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01-01-2019 | Original Research

Patterns of Use of Docetaxel-Containing Adjuvant Chemotherapy Among Chinese Patients with Operable Breast Cancer: A Multicenter Observational Study

Authors: Hui Xie, Jinping Liu, Shiyou Yu, Yiding Chen, Min Zheng, Yongchuan Deng, Shu Wang, Jun Jiang, Yafen Li, Huiping Li, Hua Kang, Chunhui Zhang, Guo-Jun Zhang, Fengxi Su, Aiqun Cheng, Shui Wang

Published in: Advances in Therapy | Issue 1/2019

Abstract

Introduction

Adjuvant docetaxel-based chemotherapy is frequently used in the treatment of operable early breast cancer (EBC). This study investigated patterns of docetaxel use in patients with EBC in real-world clinical practice in China.

Methods

This was a multicenter, prospective, observational study of Chinese women with operable breast cancer in tier 1 non-oncology-specific hospitals and other city hospitals in China. Adult Chinese female patients (≥ 18 years) with newly diagnosed breast cancer who underwent surgery and received docetaxel-containing adjuvant chemotherapy were eligible for inclusion. The primary end point of the study was to assess patterns of docetaxel use for adjuvant therapy in Chinese clinical practice. Secondary end points included factors associated with treatment selection, patterns of G-CSF use and safety.

Results

In total, 502 patients were enrolled, 475 of whom were included in the analysis. The results showed that 31.6% of patients received docetaxel and anthracyclines in combination, 47.2% received docetaxel and anthracyclines sequentially, 18.5% received docetaxel and other medication either in combination or sequentially and 2.7% received ‘other’ chemotherapy regimens. Factors influencing selection of docetaxel/anthracycline in combination versus sequentially included age, breast cancer subgroup, PR status, and preoperative neoadjuvant chemotherapy. A total of 258 (54.3%), 35 (7.4%), and 108 (22.7%) patients received G-CSF as primary prevention, secondary prevention and treatment, respectively. Treatment-emergent adverse events (TEAEs) occurred in 54.5% (259) of patients, and the most frequently reported TEAEs (≥ 5% of patients) included bone marrow failure (10.1%), granulocytopenia (9.9%), nausea (8.8%) and vomiting (6.9%). Neutropenia and febrile neutropenia were reported by 10 and 12 patients, respectively.

Conclusion

Docetaxel for adjuvant chemotherapy of operable EBC in China was most commonly given in combination or sequentially with anthracyclines. The study also showed that in China G-CSF is most frequently used as primary prophylactic, and no unexpected safety events were observed during docetaxel treatment.

Funding

Sanofi (China).

Chow LW, Biganzoli L, Leo AD, et al. Toxicity profile differences of adjuvant docetaxel/cyclophosphamide (TC) between Asian and Caucasian breast cancer patients. Asia Pac J Clin Oncol. 2017. https://doi.org/10.1111/ajco.12682.CrossRefPubMed

Li J, Zhang BN, Fan JH, et al. A nation-wide multicenter 10-year (1999–2008) retrospective clinical epidemiological study of female breast cancer in China. BMC Cancer. 2011;11:364. https://doi.org/10.1186/1471-2407-11-364.CrossRefPubMedPubMedCentral

Anampa J, Makower D, Sparano JA. Progress in adjuvant chemotherapy for breast cancer: an overview. BMC Med. 2015;13:195. https://doi.org/10.1186/s12916-015-0439-8.CrossRefPubMedPubMedCentral

Senkus E, Kyriakides S, Ohno S, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl 5):v8–30. https://doi.org/10.1093/annonc/mdv298.CrossRefPubMed

Gradishar WJ, Anderson BO, Balassanian R, et al. NCCN guidelines insights: breast cancer, version 1.2017. J Natl Compr Cancer Netw. 2017;15(4):433–51.CrossRef

Henry NL, Somerfield MR, Krop IE. Role of patient and disease factors in adjuvant systemic therapy decision making for early-stage, operable breast cancer: American society of clinical oncology endorsement of cancer care ontario guideline recommendations summary. J Oncol Pract. 2016;12(5):482–4. https://doi.org/10.1200/jop.2016.011205.CrossRef

