Meta Analysis: A Simple Graph
Here is one reason I think the mPFS will be better than 4 months. Based on below, I'm thinking 7 months stat sig. at the very least
And remember: the original study was aiming for 6 months!
And mPFS is the primary endpoint.
And mPFS is not affected / confounded by a cross over trial.
Flipper found the reference of the meta-analysis of DC studies over 409 patients (21 studies in all I believe, not sure):
journals.plos.org
For my part, I believe that DC Vax-L will perform at least as well as those. Anyways, on the PFS, here is one heck of a quote:
" Our meta-analysis showed that DC immunotherapy benefits the PFS, which could be up to 50% at the 1.5-year mark. "
i.e. mPFS should be around 18 months for the Tx population.
Using section 3.3 and some linear interpolation (given the shape of the curves, good enough for me), I put together the following:
* a summary of the PFS numbers for the aggregate:
* Interpolation:
mPFS 8.8 months for Placebos (cannot be a year with 67 % PFS events at the one year mark!)
mPFS 19.2 months for DC!!
That's an over 10 months diff between Placebo and Tx!
* the corresponding graph
Here is the abstract of the meta-analysis:
Abstract
Background
The effectiveness of immunotherapy for high-grade glioma (HGG) patients remains controversial. To evaluate the therapeutic efficacy of dendritic cells (DCs) alone in the treatment of HGG, we performed a systematic review and meta-analysis in terms of patient survival with relevant published clinical studies.
Materials and methods
A total of 409 patients, including historical cohorts, nonrandomized and randomized controls with HGG, were selected for the meta-analysis.
Results
The treatment of HGG with DCs was associated with a significantly improved one-year survival (OS) (p<0.001) and 1.5-, 2-, 3-, 4-, and 5-year OS (p<0.001) compared with the non-DC group. A meta-analysis of the patient outcome data revealed that DC immunotherapy has a significant influence on progression-free survival (PFS) in HGG patients, who showed significantly improved 1-,1.5-, 2-, 3- and 4-year PFS (p<0.001). The analysis of Karnofsky performance status (KPS) demonstrated no favorable results for DC cell therapy arm (p?=?0.23).The percentages of CD3+CD8+ and CD3+CD4+ T cells and CD16+ lymphocyte subset were not significantly increased in the DC group compared with the baseline levels observed before treatment (p>0.05), whereas CD56+ lymphocyte subset were significantly increased after DC treatment (p?=?0.0001). Furthermore, the levels of IFN-? in the peripheral blood of HGG patients, which reflect the immune function of the patients, were significantly increased after DC immunotherapy (p<0.001).
Conclusions
Thus, our meta-analysis showed that DC immunotherapy markedly prolongs survival rates and progression-free time, enhances immune function, and improves the efficacy of the treatment of HGG patients.
siliconinvestor.com |
