Annals of Oncology 13:1737-1742, 2002
© 2002 European Society for Medical Oncology
Original Paper |
Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx®) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group
1 First Department of Medicine, Laiko Hospital, University of Athens; 2 Alexandra Hospital, Department of Clinical Therapeutics, University of Athens; 3 Rio Hospital, University of Patras, Patra; 4 Metaxa Cancer Hospital, Piraeaus; 5 AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki; 6 IKA, Thessaloniki; 7 Ippokration Hospital, Athens; 8 Second Department of Internal Medicine, Propaedeutic, University of Athens; 9 Henry Dunan Hospital, Athens; 10 Hygeia Hospital, Athens, Greece
Received 7 March 2002; revised 22 April 2002; accepted 16 May 2002
Background:
To determine the activity and safety of the combination of paclitaxel and pegylated liposomal doxorubicin (Caelyx®) in patients with locally advanced breast cancer.
Patients and methods:
This was a multicenter phase II study. Thirty-five newly diagnosed patients with locally advanced breast cancer were included in the study. Histological or cytological diagnosis was necessary for inclusion. Median age was 54 years (range 26–73 years). Fifteen patients were premenopausal and 20 postmenopausal. Paclitaxel was administered at a dose of 175 mg/m2 and pegylated liposomal doxorubicin 35 mg/m2 every 3 weeks for six cycles.
Results:
Twenty-five patients (71%) responded. Six (17%) had a complete response, 19 (54%) had a partial response, four remained stable, two progressed and four were not evaluated for response due to discontinuation of chemotherapy. Three patients had a pathologically complete response. A total of 173 cycles were administered. The primary toxicity observed was skin toxicity. Grade 3 skin toxicity was noted in four patients (11%). Palmar–plantar erythrodysesthesia (PPE) grade 3 was experienced by three (9%). Two patients presented with PPE and skin toxicity. Hematological toxicities included grade 3 leukopenia in four patients (3%). Other grade 3 toxicities were uncommon and included only alopecia in 29 patients (83%). Grade 3 or 4 neurotoxicity was not observed in any patient. Dose reduction was necessary in seven patients; in six due to skin toxicity and in one due to neutropenia. Four patients discontinued treatment due to skin toxicity. There were no treatment-related deaths.
Conclusions:
The combination of pegylated liposomal doxorubicin and paclitaxel was active in locally advanced breast cancer. The primary toxicity was cutaneous toxicity and it was manageable.
Key words: breast cancer, liposomal doxorubicin, neoadjuvant, paclitaxel
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  R. Advani, B. L. Lum, G. A. Fisher, J. Halsey, D. L. Chin, C. D. Jacobs, and B. I. Sikic A phase I trial of liposomal doxorubicin, paclitaxel and valspodar (PSC-833), an inhibitor of multidrug resistance Ann. Onc., December 1, 2005; 16(12): 1968 - 1973. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. G. Estevez and W. J. Gradishar Evidence-Based Use of Neoadjuvant Taxane in Operable and Inoperable Breast Cancer Clin. Cancer Res., May 15, 2004; 10(10): 3249 - 3261. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. Rivera, V. Valero, B. Arun, M. Royce, R. Adinin, K. Hoelzer, R. Walters, J. L. Wade III, L. Pusztai, and G. N. Hortobagyi Phase II Study of Pegylated Liposomal Doxorubicin in Combination With Gemcitabine in Patients With Metastatic Breast Cancer J. Clin. Oncol., September 1, 2003; 21(17): 3249 - 3254. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 E. Rivera Liposomal Anthracyclines in Metastatic Breast Cancer: Clinical Update Oncologist, August 1, 2003; 8(90002): 3 - 9. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. Campos Liposomal Anthracyclines: Adjuvant and Neoadjuvant Therapy for Breast Cancer Oncologist, August 1, 2003; 8(90002): 10 - 16. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. Gogas and G. Fountzilas The role of taxanes as a component of neoadjuvant chemotherapy for breast cancer Ann. Onc., May 1, 2003; 14(5): 667 - 674. [Full Text] [PDF]
|
|