Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC

Smokers Clinical Trial

Official title:

Differences in the Presentation, Outcome and Response to Treatment Between Never- Smokers and Smokers With Non- Small Cell Lung Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483015
• Other study ID #: 05-0707
• Status: Completed
• Phase: N/A
• First received: June 4, 2007
• Last updated: August 9, 2013
• Start date: March 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We wish to discover if there is a difference in the presentation, response to treatment and survival of never- smokers with lung cancer as compared to ever- smokers.

We also plan to obtain tumor specimens to compare the genetic and proteomic expression between smokers and never smokers

Description:

Lung cancer is the most lethal of all malignant tumors affecting humans. In the United States alone an estimated 160,440 patients died of lung cancer 2004[1]. It is well known that tobacco smoking is a major risk factor and accounts for the majority of all lung cancer cases. But there is a sub group of patients with lung cancer who have never actively smoked tobacco. This group exhibits certain unique characteristics which separates them from lung cancer in smokers. It has been shown that never- smokers with adenocarcinoma have better outcomes in terms of overall survival as well as lung cancer specific survival when compared to current smokers with adenocarcinoma of the lung[2]. Also patients who are current smokers at diagnosis have decreased survival when compared to people who quit smoking[3]. The improved survival in never smokers could be due to several reasons. Such as increased incidence of co-morbid factors in smokers as result of exposure to tobacco smoke, differences in metabolism of chemotherapeutic agents or a reflection of differences in the underlying molecular biology of the tumor.

It has been demonstrated that chromosomal abnormalities are common in lung cancer patients with a smoking history when compared to never- smokers[4]. Gene mutations such as p53 mutations are more frequent in never- smokers than in previous smokers[5]. In addition mutations that are specific only to lung cancer in never smokers have been discovered, demonstrating the possibility of a separate or overlapping carcinogenesis pathway for lung cancer in never smokers vs. smokers [6].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.

Exclusion Criteria:

• Patients diagnosed prior to Dec 31, 1995 and after Jan 1, 2003

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Smokers

Intervention

Behavioral:
• smoking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

References & Publications (6)

Gazdar AF. Lung cancer in never smokers - A different pathway. ASCO 2005:619-21

Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. Review. — View Citation

Nordquist LT, Simon GR, Cantor A, Alberts WM, Bepler G. Improved survival in never-smokers vs current smokers with primary adenocarcinoma of the lung. Chest. 2004 Aug;126(2):347-51. — View Citation

Sanchez-Cespedes M, Ahrendt SA, Piantadosi S, Rosell R, Monzo M, Wu L, Westra WH, Yang SC, Jen J, Sidransky D. Chromosomal alterations in lung adenocarcinoma from smokers and nonsmokers. Cancer Res. 2001 Feb 15;61(4):1309-13. — View Citation

Tammemagi CM, Neslund-Dudas C, Simoff M, Kvale P. Impact of comorbidity on lung cancer survival. Int J Cancer. 2003 Mar 1;103(6):792-802. — View Citation

Vähäkangas KH, Bennett WP, Castrén K, Welsh JA, Khan MA, Blömeke B, Alavanja MC, Harris CC. p53 and K-ras mutations in lung cancers from former and never-smoking women. Cancer Res. 2001 Jun 1;61(11):4350-6. — View Citation

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine