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Limb melanoma is the main developing subsype of Asian melanoma, commonly found in the soles of the feet, palms and under the armor.
compared with skin melanoma, limb melanoma has relatively unique clinical pathological characteristics and genetic mutation characteristics, poor prognosis, higher risk of death, its immunotherapy is less efficient, there is no good treatment strategy.
recently, a study of carrely-pearl monoantigenated apatinist for advanced limb melanoma Phase II has yielded remarkable results and attracted widespread attention, which is a landmark study.
This is a forward-looking, one-armed, open Phase II clinical study in patients with pathologically confirmed ECOG 0/1, non-surgical stage III.iii.or phase IV.
study was objective mitigation rate (ORR), and secondary endpoint was PFS, DCR, 2-year OS rate and security.
patients received recombinant humanized anti-PD-1 monoclonal antibody injection (Karelli pearl monoanti) 200mg Q2W, apatinist 250mg Qd, 4 weeks for a cycle, until the disease progression or adverse reactions can not be todged.
2019, 30 cases were planned for the study, and 22 cases are currently in the group, with 1:1 for men and 58.5 years for women (29-74 years).
group were all patients with primary limb melanoma, and as of June 2020, 9 patients had been suspended (up to 118 days) due to the impact of the new crown outbreak.
Of the 19 patients evaluatable, 12 had tumor reduction, ORR 26.3% and DCR 78.9%;
The current patients are generally well-mmune, with common adverse events including liver damage (68.2%), skin reactions in the hands and feet (45.5%), abnormal lipid metabolism (40.9%), proteinuria (40.9%), hypertension (22.7%), and diarrhea (22.7%) 7%) and so on, mostly 1-2 levels, 3-4 levels of adverse events are mainly liver function impairment (18.2%, 4/22), proteinuria (9.0%, 2/22), plate plate plate reduction (4.5%, 1/22), no treatment related deaths.
For late-stage limb melanoma, Kareliju monoantigenated apatinib first-line treatment can achieve more obvious objective efficacy, adverse reactions can be toned, further efficacy and survival conditions to be studied in the follow-up results and related mechanisms.
Currently, a number of PD-1 monoantigen studies are under way in patients with Asian melanoma, but the common subtype of Asian melanoma is limb-end melanoma, whose immunotherapy is less than half of the population in Europe and the United States (of which the effective rate of kariliju single-drug second-line treatment of advanced melanoma is 13.9%), the combined treatment may be the direction of the subtype treatment strategy.
methadone tablets are small molecule angio endotrine growth factor inhibitors (VEGFR) tyrosine kinase inhibitors, pre-apatinib combined with motamine Phase II research suggests that the conventional treatment (including immunotherapy) failed advanced melanoma, combined small molecule anti-angiogenic drug apatinib still has considerable efficacy.
the researchers carried out the above-mentioned study.
the program has an efficiency of 26.3%, almost double the efficiency of single-drug PD-1 monoantigen, which is also the highest efficiency in the history of limb melanoma treatment.
is even more encouraging, the combined treatment programme has a shrinking rate of 63 per cent.
past, whether imported PD-1 monoantial or domestic PD-1 monoantial, limb melanoma shrink rate of only 25%, 63% compared to 25%, the difference is very significant.
Disease Control Rate (DCR), in the past, only 42% of DCR in PD-1 single-anti-treatment limb melanoma, while Apatini combined with Karelli pearl monoantigen DCR reached 78.9%, which is unprecedented in the history of limb melanoma treatment, can be called a landmark study in the history of limb-end melanoma.
the results of this study is of great significance to the treatment choices of Chinese patients.
sources: 1.Wei X, Wu D, Li H, et al. The Clinicopathological and Survival Profiles Comparison Across Primary Sites in Acral Melanoma. Ann Surg Oncol, 2020 Apr 6. doi: 10.1245/s10434-020-08418-5. 2. Wei X, Si L, Guo J. ASO Author Reflections: Primary Site Should Be Regarded as One Important Factor for Risk Stratification in Acral Melanoma. Ann Surg Oncol, 2020.Apr 4. doi: 10.1245/s10434-020-08420-x. 3. Zebary A, Omholt K, Vassilaki I, et al. KIT, NRAS, BRAF and PTEN mutations in a sample of Swedish patients with acral lentiginous melanoma. J Dermatol Sci, 2013. 4.Teramoto Y, Keim U, Gesierich A, et al. Acral lentiginous melanoma: a skin cancer with unfavourable prognostic features. A study of the German central malignant melanoma registry (CMMR) in 2050 patients . Br J Dermatol, 2018.