Oral Vinorelbine and Capecitabine as First-Line Therapy in Metastatic Breast Cancer: A Retrospective Analysis

Figures & data

Table 1. Patient baseline characteristics.

Patients clinical and demographic characteristics	Patients (n)	Percent
Enrolled patients	70	100
Median age, years (range)	63 (46–76)
Performance status: ECOG 0 ECOG 1 ECOG 2	48 14 8	69 21 12%
Histology: Ductal infiltrating carcinoma Lobular carcinoma	66 4	94 6
Hormone receptors: Positive Triple negative	40 30	57 43
HER status negative ^†	70	100
Previous treatments: Surgery Radiotherapy Adjuvant hormonal therapy Adjuvant chemotherapy Hormonal therapy (advanced disease) Aromatase inhibitors Tamoxifen Faslodex Everolimus - examestane	68 61 40 61 40 39 1 40 18	97 87 57 87 57 56 1 57 26
Type of chemotherapy: Anthracyclines axanes CMF	18 43 6	26 61 9
Sites of disease: Bone Lung Liver Nodes Skin	41 16 21 24 5	59 23 30 34 7
Metastatic sites (n): 1 2 ≥3	15 30 25	21 43 36

† Other than HER 3+.

CMF: Cyclophosphamide, methotrexate, 5-fluorouracil; ECOG: Eastern Cooperative Oncology Group.

Table 2. Treatment outcomes.

Objective response (RECIST criteria)
	Patients (n)	Percent	95% CL
Evaluable patients	70	100%
Overall response	37	53%	41.9–64.1
Complete response	6	9%	0–31.0
Partial response	31	44%	30.9–57.1
Stable disease	19	27%	9.9–44.1
Tumor growth control	56	80%	75.3–84.7
Progressive disease	14	20%	1.2–38.8
Survival parameters
	Median	Range
Progression-free survival	7.9 months	2–15 months
Overall survival	29.2 months	13–41 months

CL: Confidence limits.

Figure 1. Tumor shrinkage.

Table 3. Toxicity according to National Cancer Institute Common Toxicity Criteria.

Toxicities	Grade 1		Grade 2		Grade 3		Grade 4
	Patients (n)	Percent	Patients (n)	Percent	Patients (n)	Percent	Patients (n)	Percent
Leukopenia	29	41%	9	13%	11	16%	4	6%
Neutropenia	15	21%	9	13%	8	11%	3	4%
Anemia	16	23%	---	---	---	---	---	---
Platelets	13	19%	6	9%	3	4%	---	---
Nausea/vomiting	23	33%	7	10%	---	---	---	---
Mucositis	6	9%	2	3%	---	---	---	---
Transaminases	6	9%	2	3%	---	---	---	---
Peripheral neuropathy	10	14%	---	---	---	---	---	---
Abdominal pain	7	10%	1	1%	---	---	---	---
Diarrhea	15	21%	6	9%	---	---	---	---
Hand foot syndrome	12	17%	5	7%	2	3%	---	---

Table 4. Studies reporting the activity and toxicity of first-line all-oral combination of vinca alkaloid vinorelbine and capecitabine.

Study (year)	Patients (n)	Adjuvant chemotherapy	Schedule	ORR	Median PFS (months)	Median OS (months)	Grade 3–4 toxicity (>10%)	Ref.
Nolè et al. (2009)	42	78.8% anthracyclines 60.5% Taxanes 5.8%	VNR 60 mg/m^2 Day 1 + 8 + 15 q21 days CAP 1 gr/m^2 bid Day 1→14	54.8%	8.4	25.8	Neutropenia G3 21%; G4 25%	[13]
Tubiana-mattieu et al. (2009)	49	63% anthracyclines 37.1% Taxanes 5.8%	VNR 60–80 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14 750 mg/m^2 >65 years	51.0%	8.4	29.2	Neutropenia G3 26%; G4 23%	[14]
Finek et al. (2009)	58	Anthracyclines (mostly)	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	56.5%	10.5	17.5	-	[12]
Gampenrieder et al. (2010)	24	59.4% anthracyclines 53% Taxanes 34%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 500 mg/m^2 bid Day 1→14	36.7%	8.0 TTP	32.0	Neutropenia G3 12%	[15]
Hassan et al. (2010)	31	Anthracyclines 100%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	67%	7.8	21	Neutropenia G3–4 16% Diarrhea G3–4 12.6% HFS G3–4 22.4%	[16]
Strada et al. (2012)	46	97.8% anthracyclines 30.4% Taxanes 65.2%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	76.0%	8.4	34.3	Neutropenia G3 13% Leukopenia G3 10.9%	[17]
Tawfik et al. (2013)	28	anthracyclines 100% Taxanes 60%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	57.1%	8.6	27.2	Neutropenia G3 21.4% Vomiting G3 10.7%	[18]
Campone et al. (2013)	44	anthracyclines 100% Taxanes 18.2%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	31.8%	7.2	22.2	Neutropenia G3–4 47.7% Leukopenia G3–4 29.6%	[11]
Cazzaniga et al. (2016)	35	Not specified	VNR 40 mg fixed dose three-times/week CAP 15007 day continuously	35.5%	7.9 TTP	Not reported	Neutropenia 1.6% of cycles Hand foot syndrome 1% of cycles	[14]
Cinieri et al. (2017)	49	Anthracyclines 80%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	67.3%	7.6	30.2	Neutropenia G3 25%; G4 25% Febrile Neutropenia G4 12% Fatigue G3 12% Vomiting G3 10%	[15]
Present study	52	90% anthracyclines 21% Taxanes 71%	VNR 60 mg/m^2 Day 1 + 8 q21 days CAP 1 gr/m^2 bid Day 1→14	58%	7.8	29.5	Neutropenia G3 15% Leukopenia G3 12%

Reported data refer only to evaluable patients.

ORR: Overall response rate; OS: Overall survival; PFS: Progression-free survival; TTP: Time to progression.

Figure 2. Time to Progression.

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