BROOKLYN 2

RADIOTHERAPY

Patries HERST

Fri 30th Aug 2013

Session 2 / Talk 5

11:40 – 12:00

ABSTRACTPurpose: Severe acute radiation-induced skin reactions occur in a significant proportion of

women who receive radiation therapy for breast cancer. We previously showed that soft silicone dressings decreased the severity of severe skin reactions by 40% when applied from the onset of erythema. Here we report the effect of a transparent silicone film on the severity of skin reactions and the incidence of moist desquamation when used from the beginning of treatment in breast cancer patients.

Methods and Material: A total of 80 women were recruited from Dunedin Hospital. The breast or chest wall was randomly divided into lateral and medial halves at the start of radiation therapy treatment; one half was treated with Mepitel Film, the other half with aqueous cream. Skin reactions were assessed using the Radiation-Induced Skin Reaction Assessment Scale.

Results: Mepitel Film prevented the onset of moist desquamation in all patients and decreased the severity of skin reactions by more than 80%. Patients preferred the film and found it very comfortable to wear.

Conclusions: Mepitel Film prevents moist desquamation when used prophylactically

Mepitel Film for Radiation-Induced Skin Reactions

Dean Paterson, Prashika Poonam, Noelle Bennett, Annie Sutherland, Ruth Peszynski, Meredith van Beekhuizen, Katie Diggelmann, Marieke Jasperse,

Patries Herst

NZIMRT, 2013

RationaleUnavoidable side effect of external beam RT

No standard treatment

Form protective barrier

Inert

Adhere to healthy skin but do not stick to open wounds

Decrease the severity of erythema by 30% in a pilot study of 30 breast cancer patients.

(Diggelmann et al. Br J Radiol 83, 2010)

4] time to healing

Mepilex

Standard dressings

Healing

Aqueous creamMepilex

In-Patient Randomization

Erythema• Post-mastectomy• No metastatic disease

• No previous RT to chest

• Able to attend follow up

• Good performance status

Eligibility

RISRAS• 3x a week during TMT• 1x a week for 4 weeks after TMT completion

Assessment

Stage III RCT: Mepilex Lite: Management TrialAuckland (ARO), Palmerston North, Wellington, Dunedin80 patients enrolled, 74 analysed

3] time to MD2] % MD

Moist desquamation

1] severity

RISRAS (total scores between 0 and 36)*

Researcher Component (total scores between 0 and 24)

Erythema (E)

0 Normal skin

1 Dusky pink

2 Dull red

3 Brilliant red

4 Deep red-

purple

Dry Desquamation (DD)

0 Normal skin

1 (<25%)**

2 (25%-50%)

3 (50%-75%)

4 (>75%)

Moist Desquamation (MD)

0 Normal skin

1.5 (<25%)

3.0 (25%-50%)

4.5 (50%-75%)

6 (>75%)

Necrosis (N)

0 Normal skin

2.5 (<25%)

5.0 (25%-50%)

7.5 (50%-75%)

10 (>75%)

Patient Component (total scores between 0 and 12)

Symptoms Not at all A little Quite a bit Very much

Do you have any tenderness, discomfort of pain of your skin in the treatment area?

0 1 2 3

Does your skin in the treatment area itch?

0 1 2 3

Do you have a burning sensation of your skin in the treatment area? 0 1 2 3

To what extent has your skin reactions and your symptoms affected your day to day activities?

0 1 2 3

RISRAS Results of 74 mastectomy patients

Decrease in overall skin reaction severity: 40%p<0.001

Paterson et al., Journal of Cancer Science and Therapy 4(11) 347-356 (2012)

Moist Desquamation Results

Decreased the area of MD by 49%

Did not affect % MD or time to MD/healing

Fall off in shower or when perspiring, do not stick well in axilla

Are not transparent: can’t see tattoos

Have a small bolus effect (0.5mm), so must be removed during RT

We need something better: Mepitel Film?

Same features as Mepilex Lite Much thinner, transparent and more sticky than dressings and negligible bolus effect (0.1mm)

MedialLateral

1] severity

2] % MD

Moist desquamation

Aqueous creamMepitel Film

In-Patient Randomization

• No metastatic disease

• No previous RT to chest

• Able to attend follow up

• Good performance status

Eligibility

RISRAS• 3x a week during TMT• 1x a week for 4 weeks after TMT completion

Assessment

Stage III RCT: Mepitel FilmDunedin: 80 patients (both breast and mastectomy)

Start of RT treatment

RISRAS Scores of 78 patients

Decrease in severity of skin reactions: 92%P<0.001

Treatment # Patches MD % MD

Mastectomy Aqueous Cream (n=34)Mepitel (n=34)

80

24%0%

No mastectomy Aqueous Cream (n=44)Mepitel (n=44)

120

27%0%

Total Aqueous Cream (n=78)Mepitel (n=78)

200

26%0%

Moist Desquamation Results

No Moist Desquamation under the Film

No Moist Desquamation under the Film

Interesting findingStressed patients have worse skin reactions

Mepilex Lite Mepitel Film

Trial Type Management Prevention

RISRAS < 40% < 90%

% MD Same as control No MD at all

Patients“Very comforting and easy to use”

“Film? What film? I forgot it was there”

Conclusions

Is Mepitel Film the answer to RT-induced acute skin reactions?

Try it out and let me know……

Trial Participants

Staff from Departments:Southern DHBCapital and Coast DHBMid-Central DHBAuckland Regional Oncology

Funding

Rouse Educational Trust

Acknowledgements

Difference not due to differences in dose between Film and cream covered skin.

Areas measured and compared: Axilla (2TLDs) IFM fold (4 TLDs) Superior-medial (5 TLDs) Inferior Lateral (5 TLDs)