Pleo:
You are quite sanguine about this stock and the company's products. You did not address the issue I raised, which is that while the presence of undifferentiated cells in a tumor might provide a theory of why hyperthermia might be effective, or more effective than other treatments, it is only a theory, and is beside the point when the issue is actual effectiveness.
It might be good if you perceived why few doctors have yet been sold on this technology.
I would categorize the studies completed so far as small in number and small in scope, as shown by the studies listed on the URL you provided:
Such as "a retrospective analysis of 23 patients with advanced or metastatic pancreatic cancer who had relapsed after first-line chemotherapy treatment." Very small, very small. Not a blind study.
"In order to acquire additional data, the researchers are currently conducting a multicenter randomized Phase III study on the use of gemcitabine and cisplatin combined with hyperthermia compared to gemcitabine alone to treat postoperative pancreatic cancer. The study, which will accrue 332 patients, . . ." Better, but not yet done.
"Two randomized studies have demonstrated that radiotherapy combined with chemotherapy and deep hyperthermia can improve response, local control and survival rates in certain patients with rectal cancer. Berdov et al. ("Thermoradiotherapy of patients with locally advanced carcinoma of the rectum." Int J Hyperthermia. 1990) reported on 115 patients with rectal cancer who received radiotherapy alone (n=59) and radiotherapy combined with hyperthermia (n=56). Complete and partial remission rates (16% vs. 2% and 54% vs. 34%; P<0.05) as well as overall survival rates at five years (36% vs. 7%; P<0.05) were significantly improved in the hyperthermia group. Rau et al. ("Stellenwert der Hyperthermie für die chirurgische Onkologie." Viszeralchirurgie 2002) reported on a randomized trial with 137 patients with rectal cancer who were treated with neoadjuvant radiochemotherapy combined with (n=69) or without (n=68) hyperthermia. Response (complete and partial remission rates) was significantly better for the hyperthermia group (66% vs. 49%; P<0.05). Time to progression at three years was also better for the hyperthermia group (66% vs. 49%; P<0.05)." Not bad, but rather old, and not the current treatments available which supposedly are better. I suspect this study is perceived as an outlier. Otherwise why would it not now be the standard of care to provided the combined treatment?
" Hyperthermia was added to standard preoperative radiochemotherapy (combined radiotherapy and chemotherapy) for 61 patients, and results were retrospectively compared to 45 patients with locally advanced rectal cancer who were treated with standard preoperative radiochemotherapy alone."
Again, small study.
There is also the matter of negative findings. Companies have been known not to publish negative findings.
And none of this is for hyperthermia only. Studies are usually of hyperthermia combined with other treatments, possibly for perceived ethical issues. But that means you do not get a pure look at hyperthermia.
There is a reason why large phase III studies are considered the gold standard, and so far it seems there are none. A fan of BSDM might hope that smaller studies end up providing extraordinary data that will shoot BSDM ahead, or that word of mouth about great success with the current machines will spread out, but more typically things go pretty slow. Cancer is a tough adversary. |
