A phase II trial of perioperative chemotherapy involving a single intraperitoneal administration of paclitaxel followed by sequential S-1 plus intravenous paclitaxel for serosa-positive gastric cancer.

Abstract

BACKGROUND AND OBJECTIVES:

We carried out a phase II trial to evaluate the feasibility, efficacy, and tolerability of perioperative chemotherapy including single intraperitoneal(IP) administration of paclitaxel(PTX) followed by intravenous(IV) administrations of PTX with S-1 in a neoadjuvant setting for serosa-positive gastric cancer.

METHODS:

Patients with cT4a gastric cancer were enrolled. A laparoscopic survey was performed before study inclusion for the confirmation of serosal invasion, negative lavage cytology, and negative peritoneal metastasis. IP PTX (80 mg/m(2)) was administered, followed by systemic chemotherapy. Surgery was performed after the completion of chemotherapy. The primary endpoint was the treatment completion rate.

RESULTS:

37 patients were recruited. The treatment completion rate was 67.6% (25/37; 90% CI, 52.8-80.1%), which was significantly higher than 50%; we set this as a threshold value (P = 2.4% [one-sided]). 14 patients had target lesions; of these, 10 showed a partial response (71.4%), three had stable disease (21.4%), and one had progressive disease(7.2%). The response rate was 71.4% (10/14). All patients underwent gastrectomy with D2 lymph node dissection. The 3- and 5-year OS rates were 78.0 and 74.9%, respectively.

CONCLUSIONS:

Perioperative chemotherapy including neoadjuvant IP PTX followed by sequential IV PTX with S-1 for serosa-positive gastric cancer is feasible, safe, and efficient.

• Authors: Ying-Feng Peng, Motohiro Imano, Tatsuki Itoh, Takao Satoh, Yasutaka Chiba, Haruhiko Imamoto, Masahiro Tsubaki, Shozo Nishida, Takushi Yasuda, Hiroshi Furukawa
• Journal: Journal of surgical oncology (J Surg Oncol) Vol. 111 Issue 8 Pg. 1041-6 (Jun 2015) ISSN: 1096-9098 [Electronic] United States
• PMID: 26060133 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: © 2015 Wiley Periodicals, Inc.

Chemical References

• Drug Combinations
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Paclitaxel

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemotherapy, Adjuvant
• Drug Combinations
• Feasibility Studies
• Female
• Gastrectomy
• Humans
• Infusions, Intraventricular
• Infusions, Parenteral
• Injections, Intraperitoneal
• Male
• Middle Aged
• Neoadjuvant Therapy
• Oxonic Acid (administration & dosage)
• Paclitaxel (administration & dosage)
• Serous Membrane (pathology)
• Stomach Neoplasms (drug therapy)
• Tegafur (administration & dosage)
• Treatment Outcome