Download Chronic and Late Effects Template

RTOG 0522 H & N Adverse Event Grading Tool (from CTCAE, v. 3.0)
Grade
Adverse Event
Pain (Select site)
1
(Pain)
Fatigue (lethargy, malaise, asthenia)
2
3
4
Mild pain not interfering with
function
Moderate pain; pain or analgesics interfering
with function, but not interfering with ADL
Severe pain; pain or analgesics severely
interfering with ADL
Disabling
Mild fatigue over baseline
Moderate or causing difficulty performing some
ADL
Severe fatigue interfering with ADL
Disabling
(Constitutional Symptoms)
Myelitis
(Neurology)
Asymptomatic, mild signs (e.g.,
Babinski's or Lhermitte's sign)
Weakness or sensory loss not interfering with
ADL
Weakness or sensory loss interfering with ADL
Disabling
Neuropathy: motor
(Neurology)
Asymptomatic, weakness on
exam/testing only
Symptomatic weakness interfering with
function, but not interfering with ADL
Weakness interfering with ADL; bracing or
assistance to walk (e.g., cane or walker)
indicated
Life-threatening; disabling (e.g.,
paralysis)
Neuropathy: sensory
(Neurology)
Asymptomatic; loss of deep
tendon reflexes or paresthesia
(including tingling) but not
interfering with function
Sensory alteration or paresthesia (including
tingling, interfering with function, but not
interfering with ADL
Sensory alteration or paresthesia interfering
with ADL
Disabling
-
Hearing loss not requiring hearing aid or
intervention (i.e., not interfering with ADL)
Hearing loss requiring hearing aid or
intervention (i.e., interfering with ADL)
Profound bilateral hearing loss
(>90 dB)
-
Tinnitus not inferring with ADL
Tinnitus interfering with ADL
Disabling
Localized to depended areas, no
disability or functional
impairment
Localized facial or neck edema with functional
impairment
Generalized facial or neck edema with
functional impairment (e.g., difficulty in turning
neck or opening mouth compared to baseline)
Severe with ulceration or cerebral
edema; tracheotomy or feeding
tube indicated
Mild or intermittent hoarseness or
voice change, but fully
understandable
Moderate or persistent voice changes, may
require occasional repetition but understandable
on telephone
Severe voice changes including predominantly
whispered speech; may require frequent
repetition or face-to-face contact for
understandability; requires voice aid (e.g.,
electrolarynx) for ≤50% of communication
Disabling; non-understandable
voice or aphonic; requires voice
aid (e.g., electrolarynx) for >50%
of communication or requires >
50% written communication.
Asymptomatic edema by exam
only
Symptomatic edema, no respiratory distress
Stridor; respiratory distress; interfering with
ADL
Life-threatening airway
compromise; tracheotomy,
intubation, or laryngectomy
indicated
Asymptomatic obstruction or
stenosis on exam, endoscopy, or
radiograph
Symptomatic (e.g., noisy airway breathing), but
causing no respiratory distress; medical
management indicated (e.g., steroids)
Interfering with ADL; stridor or endoscopic
intervention indicated (e.g., stent, laser)
Life-threatening airway
compromise; tracheotomy or
intubation indicated
Surface stains; dental caries;
restorable, without extractions
Less than full mouth extractions; tooth fracture
or crown amputation or repair indicated
Full mouth extractions indicated
Hearing: patients without baseline
audiogram and not enrolled in a
monitoring program
(Auditory/Ear)
Tinnitus
Edema: head and neck
(Lymphatics)
Voice changes/dysarthria (e.g.,
hoarseness, loss or alteration in
voice, laryngitis)
(Pulmonary/Upper Respiratory)
Edema, larynx
(Pulmonary/Upper Respiratory)
Obstruction/stenosis of airway
Select: larynx, pharynx, or trachea
(Pulmonary/Upper Respiratory)
Dental: teeth
(Gastrointestinal)
1
-
RTOG 0522 H & N Adverse Event Grading Tool (from CTCAE, v. 3.0)
Grade
Adverse Event
1
2
3
4
-
-
Altered taste but no change in diet
Altered taste with change in diet (e.g. oral
supplements); noxious or unpleasant taste; loss
of taste
Slightly thickened saliva; slightly
