2034MO - EAGER: A randomized, controlled, multicenter trial of electro-acupuncture in gastric cancer patients undergoing adjuvant chemotherapy

Background

Patients with gastric cancer experience quality of life (QoL) decline during adjuvant chemotherapy following gastrectomy. The EAGER (Electro-Acupuncture in Gastric cancER) trial was undertaken to confirm the efficacy of electro-acupuncture (EA) for improving QoL in these patients seen in our pilot study.

Methods

Patients who has accepted R0 resection for gastric cancer, and who will receive adjuvant chemotherapy were randomly assigned to high-dose EA (HA, 7 times each chemo-cycle for 3 cycles), low-dose EA (LA, 3 times each chemo-cycle for 3 cycles), or control (Ctrl) groups. Functional Assessment of Cancer Therapy-Gastric (FACT-Ga) was reported by the patients at baseline and then once a week during the therapy. Primary endpoint was the differences on total area under curves (AUCs) of FACT-Ga Trial Outcome Index (TOI) during the 3 cycles of chemotherapy, calculated by linear interpolation, among the groups. Secondary endpoints included the differences on AUCs of FACT-Ga Gastric Cancer Subscale (GaCS) scores, AUCs of FACT-Ga scores, and the disease free survival (DFS).

Results

Of the randomized 240 patients, 222 were analyzed according to intention-to-treat (ITT) principle, and 186 were in the per-protocol set (PPS). Both HA and LA produced significant QoL improvement. AUCs (21 days/cycle × 3 cycles, the higher, the better) of TOI in the ITT were 5678±1229, 5558±1226, and 4735±1233 (HA vs. Ctrl, P<0.001; LA vs. Ctrl, P<0.001), of GaCS were 3458±725, 3356±723, and 2919±726 (HA vs. Ctrl, P<0.001; LA vs. Ctrl, P<0.001), and of FACT-Ga were 8164±1516, 8024±1516, and 7029±1521 (HA vs. Ctrl, P<0.001; LA vs. Ctrl, P<0.001), in HA, LA, and Ctrl groups, respectively. EA also produced trend of DFS improvement, although not significantly in the ITT population [HA vs. Ctrl: HR=0.56 (0.27-1.15), P=0.1089; LA vs. Ctrl: HR=0.81 (0.59-1.12), P=0.1979], while the DFS differences in the PPS were significant [HA vs. Ctrl: HR=0.37 (0.15-0.92), P=0.0258; LA vs. Ctrl: HR=0.72 (0.51-1.02), P=0.0582].

Conclusions

EA resulted in a clinically meaningful improvement of QoL in gastric cancer patients undergoing adjuvant chemotherapy. Besides, EA was also associated with promising effect in prolonging DFS in these patients.

Clinical trial identification

NCT04360577; First released on April 24^th, 2020.

Editorial acknowledgement

NA

Legal entity responsible for the study

H-B. Zhang.

Funding

National Key Research and Development Program of China (2017YFC1700603).

Disclosure

All authors have declared no conflicts of interest.