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Observational Study
. 2020 Sep;27(5):861-870.
doi: 10.1007/s12282-020-01082-3. Epub 2020 May 3.

Non-invasive quantitative measures of qualitative grading effectiveness as the indices of acute radiation dermatitis in breast cancer patients

Hiroshi Sekine  1 , Yoshikazu Kijima  2 , Masao Kobayashi  2 , Jun Itami  3 , Kana Takahashi  3 , Hiroshi Igaki  3 , Yasuo Nakai  4 , Hitoshi Mizutani  4   5 , Yoshihito Nomoto  6 , Katsuko Kikuchi  7   8 , Haruo Matsushita  9 , Keiko Nozawa  10
Affiliations
Observational Study

Non-invasive quantitative measures of qualitative grading effectiveness as the indices of acute radiation dermatitis in breast cancer patients

Hiroshi Sekine et al. Breast Cancer. 2020 Sep.

Abstract

Background: Recent improvement of machinery evaluation for the skin changes in various therapies enabled us to evaluate fine changes quantitatively. In this study, we performed evaluation of the changes in radiation dermatitis (RD) using quantitative and qualitative methods, and verified the validity of the conventional qualitative assessment for clinical use.

Methods: Forty-three breast cancer patients received conventional fractionated radiotherapy to whole breast after breast-conserving surgery. Erythema, pigmentation and skin dryness were evaluated qualitatively, and biophysical parameters of RD were measured using a Multi-Display Device MDD4 with a Corneometer for capacitance, a Tewameter for transepidermal water loss (TEWL), a Mexameter for erythema index and melanin index. Measurements were performed periodically until 1 year.

Results: The quantitative manifestations developed serially from skin erythema followed by dryness and pigmentation. Quantitative measurements detected the effects of irradiation earlier than that of qualitative indices. However, the grades of the domains in RD by qualitative and quantitative assessment showed similar time courses and peak periods. However, no significant correlation was observed between the skin dryness grade and skin barrier function. In contrast to serial increase in pigmentation grades, melanin index showed initial decrease followed by marked increase with significant correlation with pigmentation grades.

Conclusion: Subjectively and objectively measured results of RD were almost similar course and peak points through the study. Therefore, validity of the conventional qualitative scoring for RD is confirmed by the present quantitative assessments. Instrumental evaluations revealed the presence of modest inflammatory changes before radiotherapy and long-lasting skin dryness, suggesting indication of intervention for RD.

Keywords: Erythema; Pigmentation; Radiation dermatitis; Skin water content; Transepidermal water loss.

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Conflict of interest statement

Hiroshi Sekine received a research grant from the Japan Agency for Medical Research and Development for this study. Yoshikazu Kijima has no conflicts of interest. Masao Kobayashi has no conflicts of interest. Jun Itami received personal fees from HekaBio, ItoChu, and Kay-J, which were unrelated to the submitted work. Kana Takahashi has no conflicts of interest. Hiroshi Igaki received a research grant from HekaBio and personal fees from ItoChu, which were unrelated to the submitted work. Yasuo Nakai received personal fees from ONO Pharmaceutical Co. LTD, Novartis Pharma K.K, and Jiho, Inc., which were unrelated to the submitted work. Hitoshi Mizutani received a grant from the Japan Agency for Medical Research and Development during the conduct of the study; currently serves as a consultant to Asahikasei Pharma Co. Ltd., Kao Corp., Celgene Co. Ltd., Tanabe Mitsubishi Co. Ltd., Kinoushokuhin Kenkyusho, Sato Pharma, Eli Lilly Japan K.K., Maruishi Pharma Co. Ltd., Leo Pharma, Kaken Pharma, and FUJIFILM Toyama Chemical Co., Ltd.; received lecture and consultant fees from Maruho Co. Ltd.; received lecture and transportation fees from Jansen Pharma; received consultancy and manuscript fees from Shionogi Pharma Co. Ltd., and Bayer Pharma.; and received lecture fees from Taiho Pharma, Grafa Laboratory, Kyorin Pharma, Inforward Co. Ltd., Astellas Pharma., Kaken Pharma., Novartis Pharma, Kyowa-Kirin Co. Ltd., Eisai Co. Ltd., Torii Co. Ltd., Absolute Co. Ltd., Tsumura Co. Ltd., Nippon Shinyaku Co. Ltd., POLA-Pharma, and Ushio Electric Co. Ltd., which were unrelated to the submitted work. Yoshihito Nomoto has no conflicts of interest. Katsuko Kikuchi received a grant and personal fees from POLA-Pharma and personal fees from Maruho Co. Ltd. and TOKIWA Pharmaceutical Co. Ltd., which were unrelated to the submitted work. Haruo Matsushita has no conflicts of interest. Keiko Nozawa has no conflicts of interest.

Figures

Fig. 1
Fig. 1
Changes over time in the numbers of patients corresponding to each of the following grades: a CTCAE grade, b erythema grade, c dryness grade, and d pigmentation grade. 0: before radiotherapy (baseline); 1, 2, 3, 4, 5: weeks during radiotherapy; 7: 2 weeks after radiotherapy; 11: 6 weeks after radiotherapy; 17: 3 months after radiotherapy; 26: 6 months after radiotherapy; 52: 1 year after radiotherapy. CTCAE Common Terminology Criteria for Adverse Events
Fig. 2
Fig. 2
Time course of biophysical parameters: a skin temperature ratio, b erythema index ratio, c capacitance ratio, d TEWL ratio, and e melanin index ratio. †p < 0.01
Fig. 3
Fig. 3
Time course of mean melanin index ratio of patients with pigmentation grade 2 or more and grade 1 or less. **p < 0.001, *p < 0.05
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References

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