Gefitinib in combination with tamoxifen in patients with ovarian cancer refractory or resistant to platinum-taxane based therapy-A phase II trial of the AGO Ovarian Cancer Study Group (AGO-OVAR 2.6)

Gynecologic Oncology

Volumn 105, Issue 1, 2007, Pages 132-137

  Wagner, Uwe ^a   du Bois, Andreas ^b   Pfisterer, Jacobus ^c   Huober, Jens ^d   Loibl, Sybille ^e   Lück, Hans Joachim ^b,f   Sehouli, Jalid ^g   Gropp, Martina ^h   Stähle, Anne ⁱ   Schmalfeldt, Barbara ^j   Meier, Werner ^h   Jackisch, Christian ^a,k  

^a PHILIPPS UNIVERSITY MARBURG   (Germany)

^b DR HORST SCHMIDT KLINIKEN   (Germany)

^c UNIVERSITY OF MANNHEIM   (Germany)

^d UNIVERSITY OF TÜBINGEN   (Germany)

^e GOETHE UNIVERSITY   (Germany)

^f HANNOVER MEDICAL SCHOOL   (Germany)

^g CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^h Ev Hospital   (Germany)

ⁱ Obstetrics StVincencius Hospital Karlsruhe   (Germany)

^j TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^k Klinikum Offenbach   (Germany)

more..

Author keywords

Epidermal growth factor receptor; Epidermal growth factor receptor tyrosine kinase inhibitor; gefitinib; IRESSA; Ovarian cancer; Tamoxifen

Indexed keywords

GEFITINIB; PLATINUM DERIVATIVE; TAMOXIFEN; TAXANE DERIVATIVE;

ACNE; ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER RESISTANCE; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; ECZEMA; ERYTHEMA; EXFOLIATIVE DERMATITIS; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVARY CARCINOMA; PATIENT COMPLIANCE; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; UNSPECIFIED SIDE EFFECT; UTERINE TUBE CARCINOMA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRIDGED COMPOUNDS; DRUG RESISTANCE, NEOPLASM; EPITHELIAL CELLS; FEMALE; HUMANS; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; OVARIAN NEOPLASMS; PATIENT COMPLIANCE; QUINAZOLINES; TAMOXIFEN; TAXOIDS;

EID: 33947318253     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2006.10.053     Document Type: Article

References (30)