altered taste (e.g., metallic)
Thick, ropy, sticky saliva; markedly altered
taste; alteration in diet indicated; secretioninduced symptoms not interfering with ADL
Acute salivary gland necrosis; severe secretioninduced symptoms interfering with ADL
Symptomatic (dry or thick saliva)
without significant dietary
alteration; unstimulated saliva
flow >0.2 ml/min
Symptomatic and significant oral intake
alteration (e.g. copious water, other lubricants,
diet limited to purees and/or soft, moist foods);
unstimulated saliva 0.1 to 0.2 ml/min
Symptoms leading to inability to adequately
aliment orally; IV fluids, tube feedings, or TPN
indicated; unstimulated saliva <0.1 ml/min
Symptomatic, able to eat regular
diet
Symptomatic and altered eating/swallowing
(e.g., altered dietary habits, oral supplements);
IV fluids indicated < 24 hrs
Symptomatic and severely altered
eating/swallowing (e.g., inadequate oral caloric
or fluid intake); IV fluids, tube feedings, or TPN
indicated ≥ 24 hrs
Life-threatening consequences
(e.g., obstruction, perforation)
Mucositis/stomatitis (clinical exam)
Select: larynx, oral cavity, or
pharynx
(Gastrointestinal)
Erythema of the mucosa
Patchy ulcerations or pseudomembranes
Confluent ulcerations or pseudomembranes;
bleeding with minor trauma
Tissue necrosis; significant
spontaneous bleeding; lifethreatening consequences
Stricture/stenosis (including
anastomotic), GI (Late)
Asymptomatic radiographic
findings only
Symptomatic; altered GI function (e.g., altered
dietary habits, vomiting, bleeding, diarrhea); IV
fluids indicated < 24hrs
Symptomatic and severely altered GI function
(e.g., altered dietary habits, diarrhea, or GI fluid
loss); IV fluids, tube feedings or TPN indicated
≥ 24 hrs; operative intervention indicated
Life-threatening consequences;
operative intervention requiring
complete organ resection (e.g.
total colectomy)
Faint erythema or dry
desquamation
Mod to brisk erythema; patchy moist
desquamation mostly confined to skin folds;
mod edema
Moist desquamation other than skin folds;
bleeding induced by minor trauma or abrasion
Skin necrosis or ulceration of full
thickness dermis; spontaneous
bleeding from involved site
Thinning or patchy
Complete
-
-
Slight or localized
Marked or generalized
-
-
Increased density on palpation
Moderate impairment of function not interfering
with ADL; marked increase in density and
firmness on palpation with or without minimal
retraction.
Dysfunction interfering with ADL; very marked
density, retraction or fixation.
-
Taste alteration (dysgeusia)
(Gastrointestinal)
Salivary gland changes/saliva
(acute effect)
(Gastrointestinal)
Dry mouth/salivary gland
(xerostomia-late effect)
(Gastrointestinal)
Dysphagia (difficulty swallowing)
(Gastrointestinal)
Select: esophagus or pharynx
Disabling
-
(Gastrointestinal)
Dermatitis, assoc with radiation
(Select: radiation or
chemoradiation)
(Dermatology/Skin)
Hair loss/alopecia (scalp or body)
(Dermatology/Skin)
Hyperpigmentation or
Hypopigmentation (select)
(Dermatology/Skin)
Induration/fibrosis
(skin and subcutaneous tissue)
(Musculoskeletal/ Soft Tissue)
2
RTOG 0522 H & N Adverse Event Grading Tool (from CTCAE, v. 3.0)
Grade
Adverse Event
Trismus (difficulty, restriction or
pain when opening mouth)
1
Decreased range of motion
without impaired eating
2
3
4
Decreased range of motion requiring small
bites, soft foods or purees
Decreased range of motion with inability to
adequately aliment or hydrate orally
-
-
Local wound care; medical intervention
indicated
Operative debridement or other invasive
intervention indicated (e.g., hyperbaric oxygen)
Life-threatening consequences;
major invasive intervention
indicated (e.g., tissue
reconstruction, flap, or grafting)
-
Local wound care; medical intervention
indicated
Operative debridement or other invasive
intervention indicated (e.g., hyperbaric oxygen)
Life-threatening consequences;
major invasive intervention
indicated (e.g., tissue
reconstruction, flap, or grafting)
Asymptomatic, radiographic
