TY - JOUR
T1 - Single-Agent Oral Vinorelbine as First-Line Chemotherapy for Endocrine-Pretreated Breast Cancer With Bone Metastases and No Visceral Involvement
T2 - NORBREAST-228 Phase II Study
AU - Steger, Guenther G
AU - Dominguez, Adriana
AU - Dobrovolskaya, Natalia
AU - Giotta, Francesco
AU - Tubiana-Mathieu, Nicole
AU - Pecherstorfer, Martin
AU - Ardizzoia, Antonio
AU - Blasinska-Morawiec, Maria
AU - Espinosa, Enrique
AU - Villanova, Gustavo
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2018/2
Y1 - 2018/2
N2 - PURPOSE: Single-agent oral chemotherapy is widely used in patients with bone metastases without visceral involvement, especially in hormone receptor-positive metastatic breast cancer (mBC). However, this option has been poorly evaluated in clinical trials.METHODS: Eligible patients had mBC with predominantly bone but not visceral metastases, were receiving bisphosphonate therapy, and had previously received endocrine therapy (any setting) but not chemotherapy for mBC. Patients received oral vinorelbine 60 mg/m2 on days 1, 8, 15, and 22 every 4 weeks (escalating to 80 mg/m2 from cycle 2 in the absence of grade 3/4 toxicity) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included clinical benefit rate (complete/partial response or ≥24 weeks' stable disease), overall survival, and safety.RESULTS: Seventy patients were treated for a median of 6 cycles (range 1-18). Most (73%) continued treatment until disease progression. After 43 months' median follow-up, median PFS was 8.2 months (95% confidence interval [CI], 5.5-9.8). The clinical benefit rate was 56% (95% CI, 43%-68%). Median overall survival was 35.2 months (95% CI, 26.8-47.1). The most common grade 3/4 adverse event was neutropenia (38% of patients); febrile neutropenia was absent. The most common grade 1/2 adverse events were bone pain, fatigue, and gastrointestinal toxicities. Alopecia was infrequent.CONCLUSIONS: In patients with hormone receptor-positive mBC, bone disease, and prior endocrine therapy, first-line oral vinorelbine chemotherapy demonstrated long PFS and good tolerability. In this setting, it could be considered as an active oral alternative to intravenous chemotherapy.
AB - PURPOSE: Single-agent oral chemotherapy is widely used in patients with bone metastases without visceral involvement, especially in hormone receptor-positive metastatic breast cancer (mBC). However, this option has been poorly evaluated in clinical trials.METHODS: Eligible patients had mBC with predominantly bone but not visceral metastases, were receiving bisphosphonate therapy, and had previously received endocrine therapy (any setting) but not chemotherapy for mBC. Patients received oral vinorelbine 60 mg/m2 on days 1, 8, 15, and 22 every 4 weeks (escalating to 80 mg/m2 from cycle 2 in the absence of grade 3/4 toxicity) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included clinical benefit rate (complete/partial response or ≥24 weeks' stable disease), overall survival, and safety.RESULTS: Seventy patients were treated for a median of 6 cycles (range 1-18). Most (73%) continued treatment until disease progression. After 43 months' median follow-up, median PFS was 8.2 months (95% confidence interval [CI], 5.5-9.8). The clinical benefit rate was 56% (95% CI, 43%-68%). Median overall survival was 35.2 months (95% CI, 26.8-47.1). The most common grade 3/4 adverse event was neutropenia (38% of patients); febrile neutropenia was absent. The most common grade 1/2 adverse events were bone pain, fatigue, and gastrointestinal toxicities. Alopecia was infrequent.CONCLUSIONS: In patients with hormone receptor-positive mBC, bone disease, and prior endocrine therapy, first-line oral vinorelbine chemotherapy demonstrated long PFS and good tolerability. In this setting, it could be considered as an active oral alternative to intravenous chemotherapy.
KW - Administration, Oral
KW - Adult
KW - Aged
KW - Antineoplastic Agents, Hormonal/therapeutic use
KW - Antineoplastic Agents, Phytogenic/therapeutic use
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Bone Neoplasms/drug therapy
KW - Breast/pathology
KW - Breast Neoplasms/drug therapy
KW - Chemotherapy-Induced Febrile Neutropenia/epidemiology
KW - Disease Progression
KW - Fatigue/chemically induced
KW - Female
KW - Humans
KW - Middle Aged
KW - Progression-Free Survival
KW - Receptors, Estrogen/metabolism
KW - Receptors, Progesterone/metabolism
KW - Treatment Outcome
KW - Vinorelbine/therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=85021701720&partnerID=8YFLogxK
U2 - 10.1016/j.clbc.2017.05.012
DO - 10.1016/j.clbc.2017.05.012
M3 - Journal article
C2 - 28666812
SN - 1526-8209
VL - 18
SP - e41-e47
JO - Clinical Breast Cancer
JF - Clinical Breast Cancer
IS - 1
ER -