Management   |   Patient advice   |   Grading

 

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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