Active Ingredient: Vinorelbine
The treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
60 - 80 mg per m² of body surface area (BSA)
From 60 To 80 mg per m² of body surface area (BSA) once every 7 day(s)
As a single agent, the recommended regimen is:
First three administrations: 60mg/m² of body surface area, administered once weekly.
Subsequent administrations: Beyond the third administration, it is recommended to increase the dose of Vinorelbine to 80mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm³ or more than once between 500 and 1000/mm³ during the first three administrations at 60mg/m².
| Neutrophil count during the first 3 administrations of 60 mg/m²/week | Neutrophils >1,000 | Neutrophils ≥500 and <1,000 (1 episode) | Neutrophils ≥500 and <1,000 (2 episodes) | Neutrophils <500 |
|---|---|---|---|---|
| Recommended dose starting with the 4th administration | 80 | 80 | 60 | 60 |
Dose modification: For any administration planned to be given at 80mg/m², if the neutrophil count is below 500/mm³ or more than once between 500 and 1000/mm³ the administration should be delayed until recovery and the dose reduced from 80 to 60mg/m² per week during the 3 following administrations.
| Neutrophil count beyond the 4th administration of 80 mg/m²/week | Neutrophils >1,000 | Neutrophils ≥500 and <1,000 (1 episode) | Neutrophils ≥500 and <1,000 (2 episodes) | Neutrophils <500 |
|---|---|---|---|---|
| Recommended dose starting with the next administration | 80 | 60 |
It is possible to re-escalate the dose from 60 to 80 mg/m² per week if the neutrophil count did not drop below 500/mm³ or more than once between 500 and 1000/mm³ during 3 administrations given at 60 mg/m² according to the rules previously defined for the first 3 administrations.
For combination regimens, the dose and schedule will be adapted to the treatment protocol.
Based on clinical studies, the oral dose of 80 mg/m² was demonstrated to correspond to 30 mg/m² of the iv form and 60 mg/m² to 25 mg/m².
This has been the base for combination regimens alternating iv and oral forms improving patient convenience.
Capsules of different strengths (20, 30, 80 mg) are available in order to choose the adequate combination for the right dosage.
The following table gives the dose required for appropriate ranges of body surface area (BSA).
| 60 mg/m² | 80 mg/m² | |
|---|---|---|
| BSA (m²) | Dose (mg) | Dose (mg) |
| 0.95 to 1.04 | 60 | 80 |
| 1.05 to 1.14 | 70 | 90 |
| 1.15 to 1.24 | 70 | 100 |
| 1.25 to 1.34 | 80 | 100 |
| 1.35 to 1.44 | 80 | 110 |
| 1.45 to 1.54 | 90 | 120 |
| 1.55 to 1.64 | 100 | 130 |
| 1.65 to 1.74 | 100 | 140 |
| 1.75 to 1.84 | 110 | 140 |
| 1.85 to 1.94 | 110 | 150 |
| ≥1.95 | 120 | 160 |
Even for patients with BSA≥2 m² the total dose should never exceed 120 mg per week at 60 mg/m² and 160 mg per week at 80 mg/m².
Intravenous
25 - 35.4 mg per m² of body surface area (BSA)
From 25 To 35.4 mg per m² of body surface area (BSA) once every 7 day(s)
The usual dose given is 25-30 mg/m² once weekly.
Maximum tolerated dose per administration: 35.4 mg/m² of body surface area.
Maximum total dose per administration: 60 mg.
Vinorelbine solution may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of normal saline or glucose 50 mg/ml (5%) solution or by a short infusion (20-30 minutes) after dilution in 125 ml of normal saline or glucose 50 mg/ml (5%) solution.
Administration should always be followed with at least 250 ml of a normal saline infusion to flush the vein.
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