A phase II study of gefitinib as a dirst-line therapy of advanced or metastatic adenocarcinoma of the lung in lifetime non-smokers

Lee, D. H.; Han, J. Y.; Lee, H. G.; Lee, J. J.; Lee, E. K.; Kim, H. Y.; Kim, H. T.; Hong, Eun Kyung; Lee, J. S.

doi:10.1200/jco.2005.23.16_suppl.7072

Cited by 12 publications

(5 citation statements)

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“…In Phase II studies in Japan, response rates range from 21 to 33.3% 38–41 . Notably, a Phase II study in Korea observed a response rate of 61.1% 42 . A retrospective analysis in Taiwanese patients with advanced NSCLC with very poor performance status found that the objective responses to gefitinib were more frequent among patients who had never been treated with a chemotherapeutic agent (38.1%) compared with patients who had failed ≥1 regimen (16.1%) 36 .…”

Section: Methodsmentioning

confidence: 99%

Gefitinib in advanced non‐small cell lung cancer: Clinical experience in patients of Asian origin

Armour

2007

Asia-Pac J Clncl Oncology

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Background: The IRESSA Survival Evaluation in Lung cancer (ISEL) trial showed some improvement in survival which failed to reach statistical significance in the overall population and in patients with adenocarcinoma. However, gefitinib (IRESSA) treatment was associated with a significant improvement in the survival in subgroups of patients of Asian origin and never smokers. Here we review the clinical experience of gefitinib in patients of Asian origin with advanced non-small cell lung cancer (NSCLC) and discuss the evidence for the underlying biological basis for the apparent heterogeneity in clinical outcome between patients of Asian and non-Asian origin. Methods: Reports of clinical experience with gefitinib 250 mg/day in Asia were identified by searching Embase and Medline databases for publications between 1 January 2003 and 27 July 2006. Results: A large number of reports in patients of Asian origin show high objective response and diseasecontrol rates with gefitinib treatment, with median survival >6 months and time to progression >3 months. The reports also indicate that gefitinib is generally well tolerated by patients of Asian origin and epidermal growth factor receptor (EGFR) mutations, which appear to be associated with gefitinib sensitivity, occur at a much higher rate in these patients compared with patients of non-Asian origin. These reports also indicate that a high EGFR gene copy number may be associated with their response to gefitinib. Conclusion: Gefitinib appears to be a valid, efficacious, and generally well-tolerated treatment option for patients of Asian origin with advanced NSCLC. It is possible that differences in EGFR mutation rates may underlie variations in response rates to gefitinib between Asian and non-Asian patient populations. Further exploratory analyses conducted in prospective clinical trials are required to fully determine the role of EGFR mutations, a high EGFR gene copy number and other biomarkers in determining the response to gefitinib treatment.

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Section: Methodsmentioning

confidence: 99%

Gefitinib in advanced non‐small cell lung cancer: Clinical experience in patients of Asian origin

Armour

2007

Asia-Pac J Clncl Oncology

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“…The response rates varied from 24.5 [13] to 33.3% [14] in patients with advanced or metastatic NSCLC treated with gefitinib [14,15] or erlotinib [13]. One trial from South Korea disclosed response rates of 61% with a median response duration of 30 weeks in non-smokers with advanced or metastatic pulmonary adenocarcinoma [12].…”

Section: Introductionmentioning

confidence: 97%

“…Several phase II studies presented at the American Society of Clinical Oncology (ASCO) 2005 meeting examined the efficacy of single-agent erlotinib and gefitinib as first-line therapy [12][13][14][15]. The response rates varied from 24.5 [13] to 33.3% [14] in patients with advanced or metastatic NSCLC treated with gefitinib [14,15] or erlotinib [13].…”

