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11-11-2023 | Gastric Cancer | Gastrointestinal Oncology

Phase II Study of Intraperitoneal Administration of Paclitaxel Combined with S-1 and Cisplatin for Gastric Cancer with Peritoneal Metastasis

Authors: Daisuke Kobayashi, MD, PhD, Yasuhiro Kodera, MD, PhD, Ryoji Fukushima, MD, PhD, Masaru Morita, MD, PhD, Sachio Fushida, MD, PhD, Naoyuki Yamashita, MD, PhD, Kozo Yoshikawa, MD, PhD, Shugo Ueda, MD, PhD, Hiroshi Yabusaki, MD, PhD, Tetsuya Kusumoto, MD, PhD, Takaaki Arigami, MD, PhD, Akio Hidemura, MD, PhD, Takeshi Omori, MD, PhD, Hironori Yamaguchi, MD, PhD, Yasuo Hirono, MD, PhD, Yasushi Tsuji, MD, PhD, Jeong Ho Moon, MD, PhD, Toshihiko Tomita, MD, PhD, Hiroshi Imamura, MD, PhD, Koki Nakanishi, MD, PhD, Dai Shimizu, MD, PhD, Akihiro Hirakawa, PhD, Hironori Ishigami, MD, PhD, Joji Kitayama, MD, PhD

Published in: Annals of Surgical Oncology | Issue 2/2024

Abstract

Background

Intraperitoneal chemotherapy is promising for gastric cancer with peritoneal metastasis. Although a phase III study failed to show a statistically significant superiority of intraperitoneal paclitaxel combined with S-1 and intravenous paclitaxel, the sensitivity analysis suggested clinical efficacy. Thus, attempts to combine intraperitoneal paclitaxel with other systemic therapies with higher efficacy have been warranted. We sought to explore the efficacy of intraperitoneal paclitaxel with S-1 and cisplatin.

Patients and Methods

Gastric cancer patients with peritoneal metastasis were enrolled in the phase II trial. In addition to the established S-1 and cisplatin regimen every 5 weeks, intraperitoneal paclitaxel was administered on days 1, 8, and 22 at a dose of 20 mg/m². The primary endpoint was overall survival rate at 1 year after treatment initiation. Secondary endpoints were progression-free survival and toxicity.

Results

Fifty-three patients were enrolled and fully evaluated for efficacy and toxicity. The 1-year overall survival rate was 73.6% (95% confidence interval 59.5–83.4%), and the primary endpoint was met. The median survival time was 19.4 months (95% confidence interval, 16.1–24.6 months). The 1-year progression-free survival rate was 49.6% (95% confidence interval, 34.6–62.9%). The incidences of grade 3/4 hematological and non-hematological toxicities were 43% and 47%, respectively. The frequent grade 3/4 toxicities included neutropenia (25%), anemia (30%), diarrhea (13%), and anorexia (17%). Intraperitoneal catheter and implanted port-related complications were observed in four patients. There was one treatment-related death.

Conclusions

Intraperitoneal paclitaxel combined with S-1 and cisplatin is well tolerated and active in gastric cancer patients with peritoneal metastasis.

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Title: Phase II Study of Intraperitoneal Administration of Paclitaxel Combined with S-1 and Cisplatin for Gastric Cancer with Peritoneal Metastasis
Authors: Daisuke Kobayashi, MD, PhD
Yasuhiro Kodera, MD, PhD
Ryoji Fukushima, MD, PhD
Masaru Morita, MD, PhD
Sachio Fushida, MD, PhD
Naoyuki Yamashita, MD, PhD
Kozo Yoshikawa, MD, PhD
Shugo Ueda, MD, PhD
Hiroshi Yabusaki, MD, PhD
Tetsuya Kusumoto, MD, PhD
Takaaki Arigami, MD, PhD
Akio Hidemura, MD, PhD
Takeshi Omori, MD, PhD
Hironori Yamaguchi, MD, PhD
Yasuo Hirono, MD, PhD
Yasushi Tsuji, MD, PhD
Jeong Ho Moon, MD, PhD
Toshihiko Tomita, MD, PhD
Hiroshi Imamura, MD, PhD
Koki Nakanishi, MD, PhD
Dai Shimizu, MD, PhD
Akihiro Hirakawa, PhD
Hironori Ishigami, MD, PhD
Joji Kitayama, MD, PhD
Publication date: 11-11-2023
Publisher: Springer International Publishing
Keywords: Gastric Cancer
Gastric Cancer
Metastasis
Cytostatic Therapy
Published in: Annals of Surgical Oncology / Issue 2/2024
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-023-14240-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Phase II Study of Intraperitoneal Administration of Paclitaxel Combined with S-1 and Cisplatin for Gastric Cancer with Peritoneal Metastasis

Abstract

Background

Patients and Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Patients and Methods

Results

Conclusions

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