modified FOLFOX-6 - Oxaliplatin 85 / Folinic Acid 400 / Fluorouracil 2400, colon carcinoma adjuvant

Protocol-ID: 644 V1.1 (Complete), 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

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 Oxaliplatin (d1)

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	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

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
CTX Antineoplastic therapy: mFOLFOX6
Access: central venous, port
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.

Cycle diagram

Hydration: Balanced Crystalloid Solution

Substance	1	2	3	4	5	6	7
	Week 1 / d
Balanced Crystalloid Solution (i.v.)

Antiemesis: Emetogenicity moderate, GRAN i.v., DEXA i.v.

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

Antineoplastic therapy: mFOLFOX6

Substance	1	2	3	4	5	6	7
	Week 1 / d
Oxaliplatin (i.v.)
Folinic acid (i.v.)
Fluorouracil (i.v.)
Fluorouracil (i.v.)

Cycles

Cycle length 14 days, recommended cycles: 12

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

Pharmacokinetics

Fluorouracil: 90% metabolische Elimination, 10% renal Oxaliplatin: renale Elimination der Metabolite

Original indication

adjuvant treatment of colon carcinoma, stage 2/3, ECOG 0-1

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

07/2020: European Society for Medical Oncology
11/2023: National Comprehensive Cancer Network

Status

Valid since 2024-01-04, Version 1.1, last updated 2024-10-27

Last modification: V1.1: Title correction V1.0: Cato test done with cycle count and ICD-10 codes. Dexamethasone for prophylaxis of delayed emesis analogous to the guidelines on day 4 deleted. V0.1: Durations according to primary literature, sequence Oxaliplatin before Fluorouracil according to summary of product characteristics.

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.