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

Protocol-ID: 144 V1.1 (Complete), 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

Cycle diagram

Allergy prophylaxis: Docetaxel allergy prophylaxis, Dexamethasone

Substance	-7	-6	-5	-4	-3	-2	-1	1	2	3	4	5	6	7
	Week -1 / d							Week 1 / d
Dexamethasone (p.o.)

Hydration: Hydration to Cisplatin (from 50 mg/m²)

Substance	-7	1
	Week -1 / d	Week 1 / d
Balanced Crystalloid Solution (i.v.)
Potassium chloride (i.v.)
Magnesium sulfate (i.v.)

Antiemesis: Emetogenicity high, FOSAP, GRAN i.v., DEXA i.v.

Substance	-7	1
	Week -1 / d	Week 1 / d
Fosaprepitant (i.v.)
Dexamethasone (i.v.)
Granisetron (i.v.)
Dexamethasone (p.o.)

Antineoplastic therapy: CISP75/DOCE75

Substance	-7	1
	Week -1 / d	Week 1 / d
Docetaxel (i.v.)
Cisplatin (i.v.)

Hematopoietic growth factors: FN risk 10-20%, G-CSF long-acting, pegylated

Substance	-7	-6	-5	-4	-3	-2	-1	1	2	3	4	5	6	7
	Week -1 / d							Week 1 / d
Pegfilgrastim (subc)

Supportive therapy: Magnesium p.o.

Substance	-7	-6	-5	-4	-3	-2	-1	1	2	3	4	5	6	7
	Week -1 / d							Week 1 / d
Magnesium (p.o.)

Cycles

Cycle length 21 days, recommended cycles: 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 indication

Non-small cell lung Ca Std IIIb, IV or recurrence.

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

Status

Valid since 2023-02-22, Version 1.1, last updated 2023-02-22

Last modification: V1.1: Hydration update according to Crona 2017 and Hamroun 2019. V1.0: Cato test done. Hydration modified to Cisplatin, substances of the fluid module merged for Cato export. V0.1: Run times and dosing according to Milward 1997.

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.