4052 Background: We compared the health-related quality-of-life (HRQOL) of standard neoadjuvant cisplatin and 5-FU chemotherapy plus radiotherapy (N) followed by surgical resection to adjuvant cisplatin, 5-FU, and epirubicin chemotherapy with concurrent extended volume radiotherapy (A) following surgical resection for resectable esophageal carcinoma. Methods: 96 patients with stage I to III resectable cancer of the esophagus were enrolled into a prospective randomized trial (NCT00907543) from April 2009 to November 2016. Patients were randomized into 2 groups: N (47 cases) and A (49 cases). The primary end point was HRQOL using the FACT-E at one year. The secondary endpoints included other HRQOL measures, overall survival (OS), disease-free survival (DFS), and adverse events. Results: The median follow-up was 5.0 years [95% CI :4.6 to 5.5]. The majority of patients had adenocarcinomas of the distal esophagus/gastroesophageal junction (80.9% vs 87.8%). The stage distribution was: I 9%; II 22%; III 58%; TxN0-1 10%. Using an intention-to-treat analysis there was no significant difference in the FACT-E total scores between arms at one year (p = 0.759), with 35.5% vs. 41.2% respectively showing an increase of ≥ 15 points ( a priori minimal clinical difference) compared to pre-treatment (p = 0.638). The HRQOL was temporarily significantly inferior at 2 months in the N arm for FACT-E, EORTC OG25, and EQ-5D-3L in the dysphagia, reflux, pain, taste, and coughing domains (p < 0.05). There were no 30-day mortalities but 2.1% vs. 10.2% 90-day mortalities (p = 0.204). There were no significant differences in either 5-year OS (37.9% vs 28.9%, p = 0.321) or DFS (34.0% vs 25.5%, p = 0.551. 48.9% of patients required chemotherapy to be modified or stopped in the N arm compared to 57.1% in the A arm (p = 0.421). 51.1% of patients were able to complete the prescribed N arm chemotherapy without modification compared to only 14.3% in the A arm (p < 0.001). Chemotherapy related adverse events significantly more frequent in the neoadjuvant arm (p < 0.05). Surgery related adverse events were significantly more frequent in the neoadjuvant arm (p < 0.05). Conclusions: Trimodality therapy is challenging for patients with resectable esophageal cancer regardless if it is given before or after surgery. Less toxic protocols are needed. Clinical trial information: 00907543.
Impact of Neoadjuvant Chemotherapy on Physical Fitness, Physical Activity, and Health-related Quality of Life of Patients With Resectable Esophageal Cancer
