Dose-Dense Biweekly Doxorubicin/Docetaxel Versus Sequential Neoadjuvant Chemotherapy with Doxorubicin/Cyclophosphamide/Docetaxel in Operable Breast Cancer: Second Interim Analysis

Jackisch, Christian; Minckwitz, Gϋnter von; Eidtmann, Holger; Costa, Serban Dan; Raab, Günther; Blohmer, Jens U.; Schütte, Martin; Gerber, Bernd; Merkle, E.; Gademann, G.; Lampe, Dieter; Hilfrich, J.; Tulusan, A. H.; Caputo, Angelika; Kaufmann, M.

doi:10.3816/cbc.2002.n.031

Cited by 42 publications

(16 citation statements)

References 11 publications

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“…Following on from the observed complete pathological response rate of 10% with the previously described dose-intensified, 8-week AT schedule [39], the randomised Phase II GEPAR-DUO study has tested whether equivalent complete pathological response rates could be achieved for the 8-week schedule and a sequential 24-week schedule -AC for 4 cycles followed by docetaxel for 4 cycles -in the primary treatment of primary operable breast cancer [47,49]. Results presented at the 2002 American Society of Clinical Oncology (ASCO) meeting showed that while both regimens were feasible, the sequential regimen achieved a significantly higher overall complete pathological response than did AT alone (23% versus 12%, respectively) [47].…”

Section: Docetaxel-anthracycline Concomitant Regimensmentioning

confidence: 99%

Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival

Heys

Sarkar

Hutcheon

2005

Breast Cancer Res Treat

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Primary chemotherapy achieves high clinical response rates and facilitates breast conservation in many patients with large and locally advanced breast cancer. It may also serve to indicate responsiveness to chemotherapeutic agents. A pathological complete response to primary chemotherapy is a primary predictor and surrogate marker of long-term outcome, but occurs in only approximately 15% of patients. Docetaxel is of particular interest in this setting. Primary docetaxel chemotherapy has single-agent activity in both dose-dense and traditional schedules, with acceptable tolerability. Furthermore, concomitant docetaxel-anthracycline schedules have shown promise in Phase II trials, achieving clinical overall response rates (ORRs) of 77-96%, pathological complete responses of up to 24%, and breast conservation in up to 89% of patients. Two Phase III studies have shown that pathological complete response is significantly improved with the addition of docetaxel to anthracycline-based therapy versus the latter alone: the Aberdeen study achieved a rate of 34% versus 16%, respectively (p = 0.04), and the NSABP-B27 study a rate of 26% versus 14%, respectively (p < 0.001). The Aberdeen study has suggested that the addition of docetaxel may yield a survival benefit at 5 years (p = 0.04). The Phase II GEPAR-DUO study hints at a benefit for sequential over concomitant docetaxel-based therapy, with improvements in both clinical response (ORR 87% versus 77%, respectively) and pathological complete response (23% versus 12%, respectively). Non-anthracycline docetaxel-based primary regimens have shown early promise. As we continue to define the optimal regimen, a growing body of evidence supports the use of docetaxel in primary chemotherapeutic regimens for breast cancer.

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Section: Docetaxel-anthracycline Concomitant Regimensmentioning

confidence: 99%

Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival

Heys

Sarkar

Hutcheon

2005

Breast Cancer Res Treat

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“…This trial combined both dose intensity and dose density but did not control for total cumulative doses which were higher in the dose-dense arm [23]. Another German trial, presented by Jakisch et al [24], found that a dose-dense doxorubicin-docetaxel regimen given for 4 cycles was inferior to a more conventional regimen of sequential doxorubicin/cyclophosphamide-docetaxel preoperative chemotherapy in terms of complete and pathologically complete responses, as well as breast conservation rates. Almost all cancer drugs are delivered according to body surface area and individually modulated doses.…”

Section: Dose-densementioning

confidence: 99%

Is Higher Efficacy Always at the Price of More Side Effects during Chemotherapy?

Mlineritsch¹

2009

Breast Care

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Breast cancer remains the most prevalent cancer diagnosed in women worldwide. The number of effective treatments for breast cancer is on the rise, however, the benefit from specific treatments to individual patients and the adverse events experienced vary considerably. Efficacy and safety of anticancer therapies may depend on tumor, treatment, and host characteristics. Advances in the adjuvant chemotherapy of operable breast cancer have come from the introduction of effective agents and the application of the principles of combination chemotherapy. Attempts to advance these principles by substantial escalation of drug dosage have proven unsuccessful with a potentially higher rate of side effects. Another concept to increase efficacy is dose density, the administration of drugs with shortened intertreatment interval, and sequential therapy. The dose-dense concept improved clinical outcome significantly and was not accompanied by an increase in toxicity.

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“…Of note, the major difference in treatment duration (8 weeks compared with 24 weeks) may have accounted for the worse results seen in the investigational arm. The fact that this trial also compared a concurrent with a sequential schedule is another potential confounding factor [45]. ) and cyclophosphamide q2w with G-CSF support.…”

Section: Randomised Trials Investigating Different Dose Intensities Amentioning

confidence: 99%

Primary chemotherapy for breast cancer: the evidence and the future

Mano

Awada

2004

Annals of Oncology

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The first generation of randomised trials assessing the role of primary chemotherapy in breast cancer has failed to demonstrate the expected survival benefit. However, it has established the role of this treatment in 'downstaging' tumours of patients with locally advanced disease and, consequently, in improving breast conservation rates. Also, a number of surrogates of outcome have been identified, which will hopefully lead to earlier results in breast cancer clinical trials. Encouraging results have also been reported in trials investigating a number of novel approaches.

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Dose-Dense Biweekly Doxorubicin/Docetaxel Versus Sequential Neoadjuvant Chemotherapy with Doxorubicin/Cyclophosphamide/Docetaxel in Operable Breast Cancer: Second Interim Analysis

Cited by 42 publications

References 11 publications

Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival

Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival

Is Higher Efficacy Always at the Price of More Side Effects during Chemotherapy?

Primary chemotherapy for breast cancer: the evidence and the future

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