Results Summary
Patients treated at the Lentz Practice almost all suffer from late-stage metastatic cancer. Most of these patients have already failed standard of care and are immune compromised as a result. One would expect little to no clinical improvement in response to any treatment modality with patients as sick as these.It is thus all the more remarkable that for the 10 cancer types that respond best† to Immune Pheresis, the Overall Response Rate (ORR) is 75.4% (average N per cancer type = 6.9). “Overall Responses” consist exclusively of Complete Responses (CR) – i.e. remission – and Partial Responses (PR) – meaning a decrease of tumor diameters of 50% or more, which is clinically very significant. Of the above Overall Responses, 42.3% were CRs and 57.7% were PRs. For the top five cancer types†† that respond best to Immune Pheresis, the ORR is 100%. Considering all 102 evaluable patients treated by Immune Pheresis – representing 25+ solid tumor cancer types – Overall Responses have been documented in 61 cases (60%).
The leading theory as to why some patients with certain metastatic cancer types respond better to Immune Pheresis than others is that the more responsive patients have generally received less immuno-suppressive treatment – especially chemotherapy – before reaching the Lentz Practice. However, even these lower observed responses significantly exceed what would be expected with other treatment modalities.
In our patient population, most of whom have failed extensive prior therapies and are immune compromised as a result, we have documented major responses (CR/PR) in 49 of 80 cases (61%), with entirely late-stage metastatic cancers. Responses by cancer type are:
| Cancer Type | Overall Response Rate (CR+PR) | CBR | ||
|---|---|---|---|---|
| [all late stage metastatic] | # of ORs | Total N | % | % |
| Brain | 3 | 3 | 100% | 100% |
| Breast | 20 | 27 | 74% | 100% |
| Endometrial | 1 | 1 | 100% | 100% |
| Lung (various) | 6 | 13 | 46% | 100% |
| Melanoma | 2 | 3 | 67% | 100% |
| Ovarian | 3 | 4 | 75% | 100% |
| Prostate | 8 | 8 | 100% | 100% |
| Renal | 1 | 1 | 100% | 100% |
| Sarcoma/soft-tissue (various) | 6 | 7 | 86% | 100% |
| Sq-cell of head & neck | 2 | 2 | 100% | 100% |
These data suggest that the response rates are indeed significant, but the N’s are too small to draw firm conclusions, and further research is therefore indicated.
The expected response rate to third and fourth line chemotherapies is <10% for breast and ovarian cancer, and <3% for soft tissue sarcomas, brain, melanoma, non-small cell lung, colo-rectal and prostate. Clinical responses in late stage cancer patients treated by Immune Pheresis far exceed those of patients treated by chemotherapy, even without considering side effects – which are much more serious with most chemotherapies than Immune Pheresis.
We look forward to collecting efficacy data on a larger scale via planned clinical trials to determine the precise response rates for each tumor type, time to disease progression (with and without annual maintenance treatments), duration of survival and impact on quality of life. However, today we are pleased and encouraged by the results documented thus far with this purely immunologic treatment for cancer.
These data suggest that response rates to Immune Pheresis are indeed significant, but the N’s for some cancer types are too small to draw firm conclusions, and further research is therefore indicated. Additional trials are currently being planned to determine precise response rates by tumor type; time to disease progression (with and without regular maintenance treatments); duration of survival and quality of life while on treatment.
Definitions:
- CR – Complete Response: Disappearance of all measurable disease, i.e. “remission”
- PR – Partial Response: Decrease in diameters of tumors by 50% or more *
- MR – Minimal Response: Decrease in diameters of tumors by 25- 49%
- SD – Stable Disease: No increase – or decrease in diameters of tumors by <25% – while on treatment or 30 days post treatment
- PD – Progressive Disease: An increase in diameters of tumors during study or 30 days post treatment
- ORR – Overall Response Rate: The sum of the first 2 response rates above, i.e. CR+PR
- CBR – Clinical Benefit Rate: The sum of the first 4 response rates above, i.e. CR+PR+MR+SD
* All measurements are the sum of products of greatest diameters of measurable tumors.
† The 10 metastatic cancer types treated by Immune Pheresis with the highest documented ORR are Brain, Breast, Endometrial, Lung, Melanoma, Ovarian, Prostate, Renal, Soft-tissue Sarcomas, and Squamous cell of the head & neck. (Brain cancer – consisting of Astrocytoma II & Glioblastoma Multiforme – is included on this list although not metastatic.)
†† The top five responding metastatic cancer types – each with an ORR of 100% – are Brain, Endometrial, Prostate, Renal, and Squamous cell of the head & neck.