Low overexpression of HER-2/PPPNeu in advanced colorectal cancer limits the usefulness of trastuzumab (Herceptin®) and irinotecan as therapy. A phase II trial

Cancer Investigation

Volumn 22, Issue 6, 2004, Pages 858-865

  Ramanathan, Ramesh K ^a   Hwang, Jimmy J ^a,g   Zamboni, William C ^b   Sinicrope, Frank A ^c,h   Safran, Howard ^d   Wong, Michael K ^a,i   Earle, Martin ^a   Brufsky, Adam ^a   Evans, Terry ^a   Troetschel, Monica ^a   Walko, Christine ^b   Day, Roger ^a   Chen, Helen X ^e   Finkelstein, Sydney ^f  

^a UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d BROWN UNIVERSITY   (United States)

^e NATIONAL CANCER INSTITUTE   (United States)

^f UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^g GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h MAYO CLINIC   (United States)

ⁱ ROSWELL PARK CANCER INSTITUTE   (United States)

Author keywords

Clinical trial; Colorectal cancer; HER 2 neu; Irinotecan; Trastuzumab

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; GENE PRODUCT; IRINOTECAN; NSC 688097; TRASTUZUMAB;

ACUTE KIDNEY TUBULE NECROSIS; ADULT; ADVANCED CANCER; AGED; ANEMIA; CANCER SCREENING; CARDIOTOXICITY; CARDIOVASCULAR RISK; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONFERENCE PAPER; CONGESTIVE HEART FAILURE; DIABETES MELLITUS; DIAGNOSTIC VALUE; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG RESPONSE; FATIGUE; FEMALE; FLU LIKE SYNDROME; GENE OVEREXPRESSION; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; IMMUNOHISTOCHEMISTRY; KIDNEY FAILURE; LEUKOPENIA; MALE; NEPHROTOXICITY; PATIENT SELECTION; PERIPHERAL VASCULAR DISEASE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RISK FACTOR; TREATMENT PLANNING; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; RECEPTOR, ERBB-2; TREATMENT OUTCOME;

EID: 10844274194     PISSN: 07357907     EISSN: None     Source Type: Journal    
DOI: 10.1081/CNV-200039645     Document Type: Conference Paper

References (25)

