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Published in: Breast Cancer 2/2010

01-04-2010 | Original Article

Paclitaxel as a first-line chemotherapy for Japanese women with advanced or recurrent breast cancer: a multi-institutional practice-based study by the Kyushu Breast Cancer Study Group (KBC-SG)

Authors: Mikimasa Ishikawa, Yasushi Takamatsu, Shoshu Mitsuyama, Nobutaka Iwakuma, Keisei Anan, Shuyou Umeda, Kazuo Tamura

Published in: Breast Cancer | Issue 2/2010

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Abstract

Background

Anthracycline-containing chemotherapy has represented the standard treatment for advanced breast cancer. However, it is sometimes difficult to continue it because of its cumulative cardiac toxicity, and the benefit of adding anthracyclines to the chemotherapy regimen is confined to HER2-overexpressed breast cancer. A non-anthracycline-based novel therapy is necessary to improve the survival and reduce the toxicity.

Methods

We evaluated the tumor response and adverse events of a first-line paclitaxel therapy in advanced or recurrent breast cancer in a variety of practice settings. Patients were to receive paclitaxel tri-weekly (175 mg/m2), bi-weekly (120 mg/m2) or weekly (80 mg/m2) until disease progression or toxicity precluded further treatment. Tumor response and toxicities were evaluated.

Results

Thirty-three patients received a total of 191 cycles (median 5, range 2–19). All patients completed at least two cycles. In 30 patients who were evaluable for response, there were 16 overall responses [53%, 95% confidence interval (CI) 34–72%], including 5 complete responses (17%, 95% CI 3–31%). The median progression-free survival and overall survival were 16 (95% CI 9–24) months and 29 (95% CI 24–36) months, respectively. Overall treatment was well tolerated, and no myelosuppression >grade 3 was reported during this study. A grade 3 dyspnea was noted in one patient, but it recovered spontaneously, and subsequent administration of paclitaxel was successfully given with no specific treatment. No other toxicity greater than grade 3 was demonstrated.

