Postoperative chemotherapy does not improve overall survival (OS) vs chemoradiotherapy among patients with resectable gastric cancer who undergo preoperative chemotherapy, according to a study published in The Lancet Oncology.1
Perioperative chemotherapy and postoperative chemoradiotherapy are 2 standard strategies for gastric cancer management. The strategies had not, however, been previously compared in a head-to-head clinical study.
For the phase 3 CRITICS study (ClinicalTrials.gov Identifier: NCT00407186), researchers randomly assigned 788 patients with gastric or gastroesophageal adenocarcinoma to receive perioperative chemotherapy or preoperative chemotherapy followed by postoperative chemoradiotherapy.
After preoperative chemotherapy, 372 (95%) and 369 (93%) patients in the chemotherapy and chemoradiotherapy arm, respectively, proceeded to surgery. After surgery, 233 (59%) and 245 (62%) patients, respectively, continued treatment.
After a median follow-up of 61.4 months, the median OS in the chemotherapy arm was 43 months (95% CI, 31-57) compared with 37 months (95% CI, 30-48) in the chemoradiotherapy arm (hazard ratio [HR], 1.01; 95% CI, 0.84-1.22; P = .90).
There were 368 (47%) and 130 (17%) reports of grade 3 and 4 adverse events (AEs), respectively, in the entire study population after preoperative chemotherapy. Thirteen (2%) patients died after preoperative therapy; causes of death included diarrhea, dihydropyrimidine deficiency, sudden death, cardiovascular events, and functional bowel obstruction.
During postoperative therapy, 113 (48%) grade 3 and 22 (9%) grade 4 AEs were observed in the chemotherapy group, and 101 (41%) grade 3 and 10 (4%) grade 4 AEs were observed in the chemoradiotherapy group. Febrile neutropenia occurred in 79 (34%) vs 11 (4%) patients in the chemotherapy vs chemoradiotherapy group, respectively. There were no deaths during postoperative treatment.
The authors concluded that “preoperative chemotherapy with adequate surgery can be considered the backbone of resectable gastric cancer treatment. This trial provides a rationale to focus on preoperative strategies and to explore further intensification of the preoperative phase in future studies.”
- Cats A, Jansen EPM, van Grieken NCT, et al. Chemotherapy versus chemoradiotherapy after surgery and preoperative chemotherapy for resectable gastric cancer (CRITICS): an international, open-label, randomised phase 3 trial. Lancet Oncol. 2018 Apr 9. doi: 10.1016/S1470-2045(18)30132-3 [Epub ahead of print]