Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/ cyclophosphamide (AC) in operable breast cancer: Analysis of response and tolerability in a randomised phase III trial (TOPIC 2)
Authors: Chua, S., Smith, I.E., A'Hern, R.P., Coombes, G.A., Hickish, T.F., Robinson, A.C., Laing, R.W., O'Brien, M.E.R., Ebbs, S.R., Hong, A., Wardley, A., Mughal, T., Verrill, M., Dubois, D., Bliss, J.M., Allum, W., Gui, G., Dean, S., Trask, C., Kissin, M., McKinna, F., Goodman, A., Howell, T., Guilliford, T., Golding, A., McIllmurray, M., Barrett, J., Charlton, C., Price, C., Iveson, T., O'Reilley, S., Perren, T., Mithal, N., Ellis, P., Allerton, R., Bloomfield, D., Agrawal, R., Murray, P., Pratt, W., Davidson, N., Mansi, J., Rea, D.
Journal: Annals of Oncology
Publication Date: 01/01/2005
Volume: 16
Issue: 9
Pages: 1435-1441
ISSN: 0923-7534
DOI: 10.1093/annonc/mdi276
Abstract:Background: Vinorelbine is active and well tolerated against advanced breast cancer but there are no published efficacy studies in early breast cancer. We have therefore carried out a randomised phase III neoadjuvant trial in operable breast cancer. Patients and methods: Pati ents with ≥3 cm operable breast carcinoma were randomised to receive either vinorelbine 25 mg/m2 on days 1 and 8 and epirubicin 60 mg/m2 on day 1, 3 weekly for six cycles (VE) or doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 i.v. on day 1, 3 weekly for six cycles (AC), prior to standard local therapy, and adjuvant endocrine therapy as appropriate. Results: A total of 451 patients were randomised. Results f or AC and VE, respectively, were: overall clinical response 73% and 74%, complete clinical remission 20% and 24%, pathological complete remission 12% and 12%, mastectomy rate 52% and 55%. None of these differences were significant. Dose reduction was required in 8% for AC and 20% for VE (P <0.001) (GSCF support not used). Significantly more grade 3/4 toxicity for nausea, vomiting and alopecia (despite scalp cooling) was seen for AC compared with VE but significantly less grade 3/4 thrombophlebitis and neuropathy. Conclusions: Neoadjuvant VE is as effective as AC in early breast cancer and was better tolerated except for thrombophlebitis and neuropathy. © 2005 European Society for Medical Oncology.
Source: Scopus
Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/cyclophosphamide (AC) in operable breast cancer: analysis of response and tolerability in a randomised phase III trial (TOPIC 2).
Authors: Chua, S., Smith, I.E., A'Hern, R.P., Coombes, G.A., Hickish, T.F., Robinson, A.C., Laing, R.W., O'Brien, M.E.R., Ebbs, S.R., Hong, A., Wardley, A., Mughal, T., Verrill, M., Dubois, D., Bliss, J.M., TOPIC Trial Group
Journal: Ann Oncol
Publication Date: 09/2005
Volume: 16
Issue: 9
Pages: 1435-1441
ISSN: 0923-7534
DOI: 10.1093/annonc/mdi276
Abstract:BACKGROUND: Vinorelbine is active and well tolerated against advanced breast cancer but there are no published efficacy studies in early breast cancer. We have therefore carried out a randomised phase III neoadjuvant trial in operable breast cancer. PATIENTS AND METHODS: Patients with > or =3 cm operable breast carcinoma were randomised to receive either vinorelbine 25 mg/m(2) on days 1 and 8 and epirubicin 60 mg/m(2) on day 1, 3 weekly for six cycles (VE) or doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2) i.v. on day 1, 3 weekly for six cycles (AC), prior to standard local therapy, and adjuvant endocrine therapy as appropriate. RESULTS: A total of 451 patients were randomised. Results for AC and VE, respectively, were: overall clinical response 73% and 74%, complete clinical remission 20% and 24%, pathological complete remission 12% and 12%, mastectomy rate 52% and 55%. None of these differences were significant. Dose reduction was required in 8% for AC and 20% for VE (P <0.001) (GSCF support not used). Significantly more grade 3/4 toxicity for nausea, vomiting and alopecia (despite scalp cooling) was seen for AC compared with VE but significantly less grade 3/4 thrombophlebitis and neuropathy. CONCLUSIONS: Neoadjuvant VE is as effective as AC in early breast cancer and was better tolerated except for thrombophlebitis and neuropathy.
