Docetaxel 75 / Cisplatin 75, Non-Small Cell Lung Carcinoma

Protocol-ID: 144 V1.1 (Standard), DOCE75/CISP75, NSCLC

Indication(s)

Lung Carcinoma, Non-Small Cell; ICD-10 C34.-

Protocol classification

Classification: current standard
Intensity: Standard dose
Therapy mode: First line
Therapy intention: palliative

Cycles

Cycle length 21 days, recommended cycles: 6

Risks

Emetogenicity (MASCC/ESMO): high (>90%)
Neutropenia: very high (>41%)
Febrile Neutropenia: intermediate (10-20%)
Thrombocytopenia below 50 000/µl: low (<10%)
Anemia Hb below 8g/dl: moderate (6-15%)
Cardiotoxicity: low (<10%)

Therapy

Day	Substance	Dosage	Appl.	Procedure
AP Allergy prophylaxis: Docetaxel allergy prophylaxis, Dexamethasone
Access: - none -
Docetaxel SmPC
-1	Dexamethasone	8 mg	p.o.	1-0-1-0
From day before therapy with Docetaxel, antihistamine therapy not provided for in summary of product characteristics.

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
HYD Hydration: Hydration to Cisplatin (from 50 mg/m²)
Access: peripheral venous
Modified from Crona DJ et al 2017 and Hamroun A et al 2019.
1	Balanced Crystalloid Solution	3000 ml		i.v.	6 h	60 min before Docetaxel (d1)
Parallel to cisplatin and beyond. 20 mmol KCl and 4 mmol (10 ml) MgSO4 added to 1000 ml balanced crystalloid solution
1	Potassium chloride	60 mmol	none	i.v.	6 h	60 min before Docetaxel (d1)
1	Magnesium sulfate	12 mmol	none	i.v.	6 h	60 min before Docetaxel (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AE Antiemesis: Emetogenicity high, FOSAP, GRAN i.v., DEXA i.v.
Access: peripheral venous
DGHO 2016, DKG 2016, MASCC/ESMO 2016
1	Fosaprepitant	150 mg	NaCl 0.9% 150 ml	i.v.	20 min	30 min before Docetaxel (d1)
1	Dexamethasone	12 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Docetaxel (d1)
1	Granisetron	1 mg	NaCl 0.9% 50 ml	i.v.	5 min	15 min before Docetaxel (d1)
or other 5-HT3 receptor antagonist
2-4	Dexamethasone	8 mg		p.o.		1-0-0-0
alternatively 4 mg 1-0-1

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
CTX Antineoplastic therapy: CISP75/DOCE75
Access: peripheral venous
Palliative therapy in advanced NSCLC
1	Docetaxel	75 mg/m² BSA	NaCl 0.9% 250 ml	i.v.	60 min	Sequence
Give docetaxel concurrently with hydration before cisplatin.
1	Cisplatin	75 mg/m² BSA	NaCl 0.9% 500 ml	i.v.	60 min	Sequence

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HW Hematopoietic growth factors: FN risk 10-20%, G-CSF long-acting, pegylated
Access: - none -
Risk of febrile neutropenia (FN) 10-20% and 1 risk factor: age > 65 y, laboratory parameters (anemia, lymphocytopenia < 700/µl, hypalbuminemia, hyperbilirubinemia) previous chemotherapy, comorbidities, low performance status, advanced symptomatic tumor disease (DKG 2016)
2	Pegfilgrastim	6 mg	subc	Bolus	24 h after Cisplatin (d1)
Use at risk: FN 10-20% and 1 risk factor, other long-acting G-CSF possible.

Day	Substance	Dosage	Appl.	Procedure
SUP Supportive therapy: Magnesium p.o.
Access: - none -
For magnesium substitution in cisplatin therapies from 50mg/m².
1-3	Magnesium	150 mg	p.o.	1-0-1-0
For Cisplatin-containing therapies, 150 mg Magnesium corresponds to about 6.2 mmol.

Concomitant therapy supplements

For highly emetogenic chemotherapy, additional olanzapine is recommended in the acute (day 1) and delayed phases (days 2-4) at a dosing of 5-10 mg per day (NCCN, ESMO, ASCO, Onkopedia; as of 6/24). Dexamethasone for allergy prophylaxis is covered by dexamethasone for antiemesis on days 1 and 2.

Notes

in case of response 4-6 cycles, maximum 6

Controls:

Blood count: 1x weekly
Audiogram Ototoxicity of cisplatin
Echocardiography, ECG Evaluation of cardiac pump function before cisplatin therapy.
Day 1: Creatinine, glomerular filtration rate (GFR) Exclusion of renal insufficiency before cisplatin.
Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase Liver function prior to Docetaxel and Cisplatin administration, ongoing liver monitoring during therapy.
Day 1,2: Na⁺, K⁺, Ca²⁺, Mg²⁺ Exclusion of electrolyte imbalance during cisplatin and infusion therapy.
Day 1-2: Weight

Original author

Joan H. Schiller (2002)

Origin

Eastern Cooperative Oncology Group

References

Schiller JH, Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954. PMID: 11784875. [PMID]
Millward MJ, Phase I trial of docetaxel and cisplatin in previously untreated patients with advanced non-small-cell lung cancer. J Clin Oncol 1997 Feb;15(2):750-8. doi: 10.1200/JCO.1997.15.2.750. PMID: 9053501. [PMID]
Fossella F, Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 Study Group J Clin Oncol 2003 Aug 15;21(16):3016-24. doi: 10.1200/JCO.2003.12.046. PMID: 12837811. [PMID]
Novello S, Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2016 Sep;27(suppl 5):v1-v27. doi: 10.1093/annonc/mdw326. PMID: 27664245. [PMID]

Recommendations

09/2021: European Society for Medical Oncology
02/2023: National Comprehensive Cancer Network

Important notice

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