Bone Metastasis on the Survival of Gefitinib Effective Patients

Qilu Hospital of Shandong University265 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

265

Conditions

Overal Survival, Non-small Cell Lung Cancer

Interventions

GefitinibDRUG

Daily oral administration of 250 mg Gefitinib

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. histological and (or) cytological diagnosed NSCLC patients. 2. patient was effective in Gefitinib treatment more than 6 months. 3. whether patient received chemotherapy and other treatment is not restricted. 4. whether patient was detected for EGFR gene mutation was not restricted. Exclusion Criteria: 1. patient with small cell lung cancer. 2. patient without cytology or histopathology diagnosis results. 3. patient with bone metastases cannot rule out other reasons such as inflammation or trauma. 4. patient with poor treatment compliance. 5. patient with incomplete data.

Outcomes

Primary Outcomes

Overal survival of patients

The 5-year survival of NSCLC patients with or without bone metastasis

Time frame: 5 years

Secondary Outcomes

Survival of patients with both bone metastasis and brain metastasis

Time frame: 3 years

Data from ClinicalTrials.gov

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