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Clinical Trial Reports

By Stanton R. Mehr
Published: Thursday, Jun 10, 2010
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PHASE III

Second-Line Pemetrexed Does Not Provide Survival Advantage in Malignant Pleural Mesothelioma

Pemetrexed seems to be one of the few therapies to exert positive effects in patients with malignant pleural mesothelioma (MPM). Researchers from Poland, Germany, Italy, and the United States conducted a controlled, phase III study to determine whether second-line treatment with pemetrexed in patients with advanced MPM improved their overall survival.

The study group comprised 123 patients who after first-line chemotherapy experienced relapsed MPM. They were randomly assigned to receive treatment with pemetrexed 500 mg/m² plus best supportive care (BSC) every 21 days. Their progress was compared against a control group of 120 patients who received BSC alone.

The investigators did not find any significant differences in the primary outcome measure, median overall survival, between the two treatment groups (8.4 mo for the pemetrexed + BSC group and 9.7 mo for the BSC group). However, they did reveal that the combination of pemetrexed and BSC led to significantly better progression-free survival and time-to-tumor progression. Although the overall survival did not favor the second-line pemetrexed group, those receiving the combination attained a 19% rate of partial response compared with only 2% in the BSC-only group (P < .0001). The disease control rate (partial response and stable disease) was noted in 59% of the pemetrexed group and 19% of the BSC group (P < .0001).

Interestingly, the investigators found that subjects who received BSC treatment only had significantly greater use of postdiscontinuation chemotherapy than the pemetrexed group (52% vs. 28%, respectively; P = .0002) with 18.3% of patients in the BSC group being given pemetrexed versus 3.3% in the pemetrexed group (P = .0001). Chemotherapy was well tolerated in both groups, with 4% to 7% grade 3 and 4 hematologic toxicities.

Measure P+BSC BSC only
Median Overall

Survival
8.4 mo 9.7 mo
Partial Response 18.7% 1.7%
Partial Response +

Stable Disease
59.3% 19.2%


P = Pemetrexed; BSC = best supportive care.

An overall survival improvement rate was not found in this study, concluded the researchers, because of a difference in the use of post-discontinuation chemotherapy between the two treatment groups. Those using second-line pemetrexed and BSC had better tumor response and longer-delayed disease progression compared with only BSC use in patients with advanced MPM, the researchers commented.


Jassem J, Ramlau R, Santor A, et al: Phase III trial of pemetrexed plus best supportive care compared with best supportive care in previously treated patients with advanced malignant pleural mesothelioma. J Clin Oncol 2008;26:1698-1704.






PHASE III

Colon Cancer Risk Reduced Dramatically by Two-Drug Combination

The risk of colon cancer may be decreased by more than 90% in high-risk patients, according to researchers from the University of Arizona who presented their findings at the American Association for Cancer Research annual meeting in San Diego. They found that the use of a synthetic amino acid that interferes with cancer development but is highly toxic at regular doses can be given with a nonsteroidal antiinflammatory drug (NSAID) but at greatly reduced doses, reduced the risk of colorectal adenomas, without significant toxicity.

The study group comprised 375 patients with a history of colorectal polyps within the past five years. The enrollees were randomly assigned to receive either a combination of difluoromethylornithine (DFMO) 500 mg/day plus sulindac 150 mg/day or a placebo.

After a three-year follow-up period, the risk of a recurrent polyp was 41.1% in the placebo group but only 12.3% with the combination treatment, a 70% reduction. Patients with a history of advanced polyps who took the active drug combination saw their risk of recurrent polyps drop 92%.

The rate of polyp reappearance in patients with multiple previous adenomas was 13.2% in the placebo group and 0.7% in the group receiving the DFMO–sulindac combination treatment (95% reduction). The lead researcher pointed out that 17 patients in the placebo group experienced regrowth of at least one adenoma, compared with only one patient in the treatment group.


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Community Practice Connections™: 18th Annual International Lung Cancer Congress®Oct 31, 20181.5
Provider and Caregiver Connection™: Addressing Patient Concerns While Managing Chemotherapy Induced Nausea and VomitingOct 31, 20182.0
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