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. 2022 Aug 2;28(15):3277-3286.
doi: 10.1158/1078-0432.CCR-21-0985.

Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)

Morihito Okada  1 , Ken Kato  2 , Byoung Chul Cho  3 , Masanobu Takahashi  4 , Chen-Yuan Lin  5 , Keisho Chin  6 , Shigenori Kadowaki  7 , Myung-Ju Ahn  8 , Yasuo Hamamoto  9 , Yuichiro Doki  10 , Chueh-Chuan Yen  11 , Yutaro Kubota  12 , Sung-Bae Kim  13 , Chih-Hung Hsu  14 , Eva Holtved  15 , Ioannis Xynos  16 , Yasuhiro Matsumura  17 , Akira Takazawa  18 , Yuko Kitagawa  19
Affiliations

Three-Year Follow-Up and Response-Survival Relationship of Nivolumab in Previously Treated Patients with Advanced Esophageal Squamous Cell Carcinoma (ATTRACTION-3)

Morihito Okada et al. Clin Cancer Res. .

Abstract

Purpose: Limited long-term data are available on immune checkpoint inhibitor use in patients with advanced esophageal squamous cell carcinoma (ESCC). We report 3-year follow-up data from our study of nivolumab versus chemotherapy (paclitaxel or docetaxel) in patients with previously treated ESCC.

Patients and methods: ATTRACTION-3 was a randomized, multicenter, open-label, phase III trial. Overall survival (OS), time from randomization to death from any cause, was the primary endpoint. An exploratory subanalysis assessed OS according to the best overall response (BOR) with and without landmark at 4 months.

Results: Of the enrolled patients, 210 received nivolumab and 209 received chemotherapy. With a minimum follow-up of 36.0 months, OS was longer in the nivolumab versus the chemotherapy group (median, 10.9 vs. 8.5 months; HR, 0.79; P = 0.0264), with 3-year OS rates of 15.3% and 8.7%, respectively. The median OS was longer with nivolumab versus chemotherapy irrespective of the BOR (complete response/partial response: 19.9 vs. 15.4 months; stable disease: 17.4 vs. 8.8 months; and progressive disease: 7.6 vs. 4.2 months). Grade 3 or higher treatment-related adverse events were reported in 40 patients (19.1%) in the nivolumab group and 133 patients (63.9%) in the chemotherapy group.

Conclusions: Nivolumab as second-line therapy demonstrated clinically meaningful long-term improvement in OS compared with chemotherapy in previously treated patients with advanced ESCC. The OS was consistently improved in the nivolumab group compared with the chemotherapy group regardless of BOR. Nivolumab was well tolerated over the 3-year follow-up. See related commentary by Yoon et al., p. 3173.

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Figures

Figure 1. Kaplan–Meier curves for overall survival (A) andprogression-free survival (B).
Figure 1.
Kaplan–Meier curves for overall survival (A) and progression-free survival (B).
Figure 2. Overall survival analysis by best overall response. Kaplan–Meier curves show OS by BOR in patients with complete response or partial response (A), in patients with SD (B), and in patients with progressive disease (C).
Figure 2.
Overall survival analysis by best overall response. Kaplan–Meier curves show OS by BOR in patients with CR or PR (A), in patients with SD (B), and in patients with PD (C).
Figure 3. Treatment and outcomes of 3-year survivors in nivolumab group. Swimmer plot represent treatment-free period, discontinuations, BOR, and subsequent therapy of 3-year survivors (n = 31) in the nivolumab group. CDDP, cisplatin; CR, complete response; DOX, docetaxel; 5-FU, 5-Fluorouracil; L-OHP, oxaliplatin; NE, not evaluable; Nivo, Nivolumab; PTX, paclitaxel.
Figure 3.
Treatment and outcomes of 3-year survivors in nivolumab group. Swimmer plot represents treatment-free period, discontinuations, BOR, and subsequent therapy of 3-year survivors (n = 31) in the nivolumab group. CDDP, cisplatin; CR, complete response; DOX, docetaxel; 5-FU, 5-fluorouracil; L-OHP, oxaliplatin; NE, not evaluable; Nivo, nivolumab; PTX, paclitaxel.
Figure 4. Emergence of select TRAEs over time in the nivolumab group. The number of patients exhibiting the first event in a category within a certain time period is depicted.
Figure 4.
Emergence of select TRAEs over time in the nivolumab group. The number of patients exhibiting the first event in a category within a certain time period is depicted.
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References

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