Gerold Bepler

Publication Detail

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Phase II study of gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), and celecoxib, a cyclooxygenase-2 (COX-2) inhibitor, in patients with platinum refractory non-small cell lung cancer (NSCLC).

Shirish M Gadgeel; John C Ruckdeschel; Elisabeth I Heath; Lance K Heilbrun; Raghu Venkatramanamoorthy; Antoinette Wozniak (Profiled Authors: Shirish Gadgeel; Elisabeth Iljas Heath; Antoinette J Wozniak; Lance K Heilbrun)

Karmanos Cancer Institute/Wayne State University, Detroit, Michigan, USA. gadgeels@karmanos.org
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2007;2(4):299-305.

BACKGROUND: Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has demonstrated a response rate of 9%-18% in relapsed non-small cell lung cancer (NSCLC) patients. The probability of response to gefitinib was not influenced by response to previous chemotherapy. Preclinical studies have suggested that celecoxib, a cyclooxygenase-2 inhibitor, has antitumor activity in NSCLC and can enhance the activity of EGFR inhibitors. We conducted a phase II study evaluating the combination of gefitinib and celecoxib in platinum-refractory NSCLC patients, defined as patients whose disease had progressed on platinum-based chemotherapy or within 3 months of completing such therapy. METHODS: Platinum-refractory NSCLC patients with performance status of 0-2 and adequate organ function were included. Patients should not have been on a NSAID for 30 continuous days before study enrollment. Patients were treated with gefitinib 250 mg daily and celecoxib 400 mg twice daily. Disease assessment was performed every 8 weeks. RESULTS: Twenty-seven patients were enrolled. The response rate was 7% (2/27). The median time to progression was 2.2 months, and the median survival was 4.6 months. One female, nonsmoking patient is progression free more than 3 years after study enrollment. The drug combination was well tolerated, with the most common adverse effects being skin rash and diarrhea. CONCLUSION: In unselected platinum-refractory NSCLC patients, the response rate to the combination of celecoxib and gefitinib was similar to that observed with gefitinib alone.

6 Originating Grant

• 1.

  CANCER CENTER SUPPORT GRANT

  8 August 1997 - 30 November 2015

  NATIONAL CANCER INSTITUTE

  Total Funding: $ 2,553,798

• 2.

  Schwartz, Ann G

  Cancer Center Support Grant

  8 August 1997 - 30 November 2009

  NATIONAL CANCER INSTITUTE

  Total Funding: $ 2,528,988

• 3.

  BEPLER, GEROLD

  CANCER CENTER SUPPORT GRANT

  8 August 1997 - 30 November 2015

  NATIONAL CANCER INSTITUTE

  Total Funding: $ 7,029,591

• 4.

  Crissman, John D

  CANCER CENTER SUPPORT GRANT

  1 April 1988 - 30 November 2002

  NATIONAL CANCER INSTITUTE

  Total Funding: $ 895,271

• 5.

  VALERIOTE, FREDERICK A

  CANCER CENTER SUPPORT GRANT

  1 April 1988 - 31 March 1996

  NATIONAL CANCER INSTITUTE

  Total Funding: $ 41,750

• 6.

  BRENNAN, MICHAEL J

  CANCER CENTER SUPPORT GRANT

  1 April 1979 - 31 March 1984

  NATIONAL CANCER INSTITUTE

  Total Funding: $ 236,458

Scientific Context

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