tag:blogger.com,1999:blog-816984413639798719.post1686504691100553485..comments2015-05-03T09:28:44.523-07:00Comments on Melanoma Patient Network Europe: Dying for evidence- no thank you.Bettinahttp://www.blogger.com/profile/02103075738345492061noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-816984413639798719.post-308766516548435772015-05-03T09:28:44.523-07:002015-05-03T09:28:44.523-07:00For further background a quick overview on Nivolum...For further background a quick overview on Nivolumab, the drug mentioned in the article above, as the most striking but otherwise sadly typical example for recent Melanoma trials, from Wikipedia, please note the original scientific references are on the bottom of the Wiki page:<br /><br />Wkipedia<br />…..<br />Clinical trial results[edit]<br />Metastatic melanoma[edit]<br />A phase 1 dose-optimization trial of nivolumab was performed in people with melanoma, lung cancer, kidney cancer, and other cancers. Among the 107 melanoma patients in this trial, nivolumab demonstrated one-, two-year and three year survival rates of 62%, 48%, and 41%. Toxicities, which were not cumulative and which mostly occurred during the first 6 months of therapy, included pneumonitis, low grade fatigue, diarrhea, pruritus, nausea, and decreased appetite. Pneumonitis was the most important adverse effect, leading to 3 deaths. Twenty-two percent of people in the trial experienced a treatment-related Grade 3 or Grade 4 toxicity.[5][6]<br /><br />A second phase 1 trial examined combination treatment of metastatic melanoma with nivolumab plus ipilimumab. Among 53 people treated concurrently with the highest dose (1 mg/kg nivolumab and 3 mg/kg ipilimumab), 53% had an objective response, all of whom saw their tumors shrink by 80% or more. An updated report from this trial, including an additional 41 people treated with the highest dose, stated that 79% were still alive after 2 years.[7]<br /><br />In a phase 3 trial comparing nivolumab monotherapy to treatment with traditional chemotherapy, nivolumab gave superior results in terms of response rate (40% vs. 13.9%), progression-free survival (5.1 months vs. 2.2 months), and the percentage of people still alive after one year (72.1% vs. 42.1%). Nivolumab received FDA approval for the treatment of melanoma in December 2014.[8]<br /><br />source:<br />http://en.wikipedia.org/wiki/Nivolumab<br /><br /><br />Certainly, if we already see a 1 year OS benefit of that order of magnitude <br />(62%!!!) in a Phase 1 trial population that tends to be heavily pre-treated, we should come up with something better than a final Phase 3 comparing to DTIC. Which, apart from its evidence-based lack of efficiency in Melanoma, is an ill-chosen comparator considering its entirely different mode of action and the availability of two other immune therapies, namely CTL4 and a different PD1 antibody.<br /><br /><br /><br /> Bettinahttps://www.blogger.com/profile/02103075738345492061noreply@blogger.comtag:blogger.com,1999:blog-816984413639798719.post-71046923707571250772015-05-02T07:53:26.863-07:002015-05-02T07:53:26.863-07:00Lori Murdock is one such patient : she has agreed ...Lori Murdock is one such patient : she has agreed to sacrifice herself on clinical trials many times and now she needs ground-braking treatment herself , the door is rapidly closing : Having failed Keytruda - Lori has been offered the chance of Tils in Manchester - unfortunately though the facilities and expertise are ready and waiting - the funding has not been agreed so Lori is trying to sell her family home to raise the money - but she has 12 days before her window of opportunity passes - there is a campaign of action to a) raise money for her treatment and b) petition the National Health Reimbursement to pay for TILs. WE know it works durably for some patients and bizarrely it is cheaper than the anti PD1s - this is a ridiculous state of affairs ... Please read the details and help if you can - the action will help all melanoma patients to have another option ..<br /><br />https://www.change.org/p/nhs-england-me ... ion-no_msg<br /><br />http://www.youcaring.com/medical-fundra ... g.commentsGilliosa SBhttps://www.blogger.com/profile/13173418485593589640noreply@blogger.comtag:blogger.com,1999:blog-816984413639798719.post-2708561678177436842015-05-02T07:29:15.230-07:002015-05-02T07:29:15.230-07:00To share with the entire world painfull moments of...To share with the entire world painfull moments of your live is a great gest of courage and sacrifice in my opinion. I know you did it because you want a CHANGE and not our tears.Still they will come together.. Is not only emphaty, is unconditional support. Because lots of us - we lived the same!Violeta Astratineihttps://www.blogger.com/profile/12687227276797631227noreply@blogger.com