1. Jemal, A.; Tiwari, R.C.; Murray, T.; Ghafoor, A.; Samuels, A.; Ward, E.; Feuer, E.J.; Thun, M.J.; American Cancer Society. Cancer statistics, 2004. [Review] Ca: A Cancer Journal for Clinicians 2004, 54 (1), 8-29.
2. Petrelli, N.; Douglass, H.O., Jr.; Herrera, L.; Russell, D.; Stablein, D.M.; Bruckner, H.W.; Mayer, R.J.; Schinella, R.; Green, M.D.; Muggia, F.M. The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomized phase III trial. Gastrointestinal tumor study group. J. Clin. Oncol. 1989, 7, 1419-1426.
3. Poon, M.A.; O'Connell, M.J.; Moertel, C.G.; Wieand, H.S.; Cullinan, S.A.; Everson, L.K.; Krook, J.K.; Mailliard, J.A.; Laurie, J.A.; Tschetter, L.K. Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J. Clin. Oncol. 1989, 7, 1407-1418.
4. Saltz, L.B.; Cox, J.V.; Blanke, C.; Rosen, L.S.; Fehrenbacher, L.; Moore, M.J.; Maroun, J.A.; Ackland, S.P.; Locker, P.K.; Pirotta, N.; Elfring, G.L.; Miller, L.L. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan study group. N. Engl. J. Med. 2000, 343, 905-914.
5. Douillard, J.Y.; Cunningham, D.; Roth, A.D.; Navarro, M.; James, R.D.; Karasek, P.; Jandik, P.; Iverson, T.; Carmichael, J.; Alakl, M.; Gruia, G.; Awad, L.; Rougier, P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomized trial. Lancet 2000, 355, 1041-1047.
6. Goldberg, R.M.; Sargent, D.J.; Morton, R.F.; Fuchs, C.S.; Ramanathan, R.K.; Williamson, S.K.; Findlay, B.P.; Pitot, H.C.; Alberts, S.R. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J. Clin. Oncol. 2004, 22 (1), 23-30.
7. Cobbleigh, M.A.; Vogel, C.L.; Tripathy, D.; Robert, N.J.; Scholl, S.; Fehrenbacher, L.; Wolter, J.M.; Paton, V.; Shak, S.; Lieberman, G.; Slamon, D.J. Multinational study of the efficacy and safety of humanized anti-HER-2 monoclonal antibody in women who have HER-2 overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J. Clin. Oncol. 1999, 17, 2639-2648.
8. Slamon, D.J.; Clark, G.M.; Wong, S.G.; Levin, W.J.; Ullrich, A.; McGuire, W.L. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987, 235, 177-182.
9. Pegram, M.; Hsu, S.; Lewis, G.; Pietras, R.; Beryt, M.; Sliwkowski, M.; Coombs, D.; Baly, D.; Kabbinavar, F.; Slamon, D. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 1999, 18, 2241-2251.
10. Slamon, D.J.; Leyland-Jones, B.; Shak, S.; Fuchs, H.; Paton, V.; Bajamonde, A.; Fleming, T.; Eiermann, W.; Wolter, J.; Pegram, M.; Baselga, J.; Norton, L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 2001, 344, 783-792.
11. Safran, H.; Ramanathan, R.; Schwartz, J.; King, T.; Steinoff, M.; Nauman, C.; Hesketh, P.; Ianitti, D.; Quirk, D.; Akerman, P.; Cioffi, W.; Rathore, R.; Moore, T.; Ramdin, N.; Mass, R.; Wolff, R. Herceptin and gemcitabine for metastatic pancreatic cancers that overexpress HER-2/neu. Proc. Am. Soc. Clin. Oncol. 2001, 20, 130a (abstract 517).
12. Langer, C.J.; Adak, S.; Thor, A. Phase II Eastern Cooperative Oncology Group (ECOG) pilot study of paclitaxel (P), carboplatin (C) and trastuzumab (T) in HER-2/neu advanced non-small cell lung cancer (NSCLC): early analysis of E2598. Proc. Am. Soc. Clin. Oncol. 2001, 20, 315a (abstract 1257).
13. Shirai, H.; Ueno, E.; Osaki, M.; Tatebe, S.; Ito, H.; Kaibara, N. Expression of growth factors and their receptors in human early colorectal carcinomas: immunohistochemical study. Anticancer Res. 1995, 15, 2889-2894.
14. Yang, J.L.; Ow, K.T.; Russell, P.J.; Ham, J.M.; Crowe, P.J. Higher expression of oncoproteins c-myc, c-erb B-2/neu, PCNA, and p53 in metastasizing colorectal cancer than in nonmetastasizing tumors. Ann. Surg. Oncol. 1996, 3, 574-579.
15. Cunningham, D.; Pyrhonen, S.; James, R.D.; Punt, C.J.; Hickish, T.F.; Heikkila, R.; Johannesen, T.B. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998, 352, 1413-1418.
16. Simon, R. Optimal two-stage designs for phase II clinical trials. Contr. Clin. Trials. 1989, 10, 1-10.
17. Gibaldi, M.; Perrier, D. Pharmacokinetics; Marcel Dekker, Inc.: New York, 1982;445-457.
18. Tokuda, Y.; Watanabe, T.; Omuro, Y.; Ando, M.; Katsumata, N.; Okumura, A.; Ohta, M.; Fujii, H.; Sasaki, Y.; Niwa, T. Dose escalation and pharmacokinetic study of humanized anti-HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. Br. J. Cancer 1999, 81, 1419-1425.
19. Pegram, M.D.; Lipton, A.; Hayes, D.F.; Weber, B.L.; Baselga, J.M.; Tripathy, D.; Baly, D.; Baughman, S.A.; Twaddell, T.; Glaspy, J.A.; Slamon, D.J. Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J. Clin. Oncol. 1998, 16, 2659-2671.
20. Hsu, S.M.; Raine, L.; Fanger, H. Use of avidin-biotin-peroxidase complex (ABC) in immunoperoxidase techniques: a comparison between ABC and unlabeled antibody (PAP) procedure. J. Histochem. 1981, 29, 577-580.
21. Tubbs, R.R.; Pettay, J.D.; Roche, P.C.; Stoler, M.H.; Jenkins, R.B.; Grogan, T.M. Discrepancies in clinical laboratory testing of eligibility for trastuzumab therapy: apparent immunohistochemical false-positives do not get the message. J. Clin. Oncol. 2001, 19, 2714-2721.
22. Kapitanovic, S.; Radosevic, S.; Kapitanovic, M. The expression of p185 HER-2/neu correlates with the stage of disease and survival in colorectal cancer. Gastroenterology 1997, 112, 1103-1113.
23. Kay, E.W.; Mulcahy, H.; Walsh, C.B.; Leader, M.; O'Donoghue, D. Cytoplasmic c-erbB-2 protein expression correlates with survival in Dukes' B colorectal carcinoma. Histopathology 1994, 25, 455-461.
24. Osaka, T.; Miyahara, M.; Uchino, S.; Inomata, M.; Kitano, S.; Kobayashi, M. Immunohistochemical study of c-erbB-2 protein in colorectal cancer and the correlation with patient survival. Oncology 1998, 55, 548-555.
25. Xle, R.; Mathijssen, R.H.; Sparreboom, A.; Verweij, J.; Karlsson, M.O. Clinical pharmacokinetics of irinotecan and its metabolites: a population analysis. J. Clin. Oncol. 2002, 20, 3293-3301.