A new subgroup analysis of data from the pivotal Phase III PARAMOUNT study showed that continuation maintenance therapy with pemetrexed for injection (Alimta?, Eli Lilly and Company) also reduces the risk of disease progression in patients aged 70 years or older with advanced nonsquamous non-small cell lung cancer (NSCLC), the most common type of lung cancer.

Results from the new analysis were presented during the Lung Cancer ? Metastatic Poster Session (Abstract #9072) at the 2011 European Multidisciplinary Cancer Congress (formerly known as the ECCO-ESMO Cancer Congress) in Stockholm, Sweden.

Continued maintenance
PARAMOUNT is the first study to evaluate the use of continuation maintenance therapy with ALIMTA following first-line pemetrexed plus cisplatin therapy. A total of 939 patients with advanced nonsquamous NSCLC were enrolled in the study; 539 did not progress during the induction phase and entered the maintenance phase of the trial. Of those, 92 patients were elderly.

The trial
The new analysis compared pemetrexed to placebo in elderly patients aged greater than or equal to 70 years (n=92). In the group of elderly patients, pemetrexed reduced the risk of disease progression by 65%(hazard ratio, 0.35; 95% CI: 0.20?0.63), based on a median progression-free survival of 6.4 months on the pemetrexed arm compared with 3.0 months on the placebo arm. In the group of patients less than 70 years of age, pemetrexed reduced the risk of disease progression by 31% (hazard ratio, 0.69, 95% CI: 0.54?0.90), with a progression-free survival of 4.0 months for ALIMTA and 2.8 months for placebo.

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Supportive care alone?
“Lung cancer can be challenging to treat in patients over 70 years of age because they often have comorbidities and may be less tolerant of anti-cancer therapies,” said Cesare Gridelli, M.D., a clinical trial investigator for the PARAMOUNT study and physician with S. Giuseppe Moscati Hospital in Avellino, Italy. “In fact, some patients over the age of 70 may simply be offered supportive care alone. These results show that an pemetrexed maintenance regimen could provide benefit to certain elderly patients.”

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The study included patients with advanced nonsquamous NSCLC who received pemetrexed (500 mg/m2 on day one of a 21-day cycle) in combination with cisplatin (75 mg/m2) induction therapy. Patients whose disease had not progressed during the pemetrexed plus cisplatin induction and had a performance status of 0-1 were randomized to receive pemetrexed maintenance (500 mg/m2 on day one of a 21-day cycle) plus best supportive care or placebo plus best supportive care until disease progression.

Drug-related adverse events
Overall, the most serious (laboratory grade 3/4) drug-related adverse events were higher for elderly patients treated with ALIMTA continuation maintenance compared with patients less than 70 years of age (21% vs. 7%). These adverse events were primarily hematological (anemia and neutropenia). Elderly patients in the study tended to have a poorer performance status than younger patients (PS 0: 20% vs. 34%, respectively; PS 1: 79% vs. 66%, respectively), and the older group received more cycles of pemetrexed therapy (5.5 vs. 4.8 in the younger group).

ASCO 2011
Overall results of PARAMOUNT, which met its primary endpoint of progression-free survival, were presented in June 2011 at the American Society of Clinical Oncology (ASCO) Annual Meeting[1].

Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.3 million cancer deaths annually[2]. About 85 ? 90 percent of all lung cancers are NSCLC [3]. The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.

NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses [4], as well histologies classified as “other.”

For more information:
[1] Paz-Ares LG, De Marinis F, et.al. PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 29: 2011 (suppl; abstr CRA7510).
[2] World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003. Last accessed July 25, 2011.
[3] American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” December 16, 2010, American Cancer Society. Last accessed July 25, 2011.
[4] American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” December 16, 2010, American Cancer Society. Last accessed July 25, 2011.

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