Short-term safety of adjuvant nivolumab therapy after neoadjuvant docetaxel plus cisplatin and 5-FU therapy for locally advanced esophageal squamous cell carcinoma.

Authors

null

Toshiharu Hirose

Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;

Toshiharu Hirose , Shun Yamamoto , Toru Kadono , Go Ikeda , Akihiro Ohara , Mai Itoyama , Kazuki Yokoyama , Yoshitaka Honma , Koshiro Ishiyama , Junya Oguma , Hiroyuki Daiko , Ken Kato

Organizations

Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan; , Department of Esophageal Surgery, National Cancer Center Hospital, Tokyo, Japan;

Research Funding

No funding received
None.

Background: CheckMate 577 trial demonstrated efficacy of adjuvant nivolumab (Ad-Nivo) therapy in locally advanced esophageal cancer patients (pts) who underwent surgery after neoadjuvant chemoradiotherapy and did not achieve pathologic complete response. In Japan, neoadjuvant docetaxel plus cisplatin, 5-FU (NeoDCF) therapy is the standard care for locally advanced resectable esophageal squamous cell carcinoma (ESCC) based on the results of the JCOG1109 study. The efficacy and safety of Ad-Nivo therapy after NeoDCF therapy were unknown, so guidelines recommendations have not been determined. Methods: The subjects of this retrospective study were pts with histologically confirmed resectable locally advanced ESCC who received Ad-Nivo (480mg/body, every 4 weeks for 12 times) after NeoDCF in our hospital from Jan 2022 to Sep 2022. We evaluated safety as adverse events during treatments and clinical outcomes. Results: Twenty pts were selected in this study. Characteristics were median age (range) 65 (51–75) years, male/female 70/30%, PS 0/1 85/15%, Ce/Ut/Mt/Lt 5/15/50/30%, clinical stage II/III/IVA/IVB (supraclavicular lymph node) 10/70/0/20%, pathological stage IIB/IIIA/IIIB/IVA/IVB 30/5/40/10/15%. The pathological response according to Japanese Classification of Esophageal Cancer was Grade 0/1a/1b/2/3 5/20/20/40/15%. Median time (range) from surgery to Ad-Nivo was 9 weeks (4-20 weeks). The adverse events included fatigue (30%), increase AST (30%), increase ALT (15%), pruritus (15%), hyperthyroidism (15%), diarrhea (10%), decreased appetite (10%), and pneumonitis (10%). Grade >3 adverse events were not observed. Recurrence was observed in three pts (15%), which site was regional lymph node (2 pts of pathological stage III and IVB) and anastomosis (1pt of pathological stage IVA). Three pts with recurrence received definitive chemoradiotherapy, and still continue the treatment. Conclusions: The short-term toxicity of Ad-Nivo after NeoDCF was well-tolerated and acceptable.

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Abstract Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr 312)

DOI

10.1200/JCO.2023.41.4_suppl.312

Abstract #

312

Poster Bd #

C11

Abstract Disclosures

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