[Phase I study of CM-Na combined with concurrent radiochemotherapy for advanced esophageal carcinoma].

Abstract

BACKGROUND & OBJECTIVE:

Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%. This study aimed to explore maximum tolerance dose (MTD) of sodium glycididazole(CM-Na) in the combined planning as the recommended dose for phase II study.

METHODS:

Twenty-two patients with pathologically confirmed esophageal squamous carcinoma of stage III-IV were recruited according to the inclusion criteria. All patients were divided into 4 groups (at least 3 patients in a group) by turn as the dose of CM-Na escalated from 400 to 600, 700, and 800 mg x (m(2) x d)(-1) by Fibonacci's method, and treated according to the plan. All patients underwent the same concurrent radiochemotherapy. Conventional radiotherapy was performed with total dose of 60 Gy within 6 weeks. CM-Na was given 1 h before radiotherapy at Monday, Wednesday, and Friday every week, combined with 2 circles of continuous 5-day chemotherapy of 500 mg x (m(2) x d)(-1) of 5-fluoruracil (5-FU) and 20 mg x (m(2) x d)(-1) of cisplatin (DDP) at the first and the fifth week.

RESULTS:

Low-grade gastrointestinal adverse reactions were observed in the 4 groups during the period of chemotherapy, but no adverse reactions of nervous system, kidney, or heart were observed. Severe adverse reactions occurred in 800 mg x (m(2) x d) (-1) group, included 3 cases of grade III radioactive esophagitis, 2 cases of grade IV aminopherase risen, and 1 case of grade III thrombocytopenia. All the 19 patients in the rest 3 groups suffered grade I-II thrombocytopenia. The rates of complete remission and partial remission were 27% (6/22) and 68% (15/22) at the end of treating, and 46% (10/22) and 54% (12/22) 1 month after treating.

CONCLUSION:

Liver disfunction is the main dose-limited toxicity of the treatment schemeu 700 mg x (m(2) x d) (-1) of CM-Na is recommended to phase II clinical study.

• Authors: Ling Cai, Meng-Zhong Liu, Mo-Fa Gu, Hui Liu, Er-Cheng Chen, Yong-Hong Hu, Huan-Xin Lin, Han-Yu Wang, Ying Huang, Qiao-Qiao Li, Nian-Ji Cui, Tie-Hua Rong
• Journal: Ai zheng = Aizheng = Chinese journal of cancer (Ai Zheng) Vol. 24 Issue 5 Pg. 582-6 (May 2005) China
• PMID: 15890102 (Publication Type: English Abstract, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Organometallic Compounds
• Radiation-Sensitizing Agents
• Sodium
• Alanine Transaminase
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Alanine Transaminase (blood)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, radiotherapy)
• Cisplatin (administration & dosage)
• Combined Modality Therapy
• Esophageal Neoplasms (drug therapy, radiotherapy)
• Esophagitis (etiology)
• Female
• Fluorouracil (administration & dosage)
• Follow-Up Studies
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Staging
• Organometallic Compounds (administration & dosage, adverse effects)
• Radiation-Sensitizing Agents (administration & dosage, adverse effects)
• Radiotherapy, High-Energy (adverse effects)
• Sodium
• Thrombocytopenia (chemically induced)