modified FOLFOX-6 - Oxaliplatin 85 / Folinic Acid 400 / Fluorouracil 2400, colon carcinoma adjuvant
Protocol-ID: 644 V1.1 (Standard), mFOLFOX-6 (OXAL85/CFOL400/FU2400), Colon Ca, adj.Indication(s)
- Colon Cancer; ICD-10 C18.0, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C19
Protocol classification
- Classification: current standard
- Intensity: Standard dose
- Therapy phase:
- Therapy intention: curative
Cycles
Cycle length 14 days, recommended cycles: 12
Risks
- Emetogenicity (MASCC/ESMO): moderate (30-90%)
- Neutropenia: high (21-40%)
- Febrile Neutropenia: low (<10%)
- Thrombocytopenia below 50 000/µl: low (<10%) °3-4: 3.4%
- Diarrhea: CTC AE °3-4: 9.7%
- Fatigue: CTC AE °3-4: 7.2%
- Thromboembolic Event: CTC AE °3-4: 4.6%
- Neuropathy: CTC AE °3-4: 14.4%, sensory
- Dehydration: CTC AE °3-4: 4.0%
- Allergic Reaction: CTC AE °3-4: 4.7%
- Pain: CTC AE °3-4: 6.3%
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 Oxaliplatin (d1) | ||
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 | Dexamethasone | 8 mg | NaCl 0.9% 50 ml | i.v. | 5 min | 30 min before Oxaliplatin (d1) | |
| 1 | Granisetron | 1 mg | NaCl 0.9% 50 ml | i.v. | 5 min | 15 min before Oxaliplatin (d1) | |
| or other 5-HT3 receptor antagonist | |||||||
| 2-3 | Dexamethasone | 8 mg | p.o. | 1-0-0-0 | |||
CTX Antineoplastic therapy: mFOLFOX6 | |||||||
| Access: central venous, port | |||||||
| Day | Substance | Dosage | Solution | Appl. | Inf. time | Procedure | |
|---|---|---|---|---|---|---|---|
| 1 | Oxaliplatin | 85 mg/m² BSA | Dextrose 5% 500 ml | i.v. | 2 h | Sequence | |
| 1 | Folinic acid | 400 mg/m² BSA | NaCl 0.9% 250 ml | i.v. | 2 h | Sequence | |
| 1 | Fluorouracil | 400 mg/m² BSA | none | i.v. | 1 min | Sequence | |
| Bolus application | |||||||
| 1 | Fluorouracil | 2400 mg/m² BSA | NaCl 0.9% 500 ml | i.v. | 46 h | Sequence | |
| The volume of the carrier solution refers to inpatient therapy with infusion pumps. When using syringe pumps or ambulatory systems, a different volume (e.g. 100 ml) can be used. | |||||||
Notes
Oxaliplatin is administered before folinic acid for pharmacological reasons.
Controls:
- Blood count: on day 1 and subsequently weekly
- DPD Exclude deficiency: Uracil levels or DPD gene mutations.
- Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase Fluorouracil: dose reduction is necessary in the presence of concomitant impaired hepatic and renal function.
- Day 1: Creatinine, glomerular filtration rate (GFR) Oxaliplatin
Original author
Allegra CJ (2009)
Origin
University of Florida, Division of Hematology and Oncology, Gainsville, Florida, NSABP
References
- Allegra CJ, Initial safety report of NSABP C-08: A randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer. J Clin Oncol 2009 Jul 10;27(20):3385-90. doi: 10.1200/JCO.2009.21.9220. PMID: 19414665. [PMID]
- Allegra CJ, Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: results of NSABP protocol C-08. J Clin Oncol 2011 Jan 01;29(1):11-6. doi: 10.1200/JCO.2010.30.0855. PMID: 20940184. [PMID]
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.
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.
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