Denduluri N, Somerfield MR, Eisen A, et al. Selection of optimal adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2)-negative and adjuvant targeted therapy for HER2-positive breast cancers: an American society of clinical oncology guideline adaptation of the cancer care ontario clinical practice guideline. J Clin Oncol. 2016;34(20):2416–27. https://doi.org/10.1200/jco.2016.67.0182.CrossRefPubMed

Peto R, Davies C, Godwin J, et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet (London, England). 2012;379(9814):432–44. https://doi.org/10.1016/s0140-6736(11)61625-5.CrossRef

Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet (London, England). 2005;365(9472):1687–717. https://doi.org/10.1016/s0140-6736(05)66544-0.

10.

Li Q, Yang Z, Fan J, et al. A nation-wide multicenter 10-year (1999–2008) retrospective study of chemotherapy in Chinese breast cancer patients. Oncotarget. 2017. https://doi.org/10.18632/oncotarget.16439.CrossRefPubMedPubMedCentral

11.

Crozier JA, Swaika A, Moreno-Aspitia A. Adjuvant chemotherapy in breast cancer: to use or not to use, the anthracyclines. World J Clin Oncol. 2014;5(3):529–38. https://doi.org/10.5306/wjco.v5.i3.529.CrossRefPubMedPubMedCentral

12.

Giordano SH, Lin Y-L, Kuo YF, Hortobagyi GN, Goodwin JS. Decline in the use of anthracyclines for breast cancer. J Clin Oncol. 2012;30(18):2232–9. https://doi.org/10.1200/jco.2011.40.1273.CrossRefPubMedPubMedCentral

13.

Greene J, Hennessy B. The role of anthracyclines in the treatment of early breast cancer. J Oncol Pharm Pract. 2015;21(3):201–12. https://doi.org/10.1177/1078155214531513.CrossRefPubMed

14.

Qin YY, Li H, Guo XJ, et al. Adjuvant chemotherapy, with or without taxanes, in early or operable breast cancer: a meta-analysis of 19 randomized trials with 30698 patients. PLoS One. 2011;6(11):e26946. https://doi.org/10.1371/journal.pone.0026946.CrossRefPubMedPubMedCentral

15.

Ferguson T, Wilcken N, Vagg R, Ghersi D, Nowak AK. Taxanes for adjuvant treatment of early breast cancer. Cochrane Database Syst Rev. 2007;(4):Cd004421. https://doi.org/10.1002/14651858.cd004421.pub2.

16.

Crown J, O’Leary M, Ooi WS. Docetaxel and paclitaxel in the treatment of breast cancer: a review of clinical experience. Oncologist. 2004;9(Suppl 2):24–32.CrossRefPubMed

17.

Watanabe T, Kuranami M, Inoue K, et al. Comparison of an AC-taxane versus AC-free regimen and paclitaxel versus docetaxel in patients with lymph node-positive breast cancer: final results of the National Surgical Adjuvant Study of Breast Cancer 02 trial, a randomized comparative phase 3 study. Cancer. 2017;123(5):759–68. https://doi.org/10.1002/cncr.30421.CrossRefPubMed

18.

Mitchell S, Li X, Woods M, et al. Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: a systematic review. J Oncol Pharm Pract. 2016;22(5):702–16. https://doi.org/10.1177/1078155215625459.CrossRefPubMed

19.

Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005;23(6):1178–84. https://doi.org/10.1200/jco.2005.09.102.CrossRefPubMed

20.

Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med. 1991;325(3):164–70. https://doi.org/10.1056/nejm199107183250305.CrossRefPubMed

21.

Zhu X, Bouganim N, Vandermeer L, Dent SF, Dranitsaris G, Clemons MJ. Use and delivery of granulocyte colony-stimulating factor in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy-single-centre experience. Curr Oncol (Toronto, Ont). 2012;19(4):e239–43. https://doi.org/10.3747/co.19.948.CrossRefPubMedCentral

22.

