Intravenous and intraperitoneal paclitaxel with S-1 for refractory pancreatic cancer with malignant ascites: an interim analysis.

Abstract

OBJECTIVES:

Here, we reported an interim analysis of feasibility and safety in the first 10 cases of 30 cases in a phase II trial of intravenous and intraperitoneal paclitaxel combined with S-1 for gemcitabine-refractory pancreatic cancer with malignant ascites.

METHODS:

Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8 every 3 weeks, and S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7-day rest.

RESULTS:

Between April 2011 and February 2012, ten patients were enrolled. A partial response was achieved in two patients (20%) and a disease control rate of 50%. The median time to progression and overall survival were 2.1 and 3.4 months, respectively. Malignant ascites was completely resolved in two patients (20%). Major grade 3/4 adverse events were myelosuppression including neutropenia (50%) and catheter-related infection (10%).

CONCLUSIONS:

This novel combination chemotherapy was feasible and showed promising results in pancreatic cancer patients with malignant ascites (clinical trial registration number: UMIN000005306).

• Authors: Naminatsu Takahara, Hiroyuki Isayama, Yousuke Nakai, Takashi Sasaki, Hironori Ishigami, Hiroharu Yamashita, Hironori Yamaguchi, Tsuyoshi Hamada, Rie Uchino, Suguru Mizuno, Koji Miyabayashi, Dai Mohri, Kazumichi Kawakubo, Hirofumi Kogure, Natsuyo Yamamoto, Naoki Sasahira, Kenji Hirano, Hideaki Ijichi, Keisuke Tateishi, Minoru Tada, Joji Kitayama, Toshiaki Watanabe, Kazuhiko Koike
• Journal: Journal of gastrointestinal cancer (J Gastrointest Cancer) Vol. 45 Issue 3 Pg. 307-11 (Sep 2014) ISSN: 1941-6636 [Electronic] United States
• PMID: 24676891 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antimetabolites, Antineoplastic
• Drug Combinations
• Deoxycytidine
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Paclitaxel
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy, secondary)
• Aged
• Alopecia (chemically induced)
• Antimetabolites, Antineoplastic (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Ascites (drug therapy, etiology)
• Catheter-Related Infections (epidemiology, etiology)
• Deoxycytidine (analogs & derivatives, therapeutic use)
• Drug Administration Schedule
• Drug Combinations
• Drug Resistance, Neoplasm
• Fatigue (chemically induced)
• Feasibility Studies
• Female
• Gastrointestinal Diseases (chemically induced)
• Hematologic Diseases (chemically induced)
• Humans
• Infusions, Intravenous
• Infusions, Parenteral
• Male
• Middle Aged
• Oxonic Acid (administration & dosage, adverse effects)
• Paclitaxel (administration & dosage, adverse effects)
• Pancreatic Neoplasms (complications, drug therapy)
• Prospective Studies
• Salvage Therapy
• Tegafur (administration & dosage, adverse effects)
• Treatment Outcome
• Gemcitabine