Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer

Stephen Jones, Eric Winer, Charles Vogel, Leslie Laufman, Laura Hutchins, Mark O'Rourke, Barry Lembersky, Daniel Budman, Joseph Bigley, John Hohneker

Research output: Contribution to journalArticle

166 Citations (Scopus)

Abstract

Purpose: This prospective multicenter randomized trial was performed to compare the effectiveness and safety of intravenous (IV) vinorelbine tartrate (Navelbine [NVB]; Burroughs Wellcome Co, Research Triangle Park, NC) with IV melphalan (Alkeran [ALK]; Burroughs Wellcome Co) in a heavily pretreated population of patients with anthracycline-refractory advanced breast cancer (ABC). Efficacy end points included time to disease progression (TDP), time to treatment failure (TTF), survival, tumor response rates, and quality of life (QL) and relief of cancer-related symptoms. Patients and Methods: Between August 24, 1990, and December 1, 1992, 183 patients were randomized (2:1) to treatment with NVB (30 mg/m2 weekly) or ALK (25 mg/m2 every 4 weeks) IV. Patients were stratified by measurable or nonmeasurable-assessable disease and by treatment center. Results: Time to disease progression was significantly longer with NVB than with ALK, with a median 12 weeks versus 8 weeks, respectively (P < .001). NVB patients also had significantly longer time to treatment failure than ALK patients, with a median 12 weeks versus 8 weeks, respectively (P < .001). The effect of NVB on survival was also statistically significant (P = .034): 1-year survival rates were 35.7% with NVB and 21.7% with ALK and the median survival rate was 35 weeks and 31 weeks, respectively. In total, 46.5% of NVB patients and 28.2% of ALK patients achieved an objective response or stabilization of disease (P = .06). No intergroup differences were noted in patient-assessed QL and cancer-related symptoms. The most common toxicities were hematologic, including granulocytopenia with NVB and thrombocytopenia and granulocytopenia with ALK. Both drugs were generally well tolerated, and no septic deaths were reported. Conclusion: This randomized trial demonstrates a survival benefit in anthracycline-refractory ABC. NVB was well tolerated and demonstrated activity superior to ALK in anthracycline-refractory ABC, without compromising QL. Based on activity of single-agent NVB in this difficult-to-treat patient population, investigations of NVB in combination with other anticancer drugs are warranted.

Original languageEnglish
Pages (from-to)2567-2574
Number of pages8
JournalJournal of Clinical Oncology
Volume13
Issue number10
StatePublished - Oct 1 1995
Externally publishedYes

Fingerprint

Melphalan
Anthracyclines
Breast Neoplasms
Agranulocytosis
Quality of Life
Treatment Failure
Survival
Disease Progression
vinorelbine
Survival Rate
Neoplasms
Thrombocytopenia
Pharmaceutical Preparations
Population
Multicenter Studies

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Jones, S., Winer, E., Vogel, C., Laufman, L., Hutchins, L., O'Rourke, M., ... Hohneker, J. (1995). Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. Journal of Clinical Oncology, 13(10), 2567-2574.

Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. / Jones, Stephen; Winer, Eric; Vogel, Charles; Laufman, Leslie; Hutchins, Laura; O'Rourke, Mark; Lembersky, Barry; Budman, Daniel; Bigley, Joseph; Hohneker, John.

In: Journal of Clinical Oncology, Vol. 13, No. 10, 01.10.1995, p. 2567-2574.

Research output: Contribution to journalArticle

Jones, S, Winer, E, Vogel, C, Laufman, L, Hutchins, L, O'Rourke, M, Lembersky, B, Budman, D, Bigley, J & Hohneker, J 1995, 'Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer', Journal of Clinical Oncology, vol. 13, no. 10, pp. 2567-2574.
Jones, Stephen ; Winer, Eric ; Vogel, Charles ; Laufman, Leslie ; Hutchins, Laura ; O'Rourke, Mark ; Lembersky, Barry ; Budman, Daniel ; Bigley, Joseph ; Hohneker, John. / Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer. In: Journal of Clinical Oncology. 1995 ; Vol. 13, No. 10. pp. 2567-2574.
@article{e1dfa46de0724692a3eb855839a741ac,
title = "Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer",
abstract = "Purpose: This prospective multicenter randomized trial was performed to compare the effectiveness and safety of intravenous (IV) vinorelbine tartrate (Navelbine [NVB]; Burroughs Wellcome Co, Research Triangle Park, NC) with IV melphalan (Alkeran [ALK]; Burroughs Wellcome Co) in a heavily pretreated population of patients with anthracycline-refractory advanced breast cancer (ABC). Efficacy end points included time to disease progression (TDP), time to treatment failure (TTF), survival, tumor response rates, and quality of life (QL) and relief of cancer-related symptoms. Patients and Methods: Between August 24, 1990, and December 1, 1992, 183 patients were randomized (2:1) to treatment with NVB (30 mg/m2 weekly) or ALK (25 mg/m2 every 4 weeks) IV. Patients were stratified by measurable or nonmeasurable-assessable disease and by treatment center. Results: Time to disease progression was significantly longer with NVB than with ALK, with a median 12 weeks versus 8 weeks, respectively (P < .001). NVB patients also had significantly longer time to treatment failure than ALK patients, with a median 12 weeks versus 8 weeks, respectively (P < .001). The effect of NVB on survival was also statistically significant (P = .034): 1-year survival rates were 35.7{\%} with NVB and 21.7{\%} with ALK and the median survival rate was 35 weeks and 31 weeks, respectively. In total, 46.5{\%} of NVB patients and 28.2{\%} of ALK patients achieved an objective response or stabilization of disease (P = .06). No intergroup differences were noted in patient-assessed QL and cancer-related symptoms. The most common toxicities were hematologic, including granulocytopenia with NVB and thrombocytopenia and granulocytopenia with ALK. Both drugs were generally well tolerated, and no septic deaths were reported. Conclusion: This randomized trial demonstrates a survival benefit in anthracycline-refractory ABC. NVB was well tolerated and demonstrated activity superior to ALK in anthracycline-refractory ABC, without compromising QL. Based on activity of single-agent NVB in this difficult-to-treat patient population, investigations of NVB in combination with other anticancer drugs are warranted.",
author = "Stephen Jones and Eric Winer and Charles Vogel and Leslie Laufman and Laura Hutchins and Mark O'Rourke and Barry Lembersky and Daniel Budman and Joseph Bigley and John Hohneker",
year = "1995",
month = "10",
day = "1",
language = "English",
volume = "13",
pages = "2567--2574",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "10",

