Quality of Life with Gefitinib in Patients with <i>EGFR</i>-Mutated Non-Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial

Oizumi, Satoshi; Kobayashi, Kunihiko; Inoue, Akira; Maemondo, Makoto; Sugawara, Shunichi; Yoshizawa, Hirohisa; Isobe, Hiroshi; Harada, Masao; Kinoshita, Ichiro; Okinaga, Shoji; Kato, Terufumi; Harada, Toshiyuki; Gemma, Akihiko; Saijo, Yasuo; Yokomizo, Yuki; Morita, Satoshi; Hagiwara, Koichi; Nukiwa, Toshihiro

doi:10.1634/theoncologist.2011-0426

Cited by 96 publications

(57 citation statements)

References 32 publications

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“…13 In some clinical studies of patients with EGFR mutations, gefitinib as first-line therapy led to a higher ORR and greater improvements in quality of life compared with CBDCA plus paclitaxel. [14][15][16][17][18] These reports supported that EGFRmutant patients with advanced lung adenocarcinoma should receive an EGFR tyrosine kinase inhibitor (TKI) as first-line therapy. 15,19,20 Some patients with completely resected NSCLC receive postoperative adjuvant chemotherapy that does not include EGFR TKI, but rather comprises CDDP-based anticancer drugs, despite the presence of EGFR mutations.…”

Section: Discussionmentioning

confidence: 98%

Gefitinib frequently induces liver damage in patients with lung adenocarcinoma previously treated by chemotherapy

Sugiura¹,

Nemoto²,

Kawai³

et al. 2013

LCTT

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Background: Gefitinib is known as one of the agents for treating patients with both advanced lung cancer and an epidermal growth-factor receptor mutation. In the epidermal growth-factor receptor-mutant advanced non-small-cell lung cancer population, gefitinib therapy has been associated with increased response rate, longer progression-free survival, and better quality of life compared to other anticancer drugs. However, gefitinib has to be discontinued for patients in whom adverse events occur, even if it is still effective. Here, we retrospectively assessed the clinical course of patients receiving gefitinib therapy, with a particular focus on liver damage. Patients and methods: Of 24 Asian patients treated with 250 mg gefitinib daily at Kanagawa National Hospital, Japan, between January 2008 and June 2012, grade 3 liver damage (Common Terminology Criteria for Adverse Events, version 4.0) occurred in nine and were eligible for our assessment. The regimen was subsequently changed to alternate-day administration. The relationships between liver damage and each clinical factor were retrospectively examined using Fisher's exact test. Results: Of the nine patients with liver damage, seven had previous exposure to another anticancer drug. There was a significant relationship between the incidence of liver damage and previous chemotherapy (P = 0.009). The objective response rates of patients treated with daily gefitinib 250 mg and alternate-day gefitinib following liver damage were 66.7% and 46.7%, respectively; these were not significantly different (P = 0.597). Conclusion: Gefitinib for advanced adenocarcinoma patients who have previously undergone chemotherapy should be used cautiously and liver function monitored closely, because it frequently induces significant liver damage. The alternate-day administration of gefitinib may be a suitable option for patients in whom daily gefitinib therapy induces liver damage.

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Section: Discussionmentioning

confidence: 98%

Gefitinib frequently induces liver damage in patients with lung adenocarcinoma previously treated by chemotherapy

Sugiura¹,

Nemoto²,

Kawai³

et al. 2013

LCTT

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“…NEJ002, a phase III trial comparing gefitinib with carboplatin-paclitaxel as the first-line treatment 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 13 for advanced NSCLC with sensitive EGFR mutations [14], demonstrated that quality of life (QOL) was maintained much longer in patients treated with gefitinib than in those treated with standard chemotherapy [25]. Unfortunately, we were unable to evaluate QOL in the present study.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group Study

