A Phase III randomized, multicenter trial shows that a combination of two commonly used chemotherapy drugs, paclitaxel and carboplatin, significantly increases overall survival and progression-free survival in patients age 70 or older with advanced non-small cell lung cancer (NSCLC) compared to standard single-agent therapy.

"Elderly patients are often not given aggressive treatment out of concern that they will not be able to tolerate it. These results demonstrate that a more intensive regimen given to younger patients can be effective and tolerable in this group," said lead author Elisabeth Quoix, M.D., professor of medicine at University Hospital, in Strasbourg, France.

Few new clinical trials evaluate lung cancer therapies in the elderly, though more than one-half of patients with NSCLC are at least 65, and at least 30 percent of all NSCLC patients are 70 or older. While the standard treatment for elderly patients with advanced lung cancer is single-drug therapy, this recommendation is based on older studies. The combination regimen evaluated in this trial has been proven more effective in another Phase III trial that did not control for age, although a subgroup analysis suggested that this regimen would also be effective in patients 70 or older.

In the current clinical trial, conducted by the French Intergroup of Thoracic Oncology at 62 international centers between 2005 and 2009, Dr. Quoix and her colleagues compared standard single-agent therapy - with either gemcitabine (Gemzar) or vinorelbine (Navelbine) - to combination therapy with paclitaxel and carboplatin in 451 patients with advanced NSCLC between the ages of 70 and 89. The study, which was initially planned to include 520 patients, was stopped early when an interim analysis found that overall survival was longer in the combination group (10.4 months) than in those who received single agent therapy (6.2 months). They also found that patients receiving combination therapy lived nearly twice as long (6.3 months) before their lung cancer progressed as those receiving the single-drug therapy (3.2 months).

While the researchers found the combination therapy had acceptable toxicity, preliminary data in 313 patients found that the group receiving the combination regimen experienced moderate to severe neutropenia more frequently than the single-drug group (47.8 percent vs. 12.2 percent).

Disclosures: Elisabeth Quoix, Consultant or Advisory Role, Lilly, Roche, Honoraria, Lilly, Roche; Jean-Philippe Oster, Stock Ownership, Roche; Virginie Westeel, Honoraria, Lilly, Pierre Fabre Medicament, Other Remuneration, Lilly, Pierre Fabre Medicament, Roche; Eric Pichon, Honoraria, Roche, Other Remuneration, Roche; Gerard Zalcman, Consultant or Advisory Role, Lilly, Roche, Honoraria, Lilly, Roche, Research Funding, Roche; Armelle Lavole, Other Remuneration, Lilly; Marie-Paule Lebitasy, Consultant or Advisory Role, Lilly, Roche, Honoraria, Lilly, Roche, Other Remuneration, Lilly, Roche, Research Funding, Lilly, Roche.