AUTHOR=Yang Zhong-Yin , Yuan Fei , Lu Sheng , Xu Wei , Wu Jun-Wei , Xi Wen-Qi , Shi Min , Wang Zhen-Qiang , Ni Zhen-Tian , He Chang-Yu , Yao Xue-Xin , Zheng Ya-Nan , Zhu Zheng-Lun , Liu Wen-Tao , Zhang Jun , Zhang Huan , Li Chen , Yan Chao , Yan Min , Zhu Zheng-Gang TITLE=Efficacy and Safety of Conversion Therapy by Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis: A Prospective Phase II Study JOURNAL=Frontiers in Oncology VOLUME=12 YEAR=2022 URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.905922 DOI=10.3389/fonc.2022.905922 ISSN=2234-943X ABSTRACT=Background

Neoadjuvant intraperitoneal and systemic chemotherapy (NIPS) has shown promising results in gastric cancer (GC) with peritoneal metastasis. However, clinical practice experience of NIPS is still lacking in China. In this study, we investigate the efficacy and safety of NIPS in Chinese patients.

Methods

Eligible patients received NIPS every 3 weeks. Gastrectomy was performed for patients who met the criteria of conversion surgery. The primary end point was 1-year overall survival (OS) rate. Secondary end points were the response rate, toxic effects, conversion surgery outcomes and median survival time (MST).

Results

Sixty-seven patients were enrolled. The primary endpoint was achieved with 1-year OS rate reached 67.2% (95% CI, 56.8%-79.4%). Conversion surgery was performed in 42 patients (62.9%), and R0 resection was achieved in 23 patients (54.8%) with the MST of 31.3 months (95% CI, 24.3-38.3). And the MST was 19.3 months (95% CI, 16.4-22.2) for all patients. Toxicity and surgical complications were well-tolerated. Moreover, sex, R0 resection, pathological nodal stage and tumor regression grade (TRG) were independent prognostic factors for patients who underwent conversion surgery.

Conclusion

The NIPS is effective and safe in treating GC patients with peritoneal metastasis. Male patients, patients who underwent R0 resection, patients with ypN0-1 or TRG 1 after conversion surgery are more likely to benefit from the NIPS.

Clinical Trial Registration

http://www.chictr.org.cn/, identifier https://clinicaltrials.gov/ (<ChiCTR2200056029>).