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Radiolabeled somatostatin analogues therapy in advanced neuroendocrine tumors: a single centre experience.

ABSTRACT: The aim of this study was to assess the efficacy of PRRT in patients with advanced neuroendocrine tumors (NETs). Patients and Methods. From January 2007 to August 2011, we enrolled 65 patients (m/f 38/27; mean age 65 years, range 33-83) with advanced NETs having enhanced SSTR expression, treated with PRRT. The enhanced expression of SSTR was assessed using (68)Ga-DOTATOC/DOTATATE PET/CT. Among all the enrolled patients, 6 of them were excluded from the present analysis since they voluntarily interrupted treatment. Mean activity/cycle of?2.6 GBq ((90)Y-DOTATOC/DOTATATE) or 6.0?GBq ((177)Lu-DOTATOC/DOTATATE) was administrated intravenously (max 9 cycles). Results. Complete response (CR) was found in 1/59 (2%) patients, partial remission (PR) in 24/59 (40.5%) patients, stable disease (SD) in 24/59 (40.5%), and progression (PD) in 10/59 (17%) patients. The overall tumor response rate (CR + PR) was 42.5%. In 40.5% of patients, the disease could be stabilized. Overall, 49 out of 59 patients had no tumor progression (83%). Twelve patients out of 59 (20%) had grade 2-3 hematological side effects including anemia, thrombocytopenia, and leukopenia. Long-term nephrotoxicity was observed in 3 patients (2 moderate, 1 severe). Conclusions. PRRT is a promising perspective for patients with advanced NETs.

SUBMITTER: Filice A

PROVIDER: S-EPMC3425839 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Radiolabeled somatostatin analogues therapy in advanced neuroendocrine tumors: a single centre experience.

Filice A A Fraternali A A Frasoldati A A Asti M M Grassi E E Massi L L Sollini M M Froio A A Erba P A PA Versari A A

Journal of oncology 20120809

The aim of this study was to assess the efficacy of PRRT in patients with advanced neuroendocrine tumors (NETs). Patients and Methods. From January 2007 to August 2011, we enrolled 65 patients (m/f 38/27; mean age 65 years, range 33-83) with advanced NETs having enhanced SSTR expression, treated with PRRT. The enhanced expression of SSTR was assessed using (68)Ga-DOTATOC/DOTATATE PET/CT. Among all the enrolled patients, 6 of them were excluded from the present analysis since they voluntarily int ...[more]

PMID: 22934111

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Project description:PurposeEvaluate patients' and nurses' experiences, including injection problem frequency, with the somatostatin analogues (SSAs) lanreotide autogel® (Somatuline® autogel®, deep subcutaneous) and octreotide long-acting release (LAR) (Sandostatin® LAR®, intramuscular) when treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs).MethodsAn observational, cross-sectional study across 2 NET centers in Sweden. Questionnaires based on participants' most recent injection experience were sent to patients with GEP-NETs treated with octreotide or lanreotide, and to nurses administering these treatments. Nurses were identified via patients completing their questionnaires. Resource use was sourced from Swedish prescription registry records. The planned sample size was 200, based on an estimated proportion of 0.50 and ±7% precision.Results119/156 patients (n=53, lanreotide; n=66, octreotide) and 43/53 nurses (n=22, lanreotide; n=21, octreotide) completed questionnaires. Despite smaller recruitment than planned, the endpoint precision was ±9% with 119 participants, and still considered reasonable. More octreotide-treated patients reported problems (18% vs none; P=0.001) and experienced moderate-to-high anxiety pre-injection (11% vs 2%). Patients had similar physical HRQoL scores overall (Short Form-12 mean composite scores: physical: 39.4 vs 37.6; mental: 50.7 vs 49.6). The mean number of lanreotide and octreotide doses dispensed per year were 11.1 and 12.6, respectively (P<0.05). In the lanreotide group, 28% self-injected, while 29% were not aware they could self-inject. In the octreotide group, 3% self-injected and 73% were unaware of the availability of an SSA for self-injection. Most patients (61%) felt well-informed about their disease and treatment. Nurses were generally experienced and felt confident and well-informed about giving SSA injections; however, only 12% felt well-informed about the disease and treatment.ConclusionThose treated with lanreotide reported fewer injection problems and experienced less pre-injection anxiety than those treated with octreotide. SSA choice did not appear to affect patients' HRQoL. Some patients treated with octreotide were unaware of an SSA with the flexibility of self-injection.

