NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate: Efficacy, Safety, QoL Results and Subgroup Analysis

Strosberg, J.; Wolin, Edward M.; Chasen, Beth; Kulke, Michael; Bushnell, David; Caplin, ME; Baum, R. P.; Kunz, Pamela L.; Hobday, Timothy J.; Hendifar, A.; Öberg, Kjell; Sierra, Maribel Lopera; Ruszniewski, Philippe; Krenning, Eric P.

doi:10.1530/endoabs.47.oc8

Cited by 8 publications

(14 citation statements)

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“…7 The final results of the NETTER-1 study group showed t-MN risk at 1.2% post 5 years of the last patient is randomized. 8 A slightly higher percentage of patients experienced t-MN after PRRT in two other studies, both of which combined PRRT with prior or concomitant chemotherapy. Of note, a much higher rate of t-MN (20%) was reported by Brieau et al in a limited series of 20 nonresectable NETs treated with 177 Lu-PPRT after heavy pretreatment with chemotherapy.…”

mentioning

confidence: 87%

Screening for Clonal Hematopoiesis for Mitigating the Risk of Hematopoietic Neoplasms after PRRT

Chandra

Kumar

2023

World J Nucl Med

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confidence: 87%

Screening for Clonal Hematopoiesis for Mitigating the Risk of Hematopoietic Neoplasms after PRRT

Chandra

Kumar

2023

World J Nucl Med

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“…This strategy is allowed within international standards and is used when the intention is to more closely reflect the patient experience while receiving protocol therapy. 16,[33][34][35] However, it can also introduce a dependency between assessment of QOL and the patient's clinical course based on missing data, because PRO assessments were no longer required after therapy was discontinued. In part for this reason, more patients in the ipilimumab/HDI arm did not complete QOL assessments, resulting in the potential for noncompatibility of the 2 treatment arms.…”

Section: Limitationsmentioning

confidence: 99%

Effectiveness of Adjuvant Pembrolizumab vs High-Dose Interferon or Ipilimumab for Quality-of-Life Outcomes in Patients With Resected Melanoma

et al. 2023

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ImportanceA key issue for the adjuvant treatment of patients with melanoma is the assessment of the effect of treatment on relapse, survival, and quality of life (QOL).ObjectiveTo compare QOL in patients with resected melanoma at high risk for relapse who were treated with adjuvant pembrolizumab vs standard of care with either ipilimumab or high-dose interferon α 2b (HDI).Design, Setting, and ParticipantsThe S1404 phase 3 randomized clinical trial was conducted by the SWOG Cancer Research Network at 211 community/academic sites in the US, Canada, and Ireland. Patients were enrolled from December 2015 to October 2017. Data analysis for this QOL substudy was completed in March 2022. Overall, 832 patients were evaluable for the primary QOL end point.InterventionsPatients were randomized (1:1) to treatment with adjuvant pembrolizumab vs standard of care with ipilimumab/HDI.Main Outcomes and MeasuresQuality of life was assessed for patients at baseline and cycles 1, 3, 5, 7, and 9 after randomization using the Functional Assessment of Cancer Therapy (FACT) Biological Response Modifiers (FACT-BRM), FACT-General, Functional Assessment of Chronic Illness Therapy–Diarrhea, and European QOL 5-Dimension 3-Level scales. The primary end point was the comparison by arm of cycle 3 FACT-BRM trial outcome index (TOI) scores using linear regression. Linear-mixed models were used to evaluate QOL scores over time. Regression analyses included adjustments for the baseline score, disease stage, and programmed cell death ligand 1 status. A clinically meaningful difference of 5 points was targeted.ResultsAmong 1303 eligible patients (median [range] age, 56.7 [18.3-86.0] years; 524 women [40.2%]; 779 men [59.8%]; 10 Asian [0.8%], 7 Black [0.5%], 44 Hispanic [3.4%], and 1243 White [95.4%] individuals), 1188 (91.1%) had baseline FACT-BRM TOI scores, and 832 were evaluable at cycle 3 (ipilimumab/HDI = 267 [32.1%]; pembrolizumab = 565 [67.9%]). Evaluable patients were predominantly younger than 65 years (623 [74.9%]) and male (779 [58.9%]). Estimates of FACT-BRM TOI cycle 3 compliance did not differ by arm (ipilimumab/HDI, 96.0% vs pembrolizumab, 98.3%; P = .25). The adjusted cycle 3 FACT-BRM TOI score was 9.6 points (95% CI, 7.9-11.3; P &lt; .001) higher (better QOL) for pembrolizumab compared with ipilimumab/HDI, exceeding the prespecified clinically meaningful difference. In linear-mixed models, differences by arm exceeded 5 points in favor of pembrolizumab through cycle 7. In post hoc analyses, FACT-BRM TOI scores favored the pembrolizumab arm compared with the subset of patients receiving ipilimumab (difference, 6.0 points; 95% CI, 4.1-7.8; P &lt; .001) or HDI (difference, 17.0 points; 95% CI, 14.6-19.4; P &lt; .001).Conclusions and RelevanceThis secondary analysis of a phase 3 randomized clinical trial found that adjuvant pembrolizumab improved QOL vs treatment with adjuvant ipilimumab or HDI in patients with high-risk resected melanoma.Trial RegistrationClinicalTrials.gov identifier: NCT02506153

