In:
Oncology, S. Karger AG, Vol. 100, No. 11 ( 2022), p. 620-632
Abstract:
〈 b 〉 〈 i 〉 Introduction: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 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. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 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 ( 〈 i 〉 p = 〈 /i 〉 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 m 〈 sup 〉 2 〈 /sup 〉 , respectively, 〈 i 〉 p = 〈 /i 〉 0.02) and kept better even after the last administration of the study drug (82.37 and 73.49 mL/min/1.73 m 〈 sup 〉 2 〈 /sup 〉 , respectively, 〈 i 〉 p = 〈 /i 〉 0.013). 〈 b 〉 〈 i 〉 Conclusions: 〈 /i 〉 〈 /b 〉 The oral administration of 5-ALA with SFC is beneficial to patients undergoing cisplatin-based chemotherapy for lung cancer with short hydration.
Type of Medium:
Online Resource
ISSN:
0030-2414
,
1423-0232
Language:
English
Publisher:
S. Karger AG
Publication Date:
2022
detail.hit.zdb_id:
1483096-6
detail.hit.zdb_id:
250101-6
