Trastuzumab plus docetaxel with or without capecitabine as first-line therapy for HER2-positive locally advanced or metastatic breast cancer: a randomised Phase II study

Wardlev, A.; Antón-Torres, Antonio; Pivot, Xavier; Morales-Vásquez, Flavia; Zetina, L.; Gauí, Maria de Fátima Dias; Reyes, Daniela; Jassem, Jacek; Button, Peter

doi:10.1016/s1359-6349(08)70525-1

Cited by 11 publications

(8 citation statements)

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“…The recently presented first efficacy results show an overall response rate of 73% in the trastuzumab-docetaxel arm, with a median TTP of 13.8 months and OS time of 38.7 months [38]. There was no significant difference in the response rate or survival time with the addition of capecitabine, but longer follow-up results are anticipated from this study.…”

Section: Phase IImentioning

confidence: 52%

“…The phase II MO16419 (Capecitabine, Herceptin and Taxotere [CHAT]) study randomized patients (n ϭ 222) with HER-2-positive MBC to receive first-line trastuzumab plus docetaxel (75-100 mg/m 2 ) every 3 weeks either with or without capecitabine (Xeloda; Roche Laboratories Inc., Basel, Switzerland) (950 mg/m 2 ). The recently presented first efficacy results show an overall response rate of 73% in the trastuzumab-docetaxel arm, with a median TTP of 13.8 months and OS time of 38.7 months [38]. There was no significant difference in the response rate or survival time with the addition of cape-citabine, but longer follow-up results are anticipated from this study.…”

Section: Phase IImentioning

confidence: 52%

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Clinical Efficacy of Taxane–Trastuzumab Combination Regimens for HER-2–Positive Metastatic Breast Cancer

Bullock

Blackwell

2008

The Oncologist

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After completing this course, the reader will be able to:1. Evaluate the results of trials assessing the efficacy of monotherapy and doublet therapy of the taxanes, paclitaxel and docetaxel, plus trastuzumab in HER-2-positive MBC patients.2. Administer the optimal dosing schedule of taxanes in HER-2-positive MBC patients.3. Explain the possible benefits and toxicity of using anthracycline-sparing platinum chemotherapy in combination with taxane-trastuzumab therapy for HER-2-positive MBC.This article is available for continuing medical education credit at CME.TheOncologist.com. In one study, the addition of carboplatin to paclitaxeltrastuzumab therapy resulted in a higher response rate and longer progression-free survival time; in the second study, the docetaxel-trastuzumab and docetaxel-trastuzumab-carboplatin combinations were equally effective. Ongoing correlative studies of taxanes, as well as newer formulations such as nanoparticle albuminCorrespondence: Kimberly L. CME CME ABSTRACT

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Section: Phase IImentioning

confidence: 52%

Section: Phase IImentioning

confidence: 52%

Clinical Efficacy of Taxane–Trastuzumab Combination Regimens for HER-2–Positive Metastatic Breast Cancer

Bullock

Blackwell

2008

The Oncologist

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“…The ongoing XeNA study, in which treatment was assigned based on centrally performed FISH analysis, is expected to provide further clinical evidence to support the high activity observed with these regimens in patients with LABC or MBC 17,36. A particularly important feature of the XeNA study is the use of pCR plus npCR as the primary endpoint.…”

Section: Discussionmentioning

confidence: 99%

“…A randomized phase II study in patients with MBC or LABC compared 3-weekly cycles of HXT (trastuzumab 8 mg/kg loading dose followed by 6 mg/kg, capecitabine 950 mg/m 2 BID days 1-14, and docetaxel 75 mg/m 2 ) with HT (trastuzumab and docetaxel 100 mg/m 2 ) 36. Both combinations produced high ORR (71% and 73%, respectively), but the HXT combination significantly prolonged both time to progression and progression-free survival compared with HT, with the median increased by 5 months for both parameters.…”

Section: Introductionmentioning

confidence: 99%

XeNA: Capecitabine Plus Docetaxel, With or Without Trastuzumab, as Preoperative Therapy for Early Breast Cancer

Glück¹,

McKenna²,

Royce³

2008

Int. J. Med. Sci.

