VOLTAGE-B study: Nivolumab monotherapy and subsequent curative surgery following preoperative chemoradiotherapy in patients with locally recurrent rectal cancer (LRRC) without previous radiotherapy.

Authors

null

Takeshi Kato

Department of Surgery, National Hospital Organization Osaka National Hospital, Amagasaki, Japan

Takeshi Kato , Hideaki Bando , Yuichiro Tsukada , Koji Inamori , Mamoru Uemura , Satoshi Yuki , Yoshito Komatsu , Shigenori Homma , Daisuke Kotani , Shota Fukuoka , Takeshi Sasaki , Yuji Nishizawa , Naoki Nakamura , Masashi Wakabayashi , Motohiro Kojima , Yosuke Togashi , Akihiro Sato , Hiroyoshi Nishikawa , Takayuki Yoshino , Masaaki Ito

Organizations

Department of Surgery, National Hospital Organization Osaka National Hospital, Amagasaki, Japan, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan, Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan, Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan, Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan, Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan, Department of Gastroenterological Surgery, Hokkaido University Hospital, Sapporo, Japan, Division of Cancer Immunology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Kashiwa, Japan, Division of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan, Clinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan, Division of Pathology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Kashiwa, Japan, National Cancer Center Hospital East, Chiba, Japan

Research Funding

Pharmaceutical/Biotech Company
ONO Pharmaceutical

Background: Chemoradiotherapy (CRT) followed by curative resection in patients (pts) with local recurrence after radical surgery for primary rectal cancer is the preferred strategy if radiotherapy (RT) was not previously performed. In VOLTAGE-A study, nivolumab plus surgery following CRT showed a promising pathologic complete response (pCR) rate of 30% in pts with microsatellite-stable (MSS) advanced primary rectal cancer. The treatment sequence was prospectively investigated in pts with Locally Recurrent Rectal Cancer (LRRC) in VOLTAGE-B. Methods: Pts with pelvic LRRC without previous RT were included. Five cycles of nivolumab (240 mg q2 weeks) plus curative surgery following CRT (50.4 Gy with capecitabine 1,650 mg/m2) were performed. The pCR rate using AJCC tumor regression grading and curative resection rate were key endpoints. Planned sample size in VOLTAGE-B was set 10 pts in an exploratory manner. Results: From May to Oct 2018, 10 pts were included. Median age was 65 and 8 were male. Curative resection was performed in nine pts with MSS. One had a newly diagnosed supraclavicular lymph node metastasis before surgery. As one pt with AJCC grade 0, seven with grade 2, and one with grade 3, were observed, pCR rate was 10%. As of cut-off date of Apr 2019, three pts showing recurrence out of the nine pts were observed. Nivolumab-related adverse events (AEs) were only one pt with grade 1 hyperthyroidism and one with grade 1 erythema. Grade 3/4 surgery-related AEs were observed in six pts, including two pts with ileus and two with pelvic infections. No treatment-related deaths were observed. Conclusions: The pCR rate of 10% with acceptable toxicity was shown in MSS LRRC pts treated with nivolumab plus curative surgery following CRT. Translational research exploring better predictors of efficacies of study treatment are ongoing. Clinical trial information: NCT02948348

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Anal and Colorectal Cancer

Track

Colorectal Cancer,Anal Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02948348

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 100)

Abstract #

100

Poster Bd #

E8

Abstract Disclosures