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

Journal Article · Wed Sep 01 00:00:00 EDT 2010 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2009.07.1733· OSTI ID:21436154

Giatromanolaki, Alexandra; Pitiakoudis, Michael; Kouklakis, George; Tsoutsou, Pelagia; Abatzoglou, Ioannis; Panteliadou, Marianthi; Sismanidou, Kyriaki M.Sc.; Sivridis, Efthimios ^[1]; Boulikas, Teni ^[2]

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1. Departments of Radiotherapy/Oncology, Pathology and Surgery, Democritus University of Thrace, Alexandroupolis (Greece)
2. Regulon, Athens (Greece)

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.

• OSTI ID: 21436154
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 1 Vol. 78; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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62 RADIOLOGY AND NUCLEAR MEDICINE
AZINES
BODY
CHEMOTHERAPY
COMPUTERIZED TOMOGRAPHY
DIAGNOSTIC TECHNIQUES
DIGESTIVE SYSTEM
DISEASES
DRUGS
GASTROINTESTINAL TRACT
HETEROCYCLIC COMPOUNDS
HYDROXY COMPOUNDS
LIPOSOMES
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NEOPLASMS
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANIC NITROGEN COMPOUNDS
ORGANS
PYRIMIDINES
RADIOLOGY
RADIOTHERAPY
STOMACH
THERAPY
TOMOGRAPHY
URACILS