Friday, June 9, 2006
LMWH in advanced cancer patients; International pain policy fellowship
1)
The current Mayo Clinic Proceedings has a prospective trial about using low molecular weight heparin (in this case dalteparin) in patients with advanced cancer, to see whether it improves survival. This is a topic that's been discussed before on the blog (should 'palliative' patients receive LMWH to prevent thromboembolic events?), and I'll refer readers to prior posts for some of my thoughts about this (see here & here).
The trial was supposed to be a randomized, placebo-injection controlled trial involving advance cancer patients ("advanced" lung or colorectal cancer or advanced breast/prostate cancer patients who had 'failed' first line chemotherapy). Some were receiving chemotherapy. All had ECOGs of 0-2, and no recent history of thromboembolism. They had trouble recruiting patients and so midway through changed the randomized-to-placebo arm to a randomized-to-usual-care arm as they assumed their accrual problems were due to people not wanting placebo/saline injections. They ended up with data on 138 patients (which remained substantially below their goal, ie--the study was under-powered to detect a benefit). The median survival of the group as a whole appears to be about 8 months (this is me eyeballing the multiple Kaplan-Meier curves as the authors don't present this number anywhere), and there was no significant difference in survival between the groups. The authors performed multiple analyses (blinded LMWH vs blinded placebo, unblinded LMWH vs usual care, all LMWH vs all non-LMWH, etc) as well as looked at only those who lived longer than 6 months and, again, found no differences to speak of. Toxicities between groups were similar.
Referring back to the the discussions/posts I mentioned before, I'll reiterate that there remains zero evidence that so-called palliative patients benefit from LMWH, and all the evidence--as poor as it is--points to the fact that they don't benefit. The patients in this study were presumably healthier than most patients cared for in palliative care (whether in hospice, or in palliative units, or by palliative care consultants), and chances are that for a sicker population it would be even more difficult to demonstrate benefit--if one existed--because the mortality rates would be so high anyway. But, frankly, there's not much to guide us besides troubled research like the above.
2)
The Soros Foundation/Open Society Institute has announced an international pain policy fellowship. It is aimed at helping people improve access to pain meds & palliative care abroad, and is coordinated by the good people up the road from me in Madison. The deadline for applications is June 16th (oops).
The trial was supposed to be a randomized, placebo-injection controlled trial involving advance cancer patients ("advanced" lung or colorectal cancer or advanced breast/prostate cancer patients who had 'failed' first line chemotherapy). Some were receiving chemotherapy. All had ECOGs of 0-2, and no recent history of thromboembolism. They had trouble recruiting patients and so midway through changed the randomized-to-placebo arm to a randomized-to-usual-care arm as they assumed their accrual problems were due to people not wanting placebo/saline injections. They ended up with data on 138 patients (which remained substantially below their goal, ie--the study was under-powered to detect a benefit). The median survival of the group as a whole appears to be about 8 months (this is me eyeballing the multiple Kaplan-Meier curves as the authors don't present this number anywhere), and there was no significant difference in survival between the groups. The authors performed multiple analyses (blinded LMWH vs blinded placebo, unblinded LMWH vs usual care, all LMWH vs all non-LMWH, etc) as well as looked at only those who lived longer than 6 months and, again, found no differences to speak of. Toxicities between groups were similar.
Referring back to the the discussions/posts I mentioned before, I'll reiterate that there remains zero evidence that so-called palliative patients benefit from LMWH, and all the evidence--as poor as it is--points to the fact that they don't benefit. The patients in this study were presumably healthier than most patients cared for in palliative care (whether in hospice, or in palliative units, or by palliative care consultants), and chances are that for a sicker population it would be even more difficult to demonstrate benefit--if one existed--because the mortality rates would be so high anyway. But, frankly, there's not much to guide us besides troubled research like the above.
2)
The Soros Foundation/Open Society Institute has announced an international pain policy fellowship. It is aimed at helping people improve access to pain meds & palliative care abroad, and is coordinated by the good people up the road from me in Madison. The deadline for applications is June 16th (oops).
