A new treatment for peritoneal metastatic stomach cancer is out...The 6-month progression-free survival rate is 2.7 times higher than before
Mar 07, 2025
The results of the phase 2 study of the 'high-dose paclitaxel combination therapy in the abdominal cavity' that can dramatically increase the survival rate of gastric cancer patients who have metastasized to the peritoneum have been published in the latest issue by the Korean Society of Surgical Oncology.
As a result of applying a combination of high-dose anticancer drugs (Parklitaxel) and systemic SOX chemotherapy (S-1+oxaliplatin) in the abdominal cavity, it recorded a 6-month progression-free survival rate of 82.6%, showing 2.7 times better efficacy than about 30% known as a 6-month progression-free survival rate of conventional systemic chemotherapy, and safety was also proven. This achievement is considered to be an important milestone in changing the standard of peritoneal metastatic gastric cancer treatment.
Peritoneal metastasis, which occurs in 40% of gastric cancer stage 4 patients, has a fatal prognosis with a median survival period of only 11 months. Even if existing systemic anticancer drugs were used, there were limitations due to the low concentration of drugs in the abdominal cavity, and the problem of extremely poor quality of life has continued due to complications such as intestinal obstruction or malignant ascites.
In response, the gastric cancer peritoneal metastasis research group, led by the gastric cancer team at Korea University Guro Hospital (Professors Kim Jong-han, Jang Yoo-jin, Seo Won-jun, and Oh Sang-chul of Oncology at Korea University Guro Hospital), has been conducting multi-center research on intra-abdominal chemotherapy since 2020, noting that direct anti-cancer drugs can deliver high-concentration drugs to peritoneal lesions and are effective in lymphatic metastasis through systemic circulation.
In the previous phase 1 trial, the maximum allowable dose (80mg/m2) of an intra-abdominal anticancer drug (Parklitaxel) was confirmed to maximize the effect, and based on this, the therapeutic efficacy was analyzed in earnest through this phase 2 study.
The phase 2 study was conducted at six university hospitals, and 24 gastric cancer patients with peritoneal metastasis were combined with an intraperitoneal anticancer drug (IP paclitaxel) and a systemic anticancer drug (S-1+oxaliplatin) to analyze the treatment effect for not only peritoneal metastasis but also systemic distant metastasis cancer. After the port was inserted into the patient's abdominal cavity, the treatment was performed over 8 cycles at intervals of 3 weeks, and peritoneal cancer index (PCI) was measured by laparoscopy every 4 cycles, and tumor response was comprehensively analyzed by combining CT and endoscopy.
Results showed that during the median follow-up period of 13.85 months, the 6-month progression-free survival rate (the proportion of patients who survived without disease progression for 6 months) was 82.6% (95% CI 68.5-99.6%), a 2.7-fold improvement over conventional systemic chemotherapy, and the median progression-free survival (median value of survival without disease progression) was 15.8 months.
The peritoneal cancer index (0-39), which refers to the peritoneal cancer stage, decreased by an average of 12.4 points compared to before treatment, and in one patient, the peritoneal metastasis was completely extinguished. Hemotoxicity (41.7% neutropenia and 20.8% leukopenia) was the main side effect, but most of them were symptomatic manageable.
Professor Seo Won-jun of Gastrointestinal Surgery at Korea University Guro Hospital, the first author of this research paper, said "This study is significant in that it has confirmed safety by applying the highest paclitaxel dose among intraperitoneal paclitaxel therapy studies underway in Asia. Based on the results of this study, we are starting a phase 3 clinical trial, and we plan to use the overall survival rate as a major evaluation indicator and analyze the long-term effects.'
Professor Kim Jong-han of Gastrointestinal Surgery at Korea University Guro Hospital, the head of the study, stressed that "the results of this study will serve as a decisive opportunity to change the paradigm of peritoneal metastatic gastric cancer treatment. We will expand international joint research to revise standard treatment guidelines and approve new drugs in the future."
This research paper was published in the latest issue of the international journal 'European Journal of Surgical Oncology (EJSO)'.
As a result of applying a combination of high-dose anticancer drugs (Parklitaxel) and systemic SOX chemotherapy (S-1+oxaliplatin) in the abdominal cavity, it recorded a 6-month progression-free survival rate of 82.6%, showing 2.7 times better efficacy than about 30% known as a 6-month progression-free survival rate of conventional systemic chemotherapy, and safety was also proven. This achievement is considered to be an important milestone in changing the standard of peritoneal metastatic gastric cancer treatment.
Peritoneal metastasis, which occurs in 40% of gastric cancer stage 4 patients, has a fatal prognosis with a median survival period of only 11 months. Even if existing systemic anticancer drugs were used, there were limitations due to the low concentration of drugs in the abdominal cavity, and the problem of extremely poor quality of life has continued due to complications such as intestinal obstruction or malignant ascites.
In response, the gastric cancer peritoneal metastasis research group, led by the gastric cancer team at Korea University Guro Hospital (Professors Kim Jong-han, Jang Yoo-jin, Seo Won-jun, and Oh Sang-chul of Oncology at Korea University Guro Hospital), has been conducting multi-center research on intra-abdominal chemotherapy since 2020, noting that direct anti-cancer drugs can deliver high-concentration drugs to peritoneal lesions and are effective in lymphatic metastasis through systemic circulation.
In the previous phase 1 trial, the maximum allowable dose (80mg/m2) of an intra-abdominal anticancer drug (Parklitaxel) was confirmed to maximize the effect, and based on this, the therapeutic efficacy was analyzed in earnest through this phase 2 study.
The phase 2 study was conducted at six university hospitals, and 24 gastric cancer patients with peritoneal metastasis were combined with an intraperitoneal anticancer drug (IP paclitaxel) and a systemic anticancer drug (S-1+oxaliplatin) to analyze the treatment effect for not only peritoneal metastasis but also systemic distant metastasis cancer. After the port was inserted into the patient's abdominal cavity, the treatment was performed over 8 cycles at intervals of 3 weeks, and peritoneal cancer index (PCI) was measured by laparoscopy every 4 cycles, and tumor response was comprehensively analyzed by combining CT and endoscopy.
Results showed that during the median follow-up period of 13.85 months, the 6-month progression-free survival rate (the proportion of patients who survived without disease progression for 6 months) was 82.6% (95% CI 68.5-99.6%), a 2.7-fold improvement over conventional systemic chemotherapy, and the median progression-free survival (median value of survival without disease progression) was 15.8 months.
The peritoneal cancer index (0-39), which refers to the peritoneal cancer stage, decreased by an average of 12.4 points compared to before treatment, and in one patient, the peritoneal metastasis was completely extinguished. Hemotoxicity (41.7% neutropenia and 20.8% leukopenia) was the main side effect, but most of them were symptomatic manageable.
Professor Seo Won-jun of Gastrointestinal Surgery at Korea University Guro Hospital, the first author of this research paper, said "This study is significant in that it has confirmed safety by applying the highest paclitaxel dose among intraperitoneal paclitaxel therapy studies underway in Asia. Based on the results of this study, we are starting a phase 3 clinical trial, and we plan to use the overall survival rate as a major evaluation indicator and analyze the long-term effects.'
Professor Kim Jong-han of Gastrointestinal Surgery at Korea University Guro Hospital, the head of the study, stressed that "the results of this study will serve as a decisive opportunity to change the paradigm of peritoneal metastatic gastric cancer treatment. We will expand international joint research to revise standard treatment guidelines and approve new drugs in the future."
This research paper was published in the latest issue of the international journal 'European Journal of Surgical Oncology (EJSO)'.
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This article was translated by Naver AI translator.
