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Phase I/II study of a combination of capecitabine, cisplatin, and intraperitoneal docetaxel (XP ID) in advanced gastric cancer patients with peritoneal metastasis.
- Source :
-
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2017 Nov; Vol. 20 (6), pp. 970-977. Date of Electronic Publication: 2017 Mar 16. - Publication Year :
- 2017
-
Abstract
- Background: This study was conducted to determine the recommended dose (RD) of intraperitoneal docetaxel (ID) in combination with systemic capecitabine and cisplatin (XP) and to evaluate its efficacy and safety at the RD in advanced gastric cancer (AGC) patients with peritoneal metastasis.<br />Methods: AGC patients with peritoneal metastasis received XP ID, which consists of 937.5 mg/m <superscript>2</superscript> of capecitabine twice daily on days 1-14, 60 mg/m <superscript>2</superscript> of intravenous cisplatin on day 1, and intraperitoneal docetaxel at 3 different dose levels (60, 80, or 100 mg/m <superscript>2</superscript> ) on day 1, every 3 weeks. In the phase I study, the standard 3 + 3 method was used to determine the RD of XP ID. In the phase II study, patients received RD of XP ID.<br />Results: In the phase I study, ID 100 mg/m <superscript>2</superscript> was chosen as the RD, with one dose-limiting toxicity (ileus) out of six patients. The 39 AGC patients enrolled in the phase II study received the RD of XP ID. The median progression-free survival was 11.0 months (95% CI 6.9-15.1), and median overall survival was 15.1 months (95% CI 9.1-21.1). The most frequent grade 3/4 adverse events were neutropenia (38.6%) and abdominal pain (30.8%). The incidence of abdominal pain cumulatively increased in the later treatment cycles.<br />Conclusions: Our study indicated that XP ID was effective, with manageable toxicities, in AGC patients with peritoneal metastasis. As the cumulative incidence of abdominal pain was probably related to bowel irritation by ID, it might be necessary to modify the dose.
- Subjects :
- Adenocarcinoma secondary
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Capecitabine administration & dosage
Capecitabine adverse effects
Cisplatin administration & dosage
Cisplatin adverse effects
Disease-Free Survival
Docetaxel
Female
Humans
Infusions, Parenteral
Kaplan-Meier Estimate
Male
Maximum Tolerated Dose
Middle Aged
Peritoneal Neoplasms secondary
Stomach Neoplasms mortality
Stomach Neoplasms pathology
Taxoids adverse effects
Adenocarcinoma drug therapy
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Peritoneal Neoplasms drug therapy
Stomach Neoplasms drug therapy
Taxoids administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1436-3305
- Volume :
- 20
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
- Publication Type :
- Academic Journal
- Accession number :
- 28303362
- Full Text :
- https://doi.org/10.1007/s10120-017-0710-0