External Validation of a Clinical Score for Patients With Neuroendocrine Tumors Under Consideration for Peptide Receptor Radionuclide Therapy

Das, Satya; Chauhan, Aman; Du, Liping; Thomas, Katharine; Jacob, Aasems; Schad, Aimee; Jain, Shikha; Jessop, Aaron; Shah, Chirayu; Eisner, David; Cardin, Dana Backlund; Ciombor, Kristen K.; Goff, Laura Williams; Bradshaw, Marques L.; Delbeke, Dominique; Sandler, Martin P.; Ramirez, Robert A.; Berlin, Jordan

doi:10.1001/jamanetworkopen.2021.44170

Cited by 9 publications

(6 citation statements)

References 14 publications

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“…A review of patients from another tertiary center showed a progression-free survival of 21.6 months for the study group and 13.3 months for patients with pancreatic primary tumors [ 3 ]. A multi-center review of patients treated with 177 Lu-dotatate showed an objective response rate (18.7%) that was nearly identical to our findings [ 12 ]. We therefore confirm the reproducibility of these findings, which will be useful data to help design future prospective studies in pretreated populations.…”

Section: Discussionsupporting

confidence: 88%

Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience

Sukrithan,

Armbruster,

Rogers

et al. 2024

PLoS ONE

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Peptide receptor radionucleotide therapy (PRRT) with 177Lu-dotatate is widely used for the treatment of patients with neuroendocrine tumors (NETs). We analyzed data from 104 patients with NETs treated with 177Lu -dotatate at a US academic center between December 2017 and October 2020 to better understand patterns of long-term efficacy, safety, and toxicity in the real-world setting. 177Lu-dotatate (200 mCi) was administered every eight weeks for four doses. The most common sites of primary disease were small intestine NETs (n = 49, 47%), pancreatic NETs (n = 32, 31%), and lung NETs (n = 7, 7%). Twenty-seven percent had Ki-67 <3%, 49% had Ki-67 between 3–20%, and 13.5% had Ki-67 >20%. The cohort had been pretreated with a median of two prior lines of treatment. Forty percent had received prior liver-directed treatment. Seventy-four percent of patients completed all four doses of treatment. The objective response rate was 18%. The median time-to-treatment failure/death was significantly longer for small-bowel NETs when compared to pancreatic NETs (37.3 months vs. 13.2 months, p = 0.001). In a multivariate model, Ki-67, primary site, and liver tumor burden ≥50% were found to independently predict time-to-treatment failure/death. Around 40% of patients experienced adverse events of ≥grade 3 severity. Treatment-related adverse events leading to discontinuation of therapy happened in 10% of patients. Preexisting mesenteric/peritoneal disease was present in 33 patients; seven of these patients developed bowel-related toxicities including two grade 5 events. We also report two cases of delayed-onset minimal change nephrotic syndrome, which occurred 14 and 27 months after the last dose of PRRT. Lastly, we describe six patients who developed rapid tumor progression in the liver leading to terminal liver failure within 7.3 months from the start of PRRT, and identify potential risk factors associated with this occurrence, which will need further study.

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Section: Discussionsupporting

confidence: 88%

Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience

Sukrithan,

Armbruster,

Rogers

et al. 2024

PLoS ONE

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“… 38 In addition, recent retrospective studies have suggested that upfront PRRT after progression under SSA significantly improved PFS compared with upfront chemotherapy or targeted therapy in all NET, positioning PRRT earlier in the therapeutic sequence. 51 , 52 Other ongoing RCT such as Compete (NCT03049189) or Compose (NCT04919226), comparing PRRT with everolimus or chemotherapy, should help confirm these data.…”

Section: The Sequence Optionsmentioning

confidence: 99%

A practical proposal on treatment sequencing of metastatic well-differentiated neuroendocrine tumours

2023

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According to the neuroendocrine tumour (NET) characteristics, 3 to 7 different treatment options are available, corresponding to 6 to 5,040 theoretical different sequences. Even though each patient is unique and despite a large heterogeneity in NET characteristics, the present review aims to discuss the main sequences and addresses how one can propose the best sequence to treat metastatic NET (mNET) on a case-by-case basis. Each treatment must be discussed during dedicated multi-disciplinary meetings, and inclusions in clinical trials should be favoured. After a thorough characterization of patients and their mNET, and taking into account the availability of drugs, the first-line treatment should be chosen according to the treatment aim. The latter is determined based on three main topics (efficacy, safety, and patient preferences) that do not necessarily converge and must be defined a priori. At baseline, physicians should design an a priori full therapeutic sequence, which may evolve at each step depending on the response to previous treatment, the occurrence of chronic toxicities, and the patients’ perception of the prior treatment. To improve knowledge in terms of effectiveness and risk of cumulative toxicities regarding the different sequences, real-world data using long follow-up durations are necessary; such issues will not be resolved by randomized clinical trials.

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“… 52 Recent studies have also suggested that earlier incorporation of PRRT post-SSA may increase the anti-tumor benefit from the therapy patients derive. 56 The addition of everolimus to SSA therapy improves biochemical response among 61% of patients, incrementally better than the biochemical response rate of 54% among patients receiving SSA monotherapy. 53 The various liver embolization therapies generally achieve symptom reduction and biochemical response in 82% and 63% of patients, respectively.…”

Section: Gaps In Management Optionsmentioning

confidence: 99%

Carcinoid Heart Disease Management: A Multi-Disciplinary Collaboration

2023

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Carcinoid heart disease (CaHD) is an important complication among patients with metastatic neuroendocrine tumors and carcinoid syndrome (CS). CS patients (25%-65%) eventually develop CaHD; these patients face a significantly increased risk of morbidity and mortality. Guidance papers (eg, clinical practice guidelines, consensus guidelines, and expert statements) have been established by major organizations across the disciplines of cardiology and oncology; however, these recommendations are not routinely implemented. The aim of this article is to encourage the integration of current recommendations from national societies into clinical practice. Early screening upon recognition of CS and prior to the development of CaHD symptoms is paramount, as no existing therapies are approved to reverse the fibrotic damage to the heart once it occurs. Valvular replacement is the only definitive treatment for CaHD once it has developed. When patients are noted to have urinary 5-hydroxyindoleacetic acid (5-HIAA) levels ≥300 µmol/24 h and/or serum N-terminal pro B-type natriuretic peptide (NT-proBNP) levels >260 pg/mL, echocardiography is recommended. Systemic approaches to control tumor growth and hormonal secretion include somatostatin analogs (SSAs), followed by options including peptide receptor radiotherapy (PRRT), everolimus and liver embolization. Telotristat is the primary choice for control of diarrhea refractory to SSA. Diuretics are the mainstay of heart failure symptom management for patients who develop CaHD. Considerations for future research are discussed, including the ongoing TELEHEART (TELotristat Ethyl in a HEART biomarker study) trial involving telotristat and not yet activated CHARRT (Carcinoid Heart disease And peptide Receptor Radiotargetted Therapy) study involving PRRT with lutetium 177 (177Lu) dotatate.

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External Validation of a Clinical Score for Patients With Neuroendocrine Tumors Under Consideration for Peptide Receptor Radionuclide Therapy

Cited by 9 publications

References 14 publications

Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience

Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience

A practical proposal on treatment sequencing of metastatic well-differentiated neuroendocrine tumours

Carcinoid Heart Disease Management: A Multi-Disciplinary Collaboration

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