TY - JOUR
T1 - Phase 1 trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases (IPGP study)
AU - Vatandoust, Sina
AU - Bright, Tim
AU - Roy, Amitesh Chandra
AU - Abbas, Muhammad Nazim
AU - Watson, David Ian
AU - Gan, Susan
AU - Bull, Jeff
AU - Sorich, Michael
AU - Scott-Hoy, Alex
AU - Luu, Lee Jen
AU - Karapetis, Christos Stelios
PY - 2022/8
Y1 - 2022/8
N2 - Aims: Gastric cancer with peritoneal involvement has a poor prognosis. Intraperitoneal (IP) paclitaxel has shown promising results in these patients. However, this approach has only been studied in the Asian population, and in combination with S-1. We investigated the maximum tolerated dose of IP paclitaxel, with a standard chemotherapy combination, in the Australian population. Methods: The study of the population included metastatic human epidermal growth factor receptor 2 (HER2) negative gastric adenocarcinoma with peritoneal involvement. Treatment included six 21-day cycles of cisplatin (80 mg/m2 IV, day 1) plus capecitabine (1000 mg/m2 PO BD, days 1–14) plus IP paclitaxel (days 1 and 8). IP paclitaxel doses for cohort 1–3 were 10, 20, and 30 mg/m2, respectively, in a 3 + 3 standard dose-escalation design. Results: Fifteen patients were enrolled of which 6 were female and the median age was 63. Two patients developed dose-limiting toxicities. No grade 4/5 toxicities were recorded. The maximum tolerated dose was not reached. Therefore, as defined by the study protocol, the recommended phase-2 dose for IP paclitaxel was determined to be 30 mg/m2. The 12-month survival rate was 46.7%, and the median survival was 11.5 months (interquartile range [IQR]: 15.3–6.9). Conclusions: IP paclitaxel is safe in combination with cisplatin and capecitabine and the recommended phase-2 dose is 30 mg/m2.
AB - Aims: Gastric cancer with peritoneal involvement has a poor prognosis. Intraperitoneal (IP) paclitaxel has shown promising results in these patients. However, this approach has only been studied in the Asian population, and in combination with S-1. We investigated the maximum tolerated dose of IP paclitaxel, with a standard chemotherapy combination, in the Australian population. Methods: The study of the population included metastatic human epidermal growth factor receptor 2 (HER2) negative gastric adenocarcinoma with peritoneal involvement. Treatment included six 21-day cycles of cisplatin (80 mg/m2 IV, day 1) plus capecitabine (1000 mg/m2 PO BD, days 1–14) plus IP paclitaxel (days 1 and 8). IP paclitaxel doses for cohort 1–3 were 10, 20, and 30 mg/m2, respectively, in a 3 + 3 standard dose-escalation design. Results: Fifteen patients were enrolled of which 6 were female and the median age was 63. Two patients developed dose-limiting toxicities. No grade 4/5 toxicities were recorded. The maximum tolerated dose was not reached. Therefore, as defined by the study protocol, the recommended phase-2 dose for IP paclitaxel was determined to be 30 mg/m2. The 12-month survival rate was 46.7%, and the median survival was 11.5 months (interquartile range [IQR]: 15.3–6.9). Conclusions: IP paclitaxel is safe in combination with cisplatin and capecitabine and the recommended phase-2 dose is 30 mg/m2.
KW - clinical trial
KW - gastric cancer
KW - intraperitoneal infusion
KW - paclitaxel
KW - peritoneal carcinomatosis
KW - phase-1
UR - http://www.scopus.com/inward/record.url?scp=85119700726&partnerID=8YFLogxK
U2 - 10.1111/ajco.13659
DO - 10.1111/ajco.13659
M3 - Article
AN - SCOPUS:85119700726
SN - 1743-7555
VL - 18
SP - 404
EP - 409
JO - Asia-Pacific Journal of Clinical Oncology
JF - Asia-Pacific Journal of Clinical Oncology
IS - 4
ER -