Ho MY, Mackey JR. Presentation and management of docetaxel-related adverse effects in patients with breast cancer. Cancer Manag Res. 2014;6:253–9. https://doi.org/10.2147/cmar.s40601.CrossRefPubMedPubMedCentral

23.

Citron ML, Berry DA, Cirrincione C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003;21(8):1431–9. https://doi.org/10.1200/jco.2003.09.081.CrossRefPubMed

24.

Yerushalmi R, Goldvaser H, Sulkes A, et al. Adjuvant docetaxel and cyclophosphamide (DC) with prophylactic granulocyte colony-stimulating factor (G-CSF) on days 8 & 12 in breast cancer patients: a retrospective analysis. PLoS One. 2014;9(10):e107273. https://doi.org/10.1371/journal.pone.0107273.CrossRefPubMedPubMedCentral

25.

Gradishar WJ, Anderson BO, Balassanian R, et al. NCCN guidelines insights breast cancer, version 1.2016. J Natl Compr Cancer Netw. 2015;13(12):1475–85.CrossRef

26.

Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American society of clinical oncology clinical practice guideline update. J Clin Oncol. 2015;33(28):3199–212. https://doi.org/10.1200/jco.2015.62.3488.CrossRefPubMed

27.

Gandara DR, Kawaguchi T, Crowley J, et al. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol. 2009;27(21):3540–6. https://doi.org/10.1200/jco.2008.20.8793.CrossRefPubMedPubMedCentral

28.

Han HS, Reis IM, Zhao W, et al. Racial differences in acute toxicities of neoadjuvant or adjuvant chemotherapy in patients with early-stage breast cancer. Eur J Cancer (Oxford, England: 1990). 2011;47(17):2537–45. https://doi.org/10.1016/j.ejca.2011.06.027.CrossRef

29.

Hendler D, Rizel S, Yerushalmi R, et al. Different schedules of granulocyte growth factor support for patients with breast cancer receiving adjuvant dose-dense chemotherapy: a prospective nonrandomized study. Am J Clin Oncol. 2011;34(6):619–24. https://doi.org/10.1097/coc.0b013e3181f94716.CrossRefPubMed

30.

Papaldo P, Lopez M, Marolla P, et al. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol. 2005;23(28):6908–18. https://doi.org/10.1200/jco.2005.03.099.CrossRefPubMed

31.

Sparano JA, Wang M, Martino S, et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008;358(16):1663–71. https://doi.org/10.1056/nejmoa0707056.CrossRefPubMedPubMedCentral

32.

Jones S, Holmes FA, O’Shaughnessy J, et al. Docetaxel With cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of us Oncology Research Trial 9735. J Clin Oncol. 2009;27(8):1177–83. https://doi.org/10.1200/jco.2008.18.4028.CrossRefPubMed

33.

Nabholtz JM, Mackey JR, Smylie M, et al. Phase II study of docetaxel, doxorubicin, and cyclophosphamide as first-line chemotherapy for metastatic breast cancer. J Clin Oncol. 2001;19(2):314–21. https://doi.org/10.1200/jco.2001.19.2.314.CrossRefPubMed

34.

Nabholtz JM, Falkson C, Campos D, et al. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003;21(6):968–75. https://doi.org/10.1200/jco.2003.04.040.CrossRefPubMed

35.

Sparano JA, O’Neill A, Schaefer PL, Falkson CI, Wood WC. Phase II trial of doxorubicin and docetaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: Eastern Cooperative Oncology Group Study E1196. J Clin Oncol. 2000;18(12):2369–77. https://doi.org/10.1200/jco.2000.18.12.2369.CrossRefPubMed

36.

Mackey JR, Martin M, Pienkowski T, et al. Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial. Lancet Oncol. 2013;14(1):72–80. https://doi.org/10.1016/s1470-2045(12)70525-9.CrossRefPubMed

37.

Swain SM, Jeong JH, Geyer CE Jr, et al. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med. 2010;362(22):2053–65. https://doi.org/10.1056/nejmoa0909638.CrossRefPubMedPubMedCentral

38.

