Discussion
death, neutropenia, diarrhea, hyponatremia, dehydration, gastric cancer
NEUTROPENIA, ADVERSE EVENTS, DISEASE, HYPONATREMIA, DEHYDRATION, GASTRIC CANCER
This phase II study tested the safety and efficacy of SOXThe main research hypothesis of this study was that “NAC + radical gastrectomy for LAGC in older patients is as safe and effective as in the young.” The participants in this study were older than 70 years of age, were more likely to have comorbidities, and the incidence of adverse events during chemotherapy was expected to be higher than in younger patients. Therefore, we focused on safety evaluation, and set the DI of the preoperative SOXIn three trials of preoperative chemotherapy for stage III disease, the R0 resection rate was over 90% and the pRR was over 40% [All Grade or Grade 3–4 adverse events in preoperative chemotherapy in the older patients in this study were neutropenia and hyponatremia in 76.0/20.0% and 42.3/7.7%, respectively. We experienced one case of death due to severe diarrhea and dehydration. In KSCC1601 discussed above, which included patients aged 20 years and older, these adverse events were lower at 42.6/6.4% and 29.8/2.1%, respectively, suggesting that these adverse events may be more frequent and severe in older patients. We lost one patient due to diarrhea and dehydration. This may have been avoided if the patient had been hospitalized immediately after the onset of diarrhea. In the case of elderly patients, it is considered safe to hospitalize them when the first course of NAC-SOX therapy is introduced. Since the older patients have decreased organ function, careful observation should be continued even after outpatient follow-up, and hospitalization should be considered depending on the patient’s condition.There are various reports on the significance of chemotherapy in older patients with advanced or recurrent GC, although the issue remains controversial. This is because the older population is diverse, and patients cannot be stratified by age alone. A phase II study of S-1 monotherapy in patients aged 75 years or older reported favorable safety and efficacy [Another issue is the need for postoperative adjuvant chemotherapy after NAC. In the KSCC1801 study of older patients, postoperative adjuvant chemotherapy was not specified in the protocol due to safety concerns. However, 75% of the patients received postoperative adjuvant chemotherapy at the physician’s discretion. In Europe and the United States, perioperative chemotherapy is the standard treatment for locally advanced gastric cancer (NAC + surgery + postoperative chemotherapy). In East Asia, surgery plus postoperative adjuvant chemotherapy has been the standard treatment, and NAC’s additional effect has been verified. It remains unclear whether postoperative adjuvant chemotherapy can be omitted when NAC is administered, and whether there is a group of patients for whom it can be omitted. Subgroup analyses of clinical trials of postoperative adjuvant chemotherapy have not demonstrated an additional OS benefit in older patients [There were a few limitations to the study. First, the study was a single-arm, phase II clinical trial involving a small number of patients. Second, no comprehensive geriatric assessment or quality of life assessment was included in the study design.