Paclitaxel 80, Breast Cancer, adjuvant

Protocol-ID: 581 V1.2 (Standard), 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

EC (EPIR90/CYCL600), Breast Ca, adj. (PID579) -|- PACL80, Breast Ca, adj. (PID581)
EC (EPIR90/CYCL600), Breast Ca, adj., dd (PID2702) -|- PACL80, adj. (PID581)
SWOG S0221: AC (DOXO60/CYCL600), Breast Ca, adj., dd, var. 1 (PID478) -|- PACL80, adj. (PID581)
AC (DOXO60/CYCL600), Breast Ca, adj. (PID599) -|- PACL80, adj. (PID581)

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

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HYD Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
1	Balanced Crystalloid Solution	500 ml	i.v.	30 min	30 min before Paclitaxel (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AP Allergy prophylaxis: Paclitaxel Allergy Prophylaxis
Access: peripheral venous
Dexamethasone, dimetinden maleate, cimetidine
1	Dexamethasone	20 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d1)
1	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d1)
1	Cimetidine	300 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
CTX Antineoplastic therapy: Paclitaxel 80 mg/m²
Access: peripheral venous
weekly therapy
1	Paclitaxel	80 mg/m² BSA	NaCl 0.9% 250 ml	i.v.	60 min	Sequence

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.

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⁺

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

08/2019: European Society for Medical Oncology
03/2023: National Comprehensive Cancer Network

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.

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