According to the results of a phase II clinical trial published in the Journal of Clinical Oncology, the addition of Celebrex® (celecoxib) to second-line chemotherapy does not improve treatment effectiveness or toxicity among patients with non–small cell lung cancer.

Lung cancer remains the leading cause of cancer deaths in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 75–80% of all lung cancers.

Celebrex belongs to the class of drugs known as non-steroidal anti-inflammatory agents. Celebrex inhibits the COX-2 enzyme, which plays a role in inflammation. In addition, there is some evidence that COX-2 inhibitors may increase response to chemotherapy.

To evaluate the effectiveness of adding Celebrex to second-line chemotherapy, researchers conducted a phase II clinical trial among 133 patients with Stage IIIB or Stage IV NSCLC. Second-line therapy refers to therapy that is given when the initial therapy does work or stops working.

Study participants received chemotherapy consisting of either Camptosar® (irinotecan) plus Taxotere® (docetaxel) or Camptosar plus Gemzar® (gemcitabine). Half the study participants were given Celebrex (400 mg twice daily) in addition to chemotherapy and half the patients were not.

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• One-year survival was 24% among patients treated with Celebrex and chemotherapy and 36% among patients treated with chemotherapy alone.

• In the patients treated with Celebrex and chemotherapy, half the patients survived longer than 6.3 months. In the patients treated with chemotherapy alone, half the patients survived for longer than nine months.

• Aside from pain, the addition of Celebrex to chemotherapy did not improve patient symptoms.

The researchers conclude that at this time, the addition of Celebrex to second-line chemotherapy for advanced NSCLC “cannot be recommended.”

An accompanying editorial points out that this study leaves some important questions unanswered, and notes that it’s still possible that specific subsets of NSCLC patients may benefit from COX-2 inhibitors. Further research in this area may be warranted.

Reference: Lilenbaum R, Socinski MA, Altorki NK et al. Randomized Phase II Trial of Docetaxel/Irinotecan and Gemcitabine/Irinotecan With or Without Celexocib in the Second-Line Treatment of Non-small Cell Lung Cancer. Journal of Clinical Oncology. 2006;24:4825-4832.

Accompanying Editorial: Csiki I, Johnson DH. Did Targeted Therapy Fail Cyclooxygenase Too? Journal of Clinical Oncology. 2006;24:4798

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