Primary chemotherapy with gemcitabine as prolonged infusion, non-pegylated liposomal doxorubicin and docetaxel in patients with early breast cancer: final results of a phase II trial

Schmid, Peter; Krocker, J.; Jehn, Christian; Michniewicz, K.; Lehenbauer-Dehm, Silvia; Eggemann, Holm; Heilmann, V.; Kümmel, Sherko; Schulz, Carsten-Oliver; Dieing, Annette; Wischnewsky, Manfred; Hauptmann, S; Elling, Dirk; Possinger, K.; Flath, Bernd

doi:10.1093/annonc/mdi321

Cited by 35 publications

(19 citation statements)

References 32 publications

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“…In addition, substituting NPLD for conventional doxorubicin as the standard anthracycline in early breast cancer (EBC) may help address the growing concerns regarding the longer-term impact of treatment on cardiac function [1, 2]. Current evidence on the use of NPLD in early disease is restricted to two phase II trials [8, 9], both of which report limited cardiac data for NPLD.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, substituting NPLD for doxorubicin as the standard anthracycline in early breast cancer may help address the growing concerns regarding the longer-term impact of treatment on cardiac function, a key survivorship issue [1, 2]. However, whilst NPLD has been extensively studied in metastatic breast cancer and is licensed in this regard [3–7], data on its use in early disease are currently scarce [8, 9]. …”

Section: Introductionmentioning

confidence: 99%

“…The results of two small phase II studies [8, 9] suggest that the benefits observed in metastatic patients may be maintained in early breast cancer, but further data are required. The objective of our study, therefore, was to assess the use of NPLD in place of conventional doxorubicin in standard regimens as a novel therapeutic option for the treatment of patients with early breast cancer.…”

Section: Introductionmentioning

confidence: 99%

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Substituting Doxorubicin with Nonpegylated Liposomal Doxorubicin for the Treatment of Early Breast Cancer: Results of a Retrospective Study

Davidson

Camburn

Keary³

et al. 2014

International Journal of Breast Cancer

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Introduction. Evidence from the metastatic setting suggests that replacing conventional doxorubicin with nonpegylated liposomal doxorubicin (NPLD) for early breast cancer may maintain efficacy whilst reducing long-term cardiotoxicity, an important consideration with many patients going on to receive multiple lines of treatment. Methods. Consecutive patients with early breast cancer treated with NPLD were assessed for disease progression and changes in cardiac function according to left ventricular ejection fraction (LVEF). Results. Ninety-seven patients (median age at diagnosis 51 (32–76) years) were studied. The majority received NPLD (60 mg/m2 plus cyclophosphamide 600 mg/m2) adjuvantly (79.4%) and in sequence with a taxane (79.4%; docetaxel 75 mg/m2). 80.4% had radiotherapy and 15.5% received trastuzumab. Mean time to disease recurrence was 87.0 months (80.7–93.2 [95% confidence interval]) and 5-year disease-free survival was 86.0%. Mean LVEF values remained within the normal range of ≥55% during treatment and throughout the cardiac follow-up period (median 7 months, range 1–21 months). Use of trastuzumab and age at diagnosis did not appear to influence LVEF. Conclusion. NPLD appeared to be a well-tolerated substitute for conventional doxorubicin in patients with early breast cancer.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Substituting Doxorubicin with Nonpegylated Liposomal Doxorubicin for the Treatment of Early Breast Cancer: Results of a Retrospective Study

Davidson

Camburn

Keary³

et al. 2014

International Journal of Breast Cancer

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“…Therefore, NPLD is considered to be able to enter phase-II clinical research in neoadjuvant chemotherapy of breast cancer (Schmid et al, 2005a). In addition, Schmid et al (2005b) found from a phase-II clinical study that a combination of NPLD (60 mg/m 2 ), paclitaxel (75 mg/m 2 ), and gemcitabine (350 mg/m 2 ) in the initial chemotherapy of breast cancer achieved a remission rate of 80% among phases II-III patients, and complete clinical remission was detected in about 25% of patients. In terms of side effects, only above grade III was reached by myelosuppression, and non-hematologic adverse reactions were mild.…”

Section: Early or Locally Advanced Breast Cancermentioning

confidence: 99%

Use of liposomal doxorubicin for adjuvant chemotherapy of breast cancer in clinical practice

