Active Ingredient: Docetaxel
Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
75 - 75 mg per m² of body surface area (BSA)
From 75 To 75 mg per m² of body surface area (BSA) once every 21 day(s)
The recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion, followed by cisplatin 75 mg/m², as a 1-to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration. Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities.
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m². If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m². In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m². Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500 cells/mm³ and platelets recover to a level >100,000 cells/mm³. Discontinue treatment if these toxicities persist.
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
| Toxicity | Dose adjustment |
|---|---|
| Diarrhoea grade 3 | First episode: reduce 5-FU dose by 20%. Second episode: then reduce docetaxel dose by 20%. |
| Diarrhoea grade 4 | First episode: reduce docetaxel and 5-FU doses by 20%. Second episode: discontinue treatment. |
| Stomatitis/mucositis grade 3 | First episode: reduce 5-FU dose by 20%. Second episode: stop 5-FU only, at all subsequent cycles. Third episode: reduce docetaxel dose by 20%. |
| Stomatitis/mucositis grade 4 | First episode: stop 5-FU only, at all subsequent cycles. Second episode: reduce docetaxel dose by 20%. |
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Docetaxel is administered as a one-hour infusion every three weeks.
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