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Paclitaxel 80, Breast Cancer, adjuvant

Protocol-ID: 581 V1.2 (Complete), PACL80, Breast Ca, adj.

Indication(s)

  • Breast Cancer; ICD-10 C50.-

Protocol classification

  • Classification: alternative
  • Intensity: Standard dose
  • Therapy phase:
  • Therapy intention: curative

Cycles

Cycle length 7 days, recommended cycles: 12

Protocol sequences

Risks

  • Emetogenicity (MASCC/ESMO): low (10-30%)
  • Neutropenia: low (<10%) °3-4: 2%
  • Febrile Neutropenia: low (<10%) °3-4: 1%
  • Infections: CTC AE °3-4: 3%
  • Fatigue: CTC AE °3-4: 3%
  • Neuropathy: CTC AE °2-4: 27%
  • Myalgias: CTC AE °3-4: 2%

Therapy

HYD
Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
1 Balanced Crystalloid Solution 500 ml   i.v.30 min30 min before Paclitaxel (d1) 
AP
Allergy prophylaxis: Paclitaxel Allergy Prophylaxis
Access: peripheral venous
Dexamethasone, dimetinden maleate, cimetidine
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
1 Dexamethasone 20 mg NaCl 0.9% 50 ml i.v.5 min30 min before Paclitaxel (d1) 
1 Dimetinden 4 mg NaCl 0.9% 50 ml i.v.5 min30 min before Paclitaxel (d1) 
1 Cimetidine 300 mg NaCl 0.9% 50 ml i.v.5 min30 min before Paclitaxel (d1) 
CTX
Antineoplastic therapy: Paclitaxel 80 mg/m²
Access: peripheral venous
weekly therapy
DaySubstanceDosageSolutionAppl.Inf. timeProcedure
1 Paclitaxel 80 mg/m² BSA NaCl 0.9% 250 ml i.v.60 minSequence 

Concomitant therapy supplements

Dexamethasone for antiemesis is covered by dexamethasone of allergy prophylaxis.

Notes

Paclitaxel administration over 60 minutes is only up to a dose of 100 mg/m².

Cycle diagram

Hydration: Balanced Crystalloid Solution

Week 1 / d
Substance 1234567
Balanced Crystalloid Solution (i.v.)       

Allergy prophylaxis: Paclitaxel Allergy Prophylaxis

Week 1 / d
Substance 1234567
Dexamethasone (i.v.)       
Dimetinden (i.v.)       
Cimetidine (i.v.)       

Antineoplastic therapy: Paclitaxel 80 mg/m²

Week 1 / d
Substance 1234567
Paclitaxel (i.v.)       

Cycles

Cycle length 7 days, recommended cycles: 12

Controls:

  • Blood count: on day 1 and subsequently weekly
  • ECG Risk of developing conduction disorder during paclitaxel therapy, regular ECG monitoring.
  • Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase Liver value monitoring before and during paclitaxel therapy.
  • Day 1: Na+, K+, Ca2+, Mg2+

Pharmacokinetics

Paclitaxel: hepatischer Abbau, biliäre Elimination 25%, renal < 10% Cimetidin: CYP450 Inhibitor, vielschichtige Interaktionen möglich

Original indication

Paclitaxel weekly, Breast Cancer, adjuvant

Original author

Sparano JA (2008)

Origin

Eastern Cooperative Oncology Group, Philadelphia, US

References

  • Sparano JA, Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med 2008 Apr 17;358(16):1663-71. doi: 10.1056/NEJMoa0707056. PMID: 18420499. [PMID]
  • De Laurentiis M, Taxane-based combinations as adjuvant chemotherapy of early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 2008 Jan 01;26(1):44-53. doi: 10.1200/JCO.2007.11.3787. PMID: 18165639. [PMID]
  • Budd GT, SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer. J Clin Oncol 2015 Jan 01;33(1):58-64. doi: 10.1200/JCO.2014.56.3296. PMID: 25422488. [PMID]
  • Shulman LN, Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (Alliance). J Clin Oncol 2014 Aug 01;32(22):2311-7. doi: 10.1200/JCO.2013.53.7142. PMID: 24934787. [PMID]

Recommendations

Links

  • One-hour paclitaxel infusions: review of safety and efficacy. [PMID]

Status

Valid since 2023-09-16, Version 1.2, last updated 2023-09-16

Last modification: V1.2: Protocol name changed according to current standard V1.1: Cato test done. Revision of allergy prophylaxis according to summary of product characteristics, change of H2- antagonist for Paclitaxel from Ranitidine to Cimetidine according to DGHO recommendations 10/2019. V1.0: Cato test again due to correct cycle count and diagnoses. V0.1: Cato test successful. Application of this protocol after 4 cycles of EC, see EC x 4 followed by Pacl, Breast Ca, adjuvant, A. Duration according to primary literature. This protocol was established based on AGO and NCCN recommendation allowing extrapolation from AC+Paclitaxel to EC+Paclitaxel and recommending use in dose equivalent due to more favorable side effect profile.

Important notice

The copyrighted protocols are treatment recommendations. The information contained in this compilation on cytostatic drugs, concomitant medication and other therapeutic procedures, as well as dosage and application information, is continuously reviewed with all due care by the authors and editors involved. Nevertheless, the publishers and authors do not assume any liability for the correctness - also with regard to possible printing errors.

The protocols may not be changed in terms of content.

Diagnosis, indication for therapy and treatment of malignant diseases must be carried out in each individual case by the hematologist and oncologist on his or her own responsibility. The treating physician is obligated to this personal responsibility to weigh in each case before a diagnostic or therapeutic measure, indication, contraindications, dosage and application under consideration of the specialized information or other documents of the manufacturers. This applies in particular to rarely used preparations or preparations that are new to the market.

The publishers and authors assume no liability for the accuracy of the contents. The application is at the own responsibility of the treating physician. ©Onkopti.