Project description:In recent decades, the incidence of neuroendocrine tumors (NETs) has steadily increased. Due to the slow-growing nature of these tumors and the lack of early symptoms, most cases are diagnosed at advanced stages, when curative treatment options are no longer available. Prognosis and survival of patients with NETs are determined by the location of the primary lesion, biochemical functional status, differentiation, initial staging, and response to treatment. Somatostatin analogue (SSA) therapy has been a mainstay of antisecretory therapy in functioning neuroendocrine tumors, which cause various clinical symptoms depending on hormonal hypersecretion. Beyond symptomatic management, recent research demonstrates that SSAs exert antiproliferative effects and inhibit tumor growth via the somatostatin receptor 2 (SSTR2). Both the PROMID (placebo-controlled, prospective, randomized study in patients with metastatic neuroendocrine midgut tumors) and the CLARINET (controlled study of lanreotide antiproliferative response in neuroendocrine tumors) trial showed a statistically significant prolongation of time to progression/progression-free survival (TTP/PFS) upon SSA treatment, compared to placebo. Moreover, the combination of SSA with peptide receptor radionuclide therapy (PRRT) in small intestinal NETs has proven efficacy in the phase 3 neuroendocrine tumours therapy (NETTER 1) trial. PRRT is currently being tested for enteropancreatic NETs versus everolimus in the COMPETE trial, and the potential of SSTR-antagonists in PRRT is now being evaluated in early phase I/II clinical trials. This review provides a synopsis on the pharmacological development of SSAs and their use as antisecretory drugs. Moreover, this review highlights the clinical evidence of SSAs in monotherapy, and in combination with other treatment modalities, as applied to the antiproliferative management of neuroendocrine tumors with special attention to recent high-quality phase III trials.

Project description:Radiolabeled somatostatin analog therapy has become an established treatment method for patients with well to moderately differentiated unresectable or metastatic neuroendocrine tumors (NETs). The most frequently used somatostatin analogs in clinical practice are octreotide and octreotate. However, both peptides showed suboptimal retention within tumors. The aim of this first-in-humans study is to explore the safety and dosimetry of a long-acting radiolabeled somatostatin analog, 177Lu-1, 4, 7, 10-tetra-azacyclododecane-1, 4, 7, 10-tetraacetic acid-Evans blue-octreotate (177Lu-DOTA-EB-TATE). Methods: Eight patients (6 men and 2 women; age range, 27-61 y) with advanced metastatic NETs were recruited. Five patients received a single dose, 0.35-0.70 GBq (9.5-18.9 mCi), of 177Lu-DOTA-EB-TATE and underwent serial whole-body planar and SPECT/CT scans at 2, 24, 72, 120, and 168 h after injection. The other 3 patients received intravenous injection of 0.28-0.41 GBq (7.5-11.1 mCi) of 177Lu-DOTATATE for the same imaging acquisition procedures at 1, 3, 4, 24, and 72 h after injection. The dosimetry was calculated using the OLINDA/EXM 1.1 software. Results: Administration of 177Lu-DOTA-EB-TATE was well tolerated, with no adverse symptoms being noticed or reported in any of the patients. Compared with 177Lu-DOTATATE, 177Lu-DOTA-EB-TATE showed extended circulation in the blood and achieved a 7.9-fold increase of tumor dose delivery. The total-body effective doses were 0.205 ± 0.161 mSv/MBq for 177Lu-DOTA-EB-TATE and 0.174 ± 0.072 mSv/MBq for 177Lu-DOTATATE. Significant dose delivery increases to the kidneys and bone marrow were also observed in patients receiving 177Lu-DOTA-EB-TATE compared with those receiving 177Lu-DOTATATE (3.2 and 18.2-fold, respectively). Conclusion: By introducing an albumin-binding moiety, 177Lu-DOTA-EB-TATE showed remarkably higher uptake and retention in NETs as well as significantly increased accumulation in the kidneys and red marrow. It has great potential to be used in peptide receptor radionuclide therapy for NETs with lower dose and less frequency of administration.

Dataset Information

Radiolabeled somatostatin analogues therapy in advanced neuroendocrine tumors: a single centre experience.

Publications

Radiolabeled somatostatin analogues therapy in advanced neuroendocrine tumors: a single centre experience.

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