-
Tytuł:
-
Safety and Outcome Measures of First-in-Human Intraperitoneal α Radioimmunotherapy With 212Pb-TCMC-Trastuzumab.
-
Autorzy:
-
Meredith RF; Departments of Radiation Oncology.
Torgue JJ; AREVA Med, Plano, TX.
Rozgaja TA; AREVA Med, Plano, TX.
Banaga EP; AREVA Med, Plano, TX.
Bunch PW; Gynecology, Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL.
Alvarez RD; Gynecology, Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL.
Straughn JM Jr; Gynecology, Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL.
Dobelbower MC; Departments of Radiation Oncology.
Lowy AM; Department of Surgery, Division of Surgical Oncology, Moores Cancer Center, University of California, San Diego, CA.
-
Źródło:
-
American journal of clinical oncology [Am J Clin Oncol] 2018 Jul; Vol. 41 (7), pp. 716-721.
-
Typ publikacji:
-
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
-
Język:
-
English
-
Imprint Name(s):
-
Publication: Hagerstown, MD : Lippincott Williams & Wilkins
Original Publication: New York, N.Y. : Masson Pub. USA, c1982-
-
MeSH Terms:
-
Isothiocyanates/*chemistry
Lead Radioisotopes/*therapeutic use
Neoplasm Recurrence, Local/*mortality
Ovarian Neoplasms/*mortality
Peritoneal Neoplasms/*mortality
Radioimmunotherapy/*mortality
Trastuzumab/*therapeutic use
Aged ; Aged, 80 and over ; Antineoplastic Agents, Immunological/therapeutic use ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Neoplasm Recurrence, Local/pathology ; Neoplasm Recurrence, Local/therapy ; Outcome Assessment, Health Care ; Ovarian Neoplasms/pathology ; Ovarian Neoplasms/therapy ; Peritoneal Neoplasms/pathology ; Peritoneal Neoplasms/therapy ; Prognosis ; Survival Rate
-
References:
-
Eur J Cancer. 2009 Jan;45(2):228-47. (PMID: 19097774)
J Ovarian Res. 2014 Dec 05;7:109. (PMID: 25477184)
Gynecol Oncol. 2012 Nov;127(2):379-83. (PMID: 22835718)
J Natl Compr Canc Netw. 2008 Sep;6(8):795-802. (PMID: 18926090)
J Nucl Med. 2009 Jul;50(7):1153-60. (PMID: 19525452)
J Nucl Med. 2014 Oct;55(10):1636-42. (PMID: 25157044)
Pharmaceuticals (Basel). 2015 Jul 24;8(3):416-34. (PMID: 26213947)
Cancer Biother Radiopharm. 2005 Oct;20(5):557-68. (PMID: 16248771)
J Clin Pathol. 2005 Mar;58(3):308-12. (PMID: 15735166)
J Nucl Med. 2008 Jan;49(1):30-8. (PMID: 18077533)
Int J Gynecol Cancer. 2005 Nov-Dec;15 Suppl 3:274-81. (PMID: 16343244)
Oncotarget. 2015 Jul 30;6(21):18641-52. (PMID: 26215675)
J Gynecol Oncol. 2015 Jan;26(1):46-53. (PMID: 25310857)
J Nucl Med. 2010 Feb;51(2):311-28. (PMID: 20080889)
Cancer Res. 1986 Jun;46(6):3118-24. (PMID: 3516392)
Cancer. 1992 Feb 1;69(3):741-9. (PMID: 1730124)
Clin Cancer Res. 2008 Aug 15;14(16):5108-15. (PMID: 18698028)
Eur J Gynaecol Oncol. 2015;36(3):260-7. (PMID: 26189250)
Cancer Prev Res (Phila). 2011 Mar;4(3):365-74. (PMID: 21372036)
Int J Gynecol Cancer. 2016 Jan;26(1):43-51. (PMID: 26588231)
J Clin Oncol. 2010 May 1;28(13):2159-66. (PMID: 20368574)
Cancer Biother Radiopharm. 2012 Feb;27(1):36-40. (PMID: 22239432)
Cancer Biother Radiopharm. 2014 Feb;29(1):12-7. (PMID: 24229395)
Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):569-76. (PMID: 26460999)
Br J Obstet Gynaecol. 1989 May;96(5):529-36. (PMID: 2757980)
Front Oncol. 2014 Jan 14;3:324. (PMID: 24459634)
J BUON. 2015 May-Jun;20(3):855-61. (PMID: 26214640)
Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:141-6. (PMID: 26398337)
J Clin Oncol. 2015 May 1;33(13):1460-6. (PMID: 25800756)
Cancer Biol Ther. 2005 Dec;4(12):1318-24. (PMID: 16322682)
J Cancer Res Clin Oncol. 2010 Jul;136(7):1079-88. (PMID: 20082099)
Eur J Gynaecol Oncol. 2013;34(2):163-5. (PMID: 23781590)
J Natl Cancer Inst. 1986 Jun;76(6):995-1006. (PMID: 3520078)
J Ovarian Res. 2013 Apr 17;6(1):29. (PMID: 23590973)
J Ovarian Res. 2013 Jul 01;6(1):44. (PMID: 23816286)
J Histochem Cytochem. 2010 Nov;58(11):1015-23. (PMID: 20713982)
Eur J Gynaecol Oncol. 2015;36(4):457-62. (PMID: 26390703)
MAbs. 2010 Sep-Oct;2(5):550-64. (PMID: 20716957)
Womens Health (Lond). 2013 Mar;9(2):171-85; quiz 186-7. (PMID: 23477323)
Biologics. 2014 Nov 10;8:255-67. (PMID: 25422581)
Nucl Med Biol. 2016 Jul;43(7):391-6. (PMID: 27179247)
Hum Pathol. 1986 May;17(5):501-13. (PMID: 2422108)
Nature. 1962 Mar 24;193:1153-5. (PMID: 13864967)
Blood. 2002 Aug 15;100(4):1233-9. (PMID: 12149203)
N Engl J Med. 1971 Jul 15;285(3):138-41. (PMID: 5104234)
Int J Cancer. 2007 Jun 15;120(12):2710-4. (PMID: 17354223)
-
Grant Information:
-
UL1 TR001417 United States TR NCATS NIH HHS; UL1 RR025777 United States RR NCRR NIH HHS
-
Substance Nomenclature:
-
0 (Antineoplastic Agents, Immunological)
0 (Isothiocyanates)
0 (Lead Radioisotopes)
0 (Lead-212)
P188ANX8CK (Trastuzumab)
-
Entry Date(s):
-
Date Created: 20161202 Date Completed: 20190513 Latest Revision: 20200306
-
Update Code:
-
20240105
-
PubMed Central ID:
-
PMC5449266
-
DOI:
-
10.1097/COC.0000000000000353
-
PMID:
-
27906723
-
Purpose: One-year monitoring of patients receiving intraperitoneal (IP) Pb-TCMC-trastuzumab to provide long-term safety and outcome data. A secondary objective was to study 7 tumor markers for correlation with outcome.
Methods: Eighteen patients with relapsed intra-abdominal human epidermal growth factor receptor-2 expressing peritoneal metastases were treated with a single IP infusion of Pb-TCMC-trastuzumab, delivered <4 h after 4 mg/kg IV trastuzumab. Seven tumor markers were studied for correlation with outcome.
Results: Six dose levels (7.4, 9.6, 12.6, 16.3, 21.1, 27.4 MBq/m) were well tolerated with early possibly agent-related adverse events being mild, transient, and not dose dependent. These included asymptomatic, abnormal laboratory values. No late renal, liver, cardiac, or other toxicity was noted up to 1 year. There were no clinical signs or symptoms of an immune response to Pb-TCMC-trastuzumab, and assays to detect an immune response to this conjugate were negative for all tested. Tumor marker studies in ovarian cancer patients showed a trend of decreasing Cancer antigen 72-4 (CA 72-4) aka tumor-associated glycoprotein 72 (TAG-72) and tumor growth with increasing administered radioactivity. Other tumor markers, including carbohydrate antigen (CA125), human epididymis protein 4 (HE-4), serum amyloid A (SAA), mesothelin, interleukin-6 (IL-6), and carcinoembryonic antigen (CEA) did not correlate with imaging outcome.
Conclusions: IP Pb-TCMC-trastuzumab up to 27 MBq/m seems safe for patients with peritoneal carcinomatosis who have failed standard therapies. Serum TAG-72 levels better correlated to imaging changes in ovarian cancer patients than the more common tumor marker, CA125.