Randomized phase III study comparing best supportive care to biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation therapy oncology group (RTOG) 97-13

Fisher, James N.; Scott, Charles; Stevens, Ryan W; Marconi, Barbara; Champion, Lorraine A. A.; Freedman, Gary M.; Asrari, F.; Pilepich, M.V.; Gagnon, James D.; Wong, Gene K.

doi:10.1016/s0360-3016(00)00782-3

Cited by 263 publications

(214 citation statements)

References 2 publications

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“…A reliable comparison of these effects after 30 Gy in five fractions over 15 days with the effects of 50 Gy in 25 fractions is limited by the lack of a randomised comparator group. A Radiation Therapy Oncology Group trial (RTOG 97-13) testing supportive care of skin toxicity in women undergoing breast radiotherapy, combined with the results of previous RTOG experience, reported 7% grade 0, 58% grade 1, 32% grade 2, 3% grade 3, and no grade 4 acute skin toxicity [9]. Retrospective re-grading of skin reactions in the present pilot study, applying RTOG criteria, produced comparable rates: 3% grade 0, 67% grade 1, 30% grade 2 and no grade 3 or 4 toxicity.…”

Section: Discussionmentioning

confidence: 99%

Acute Toxicity and 2-year Adverse Effects of 30 Gy in Five Fractions over 15 Days to Whole Breast after Local Excision of Early Breast Cancer

et al. 2008

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ABSTRACT:Aims: A pilot study was undertaken with the aim of documenting acute skin reactions and 2-year late adverse effects of a five-fraction course of adjuvant whole breast radiotherapy delivered over 15 days after local tumour excision of early breast cancer. Materials and methods: Thirty women with early invasive breast cancer aged R 50 years with a pathological tumour size !3 cm, complete microscopic resection, negative axillary node status and no requirement for cytotoxic therapy were prescribed 30 Gy in five fractions over 15 days to the whole breast using tangential 6e10 MV X-ray beams and three-dimensional dose compensation with written informed consent. Post-surgical baseline photographs of the breasts were taken, and acute skin erythema and moist desquamation were each scored weekly for 7 weeks using four-point graded scales (grade 0 [ none, 1 [ mild, 2 [ moderate, 3 [ severe). This was followed by an annual clinical assessment, including repeat photographs at 2 years. Results: Nine patients (30%, 95% confidence interval 14.7e49.4%) developed grade 2 erythema, with the remaining 21 patients developing milder degrees of reaction. Four (13.3%, 95% confidence interval 3.7e30.7) patients developed moist desquamation, grade 1 in three women and grade 2 in the fourth. At 2 years after treatment, 23/30 (77%) patients scored no change in photographic breast appearance compared with the pre-treatment baseline; seven (23%, 95% confidence interval 9.9e42.3) scored a mild change in breast appearance, and none developed a marked change. After a mean follow-up of 3.1 years (standard deviation 0.37, range 2.1e3.9 years) there have been no ipsilateral local tumour relapses. Conclusions: Further evaluation of a five-fraction regimen of adjuvant whole breast radiotherapy in a phase III randomised trial is justified, including a regimen delivered in a total of 5 days. Martin, S. et al.

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Section: Discussionmentioning

confidence: 99%

Acute Toxicity and 2-year Adverse Effects of 30 Gy in Five Fractions over 15 Days to Whole Breast after Local Excision of Early Breast Cancer

et al. 2008

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“…Reasons for exclusion of patients from analysis included lack of compliance with the agent or dressing, withdrawal from the study, or failure to show up to clinic appointments. Skin reactions were often assessed by one evaluator, which was commonly a radiation oncologist, dermatologist, research nurse, research assistant, radiation therapist, principal investigator, or other medical professional 3,17,20,21,24,26,27,32,33,35,39,44,46,50 . A few studies incorporated an inter-rater reliability measure by having more than one evaluator assess the skin reactions 23,34,36,45,49,51 ; the remaining studies did not describe who assessed the radiated area or areas 2,16,19,25,28,30,31,38,[41][42][43]47,48 .…”

Section: Resultsmentioning

confidence: 99%

“…Biafine Cream: Six studies assessed Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) for the prevention of radiation-induced skin reactions [24][25][26][27][28][29] . Five of those trials compared Biafine with another topical agent 24,25,[27][28][29] , and one evaluated the efficacy of Biafine cream without a comparator product 26 .…”

