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Reduced Incidence Of Severe Palmar-Plantar Erythrodysesthesia And Mucositis In A Prospective Multicenter Phase II Trial With Pegylated Liposomal Doxorubicin At 40 Mg/m2 Every 4 Weeks In Previously Treated Patients With Metastatic Breast Cancer

S. Al-Batran, H. Meerpohl, G. von Minckwitz, A. Atmaca, U. Kleeberg, N. Harbeck, W. Lerbs, D. Hecker, J. Sehouli, A. Knuth, E. Jager
Published 2006 · Medicine

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Purpose: The aim of this study was to assess whether the reduction in the total dose of pegylated liposomal doxorubicin (PLD) per cycle from 50 mg/m2 every 4 weeks to 40 mg/m2 every 4 weeks can effectively lower the incidence of treatment-related palmar-plantar erythrodysesthesia (PPE) and mucositis. Methods: Patients received PLD 40 mg/m2 every 4 weeks, and were evaluated for toxicity prior to each treatment and for response every 8 weeks. Results: All patients were previously treated with at least one chemotherapy regimen for metastatic disease, and 72% of the patients had a prior exposure to an anthracycline. Forty-six evaluable patients received a median of four PLD cycles, with a median dose intensity of 10 mg/m2/week and a median cumulative dose of 160 mg/m2. No National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3 or 4 PPE was observed in these patients. NCI-CTC grade 3 or 4 mucositis occurred in 4.3% of patients, only. Response rates and survival results observed here were comparable to those observed with PLD 50 mg/m2 every 4 weeks in a matched patient population. However, patients treated with PLD 40 mg/m2 every 4 weeks experienced less PPE and mucositis and required clearly less dose reductions and treatment delays. Conclusion: The favorable safety profile observed in this study leads us to recommend the use of PLD 40 mg/m2 every 4 weeks for patients with advanced breast cancer.
This paper references
Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes.
A. Gabizon (1994)
10.1056/NEJM199809243391307
Doxorubicin-induced cardiomyopathy.
P. Singal (1998)
10.1002/1097-0142(20000901)89:5<1037::AID-CNCR13>3.0.CO;2-Z
Correlation of toxicity with pharmacokinetics of pegylated liposomal doxorubicin (Doxil) in metastatic breast carcinoma
O. Lyass (2000)
10.3816/CBC.2003.N.037
Pegylated liposomal doxorubicin in the treatment of breast cancer.
J. O'Shaughnessy (2003)
Polyethylene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours.
A. Gabizon (1997)
10.1006/GYNO.2001.6272
Liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: a retrospective comparative study of single-agent dosages.
P. Rose (2001)
Iliskovic N: Doxorubicin-induced cardiomyopathy
PK Singal (1998)
10.1200/JCO.2005.05.098
Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.
K. Miller (2005)
10.1002/cncr.20207
Cardiac profiles of liposomal anthracyclines
M. Theodoulou (2004)
10.1200/JCO.2004.08.157
Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer.
Alan M. Keller (2004)
10.2165/00003088-200342050-00002
Pharmacokinetics of Pegylated Liposomal Doxorubicin
A. Gabizon (2003)
Population pharmacokinetics and pharmacodynamics of pegylated - liposomal doxorubicin in patients with AIDS - related Kaposi ’ s sarco
MA Amantea (1997)
10.1002/j.1552-4604.1996.tb04152.x
Doxorubicin Encapsulated in Liposomes Containing Surface‐Bound Polyethylene Glycol: Pharmacokinetics, Tumor Localization, and Safety in Patients with AIDS‐Related Kaposi's Sarcoma
D. Northfelt (1996)
10.2165/00002018-200022040-00002
Cardiotoxicity of Chemotherapeutic Agents
V. Pai (2000)
10.1093/ANNONC/MDG346
Multicenter phase II study of oral capecitabine (Xeloda(")) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy.
P. Reichardt (2003)
10.1159/000080363
Phase II Study of Single-Agent Pegylated Liposomal Doxorubicin HCl (PLD) in Metastatic Breast Cancer After First-Line Treatment Failure
B. Mlineritsch (2004)
10.1006/GYNO.2000.5980
The clinical utility of liposomal doxorubicin in recurrent ovarian cancer.
S. Campos (2001)
10.1002/(SICI)1097-0142(19990701)86:1<72::AID-CNCR12>3.0.CO;2-1
Selective delivery of doxorubicin to patients with breast carcinoma metastases by stealth liposomes
Z. Symon (1999)
10.1006/GYNO.2000.5921
Phase 2 trial of liposomal doxorubicin (40 mg/m(2)) in platinum/paclitaxel-refractory ovarian and fallopian tube cancers and primary carcinoma of the peritoneum.
M. Markman (2000)
10.1016/S0009-9236(97)90162-4
Population pharmacokinetics and pharmacodynamics of pegylated‐liposomal doxorubicin in patients with AIDS‐related Kaposi's sarcoma
M. Amantea (1997)
10.1093/ANNONC/MDH097
Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer.
M. O'Brien (2004)
10.1634/THEONCOLOGIST.10-3-205
Pegylated liposomal doxorubicin: optimizing the dosing schedule in ovarian cancer.
P. Rose (2005)
10.3109/14733400500089500
Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer
A. A. García (2005)
domized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer
KD Miller (2005)
Cardiotoxicity of chemotherapeutic agents: incidence, treatment and prevention.
V. Pai (2000)
10.1093/ANNONC/MDF157
EORTC 10968: a phase I clinical and pharmacokinetic study of polyethylene glycol liposomal doxorubicin (Caelyx, Doxil) at a 6-week interval in patients with metastatic breast cancer. European Organization for Research and Treatment of Cancer.
A. Hamilton (2002)
10.1200/JCO.2001.19.14.3312
Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan.
A. Gordon (2001)
10.1200/JCO.1997.15.10.3185
Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: results of a multicenter phase II trial.
M. Ranson (1997)



