Difference between revisions of "Neuroendocrine tumor"
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Revision as of 02:56, 1 July 2021
Note: This page is now exclusively focused on those tumors commonly called carcinoids, which may or may not be associated with the carcinoid syndrome; there are now separate pages for pancreatic NET and other endocrine cancers. Neuroendocrine tumors of unknown primary and poorly differentiated (high-grade) neuroendocrine tumors are usually treated with a small cell lung cancer regimen.
14 regimens on this page
20 variants on this page
|
Guidelines
ESMO
- 2012: Öberg et al. Neuroendocrine bronchial and thymic tumors: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.
- 2012: Öberg et al. Neuroendocrine gastro-entero-pancreatic tumors: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. PubMed
NCCN
All lines of therapy
Everolimus monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy | Comparative Toxicity |
---|---|---|---|---|---|
Yao et al. 2015 (RADIANT-4) | 2012-2013 | Phase III (E-RT-esc) | Placebo | Superior PFS | Equivalent HRQoL |
Targeted therapy
- Everolimus (Afinitor) 10 mg PO once per day
Continued indefinitely
References
- RADIANT-4: Yao JC, Fazio N, Singh S, Buzzoni R, Carnaghi C, Wolin E, Tomasek J, Raderer M, Lahner H, Voi M, Pacaud LB, Rouyrre N, Sachs C, Valle JW, Fave GD, Van Cutsem E, Tesselaar M, Shimada Y, Oh DY, Strosberg J, Kulke MH, Pavel ME; RAD001 in Advanced Neuroendocrine Tumours Fourth Trial (RADIANT-4) Study Group. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016 Mar 5;387(10022):968-977. Epub 2015 Dec 17. link to original article contains protocol link to PMC article PubMed NCT01524783
- HRQoL analysis: Pavel ME, Singh S, Strosberg JR, Bubuteishvili-Pacaud L, Degtyarev E, Neary MP, Carnaghi C, Tomasek J, Wolin E, Raderer M, Lahner H, Valle JW, Pommier R, Van Cutsem E, Tesselaar MET, Fave GD, Buzzoni R, Hunger M, Eriksson J, Cella D, Ricci JF, Fazio N, Kulke MH, Yao JC. Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1411-1422. Epub 2017 Aug 30. link to original article PubMed
Everolimus & Octreotide
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Regimen variant #1
Study | Years of enrollment | Evidence |
---|---|---|
Yao et al. 2008 | 2005-2006 | Phase II |
Targeted therapy
- Everolimus (Afinitor) 5 mg PO once per day
Endocrine therapy
- Octreotide LAR (Sandostatin LAR) 30 mg IM once on day 1
28-day cycles
Regimen variant #2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Yao et al. 2008 | 2005-2006 | Phase II | ||
Pavel et al. 2011 (RADIANT-2) | 2007-2010 | Phase III (E-esc) | Octreotide LAR | Seems to have superior PFS |
Note: RADIANT-2 did not meet its primary endpoint, based on a pre-specified p-value cutoff of 0.0246.
Targeted therapy
- Everolimus (Afinitor) 10 mg PO once per day
Endocrine therapy
- Octreotide LAR (Sandostatin LAR) 30 mg IM once on day 1
28-day cycles
References
- Yao JC, Phan AT, Chang DZ, Wolff RA, Hess K, Gupta S, Jacobs C, Mares JE, Landgraf AN, Rashid A, Meric-Bernstam F. Efficacy of RAD001 (everolimus) and octreotide LAR in advanced low- to intermediate-grade neuroendocrine tumors: results of a phase II study. J Clin Oncol. 2008 Sep 10;26(26):4311-8. link to original article contains verified protocol link to PMC article PubMed
- RADIANT-2: Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-12. Epub 2011 Nov 25. link to original article contains verified protocol PubMed NCT00412061
- Update: Pavel ME, Baudin E, Öberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. link to original article PubMed
Fluorouracil & Streptozocin
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Engstrom et al. 1984 (ECOG E5275) | 1976-1981 | Phase III (E-esc) | Doxorubicin | Did not meet primary endpoints of ORR/OS |
Sun et al. 2005 | 1981-1990 | Phase III (E-switch-ic) | Doxorubicin & Fluorouracil | Seems to have superior OS |
Chemotherapy
References
- ECOG E5275: Engstrom PF, Lavin PT, Moertel CG, Folsch E, Douglass HO Jr. Streptozocin plus fluorouracil versus doxorubicin therapy for metastatic carcinoid tumor. J Clin Oncol. 1984 Nov;2(11):1255-9. link to original article PubMed
- ECOG E1281: Sun W, Lipsitz S, Catalano P, Mailliard JA, Haller DG; ECOG. Phase II/III study of doxorubicin with fluorouracil compared with streptozocin with fluorouracil or dacarbazine in the treatment of advanced carcinoid tumors: Eastern Cooperative Oncology Group Study E1281. J Clin Oncol. 2005 Aug 1;23(22):4897-904. link to original article PubMed
Interferon alfa-2b monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Oberg et al. 1983 | NR | Non-randomized, <20 pts | ||
Faiss et al. 2003 | 1995-1998 | Phase III (E-de-esc) | 1. Lanreotide | Did not meet primary endpoint of ORR at 12 mo |
2. Lanreotide & Interferon alfa-2b | Did not meet primary endpoint of ORR at 12 mo |
Treatment details are from Faiss et al. 2003.
Immunotherapy
- Interferon alfa-2b (Intron-A) 5,000,000 units SC once per day, 3 times per week
Continued indefinitely
Subsequent treatment
- Patients who progressed on monotherapy then received lanreotide & interferon alfa
References
- Oberg K, Funa K, Alm G. Effects of leukocyte interferon on clinical symptoms and hormone levels in patients with mid-gut carcinoid tumors and carcinoid syndrome. N Engl J Med. 1983 Jul 21;309(3):129-33. linkt to original article PubMed
- Faiss S, Pape UF, Böhmig M, Dörffel Y, Mansmann U, Golder W, Riecken EO, Wiedenmann B; International Lanreotide and Interferon Alfa Study Group. Prospective, randomized, multicenter trial on the antiproliferative effect of lanreotide, interferon alfa, and their combination for therapy of metastatic neuroendocrine gastroenteropancreatic tumors--the International Lanreotide and Interferon Alfa Study Group. J Clin Oncol. 2003 Jul 15;21(14):2689-96. link to original article contains verified protocol PubMed
Lanreotide monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Faiss et al. 2003 | 1995-1998 | Phase III (E-de-esc) | 1. Interferon alfa-2b | Did not meet primary endpoint of ORR at 12 mo |
2. Lanreotide & Interferon alfa-2b | Did not meet primary endpoint of ORR at 12 mo |
Endocrine therapy
- Lanreotide (Somatuline) 1 mg SC three times per day
Continued indefinitely
Subsequent treatment
- Patients who progressed on monotherapy then received combination lanreotide & interferon alfa
References
- Faiss S, Pape UF, Böhmig M, Dörffel Y, Mansmann U, Golder W, Riecken EO, Wiedenmann B; International Lanreotide and Interferon Alfa Study Group. Prospective, randomized, multicenter trial on the antiproliferative effect of lanreotide, interferon alfa, and their combination for therapy of metastatic neuroendocrine gastroenteropancreatic tumors--the International Lanreotide and Interferon Alfa Study Group. J Clin Oncol. 2003 Jul 15;21(14):2689-96. link to original article contains verified protocol PubMed
Lanreotide & Interferon alfa-2b
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Faiss et al. 2003 | 1995-1998 | Phase III (E-esc) | 1. Interferon alfa-2b | Did not meet primary endpoint of ORR at 12 mo |
2. Lanreotide | Did not meet primary endpoint of ORR at 12 mo |
Endocrine therapy
- Lanreotide (Somatuline) 1 mg SC three times per day
Immunotherapy
- Interferon alfa-2b (Intron-A) 5,000,000 units SC once per day, 3 times per week
References
- Faiss S, Pape UF, Böhmig M, Dörffel Y, Mansmann U, Golder W, Riecken EO, Wiedenmann B; International Lanreotide and Interferon Alfa Study Group. Prospective, randomized, multicenter trial on the antiproliferative effect of lanreotide, interferon alfa, and their combination for therapy of metastatic neuroendocrine gastroenteropancreatic tumors--the International Lanreotide and Interferon Alfa Study Group. J Clin Oncol. 2003 Jul 15;21(14):2689-96. link to original article contains verified protocol PubMed
Lutetium Lu 177 dotatate & Octreotide LAR
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FDA-recommended dose |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Strosberg et al. 2017 (NETTER-1) | 2012-2016 | Phase III (E-RT-switch-ooc) | Octreotide LAR | Superior PFS |
This is the FDA-recommended dose.
Radioconjugate therapy
- Lutetium Lu 177 dotatate (Lutathera) 7.4 GBq (200 mCi) IV over 30 minutes once on day 1
8-week cycle for 4 cycles
Endocrine therapy
- Octreotide LAR (Sandostatin LAR) as follows:
- Cycles 1 to 4: 30 mg IM once on day 2, given approximately 24 hours after lutetium Lu 177 dotatate
- Cycle 5 onwards: 30 mg IM once on day 1
8-week cycle for 4 cycles, then monthly cycles
References
- NETTER-1: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 trial of (177)Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. link to original article contains verified protocol link to PMC article PubMed NCT01578239
Octreotide monotherapy
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Regimen variant #1
Study | Evidence |
---|---|
Oberg et al. 2004 | Consensus guideline |
Endocrine therapy
- Octreotide (Sandostatin) 0.1 to 0.5 mg SC given 2 to four times per day, with dose increased by doubling the dose every 3 to 4 days as needed to control symptoms
- "A reasonable starting dose is" 0.15 mg SC three times per day
Continued indefinitely
Regimen variant #2
Study | Evidence |
---|---|
Kvols et al. 1986 | Phase II |
Endocrine therapy
- Octreotide (Sandostatin) 0.15 mg SC twice per day on days 1 & 2, then 0.15 mg SC three times per day from day 3 onward
Continued indefinitely
Regimen variant #3
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kölby et al. 2003 | 1991-1998 | Randomized Phase II (C) | Octreotide & Interferon alfa | Inferior TTP |
Endocrine therapy
- Octreotide (Sandostatin) 0.1 mg SC twice per day
- Patients with persistent carcinoid symptoms could receive increased doses up to 0.2 mg SC three times per day
Continued indefinitely
Regimen variant #4, low-dose
Study | Evidence |
---|---|
Janson & Oberg 1993 | Non-randomized |
Endocrine therapy
- Octreotide (Sandostatin) 0.05 mg SC twice per day
Continued indefinitely
References
- Kvols LK, Moertel CG, O'Connell MJ, Schutt AJ, Rubin J, Hahn RG. Treatment of the malignant carcinoid syndrome: evaluation of a long-acting somatostatin analogue. N Engl J Med. 1986 Sep 11;315(11):663-6. link to original article contains verified protocol PubMed
- Janson ET, Oberg K. Long-term management of the carcinoid syndrome: treatment with octreotide alone and in combination with alpha-interferon. Acta Oncol. 1993;32(2):225-9. link to original article contains protocol PubMed
- Kölby L, Persson G, Franzén S, Ahrén B. Randomized clinical trial of the effect of interferon alpha on survival in patients with disseminated midgut carcinoid tumours. Br J Surg. 2003 Jun;90(6):687-93. link to original article contains verified protocol PubMed
- Review: Oberg K, Kvols L, Caplin M, Delle Fave G, de Herder W, Rindi G, Ruszniewski P, Woltering EA, Wiedenmann B. Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol. 2004 Jun;15(6):966-73. link to original article contains verified protocol PubMed
Octreotide LAR monotherapy
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Regimen variant #1, 30 mg
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Rinke et al. 2009 (PROMID) | 2001-2008 | Phase III (E-esc) | Placebo | Superior TTP |
Pavel et al. 2011 (RADIANT-2) | 2007-2010 | Phase III (C) | Octreotide LAR & Everolimus | Seems to have inferior PFS |
Note: RADIANT-2 did not meet its primary endpoint, based on a pre-specified p-value cutoff of 0.0246.
Endocrine therapy
- Octreotide LAR (Sandostatin LAR) 30 mg IM once on day 1, with potentially higher doses if needed for symptom control
28-day cycles
Regimen variant #2, 40 mg
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wolin et al. 2015 (CSOM230C2303) | 2008-2012 | Phase III (C) | Pasireotide LAR | Did not meet primary endpoint of symptom control |
Endocrine therapy
- Octreotide LAR (Sandostatin LAR) 40 mg IM once on day 1
28-day cycles
Regimen variant #3, 60 mg
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Strosberg et al. 2017 (NETTER-1) | 2012-2016 | Phase III (C) | Lutetium Lu 177 dotatate & Octreotide LAR | Inferior PFS |
Endocrine therapy
- Octreotide LAR (Sandostatin LAR) 60 mg IM once on day 1
28-day cycles
References
- Review: Oberg K, Kvols L, Caplin M, Delle Fave G, de Herder W, Rindi G, Ruszniewski P, Woltering EA, Wiedenmann B. Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol. 2004 Jun;15(6):966-73. link to original article contains verified protocol PubMed
- PROMID: Rinke A, Müller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Bläker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009 Oct 1;27(28):4656-63. Epub 2009 Aug 24. link to original article contains verified protocol PubMed NCT00171873
- RADIANT-2: Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-12. Epub 2011 Nov 25. link to original article contains verified protocol PubMed NCT00412061
- Update: Pavel ME, Baudin E, Öberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. link to original article PubMed
- CSOM230C2303: Wolin EM, Jarzab B, Eriksson B, Walter T, Toumpanakis C, Morse MA, Tomassetti P, Weber MM, Fogelman DR, Ramage J, Poon D, Gadbaw B, Li J, Pasieka JL, Mahamat A, Swahn F, Newell-Price J, Mansoor W, Öberg K. Phase III study of pasireotide long-acting release in patients with metastatic neuroendocrine tumors and carcinoid symptoms refractory to available somatostatin analogues. Drug Des Devel Ther. 2015 Sep 3;9:5075-86. link to original article link to PMC article contains protocol PubMed NCT00690430
- NETTER-1: Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 trial of (177)Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. link to original article contains verified protocol link to PMC article PubMed NCT01578239
Octreotide & Interferon alfa
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kölby et al. 2003 | 1991-1998 | Randomized Phase II (E-esc) | Octreotide LAR | Superior TTP |
Yao et al. 2017 (SWOG S0518) | 2007-2012 | Phase III (C) | Octreotide & Bevacizumab | Did not meet primary endpoint of PFS |
Kölby et al. 2003 did not specifically say whether Interferon alfa-2b (Intron-A) or Interferon alfa-2a (Roferon-A) was used.
Endocrine therapy
- Octreotide (Sandostatin) 0.1 mg SC twice per day
- Patients with persistent carcinoid symptoms could receive increased doses up to 0.2 mg SC three times per day
Immunotherapy
- Interferon alfa-2b (Intron-A) 3,000,000 units (route not specified) once per day, 3 days per week
- Increased as needed based on symptoms up to 5,000,000 units (route not specified) once per day, 5 days per week
References
- Janson ET, Oberg K. Long-term management of the carcinoid syndrome: treatment with octreotide alone and in combination with alpha-interferon. Acta Oncol. 1993;32(2):225-9. link to original article PubMed
- Kölby L, Persson G, Franzén S, Ahrén B. Randomized clinical trial of the effect of interferon alpha on survival in patients with disseminated midgut carcinoid tumours. Br J Surg. 2003 Jun;90(6):687-93. link to original article contains verified protocol PubMed
- SWOG S0518: Yao JC, Guthrie KA, Moran C, Strosberg JR, Kulke MH, Chan JA, LoConte N, McWilliams RR, Wolin EM, Mattar B, McDonough S, Chen H, Blanke CD, Hochster HS. Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients With Advanced Carcinoid Tumors: SWOG S0518. J Clin Oncol. 2017 May 20;35(15):1695-1703. Epub 2017 Apr 6. link to original article link to PMC article PubMed NCT00569127
Temozolomide monotherapy
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Regimen
Study | Evidence |
---|---|
Ekeblad et al. 2007 | Retrospective |
Chemotherapy
- Temozolomide (Temodar) as follows:
- Cycle 1: 100 or 150 mg/m2 PO once per day on days 1 to 5
- Cycle 2 onwards: increased as tolerated up to 200 mg/m2 PO once per day on days 1 to 5
Supportive medications
- Tropisetron (Navoban) (dose/route/schedule not specified) routinely used as an antiemetic
28-day cycles
References
- Retrospective: Ekeblad S, Sundin A, Janson ET, Welin S, Granberg D, Kindmark H, Dunder K, Kozlovacki G, Orlefors H, Sigurd M, Oberg K, Eriksson B, Skogseid B. Temozolomide as monotherapy is effective in treatment of advanced malignant neuroendocrine tumors. Clin Cancer Res. 2007 May 15;13(10):2986-91. link to original article contains verified protocol PubMed