Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group

European Journal of Cancer

Volumn 47, Issue 2, 2011, Pages 215-220

  Fraser, Judith ^a,b   Steele, Nicola ^a   Al Zaman, Aysha ^a   Yule, Alison ^b  

^a BEATSON WEST OF SCOTLAND CANCER CENTRE   (United Kingdom)

^b NHS FORTH VALLEY   (United Kingdom)

Author keywords

Breast cancer; Docetaxel; Febrile neutropaenia; Toxicity

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; EPIRUBICIN; ESTROGEN RECEPTOR; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR; PROGESTERONE RECEPTOR;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DRUG DOSE REDUCTION; FEBRILE NEUTROPENIA; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; ONCOGENE NEU; PRIORITY JOURNAL;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; EPIRUBICIN; FEMALE; FEVER; HUMANS; MAXIMUM TOLERATED DOSE; MEDICAL AUDIT; MIDDLE AGED; NEUTROPENIA; RETROSPECTIVE STUDIES; TAXOIDS; TREATMENT OUTCOME;

EID: 78650695919     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2010.10.001     Document Type: Article

References (15)

1. H. Roche, P. Fumoleau, and M. Spielmann Sequential Adjuvant epirubicin-based and docetaxel chemotherapy for node positive breast cancer patients: the FNCLCC PACS 01 trial J Clin Oncol 24 2006 5664 5671
2. C. Henderson, D.A. Berry, and G.D. Demetri Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer J Clin Oncol 21 2003 976 983
3. E.P. Mamounas, J. Bryant, and B.C. Lembersky Paclitaxel(T) following doxorubicin/cyclophosphamide (AC) as adjuvant chemotherapy for node positive breast cancer results from NSA B-28 Proc Am Soc Oncol 22 2003 A12
4. A.U. Buzdar, S.E. Singletary, and V. Valero Evaluation of paclitaxel in adjuvant chemotherapy for patients with operable breast cancer: preliminary data of a prospective randomised trial Clin Cancer Res 8 2002 1073 1079
5. M.L. Citron, D.A. Berry, and C. Cirrincione Randomised trial of dose-dense versus conventional 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 Leukaemia Group B Trial 9741 J Clin Oncol 21 2003 1431 1439
6. M. Martin, T. Pienkowski, and J. Mackey Adjuvant docetaxel for node positive breast cancer NEJM 352 2005 2302 2313
7. S.E. Jones, M.A. Savin, and F.A. Holmes Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer J Clin Oncol 24 2006 5381 5387
8. P. Ellis, P. Barrett-Lee, and L. Johnson Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial Lancet 373 2009 1681 1692
9. M.J. Piccart-Gebhart, M. Procter, and B. Leyland-Jones Trastuzumab after adjuvant chemotherapy in Her2-positive breast cancer NEJM 353 16 2005 1659 1672
10. Head J, Archer C, Harper-Wynne C, et al. Rates of neutropaenic sepsis with the use of adjuvant FEC100-Docetaxel (FEC100-T) chemotherapy in high-risk node-positive patients with early breast cancer; A UK perspective. In: NCRI cancer conference poster; 2008. p. B64.
11. Ali Z, O'Reilly S, Zahoor T, et al. Experience of febrile neutropaenia and secondary G-CSF prophylaxis during FEC-D chemotherapy in Merseyside and Cheshire Cancer Network. In NCRI cancer conference poster; 2008. p. B67.
12. Gohil S, Sharma A, Harper-Wynne C. Comparison of rates of febrile neutropaenia using FEC100/Docetaxel100 chemotherapy in breast cancer patients with and without primary GCSF prophylaxis. In: NCRI cancer conference poster; 2009. p. B75.
13. D. Soong, R. Haj, and M. Leung High rate of febrile neutropaenia in patients with operable breast cancer receiving docetaxel and cyclophosphamide J Clin Oncol 27 2009 101 102
14. T.J. Smith, J. Khatcheressian, and G.H. Lyman 2006 Update of ASCO practice guideline recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline J Clin Oncol 24 2006 3187 3205
15. V. Cottin, D. Arpin, and C. Lasset Small-cell lung cancer: patients included in clinical trials are not representative of the patient population as a whole Ann Oncol 10 1999 809 815