Mackey JR, Pienkowski T, Crown J, et al. Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. Ann Oncol. 2016;27(6):1041–7. https://doi.org/10.1093/annonc/mdw098.CrossRefPubMed

39.

Kim SB, Sayeed A, Villalon AH, et al. Safety analysis of adjuvant chemotherapy with docetaxel administered with or without anthracyclines to early stage breast cancer patients: combined results from the Asia-Pacific breast initiatives I and II. Asian Pac J Cancer Prev. 2016;17(2):697–702.CrossRefPubMed

40.

Kim SB, Kok YT, Thuan TV, Chao TY, Shen ZZ. safety results of Docetaxel-(Taxotere(R))-based chemotherapy in early breast cancer patients of Asia-Pacific region: Asia-Pacific Breast Initiative II. J Breast Cancer. 2015;18(4):356–64. https://doi.org/10.4048/jbc.2015.18.4.356.CrossRefPubMedPubMedCentral

41.

Eiermann W, Pienkowski T, Crown J, et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol. 2011;29(29):3877–84. https://doi.org/10.1200/jco.2010.28.5437.CrossRefPubMed

42.

Ganz PA, Land SR, Geyer CE Jr, et al. Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial. J Clin Oncol. 2011;29(9):1110–6. https://doi.org/10.1200/jco.2010.29.7689.CrossRefPubMedPubMedCentral

43.

DaCosta Byfield S, Buck PO, Blauer-Peterson C, et al. ReCAP: treatment patterns and cost of care associated with initial therapy among patients diagnosed with operable early-stage human epidermal growth factor receptor 2-overexpressed breast cancer in the united states: a real-world retrospective study. J Oncol Pract. 2016;12(2):159–67. https://doi.org/10.1200/jop.2015.004747.CrossRef

44.

Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659–72. https://doi.org/10.1056/nejmoa052306.CrossRefPubMed

45.

Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673–84. https://doi.org/10.1056/nejmoa052122.CrossRefPubMed

46.

Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273–83. https://doi.org/10.1056/nejmoa0910383.CrossRefPubMedPubMedCentral

47.

Fan L, Strasser-Weippl K, Li JJ, et al. Breast cancer in China. Lancet Oncol. 2014;15(7):e279–89. https://doi.org/10.1016/s1470-2045(13)70567-9.CrossRefPubMed

48.

Kim SB, Sayeed A, Villalon AH, et al. Docetaxel-based adjuvant therapy for breast cancer patients in Asia-Pacific region: results from 5 years follow-up on Asia-Pacific Breast Initiative-I. Asia Pac J Clin Oncol. 2016;12(2):125–32. https://doi.org/10.1111/ajco.12454.CrossRefPubMed

49.

Martin M, Lluch A, Segui MA, et al. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol. 2006;17(8):1205–12. https://doi.org/10.1093/annonc/mdl135.CrossRefPubMed

50.

Maenpaa J, Varthalitis I, Erdkamp F, et al. The use of granulocyte colony stimulating factor (G-CSF) and management of chemotherapy delivery during adjuvant treatment for early-stage breast cancer–further observations from the IMPACT solid study. Breast (Edinburgh, Scotland). 2016;25:27–33. https://doi.org/10.1016/j.breast.2015.11.007.CrossRef

Title: Patterns of Use of Docetaxel-Containing Adjuvant Chemotherapy Among Chinese Patients with Operable Breast Cancer: A Multicenter Observational Study
Authors: Hui Xie
Jinping Liu
Shiyou Yu
Yiding Chen
Min Zheng
Yongchuan Deng
Shu Wang
Jun Jiang
Yafen Li
Huiping Li
Hua Kang
Chunhui Zhang
Guo-Jun Zhang
Fengxi Su
Aiqun Cheng
Shui Wang
Publication date: 01-01-2019
Publisher: Springer Healthcare
Published in: Advances in Therapy / Issue 1/2019
Print ISSN: 0741-238X
Electronic ISSN: 1865-8652
DOI: https://doi.org/10.1007/s12325-018-0841-7

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Abstract

Introduction

Methods

Results

Conclusion

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