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Multi-day fractionated administration schedule for paclitaxel

J Lokich1, N Anderson, M Bern

  • 1Cancer Center of Boston, MA, USA.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|November 1, 1995
PubMed
Summary

Daily fractionated paclitaxel infusions are feasible in an outpatient setting, offering a potentially higher dose per cycle with manageable toxicity. This administration method does not require premedication and shows promise for dose escalation in select patients.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Paclitaxel is a crucial chemotherapeutic agent.
  • Traditional administration involves longer infusion times.
  • Optimizing paclitaxel delivery is essential for improving patient outcomes and treatment efficiency.

Purpose of the Study:

  • To assess the feasibility of fractionating paclitaxel administration using daily one-hour infusions over three to five days.
  • To determine dose-escalation patterns and associated hematologic and non-hematologic toxicities.
  • To evaluate the safety and logistical aspects of outpatient paclitaxel fractionation.

Main Methods:

  • Forty patients received 87 courses of daily fractionated paclitaxel (3, 4, or 5 days per cycle) every 21 days.
  • Dose escalation ranged from 120 mg/m² to 250 mg/m² per cycle.

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  • Six patients received concomitant daily cisplatin.

    • Main Results:

    • Cumulative doses per cycle reached up to 250 mg/m², with 25% of cycles at 200 mg/m² or higher.
    • Dose-limiting neutropenia occurred in 11.5% of cycles (grades 3 and 4).
    • No hypersensitivity reactions, hospitalizations, or need for cytokine support were observed.

    Conclusions:

    • Daily fractionated paclitaxel administration is logistically feasible in an ambulatory setting without requiring premedication.
    • Toxicity profiles are similar to single-day infusion schedules, with potential for higher dose intensity.
    • Optimal dosing for five-day schedules is 200-250 mg/m² per cycle; dose escalation beyond this may be possible in select patients. Concomitant cisplatin may increase neurotoxicity.