(Esophageal Cancer) Preoperative Chemoradiotherapy + Trastuzumab Effective?
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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
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