Single-agent therapy is the standard of care for older patients (70 and above) because of toxicity concerns, while younger patients generally receive more potent combination therapy. Data from the French Intergroup of Thoracic Oncology have indicated that older patients may also benefit from combination therapy, and the results could herald a new treatment paradigm for a graying patient population.
"This is the first study entirely devoted to elderly patients showing the superiority of a carboplatin doublet over single-agent therapy in advanced non-small-cell lung cancer," said lead investigator Elisabeth Quoix, MD, a professor of medicine at University Hospital in Strasbourg, France.
IFCT-0501 trial treatment arms
|•||Arm A: 1,150 mg/m2 gemcitabine (Gemzar) or 30 mg/m2 vinorelbine (Navelbine) given on days 1 and 8 every three weeks|
|•||Arm B: Carboplatin given every four weeks and 90 mg/m2 paclitaxel on days 1, 8, and 15 every four weeks|
The phase III study (IFCT-0501) evaluated the efficacy and safety of weekly paclitaxel combined with monthly carboplatin vs single-agent therapy in patients aged 70 to 89 years old with advanced lung cancer. Patients (n = 451) were randomized into two treatment arms (see Table 1). Patient characteristics were similar between the two (see Table 2).
IFCT-0501 patient characteristics
|•||Median age of 77.2 years|
|•||73.8% of patients were male|
|•||73.6% had a performance status of 0 1|
Of the 451 patients analyzed, overall survival was significantly longer in patients treated with the combination therapy vs those in the single-agent arm (10.3 months vs 6.2 months, P = .0004). Survival at one year was 45.1% for arm A vs 26.9% for arm B.
MARK G. KRIS, MD
Four-month improvement is significant
The 2009 ASCO guidelines state that age should not be used as a criterion for choosing therapy. The data from the French Intergroup study supports the idea that people over 70 should be offered the same kind of treatment as younger patients, said Dr. Kris, chief of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center in New York.
"The average age of a person with lung cancer in the U.S. today is 71 years," Dr. Kris said. "These data tell us exactly what we need to know about most patients with lung cancer in this country, and these data help inform our decisions about these patients."
He added that "a four-month improvement is a huge one. Other large clinical and cooperative trials have generally [been viewed as] practice-changing with two-month improvement in median survival, so I think this four-month improvement in our largest population of patients [with lung cancer] is very important."
Additional reporting by Shalmali Pal.