findings only
Symptomatic and interfering with function, but
not interfering with ADL; minimal bone
removal indicated (i.e., minor sequestrectomy)
Symptomatic and interfering with ADL;
operative intervention or hyperbaric oxygen
indicated
Disabling
Asymptomatic, intervention not
indicated
Symptomatic, not interfering with ADL; thyroid
replacement indicated
Symptoms interfering with ADL;
hospitalization indicated
Life-threatening myxedema coma
(Musculoskeletal/ Soft Tissue)
Soft tissue necrosis-head and neck
(select site: skin/soft tissue, neck)
(Musculoskeletal/ Soft Tissue)
Soft tissue necrosis-head and neck
(Select site: mucosa, oral cavity,
larynx or pharynx)
(Musculoskeletal/ Soft Tissue)
Osteonecrosis
(Musculoskeletal/ Soft Tissue)
Thyroid function, low
(hypothyroidism)
(Endocrine)
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RTOG 0522 H & N Adverse Event Grading Tool (from CTCAE, v. 3.0)
Grade
Adverse Event
1
2
3
4
GRADING OF ERBITUX RASH
Pruritus/itching
Mild of localized
Intense or widespread
Intense or widespread and interfering with ADL
Rash/desquamation
Macular or papular eruption or
erythema without associated
symptoms
Macular or papular eruption or erythema with
pruritus or other associated symptoms; localized
desquamation or other lesions covering < 50%
of body surface area (BSA)
Severe, generalized erythroderma or macular,
papular or vesicular eruption; desquamation
covering > 50% BSA
-
Rash/acne/acneiform
Intervention not indicated
Intervention indicated
Associated with pain, disfigurement, ulceration,
or desquamation
-
Nail changes
Discoloration; ridging
(koilonychias); pitting
Partial or complete loss of nail(s); pain in
nailbed(s)
Interfering with ADL
-
Generalized, exfoliative,
ulcerative, or bullous dermatitis
Comments: EGFR-inhibitor rash is a new dermatological entity--there are currently no well-defined criteria for grading. Effects include itching, follicle-based papules,
discomfort and cosmetic disturbance. Rash intensity (the size and number of papules, level of discomfort and extent of erythema) may be an important consideration.
However, the absolute number of lesions, without associated physical discomfort, does not necessarily constitute a basis for a dose reduction or delay. Rash considered
“intolerable” (because of pain, itching, or appearance) or where symptomatic management has failed may be considered grade 3 and thus prompt Erbitux dose reduction or
delay. See section 7.4.5.3.1 for suggestions for managing Erbitux rash, and section 7.4.5.3 for dose modifications.
Drug related rash on face, trunk or extremities (out of the radiation field) should be graded using one or more events/terms listed above (Erbitux rash).
In-field acute skin changes should be graded using the “Dermatitis, associated with radiation”. Acute radiation dermatitis may be exacerbated by Erbitux or chemotherapy,
but the severity should be graded using radiation dermatitis. Complex rash, secondary infection or cellulitis should be graded per additional CTCAE events/terms.
For late skin changes including consequential scarring/ pock marking in or out of the radiation field, you may report dermatological injury, “other”, and use the following
language for guidance: Grade 1-mild; seen only on close inspection; Grade 2- moderate scarring; intervention or cosmetic coverage/intervention indicated; Grade 3-
severe; significant disfigurement, deep scarring or ulceration; Grade 4- deep cratering/scarring, skin necrosis or disabling.
This grading tool is provided to facilitate important or commonly encountered acute and late events expected in RTOG 0522. This list represents only a subset
of possible adverse events that may be experienced by a patient. Many acute hematologic and chemotherapy-related toxicities are not listed. Additional criteria
for adverse events may be found in NCI CTCAE v. 3.0 flip-charts or on-line at ctep.cancer.gov/reporting/ctc
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