title: Cisplatin plus oral etoposide (EoP) combination is more effective than paclitaxel in patients with advanced breast cancer pretreated with anthracyclines: a randomised phase III trial of Turkish Oncology Group.
abstract: Our objective was to determine whether oral etoposide and cisplatin combination (EoP) is superior to paclitaxel in the treatment of advanced breast cancer (ABC) patients pretreated with anthracyclines. From December 1997 to August 2003, 201 patients were randomised, 100 to EoP and 101 to paclitaxel arms. Four patients in each arm were ineligible. The doses of etoposide and cisplatin were 50 mg p.o. twice a day for 7 days and 70 mg m(-2) intravenously (i.v.) on day 1, respectively, and it was 175 mg m(-2) on day 1 for paclitaxel. Both treatments were repeated every 3 weeks. A median of four cycles of study treatment was given in both arms. The response rate obtained in the EoP arm was significantly higher (36.3 vs 22.2%; P=0.038). Median response duration was longer for the EoP arm (7 vs 4 months) (P=0.132). Also, time to progression was significantly in favour of the EoP arm (5.5 vs 3.9 months; P=0.003). Median overall survival was again significantly longer in the EoP arm (14 vs 9.5 months; P=0.039). Toxicity profile of both groups was similar. Two patients in each arm were lost due to febrile neutropenia. The observed activity and acceptable toxicity of EoP endorses the employment of this combination in the treatment of ABC following anthracyclines.
authors.affiliation: Department of Medical Oncology, Ibni Sina Hospital, Ankara University School of Medicine, Ankara 06100, Turkey. ficli@dialup.ankara.edu.tr
authors.forename: F
authors.initials: F
authors.lastname: Icli
authors.forename: H
authors.initials: H
authors.lastname: Akbulut
authors.forename: A
authors.initials: A
authors.lastname: Uner
authors.forename: B
authors.initials: B
authors.lastname: Yalcin
authors.forename: E
authors.initials: E
authors.lastname: Baltali
authors.forename: M
authors.initials: M
authors.lastname: Altinbas
authors.forename: S
authors.initials: S
authors.lastname: Coşkun
authors.forename: S
authors.initials: S
authors.lastname: Komurcu
authors.forename: M
authors.initials: M
authors.lastname: Erkisi
authors.forename: A
authors.initials: A
authors.lastname: Demirkazik
authors.forename: F C
authors.initials: FC
authors.lastname: Senler
authors.forename: O
authors.initials: O
authors.lastname: Sencan
authors.forename: A
authors.initials: A
authors.lastname: Büyükcelik
authors.forename: C
authors.initials: C
authors.lastname: Boruban
authors.forename: H
authors.initials: H
authors.lastname: Onur
authors.forename: N
authors.initials: N
authors.lastname: Zengin
authors.forename: S D
authors.initials: SD
authors.lastname: Sak
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use*; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D014421:Turkey
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D005047:Etoposide; D017239:Paclitaxel; D002945:Cisplatin
references.citation: Cancer Chemother Pharmacol. 1994;33(6):527-9
references.pmid: 8137464
references.citation: J Clin Oncol. 1999 May;17(5):1413-24
references.pmid: 10334526
references.citation: Cancer Treat Rev. 1993;19 Suppl C:27-33
references.pmid: 8221713
references.citation: J Clin Oncol. 1995 Aug;13(8):2056-65
references.pmid: 7543562
references.citation: Cancer. 1991 Jan 1;67(1 Suppl):266-70
references.pmid: 1984826
references.citation: J Clin Oncol. 1996 Jun;14(6):1858-67
references.pmid: 8656254
references.citation: Cancer. 1990 Feb 1;65(3):418-21
references.pmid: 2297632
references.citation: Tumori. 1988 Apr 30;74(2):191-3
references.pmid: 3368973
references.citation: Med Pediatr Oncol. 2000 Jan;34(1):10-3
references.pmid: 10611578
references.citation: Tumori. 1995 Jul-Aug;81(4):241-4
references.pmid: 8540119
references.citation: Am J Clin Oncol. 1996 Apr;19(2):125-31
references.pmid: 8610634
references.citation: Breast Cancer Res Treat. 1995 May;34(2):185-9
references.pmid: 7647335
references.citation: J Clin Oncol. 2005 Aug 20;23(24):5542-51
references.pmid: 16110015
references.citation: Chemioterapia. 1986 Apr;5(2):125-7
references.pmid: 3518965
references.citation: J Surg Oncol. 1992 Aug;50(4):251-3
references.pmid: 1640710
references.citation: J Clin Oncol. 1994 May;12(5):986-91
references.pmid: 8164052
references.citation: Am J Clin Oncol. 1989 Feb;12(1):53-6
references.pmid: 2643295
references.citation: Cancer Treat Rep. 1979 Sep-Oct;63(9-10):1493-8
references.pmid: 498148
references.citation: Ann Oncol. 2001 Jul;12(7):1011-3
references.pmid: 11521785
references.citation: Cancer. 1995 Dec 15;76(12):2485-90
references.pmid: 8625074
references.citation: Br J Cancer. 2002 May 6;86(9):1367-72
references.pmid: 11986765
references.citation: Semin Oncol. 1989 Aug;16(4 Suppl 6):110-5
references.pmid: 2669132
references.citation: Eur J Cancer. 1999 Aug;35(8):1194-201
references.pmid: 10615229
references.citation: Eur J Cancer Clin Oncol. 1986 Jul;22(7):761-4
references.pmid: 3770033
references.citation: Br J Cancer. 2002 Nov 18;87(11):1210-5
references.pmid: 12439707
references.citation: J Clin Oncol. 2004 Jun 1;22(11):2061-8
references.pmid: 15169793
references.citation: J Clin Oncol. 1991 Apr;9(4):664-9
references.pmid: 2066763