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dc.contributor.authorSmith, I
dc.contributor.authorAhern, Roger
dc.contributor.authorCoombes, G
dc.contributor.authorHowell, Anthony
dc.contributor.authorEbbs, S
dc.contributor.authorHickish, T
dc.contributor.authorO'Brien, M
dc.contributor.authorMansi, J
dc.contributor.authorWilson, C
dc.contributor.authorRobinson, A
dc.contributor.authorMurray, P
dc.contributor.authorPrice, C
dc.contributor.authorPerren, T
dc.contributor.authorLaing, R
dc.contributor.authorBliss, Judith M
dc.date.accessioned2009-08-19T15:42:14Z
dc.date.available2009-08-19T15:42:14Z
dc.date.issued2004-05
dc.identifier.citationA novel continuous infusional 5-fluorouracil-based chemotherapy regimen compared with conventional chemotherapy in the neo-adjuvant treatment of early breast cancer: 5 year results of the TOPIC trial. 2004, 15 (5):751-8 Ann. Oncol.en
dc.identifier.issn0923-7534
dc.identifier.pmid15111342
dc.identifier.doi10.1093/annoc/mdh175
dc.identifier.urihttp://hdl.handle.net/10541/77919
dc.description.abstractBACKGROUND: To compare the efficacy of continuous infusional 5-fluorouracil (5-FU)-based chemotherapy against conventional bolus chemotherapy in the preoperative treatment of patients with large operable early breast cancer. PATIENTS AND METHODS: Four hundred and twenty-six women with histologically proven 3 cm invasive early breast cancer were randomised to receive pre-operative infusional 5-FU 200 mg/m(2) by daily 24 h continuous infusion via a Hickman line for 18 weeks with epirubicin 60 mg/m(2) intravenous (i.v.) bolus on day 1 and cisplatin 60 mg/m(2) i.v. bolus on day 1, both repeating 3-weekly (infusional ECisF), or conventional bolus doxorubicin 60 mg/m(2) i.v. on day 1 and cyclophosphamide 600 mg/m(2) i.v. on day 1, both repeating 3-weekly (AC), both schedules for six courses. Patients subsequently had local therapy (surgery or radiotherapy or both) and tamoxifen 20 mg orally daily as appropriate. RESULTS: The 5 year results for AC and infusional ECisF, respectively, were as follows: overall response, 75% and 77%; complete clinical remission, 31% and 34%; pathological complete remission (pathCR), 16% for both; and pathCR with residual ductal carcinoma in situ (DCIS), 25% and 24%. Mastectomy rates were 37% and 34%, respectively. Five-year overall survival was 74% for AC and 82% for infusional ECisF (hazard ratio 0.76, 95% confidence interval 0.51-1.13; P = 0.18). Both treatments were well tolerated. Grade III/IV lethargy, vomiting, alopecia and plantar-palmar erythema were significantly greater for infusional ECisF; grade III/IV leucopenia was significantly greater for AC. CONCLUSIONS: Preoperative continuous infusional 5-FU-based chemotherapy is no more active than conventional AC for early breast cancer; with a median 5 year follow-up, the infusion-based schedule shows a non-significant trend towards improved survival.
dc.language.isoenen
dc.subjectBreast Canceren
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshBreast Neoplasms
dc.subject.meshCyclophosphamide
dc.subject.meshDoxorubicin
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshInfusions, Intravenous
dc.subject.meshInjections, Intravenous
dc.subject.meshMiddle Aged
dc.subject.meshNeoadjuvant Therapy
dc.subject.meshSurvival Analysis
dc.subject.meshTreatment Outcome
dc.titleA novel continuous infusional 5-fluorouracil-based chemotherapy regimen compared with conventional chemotherapy in the neo-adjuvant treatment of early breast cancer: 5 year results of the TOPIC trial.en
dc.typeArticleen
dc.contributor.departmentRoyal Marsden Hospital, Fulham Road, Lonson SW3 6JJ, UK. ian.smith@rmh.nthames.nhs.uken
dc.identifier.journalAnnals of Oncologyen
html.description.abstractBACKGROUND: To compare the efficacy of continuous infusional 5-fluorouracil (5-FU)-based chemotherapy against conventional bolus chemotherapy in the preoperative treatment of patients with large operable early breast cancer. PATIENTS AND METHODS: Four hundred and twenty-six women with histologically proven 3 cm invasive early breast cancer were randomised to receive pre-operative infusional 5-FU 200 mg/m(2) by daily 24 h continuous infusion via a Hickman line for 18 weeks with epirubicin 60 mg/m(2) intravenous (i.v.) bolus on day 1 and cisplatin 60 mg/m(2) i.v. bolus on day 1, both repeating 3-weekly (infusional ECisF), or conventional bolus doxorubicin 60 mg/m(2) i.v. on day 1 and cyclophosphamide 600 mg/m(2) i.v. on day 1, both repeating 3-weekly (AC), both schedules for six courses. Patients subsequently had local therapy (surgery or radiotherapy or both) and tamoxifen 20 mg orally daily as appropriate. RESULTS: The 5 year results for AC and infusional ECisF, respectively, were as follows: overall response, 75% and 77%; complete clinical remission, 31% and 34%; pathological complete remission (pathCR), 16% for both; and pathCR with residual ductal carcinoma in situ (DCIS), 25% and 24%. Mastectomy rates were 37% and 34%, respectively. Five-year overall survival was 74% for AC and 82% for infusional ECisF (hazard ratio 0.76, 95% confidence interval 0.51-1.13; P = 0.18). Both treatments were well tolerated. Grade III/IV lethargy, vomiting, alopecia and plantar-palmar erythema were significantly greater for infusional ECisF; grade III/IV leucopenia was significantly greater for AC. CONCLUSIONS: Preoperative continuous infusional 5-FU-based chemotherapy is no more active than conventional AC for early breast cancer; with a median 5 year follow-up, the infusion-based schedule shows a non-significant trend towards improved survival.


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