\n| \n Chemotherapy<\/p>\n<\/td>\n | \n 155<\/p>\n<\/td>\n | \n 64.0 \u00b1 21.9<\/p>\n<\/td>\n | \n 108<\/p>\n<\/td>\n | \n 59.0 \u00b1 23.2<\/p>\n<\/td>\n | \n \u22129.1 (\u221212.9 t \u22125.4)<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n a P<\/em> = 0.01 versus chemotherapy.<\/p>\n<\/span>The KEYNOTE-006 Study<\/span><\/h2>\n<\/span>Effectiveness<\/span><\/h3>\n\n- The KEYNOTE-006 Phase III study showed higher<\/span> Overall and progression-free survival of pembrolizumab versus ipilimumab in patients with advanced melanoma.<\/li>\n
- 834 patients with advanced melanoma were enrolled and randomized to receive intravenous pembrolizumab every 2 weeks (n = 279), intravenous or every 3 weeks (n = 277), or intravenous ipilimumab every 3 weeks (n = 278).<\/li>\n
- The median follow-up was 22.9 months.<\/li>\n
- The estimated 6-month progression-free survival rates were 47.3% for patients receiving pembrolizumab every 2 weeks, 46.4% for those receiving pembrolizumab every 3 weeks, and 26.5% for those receiving ipilimumab.<\/li>\n
- Estimates of one-year overall survival were 74.1% for patients receiving pembrolizumab every 2 weeks (hazard ratio of death compared to ipilimumab group 0.63; 95% CI 0.47-0, 83; p <0.0005), 68.4% for those receiving pembrolizumab every 3 weeks (hazard ratio of death compared to ipilimumab group 0.69, 951 CITP1T 0.52 to 0.90; p = 0.0036) and 58.2% for those who received ipilimumab.<\/li>\n
- The overall survival rate at 24 months was 55% in the 2-week group, 55% in the 3-week group, and 43% in the ipilimumab group.<\/li>\n<\/ul>\n
<\/span>Quality of life related to health<\/span><\/h3>\n\n- The primary patient-related outcome assessment in KEYNOTE-006 was score change from baseline to week 12 in the EORTC QLQ-C30 GHS \/ HRQoL score between treatment arms, using restricted longitudinal data analysis.<\/li>\n
- From baseline to week 12, GHS \/ HRQoL scores were better maintained with pembrolizumab than with ipilimumab (decrease of \u22121.9 and \u22122.5 for pembrolizumab vs \u221210.0 for ipilimumab; p <0.001 for each arm of pembrolizumab vs ipilimumab; see Table 5).<\/li>\n
- Fewer pembrolizumab-treated patients experienced deterioration in GHS at week 12 (31% for pembrolizumab every 2 weeks; 29% for pembrolizumab every 3 weeks, and 44% for ipilimumab), with similar trends seen for individual functioning and symptom scales.<\/li>\n<\/ul>\n
Table 5. Change from baseline to week 12 in EORTC QLQ-C30 GHS score - KEYNOTE-006<\/strong><\/p>\n\n\n\n| Treatment<\/th>\n | north<\/th>\n | Base<\/th>\n | Week 12<\/th>\n | Change from baseline<\/th>\n<\/tr>\n | \n| Half of)<\/th>\n | north<\/th>\n | Half of)<\/th>\n | LS mean (CI 95%)<\/th>\n<\/tr>\n | \n| Pembrolizumab 10 mg \/ kg Q2W<\/td>\n | 239<\/td>\n | 71,4 (20,4)<\/td>\n | 172<\/td>\n | 71,1 (19,3)<\/td>\n | \u22121.9 (\u22124.86 to 1.01)<\/td>\n<\/tr>\n | \n| Pembrolizumab 10 mg \/ kg Q3W<\/td>\n | 230<\/td>\n | 70,5 (21,9)<\/td>\n | 188<\/td>\n | 69,5 (22,3)<\/td>\n | \u22122.5 (\u22125.32 to 0.37)<\/td>\n<\/tr>\n | \n| Ipilimumab<\/td>\n | 213<\/td>\n | 67,4 (24,0)<\/td>\n | 149<\/td>\n | 64,3 (25,8)<\/td>\n | \u221210.0 (\u221213.16 to \u22126.85)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n CI, confidence interval; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; GHS, global health status; LS, least squares; Q2W, every 2 weeks; Q3W, every 3 weeks; SD, standard deviation<\/p>\n <\/span>Adverse events<\/span><\/h3>\n\n- In KEYNOTE-006, the most common treatment-related adverse events of any grade that occurred in the pembrolizumab groups were fatigue (20.9% in the 2-week group and 19.1% in the 3-week group), diarrhea (16.9% and 14.4%, respectively), skin rash (14.7% and 13.4%, respectively), and pruritus (14.4% and 14.1%, respectively).<\/li>\n
- For ipilimumab, the most common adverse events were pruritus (25.4%), diarrhea (22.7%), fatigue (15.2%), and rash (14.5%).<\/li>\n<\/ul>\n
<\/span>Conclusions<\/span><\/h2>\n\n- Results from the KEYNOTE-001, KEYSTONE-002 and KEYSTONE-006 Trials Establish Pembrolizumab as a New Standard of Care for Melanoma and Support Accelerated US FDA Approval for Pembrolizumab in Patients with unresectable or metastatic melanoma whose disease had progressed after ipilimumab and, if BRAF<\/em> V600 positive mutant, a BRAF inhibitor<\/span>.<\/li>\n
- HRQoL was better maintained with pembrolizumab than chemotherapy (KEYNOTE-002) or ipilimumab (KEYNOTE-006), further supporting the use of pembrolizumab in patients with melanoma refractory to ipilimumab.<\/li>\n
- Overall, the combination of long progression-free survival and overall survival, a lower incidence of high-grade toxicity, and a better HRQoL provided by pembrolizumab compared to ipilimumab or chemotherapy, supports the use of this drug as a standard of care for patients with advanced melanoma<\/li>\n<\/ul>\n\n
New Zealand approved data sheets are the official source of information for these prescription drugs, including approved uses and risk information. See the New Zealand individual data sheet on the Medsafe website.<\/span><\/em><\/div>\n<\/section>\n<\/div>\n<\/section>","protected":false},"excerpt":{"rendered":" Introducci\u00f3n Pembrolizumab (Keytruda\u00ae) es un humanizado altamente selectivo monoclonal anticuerpo dirigido contra la muerte celular programada 1 (PD-1) receptor en C\u00e9lulas T. El f\u00e1rmaco bloquea el receptor PD-1, evitando as\u00ed…<\/p>","protected":false},"author":8,"featured_media":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","format":"standard","meta":{"footnotes":""},"categories":[204],"tags":[],"class_list":["post-16576","wiki","type-wiki","status-publish","format-standard","category-glosario-definiciones"],"_links":{"self":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki\/16576","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki"}],"about":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/types\/wiki"}],"author":[{"embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/comments?post=16576"}],"version-history":[{"count":0,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/wiki\/16576\/revisions"}],"wp:attachment":[{"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/media?parent=16576"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/categories?post=16576"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/doctorhoogstra.com\/en\/wp-json\/wp\/v2\/tags?post=16576"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}} | |