Conclusion

Paclitaxel as a first-line therapy at this dose and schedule is an effective and well-tolerated treatment regimen in Japanese patients with advanced or recurrent breast cancer.
Literature
1.
go back to reference Gennari A, Sormani MP, Pronzato P, Puntoni M, Colozza M, Pfeffer U, et al. HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: a pooled analysis of randomized trials. J Natl Cancer Inst. 2008;100:14–20.PubMedCrossRef Gennari A, Sormani MP, Pronzato P, Puntoni M, Colozza M, Pfeffer U, et al. HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: a pooled analysis of randomized trials. J Natl Cancer Inst. 2008;100:14–20.PubMedCrossRef
2.
go back to reference O’Malley FP, Chia S, Tu D, Shepherd LE, Levine MN, Huntsman DG, et al. Prognostic and predictive value of topoisomerase II alpha in a randomized trial comparing CMF to CEF in premenopausal women with node positive breast cancer (NCIC CTG MA.5). J Clin Oncol. 2006;24:S533.CrossRef O’Malley FP, Chia S, Tu D, Shepherd LE, Levine MN, Huntsman DG, et al. Prognostic and predictive value of topoisomerase II alpha in a randomized trial comparing CMF to CEF in premenopausal women with node positive breast cancer (NCIC CTG MA.5). J Clin Oncol. 2006;24:S533.CrossRef
3.
go back to reference Seidman AD, Hudis CA, Albanel J, Tong W, Tepler I, Currie V, et al. Dose-dense therapy with weekly 1-h paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol. 1998;16:3353–61.PubMed Seidman AD, Hudis CA, Albanel J, Tong W, Tepler I, Currie V, et al. Dose-dense therapy with weekly 1-h paclitaxel infusions in the treatment of metastatic breast cancer. J Clin Oncol. 1998;16:3353–61.PubMed
4.
go back to reference Seidman AD, Reichman BS, Crown JP, Yao TJ, Currie V, Hakes TB, et al. Paclitaxel as second and subsequent therapy for metastatic breast cancer: activity independent of prior anthracycline response. J Clin Oncol. 1995;13:1152–9.PubMed Seidman AD, Reichman BS, Crown JP, Yao TJ, Currie V, Hakes TB, et al. Paclitaxel as second and subsequent therapy for metastatic breast cancer: activity independent of prior anthracycline response. J Clin Oncol. 1995;13:1152–9.PubMed
5.
go back to reference Wist EA, Sommer HH, Ostenstad B, Risberg T, Fjaestad K. Weekly 1-h paclitaxel as first-line chemotherapy for MBC. Acta Oncol. 2004;43:5–7. Wist EA, Sommer HH, Ostenstad B, Risberg T, Fjaestad K. Weekly 1-h paclitaxel as first-line chemotherapy for MBC. Acta Oncol. 2004;43:5–7.
6.
go back to reference ten Tije AJ, Smorenburg CH, Seynaeve C, Sparreboom A, Schothorst KL, Kerkhofs LG, et al. Weekly paclitaxel as first-line chemotherapy for elderly patients with MBC. A multicentre phase II trial. Eur J Cancer. 2004;40:352–7.CrossRefPubMed ten Tije AJ, Smorenburg CH, Seynaeve C, Sparreboom A, Schothorst KL, Kerkhofs LG, et al. Weekly paclitaxel as first-line chemotherapy for elderly patients with MBC. A multicentre phase II trial. Eur J Cancer. 2004;40:352–7.CrossRefPubMed
7.
go back to reference Gelmon KA, Tolcher A, O’Reilly S, Campbell C, Bryce C, Shenkier T, et al. A phase I–II study of bi-weekly paclitaxel as first-line treatment in metastatic breast cancer. Ann Oncol. 1998;9:1247–9.CrossRefPubMed Gelmon KA, Tolcher A, O’Reilly S, Campbell C, Bryce C, Shenkier T, et al. A phase I–II study of bi-weekly paclitaxel as first-line treatment in metastatic breast cancer. Ann Oncol. 1998;9:1247–9.CrossRefPubMed
8.
go back to reference Sledge GW, Neuberg D, Bernardo P, Ingle JN, Martino S, Rowinsky EK, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol. 2003;21:588–92.CrossRefPubMed Sledge GW, Neuberg D, Bernardo P, Ingle JN, Martino S, Rowinsky EK, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol. 2003;21:588–92.CrossRefPubMed
9.
go back to reference Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982;38:143–51.CrossRefPubMed Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982;38:143–51.CrossRefPubMed
10.
go back to reference Chan S, Davidson N, Juozaityte E, Erdkamp F, Pluzanska A, Azarnia N, et al. Phase III trial of liposomal doxorubicin and cyclophosphamide compared with epirubicin and cyclophosphamide as first-line therapy for metastatic breast cancer. Ann Oncol. 2004;15:1527–34.CrossRefPubMed Chan S, Davidson N, Juozaityte E, Erdkamp F, Pluzanska A, Azarnia N, et al. Phase III trial of liposomal doxorubicin and cyclophosphamide compared with epirubicin and cyclophosphamide as first-line therapy for metastatic breast cancer. Ann Oncol. 2004;15:1527–34.CrossRefPubMed
11.
