NET εντέρου Τι νεότερο/ Νέες μελέτες. Μαντώ Νικολαΐδη παθολόγος-ογκολόγος ΜΗΤΕΡΑ

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1 NET εντέρου Τι νεότερο/ Νέες μελέτες Μαντώ Νικολαΐδη παθολόγος-ογκολόγος ΜΗΤΕΡΑ

2 NET: A Diverse Group of Malignancies 1-3 Wide spectrum of malignancies arising in neuroendocrine cells throughout the body 1 pnet (formerly called islet cell tumors) Functional a (<10%) 4 Gastrinoma Insulinoma Glucagonoma VIPoma Somatostatinoma Pancreatic polypeptidoma Nonfunctional a (<90%) 4 a A consensus definition of functional vs nonfunctional pnet does not exist. 5 Estimates of frequency vary widely. Other NET (also referred to as carcinoid tumors) Foregut Lung Stomach Duodenum Thymus Midgut Jejunum Ileum Transverse, right colon Appendix Hindgut Left, sigmoid colon Rectum Additional sites Ovary Medullary thyroid carcinoma Adrenal medulla Paraganglia 1. Yao JC et al. J Clin Oncol. 2008;26: NCCN Clinical Practice Guidelines in Oncology. Neuroendocrine Tumors. Version Available at: Accessed January, Ramage JK et al. Gut. 2005;54(suppl IV):iv1- iv Pavel M et al. Neuroendocrinology. 2016;103: Halfdanarson TR et al. Endocr Relat Cancer. 2008;15: NCCN, National Comprehensive Cancer Network; NET, neuroendocrine tumors; pnet, pancreatic neuroendocrine tumors; VIPoma, vasoactive intestinal polypeptide-secreting tumors.

3 Broad range of treatment options for NET 1,2,3 Surgery Resection of primary tumor Cytoreductive surgery of unresectable tumor Curative (rarely), ablative (very often) Medical therapy Somatostatin analogs (SSAs) Interferon-alfa Targeted therapies mtor inhibitors VEGFR inhibitors other TKIs Chemotherapy Debulking / locoregional therapy Radiofrequency ablation (RFA) Embolization / chemoembolization / radioembolization Nuclear medicine and irradiation Tumor-targeted, radioactive therapy: PRRT using e.g. MIBG 90 Y-DOTATOC 177 Lu-DOTATATE External irradiation (for bone-, brainmetastases) Brachytherapy (for liver metastases) Personalized treatment required 1. ENETS consensus guidelines for the management of NET. 2. Neuroendocrinology. 2012;95: NCCN Clinical Practice Guidelines in Oncology. Neuroendocrine Tumors. Version Available at: Accessed January, MIBG, meta iodobenzylguanidine; mtor, mammalian target of rapamycin; PRRT, peptide-receptor radiotherapy; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptor.

4 RANDOMIZATION (1:1) PROMID: Evaluation of the antiproliferative effect of octreotide LAR Phase III randomized, double-blind, placebo-controlled study Primary endpoint: TTP: Time to Tumor Progression (blinded central review) Secondary endpoints: objective response rate, OS, quality of life, safety Patients with midgut NETs Treatment-naïve Histologically confirmed Locally inoperable or metastatic Well-differentiated Measurable (CT/MRI) Functioning or nonfunctioning Octreotide LAR 30 mg im every 28 days (42 pts) Placebo im every 28 days (43 pts) Treatment until CT/MRI documented tumour progression or death Month Rinke et al. J Clin Oncol. 2009; 27:

5 PROMID: Octreotide LAR 30 mg significantly extends TTP compared to placebo 66% reduction in the risk of tumor progression 1 HR=0.34; 95% CI: ; P= TTP, time to progression; HR, hazard ratio; CI, confidence interval. 1. Rinke A et al. J Clin Oncol. 2009; 27: Reprinted with permission of Journal of Clinical Oncology.

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15 RADIANT-2: Everolimus and Octreotide LAR Combination Therapy Patients with advanced NET and a history of secretory symptoms (N = 429; pnet, n = 26) Advanced low- or intermediate-grade NET Measurable disease per RECIST 1.0 Radiologic progression 12 months History of secretory symptoms (flushing, diarrhea) Prior antitumor therapy allowed R A N D O M I Z E 1:1 Everolimus 10 mg/day + octreotide LAR depot 30 mg/28 days n = 216 Crossover at time of disease progression Placebo + octreotide LAR depot 30 mg/28 days n = 213 Treatment until disease progression WHO PS 2 Multiphasic CT or MRI performed every 12 weeks Primary end points PFS (RECIST 1.0) by central review Secondary end points Tumor response, OS, biomarkers, safety, PK Pavel ME et al. Lancet. 2011;378:

