Active Ingredient: Paclitaxel
Paclitaxel in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
For this indication, competent medicine agencies globally authorize below treatments:
For:
From cycle 1 and thereafter
Intravenous, 125 milligrams paclitaxel per square meter of body surface, once every 7 days, 3 doses in total, over the duration of 28 days.
The recommended dose of paclitaxel in combination with gemcitabine is 125 mg/m² administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. The concurrent recommended dose of gemcitabine is 1000 mg/m² administered intravenously over 30 minutes immediately after the completion of paclitaxel administration on Days 1, 8 and 15 of each 28-day cycle.
Table 1. Dose level reductions for patients with pancreatic adenocarcinoma:
| Dose Level | Paclitaxel Dose (mg/m²) | Gemcitabine Dose (mg/m²) |
|---|---|---|
| Full dose | 125 | 1000 |
| 1st dose level reduction | 100 | 800 |
| 2nd dose level reduction | 75 | 600 |
| If additional dose reduction required | Discontinue treatment | Discontinue treatment |
Table 2. Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma:
| Cycle Day | ANC count (cells/mm³) | Platelet count (cells/mm³) | Paclitaxel Dose | Gemcitabine Dose | |
|---|---|---|---|---|---|
| Day 1 | < 1500 | OR | < 100,000 | Delay doses until recovery | |
| Day 8 | ≥ 500 but < 1000 | OR | ≥ 50,000 but < 75,000 | Reduce doses 1 dose level | |
| < 500 | OR | < 50,000 | Withhold doses | ||
| Day 15: If Day 8 doses were given without modification: | |||||
| Day 15 | ≥ 500 but < 1000 | OR | ≥ 50,000 but < 75,000 | Treat with Day 8 dose level and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses | |
| < 500 | OR | < 50,000 | Withhold doses | ||
| Day 15: If Day 8 doses were reduced: | |||||
| Day 15 | ≥ 1000 | AND | ≥ 75,000 | Return to the Day 1 dose levels and follow with WBC Growth Factors OR Treat with same doses as Day 8 | |
| ≥ 500 but < 1000 | OR | ≥ 50,000 but < 75,000 | Treat with Day 8 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses | ||
| < 500 | OR | < 50,000 | Withhold doses | ||
| Day 15: IF Day 8 doses were withheld: | |||||
| Day 15 | ≥ 1000 | AND | ≥ 75,000 | Return to Day 1 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 1 doses | |
| ≥ 500 but < 1000 | OR | ≥ 50,000 but < 75,000 | educe 1 dose level and follow with WBC Growth Factors OR Reduce doses 2 dose levels from Day 1 doses | ||
| < 500 | OR | < 50,000 | Withhold doses | ||
Abbreviations: ANC = Absolute Neutrophil Count; WBC = white blood cell
Table 3. Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma:
| Adverse Drug Reaction (ADR) | Paclitaxel Dose | Gemcitabine Dose |
|---|---|---|
| Febrile Neutropenia: Grade 3 or 4 | Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela | |
| Peripheral Neuropathy: Grade 3 or 4 | Withhold dose until improves to ≤ Grade 1; resume at next lower dose levela | Treat with same dose |
| Cutaneous Toxicity: Grade 2 or 3 | Reduce to next lower dose levela; discontinue treatment if ADR persists | |
| Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea | Withhold doses until improves to ≤ Grade 1; resume at next lower dose levela | |
a See Table 1 for dose level reductions
Administered intravenously over 30 minutes.
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