Gastric Research Secretariat, Kanagawa Cancer Center, Nozomu Machida
*6：Esophageal Research Secretariat, NCC Hospital, Ken Kato
*7：Esophageal Research Secretariat, NCC Hospital, Yoshitaka Honma

Publication Date

August 18, 2022 (JST August 19, 2022)

DOI

10.1001/jamaoncol.2022.3395

URL

https://jamanetwork.com/journals/jamaoncology/fullarticle/2795418　（link to external site）