التفاصيل البيبلوغرافية
| العنوان: |
A Randomized Phase 2 Study of 5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate for the Prevention of Nephrotoxicity Induced by Cisplatin-Based Chemotherapy of Lung Cancer. |
| المؤلفون: |
Kawamura, Kodai, Matsushima, Hidekazu, Sakai, Hiroshi, Iwashima, Akira, Nakamura, Sukeyuki, Kojima, Tohru, Sasaki, Shinichi, Shigenaga, Takehiko, Natsume, Ichiro, Sasaki, Takaaki, Ohsaki, Yoshinobu, Iwanaga, Kentaro, Nishi, Koichi, Mitsuishi, Yoichiro, Taniguchi, Hirokazu, Sato, Kazuhiro, Yamauchi, Mitsugu, Nakajima, Motowo, Takahashi, Kazuhisa |
| المصدر: |
Oncology; 2022, Vol. 100 Issue 11, p620-632, 13p |
| مصطلحات موضوعية: |
NEPHROTOXICOLOGY, DRUG efficacy, GLOMERULAR filtration rate, RESEARCH, COMBINATION drug therapy, FLUID therapy, CANCER chemotherapy, ORAL drug administration, SERUM, ANTI-inflammatory agents, LUNG tumors, CITRATES, INVESTIGATIONAL drugs, ANTIOXIDANTS, CANCER patients, RANDOMIZED controlled trials, CISPLATIN, BLIND experiment, DRUGS, DESCRIPTIVE statistics, AMINO acids, STATISTICAL sampling, PATIENT compliance, IRON compounds, CREATININE, THERAPEUTICS |
| مصطلحات جغرافية: |
JAPAN |
| مستخلص: |
Introduction: Cisplatin-based chemotherapy was established in the 1980s, and it has been improved by the development of a short hydration protocol in lung cancer therapy. However, cisplatin-based chemotherapy is still associated with renal toxicity. Because 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC) is known to be a mitochondrial activator and a heme oxygenase-1 (HO-1) inducer, 5-ALA with SFC is speculated to mitigate cisplatin-induced renal inflammation. Methods: We investigated the effects of oral administration of 5-ALA with SFC for preventing cisplatin-based nephrotoxicity in patients with lung cancer and evaluated its benefits for patients who received cisplatin-based chemotherapy. The primary endpoint was the significance of the difference between the serum creatinine (sCr) levels of the patients administered 5-ALA with SFC and those given placebo after course 1 of chemotherapy. The difference in the estimated glomerular filtration rate (eGFR) between the two groups was also evaluated as the secondary endpoint. Results: The double-blind, randomized two-arm studies were conducted at 15 medical facilities in Japan; 54 male and 20 female patients with lung cancer who received cisplatin-based chemotherapy between the ages of 42 and 75 years were included in the study. The compliance rate was greater than 94% in the primary assessment and subsequent drug administration periods. All enrolled patients completed the four cycles of cisplatin-based chemotherapy with short hydration. The average level of sCr on day 22 of course 1 was 0.707 mg/dL in the group treated with 5-ALA and SFC and 0.735 mg/dL in the placebo group, respectively, and the sCr in the test group was significantly lower than that in the placebo group (p = 0.038). In addition, the eGFR was significantly higher in the SPP-003 group than in the placebo group up to day 1 of course 3 (84.66 and 75.68 mL/min/1.73 m2, respectively, p = 0.02) and kept better even after the last administration of the study drug (82.37 and 73.49 mL/min/1.73 m2, respectively, p = 0.013). Conclusions: The oral administration of 5-ALA with SFC is beneficial to patients undergoing cisplatin-based chemotherapy for lung cancer with short hydration. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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