Two-Drug NSCLC Therapy Can’t Boost Survival (CME/CE)

By Charles Bankhead, , MedPage TodayPublished: September 08, 2012Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

CHICAGO — Survival in advanced nonsmall cell lung cancer (NSCLC) failed to improve with pemetrexed (Alimta) versus paclitaxel in combination chemotherapy, results of a massive randomized trial showed.

Patients had a median overall survival (OS) of 12.8 months with the combination of pemetrexed, carboplatin, and bevacizumab (Avastin) versus 13.4 months with paclitaxel, carboplatin, and bevacizumab. A modest improvement in progression-free survival (PFS) did occur in the pemetrexed arm.

Patients who had stable disease or better response after upfront therapy received maintenance therapy with pemetrexed and bevacizumab or bevacizumab alone. A prespecified analysis limited to patients who received maintenance therapy showed a 2-month improvement in OS in the pemetrexed group, as reported here at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

“The primary endpoint of this trial was not met. The hazard ratio was 1. The survival curves were superimposable,” Jyoti Patel, MD, of Northwestern University in Chicago, stated during a press briefing. “The secondary endpoint was PFS, and that favored the pemetrexed arm.”

“The toxicity profiles differed, even though both profiles were certainly tolerable,” he added.

OS was the primary endpoint, and the trial was statistically powered to demonstrate the superiority of the pemetrexed regimen.

The final analysis included 939 randomized patients and did not produce any evidence of a survival benefit with the pemetrexed regimen, Patel said

Patients in the pemetrexed arm had a median PFS of 6 months compared with 5.6 months in the paclitaxel group. Though less than half a month, the difference demonstrated statistical significance in favor of the pemetrexed arm (P=0.012).

Overall response rates were 33% to 34% in both arms, and the disease control rates (response plus stable disease) were 65.9% in the pemetrexed group and 69.8% in the paclitaxel group.

About 3% of patients in the pemetrext arm had to discontinue the study because of serious adverse events compared with 3.6% in the paclitaxel arm. Study drug-related deaths because of adverse events were similar at 1.8% and 2.3%, respectively.

The prespecified analysis limited to patients who received maintenance therapy consisted of 292 patients in the pemetrexed arm and 298 in the paclitaxel group.

The pemetrexed patients had a median OS of 17.7 months and median PFS of 8.6 months compared with 15.7 and 6.9 months for the paclitaxel arms. In contrast, in patients who did not receive maintenance therapy because of progressive disease or toxicity, median OS was 4.6 months in the pemetrexed group and 6.1 months in the paclitaxel group.

Patel reported that 53% of patients in the pemetrexed arm received additional therapy in second line and beyond as did 59% of patients in the paclitaxel arm.

The results were “profoundly disappointing but scarcely surprising,” stated invited discussant Corey Langer, MD. The results are in line with previous reports of chemotherapy followed by bevacizumab maintenance therapy.

“The numbers are quite consistent, and we see very tiny variation, no matter which combination is given with bevacizumab, and they are probably relatively interchangeable,” stated Langer, of the University of Pennsylvania in Philadelphia.

The results probably were greeted by a collective sigh of relief by insurers who might have contemplated the cost of covering a regimen containing both pemetrexed and bevacizumab, Langer said

Langer suggested that cost would remain a limiting factor for a regimen containing both pemetrexed and bevacizumab. His calculations showed an estimated cost per life-year gained of $228,318.

The study was supported by Eli Lilly.

Working from Houston, home to one of the world’s largest medical complexes, has more than 20 years of experience as a medical writer and editor. His career began as a science and medical writer at an academic medical center. He later spent nearly a decade as a writer and editor for Medical World News, one of the leading medical trade magazines of its era. His byline has appeared in medical publications that have included Cardio, Cosmetic Surgery Times, Dermatology Times, Diagnostic Imaging, Family Practice, Journal of the National Cancer Institute, Medscape, Oncology News International, Oncology Times, Ophthalmology Times, Patient Care, Renal and Urology News, The Medical Post, Urology Times, and the International Medical News Group newspapers. He has a BA in journalism and MA in mass communications, both from Texas Tech University.

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Submited at Sunday, September 9th, 2012 at 12:15 am on Uncategorized by hilman
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