Bone Metastasis on the Survival of Gefitinib Effective Patients

Study Overview
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Brief Summary
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Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Detailed Description
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The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Official Title
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Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer

Conditions
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Overal Survival, Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histological and (or) cytological diagnosed NSCLC patients. patient was effective in Gefitinib treatment more than 6 months. whether patient received chemotherapy and other treatment is not restricted. whether patient was detected for EGFR gene mutation was not restricted. Exclusion Criteria: patient with small cell lung cancer. patient without cytology or histopathology diagnosis results. patient with bone metastases cannot rule out other reasons such as inflammation or trauma. patient with poor treatment compliance. patient with incomplete data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gefitinib<br>Gefitinib is an selective small molecule epidermal growth factor receptors (EGFRs) tyrosine kinase inhibitors (EGFR-TKI) for non-small cell lung cancer. | Drug: Gefitinib<br>* Daily oral administration of 250 mg Gefitinib<br>* Other names: Iressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overal survival of patients | The 5-year survival of NSCLC patients with or without bone metastasis | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with both bone metastasis and brain metastasis | Survival of patients with both bone metastasis and brain metastasis | 3 years |