ZD1839 for the treatment of heavily pretreated non-small cell lung cancer

Wu, Yi‐Long; Yang, Xiaohui; Yang, Ji Jin; Huang, Yi; Chen, G.; Gu, Liang

doi:10.1200/jco.2004.22.14_suppl.7341

Cited by 5 publications

(3 citation statements)

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“…In addition to the findings of IDEAL 1 and ISEL, there are extensive data on the use of gefitinib to treat refractory patients of Asian origin with advanced NSCLC, described in more detail in Table 1 4,10–37 …”

Section: Methodsmentioning

confidence: 99%

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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%

“…Six Phase II studies and one retrospective study evaluating gefitinib therapy in patients with refractory NSCLC have been conducted in China 25–31 . Efficacy results from these studies reported positive outcomes for gefitinib with regards to response rates (20.0–54.5%), disease control rates (54.1–86.4%) and OS (5.0–15.3 months).…”

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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“…4,6 These clinical trial data have been supported by other gefitinib monotherapy reports in which patients of Asian origin seem to have benefitted more than patients of non-Asian origin. [7][8][9][10][11][12][13] The effect of gefitinib on survival in the advanced NSCLC setting was further evaluated in a placebo-controlled phase III study (IRESSA Survival Evaluation in Lung cancer [ISEL]), which included approximately 20% of patients who were of Asian origin. This study evaluated either gefitinib (250 mg/day) or placebo plus BSC in patients with advanced NSCLC who were refractory to or intolerant of their most recent chemotherapy regimen.…”

mentioning

confidence: 99%

Gefitinib (IRESSA) in Patients of Asian Origin with Refractory Advanced Non-small Cell Lung Cancer: Subset Analysis from the ISEL Study

Chang

Parikh

Thongprasert

et al. 2006

Journal of Thoracic Oncology

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Introduction:The IRESSA Survival Evaluation in Lung Cancer (ISEL) phase III study compared the efficacy of gefitinib (IRESSA) versus placebo in patients with refractory advanced non-small cell lung cancer (NSCLC). Although a statistically significant difference in survival was not seen between gefitinib and placebo in the overall ISEL population, preplanned subset analyses demonstrated a significant survival benefit in patients who had never smoked and in patients of Asian origin. Methods: In ISEL, 1692 patients who were refractory to or intolerant of their latest chemotherapy were randomized to receive either gefitinib (250 mg/day) or placebo, plus best supportive care. Preplanned subgroup analyses included an assessment of patients who were of Asian origin (n ϭ 342). Results: Two hundred thirty-five patients of Asian origin received gefitinib, and 107 received placebo. In these patients, treatment with gefitinib significantly improved survival compared with placebo (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.48, 0.91; p ϭ 0.010; median survival, 9.5 versus 5.5 months). Patients of Asian origin also experienced statistically significant improvements in time to treatment failure with gefitinib compared with placebo (HR, 0.69; 95% CI, 0.52, 0.91; p ϭ 0.0084; 4.4 versus 2.2 months), and objective response rates were higher with gefitinib than with placebo (12 versus 2%). Gefitinib was generally well tolerated in patients of Asian origin, with rash and diarrhea being the most common adverse events. No unexpected adverse events were observed. Conclusions: Treatment with gefitinib was associated with a significant improvement in survival in a subgroup of patients of Asian origin with previously treated refractory advanced NSCLC.

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Current therapeutic uses of lenalidomide in multiple myeloma

Hideshima¹,

Richardson²,

Anderson³

2006

Expert Opinion on Investigational Drugs

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Thalidomide has demonstrated a broad spectrum of pharmacological and immunological effects, with potential therapeutic applications that span a wide spectrum of diseases: cancer and related conditions; infectious diseases; autoimmune diseases; dermatological diseases; and other disorders such as sarcoidosis, macular degeneration and diabetic retinopathy. Immunomodulatory derivative lenalidomide has more potent antitumour and anti-inflammatory effects. The molecular mechanisms of antitumour activity of lenalidomide have been extensively studied in multiple myeloma (MM). It directly induces growth arrest and/or apoptosis of even drug-resistant MM cells; inhibits binding of MM cells to bone marrow extracellular matrix proteins and stromal cells; modulates cytokine secretion and inhibits angiogenesis in the bone marrow milieu; and augments host antitumour immunity. Importantly, lenalidomide induces significant clinical responses even in patients with relapsed/refractory MM. Therefore, lenalidomide represents a new class of antitumour agents that is useful in the treatment of MM. Lenalidomide has received fast track designation from the FDA for the treatment of MM and myelodysplastic syndromes.

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ZD1839 for the treatment of heavily pretreated non-small cell lung cancer

Cited by 5 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 (IRESSA) in Patients of Asian Origin with Refractory Advanced Non-small Cell Lung Cancer: Subset Analysis from the ISEL Study

Current therapeutic uses of lenalidomide in multiple myeloma

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