Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy

Kim, Seung Tae; Uhm, Jieun; Lee, Jeeyun; Sun, Jong‐Mu; Sohn, Insuk; Kim, Seon Woo; Jung, Sin‐Ho; Park, Yeon Hee; Ahn, Jin Seok; Park, Keunchil; Ahn, Myung‐Ju

doi:10.1016/j.lungcan.2011.05.022

Cited by 87 publications

(95 citation statements)

References 30 publications

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“…These patients were young (median age 58 years), mostly non-smokers (64%), in very good or good performance status (91%), and received EGFR-TKIs treatment mainly in the second-line (74%) Patients showed excellent overall response rates to erlotinib and gefitinib (77 and 74.5%, respectively) (13). However, Kim et al showed the drugs were not as efficient in a randomized phase II study of 96 Asian patients with advanced NSCLC: In the erlotinib-and gefitinib-treatment arms the response rates were 40 and 48%, and the median PFS was only 3.1 and 4.9 months, respectively (6). The authors concluded that the reason for treatment failure was including patients with unknown EGFR gene mutations with at least two out of three clinical factors associated with a higher incidence of EGFR gene mutations (6).…”

Section: Univariate Analysis Multivariate Analysis Median Pfs -------mentioning

confidence: 99%

“…However, Kim et al showed the drugs were not as efficient in a randomized phase II study of 96 Asian patients with advanced NSCLC: In the erlotinib-and gefitinib-treatment arms the response rates were 40 and 48%, and the median PFS was only 3.1 and 4.9 months, respectively (6). The authors concluded that the reason for treatment failure was including patients with unknown EGFR gene mutations with at least two out of three clinical factors associated with a higher incidence of EGFR gene mutations (6). Similarly, in a recent randomized phase III study of 562 pretreated patients with lung adenocarcinoma (including 401 with EGFR mutations), the response rates were 44 and 46% and the median PFS was 7.5 and 6.5 months in erlotinib-and gefitinib-treatment arms, respectively (14).…”

Section: Univariate Analysis Multivariate Analysis Median Pfs -------mentioning

confidence: 99%

“…First of all, few prospective and randomized studies have directly compared the efficacy of the various classes of EGFR-TKIs in patients with NSCLC harboring activating EGFR mutations (6)(7)(8). There are the preliminary results of a single-center randomized phase II trial comparing the efficacy of gefitinib and erlotinib in second-line therapy of Asian NSCLC patients with activating EGFR mutations (6), as well as the results of the global, multi-center LUX-Lung 7 trial comparing the efficacy of afatinib and gefitinib in first-line treatment of NSCLC patients with common activating EGFR mutations (7).…”

Section: Introductionmentioning

confidence: 99%

“…There are the preliminary results of a single-center randomized phase II trial comparing the efficacy of gefitinib and erlotinib in second-line therapy of Asian NSCLC patients with activating EGFR mutations (6), as well as the results of the global, multi-center LUX-Lung 7 trial comparing the efficacy of afatinib and gefitinib in first-line treatment of NSCLC patients with common activating EGFR mutations (7). The results of the multinational, randomized…”

Section: Introductionmentioning

confidence: 99%

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Comparison of the effectiveness of erlotinib, gefitinib, and afatinib for treatment of non-small cell lung cancer in patients with common and rare EGFR gene mutations

et al. 2017

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Abstract. Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) are routinely used to treat non-small cell lung cancer (NSCLC) in patients with common activating mutations of the EGFR gene. The aim of the study was to compare the efficacies of EGFR-TKIs in patients with common (exon 19 deletions and exon 21 p.Leu858Arg) and rare EGFR mutations. A retrospective analysis of 180 NSCLC patients with common (n=167) and rare (n=13) EGFR mutations treated with erlotinib (n=98), gefitinib (n=66) and afatinib (n=16) was performed. EGFR mutations were determined using RT-PCR and the EntroGen EGFR Mutations Analysis kit. Partial and complete response (PR and CR), progression-free survival (PFS), and overall survival (OS) were analyzed. Demographic and clinical factors had no impact on PFS or OS in patients treated with EGFR-TKIs. Erlotinib, gefitinib, and afatinib showed similar efficacies based on treatment response, median PFS, and OS. The type of EGFR mutation had no impact on median OS; however, median PFS was significantly longer in patients with the exon 19 deletion compared to patients with the exon 21 p.Leu858Arg substitution and rare EGFR gene mutations (P=0.013). Patients with common EGFR mutations showed significantly longer median PFS than those with rare EGFR mutations (10 vs. 5 months; P=0.009). Erlotinib, gefitinib, and afatinib show similar efficacies in NSCLC patients with both common and rare EGFR mutations. When undergoing EGFR-TKI treatment, patients with rare EGFR mutations showed similar OS but poorer PFS. Further investigation into the associations between particular rare EGFR mutations and EGFR-TKIs treatment outcomes is required.

