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 (Standard), Pola-R-CHP (POLVED1.8/RITU375/CYCL750/DOXO50/PRED100), DLBCL, C1-6Indication(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
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
HYD Hydration: Balanced Crystalloid Solution | |||||||
| Access: peripheral venous | |||||||
| Hydration before, during, or after antitumor therapy | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 1 | Balanced Crystalloid Solution | 500 ml | i.v. | 60 min | 60 min before Polatuzumab Vedotin | ||
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 | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 1 | Granisetron | 1 mg | NaCl 0.9% 50 ml | i.v. | 5 min | 15 min before Cyclophosphamide (d1) | |
| or other 5-HT3 receptor antagonist | |||||||
ASR Prevention of Acute Systemic Reactions: Rituximab (paracetamol, Dimetinden, Prednisolone i.v.) | |||||||
| Access: peripheral venous | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 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 | |
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. | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 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) | |||
ANTX Antineoplastic therapy: Pola-R-CHP | |||||||
| Access: central venous | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 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 | |
HW Hematopoietic growth factors: FN risk over 20%, G-CSF long-acting | |||||||
| Access: - none - | |||||||
| Risk of febrile neutropenia (FN) >20%, ASCO 2015, DKG 2016 | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 2 | Pegfilgrastim | 6 mg | subc | Bolus | 24 h after Doxorubicin (d1) | ||
| or other long-acting G-CSF | |||||||
Substance links
Links to substances are found here.
Concomitant therapy supplements
Prednisolon in der Allergieprophylaxe entspricht Prednisolon in der Therapie an Tag 1. Tumorlysesyndrom-Risikoeinteilung nach Cairo 2010 beachten, bei LDH-Erhöhung ohne Tumor-Bulk Protokoll "Tumorlysesyndrom-Prophylaxe, mittleres Risiko" verwenden. Bei LDH-Erhöhung über das zweifache des oberen Grenzwertes und Tumor-Bulk Protokoll "Tumorlysesyndrom-Prophylaxe, hohes Risiko" benutzen.
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.
Notes
Die Patienten sind während der Infusion von Polatuzumab Vedotin und für mindestens 90 Minuten nach Beendigung der Initialdosis auf infusionsbedingte Reaktionen/Überempfindlichkeitsreaktionen zu überwachen. Wenn die vorherige Infusion gut vertragen wurde, sind die Patienten während der Infusion und für mindestens 30 Minuten nach Beendigung der Infusion zu überwachen. Dexamethason zur Antiemese an den Tagen 2-3 durch Prednisolon der Antitumortherapie abgedeckt. Die Kombination aus einem Anthrazyklin und Cyclophosphamid kann bei einzelnen Patienten hoch emetogen sein und eine Zugabe eines Neurokininrezeptor-Antagonists erfordern. Hierbei muss auf die Erhöhung der Plasmakonzentration von Prednisolon geachtet und dieses eventuell angepasst werden.
Controls:
- Blood count: 1x weekly
- Echocardiography, ECG, chest X-ray Cardiotoxicity of doxorubicin, review of cardiac function before/under therapy recommended.
- Hepatitis B (HBV) Test: HBsAg and anti-HBc Rituximab: Hep-B reactivation possible. If Hep-B serology is positive, initiate measures to prevent hepatitis B reactivation.
- IgG Rituximab: Risk of Infection: It is recommended that immunoglobulin levels be determined prior to initiating treatment with rituximab.
- Day 1: Na+, K+, Ca2+, Mg2+
- Day 1: Creatinine, glomerular filtration rate (GFR)
- Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase
- Day 1: Urine status
Original author
Tilly H (2021)
Origin
Centre Henri-Becquerel, Rouen Cedex, France, POLARIX trial
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] [DOI]
- Morschhauser F, Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma. J Clin Oncol 2025 Dec 10;43(35):3698-3705. doi: 10.1200/JCO-25-00925. PMID: 40991874. [PMID] [DOI]
Recommendations
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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