16 RADIANT-2: Baseline Demographics & Disease Characteristics Imbalances in favor of placebo plus octreotide LAR arm Everolimus + Octreotide LAR n = 216 Placebo + Octreotide LAR n = 213 Median age, years (range) 60 (22-83) 60 (27-81) Male/female sex, n (%) 97(45)/ 119 (55) 124 (58)/ 89 (42) WHO PS, n (%) (55) 140 (66) 1 / 2 84 (39)/ 14 (6) 62 (29)/ 10 (5) Primary site of cancer Small intestine 111 (51) 113 (53) Lung 33 (15) 11 (5) Colon 14 (6) 14 (7) Pancreas 11 (5) 15 (7) Liver 7 (3) 11 (5) Other/ Missing 40 (19)/ 0 (0) 48 (23)/ 1 (0.5) *Data missing for one patent in the placebo-octreotide LAR group. Pavel M, et al. Lancet. 2011;378(9808):

17 RADIANT-2 subgroups: PFS per Central Radiology Review in Patients with Primary Colorectal NET Colorectal NET 1 1. Castellano D et al. The Oncologist. 2013;18:46 53; 2. Fazio N, et al. Chest. 2013;143:955-62

18 RADIANT-4 Study Design 1 Patients with welldifferentiated (G1/G2), advanced, progressive, nonfunctional NET of lung or GI origin (N = 302) Absence of active or any history of carcinoid syndrome Pathologically confirmed advanced disease R A N D O M I Z E 2:1 Everolimus 10 mg/day N = 205 Placebo N = 97 Treated until PD, intolerable AE, or consent withdrawal Enrolled within 6 months from radiologic progression Endpoints: Primary: PFS (central) Key Secondary: OS Secondary: ORR, DCR, safety, HRQoL (FACT-G), WHO PS, NSE/CgA, PK Stratified by: Prior SSA treatment (yes vs. no) Tumor origin (stratum A vs. B)* WHO PS (0 vs. 1) *Based on prognostic level, grouped as: Stratum A (better prognosis) appendix, caecum, jejunum, ileum, duodenum, and NET of unknown primary. Stratum B (worse prognosis) lung, stomach, rectum, and colon except caecum. Crossover to open label everolimus after progression in the placebo arm was not allowed prior to the primary analysis. 1. Yao JC et al. Lancet. 2016;387:

19 Probability of Progression-free Survival (%) RADIANT-4: PFS by Central Review Primary Endpoint 52% reduction in the relative risk of progression or death with everolimus vs placebo HR = 0.48 (95% CI, ); P < Kaplan-Meier medians Everolimus: 11.0 months (95% CI, ) Placebo: 3.9 months (95% CI, ) Everolimus Placebo Censoring Times Everolimus (n/n = 113/205) Placebo (n/n = 65/97) No.of patients still at risk Months P-value is obtained from the stratified one-sided log-rank test; Hazard ratio is obtained from stratified Cox model. 1. Yao JC et al. Lancet. 2016;387:

20 RADIANT-4: Consistent PFS HR by Stratification Factors Central Review Subgroups No. Hazard Ratio (95% CI) Prior SSA treatment Yes No Tumor origin* Stratum A Stratum B WHO PS ( ) 0.60 ( ) 0.63 ( ) 0.43 ( ) 0.58 ( ) 0.50 ( ) Everolimus Better Placebo Better *Based on prognostic level, grouped as: Stratum A (better prognosis) - appendix, caecum, jejunum, ileum, duodenum, and NET of unknown primary). Stratum B (worse prognosis) - lung, stomach, rectum, and colon except caecum). Hazard ratio obtained from unstratified Cox model. NET, neuroendocrine tumors; SSA, somatostatin analogues; WHO PS, World Health Organization performance status. 1. Yao JC et al. Lancet. 2016;387:

21 Primary tumor origin RADIANT-4: PFS Treatment Effect by Primary Tumor Per Central Review PFS events Hazard Ratio [95% CI] Everolimus n/n (%) Placebo n/n (%) Lung (N=90) 0.50 [ ] 42/63 (66.7) 18/27 (66.7) Stomach (N=11) 0.31 [ ] 3/7 (42.9) 4/4 (100) Rectum (N=40) 0.17 [ ] 21/25 (84.0) 14/15 (93.3) Ileum (N=71) 1.34 [ ] 22/47 (46.8) 11/24 (45.8) Jejunum (N=22) CUP (N=36) Other (N=32) Everolimus Placebo 4 5 In favor of All hazard ratios presented for these subgroup analyses were unstratified and unadjusted for any covariates [ ] 0.60 [ ] 0.38 [ ] 5/16 (31.3) 11/23 (47.8) 9/24 (37.5) 5/6 (83.3) 8/13 (61.5) 5/8 (62.5) Everolimus demonstrated a consistent positive treatment effect across multiple primary tumor locations In the ileum subgroup only 22 progression events were reported out of 47 patients in the everolimus arm vs 11 out of 24 patients in the placebo arm The better prognosis for the ileum subgroup in relation to the median duration of follow-up may have been insufficient to demonstrate the potential benefit of treatment 1. Singh S et al European Neuroendocrine Tumor Society (ENETS), Barcelona, Spain. Abstract L20 26

