Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: A multicentre phase II study

British Journal of Cancer

Volumn 98, Issue 12, 2008, Pages 1916-1921

  Adamo, V ^a   Lorusso, V ^b   Rossello, R ^a   Adamo, B ^a   Ferraro, G ^a   Lorusso, D ^c   Condemi, G ^d   Priolo, D ^e   Di Lullo, L ^f   Paglia, A ^g   Pisconti, S ^h   Scambia, G ^c   Ferrandina, G ^g  

^a UNIVERSITY OF MESSINA   (Italy)

^b VITO FAZZI HOSPITAL   (Italy)

^c CATHOLIC UNIVERSITY   (Italy)

^d Medical Oncology

^e San Vincenzo Hospital   (Italy)

^f Medical Oncology   (Italy)

^g CATHOLIC UNIVERSITY   (Italy)

^h Hospital of Taranto   (Italy)

Author keywords

Gemcitabine; Metastatic breast cancer; Pegylated liposomal doxorubicin

Indexed keywords

DOXORUBICIN; GEMCITABINE;

ADULT; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CANCER PATIENT; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; CONTINUOUS INFUSION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ERYTHEMA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTENSION; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RECURRENT CANCER; SIDE EFFECT; TACHYCARDIA; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; DOXORUBICIN; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; POLYETHYLENE GLYCOLS; RECURRENCE; TREATMENT OUTCOME;

EID: 44949259900     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6604409     Document Type: Article

References (32)