et al. 2013

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ABSTRACT[214 words (do not exceed 250)]Purpose: The clinical efficacy and outcomes of gefitinib therapy as a first-line treatment for elderly patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations were analyzed retrospectively. Patients and methods:We analyzed chemotherapy-naïve NSCLC patients aged 75 years or older who had EGFR mutations (exon 19 deletion mutation or L858R), who were initially treated with gefitinib (250 mg) once daily in Nagano Prefecture.Results: A total of 55 patients (16 men, 39 women) with a median age of 81.1 years (range: 75 -94 years) treated between April 2007 and July 2012, were analyzed. The overall response rate and disease control rate were 72.7% (95% confidence interval (CI); 59.5% -82.9%) and 92.7% (95% CI: 82.0% -97.6%), respectively. Median progression-free survival and overall survival from the start of gefitinib treatment were 13.8 months (CI: 9.9 -18.8 months) and 29.1 months (95% CI: 22.4 -not reached), respectively. Two-year survival rate was 59.5% (95% CI; 41.0% -78.8%). Major grade 3 toxicities were skin rash (1.8%) and increased levels of aspartate aminotransferase or alanine aminotransferase (7.3%). Conclusion:First-line treatment with gefitinib for elderly EGFR-mutated NSCLC patients was effective and well tolerated. The results suggest that first-line gefitinib should be considered as a preferable standard treatment in elderly patients with advanced NSCLC harboring EGFR mutations.

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“…These treatments are preferred over standard intravenous chemotherapy, not only because of their advantages in terms of outcomes, but also because of the better quality of life that patients report. Other advantages include fewer visits to chemotherapy infusion centers and the convenience of administration (22). However, most patients develop resistance to the treatment after 12-15 months of continuous therapy (23)(24)(25)(26).…”

Section: Review Articlementioning

confidence: 99%

Histopathological transformation to small-cell lung carcinoma in non-small cell lung carcinoma tumors

Dorantes-Heredia¹,

Ruíz-Morales²,

Cano-García³

2016

Transl. Lung Cancer Res.

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Lung cancer is the principal cause of cancer-related death worldwide. The use of targeted therapies, especially tyrosine kinase inhibitors (TKIs), in specific groups of patients has dramatically improved the prognosis of this disease, although inevitably some patients will develop resistance to these drugs during active treatment. The most common cancer-associated acquired mutation is the epidermal growth factor receptor (EGFR) Thr790Met (T790M) mutation. During active treatment with targeted therapies, histopathological transformation to small-cell lung carcinoma (SCLC) can occur in 3-15% of patients with non-small-cell lung carcinoma (NSCLC) tumors. By definition, SCLC is a high-grade tumor with specific histological and genetic characteristics. In the majority of cases, a good-quality hematoxylin and eosin (H&E) stain is enough to establish a diagnosis. Immunohistochemistry (IHC) is used to confirm the diagnosis and exclude other neoplasia such as sarcomatoid carcinomas, large-cell carcinoma, basaloid squamous-cell carcinoma, chronic inflammation, malignant melanoma, metastatic carcinoma, sarcoma, and lymphoma. A loss of the tumor-suppressor protein retinoblastoma 1 (RB1) is found in 100% of human SCLC tumors; therefore, it has an essential role in tumorigenesis and tumor development. Other genetic pathways probably involved in the histopathological transformation include neurogenic locus notch homolog (NOTCH) and achaete-scute homolog 1 (ASCL1). Histological transformation to SCLC can be suspected in NSCLC patients who clinically deteriorate during active treatment. Biopsy of any new lesion in this clinical setting is highly recommended to rule out a SCLC transformation. New studies are trying to assess this histological transformation by noninvasive measures such as measuring the concentration of serum neuronspecific enolase.

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Quality of Life with Gefitinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer: Quality of Life Analysis of North East Japan Study Group 002 Trial

Cited by 96 publications

References 32 publications

Gefitinib frequently induces liver damage in patients with lung adenocarcinoma previously treated by chemotherapy

Gefitinib frequently induces liver damage in patients with lung adenocarcinoma previously treated by chemotherapy

Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group Study

Histopathological transformation to small-cell lung carcinoma in non-small cell lung carcinoma tumors

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