Is Tislelizumab + Chemotherapy Effective for Esophageal Squamous Cell Carcinoma?

On April 17, 2023, Jianming Xu and colleagues from the Chinese PLA General Hospital published the results of the Phase 3 RATIONALE-306 trial in "The Lancet Oncology." The study evaluated the efficacy and safety of first-line Tislelizumab + chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).

RATIONALE-306 is an international, multi-center, randomized, double-blind Phase 3 trial. A total of 649 patients with advanced or metastatic ESCC were randomized 1:1 to receive either Tislelizumab (200 mg every 3 weeks) + chemotherapy (N=326) or placebo + chemotherapy (N=323). Treatment continued until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), duration of response (DOR), objective response rate (ORR), and safety.

The median age of the participants was 64 years; 87% (N=563) were male and 13% (N=86) were female. Geographically, 75% (N=486) were Asian and 24% (N=155) were White. With a median follow-up of 16.3 months, the results were as follows:

The primary endpoint of median OS was 17.2 months in the Tislelizumab + chemotherapy group compared to 10.6 months in the placebo group. Regarding safety, the most common Grade 3-4 adverse events were neutropenia (Tislelizumab + chemotherapy: 31% [N=99], placebo: 33% [N=105]), leukopenia (Tislelizumab + chemotherapy: 11% [N=35], placebo: 16% [N=50]), and anemia (Tislelizumab + chemotherapy: 15% [N=47], placebo: 13% [N=41]). Six deaths occurred in the Tislelizumab + chemotherapy group: gastrointestinal hemorrhage (2), myocarditis (1), tuberculosis (1), electrolyte abnormality (1), and respiratory failure (1).

Based on the RATIONALE-306 results, Jianming Xu stated that first-line Tislelizumab + chemotherapy significantly improved OS compared to chemotherapy alone in patients with advanced or metastatic ESCC, with a manageable safety profile.

Source: https://www.thelancet.com/journals/laonc/article/PIIS1470-2045(23)00108-0/fulltext#%20

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