Section: Introductionmentioning

confidence: 99%

Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer

et al. 2006

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“…48,49 A recently reported second-line study (n = 240) of pemetrexed (day 1) and erlotinib (days 2–14) resulted in statistically significant improvements in PFS and OS compared to either pemetrexed or erlotinib monotherapy in clinically enriched advanced nonsquamous NSCLC patients whose EGFR genotype status was only known in 44 cases (18%). 50 Another study suggested that East Asian patients treated with pemetrexed and erlotinib combination experienced a longer median PFS (7.4 months) compared to erlotinib (4.5 months) and pemetrexed (4.0 months).…”

Section: Discussionmentioning

confidence: 99%

Randomized Phase 2 Trial of Pharmacodynamic Separation of Pemetrexed and Intercalated Erlotinib Versus Pemetrexed Alone for Advanced Nonsquamous, Non–small-cell Lung Cancer

Piperdi

Walsh

et al. 2017

Clinical Lung Cancer

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This randomized phase 2 study demonstrated promising clinical synergism between pemetrexed and intercalated erlotinib in patients with unselected nonsquamous non–small-cell lung cancer (NSCLC) as second-line therapy. EGFR (epidermal growth factor receptor) genotyping by Sequenom multiplex oncogenotyping assay was feasible in 79% of eligible patients using tumor DNA from either archival specimens and/or plasma. Because patients with EGFR-mutant NSCLC respond well to EGFR tyrosine kinase inhibitor monotherapy alone or in combination with bevacizumab, the combination might merit further evaluation as second-line or maintenance therapy against new standards in patients with EGFR wild-type advanced NSCLC. Background Pharmacodynamic separation of pemetrexed and erlotinib avoids negative cellular interactions and results in antitumor synergy in erlotinib-resistant non–small-cell lung cancer (NSCLC) cells, independent of EGFR (epidermal growth factor receptor) genotype. Patients and Methods Patients with platinum-treated metastatic nonsquamous NSCLC were randomly assigned 1:2 to pemetrexed alone (500 mg/m2 provided intravenously on day 1) or pemetrexed followed by erlotinib (150 mg provided orally once daily on days 2–17) every 21 days. EGFR genotype was centrally confirmed by Sequenom multiplex oncogenotyping assay. The primary end point was progression-free survival (PFS), which would be considered promising for future study if median PFS was ≥ 4.5 months. Results Of 83 patients enrolled, 79 were randomized to either pemetrexed alone (n = 27) or in combination (n = 52). Fifty-nine (79%) of 75 eligible patients had tumors with confirmed EGFR genotype: 7 with activating mutations and 52 wild type. Median PFS was 4.7 and 2.9 months in the combination and pemetrexed-alone groups, respectively. In patients with EGFR wild-type tumors, median PFS was 5.3 and 3.5 months in the combination and pemetrexed-alone groups, respectively. Objective response rate (29% vs. 10%, P = .17), 6-month PFS (45% vs. 29%, P = .26), and 12-month PFS (23% vs. 10%, P = .28) were all higher in the combination arm. Rash (67% vs. 26%, P = .0007) and diarrhea (44% vs. 11%, P = .003) were significantly more common in the combination arm. Conclusion In patients with unselected or EGFR wild-type advanced nonsquamous NSCLC, pharmacodynamic separation of pemetrexed and intercalated erlotinib had promising antitumor activity without new safety concerns. The combination merits further evaluation as maintenance or second-line therapy against new standards in patients with EGFR wild-type advanced NSCLC.

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A phase II study of gefitinib as a dirst-line therapy of advanced or metastatic adenocarcinoma of the lung in lifetime non-smokers

Cited by 12 publications

References 0 publications

Gefitinib in advanced non‐small cell lung cancer: Clinical experience in patients of Asian origin

Gefitinib in advanced non‐small cell lung cancer: Clinical experience in patients of Asian origin

Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer

Randomized Phase 2 Trial of Pharmacodynamic Separation of Pemetrexed and Intercalated Erlotinib Versus Pemetrexed Alone for Advanced Nonsquamous, Non–small-cell Lung Cancer

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