Fractionated radioimmunotherapy with 90Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial

Cancer

Volumn 118, Issue 22, 2012, Pages 5497-5506

  Ocean, Allyson J ^a   Pennington, Kenneth L ^b   Guarino, Michael J ^c   Sheikh, Arif ^d   Bekaii Saab, Tanios ^e   Serafini, Aldo N ^f   Lee, Daniel ^g   Sung, Max W ^h   Gulec, Seza A ⁱ   Goldsmith, Stanley J ^j   Manzone, Timothy ^c   Holt, Michael ^b   O'Neil, Bert H ^d   Hall, Nathan ^e   Montero, Alberto J ^f   Kauh, John ^g   Gold, David V ^k   Horne, Heather ^l   Wegener, William A ^l   Goldenberg, David M ^k  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b Goshen Health System Center for Cancer Care   (United States)

^c HELEN F GRAHAM CANCER CENTER   (United States)

^d UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^e THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER   (United States)

^f UNIVERSITY OF MIAMI   (United States)

^g EMORY UNIVERSITY   (United States)

^h MOUNT SINAI SCHOOL OF MEDICINE   (United States)

ⁱ FLORIDA INTERNATIONAL UNIVERSITY   (United States)

^j Department of Obstetrics Gynecology   (United States)

^k CENTER FOR MOLECULAR MEDICINE AND IMMUNOLOGY   (United States)

^l IMMUNOMEDICS INC   (United States)

more..

Author keywords

90Y; clivatuzumab tetraxetan; combination therapy; ductal pancreatic cancer; gemcitabine; radioimmunotherapy

Indexed keywords

CLIVATUZUMAB TETRAXETAN Y 90; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE MARROW SUPPRESSION; CANCER CONTROL; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; COMPUTER ASSISTED TOMOGRAPHY; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TOLERANCE; FEMALE; FRACTIONATED RADIOIMMUNOTHERAPY; HUMAN; MALE; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PRIORITY JOURNAL; RADIATION DOSE; RADIOIMMUNOTHERAPY; RETREATMENT; SOLID TUMOR; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIMETABOLITES, ANTINEOPLASTIC; CARCINOMA, PANCREATIC DUCTAL; COMBINED MODALITY THERAPY; DEOXYCYTIDINE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEUTROPENIA; PANCREATIC NEOPLASMS; RADIATION DOSAGE; RADIATION-SENSITIZING AGENTS; RADIOIMMUNOTHERAPY; THROMBOCYTOPENIA; YTTRIUM RADIOISOTOPES;

EID: 84868191187     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.27592     Document Type: Article

References (26)

1. Burris HA 3rd, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997; 15: 2403-2413.
2. Hidalgo M,. Pancreatic cancer. N Engl J Med. 2010; 362: 1605-1617.
3. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007; 25: 1960-1966.
4. Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011; 364: 1817-1825.
5. Von Hoff DD, Ramanathan RK, Borad MJ, et al. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011; 29: 4548-4554.
6. Cardillo TM, Ying Z, Gold DV,. Therapeutic advantage of 90yttrium- versus 131iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001; 7: 3186-3192.
7. Gold DV, Cardillo T, Vardi Y, Blumenthal R,. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997; 71: 660-667.
8. Stein R, Basu A, Goldenberg DM, Lloyd KO, Mattes MJ,. Characterization of cluster 13: the epithelial/carcinoma antigen recognized by MAb RS7. Int J Cancer. 1994; 8 (suppl): 98-102.
9. Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH,. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007; 13: 7380-7387.
10. Gold DV, Goggins M, Modrak DE, et al. Detection of early-stage pancreatic adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2010; 19: 2786-2794.
11. Morschhauser F, Kraeber-Bodere F, Wegener WA, et al. High rates of durable responses with anti-CD22 fractionated radioimmunotherapy: results of a multicenter, phase I/II study in non-Hodgkin's lymphoma. J Clin Oncol. 2010; 28: 3709-3716.
12. Cardillo TM, Blumenthal R, Ying Z, Gold DV,. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002; 97: 386-392.
13. Gold DV, Modrak DE, Schutsky K, Cardillo TM,. Combined 90yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004; 109: 618-626.
14. 90Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003; 9: 3929S-3937S.
15. Morgan MA, Parsels LA, Maybaum J, Lawrence TS,. Improving gemcitabine-mediated radiosensitization using molecularly targeted therapy: a review. Clin Cancer Res. 2008; 14: 6744-6750.
16. Pauwels B, Korst AE, Lardon F, Vermorken JB,. Combined modality therapy of gemcitabine and radiation. Oncologist. 2005; 10: 34-51.
17. 90Y-clivatuzumab tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011; 17: 4091-4100.
18. 90Y-DOTA-hLL2: an agent for radioimmunotherapy of non-Hodgkin's lymphoma. J Nucl Med. 2003; 44: 77-84.
19. 90Y radioimmunotherapy (RAIT): development of a method suitable for clinical use with pretherapy 111In imaging [abstract]. J Nucl Med. 2004; 45: 436. Abstract 1358.
20. Sgouros G,. Bone marrow dosimetry for radioimmunotherapy: theoretical considerations. J Nucl Med. 1993; 34: 689-694.
21. Stabin MG,. MIRDOSE. personal computer software for internal dose assessment in nuclear medicine. J Nucl Med. 1996; 37: 538-546.
22. Schwartz LH, Bogaerts J, Ford R, et al. Evaluation of lymph nodes with RECIST 1.1. Eur J Cancer. 2009; 45: 261-267.
23. Sharkey RM, Goldenberg DM,. Cancer radioimmunotherapy. Immunotherapy. 2011; 3: 349-370.
24. 90Y-linked monoclonal MUC-1 antibodies. Crit Rev Oncol Hematol. 2001; 38: 25-35.
25. 90Y-anti-carcinoembryonic antigen chimeric T84.66 radioimmunotherapy with 5-fluorouracil in patients with metastatic colorectal cancer. Clin Cancer Res. 2003; 9: 5842-5852.
26. Wong JYC, Chu DZ, Yamauchi DM, et al. A phase I radioimmunotherapy trial evaluating 90yttrium-labeled anti-carcinoembryonic antigen (CEA) chimeric T84.66 in patients with metastatic CEA-producing malignancies. Clin Cancer Res. 2000; 6: 3855-3863.