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Section: Univariate Analysis Multivariate Analysis Median Pfs -------mentioning

confidence: 99%

Section: Univariate Analysis Multivariate Analysis Median Pfs -------mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparison of the effectiveness of erlotinib, gefitinib, and afatinib for treatment of non-small cell lung cancer in patients with common and rare EGFR gene mutations

et al. 2017

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“…Both gefitinib and erlotinib showed activity and tolerable toxicity profiles. 144 Several randomized studies that compared an EGFR-TKI versus chemotherapy in unselected or EGFR wild-type patients are summarized in Table 5 and Table 6. All of these studies indicate a marginal or detrimental effect of EGFR TKIs on PFS, especially in EGFR wild-type patients, without registering any difference in terms of OS.…”

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confidence: 99%

Extending Survival of Stage IV Non-Small Cell Lung Cancer

Carnio

Novello²,

Mele³

et al. 2014

Seminars in Oncology

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Extending survival of stage IV non-small cell lung cancer. Carnio S, Novello S, Mele T, Levra MG, Scagliotti GV. La versione definitiva è disponibile alla URL: http://www.sciencedirect.com/science/article/pii/S0093775413002236 Extending Survival of Stage IV Non-Small Cell Lung CancerCarnio S, Novello S, Mele T, Levra MG, Scagliotti GV.Most of patients with newly diagnosed non-small cell lung cancer (NSCLC) present with locally advanced or metastatic disease. In this setting the goal of treatment is to prolong survival and to control disease-and treatment-related symptoms. Currently systemic cytotoxic chemotherapy remains the first-line treatment for most patients with stage IV NSCLC, but preferred treatments are now defined by histology and based on the presence of specific molecular abnormalities. In firstline the combination of platinum plus pemetrexed with or without bevacizumab is a reasonable choice in patients with non-squamous NSCLC. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) as first-line therapy are the recommended for patients with EGFRsensitizing mutations. A small-molecule TKI of anaplastic lymphoma kinase (ALK), crizotinib, showed pronounced clinical activity in the treatment of patients with NSCLC positive for EML4-ALK and it has rapidly entered into daily clinical practice. Currently no agents are specifically approved for the treatment of squamous cell carcinoma of the lung. Second-line treatments include docetaxel, pemetrexed, or erlotinib as single agents. There is a growing evidence that cytotoxics are better than EGFR-TKIs in EGFR wild-type patients. In the setting of the third line, the only approved agent is erlotinib. In elderly patients with good performance status (PS), doublet chemotherapy including platinum should not be excluded, especially for those patients 70-75 years of age without comorbidities. The better selection of patients, the identification of specific predictive biomarkers, a reasonable sequencing of all active and available treatments, including targeted therapies and cytotoxic, may significantly contribute to extend the natural history of stage IV NSCLC.Lung cancer remains a relevant health care problem and in the near future will account for almost 30% of all cancer-related deaths. Non-small cell lung cancer (NSCLC) represents more than 80% of all lung cancer cases. The majority of patients with lung cancer are diagnosed at baseline with locally advanced or metastatic disease. The increase in life expectancy with the associated cumulative increase in the risk of cancer has led to an increased incidence of this disease in the elderly population. Overall the incidence and death rates for lung cancer are decreasing for both men and women 1 ; however, the 5-year survival in stage IV NSCLC remains as low as 1%. 2According to the current World Health Organization (WHO) classification for lung tumors, NSCLC includes many histological subtypes, but for therapeutic purposes it can be broadly categorized as squamous and non-squamous. This non-canon...

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Gefitinib for advanced non-small cell lung cancer

Sim¹,

Yang

Wood‐Baker

et al. 2018

Cochrane Database of Systematic Reviews

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This systematic review shows that gefitinib, when compared with standard first- or second-line chemotherapy or maintenance therapy, probably has a beneficial effect on progression-free survival and quality of life in selected patient populations, particularly those with tumours bearing sensitising EGFR mutations.Patients with EGFR mutations lived longer when given maintenance gefitinib than those given placebo.One study conducted subgroup analysis and showed that gefitinib improved overall survival over placebo in the second-line setting in patients of Asian ethnicity. All other studies did not detect any benefit on overall survival. The data analysed in this review were very heterogenous. We were limited in the amount of data that could be pooled, largely due to variations in study design. The risk of bias in most studies was moderate, with some studies not adequately addressing potential selection, attrition and reporting bias. This heterogeneity may have an impact on the applicability of the resultsCombining gefitinib with chemotherapy appears to be superior in improving progression-free survival to either gefitinib or chemotherapy alone, however further data and phase III studies in these settings are required.Gefitinib has a favourable toxicity profile when compared with current chemotherapy regimens. Although there is no improvement in overall survival, gefitinib compares favourably with cytotoxic chemotherapy in patients with EGFR mutations with a prolongation of progression-free survival and a lesser side effect profile.

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Randomized phase II study of gefitinib versus erlotinib in patients with advanced non-small cell lung cancer who failed previous chemotherapy

Cited by 87 publications

References 30 publications

Comparison of the effectiveness of erlotinib, gefitinib, and afatinib for treatment of non-small cell lung cancer in patients with common and rare EGFR gene mutations

Comparison of the effectiveness of erlotinib, gefitinib, and afatinib for treatment of non-small cell lung cancer in patients with common and rare EGFR gene mutations

Extending Survival of Stage IV Non-Small Cell Lung Cancer

Gefitinib for advanced non-small cell lung cancer

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