(Esophageal Cancer) Preoperative Chemoradiotherapy + Trastuzumab Effective?

On January 14, 2022, Howard P. Safran et al. from Rhode Island Hospital published in the medical journal The Lancet Oncology the efficacy and safety results of preoperative chemoradiotherapy + Trastuzumab in previously untreated HER2-positive resectable esophageal adenocarcinoma patients from the NRG Oncology/RTOG-1010 Phase III clinical trial.

NRG Oncology/RTOG-1010 was a randomized open-label Phase III trial that randomized previously untreated HER2-positive resectable esophageal adenocarcinoma patients (N=203) in a 1:1 ratio into:

• Trastuzumab group (6 weeks of chemotherapy + radiotherapy followed by surgical resection; additional Trastuzumab 2–4 mg/kg administered weekly for 5 weeks during chemoradiotherapy; one preoperative Trastuzumab dose at 6 mg/kg; 13 postoperative doses of Trastuzumab 6 mg/kg on a 3-week cycle starting 21–56 days after surgery; N=102)
• Chemoradiotherapy group (N=101)

Primary endpoint: disease-free survival (DFS).

At a median follow-up of 2.8 years, the primary endpoint DFS was: Trastuzumab group 19.6 months vs. chemoradiotherapy group 14.2 months — with a 1% reduction in the risk of death (DFS) in the Trastuzumab group.

Regarding safety, the most common Grade 3 or higher adverse events observed in the majority of patients were hematological and gastrointestinal. Hematological adverse event rates: Trastuzumab group 56% (N=53/95) vs. chemoradiotherapy group 57% (N=55/96). Gastrointestinal adverse event rates: Trastuzumab group 29% (N=28) vs. chemoradiotherapy group 21% (N=20).

Serious adverse event rates: Trastuzumab group 36% vs. chemoradiotherapy group 28%. Treatment-related deaths: Trastuzumab group 5 patients vs. chemoradiotherapy group 3 patients.

Based on NRG Oncology/RTOG-1010 results, Howard P. Safran et al. concluded: In HER2-positive resectable esophageal adenocarcinoma patients, preoperative chemoradiotherapy + Trastuzumab did not improve disease-free survival; however, adding postoperative Trastuzumab treatment did not increase the rate of adverse events.

Source: thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00718-X/fulltext

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

Figure 1

Figure 2

Figure 3

Figure 4