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Title: Concurrent Liposomal Cisplatin (Lipoplatin), 5-Fluorouracil and Radiotherapy for the Treatment of Locally Advanced Gastric Cancer: A Phase I/II Study

Abstract

Purpose: Liposomal drugs have a better tolerance profile and are highly accumulated in the tumor environment, properties that promise an optimal radiosensitization. We investigated the feasibility of the combination of 5-fluorouracil/lecovorin-based radio-chemotherapy with the administration of high weekly dose of a liposomal platinum formulation (Lipoplatin{sup TM}). Methods and Materials: Lipoplatin was given at a dose of 120mg/m{sup 2}/week, 5-fluorouracil at 400mg/m{sup 2}/week (Day 1), whereas radiotherapy was given through 3.5-Gy fractions on Days 2, 3, and 4. Two groups of 6 patients received four and five consecutive cycles, respectively. Results: Minimal nephrotoxicity (18.2% Grade 1) and neutropenia (9% Grade 3) was noted. Fatigue Grade 2 appeared in 25% of cases. Abdominal discomfort was reported by 18% of patients. No liver, kidney, gastric, or intestinal severe acute or late sequellae were documented, although the median follow-up of 9 months is certainly too low to allow safe conclusions. A net improvement in the performance status (from a median of 1 to 0) was recorded 2 months after the end of therapy. The response rates assessed with computed tomography, endoscopy, and biopsies confirmed 33% (2 of 6) tumor disappearance in patients treated with four cycles, which reached 80% (4 of 5) in patientsmore » receiving five cycles. Conclusions: Lipoplatin radio-chemotherapy is feasible, with minor hematological and nonhematological toxicity. The high complete response rates obtained support the testing of Lipoplatin in the adjuvant postoperative or preoperative radio-chemotherapy setting for the treatment of gastric cancer.« less

Authors:
; ; ; ; ; ; ;  [1];  [2]
  1. Departments of Radiotherapy/Oncology, Pathology and Surgery, Democritus University of Thrace, Alexandroupolis (Greece)
  2. Regulon, Athens (Greece)
Publication Date:
OSTI Identifier:
21436154
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 78; Journal Issue: 1; Other Information: DOI: 10.1016/j.ijrobp.2009.07.1733; PII: S0360-3016(09)02937-X; Copyright (c) 2010 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CHEMOTHERAPY; COMPUTERIZED TOMOGRAPHY; DRUGS; LIPOSOMES; NEOPLASMS; RADIOTHERAPY; STOMACH; URACILS; AZINES; BODY; DIAGNOSTIC TECHNIQUES; DIGESTIVE SYSTEM; DISEASES; GASTROINTESTINAL TRACT; HETEROCYCLIC COMPOUNDS; HYDROXY COMPOUNDS; MEDICINE; NUCLEAR MEDICINE; ORGANIC COMPOUNDS; ORGANIC NITROGEN COMPOUNDS; ORGANS; PYRIMIDINES; RADIOLOGY; THERAPY; TOMOGRAPHY

Citation Formats

Koukourakis, Michael I., E-mail: targ@her.forthnet.g, Giatromanolaki, Alexandra, Pitiakoudis, Michael, Kouklakis, George, Tsoutsou, Pelagia, Abatzoglou, Ioannis, Panteliadou, Marianthi, Sismanidou, Kyriaki M.Sc., Sivridis, Efthimios, and Boulikas, Teni. Concurrent Liposomal Cisplatin (Lipoplatin), 5-Fluorouracil and Radiotherapy for the Treatment of Locally Advanced Gastric Cancer: A Phase I/II Study. United States: N. p., 2010. Web. doi:10.1016/j.ijrobp.2009.07.1733.
Koukourakis, Michael I., E-mail: targ@her.forthnet.g, Giatromanolaki, Alexandra, Pitiakoudis, Michael, Kouklakis, George, Tsoutsou, Pelagia, Abatzoglou, Ioannis, Panteliadou, Marianthi, Sismanidou, Kyriaki M.Sc., Sivridis, Efthimios, & Boulikas, Teni. Concurrent Liposomal Cisplatin (Lipoplatin), 5-Fluorouracil and Radiotherapy for the Treatment of Locally Advanced Gastric Cancer: A Phase I/II Study. United States. https://doi.org/10.1016/j.ijrobp.2009.07.1733
Koukourakis, Michael I., E-mail: targ@her.forthnet.g, Giatromanolaki, Alexandra, Pitiakoudis, Michael, Kouklakis, George, Tsoutsou, Pelagia, Abatzoglou, Ioannis, Panteliadou, Marianthi, Sismanidou, Kyriaki M.Sc., Sivridis, Efthimios, and Boulikas, Teni. 2010. "Concurrent Liposomal Cisplatin (Lipoplatin), 5-Fluorouracil and Radiotherapy for the Treatment of Locally Advanced Gastric Cancer: A Phase I/II Study". United States. https://doi.org/10.1016/j.ijrobp.2009.07.1733.
@article{osti_21436154,
title = {Concurrent Liposomal Cisplatin (Lipoplatin), 5-Fluorouracil and Radiotherapy for the Treatment of Locally Advanced Gastric Cancer: A Phase I/II Study},
author = {Koukourakis, Michael I., E-mail: targ@her.forthnet.g and Giatromanolaki, Alexandra and Pitiakoudis, Michael and Kouklakis, George and Tsoutsou, Pelagia and Abatzoglou, Ioannis and Panteliadou, Marianthi and Sismanidou, Kyriaki M.Sc. and Sivridis, Efthimios and Boulikas, Teni},
abstractNote = {Purpose: Liposomal drugs have a better tolerance profile and are highly accumulated in the tumor environment, properties that promise an optimal radiosensitization. We investigated the feasibility of the combination of 5-fluorouracil/lecovorin-based radio-chemotherapy with the administration of high weekly dose of a liposomal platinum formulation (Lipoplatin{sup TM}). Methods and Materials: Lipoplatin was given at a dose of 120mg/m{sup 2}/week, 5-fluorouracil at 400mg/m{sup 2}/week (Day 1), whereas radiotherapy was given through 3.5-Gy fractions on Days 2, 3, and 4. Two groups of 6 patients received four and five consecutive cycles, respectively. Results: Minimal nephrotoxicity (18.2% Grade 1) and neutropenia (9% Grade 3) was noted. Fatigue Grade 2 appeared in 25% of cases. Abdominal discomfort was reported by 18% of patients. No liver, kidney, gastric, or intestinal severe acute or late sequellae were documented, although the median follow-up of 9 months is certainly too low to allow safe conclusions. A net improvement in the performance status (from a median of 1 to 0) was recorded 2 months after the end of therapy. The response rates assessed with computed tomography, endoscopy, and biopsies confirmed 33% (2 of 6) tumor disappearance in patients treated with four cycles, which reached 80% (4 of 5) in patients receiving five cycles. Conclusions: Lipoplatin radio-chemotherapy is feasible, with minor hematological and nonhematological toxicity. The high complete response rates obtained support the testing of Lipoplatin in the adjuvant postoperative or preoperative radio-chemotherapy setting for the treatment of gastric cancer.},
doi = {10.1016/j.ijrobp.2009.07.1733},
url = {https://www.osti.gov/biblio/21436154}, journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 1,
volume = 78,
place = {United States},
year = {Wed Sep 01 00:00:00 EDT 2010},
month = {Wed Sep 01 00:00:00 EDT 2010}
}