This paper is only available as a PDF. To read, Please Download here.
Abstract
Thirty-five patients with metastatic breast cancer (MBC) entered a phase II study
of pegylated liposomal doxorubicin 35 mg/m2 intravenously (I.V.) on day 1 plus vinorelbine 30 mg/m2 I.V. on day 1 every 4 weeks. Patients were required to have measurable disease, previous
chemotherapy with an anthracycline-containing regimen, and a normal left ventricular
ejection fraction (LVEF). Thirty-four patients were assessable for response and toxicity.
The overall response rate (on an intent-to-treat basis) was 35% (12 of 34; 95% CI,
20%-54%). One complete response and 11 partial responses were noted. In addition,
14 patients (41%) had stable disease of > 4 months duration, and 7 patients (20.5%)
had disease progression. The response rates to the combination when it was used as
first- and second-line chemotherapy were 31% (4 of 13) and 38% (8 of 21), respectively.
Median time to disease progression was 7 months (range, 1–35 months) and median overall
survival was 13 months (range, 2 to > 62 months). Neutropenia was the most frequent
toxicity (grade 4 in 44% of patients and 19% of cycles), but neutropenic fever was
seen in only 3 cases. No septic deaths occurred. Nonhematologic grade 3 side effects
included skin toxicity (palmar-plantar erythrodysesthesia syndrome, 6%) and mucositis
(15%). Late alopecia was seen in 53% of patients (grade 1 in 41%, and grade 2 in 12%).
The median LVEFs were 64% (range, 50%-81%) at baseline and 62% (range, 37%–70%) after
treatment. Three patients presented an LVEF decrease to < 50%; however, no clinical
heart failure was noted, and 2 of these patients recovered normal values after cessation
of therapy. The combination of pegylated liposomal doxorubicin and vinorelbine can
be safely administered to patients with anthracycline-pretreated MBC and is active
in this population.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical Breast CancerAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Polyethilene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours.Drugs. 1997; 54: 15-21
- Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: Results of a multicenter phase II trial.J Clin Oncol. 1997; 15: 3185-3191
- Correlation of toxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin (CAELYX"/Doxyl) vs. doxoribicin for first-line treatment of metastatic breast cancer.Cancer. 2000; 89: 1037-1047
- Doxil and intravenous cyclophosphamide as first-line therapy for patients with metastatic breast cancer (MBC): interim results of an ongoing pilot trial.Breast Cancer Res Treat. 1998; 50: 324
- Phase II study of weekly paclitaxel (Taxol) and liposomal doxorubicin (Doxil) in patients with locally advanced breast cancer.Proc Am Soc Clin Oncol. 2000; 21 (Abstract #451).: 113a
- 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.Ann Oncol. 2002; 13: 1737-1742
- Phase I trial of pegylated lipososmal doxorubicin and docetaxel in advanced breast cancer.J Clin Oncol. 2001; 19: 3117-3125
- Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer.J Clin Oncol. 2003; 21: 3249-3254
- Phase I study of Doxil and vinorelbine in metastatic breast cancer.Ann Oncol. 1999; 10: 1113-1116
- Unexpected low efficacy of stealth liposomal doxorubicin (Caelyx) and vinorelbine in metastatic breast cancer.Breast Cancer Res Treat. 2003; 77: 185-188
- Pegylated liposomal doxorubicin with vinorelbine in metastatic breast carcinoma.Oncology. 2002; 63: 31-37
- Current status of vinorelbine for breast cancer.Oncology. 1995; 9: 767-773
- The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent.J Chronic Dis. 1961; 13: 346-353
Article info
Publication history
Accepted:
June 17,
2004
Received in revised form:
June 14,
2004
Received:
April 26,
2004
Identification
Copyright
© 2004 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