Source: PubMed
Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/cyclophosphamide (AC) in operable breast cancer: analysis of response and tolerability in a randomised phase III trial (TOPIC 2)
Authors: Chua, S., Smith, I.E., A'Hern, R.P., Coombes, G.A., Hickish, T.F., Robinson, A.C., Laing, R.W., O'Brien, M.E.R., Ebbs, S.R., Hong, A., Wardley, A., Mughal, T., Verrill, M., Dubois, D., Bliss, J.M.
Journal: ANNALS OF ONCOLOGY
Publication Date: 09/2005
Volume: 16
Issue: 9
Pages: 1435-1441
eISSN: 1569-8041
ISSN: 0923-7534
DOI: 10.1093/annonc/mdi276
Source: Web of Science
Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/cyclophosphamide (AC) in operable breast cancer: analysis of response and tolerability in a randomised phase III trial (TOPIC 2)
Authors: Chua, S., Smith, E., AHern, R.P., Coombes, G.A., Hickish, T.F., Robinson, A.C., Laing, R.W., O'Brien, M.E.R., Ebbs, S.R., Hong, A., Wardley, A., Mughal, T., Verrill, M., Dubois, D., Bliss, J.M.
Journal: Annals of Oncology
Publication Date: 09/06/2005
Volume: 16
Pages: 1435-1441
ISSN: 0923-7534
DOI: 10.1093/annonc/mdi276
Abstract:Background: Vinorelbine is active and well tolerated against advanced breast cancer but there are no published efficacy studies in early breast cancer. We have therefore carried out a randomised phase III neoadjuvant trial in operable breast cancer.
Patients and methods: Patients with 3 cm operable breast carcinoma were randomised to receive either vinorelbine 25 mg/m2 on days 1 and 8 and epirubicin 60 mg/m2 on day 1, 3 weekly for six cycles (VE) or doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 i.v. on day 1, 3 weekly for six cycles (AC), prior to standard local therapy, and adjuvant endocrine therapy as appropriate.
Results: A total of 451 patients were randomised. Results for AC and VE, respectively, were: overall clinical response 73% and 74%, complete clinical remission 20% and 24%, pathological complete remission 12% and 12%, mastectomy rate 52% and 55%. None of these differences were significant. Dose reduction was required in 8% for AC and 20% for VE (P <0.001) (GSCF support not used). Significantly more grade 3/4 toxicity for nausea, vomiting and alopecia (despite scalp cooling) was seen for AC compared with VE but significantly less grade 3/4 thrombophlebitis and neuropathy.
Conclusions: Neoadjuvant VE is as effective as AC in early breast cancer and was better tolerated except for thrombophlebitis and neuropathy.
http://annonc.oxfordjournals.org/cgi/content/abstract/16/9/1435
Source: Manual
Preferred by: Tamas Hickish
Neoadjuvant vinorelbine/epirubicin (VE) versus standard adriamycin/cyclophosphamide (AC) in operable breast cancer: analysis of response and tolerability in a randomised phase III trial (TOPIC 2).
Authors: Chua, S., Smith, I.E., A'Hern, R.P., Coombes, G.A., Hickish, T.F., Robinson, A.C., Laing, R.W., O'Brien, M.E.R., Ebbs, S.R., Hong, A., Wardley, A., Mughal, T., Verrill, M., Dubois, D., Bliss, J.M., TOPIC Trial Group
Journal: Annals of oncology : official journal of the European Society for Medical Oncology
Publication Date: 09/2005
Volume: 16
Issue: 9
Pages: 1435-1441
eISSN: 1569-8041
ISSN: 0923-7534
DOI: 10.1093/annonc/mdi276
Abstract:Background
Vinorelbine is active and well tolerated against advanced breast cancer but there are no published efficacy studies in early breast cancer. We have therefore carried out a randomised phase III neoadjuvant trial in operable breast cancer.Patients and methods
Patients with > or =3 cm operable breast carcinoma were randomised to receive either vinorelbine 25 mg/m(2) on days 1 and 8 and epirubicin 60 mg/m(2) on day 1, 3 weekly for six cycles (VE) or doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2) i.v. on day 1, 3 weekly for six cycles (AC), prior to standard local therapy, and adjuvant endocrine therapy as appropriate.Results
A total of 451 patients were randomised. Results for AC and VE, respectively, were: overall clinical response 73% and 74%, complete clinical remission 20% and 24%, pathological complete remission 12% and 12%, mastectomy rate 52% and 55%. None of these differences were significant. Dose reduction was required in 8% for AC and 20% for VE (P <0.001) (GSCF support not used). Significantly more grade 3/4 toxicity for nausea, vomiting and alopecia (despite scalp cooling) was seen for AC compared with VE but significantly less grade 3/4 thrombophlebitis and neuropathy.Conclusions
Neoadjuvant VE is as effective as AC in early breast cancer and was better tolerated except for thrombophlebitis and neuropathy.Source: Europe PubMed Central