90Y-edotreotide for metastatic carcinoid refractory to octreotide

David L. Bushnell, Thomas M. O'Dorisio, M. Sue O'Dorisio, Yusuf Menda, Rodney J. Hicks, Eric Van Cutsem, Jean Louis Baulieu, Francoise Borson-Chazot, Lowell Anthony, Al B. Benson, Kjell Oberg, Ashley B. Grossman, Mary Connolly, Hakim Bouterfa, Yong Li, Katherine A. Kacena, Norman LaFrance, Stanislas A. Pauwels

Research output: Contribution to journalArticle

220 Citations (Scopus)

Abstract

Purpose: Metastatic carcinoid is an incurable malignancy whose symptoms, such as diarrhea and flushing, can be debilitating and occasionally life-threatening. Although symptom relief is available with octreotide, the disease eventually becomes refractory to octreotide, leaving no proven treatment options. The goal of this study was to evaluate the clinical effect of using 90Y-edotreotide to treat symptomatic patients with carcinoid tumors. Patients and Methods: Patients enrolled had metastatic carcinoid, at least one sign/symptom refractory to octreotide, and at least one measurable lesion. Study treatment consisted of three cycles of 4.4 GBq (120 mCi) 90Y- edotreotide each, once every 6 weeks. Results: Ninety patients were enrolled in the study. Using Southwest Oncology Group tumor response criteria, 67 (74.4%) of 90 patients (95% CI, 65.4% to 83.4%) were objectively stable or responded. A statistically significant linear trend toward improvement was demonstrated across all 12 symptoms assessed. Median progression-free survival was significantly greater (P = .03) for the 38 patients who had durable diarrhea improvement than the 18 patients who did not (18.2 v 7.9 months, respectively). Adverse events (AEs) were reported in 96.7% (87 of 90) of patients. These AEs consisted primarily of reversible GI events (76 of 90), which could be caused in part by concomitant administration of amino acid solution given to reduce radiation exposure to the kidneys. There was one case each of grade 3 oliguria and grade 4 renal failure, each lasting 6 days. Conclusion: 90Y- edotreotide treatment improved symptoms associated with malignant carcinoid among subjects with no treatment alternatives. Treatment was well-tolerated and had an acceptable expected AE profile.

Original languageEnglish (US)
Pages (from-to)1652-1659
Number of pages8
JournalJournal of Clinical Oncology
Volume28
Issue number10
DOIs
StatePublished - Apr 1 2010

Fingerprint

Octreotide
Carcinoid Tumor
Diarrhea
Oliguria
Therapeutics
Edotreotide
Disease-Free Survival
Signs and Symptoms
Renal Insufficiency
Neoplasms
Kidney
Amino Acids

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Bushnell, D. L., O'Dorisio, T. M., O'Dorisio, M. S., Menda, Y., Hicks, R. J., Van Cutsem, E., ... Pauwels, S. A. (2010). 90Y-edotreotide for metastatic carcinoid refractory to octreotide. Journal of Clinical Oncology, 28(10), 1652-1659. https://doi.org/10.1200/JCO.2009.22.8585
Bushnell, David L. ; O'Dorisio, Thomas M. ; O'Dorisio, M. Sue ; Menda, Yusuf ; Hicks, Rodney J. ; Van Cutsem, Eric ; Baulieu, Jean Louis ; Borson-Chazot, Francoise ; Anthony, Lowell ; Benson, Al B. ; Oberg, Kjell ; Grossman, Ashley B. ; Connolly, Mary ; Bouterfa, Hakim ; Li, Yong ; Kacena, Katherine A. ; LaFrance, Norman ; Pauwels, Stanislas A. / 90Y-edotreotide for metastatic carcinoid refractory to octreotide. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 10. pp. 1652-1659.
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abstract = "Purpose: Metastatic carcinoid is an incurable malignancy whose symptoms, such as diarrhea and flushing, can be debilitating and occasionally life-threatening. Although symptom relief is available with octreotide, the disease eventually becomes refractory to octreotide, leaving no proven treatment options. The goal of this study was to evaluate the clinical effect of using 90Y-edotreotide to treat symptomatic patients with carcinoid tumors. Patients and Methods: Patients enrolled had metastatic carcinoid, at least one sign/symptom refractory to octreotide, and at least one measurable lesion. Study treatment consisted of three cycles of 4.4 GBq (120 mCi) 90Y- edotreotide each, once every 6 weeks. Results: Ninety patients were enrolled in the study. Using Southwest Oncology Group tumor response criteria, 67 (74.4{\%}) of 90 patients (95{\%} CI, 65.4{\%} to 83.4{\%}) were objectively stable or responded. A statistically significant linear trend toward improvement was demonstrated across all 12 symptoms assessed. Median progression-free survival was significantly greater (P = .03) for the 38 patients who had durable diarrhea improvement than the 18 patients who did not (18.2 v 7.9 months, respectively). Adverse events (AEs) were reported in 96.7{\%} (87 of 90) of patients. These AEs consisted primarily of reversible GI events (76 of 90), which could be caused in part by concomitant administration of amino acid solution given to reduce radiation exposure to the kidneys. There was one case each of grade 3 oliguria and grade 4 renal failure, each lasting 6 days. Conclusion: 90Y- edotreotide treatment improved symptoms associated with malignant carcinoid among subjects with no treatment alternatives. Treatment was well-tolerated and had an acceptable expected AE profile.",
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Bushnell, DL, O'Dorisio, TM, O'Dorisio, MS, Menda, Y, Hicks, RJ, Van Cutsem, E, Baulieu, JL, Borson-Chazot, F, Anthony, L, Benson, AB, Oberg, K, Grossman, AB, Connolly, M, Bouterfa, H, Li, Y, Kacena, KA, LaFrance, N & Pauwels, SA 2010, '90Y-edotreotide for metastatic carcinoid refractory to octreotide', Journal of Clinical Oncology, vol. 28, no. 10, pp. 1652-1659. https://doi.org/10.1200/JCO.2009.22.8585

