Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer

Mavroudis, Dimitriοs; Papakotoulas, Pavlos; Ardavanis, Alexandros; Syrigos, K.; Kakolyris, S; Ziras, Nikolaos; Kouroussis, Ch.; Malamos, Nikolaos; Polyzos, Aristidis; Christophyllakis, C.; Kentepozidis, Nikolaos; Georgoulias, Vassilis

doi:10.1093/annonc/mdp498

Cited by 33 publications

(25 citation statements)

References 16 publications

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“…Taxanes – paclitaxel and semisynthetic docetaxel (DT) – are approved as first-line treatment for non-small cell lung cancer (NSCLC) [6,7], breast [8,9] and ovarian [10] carcinomas and are also used in the treatment of numerous other malignancies [11,12,13,14,15]. Paclitaxel is a natural alkaloid isolated from Taxus brevifolia, whereas DT is a semi-synthetic compound produced from 10-deacetylbaccatin III found in Taxus baccata [16].…”

Section: Introductionmentioning

confidence: 99%

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Syrigou¹,

Dannos²,

Κοττέας³

et al. 2011

Int Arch Allergy Immunol

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Background: Docetaxel (DT) is an extensively used taxane, frequently associated with hypersensitivity reactions. The aim of this study was to record the epidemiological and clinical features of hypersensitivity to DT in non-small cell lung cancer patients in order to obtain useful information concerning the management of these patients. We also developed a desensitization protocol and evaluated its clinical application. Methods: We retrospectively reviewed records of 620 non-small cell lung cancer patients treated with DT-containing regimens in the adjuvant, first-, second- or next-line setting. Data from 102 patients who had exhibited hypersensitivity reactions were analyzed according to the Common Toxicity Criteria for Adverse Events version 3.0. Five patients were chosen for the desensitization protocol. We applied the standard protocol for parenteral desensitization to β-lactam antibiotics, and DT treatment was carried out with a series of 10-fold dilutions in sufficient volume to administer the total dose. Results: One hundred and two patients (16.5%) were recorded as having hypersensitivity to DT. Reactions were observed after approximately 2.5 ± 1.0 cycles. Only 14 patients (14/620, 2%) developed grade 3–4 hypersensitivity. Reactions were more likely in patients during second- or third-line chemotherapy, but no other correlation (age, gender, atopic status) was observed. Five patients completed a parenteral desensitization protocol and continued their treatment uneventfully. Conclusions: Hypersensitivity reactions to DT respond quickly to discontinuation along with appropriate supportive care. Premedication and increased infusion time may allow readministration. The desensitization protocol that we developed provides a reliable alternative to permanent discontinuation of DT.

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Section: Introductionmentioning

confidence: 99%

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Syrigou¹,

Dannos²,

Κοττέας³

et al. 2011

Int Arch Allergy Immunol

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“…In the second trial, with a superiority design unlike the non-inferiority design of MAMMA-3, the 2 treatment regimens were almost identical to those evaluated in ERASME-4, except that the capecitabine dose was 950 mg/m 2 b.i.d. instead of 1,000 mg/m 2 [4]. As with ERASME-4, the primary endpoint was not met, although arguably the statistical design was based on unrealistic assumptions: to increase median time to progression from 9 months with ET to 14 months with XT.…”

Section: Discussionmentioning

confidence: 99%

“…The combination was associated with a relatively high incidence of toxicity, particularly hand-foot syndrome and gastrointestinal toxicities, leading to frequent dose modification or treatment interruption. More recently, the XT combination has been tested in the first-line setting, typically using a lower capecitabine dose in combination with docetaxel [4,5]. Three phase III trials compared first-line XT with alternative docetaxel-containing doublets in HER2-negative MBC [4,5,6].…”

Section: Introductionmentioning

confidence: 99%

“…More recently, the XT combination has been tested in the first-line setting, typically using a lower capecitabine dose in combination with docetaxel [4,5]. Three phase III trials compared first-line XT with alternative docetaxel-containing doublets in HER2-negative MBC [4,5,6]. In addition, the randomized, phase II CHAT trial compared XT versus docetaxel, with trastuzumab given in both arms, as first-line therapy for HER2-positive MBC [7].…”

