Expert Point of View: PARAMOUNT

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Formal discussant Gregory Peter Kalemkerian, MD, of the University of Michigan Comprehensive Cancer Center, Ann Arbor, questioned whether all patients need maintenance therapy, since some patients on placebo lived as long as those on pemetrexed maintenance, and quality of life, as reported previously, was no better on pemetrexed than on placebo. “This doesn’t exactly arouse enthusiastic support,” he noted. “Pemetrexed is an expensive drug, at least in the United States.”

Goals of maintenance therapy are to prolong survival and improve quality of life, with low cumulative toxicity and cost-effectiveness, he said. Pemetrexed improves survival, is well tolerated, has low cumulative toxicity, but may not improve quality of life. It is not known if the drug is cost-effective, he said.

Continuation Maintenance

“We know that continuation maintenance therapy [the continued use of an agent given as first-line therapy after four to six cycles of initial therapy in the absence of disease progression] with pemetrexed prolongs overall survival. We know that continuation maintenance therapy with bevacizumab [Avastin] is standard of care, but we do not know if it is beneficial. There is no statistically or clinically significant survival benefit for continuation maintenance therapy with other agents or regimens,” Dr. Kalemkerian stated.

He noted that maintenance therapy should be considered for patients who are symptomatic from disease and have a good performance status. But for those who are symptomatic from treatment or have a marginal performance status, a “drug holiday” with close surveillance is the most reasonable approach, with reinitiation therapy on progression of disease. Dr. Kalemkerian added that treatment strategies must be adjusted based on the patient’s status and goals. “Everyone does not need maintenance therapy. One patient received 38 cycles of placebo in this trial,” he said. “Some patients do well without maintenance therapy.” ■

Disclosure:Dr. Kalemkerian has received research funding from Lilly.

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