Zhao

Ding

Shen

et al. 2017

J. Zhejiang Univ. Sci. B

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Breast cancer is one of the malignant tumors with the highest morbidity and mortality. It is helpful to reduce the rate of tumor recurrence and metastasis by treating breast cancer with adjuvant chemotherapy, so as to increase the cure rate or survival of patients. In recent years, liposomes have been regarded as a kind of new carrier for targeted drugs. Being effective for enhancing drug efficacy and reducing side effects, they have been widely used for developing anticancer drugs. As a kind of anthracycline with high anticancer activity, doxorubicin can treat or alleviate a variety of malignant tumors effectively when it is used on its own or in combination with other anticancer drugs. Although liposomal doxorubicin has been extensively used in the adjuvant chemotherapy of breast cancer, its exact therapeutic efficacy and side effects have not been definitely proven. Various clinical studies have adopted different combined regimes, dosages, and staging, so their findings differ to certain extent. This paper reviews the clinical application of liposomal doxorubicin in the adjuvant chemotherapy of breast cancer and illustrates therapeutic effects and side effects of pegylated liposomal doxorubicin (PLD) and non-PLD (NPLD) in clinical research, in order to discuss the strategies for applying these drugs in such adjuvant chemotherapy, looking forward to providing references for related research and clinical treatment in terms of dosage, staging, combined regimes, and analysis methods and so on.

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“…A number of small clinical trials with LAs in the neoadjuvant setting have been published, where LAs were combined with docetaxel and gemcitabine, or with paclitaxel, all reporting satisfactory activity and absence of cardiotoxicity 32,33, even if most of them are in HER2 positive tumors, in combination with trastuzumab 34,35.…”

Section: Introductionmentioning

confidence: 99%

Non-Pegylated Liposomal Doxorubicin-Cyclophosphamide in Sequential Regimens with Taxanes as Neoadjuvant Chemotherapy in Breast Cancer Patients

Vici¹,

Pizzuti²,

Gamucci

et al. 2014

J. Cancer

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Purpose: Chemotherapy regimens containing anthracyclines and taxanes represent the landmark of neoadjuvant systemic therapy of breast cancer. In advanced breast cancer patients liposomal anthracyclines (LA) have shown similar efficacy and less cardiac toxicity when compared to conventional anthracyclines. We performed this retrospective analysis in order to evaluate the efficacy and tolerability of neoadjuvant regimens including LA outside of clinical trials in routine clinical practice.Methods: Fifty operable or locally advanced, HER2 negative, breast cancer patients were retrospectively identified in 5 Italian cancer centres. Nineteen patients had received 4 cycles of non-pegylated liposomal doxorubicin (NPLD) and cyclophosphamide, followed by 4 cycles of docetaxel, every 3 weeks. In 25 patients the reverse sequence was employed, and a third subgroup of 6 patients received 4 cycles of NPLD/cyclophosphamide every 3 weeks followed by 4 cycles of weekly carboplatin and paclitaxel.Results: We observed 10 pathological complete responses (pCR) (20.0%, 95%CI, 9% to 31%), and 35 (70%, 95%CI, 57.3% to 82.7%) partial responses (pPR), whereas no patients progressed onto therapy. In the small subset of triple negative tumors the pCR rate was 37.5%, and in tumors expressing ER and/or PgR it was 16.7%. A pCR rate of 26.5% was observed in tumors with high Ki-67, whereas in tumors with low Ki-67 only one (6.2%) pCR was observed (p=0.14). Treatments were well tolerated. The most common toxicities were myelosuppression and palmar-plantar erytrodysesthesia; 4 asymptomatic and transient LVEF decrease have been recorded, without any case of clinical cardiotoxicity.Conclusions: NPLD-cyclophosphamide and taxanes sequential regimens were proven effective and well tolerated in breast cancer patients with contra-indication to conventional anthracyclines undergoing neoadjuvant chemotherapy, even outside of clinical trials in everyday clinical practice.

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Primary chemotherapy with gemcitabine as prolonged infusion, non-pegylated liposomal doxorubicin and docetaxel in patients with early breast cancer: final results of a phase II trial

Abstract: The evaluated schedule provides a safe and highly effective combination treatment for patients with early breast cancer, which is suitable for phase III studies.

Cited by 35 publications

References 32 publications

Substituting Doxorubicin with Nonpegylated Liposomal Doxorubicin for the Treatment of Early Breast Cancer: Results of a Retrospective Study

Substituting Doxorubicin with Nonpegylated Liposomal Doxorubicin for the Treatment of Early Breast Cancer: Results of a Retrospective Study

Use of liposomal doxorubicin for adjuvant chemotherapy of breast cancer in clinical practice

Non-Pegylated Liposomal Doxorubicin-Cyclophosphamide in Sequential Regimens with Taxanes as Neoadjuvant Chemotherapy in Breast Cancer Patients

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