1. Jemal A., Murray T., Ward E., Samuels A., Tiwari R.C., Ghafoor A., et al. Cancer statistics 2005. CA Cancer J. Clin. 55 (2005) 10-30
2. Markmann M., and Bookman M.A. Second-line treatment of ovarian cancer. Oncologist 5 (2000) 26-35
3. Berek J.S., Bertelsen K., du Bois A., Brady M.F., Carmichael J., Eisenhauer E.A., et al. Advanced epithelial ovarian cancer: 1998 consensus statements. Ann. Oncol. 10 Suppl. 1 (1999) 87-92
4. Markman M., Webster K., Zanotti K., Rokl J., and Belinson J. Use of tamoxifen in asymptomatic patients with recurrent small-volume ovarian cancer. Gynecol. Oncol. 93 (2004) 390-393
5. Makar A.P. Hormone therapy in epithelial ovarian cancer. Endocr. Relat. Cancer 7 (2000) 85-93
6. Ranson M. ZD 1839 (IRESSA): for more than just non-small cell lung cancer. Oncologist 7 Suppl. 4 (2002) 16-24
7. Scambia G., Benedetti-Panici P., Ferrandina G., Distefano M., Salerno G., Romanici M.E., et al. Epidermal growth factor, oestrogen and progesterone receptor expression in primary ovarian cancer: correlation with clinical outcome and response to chemotherapy. Br. J. Cancer 72 (1995) 361-366
8. Bartlett J.M., Langdon S.P., Simpson B.J., Stewart M., Katsaros D., Sismondi P., et al. The prognostic value of epidermal growth factor receptor mRNA expression in primary ovarian cancer. Br. J. Cancer 73 (1996) 301-306
9. Fukuoka M., Yano S., Giaccone G., Tamura T., Nakagawa K., Douillard J.Y., et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial). J. Clin. Oncol. 21 (2003) 2237-2246
10. Ranson M., Hammond L.A., Ferry D., Kris M., Tullo A., Murray P.I., et al. ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial. J. Clin. Oncol. 20 (2002) 2240-2250
11. Pautier P., Joly F., Kerbrat P., Bougnoux P., Fumoleau P., Petit T., et al. Preliminary results of a phase II study to evaluate gefitinib (ZD1839) combined with paclitaxel and carboplatin as second-line therapy in patients with ovarian carcinoma. Proc. Am. Soc. Clin. Oncol. 22 (2004) 5015 (abstr)
12. Mavroudis D., Efstathiou E., Polyzos A., Athanasiadis A., Milaki G., Kastritis E., et al. A phase I-11 trial of gefitinib in combination with vinorelbine and oxaliplatin as salvage therapy in women with advanced ovarian cancer. Proc. Am. Soc. Clin. Oncol. 22 (2004) 5020 (abstr)
13. Schilder R.J., Sill M.W., Chen X., Darcy K.M., Decesare S.L., Lewandowski G., et al. Phase II study of gefitinib in patients with relapsed or persistent ovarian or primary peritoneal cancer and evaluation of epidermal growth factor receptor mutations and immunohistochemical expression: a Gynecology Oncology Group study. Clin. Cancer Res. 11 (2005) 5538-5548
14. Shou J., Massareweh S., Osborne K., Wakeling A.E., Ali S., Weiss H., et al. Mechanisms of tamoxifen resistance: Increased estrogen receptor-Her2/neu cross-talk in ER/Her2-positive breast cancer. J. Natl. Cancer Inst. 96 (2004) 926-935
15. Nicholson R.I., Gee J.M., Knowlden J.M., McClelland R., Madden T.A., Barrow D., et al. The biology of antihormone failure in breast cancer. Breast Cancer Res. Treat. 80 Suppl 1 (2003) S29-S34
16. Gutierrez M.C., Detre S., Johnston S., Mohsin S.K., Shou J., Allred D.C., et al. Molecular changes in tamoxifen-resistant breast cancer: relationship between estrogen receptor, HER-2 and p38 mitogen-activated protein kinase. J. Clin. Oncol. 23 (2005) 2469-2476
17. Gee J.M., Hutcheson I.R., Knowlden J.M., Barrow D., Harper M.E., Wakeling A.E., et al. The EGFR-selective tyrosine kinase inhibitor ZD 1839 ('IRESSA') is an effective inhibitor of tamoxifen-resistant breast cancer growth. Proc. ASCO 20 (2001) 282 (abstr)
18. Hiscox S., Morgan L., Barrow D., Dutkowskil C., Wakeling A., and Nicholson R.I. Tamoxifen resistance in breast cancer cells is accompanied by an enhanced motile and invasive phenotype: inhibition by gefitinib ('Iressa', ZD1839). Exp. Metastasis 21 (2004) 201-212
19. Kalli K.R., Bradley S.V., Fuchshuber S., and Conover C.A. Estrogen receptor-positive human epithelial ovarian carcinoma cells respond to the antitumor drug surmain with increased proliferation: possible insight into ER and epidermal growth factor signaling interactions in ovarian cancer. Gynecol. Oncol. 94 (2004) 705-712
20. Polychronis A., Sinnett H.D., Hadjiminas J., Singhal H., Mansi J.L., Shivapatham D., et al. Prepoperative gefitinib versus gefitinib and anastrozole in postmenopausal patients with oestrogen-receptor positive and epidermal-growth-factor-receptor-positive primary breast cancer: a double-blind placebo-controlled phase II randomised trial. Lancet Oncol. 6 (2005) 383-391
21. Ciardiello F., Caputo R., Bianco R., Damiano V., Pomatico G., De Placido S., et al. Antitumor effect and potentiation of cytotoxic drugs activity in human cancer cells by ZD-1839 (IRESSA), an epidermal growth factor receptor-selective tyrosine kinase inhibitor. Clin. Cancer Res. 6 (2000) 2053-2063
22. Finn R.S., Beryt M., Konecny G., Pegram M.D., and Slamon D.J. ZD1839 ('IRESSA') acts synergistically with chemotherapy in ovarian cells expressing high levels of the epidermal growth factor receptor. Proc. Am. Soc. Clin. Oncol. 21 (2002) 1928 (abstr)
23. Nicholson R.I., Hutcheson I.R., Harper M.E., Knowlden J.M., Barrow D., McClelland R.A., et al. Modulation of epidermal growth factor receptor in endocrine-resistant, oestrogen receptor-positive breast cancer. Endocr. Relat. Cancer 8 (2001) 175-182
24. Harris A.L., Nicholson S., Sainsbury R., Wright C., and Farndon J. Epidermal growth factor receptor and other oncogenes as prognostic markers. J. Natl. Cancer Inst. Monographs 11 (1992) 181-187
25. Massarweh S., Shou J., Mohsin S.K., Gee M., Wakeling A.E., Osborne C.K., et al. Inhibition of epidermal growth factor/HER2 receptor signaling using ZD1839 ('IRESSA') restores tamoxifen sensitivity and delays resistance to estrogen deprivation in HER2-overexpressing breast tumors. Proc. Am. Soc. Clin. Oncol. 21 (2002) 130 (abstr)
26. Wakeling A., Nicholson R.I., and Gee J.M. Prospects for combining hormonal and nonhormonal growth factor inhibition. Clin. Cancer Res. 1 Suppl. 12 (2001) 4350s-4355s
27. Campos S., Hamid O., Seiden M.V., Oza A., Plante M., Potkul R.K., et al. Multicenter, randomized phase II trial of oral CI-1033 for previously treated advanced ovarian cancer. J. Clin. Oncol. 23 (2005) 5597-5604
28. Blank S.V., Chang R., and Muggia F. Epidermal growth factor receptor inhibitors for the treatment of epithelial ovarian cancer. Background and current trials. Oncology 19 (2005) 553-559
29. Lynch T.J., Bell D.W., Sordella R., Gurubhagavatula S., Okimoto R.A., Brannigan B.W., et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N. Engl. J. Med. 350 (2004) 2129-2139
30. Paez J.G., Janne P.A., Lee J.C., Tracy S., Greulich H., Gabriel S., et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304 (2004) 1497-1500