Adverse event management: stomatitis

Management recommendations¹^,2

Grade 1–2:

Continue GIOTRIF^® (afatinib) treatment at current dose

Grade ≥3 or intolerable Grade 2:

Interrupt GIOTRIF^® (afatinib), resuming treatment at a reduced dose (10 mg lower) if patient recovers to grade ≤1. Permanent discontinuation should be considered in patients who cannot tolerate 20 mg/day of GIOTRIF^® (afatinib) treatment

All Grades:³

Stomatitis may be managed through palliation with: bland saline rinses, topical lidocaine anaesthetics, mucosal coating agents or analgesics
This choice of management should be driven by patient preference

Advice for patients²^-⁴

Brush teeth and gums gently with a soft toothbrush and rinse with warm salt water, after every meal and before bed. Avoid alcohol-based mouthwashes
Eat foods cold or at room temperature; hot and warm food can irritate a tender mouth
Avoid acidic, spicy or salty juices and food which may irritate the mouth. Also avoid foods which require a lot of chewing
Drink plenty of water and use a straw to drink liquids
Use lip balm or petroleum jelly for dry lips
When needed, numb the mouth with ice chips or flavoured ice blocks

Grading⁵

Adverse Event	Grade 1	Grade 2	Grade 3	Grade 4
Stomatitis (clinical exam)	Erythema of the mucosa	Patchy ulcerations or pseudomembranes	Confluent ulcerations or pseudomembranes; bleeding with minor trauma	Tissue necrosis; significant spontaneous bleeding; life-threatening consequences
Stomatitis (functional/symptomatic)	Upper aerodigestive tract sites: Minimal symptoms, normal diet; minimal respiratory symptoms but not interfering with function Lower GI sites: Minimal discomfort, intervention not indicated	Upper aerodigestive tract sites: Symptomatic but can eat and swallow modified diet; respiratory symptoms interfering with function but not interfering with ADL Lower GI sites: Symptomatic, medical intervention indicated but not interfering with ADL	Upper aerodigestive tract sites: Symptomatic and unable to adequately aliment or hydrate orally; respiratory symptoms interfering with ADL Lower GI sites: Stool incontinence or other symptoms interfering with ADL	Symptoms associated with life-threatening consequences

Adverse Event	Stomatitis (clinical exam)	Stomatitis (functional/symptomatic)
Grade 1	Erythema of the mucosa	Upper aerodigestive tract sites: Minimal symptoms, normal diet; minimal respiratory symptoms but not interfering with function Lower GI sites: Minimal discomfort, intervention not indicated
Grade 2	Patchy ulcerations or pseudomembranes	Upper aerodigestive tract sites: Symptomatic but can eat and swallow modified diet; respiratory symptoms interfering with function but not interfering with ADL Lower GI sites: Symptomatic, medical intervention indicated but not interfering with ADL
Grade 3	Confluent ulcerations or pseudomembranes; bleeding with minor trauma	Upper aerodigestive tract sites: Symptomatic and unable to adequately aliment or hydrate orally; respiratory symptoms interfering with ADL Lower GI sites: Stool incontinence or other symptoms interfering with ADL
Grade 4	Tissue necrosis; significant spontaneous bleeding; life-threatening consequences	Symptoms associated with life-threatening consequences

Adapted from CTCAE version 3.⁵

CTCAE=common terminology criteria for adverse events

References

1: GIOTRIF^® (afatinib) Summary of Product Characteristics, 2018.
2: Bensinger W, et al. J Natl Compr Canc Netw 2008;6(Suppl 1):S1-21.
3: Gupta A, West H. JAMA Oncol 2016;2(10):1379.
4: Aw DC, et al. Asia-Pac J Clin Oncol 2018;14(1):23–31.
5: Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.

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