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Safety and Efficacy of Intraperitoneal Paclitaxel Plus Intravenous Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) for Gastric Cancer with Peritoneal Metastasis

  • Gastrointestinal Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Peritoneal metastasis (PM) remains a major obstacle in the treatment of stage IV gastric cancer. This is a dose-escalation study of intraperitoneal (IP) paclitaxel combined with intravenous (IV) fluorouracil, leucovorin, and oxaliplatin (FOLFOX) to determine the recommended phase II dose in gastric cancer patients.

Methods

Patients with gastric adenocarcinoma and PM were enrolled. The recommended phase II dose of IP paclitaxel was determined using the standard “3 + 3” dose escalation with planned doses ranging from 40 to 100 mg/m2. IV FOLFOX was administered on the same day (oxaliplatin 100 mg/m2 (day 1), leucovorin 100 mg/m2 (day 1), fluorouracil 2,400 mg/m2 over 46 hours (day 1)). Both IP and IV regimens were repeated every 2 weeks.

Results

Among the 13 patients, there was no DLT at 40 and 60 mg/m2. Two patients had grade 3 febrile neutropenia at 80 mg/m2, and the recommended phase II dose was 60 mg/m2. Other patients underwent IP paclitaxel and FOLFOX without serious adverse events. Seven patients underwent second-look diagnostic laparoscopy, and the average change in PCI score was −7.0 ± 9.7. Conversion surgery rate was 23.1% (n = 3). The median overall survival was 16.6 months (95% confidence interval, 16.6–N/A), and progression-free survival was 9.6 months (95% confidence interval, 4.7–N/A). All adverse events were tolerable and manageable.

Conclusions

The biweekly regimen of IP paclitaxel and FOLFOX is safe and the recommended dose of IP paclitaxel for a phase II trial is 60 mg/m2.

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Acknowledgments

This study received funding from Boryung Pharmaceutical Co., Ltd, and B. Braun Korea Co., Ltd.

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Authors and Affiliations

  1. Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea

    So Hyun Kang MD, Eunju Lee MD, Sang Woo Park MD, Sangjun Lee MD, Young Suk Park MD, Sang-Hoon Ahn MD, Yun-Suhk Suh MD, PhD & Hyung-Ho Kim MD, PhD

  2. Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

    Sa-Hong Min MD

  3. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

    Jin Won Kim MD, PhD, Ji-Won Kim MD, PhD & Keun-Wook Lee MD, PhD

  4. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea

    Jin Won Kim MD, PhD, Ji-Won Kim MD, PhD & Keun-Wook Lee MD, PhD

  5. Department of Pathology, Seoul National University Bundang Hospital, Seongnam, Korea

    Hyeon Jeong Oh MD, PhD

  6. Department of Pathology, Seoul National University College of Medicine, Seoul, Korea

    Hyeon Jeong Oh MD, PhD & Hye Seung Lee MD, PhD

  7. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea

    Young Suk Park MD, Sang-Hoon Ahn MD, Yun-Suhk Suh MD, PhD & Hyung-Ho Kim MD, PhD

  8. Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Korea

    Yoon Jin Lee MD, PhD

  9. Department of Radiology, Seoul National University College of Medicine, Seoul, Korea

    Yoon Jin Lee MD, PhD

  10. Department of Pathology, Seoul National University Hospital, Seoul, Korea

    Hye Seung Lee MD, PhD

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  1. So Hyun Kang MD
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Correspondence to Sa-Hong Min MD or Jin Won Kim MD, PhD.

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Kang, S.H., Min, SH., Kim, J.W. et al. Safety and Efficacy of Intraperitoneal Paclitaxel Plus Intravenous Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) for Gastric Cancer with Peritoneal Metastasis. Ann Surg Oncol 29, 5084–5091 (2022). https://doi.org/10.1245/s10434-022-11582-5

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