Section: Introductionmentioning

confidence: 99%

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Final Results of ERASME-4: A Randomized Trial of First-Line Docetaxel plus either Capecitabine or Epirubicin for Metastatic Breast Cancer

et al. 2011

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Objective: To assess the efficacy of capecitabine plus docetaxel (XT) versus epirubicin plus docetaxel (ET) as first-line therapy for metastatic breast cancer (MBC). Patients and Methods: Patients with no prior chemotherapy for MBC were randomized to 3-weekly cycles of either XT (capecitabine 1,000 mg/m² twice daily, days 1–14; docetaxel 75 mg/m², day 1) or ET (epirubicin 75 mg/m², day 1; docetaxel 75 mg/m², day 1). The primary endpoint was non-progression rate 6 months after randomization. The planned sample size was 106 patients based on a randomized, phase II selection design. Results: Between April 2004 and January 2007, 68 patients were randomized, giving 82% power to select the best regimen according to a 6-month non-progression rate. Slow accrual led to premature study termination. Baseline characteristics were generally well balanced between arms. The 6-month non-progression rates were 75.8% with XT versus 65.7% with ET (p = 0.36). After 42 months’ median follow-up, median progression-free survival was 12.4 versus 6.8 months, respectively (p = 0.040). The safety profiles were consistent with previous experience. Conclusion: Further larger studies are warranted to validate these results. Despite more grade 3 hand-foot syndrome, first-line XT may be a valid alternative to ET, potentially improving efficacy.

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“…In patients never exposed to taxanes, the combination of taxanes plus antimetabolites is an attractive option: two randomized trials have shown a higher ORR, longer TTP, and longer OS time for the combination of docetaxel plus capecitabine versus docetaxel alone and for paclitaxel plus gemcitabine versus gemcitabine alone [60,61]. Another phase III randomized trial tested the combination docetaxel plus capecitabine versus docetaxel plus gemcitabine, showing no difference in efficacy with different tolerability profiles [62]. The incorporation of antiangiogenic agents is an attractive tool for this subset of patients who lack the benefits of other targeted agents.…”

Section: Metastatic Breast Cancermentioning

confidence: 99%

Metastatic Breast Cancer: Therapeutic Options According to Molecular Subtypes and Prior Adjuvant Therapy

2009

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In spite of advances in treatment strategies, about 25%-40% of patients with breast cancer still eventually develop metastatic disease that is largely incurable. Treatment goals vary from symptom control to lengthening survival, mainly on the basis of patient age and performance status, tumor biology, site and extent of disease, and prior therapies. In particular, breast cancer molecular characterization allows for the identification of breast cancer subtypes with distinct biological features, a distinct clinical course, and distinct treatment sensitivity.Endocrine manipulation is the cornerstone of therapy in hormone receptor-positive tumors; anti-human epidermal growth factor receptor (HER)-2 agents are essential in the management of HER-2 ؉ tumors; and chemotherapy is the only available option so far for the triple-negative subtype. In each of these subtypes, the more efficacious agents have been progressively incorporated into adjuvant treatment. As a consequence, the choice of the optimal therapeutic strategy for patients with metastatic disease is largely influenced by prior exposure to adjuvant therapies. This review contextualizes the data from clinical trials into different clinical scenarios of metastatic disease, taking into account the molecular subtype and prior adjuvant treatments. The Oncologist 2009;14:645-656

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Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer

Abstract: The DE and DC regimens have similar efficacy but different toxicity. Either regimen can be used as front-line treatment of ABC.

Cited by 33 publications

References 16 publications

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Hypersensitivity Reactions to Docetaxel: Retrospective Evaluation and Development of a Desensitization Protocol

Final Results of ERASME-4: A Randomized Trial of First-Line Docetaxel plus either Capecitabine or Epirubicin for Metastatic Breast Cancer

Metastatic Breast Cancer: Therapeutic Options According to Molecular Subtypes and Prior Adjuvant Therapy

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