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Integrating Xeloda into primary systemic therapy of breast cancer: case study

Integrating Xeloda into primary systemic therapy of breast cancer: case study. Marjorie Green MD Anderson Cancer Center University of Texas Texas, USA. Patient history: November 2003. A 42-year-old woman (premenopausal) reported lump in left breast PET showed tumours in left breast and axilla

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Integrating Xeloda into primary systemic therapy of breast cancer: case study

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  1. Integrating Xeloda into primary systemic therapy of breast cancer: case study Marjorie Green MD Anderson Cancer CenterUniversity of TexasTexas, USA

  2. Patient history: November 2003 • A 42-year-old woman (premenopausal) reported lump in left breast • PET showed tumours in left breast and axilla • infiltrating ductal carcinoma • histological grade 3 • ER positive • PR positive • HER2 3+ by IHC PET = positron electron tomography; ER = oestrogen receptorPR = progesterone receptor; IHC = immunohistochemistry

  3. Tumours at diagnosis: November 2003

  4. Is there a danger ofovertreating patients? • ‘Healthy’ patients should be able to tolerate the side effects associated with intense chemotherapy regimens if improved clinical outcomes • XT dose is not yet optimised in this population with ‘non-life-threatening’ disease • needs to be refined to improve tolerability • active dose management with XT provides manageable safety

  5. Pivotal studies of primary systemic therapy (PST) • NSABP B-181,2 • four cycles of pre-operative AC = four cycles of post-operative AC; in terms of 5-year disease-free and overall survival • NSABP B-273,4 • pre-operative AC  docetaxel versus pre-operative AC alone improves CR and pCR • in patients achieving a pCR, pre-operative AC  docetaxel significantly increased disease-free survival versus AC alone • Aberdeen study (TAX 301)5 • pre-operative CVAP  docetaxel versus CVAP  CVAP significantly increased CR, breast conservation rate, survival (median follow-up of 3 years) AC = doxorubicin/cyclophosphamide CR = clinical response pCR = pathological complete response CVAP = cyclophosphamide/vincristine/doxorubicin/prednisone 1Fisher B, et al. J Clin Oncol 1997;15:2483–932Fisher B, et al. J Clin Oncol 1998;16:2672–85 3Bear HD, et al. J Clin Oncol 2003;21:4165–74 4Bear HD, et al. Breast Cancer Res Treat 2004;88(Suppl. 1):S16 (Abst 26) 5Heys SD, et al. Clin Breast Cancer 2002;3(Suppl. 2):S69–74

  6. International Expert Panelrecommendations for use of PST • Standard treatment for patients with inoperable primary breast cancer • Mostly patients with an unfavourable prognosis • stage IIIA–B or T3–4 disease • classic inflammatory breast cancer • ipsilateral supra- or infraclavicular lymph nodes (N3) • In operable breast cancer, PST can be considered as an alternative to adjuvant therapy Kaufmann M, et al. J Clin Oncol 2003;21:2600–8

  7. Phase III trial: XT versus AC as primary therapy for early breast cancer • Patient enrolled in the phase III XT versus AC trial of pre-operative chemotherapy: randomised to receive XT RANDO MIS ATION SURGERY AC x 4 (60/600) XT x 4 (1000/75) Primary Adjuvant AC x 4 (60/600) XT x 4 (1000/75) T = Taxotere; X = Xeloda Ahn J-B, et al. Ann Oncol 2004;15(Suppl. 3):iii57 (Abst 215PD)

  8. Patient’s treatment course Four cycles of XT (November 2003–February 2004) Left lumpectomy with axillary dissection (February 2004) Four cycles of AC (March 2004–May 2004) + Tamoxifen 20mg daily Radiation therapy (May 2004 onwards)

  9. Response to neoadjuvant XT • At diagnosis (ultrasound, November 2003) • left breast tumours: 2.6 x 1.6cm, 0.5 x 0.3cm • left axillary node tumour: 2.4 x 1.5cm • After XT (ultrasound, February 2004) • left breast tumours: 0.6 x 0.5cm, 0.5 x 0.3cm • left axillary node tumour: 0.6 x 0.6cm • Left breast-conserving surgery (February 2004) • pCR in primary tumour and axillary lymph node (0/9)

  10. Tumour before and after treatment with XT November 2003(at diagnosis) February 2004(post-XT x 4)

  11. XT was associated with manageable toxicity • The patient completed four cycles of XT with a relative dose intensity of 100% • Side effects with pre-operative XT included • grade 1 nail change, fatigue, constipation, mucositis, decreased appetite • grade 2 hand-foot syndrome, arthralgia, myalgia • grade 4 neutropenia • Side effects with adjuvant AC included • grade 2 leucopenia, neutropenia, anemia, loss of appetite, alopecia • grade 1 nausea, myalgia

  12. Case summary • 42-year-old patient • two tumours in left breast, axillary node involvement • enrolled into the phase III XT versus AC trial • PST with four cycles of XT • tumour downsizing enabling breast-conserving surgery • left breast lumpectomy, axillary lymph node dissection • pCR • Four cycles of adjuvant AC, plus radiation therapy and tamoxifen for 5 years • XT well tolerated

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