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

• DOI: 10.1200/jco.2020.38.4_suppl.100
• Publication Date: 2020-02-04T21:41:51Z
• Authors: 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
• Keywords: Chemoradiotherapy

100 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 following CRT showed a promising pathologic complete response (pCR) rate of 30% pts microsatellite-stable (MSS) advanced cancer. The treatment sequence prospectively investigated Locally Recurrent Rectal Cancer (LRRC) VOLTAGE-B. Methods: Pts pelvic LRRC without previous RT were included. Five cycles (240 mg q2 weeks) (50.4 Gy capecitabine 1,650 mg/m 2 ) pCR using AJCC tumor regression grading and key endpoints. Planned sample size VOLTAGE-B set 10 an exploratory manner. Results: From May to Oct 2018, Median age 65 8 male. Curative performed nine MSS. One had newly diagnosed supraclavicular lymph node metastasis before surgery. As one pt grade 0, seven 2, 3, observed, 10%. cut-off date Apr 2019, three showing out observed. Nivolumab-related adverse events (AEs) only 1 hyperthyroidism erythema. Grade 3/4 surgery-related AEs observed six pts, including two ileus infections. No treatment-related deaths Conclusions: 10% acceptable toxicity shown MSS treated CRT. Translational research exploring better predictors efficacies study are ongoing. Clinical trial information: NCT02948348.