1. Addeo R, Faiola V, Guarrasi R, Montella L, Vincenzi B, Capasso E, Cennamo G, Rotundo MS, Tagliaferri P, Caraglia M, Del Prete S (2007) Liposomal pegylated doxorubicin plus vinorelbine combination as first line chemotherapy for metastatic breast cancer in elderly women >/=65 years of age. Cancer Chemother Pharmacol (e-pub ahead of print)
2. Blackstein M, Vogel CL, Ambinder R, Cowan J, Iglesias J, Melemed A (2002) Gemcitabine as first-line therapy in patients with metastatic breast cancer: a phase II trial. Oncology 62(1): 2-8
3. Cardoso F, Leo AD, Lohrisch C, Bernard C, Ferreira F, Piccart MJ (2002) Second and subsequent lines of chemotherapy for metastatic breast cancer. What did we learn in the last two decades? Ann Oncol 13: 197-207
4. Carmichael J, Possinger K, Philip P, Beykirch M, Kerr H, Walling J, Harris AL (1995) Advanced breast cancer: a phase II trial with gemcitabine. J Clin Oncol 13: 2731-2736
5. Chow KU, Ries J, Weidmann E, Pourebrahim F, Napieralski S, Stieler M, Boehrer S, Rummel MJ, Stein J, Hoelzer D, Mitrou PS (2000) Induction of apoptosis using 2′,2′-difluorodeoxycytidine (gemcitabine) in combination with antimetabolites or anthracyclines on malignant lymphatic and myeloid cells. Antagonism or synergism depends on incubation schedule and origin of neoplastic cells. Ann Hematol 79: 485-492
6. Cianfrocca M, Gradishar WJ (2007) Counterpoint: the argument for combination chemotherapy in the treatment of metastatic breast cancer. J Natl Compr Cancer Netw 5(8): 673-675
7. D'agostino G, Ferrandina G, Ludovisi M, Testa A, Lorusso D, Gbaguidi N, Breda E, Mancuso S, Scambia G (2003) Phase II study of liposomal doxorubicin and gemcitabine in the salvage treatment of ovarian cancer. Br J Cancer 89: 1180-1184
8. Fabi A, Ferretti G, Papaldo P, Salesi N, Ciccarese M, Lorusso V, Carlini P, Carpino A, Mottolese M, Cianciulli AM, Giannarelli D, Sperduti I, Felici A, Cognetti F (2006) Pegylated liposomal doxorubicin in combination with gemcitabine: a Phase II study in anthracyclines-naive and anthracycline pretreated metastatic breast cancer patients. Cancer Chemother Pharmacol 57: 615-623
9. Ferrandina G, Paris I, Ludovisi M, D'Agostino G, Testa A, Lorusso D, Zanghi' M, Pisconti S, Pezzella G, Adamo V, Breda E, Scambia G (2005) Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: updated results and long-term survival. Gynecol Oncol 98(2): 267- 273
10. Gallo D, Fruscella E, Ferlini C, Apollonio P, Mancuso S, Scambia G (2006) Preclinical in vivo activity of a combination gemcitabine/liposomal doxorubicin against cisplatin-resistant human ovarian cancer (A2780/CDDP). Int J Gynecol Cancer 16: 222- 230
11. Gamucci T, D'Ottavio AM, Magnolfi E, Barduagni M, Vaccaro A, Sperduti I, Moscetti L, Belli F, Meliffi L (2007) Weekly epirubicin plus docetaxel as first-line treatment in metastatic breast cancer. Br J Cancer 97: 1040- 1045
12. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ (2007) Cancer statistics 2007. CA Cancer J Clin 57: 43-66
13. Kaplan E, Meyer P (1958) Non parametric estimation from incomplete observations. J Am Statist Assoc 53: 457- 481
14. Lyass O, Uziely B, Ben-Yosef R, Tzemach D, Heshing NI, Lotem M, Brufman G, Gabizon A (2000) Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma. Cancer 89: 1037- 1047
15. Mavroudis D, Alexolpoulos A, Ziras N, Malamos N, Kouroussis C, Kakolyris S, Agelaki S, Kalbakis K, Tsavaris N, Potamianou A, Rigatos G, Georgoulias V (2000) Front-line treatment of advanced breast cancer with docetaxel and epirubicin: a multicenter phase II study. Ann Oncol 11(10): 1249-1254
16. Moliterni A, Menard S, Valagussa P, Biganzoli E, Boracchi P, Valsari A, Casalini P, Tomasic G, Marubini E, Pilotti S, Bonadonna G (2003) HER2 overexpression and doxorubicin in adjuvant chemotherapy for resectable breast cancer. J Clin Oncol 21(3): 458-462
17. Morales S, Lorenzo A, Ramos M, Ballesteros P, Mendez M, Almanza C, Castelanos J, Moreno-Nogueira JA, Casal J, Lizon J, Oltra A, Frau A, Machengs I, Galan A, Belon J, Llorca C (2004) Docetaxel plus epirubicin is a highly active, well tolerated, first line chemotherapy for metastatic breast cancer: results of a large, multicentre Phase II study. Cancer Chemother Pharmacol 53(1): 75-81
18. National Cancer Institute (1999) Cancer Therapy Evaluation Program: Common Toxicity Criteria. Version 2.0. 30 April 1999 [http://ctep.info.nih. gov]
19. O'Brien ME (2008) Single agent treatment with pegylated liposomal doxorubicin for metastatic breast cancer. Anticancer Drugs 19(1): 1-7
20. O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C (2004) Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYXTM/Doxil™) vs conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 15: 440-449
21. Paridaens R (2000) Algorithms for the management of advanced breast cancer. Eur J Cancer 36(Suppl 5): S6-S10
22. Ranson MR, Carmichael J, O'Byrne K, Stewart S, Smith D, Howell A (1997) Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: results of a multicenter phase II trial. J Clin Oncol 15(3): 185-3191
23. Rivera E, Valero V, Arun B, Royce M, Adinin R, Hoelzer K, Walters R, Wade III JL, Pusztai L, Hortobagyi GN (2003) Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. J Clin Oncol 21(17): 3249-3254
24. Rizzo JD, Lichtin AE, Woolf SH, Seidenfeld J, Bennett CL, Cella D, Djulbegovic B, Goode MJ, Jakubowski AA, Lee SJ, Miller CB, Rarick MU, Regan DH, Browman GP, Gordon MS, American Society of Clinical Oncology, American Society of Hematology (2002) Use of epoetin in patients with cancer. Evidence-based clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 20: 4083- 4107
25. Robert NJ, Vogel CL, Henderson IC, Sparano JA, Moore MR, Silverman P, Overmoyer BA, Shapiro CL, Park JW, Colbern GT, Winer EP, Gabizon AA (2004) The role of the liposomal anthracyclines and other systemic therapies in the management of advanced breast cancer. Semin Oncol 31(Suppl. 13): 106-146
26. Simon R (1989) Optimal two stage design for Phase II clinical trials. Control Clin Trials 10: 1-10
27. Sledge GW (2001) Is HER-2/neu a predictor of anthracycline utility? No. J Natl Cancer Inst Monogr 30: 85-87
28. Tanner M, Isola J, Wiklund T, Erikstein B, Kello-Kumpu-Lehtinen P, Malmstrom P, Wilking N, Nilsson J, Bergh J (2006) Topoisomerase IIα gene amplification predicts favourable treatment response to tailored and dose-escalated anthracycline-based adjuvant chemotherapy in Her-2/neu amplified breast cancer: Scandinavian breast group trial 9401. J Clin Oncol 161: 2428-2436
29. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Serweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216
30. Trost Jorgensen J, Vang Nielsen K, Ejlertsen B (2007) Pharmacodiagnostics and targeted therapies - a rational approach for individualizing medical anticancer therapy in breast cancer. Oncologist 12: 397-405
31. Ulrich-Pur H, Kornek GV, Haider K, Kwasny W, Payrits T, Dworan N, Vormittag LL, Depisch D, Lang F, Scheithauer W (2007) Phase II trial of pegylated liposomal doxorubicin (Caelyx) plus gemcitabine in chemotherapeutically pretreated patients with advanced breast cancer. Acta Oncol 46(2): 208-213
32. Von Minckwitz G (2007) Docetaxel/anthracyclines combination for breast cancer treatment. Expert Opin Pharmacother 8(4): 485-495