Section: Nonsteroidal Topical Creamsmentioning

confidence: 99%

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

et al. 2010

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Radiation therapy is a common treatment for cancer patients. One of the most common side effects of radiation is acute skin reaction (radiation dermatitis) that ranges from a mild rash to severe ulceration. Approximately 85% of patients treated with radiation therapy will experience a moderate-to-severe skin reaction. Acute radiation-induced skin reactions often lead to itching and pain, delays in treatment, and diminished aesthetic appearance-and subsequently to a decrease in quality of life.Surveys have demonstrated that a wide variety of topical, oral, and intravenous agents are used to prevent or to treat radiation-induced skin reactions. We conducted a literature review to identify trials that investigated products for the prophylaxis and management of acute radiation dermatitis. Thirty-nine studies met the pre-defined criteria, with thirty-three being categorized as prophylactic trials and six as management trials.For objective evaluation of skin reactions, the Radiation Therapy Oncology Group criteria and the U.S. National Cancer Institute Common Toxicity Criteria were the most commonly used tools (65% of the studies). Topical corticosteroid agents were found to significantly reduce the severity of skin reactions; however, the trials of corticosteroids evaluated various agents, and no clear indication about a preferred corticosteroid has emerged. Amifostine and oral enzymes were somewhat effective in preventing radiation-induced skin reactions in phase ii and phase iii trials respectively; further large randomized controlled trials should be undertaken to better investigate those products. Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) was found not to be superior to standard regimes in the prevention of radiation-induced skin reactions (n = 6).In conclusion, the evidence is insufficient to support the use of a particular agent for the prevention and management of acute radiation-induced skin reactions. Future trials should focus on comparing agents and approaches that, in phase i and ii trials, suggest efficacy. These future phase iii randomized controlled trials must clearly distinguish between preventive and management strategies for radiation-induced dermatitis. Only then can evidence-based guidelines be developed, with the hope of standardizing the approach across centres and of improving the prevention and management of radiation-induced dermatitis.

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“…Currently, the recommended radiotherapy technique includes treatment of the entire breast with tangential opposed fields using Cobalt 60 beam or X-rays (26). Acute skin reactions during RT of the breast occur in ϳ50% of the cases, and may include brisk erythema to confluent moist desquamation (29). The acute skin reactions usually start during the second week of treatment, culminate during the fifth week, and resolve after the tenth week (30).…”

mentioning

confidence: 99%

“…Patients treated with a combination of chemotherapy and radiation therapy are also at higher risk of developing acute skin reaction (31). Furthermore, the acute skin reactions observed at 1 month have been correlated to the long-term cosmetic result of breast radiation (29,32).…”

mentioning

confidence: 99%

Role of radiation therapy in patients with a diagnosis of both systemic lupus erythematosus and cancer

Benk¹,

Al‐Herz²,

Gladman³

et al. 2005

Arthritis & Rheumatism

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Objective. To determine whether radiation therapy (RT) is denied to patients with lupus and cancer and whether RT causes unusual toxicity in those receiving it. Methods. We included patients with lupus followed at the University of Toronto Lupus Clinic between 1972 and 2001 who had developed cancer. Demographic, clinical, and laboratory information were collected prospectively. Pathologic proof of cancer was obtained. Three radiation oncologists blinded for the diagnosis of lupus, the modalities of cancer treatment, and the hypothesis of the study reviewed patient data independently. They assessed the indication for RT and whether it should be curative or symptomatic. Recommendation for RT was considered when at least 2 of the 3 radiation oncologists concurred. A review of the literature was conducted. Results. Forty cases of cancer in 38 patients were identified. Most frequent cancer sites were breast (8), skin (8), digestive (7), and hematologic (7). Median patient age was 58 years. The radiation oncologists recommended RT in 26 cases, either with a curative (14) or a symptomatic intent (12). Only 4 patients received RT, 3 with a curative intent and 1 with a symptomatic intent. None of these 4 patients developed any unusual toxicity. The literature review did not support the fact that lupus patients do not tolerate RT. Conclusion. Sixty-five percent of our lupus patients with cancer could have received curative or symptomatic RT but only 10% received it. No patient developed any toxicity. RT may be inappropriately withheld from lupus patients with cancer.

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Randomized phase III study comparing best supportive care to biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation therapy oncology group (RTOG) 97-13

Cited by 263 publications

References 2 publications

Acute Toxicity and 2-year Adverse Effects of 30 Gy in Five Fractions over 15 Days to Whole Breast after Local Excision of Early Breast Cancer

Acute Toxicity and 2-year Adverse Effects of 30 Gy in Five Fractions over 15 Days to Whole Breast after Local Excision of Early Breast Cancer

Prophylaxis and Management of Acute Radiation-Induced Skin Reactions: A Systematic Review of the Literature

Role of radiation therapy in patients with a diagnosis of both systemic lupus erythematosus and cancer

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