90Y-edotreotide for metastatic carcinoid refractory to octreotide. / Bushnell, David L.; O'Dorisio, Thomas M.; O'Dorisio, M. Sue; Menda, Yusuf; Hicks, Rodney J.; Van Cutsem, Eric; Baulieu, Jean Louis; Borson-Chazot, Francoise; Anthony, Lowell; Benson, Al B.; Oberg, Kjell; Grossman, Ashley B.; Connolly, Mary; Bouterfa, Hakim; Li, Yong; Kacena, Katherine A.; LaFrance, Norman; Pauwels, Stanislas A.

In: Journal of Clinical Oncology, Vol. 28, No. 10, 01.04.2010, p. 1652-1659.

Research output: Contribution to journalArticle

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T1 - 90Y-edotreotide for metastatic carcinoid refractory to octreotide

AU - Bushnell, David L.

AU - O'Dorisio, Thomas M.

AU - O'Dorisio, M. Sue

AU - Menda, Yusuf

AU - Hicks, Rodney J.

AU - Van Cutsem, Eric

AU - Baulieu, Jean Louis

AU - Borson-Chazot, Francoise

AU - Anthony, Lowell

AU - Benson, Al B.

AU - Oberg, Kjell

AU - Grossman, Ashley B.

AU - Connolly, Mary

AU - Bouterfa, Hakim

AU - Li, Yong

AU - Kacena, Katherine A.

AU - LaFrance, Norman

AU - Pauwels, Stanislas A.

PY - 2010/4/1

Y1 - 2010/4/1

N2 - Purpose: Metastatic carcinoid is an incurable malignancy whose symptoms, such as diarrhea and flushing, can be debilitating and occasionally life-threatening. Although symptom relief is available with octreotide, the disease eventually becomes refractory to octreotide, leaving no proven treatment options. The goal of this study was to evaluate the clinical effect of using 90Y-edotreotide to treat symptomatic patients with carcinoid tumors. Patients and Methods: Patients enrolled had metastatic carcinoid, at least one sign/symptom refractory to octreotide, and at least one measurable lesion. Study treatment consisted of three cycles of 4.4 GBq (120 mCi) 90Y- edotreotide each, once every 6 weeks. Results: Ninety patients were enrolled in the study. Using Southwest Oncology Group tumor response criteria, 67 (74.4%) of 90 patients (95% CI, 65.4% to 83.4%) were objectively stable or responded. A statistically significant linear trend toward improvement was demonstrated across all 12 symptoms assessed. Median progression-free survival was significantly greater (P = .03) for the 38 patients who had durable diarrhea improvement than the 18 patients who did not (18.2 v 7.9 months, respectively). Adverse events (AEs) were reported in 96.7% (87 of 90) of patients. These AEs consisted primarily of reversible GI events (76 of 90), which could be caused in part by concomitant administration of amino acid solution given to reduce radiation exposure to the kidneys. There was one case each of grade 3 oliguria and grade 4 renal failure, each lasting 6 days. Conclusion: 90Y- edotreotide treatment improved symptoms associated with malignant carcinoid among subjects with no treatment alternatives. Treatment was well-tolerated and had an acceptable expected AE profile.

AB - Purpose: Metastatic carcinoid is an incurable malignancy whose symptoms, such as diarrhea and flushing, can be debilitating and occasionally life-threatening. Although symptom relief is available with octreotide, the disease eventually becomes refractory to octreotide, leaving no proven treatment options. The goal of this study was to evaluate the clinical effect of using 90Y-edotreotide to treat symptomatic patients with carcinoid tumors. Patients and Methods: Patients enrolled had metastatic carcinoid, at least one sign/symptom refractory to octreotide, and at least one measurable lesion. Study treatment consisted of three cycles of 4.4 GBq (120 mCi) 90Y- edotreotide each, once every 6 weeks. Results: Ninety patients were enrolled in the study. Using Southwest Oncology Group tumor response criteria, 67 (74.4%) of 90 patients (95% CI, 65.4% to 83.4%) were objectively stable or responded. A statistically significant linear trend toward improvement was demonstrated across all 12 symptoms assessed. Median progression-free survival was significantly greater (P = .03) for the 38 patients who had durable diarrhea improvement than the 18 patients who did not (18.2 v 7.9 months, respectively). Adverse events (AEs) were reported in 96.7% (87 of 90) of patients. These AEs consisted primarily of reversible GI events (76 of 90), which could be caused in part by concomitant administration of amino acid solution given to reduce radiation exposure to the kidneys. There was one case each of grade 3 oliguria and grade 4 renal failure, each lasting 6 days. Conclusion: 90Y- edotreotide treatment improved symptoms associated with malignant carcinoid among subjects with no treatment alternatives. Treatment was well-tolerated and had an acceptable expected AE profile.

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Bushnell DL, O'Dorisio TM, O'Dorisio MS, Menda Y, Hicks RJ, Van Cutsem E et al. 90Y-edotreotide for metastatic carcinoid refractory to octreotide. Journal of Clinical Oncology. 2010 Apr 1;28(10):1652-1659. https://doi.org/10.1200/JCO.2009.22.8585