This paper is referenced by
Comparison of safety and toxicity of liposomal doxorubicin vs. conventional anthracyclines: a
M. Rafiyath (2012)
10.1186/2162-3619-1-10
Comparison of safety and toxicity of liposomal doxorubicin vs. conventional anthracyclines: a meta-analysis
S. Rafiyath (2012)
10.1038/cgt.2017.9
The most prevalent side effects of pegylated liposomal doxorubicin monotherapy in women with metastatic breast cancer: a systematic review of clinical trials
L. Ansari (2017)
10.1188/10.ONF.137-139
Hand-foot syndrome related to liposomal doxorubicin.
K. Swenson (2010)
10.1016/j.jgo.2013.07.004
Bi-weekly liposomal doxorubicin for advanced breast cancer in elderly women (≥ 70 years).
U. Basso (2013)
10.1016/j.ijwd.2019.10.003
Dermatologic conditions in women receiving systemic cancer therapy☆
Michelle Ferreira (2019)
10.1200/JCO.2009.22.7504
Phase II multicenter trial of anthracycline rechallenge with pegylated liposomal doxorubicin plus cyclophosphamide for first-line therapy of metastatic breast cancer previously treated with adjuvant anthracyclines.
M. Trudeau (2009)
10.1007/s10549-015-3415-2
Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study
M. Gil-Gil (2015)
10.2165/11207510-000000000-00000
Pegylated Liposomal Doxorubicin
S. Duggan (2012)
10.1007/s00280-017-3279-8
Phase Ib dose-finding trial of lapatinib plus pegylated liposomal doxorubicin in advanced HER2-positive breast cancer
A. Rocca (2017)
10.1016/j.breast.2009.10.003
Metronomic administration of pegylated liposomal-doxorubicin in extensively pre-treated metastatic breast cancer patients: a mono-institutional case-series report.
E. Munzone (2010)
10.1007/s00280-014-2378-z
Age affects pegylated liposomal doxorubicin elimination and tolerability in patients over 70 years old
M. Gusella (2014)
10.1016/j.ejca.2013.04.027
Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial.
C. Falandry (2013)
10.1007/978-3-319-66200-8
Skin Tumors and Reactions to Cancer Therapy in Children
J. Huang (2018)
10.1159/000148043
Influence of Microparticles on the Homogeneity of Distribution of Topically Applied Substances
J. Lademann (2008)
10.1159/000258880
Hand-Foot Syndrome (Hand-Foot Skin Reaction, Palmar-Plantar Erythrodysesthesia): Focus on Sorafenib and Sunitinib
Adam D Lipworth (2009)
10.1038/s41598-019-54387-5
Pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant chemotherapy in locally advanced breast cancer (registration number: ChiCTR1900023052)
R. Li (2019)
10.1038/sj.bjc.6605961
Anthracycline rechallenge using pegylated liposomal doxorubicin in patients with metastatic breast cancer: a pooled analysis using individual data from four prospective trials
S. Al-Batran (2010)
10.1097/CAD.0b013e3282f14a00
Single-agent treatment with pegylated liposomal doxorubicin for metastatic breast cancer
M. O'Brien (2008)
10.1002/jps.21358
Pharmacokinetics and in vivo drug release rates in liposomal nanocarrier development.
D. Drummond (2008)
TARGETED DELIVERY OF ANTICANCER AGENTS TO CANCER
Jianqin Lu (2014)
10.1136/ejhpharm-2020-002311
Pegylated liposomal doxorubicin-related palmar-plantar erythrodysesthesia: a literature review of pharmaceutical and clinical aspects
Yu-ping Zhu (2020)
10.1002/9781118590638.CH16
Topoisomerase‐Interacting Agents
T. Skácel (2013)
10.1016/j.ejca.2008.01.028
Pegylated liposomal doxorubicin-associated hand-foot syndrome: recommendations of an international panel of experts.
R. von Moos (2008)
10.1097/CAD.0000000000000037
Efficacy and toxicity profile of pegylated liposomal doxorubicin (Caelyx) in patients with advanced breast cancer
J. Rom (2014)
10.1016/j.biopha.2017.09.059
A review on the efficacy and toxicity of different doxorubicin nanoparticles for targeted therapy in metastatic breast cancer.
A. Shafei (2017)
10.1007/s12032-012-0407-5
Pegylated liposomal doxorubicin as third-line chemotherapy in patients with metastatic transitional cell carcinoma of urothelial tract: results of a phase II study
A. Rozzi (2013)
10.1007/978-3-319-66200-8_7
Cutaneous Reactions to Traditional Chemotherapy and Radiation Therapy
L. Kohn (2018)
10.1016/j.canlet.2011.07.017
Pegylated liposomal doxorubicin as first-line monotherapy in elderly women with locally advanced or metastatic breast cancer: novel treatment predictive factors identified.
H. Gréen (2011)
10.1586/14737140.8.3.331
Pegylated liposomal doxorubicin in elderly patients with metastatic breast cancer
A. Minisini (2008)
10.1016/j.ctrv.2008.01.008
Metastatic breast cancer: the role of pegylated liposomal doxorubicin after conventional anthracyclines.
S. Verma (2008)
10.1177/1758835920905412
‘The same old story’: thoughts on authorized doses of anticancer drugs
F. Meriggi (2020)
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