Pola-R-CHP - Polatuzumab Vedotin 1.8 / Rituximab 375 / Cyclophosphamide 750 / Doxorubicin 50 / Prednisolone 100, diffuse large B-non-Hodgkin Lymphoma, cycle 1-6

Protocol-ID: 1920 V1.0 (Short), Pola-R-CHP (POLVED1.8/RITU375/CYCL750/DOXO50/PRED100), DLBCL, C1-6

Indication(s)

NHL, B-Cell Type, Diffuse Large Cell; ICD-10 C83.3

Protocol classification

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

Cycles

Cycle length 21 days, recommended cycles: 6

Protocol sequences

POLARIX: Pola-R-CHP (POLVED1,8/RITU375/CYCL750/DOXO50/PRED100), DLBCL, C1-6 (PID1920) -|- RITU375, C7-8 (PID1921)

Risks

Emetogenicity (MASCC/ESMO): moderate (30-90%)
Neutropenia: very high (>41%)
Febrile Neutropenia: high (>20%)
Anemia Hb below 8g/dl: moderate (6-15%)
Diarrhea: CTC AE °1-2: 27%; °3-4: 4%
Headache: CTC AE °1-2: 12%; °3-4: 1%
Neuropathy: CTC AE °1-2: 52%; °3-4: 2%
Asthenia: CTC AE °1-2: 10%; °3-4: 2%
Constipation: CTC AE °1-2: 28%; °3-4: 1%
Pyrexia: CTC AE °1-2: 14%; °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.	60 min	60 min before Polatuzumab Vedotin

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AE Antiemesis: Emetogenicity moderate, GRAN i.v., DEXA i.v.
Access: peripheral venous
ASCO 2015, DGHO 2016, DKG 2016, MASCC/ESMO 2016, if palonosetron not available
1	Granisetron	1 mg	NaCl 0.9% 50 ml	i.v.	5 min	15 min before Cyclophosphamide (d1)
or other 5-HT3 receptor antagonist

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AP Allergy prophylaxis: Rituximab (paracetamol, Dimetinden, Prednisolone i.v.)
Access: peripheral venous
1	Paracetamol	1000 mg		p.o.		60 min before Polatuzumab Vedotin
1	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Polatuzumab Vedotin
1	Prednisolone	100 mg	NaCl 0.9% 50 ml	i.v.	15 min	60 min before Polatuzumab Vedotin

Day	Substance	Dosage	Appl.	Inf. time	Procedure
SUP Supportive therapy: Mesna i.v., hour 0 (pre), p.o. 2 h, 6 h after onset Cyclophosphamide
Access: peripheral venous
Mesna 0h,2h,6h, prophylaxis of urinary tract toxicity by Cyclophosphamide. At the time of oxazaphosphorin injection, 20% of the oxazaphosphorin dose is injected simultaneously as Mesna. 2 and 6 h after onset, oral Medication of 40% of the oxazaphosporin dose, summary of product characteristics.
1	Mesna	150 mg/m² BSA	i.v.	1 min	1 min before Cyclophosphamide (d1)
1	Mesna	300 mg/m² BSA	p.o.		1 h after Cyclophosphamide (d1)
1	Mesna	300 mg/m² BSA	p.o.		5 h after Cyclophosphamide (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
CTX Antineoplastic therapy: Pola-R-CHP
Access: central venous
2-5	Prednisolone	100 mg		p.o.		1-0-0-0
1	Polatuzumab vedotin	1.8 mg/kg bw	NaCl 0.9% 150 ml	i.v.	90 min	Sequence
If the previous infusion was well tolerated, the subsequent dose of polatuzumab vedotin may be administered as a 30-minute infusion.
1	Rituximab	375 mg/m² BSA	NaCl 0.9% 500 ml	i.v.	4 h	Sequence
Init. Infusion rate 50mg/h; it can be increased by 50mg/h every 30min to max. 400mg/h. Further infusions: init. Infusion speed 100mg/h, which can be increased by 100mg/h every 30min to max. 400mg/h.
1	Cyclophosphamide	750 mg/m² BSA	NaCl 0.9% 500 ml	i.v.	1 h	Sequence
1	Doxorubicin	50 mg/m² BSA	Dextrose 5% 250 ml	i.v.	30 min	Sequence

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HW Hematopoietic growth factors: FN risk above 20%, G-CSF long-acting, pegylated
Access: - none -
Risk of febrile neutropenia (FN) >20%, ASCO 2015, DKG 2016
2	Pegfilgrastim	6 mg	subc	Bolus	24 h after Doxorubicin (d1)
or other long-acting G-CSF

Concomitant therapy supplements

Prednisolone in allergy prophylaxis is equivalent to Prednisolone in day 1 therapy.

Warnings

If an infusion-related reaction occurs in a patient, slow the infusion rate of Polatuzumab Vedotin or discontinue use. Discontinue use immediately and permanently if a life-threatening reaction occurs in a patient. Doxorubicin: increased risk of cardiomyopathy, maximum cumulative dose 450-550 mg/m² KOF. In mediastinal irradiation, arterial hypertension for more than 5 years, age over 70 years or previous cardiac damage, maximum 400 mg/m². For DOXO extravasation: dry cold (not just before or after Dexrazoxane infusion) on day of extravasation. Dexrazoxane i.v. for 3 days: 2 days 1000 mg/m², 3rd day 500 mg/m², do not use in parallel with DMSO. First infusion as soon as possible and within the first 6 hours.

References

Tilly H, Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. PMID: 34904799. [PMID]

Recommendations

04/2024: National Comprehensive Cancer Network

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Valid since: 07.01.2022