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 language | English (US) |
|---|---|
| Pages (from-to) | 1652-1659 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 28 |
| Issue number | 10 |
| DOIs | |
| State | Published - Apr 1 2010 |
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ASJC Scopus subject areas
- Oncology
- Cancer Research
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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 journal › Article
TY - JOUR
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.
UR - http://www.scopus.com/inward/record.url?scp=77950506150&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77950506150&partnerID=8YFLogxK
U2 - 10.1200/JCO.2009.22.8585
DO - 10.1200/JCO.2009.22.8585
M3 - Article
C2 - 20194865
AN - SCOPUS:77950506150
VL - 28
SP - 1652
EP - 1659
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 10
ER -