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PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC) : A Cost-Effectiveness Analysis and Cost-Utility Analysis

Phase 4
20 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

PharmacoEconomic Assessment IRESSA® in the Treatment of Non-Small-Cell Lung Cancer (NSCLC) : A Cost-Effectiveness Analysis and Cost-Utility Analysis

Patients with late-stage NSCLC are often symptomatic, with specific pulmonary problems (eg,
cough, breathlessness, hemoptysis) and general symptoms (eg. fatigue, weight loss) that can
cause extreme distress to the patient. Therefore, improvements in disease-related symptoms
and quality of life (QoL) are the key desired outcomes of medical management.7 Effective,
palliative, low-toxicity with reasonable treatment cost for patients with advanced NSCLC are
needed. Recently, more and more countries consider evidence of economic value along with
clinical efficacy.

The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy
because it is expressed or highly expressed in a variety of tumors, including NSCLC. 8,9
Furthermore, high levels of EGFR expression have been associated with a poor prognosis in
lung cancer patients in several studies. 10-12 EGFR-targeted cancer therapies are currently
being developed; strategies include inhibition of the intracellular tyrosine kinase domain
of the receptor by small molecules such as gefitinib (Iressa [ZD1839]; AstraZeneca,
Wilmington, DE).13 Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that
blocks signal transduction pathways implicated in the proliferation and survival of cancer

Inclusion Criteria:

- Histologically or cytologically confirmed stage IIIB/IV NSCLC No immediate need for
palliative radiotherapy and No prior chemotherapy ; age > 20 Y/O; ECOG PS: 0 - 2; ANC
>2000 ; PLT >100k ; Hb > 10; total bilirubin < 2.0 mg/dL; serum creatinine < 2 mg/dl;
SGPT and SGOT < 2.5 ×ULN, alkaline phosphatase < 5 ×ULN ; life expectancy >6mos

Exclusion Criteria:

- If the patients have brain metastases or receive radiotherapy, the disease must be
stable for more than 6 weeks after the last dose of radiotherapy;

- 2nd malignancies;

- Unable to swallow tablets;

- Patients (M/F) with reproductive potential not implementing adequate contraceptive

- Pregnant or lactating patients;

- Participation in other clinical trials within 30 days of study entry;

- Major systemic disease which in the investigator's opinion might confound the
clinical trial.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The objective of this PE study is to evaluate the cost- effectiveness analysis and cost-utility analysis of IRESSA® as first line treatment of NSCLC from the society perspective, comparing to existing first line platinum-based regimen chemotherapy.

Outcome Time Frame:

2-3 years

Safety Issue:


Principal Investigator

Lin Zone-Zhe, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology , National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

September 2005

Completion Date:

September 2005

Related Keywords:

  • Non-Small Cell Lung Cancer
  • EGFR Non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms