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Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors.
Strosberg, Jonathan; El-Haddad, Ghassan; Wolin, Edward; Hendifar, Andrew; Yao, James; Chasen, Beth; Mittra, Erik; Kunz, Pamela L; Kulke, Matthew H; Jacene, Heather; Bushnell, David; O'Dorisio, Thomas M; Baum, Richard P; Kulkarni, Harshad R; Caplin, Martyn; Lebtahi, Rachida; Hobday, Timothy; Delpassand, Ebrahim; Van Cutsem, Eric; Benson, Al; Srirajaskanthan, Rajaventhan; Pavel, Marianne; Mora, Jaime; Berlin, Jordan; Grande, Enrique; Reed, Nicholas; Seregni, Ettore; Öberg, Kjell; Lopera Sierra, Maribel; Santoro, Paola; Thevenet, Thomas; Erion, Jack L; Ruszniewski, Philippe; Kwekkeboom, Dik; Krenning, Eric.
Afiliación
  • Strosberg J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • El-Haddad G; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Wolin E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Hendifar A; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Yao J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Chasen B; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Mittra E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Kunz PL; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Kulke MH; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Jacene H; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Bushnell D; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • O'Dorisio TM; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Baum RP; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Kulkarni HR; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Caplin M; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Lebtahi R; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Hobday T; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Delpassand E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Van Cutsem E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Benson A; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Srirajaskanthan R; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Pavel M; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Mora J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Berlin J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Grande E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Reed N; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Seregni E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Öberg K; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Lopera Sierra M; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Santoro P; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Thevenet T; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Erion JL; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Ruszniewski P; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Kwekkeboom D; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
  • Krenning E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Canc
N Engl J Med ; 376(2): 125-135, 2017 01 12.
Article en En | MEDLINE | ID: mdl-28076709
ABSTRACT

BACKGROUND:

Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 (177Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors.

METHODS:

We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either 177Lu-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) (177Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here.

RESULTS:

At the data-cutoff date for the primary analysis, the estimated rate of progression-free survival at month 20 was 65.2% (95% confidence interval [CI], 50.0 to 76.8) in the 177Lu-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The response rate was 18% in the 177Lu-Dotatate group versus 3% in the control group (P<0.001). In the planned interim analysis of overall survival, 14 deaths occurred in the 177Lu-Dotatate group and 26 in the control group (P=0.004). Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the 177Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame.

CONCLUSIONS:

Treatment with 177Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the 177Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compuestos Organometálicos / Octreótido / Tumores Neuroendocrinos / Neoplasias Gastrointestinales / Antineoplásicos Tipo de estudio: Clinical_trials / Guideline Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2017 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Compuestos Organometálicos / Octreótido / Tumores Neuroendocrinos / Neoplasias Gastrointestinales / Antineoplásicos Tipo de estudio: Clinical_trials / Guideline Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Año: 2017 Tipo del documento: Article