Gefitinib-induced Acute Kidney Injury in a Patient with Advanced NSCLC Harbouring an EGFR-activating Mutation

2015 ◽  
Vol 11 (1) ◽  
pp. 41 ◽  
Author(s):  
Ourania Romanidou ◽  
Raffaele Califano ◽  
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Gefitinib, erlotinib or afatinib represent standard of care as first-line treatment for advanced non-small cell lung cancer (NSCLC) harbouring an activating mutation of epidermal growth factor receptor (EGFR). The toxicity profile of these drugs is well known with rash, diarrhoea, nausea, anorexia, fatigue and derangement of liver function being the most commonly observed adverse events. We report a case of an 82-year-old patient with EGFR-mutant advanced NSCLC who developed gefitinib-induced acute kidney injury, which slowly improved on discontinuation of the drug.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8064-8064 ◽  
Author(s):  
Shintaro Kanda ◽  
Yuichiro Ohe ◽  
Hidehito Horinouchi ◽  
Yutaka Fujiwara ◽  
Hiroshi Nokihara ◽  
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8064 Background: Gefitinib yields a longer progression-free survival (PFS) period than platinum–doublet chemotherapy as a first–line treatment for patients with advanced non–small–cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, but most patients develop resistance against gefitinib after the initial response. We hypothesized that the insertion of platinum–doublet chemotherapy during the initial response could prevent the emergence of acquired resistance and prolong survival, compared with gefitinib alone. Methods: We performed a phase ΙΙ study of the following first–line treatment for patients with advanced NSCLC with EGFR mutation. Gefitinib (250 mg) was administrated on days 1–56. After a two–week rest, three cycles of cisplatin (80 mg/m2) and docetaxel (60 mg/m2) were administered on days 71, 92, and 113. Gefitinib was re–started on day 134 and was continued until progression. The primary endpoint was the two–year PFS rate. The sample size was estimated at 33, and this treatment was considered worthy for further development if more than 11 of the 33 patients who started treatment had a 2–year PFS. Results: Thirty–three Japanese patients were enrolled. Twenty–five patients could re–start gefitinib, 12 achieved a PFS period of over 2 years, and 9 continued to receive the protocol treatment without experiencing progression. The 1–, 2–, and 3–year estimated PFS rates were 59.4%, 37.5%, and 33.8%, respectively, and the median PFS time was 19.2 months. The 1–, 2–, and 3–year estimated survival rates were 90.0%, 82.9%, and 62.4%, respectively, and the median survival time had not been reached at the time of analysis. Treatment–related deaths and unexpected severe toxicities were not seen. Conclusions: Our results indicated that first–line treatment consisting of gefitinib and inserted cisplatin plus docetaxel is promising for patients with advanced NSCLC with EGFR mutation. A phase ΙΙΙ study of this treatment compared with gefitinib alone is warranted. Clinical trial information: 000001738.


2009 ◽  
Vol 27 (9) ◽  
pp. 1394-1400 ◽  
Author(s):  
Akira Inoue ◽  
Kunihiko Kobayashi ◽  
Kazuhiro Usui ◽  
Makoto Maemondo ◽  
Shoji Okinaga ◽  
...  

Purpose This multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS). Patients and Methods Chemotherapy-naïve patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and ≥ 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone. Results Between February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66% (90% CI, 51% to 80%), and the disease control rate was 90%. PS improvement rate was 79% (P < .00005); in particular, 68% of the 22 patients improved from ≥ PS 3 at baseline to ≤ PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63%, respectively. No treatment-related deaths were observed. Conclusion This is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population.


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