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Pemetrexed vs Docetaxel:Vitam B12/Folic Acid Added

Pemetrexed vs docetaxel for non-small cell lung cancer (NSCLC): Could vitamin supplementation affect docetaxel survival? An exploratory analysis.

F. Fossella, C. Obasaju, S. Paul;

M. D. Anderson Cancer Center, Houston, TX; Eli Lilly & Co, Indianapolis, IN

Abstract: Background: Based on randomized phase III studies, docetaxel is standard second-line treatment for NSCLC. In a recent comparison of pemetrexed, a novel multitargeted antifolate, versus docetaxel in previously treated patients (pts) with advanced NSCLC, survival time with pemetrexed therapy was similar to docetaxel (median 8.3 vs 7.9 months).

Pts (N=571) were randomized to receive either pemetrexed (500 mg/m2 IV), supplemented with vitamin B12 injections and oral folic acid, or docetaxel (75 mg/m2 IV) on day 1 of 21-day cycles.

This exploratory analysis compares overall survival time between two subgroups of pts on docetaxel therapy, those with and without patient reported vitamin supplementation, to evaluate the potential effect of supplementation on survival.

In addition, a second analysis compared the survival of supplemented docetaxel pts with those treated with pemetrexed. Methods: Survival analyses were performed using the Kaplan-Meier method in all the subsets of pts.

Results: Although not required by the protocol, 82 pts in the docetaxel arm reported receiving folic acid and/or vitamin B12 as concomitant medication while on study and were included in this analysis. Baseline characteristics were well-balanced between the docetaxel subgroups with the exception of Stage and ECOG performance status (PS).

Conclusions: In the original study, overall survival was similar for both treatment arms. In this evaluation, these results provide no evidence that the overall survival in docetaxel treated pts is influenced by vitamin supplementation status.

It does not appear that the survival result observed between pemetrexed and docetaxel would have been affected if all pts in the docetaxel arm had been supplemented with folic acid and B12.

Abstract No: 7131

Ann's NOTE:

This study saddens me so much. ( "82 pts in the docetaxel arm reported receiving folic acid and/or vitamin B12 as concomitant medication while on study")

What I see here are Stage III patients so needy for nutritional and dietary supplement information, advice and recommendation. If more mainstream doctors would only learn about this area OR recommend their patients consult those who do know, perhaps survival could be impacted.

We don't know because the randomized controlled trials that 'science' calls for have never been done. It is not because patients are not interested. Remember studies continue to show 60-80% of us are very interested in complementary/alternative modalities.

But studying the field this piecemeanl way, it will never work out properly for the patient population. We need to look at a complete healthy lifestyle as the base for treatment. What if people took all the important dietary supplements and then commenced chemotherapy?

We have some inkling of the value of this. At NY Presbyterian Hospital, children who have more antioxidants in their system fare better during treatment. Can't we explore this?

The value to patients is much higher than to the pharmaceutical industry. That seems to matter. Money talks in case you did not know.

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