Intraperitoneal Paclitaxel Combined with S-1 Plus Oxaliplatin for Advanced Gastric Cancer with Peritoneal Metastasis: a Phase I Study

김동욱; 서원준; Sang Il Youn; Ye Seob Jee; 장유진; 김종한; Perioperative Intra-Peritoneal & Systemic Chemotherapy for Gastric Cancer (PIPS-GC) study group

doi:10.5230/jgc.2021.21.e38

추천

검색

자료유형: 학술저널

저자정보: 김동욱 (단국대학교) 서원준 (고려대학교) Sang Il Youn (Department of Surgery Dankook University College of Medicine Cheonan Korea) Ye Seob Jee (Department of Surgery Dankook University College of Medicine Cheonan Korea) 장유진 (고려대학교) 김종한 (고려대학교) Perioperative Intra-Peritoneal & Systemic Chemotherapy for Gastric Cancer (PIPS-GC) study group (Perioperative Intra-Peritoneal & Systemic Chemotherapy for Gastric Cancer (PIPS-GC) study group)

저널정보: 대한위암학회 Journal of Gastric Cancer Journal of Gastric Cancer 제21권 제4호

발행연도: 2021.12

수록면: 418 - 425 (8page)

DOI: 10.5230/jgc.2021.21.e38

이용수

📌

연구주제

📖

연구배경

🔬

연구방법

🏆

연구결과

초록· 키워드

오류제보하기

Purpose: We designed a new regimen by combining intraperitoneal (IP) paclitaxel (PTX) with systemic S-1 plus oxaliplatin (SOX) for the treatment of advanced gastric cancer with peritoneal metastasis. This dose-escalation study aimed to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IP PTX administered weekly to patients. Materials and Methods: Eight cycles of IP PTX plus SOX regimen were administered to the patients. S-1 was administered orally twice daily at a dose of 80 mg/m2/day for 14 consecutive days, followed by 7 days of rest. Intravenous oxaliplatin was administered at a fixed dose of 100 mg/m2 on day 1, while IP PTX was administered on days 1 and 8. The initial dose of IP PTX was 40 mg/m2, and the dose escalation was set in units of 20 mg/m2 up to 80 mg/m2. Dose-limiting toxicities (DLTs) were defined as grade 3 non-hematologic toxicities, grade 4 leukopenia, grade 3 febrile neutropenia, and grade 3 thrombocytopenia. Results: Nine patients were included in the study. No DLTs were observed in any of the enrolled patients. Therefore, the MTD was not reached, and the RD of IP PTX was determined to be 80 mg/m2. Four patients (44%) showed a decreased peritoneal cancer index score on second-look laparoscopic examination. Conclusions: The present study determined the dose for further clinical trials of IP PTX to be 80 mg/m2, when combined with a systemic SOX regimen.

#Stomach neoplasm #Peritoneal neoplasm #Injections #Intraperitoneal #Clinical trial #phase I

참고문헌 (18)

참고문헌 신청

Lee JH / 2014 / Factors predicting peritoneal recurrence in advanced gastric cancer: implication for adjuvant intraperitoneal chemotherapy. / Gastric Cancer 17:529~536

Koizumi W / 2008 / S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer(SPIRITS trial) : a phase III trial / Lancet Oncol 9:215~221

Kang YK / 2009 / Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer : a randomised phase III noninferiority trial / Ann Oncol 20:666~673

Wilke H / 2014 / Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma(RAINBOW) : a double-blind, randomised phase 3 trial / Lancet Oncol 15:1224~1235

Bang YJ / 2010 / Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer(ToGA) : a phase 3, open-label, randomised controlled trial / Lancet 376:687~697

함께 읽어보면 좋을 논문

논문 유사도에 따라 DBpia 가 추천하는 논문입니다. 함께 보면 좋을 연관 논문을 확인해보세요!