}

TY - JOUR

T1 - Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer

AU - Jones, Stephen

AU - Winer, Eric

AU - Vogel, Charles

AU - Laufman, Leslie

AU - Hutchins, Laura

AU - O'Rourke, Mark

AU - Lembersky, Barry

AU - Budman, Daniel

AU - Bigley, Joseph

AU - Hohneker, John

PY - 1995/10/1

Y1 - 1995/10/1

N2 - Purpose: This prospective multicenter randomized trial was performed to compare the effectiveness and safety of intravenous (IV) vinorelbine tartrate (Navelbine [NVB]; Burroughs Wellcome Co, Research Triangle Park, NC) with IV melphalan (Alkeran [ALK]; Burroughs Wellcome Co) in a heavily pretreated population of patients with anthracycline-refractory advanced breast cancer (ABC). Efficacy end points included time to disease progression (TDP), time to treatment failure (TTF), survival, tumor response rates, and quality of life (QL) and relief of cancer-related symptoms. Patients and Methods: Between August 24, 1990, and December 1, 1992, 183 patients were randomized (2:1) to treatment with NVB (30 mg/m2 weekly) or ALK (25 mg/m2 every 4 weeks) IV. Patients were stratified by measurable or nonmeasurable-assessable disease and by treatment center. Results: Time to disease progression was significantly longer with NVB than with ALK, with a median 12 weeks versus 8 weeks, respectively (P < .001). NVB patients also had significantly longer time to treatment failure than ALK patients, with a median 12 weeks versus 8 weeks, respectively (P < .001). The effect of NVB on survival was also statistically significant (P = .034): 1-year survival rates were 35.7% with NVB and 21.7% with ALK and the median survival rate was 35 weeks and 31 weeks, respectively. In total, 46.5% of NVB patients and 28.2% of ALK patients achieved an objective response or stabilization of disease (P = .06). No intergroup differences were noted in patient-assessed QL and cancer-related symptoms. The most common toxicities were hematologic, including granulocytopenia with NVB and thrombocytopenia and granulocytopenia with ALK. Both drugs were generally well tolerated, and no septic deaths were reported. Conclusion: This randomized trial demonstrates a survival benefit in anthracycline-refractory ABC. NVB was well tolerated and demonstrated activity superior to ALK in anthracycline-refractory ABC, without compromising QL. Based on activity of single-agent NVB in this difficult-to-treat patient population, investigations of NVB in combination with other anticancer drugs are warranted.

AB - Purpose: This prospective multicenter randomized trial was performed to compare the effectiveness and safety of intravenous (IV) vinorelbine tartrate (Navelbine [NVB]; Burroughs Wellcome Co, Research Triangle Park, NC) with IV melphalan (Alkeran [ALK]; Burroughs Wellcome Co) in a heavily pretreated population of patients with anthracycline-refractory advanced breast cancer (ABC). Efficacy end points included time to disease progression (TDP), time to treatment failure (TTF), survival, tumor response rates, and quality of life (QL) and relief of cancer-related symptoms. Patients and Methods: Between August 24, 1990, and December 1, 1992, 183 patients were randomized (2:1) to treatment with NVB (30 mg/m2 weekly) or ALK (25 mg/m2 every 4 weeks) IV. Patients were stratified by measurable or nonmeasurable-assessable disease and by treatment center. Results: Time to disease progression was significantly longer with NVB than with ALK, with a median 12 weeks versus 8 weeks, respectively (P < .001). NVB patients also had significantly longer time to treatment failure than ALK patients, with a median 12 weeks versus 8 weeks, respectively (P < .001). The effect of NVB on survival was also statistically significant (P = .034): 1-year survival rates were 35.7% with NVB and 21.7% with ALK and the median survival rate was 35 weeks and 31 weeks, respectively. In total, 46.5% of NVB patients and 28.2% of ALK patients achieved an objective response or stabilization of disease (P = .06). No intergroup differences were noted in patient-assessed QL and cancer-related symptoms. The most common toxicities were hematologic, including granulocytopenia with NVB and thrombocytopenia and granulocytopenia with ALK. Both drugs were generally well tolerated, and no septic deaths were reported. Conclusion: This randomized trial demonstrates a survival benefit in anthracycline-refractory ABC. NVB was well tolerated and demonstrated activity superior to ALK in anthracycline-refractory ABC, without compromising QL. Based on activity of single-agent NVB in this difficult-to-treat patient population, investigations of NVB in combination with other anticancer drugs are warranted.

UR - http://www.scopus.com/inward/record.url?scp=0029092360&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029092360&partnerID=8YFLogxK

M3 - Article

C2 - 7595708

AN - SCOPUS:0029092360

VL - 13

SP - 2567

EP - 2574

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 10

ER -