Catumaxomab for the treatment of malignant ascites in patients with chemotherapy-refractory ovarian cancer a phase II study

International Journal of Gynecological Cancer

Volumn 24, Issue 9, 2014, Pages 1583-1589

  Berek, Jonathan S ^a   Edwards, Robert P ^b   Parker, Lynn P ^c   Demars, Leslie R ^d   Herzog, Thomas J ^e   Lentz, Samuel S ^f   Morris, Robert T ^g   Akerley, Wallace L ^h   Holloway, Robert W ⁱ   Method, Michael W ^j   Plaxe, Steven C ^k   Walker, Joan L ^l   Friccius Quecke, Hilke ^m   Krasner, Carolyn N ⁿ  

^a STANFORD CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c UNIVERSITY OF LOUISVILLE SCHOOL OF MEDICINE   (United States)

^d DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^e Columbia University Cancer Center ^*  (United States)

^f WAKE FOREST BAPTIST HEALTH   (United States)

^g WAYNE STATE UNIVERSITY   (United States)

^h UNIVERSITY OF UTAH   (United States)

ⁱ FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^j Northern Indiana Cancer Research Consortium   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER   (United States)

^m Fresenius Biotech   (Germany)

ⁿ MASSACHUSETTS GENERAL HOSPITAL   (United States)

more..

Author keywords

Catumaxomab; Malignant ascites; Ovarian cancer; Trifunctional antibody

Indexed keywords

CATUMAXOMAB; BISPECIFIC ANTIBODY;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ARTICLE; CANCER PATIENT; CANCER RECURRENCE; CANCER SURVIVAL; CHILL; CLINICAL ARTICLE; CONSTIPATION; CYTOKINE RELEASE SYNDROME; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; FEVER; HEPATOBILIARY DISEASE; HUMAN; HYPERTENSION; HYPOTENSION; LEUKOCYTE DISORDER; LIVER TOXICITY; LYMPHOCYTE; MALIGNANT ASCITES; MULTICENTER STUDY; NAUSEA; OVARY CARCINOMA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PUNCTURE; PUNCTURE FREE SURVIVAL; QUALITY OF LIFE; RASH; SIDE EFFECT; SYMPTOMATOLOGY; VOMITING; ASCITES; CANCER STAGING; CLINICAL TRIAL; DRUG EFFECTS; DRUG RESISTANCE; FALLOPIAN TUBE NEOPLASMS; FOLLOW UP; INFUSION; MIDDLE AGED; MORTALITY; OVARIAN NEOPLASMS; PATHOLOGY; PERITONEAL NEOPLASMS; PROGNOSIS; SECONDARY; SURVIVAL RATE;

ADULT; AGED; ANTIBODIES, BISPECIFIC; ASCITES; DRUG RESISTANCE, NEOPLASM; FALLOPIAN TUBE NEOPLASMS; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, PARENTERAL; MIDDLE AGED; NEOPLASM STAGING; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; PROGNOSIS; QUALITY OF LIFE; SURVIVAL RATE;

EID: 84925943630     PISSN: 1048891X     EISSN: 15251438     Source Type: Journal    
DOI: 10.1097/IGC.0000000000000286     Document Type: Article

References (30)

1. Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. 2010. Int J Cancer. 127:2893-2917.
2. American Cancer Society. Global Cancer Facts & Figures. 2nd ed. Atlanta, GA: American Cancer Society; 2011. Available at: http://www.cancer.org/acs/groups/content/@ epidemiologysurveilance/documents/document/acspc-027766.pdf. Accessed January 23, 2014.
3. Berek JS, Crum C, Friedlander M. Cancer of the ovary, fallopian tube, and peritoneum. Int J Gynaecol Obstet. 2012;119(suppl 2):S118-S129.
4. Yoshida S, Furukawa N, Haruta S, et al. Expression profiles of genes involved in poor prognosis of epithelial ovarian carcinoma: a review. Int J Gynecol Cancer. 2009;19:992-997.
5. Burges A, Wimberger P, Kümper C, et al. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007;13:3899-3905.
6. Singh AP, Senapati S, Ponnusamy MP, et al. Clinical potential of mucins in diagnosis, prognosis, and therapy of ovarian cancer. Lancet Oncol. 2008;9:1076-1085.
7. Ayantunde AA, Parsons S. Pattern and prognostic factors in patients with malignant ascites: a retrospective study. Ann Oncol. 2007;18:945-949.
8. Cavazzoni E, Bugiantella W, Graziosi L, et al. Malignant ascites: pathophysiology and treatment. Int J Clin Oncol. 2013;18:1-9.
9. Becker G, Galandi D, Blum HE. Malignant ascites: systematic review and guideline for treatment. Eur J Cancer. 2006;42:589-597.
10. Balzar M, Briaire-de Bruijn IH, Rees-Bakker HA, et al. Epidermal growth factor-like repeats mediate lateral and reciprocal interactions of Ep-CAM molecules in homophilic adhesions. Mol Cell Biol. 2001;21:2570-2580.
11. Baeuerle PA, Gires O. EpCAM (CD326) finding its role in cancer. Br J Cancer. 2007;96:417-423.
12. Maetzel D, Denzel S, Mack B, et al. Nuclear signalling by tumour-associated antigen EpCAM. Nat Cell Biol. 2009;11:162-171.
13. Patriarca C, Macchi RM, Marschner AK, et al. Epithelial cell adhesion molecule expression (CD326) in cancer: a short review. Cancer Treat Rev. 2012;38:68-75.
14. Trzpis M, McLaughlin P M J, de Leij L M F H, et al. Epithelial cell adhesion molecule: more than a carcinoma marker and adhesion molecule. Am J Pathol. 2007;171:386-395.
15. Heinzelmann-Schwarz VA, Gardiner-Garden M, Henshall SM, et al. Overexpression of the cell adhesion molecules DDR1, claudin 3, and Ep-CAM in metaplastic ovarian epithelium and ovarian cancer. Clin Cancer Res. 2004;10:4427-4436.
16. Spizzo G, Fong D, Wurm M, et al. EpCAM expression in primary tumour tissues and metastases: an immunohistochemical analysis. Clin Pathol. 2011;64:415-420.
17. Went PT, Lugli A, Meier S, et al. Frequent EpCAM protein expression in human carcinomas. Hum Pathol. 2004;35:122-128.
18. Spizzo G, Went P, Dirnhofer S, et al. Overexpression of epithelial cell adhesion molecule (Ep-CAM) is an independent prognostic marker for reduced survival of patients with epithelial ovarian cancer. Gynecol Oncol. 2006;103:483-488.
19. Davidson B, Risberg B, Kristensen G, et al. Detection of cancer cells in effusions from patients diagnosed with gynaecological malignancies: evaluation of five epithelial markers. Virchows Arch. 1999;435:43-49.
20. Passebosc-Faure K, Li G, Lambert C, et al. Evaluation of a panel of molecular markers for the diagnosis of malignant serous effusions. Clin Cancer Res. 2005;11:6862-6867.
21. Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001;98:2526-2534.
22. Zeidler R, Mysliwietz J, Csánady M, et al. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000;83:261-266.
23. Jäger M, Schobert A, Ruf P, et al. Immunomonitoring results of a phase II/III study of malignant ascites patients treated with the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3). Cancer Res. 2012;72:24-32.
24. Zeidler R, Reisbach G, Wollenberg B, et al. Simultaneous activation of T-cells and accessory cells by a new class of intact bispecific antibody results in efficient tumour cell killing. J Immunol. 1999;163:1246-1252.
25. Heiss MM, Murawa P, Koralewski P, et al. The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: results of a prospective randomized phase II/III trial. Int J Cancer. 2010;127:2209-2221.
26. Seimetz D, Lindhofer H, Bokemeyer C. Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010;36:458-467.
27. Baumann K, Pfisterer J, Wimberger P, et al. Intraperitoneal treatment with the trifunctional bispecific antibody catumaxomab in patients with platinum-resistant epithelial ovarian cancer: a phase IIa study of the AGO study group. Gynecol Oncol. 2011;123:27-32.
28. Ströhlein MA, Lordick F, Rüttinger D, et al. Immunotherapy of peritoneal carcinomatosis with the antibody catumaxomab in colon, gastric, or pancreatic cancer: an open-label, multicenter, phase I/II trial. Onkologie. 2011;34:101-108.
29. Gotlieb WH, Amant F, Advani S, et al. Intravenous aflibercept for treatment of recurrent symptomatic malignant ascites in patients with advanced ovarian cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2012;13:154-162.
30. Pietzner K, Vergote I, Santoro A, et al. Results of a phase II clinical trial to evaluate a re-challenge of intraperitoneal catumaxomab for treatment of malignant ascites due to epithelial cancer (SECIMAS). J Clin Oncol. 2013;31(suppl):abstr 5582.