Clin Cancer Res clincanres.1823.2011;
Published Online First January 23, 2012
Abstract
Purpose: Treatment with ipilimumab can cause objective tumor responses in patients with metastatic melanoma. We have treated 177 evaluable patients in three clinical trials and have long-term follow-up to evaluate the durability of responses. Patients and Methods: Patients with metastatic melanoma were treated in three trials from 2002 to 2005: In Protocol 1, fifty-six patients received ipilimumab with gp100 peptides. In Protocol 2, thirty-six patients received ipilimumab with interleukin-2. In Protocol 3, eighty-five patients received ipilimumab with intra-patient dose escalation and were randomized to receive gp100 peptides. We have analyzed their long-term follow-up and survival data. Results: With median follow-up for Protocols 1, 2, and 3 being 92, 84, and 71 months, median survival was 14, 16, and 13 months with five-year survival being 13%, 25%, and 23%, respectively. Patients in Protocol 2 had a 17% complete response (CR) rate, compared to 7% in Protocol 1 and 6% in Protocol 3. These CR rates are higher than previously reported for the same trials because some patients who eventually became CRs had continual tumor regression months to years after therapy. All but one of the 15 complete responders are ongoing at 54+ to 99+ months. Conclusions: This report provides the longest follow-up of melanoma patients treated with ipilimumab and shows that ipilimumab can induce durable, potentially curative tumor regression in a small percentage of patients with metastatic melanoma.
The combination of ipilimumab and IL-2 appears to have an increased (CR)Complete Response rate, but this needs to be tested in a randomized trial.
If you have been following me on Carepage and or Melanoma Missionary, we knew about this combination back in 2009. I have been pushing for this trial. I even wrote and posted an email to Dr. Steven A. Rosenberg on 3/29/2009 at NCI.
"To summarize, Timing and Doses of both Anti-CTLA-4 and IL-2 can have a major effect on the immune response outcome. If you follow the dosing and timing regime, I postulate that you will see a synergist outcome with this combination therapy."
Jimmy B ..3/29/2009
I have learned a lot through my researched and still believe that my systematic combination theory of Anti-CTLA-4 and IL-2 still holds water. In fact as we speak, I am reseaching the tumor's microenviroment to see how we can improve on this response rate. How the tumor operates in the neighborhood of cells. How it changes the neighborhood with Cytokines, Tregs and cell to cell contact. It is simular to having one bad apple in the basket and how it causes other bad apples.
And By adding Cancer Vaccines to this combination, I believe we can CURE Melanoma.
Best Regards,
Jimmy B
“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”
~Charles Darwin~
Take Care,
Jimmy B
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