Phase III Trial Evaluates Preoperative Chemotherapy for Non–Small Cell Lung Cancer

Posted on May 21st, 2010 by

A Phase III clinical trial of preoperative chemotherapy for non–small cell lung cancer did not provide definitive evidence of a benefit. The results of this prematurely closed study were recently published in the Journal of Clinical Oncology.[1]

Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. For patients with lung cancer that can be surgically removed, several studies have addressed the benefit of post-surgery (adjuvant) chemotherapy as well as pre-surgery (induction) chemotherapy.

In this study, researchers conducted a randomized, Phase III trial to evaluate the survival benefit of treating early-stage NSCLC patients with chemotherapy consisting of paclitaxel and carboplatin administered prior to surgery compared with surgery alone.

Overall survival and progression-free survival were reported to be higher in the patients who received a combination of chemotherapy prior to surgery than in the group that received surgery alone; however, these differences were not statistically significant, suggesting that they could have occurred by chance alone.

This trial closed early after accrual of only 354 patients due to results from other trials indicating a statistically significant survival benefit for chemotherapy following surgery versus surgery alone in early-stage NSCLC.[2],[3]

The researchers concluded that, currently, “stronger evidence exists for postoperative chemotherapy in early-stage NSCLC.” Studies are ongoing to further elucidate optimal strategies in early-stage NSCLC that may individualize care in order to improve survival and maintain quality of life.

Reference:


[1] KMW Pisters, Vallieres E, Crowley JJ, et al. Surgery With or Without Preoperative Paclitaxel and Carboplatin in Early-Stage Non–Small-Cell Lung Cancer: Southwest Oncology Group Trial S9900, an Intergroup, Randomized, Phase III Trial. Journal of Clinical Oncology. 2010;28:1843-1849.

[2] The International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small cell lung cancer. N Engl J Med. 2004;350:351-360.

[3] Winton T, Livingston R, Johnson D, et al. Vinorelbine plus cisplatin vs observation in resected on-small cell lung cancer. N Engl J Med. 2005;353:2589-2597.

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