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“…The efficacy of [ 177 Lu]-DOTATATE (Lutathera), a conjugate consisting of octreotate radiolabelled with 177 Lu, has been evaluated in patients with advanced midgut NET in the NETTER-1 Phase III study (Strosberg et al 2016 (Strosberg et al 2016). Longer follow-up will better determine the impact of [ 177 Lu]-DOTATATE on overall survival.…”

Section: Peptide Receptor Radionuclide Therapy In Netmentioning

confidence: 99%

Somatostatin analogues in acromegaly and gastroenteropancreatic neuroendocrine tumours: past, present and future

Öberg¹,

Lamberts²

2016

Endocrine-Related Cancer

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Acromegaly is a hormonal disorder that arises when the pituitary gland secretes excess growth hormone (GH), which in turn stimulates a concomitant increase in serum insulin-like growth factor 1 (IGF-1) levels. Gastroenteropancreatic neuroendocrine tumours (GEP-NET) constitute a heterogeneous group of tumours that can secrete serotonin and a variety of peptide hormones that may cause characteristic symptoms known as carcinoid syndrome or other symptoms and hormonal hypersecretion syndromes depending on the tumour's site of origin. Current medical therapy for the treatment of acromegaly and GEP-NET involves the administration of somatostatin analogues that effectively suppress excess hormone secretion. After its discovery in 1979, octreotide became the first synthetic biologically stable somatostatin analogue with a short-acting formulation of octreotide introduced into clinical practice in the late 1980s. Lanreotide, another somatostatin analogue, became available in the mid-1990s initially as a prolonged-release formulation administered every 10 or 14 days. Long-acting release formulations of both octreotide (Sandostatin LAR and Novartis) and lanreotide (Somatuline Autogel, Ipsen), based on microparticle and nanoparticle drug-delivery technologies, respectively, were later developed, which allowed for once-monthly administration and improved convenience. First-generation somatostatin analogues remain one of the cornerstones of medical therapy in the management of pituitary and GEP-NET hormone hypersecretion, with octreotide having the longest established efficacy and safety profile of the somatostatin analogue class. More recently, pasireotide (Signifor), a next-generation multireceptor-targeted somatostatin analogue, has emerged as an alternative therapeutic option for the treatment of acromegaly. This review summarizes the development and clinical success of somatostatin analogues.

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NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate: Efficacy, Safety, QoL Results and Subgroup Analysis

Cited by 8 publications

References 0 publications

Screening for Clonal Hematopoiesis for Mitigating the Risk of Hematopoietic Neoplasms after PRRT

Screening for Clonal Hematopoiesis for Mitigating the Risk of Hematopoietic Neoplasms after PRRT

Effectiveness of Adjuvant Pembrolizumab vs High-Dose Interferon or Ipilimumab for Quality-of-Life Outcomes in Patients With Resected Melanoma

Somatostatin analogues in acromegaly and gastroenteropancreatic neuroendocrine tumours: past, present and future

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