22 Probability of progression-free survival (%) Probability of progression-free survival (%) Everolimus Placebo RADIANT-4 subgroups: PFS HR by Primary tumor origin GI-NET and Unknown Primary (Central Review) Everolimus improved median PFS in both the GI and unknown primary subgroups GI Subgroup Kaplan-Meier medians Everolimus: months (95% CI, ) Placebo: 5.36 months (95% CI, ) HR (95% CI): 0.56 (0.37; 0.84) 1 Censoring Times Everolimus (n/n = 59/118) Placebo (n/n = 39/57) Time (Months) No. of patients still at risk Everolimus Placebo Unknown Primary Subgroup Kaplan-Meier medians Everolimus: months (95% CI, 4.14-NA) Placebo: 7.52 months (95% CI, ) HR (95% CI): 0.60 (0.24; 1.51) 1 Censoring Times Everolimus (n/n = 11/23) Placebo (n/n = 8/13) Time (Months) No. of patients still at risk This is a retrospective post-hoc analysis. Stomach, colon, rectum, appendix, caecum, ileum, duodenum, and jejunum are grouped under GI subgroup. The HRs in both subgroups are obtained from an unstratified Cox model. CI, confidence interval; GI, gastrointestinal; HR, hazard ratio; NET, neuroendocrine tumors; PFS, progression free survival 1. Singh S et al. Presented at ENETS 2016; Abstract L20.

23 NETTER 1: Phase III Study of 177 Lu-DOTATATE + Octreotide vs. High-Dose Octreotide in Advanced Midgut NET Study design Treatment and Assessments Tumor burden assessment (RECIST, v1.1 criteria) every 12 weeks Dose 1 Dose 2 Dose 3 Dose 4 Patients with inoperable, SSR positive, WD midgut NET progressive under octreotide LAR 30 mg n = 115 n = administrations of 7.4 GBq of 177 Lu-Dotatate every 8 weeks + octreotide LAR 30 mg Octreotide LAR 60 mg every 4 weeks 5 years of followup after LPFV Primary endpoint: PFS Secondary endpoints: ORR, OS, safety, safety profile and QoL Stratification: According to a. the highest tumor uptake score on somatostatin receptor scintigraphy, b. the length of time that a patient had been receiving a constant dose of octreotide ( 6 months or >6 months). RECIST, Response Evaluation Criteria in Solid Tumors, LAR, long-acting release; RECIST, response evaluation criteria in solid tumours; SSR, somatostatin receptor; WD, well differentiated; LPFV, Last Patient First Visit 1. Strosberg J et al. N Engl J Med. 2017;376:125-35

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25 PFS probability (%) NETTER-1: PFS in Midgut NET Kaplan-Meier medians 177 Lu-Dotatate + long-acting octreotide 30 mg a : not reached Long-acting octreotide 60 mg: 8.4 months Lu-Dotatate + long-acting octreotide 30 mg a Long-acting octreotide 60 mg Time (months) a Received 177 Lu-Dotatate at a dose of 7.4 GBq every 8 weeks (4 intravenous infusions plus best supportive care, including 30 mg long-acting octreotide). Figure from N Engl J Med. Strosberg J et al. Phase 3 Trial of 177 Lu-Dotatate for Midgut Neuroendocrine Tumors. 376: Copyright 2017 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. 30

26 NETTER-1: Safety Profile (1/2) Treatment-emergent AEs in 20% of patients treated with 177Lu- Dotatate (vs control [long-acting octreotide 60 mg]) Lu-Dotatate (n = 111) All Grades, % Grade 3/4, % Mean leukocyte, lymphocyte, platelet and neutrophil count decreased from baseline in patients treated with 177 Lu-Dotatate Octreotide LAR 60 mg (n = 110) All Grades, % Grade 3/4, % Nausea Vomiting Fatigue/asthenia Abdominal pain Diarrhea Musculoskeletal pain Strosberg J et al. N Engl J Med. 2017;376:

27 NETTER-1: QOL Global Health Status Treatment with 177 Lu-Dotatate is associated with improvement in QOL in QLQ-C30 Global Health Status No evidence of significantly decreased QOL with 177 Lu-Dotatate observed in any domain 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Oct Lu Week 12 Worsened No change Improved Oct Lu Oct Lu Oct Lu Oct Lu Oct Lu Week Week a 36 Week Week 48 a 60 Week 72 Lu, 177 Lu-Dotatate; Oct, octreotide; QLQ-C30, European Organization for Research and Treatment of Cancer quality of life questionnaire core 30. a Statistically significant difference between the arms at weeks 24 and 48. Figure reproduced with permission from Strosberg J et al. Presented at: 14th Annual European Neuroendocrine Tumor Society 2017 Conference; March 8-10, 2017; Barcelona, Spain. 32

28 Objective To provide additional OLE data on the effect of telotristat ethyl, compared with placebo, on the incidence of treatment-emergent adverse events (TEAEs) and on u5-hiaa levels. Methods Study treatment and design Telotristat Etiprate for Carcinoid Syndrome Therapy (TELECAST) is a Phase 3, randomized, multicenter, parallel-group, double-blind, placebo-controlled study (ClinicalTrials.gov identifier: NCT , Figure 1). Efficacy and safety assessments Primary safety and efficacy endpoints were the incidence of TEAEs and percentage change from Baseline in 24-hour u5-hiaa levels at Week 12.3

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