go back to reference Biganzoli L, Cufer T, Bruning P, Coleman R, Duchateau L, Calvert AH, et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-Line chemotherapy in metastatic breast cancer: the European organization for research and treatment of cancer 10961 multicenter phase III trial. J Clin Oncol. 2002;20:3114–21.CrossRefPubMed Biganzoli L, Cufer T, Bruning P, Coleman R, Duchateau L, Calvert AH, et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-Line chemotherapy in metastatic breast cancer: the European organization for research and treatment of cancer 10961 multicenter phase III trial. J Clin Oncol. 2002;20:3114–21.CrossRefPubMed
12.
go back to reference Norris B, Pritchard KI, James K, Myles J, Bennett K, Marlin S, et al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group study MA8. J Clin Oncol. 2000;18:2385–94.PubMed Norris B, Pritchard KI, James K, Myles J, Bennett K, Marlin S, et al. Phase III comparative study of vinorelbine combined with doxorubicin versus doxorubicin alone in disseminated metastatic/recurrent breast cancer: National Cancer Institute of Canada Clinical Trials Group study MA8. J Clin Oncol. 2000;18:2385–94.PubMed
13.
go back to reference Italian Multicentre Breast Study with Epirubicin. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. J Clin Oncol. 1988;6:976–82. Italian Multicentre Breast Study with Epirubicin. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. J Clin Oncol. 1988;6:976–82.
14.
go back to reference Tashiro H. Standard chemotherapy for metastatic breast cancer (in Japanese with English abstract). Nippon Rinsho. 2000;58:S246–53. Tashiro H. Standard chemotherapy for metastatic breast cancer (in Japanese with English abstract). Nippon Rinsho. 2000;58:S246–53.
15.
go back to reference Nishimura R, Ogawa T, Kato M, Tanaka M, Hamada Y, Shibata T, et al. Weekly paclitaxel in the treatment of advanced or metastatic breast cancer previously treated or not treated with docetaxel: a phase II study. Chemotherapy. 2005;51:126–31.CrossRefPubMed Nishimura R, Ogawa T, Kato M, Tanaka M, Hamada Y, Shibata T, et al. Weekly paclitaxel in the treatment of advanced or metastatic breast cancer previously treated or not treated with docetaxel: a phase II study. Chemotherapy. 2005;51:126–31.CrossRefPubMed
16.
go back to reference Kuroi K, Tanaka C, Bando H, Saji S, Hayashi K, Toi M. Efficacy of biweekly paclitaxel therapy in advanced or recurrent breast cancer (in Japanese with English abstract). Gan To Kagaku Ryoho. 2002;29:55–60.PubMed Kuroi K, Tanaka C, Bando H, Saji S, Hayashi K, Toi M. Efficacy of biweekly paclitaxel therapy in advanced or recurrent breast cancer (in Japanese with English abstract). Gan To Kagaku Ryoho. 2002;29:55–60.PubMed
17.
go back to reference Ito Y, Horikoshi N, Watanabe T, Sasaki Y, Tominaga T, Okawa T, et al. Phase II study of paclitaxel (BMS-181339) intravenously infused over 3 h for advanced or metastatic breast cancer in Japan. BMS-181339 Breast Cancer Study Group. Invest New Drugs. 1998;16:183–90.CrossRefPubMed Ito Y, Horikoshi N, Watanabe T, Sasaki Y, Tominaga T, Okawa T, et al. Phase II study of paclitaxel (BMS-181339) intravenously infused over 3 h for advanced or metastatic breast cancer in Japan. BMS-181339 Breast Cancer Study Group. Invest New Drugs. 1998;16:183–90.CrossRefPubMed
18.
go back to reference Jones SE, Savin MA, Holmes FA, O’Shaughnessy JA, Blum JL, Vukelja S, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006;24:5381–7.CrossRefPubMed Jones SE, Savin MA, Holmes FA, O’Shaughnessy JA, Blum JL, Vukelja S, et al. Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J Clin Oncol. 2006;24:5381–7.CrossRefPubMed
19.
go back to reference Yoneyama K, Koshida Y, Toriumi F, Murayama T, Toeda H, Imazu Y, et al. Examination of the safety of docetaxel/cyclophosphamide combination therapy for advanced recurrent breast cancer (in Japanese with English abstract). Gan To Kagaku Ryoho. 2006;33:1525–7.PubMed Yoneyama K, Koshida Y, Toriumi F, Murayama T, Toeda H, Imazu Y, et al. Examination of the safety of docetaxel/cyclophosphamide combination therapy for advanced recurrent breast cancer (in Japanese with English abstract). Gan To Kagaku Ryoho. 2006;33:1525–7.PubMed
Metadata
Title
Paclitaxel as a first-line chemotherapy for Japanese women with advanced or recurrent breast cancer: a multi-institutional practice-based study by the Kyushu Breast Cancer Study Group (KBC-SG)
Authors
Mikimasa Ishikawa
Yasushi Takamatsu
Shoshu Mitsuyama
Nobutaka Iwakuma
Keisei Anan
Shuyou Umeda
Kazuo Tamura
Publication date
01-04-2010
Publisher
Springer Japan
Published in
Breast Cancer / Issue 2/2010
Print ISSN: 1340-6868
Electronic ISSN: 1880-4233
DOI
https://doi.org/10.1007/s12282-009-0118-8

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