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Combinations of capecitabine and a taxane are highly active in metastatic breast cancer, and synergy between capecitabine and docetaxel has also been demonstrated. Such combinations potentially would provide a promising non–anthracycline-based alternative for patients with early breast cancer. Non-anthracycline preoperative regimens are a particularly interesting proposition in human epidermal growth factor receptor 2 (HER2)-positive breast cancer, as they offer less cardiotoxicity and thus can be used concomitantly with preoperative trastuzumab therapy. Capecitabine plus docetaxel (XT) and trastuzumab with XT (HXT) are promising non-anthracycline regimens for the preoperative treatment of women with HER2-negative and HER2-positive breast cancer, respectively. The Xeloda in Neoadjuvant (XeNA) trial, an open-label, multicenter, phase II study, independently assesses the efficacy of preoperative XT in HER2-negative and HXT in HER2-positive breast cancer. A particularly important feature of the XeNA study is the use of pathologic complete response (pCR) plus near pCR (npCR) as the primary endpoint. pCR is associated with long-term survival, and although it is valuable as a surrogate marker, pCR has some limitations. Measurement of residual breast cancer burden (RCB) has been proposed as a more practical alternative to predict survival after preoperative chemotherapy. The combination of RCB-0 and RCB-I (npCR) expands the subset of patients shown to benefit from preoperative chemotherapy, and achievement of pCR or npCR is associated with long disease-free survival. In XeNA, the sum of pCR and npCR will facilitate correlative studies designed to identify patients most likely to benefit from XT and HXT and may expedite the clinical evaluation of these novel preoperative regimens.

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“…Capecitabineisanestablishedtreatmentoptionformetastatic breast cancer, with proven efficacy as monotherapy [1][2][3][4][5] or incombinationwithchemotherapy [6,7],anti-HER2therapy [8][9][10],orbevacizumab [11].Thesafetyprofileofcapecitabineischaracterizedbymanageablehand-footsyndromeand diarrhea.…”

Section: Introductionmentioning

confidence: 99%

Capecitabine in the Routine Treatment of Advanced Breast Cancer: Results from a Non-Interventional Observational Study in 870 Patients

et al. 2009

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Background: This observational study evaluated patient characteristics, treatment schedule and setting, efficacy and tolerability of capecitabine in routine clinical practice in Germany. Patients and Methods: Patients with advanced breast cancer pretreated with or ineligible for anthracycline-containing therapy were treated with capecitabine. Data were collected until disease progression or completion of 12 cycles (with long-term follow-up in progression-free patients). Results: 846 of the 876 patients enrolled between 2002 and 2007 were eligible. Capecitabine was administered as monotherapy in 64% (median starting dose 1,070 mg/m² bis in diem (b.i.d.)) and combination chemotherapy (typically with vinorelbine or docetaxel) in 36% (median starting dose 987 mg/m2 b.i.d.). Capecitabine was given as first-line therapy in 35% of patients. Objective response rate was 41% and median progression-free survival was 7.5 months. Good performance status at baseline was a significant predictor of efficacy. The most common non-hematological toxicity was hand-foot syndrome (all grades: 54%; grade 3: 7%). Myelosuppression and alopecia were substantially less common with capecitabine monotherapy than with capecitabine combination regimens. Conclusions: Capecitabine, alone or in combination, is a feasible, effective treatment for breast cancer. Our findings in real-life clinical practice compare favorably with results from interventional studies, perhaps reflecting the longer treatment duration possible at more tolerable doses.

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Trastuzumab plus docetaxel with or without capecitabine as first-line therapy for HER2-positive locally advanced or metastatic breast cancer: a randomised Phase II study

Cited by 11 publications

References 0 publications

Clinical Efficacy of Taxane–Trastuzumab Combination Regimens for HER-2–Positive Metastatic Breast Cancer

Clinical Efficacy of Taxane–Trastuzumab Combination Regimens for HER-2–Positive Metastatic Breast Cancer

XeNA: Capecitabine Plus Docetaxel, With or Without Trastuzumab, as Preoperative Therapy for Early Breast Cancer

Capecitabine in the Routine Treatment of Advanced Breast Cancer: Results from a Non-Interventional Observational Study in 870 Patients

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