We are analyzing https://link.springer.com/article/10.1007/s00520-015-2783-9.

Title:
Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects | Supportive Care in Cancer
Description:
The efficacy of erlotinib, the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has been demonstrated in patients with non-small cell lung cancer (NSCLC) and pancreatic cancer (PC). In the present study, we evaluated the effect of epidermal growth factor (EGF) ointment on erlotinib-related skin effects (ERSEs). This was an open-label, non-comparative, multicenter, phase II trial. The patients included those diagnosed with NSCLC or PC who were treated with erlotinib. The effectiveness of the ointment was defined as follows: (1) grade 2, 3, or 4 ERSEs downgraded to ≤grade 1 or (2) grade 3 or 4 ERSEs downgraded to grade 2 and persisted for at least 2 weeks. Fifty-two patients from seven institutes in Korea were enrolled with informed consent. The final assessment included 46 patients (30 males, 16 females). According to the definition of effectiveness, the EGF ointment was effective in 36 (69.2 %) intention to treat patients. There were no statistically significant differences in the effectiveness of the EGF ointment by gender (p = 0.465), age (p = 0.547), tumor type (p = 0.085), erlotinib dosage (p = 0.117), and number of prior chemotherapy sessions (p = 0.547). The grading for the average National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) rating of rash/acne and itching improved from 2.02 ± 0.83 to 1.13 ± 0.89 and 1.52 ± 0.84 to 0.67 ± 0.90, respectively (p < 0.001). The most common reason for discontinuing the study was progression of cancer (37 %). Based on the results, the EGF ointment is effective for ERSEs, regardless of gender, age, type of tumor, and dosage of erlotinib. The EGF ointment evenly improved all kinds of symptoms of ERSEs. ClinicalTrials.gov identifier: NCT01593995
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Keywords {🔍}

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Topics {✒️}

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Schema {🗺️}

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         description:The efficacy of erlotinib, the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has been demonstrated in patients with non-small cell lung cancer (NSCLC) and pancreatic cancer (PC). In the present study, we evaluated the effect of epidermal growth factor (EGF) ointment on erlotinib-related skin effects (ERSEs). This was an open-label, non-comparative, multicenter, phase II trial. The patients included those diagnosed with NSCLC or PC who were treated with erlotinib. The effectiveness of the ointment was defined as follows: (1) grade 2, 3, or 4 ERSEs downgraded to ≤grade 1 or (2) grade 3 or 4 ERSEs downgraded to grade 2 and persisted for at least 2 weeks. Fifty-two patients from seven institutes in Korea were enrolled with informed consent. The final assessment included 46 patients (30 males, 16 females). According to the definition of effectiveness, the EGF ointment was effective in 36 (69.2 %) intention to treat patients. There were no statistically significant differences in the effectiveness of the EGF ointment by gender (p = 0.465), age (p = 0.547), tumor type (p = 0.085), erlotinib dosage (p = 0.117), and number of prior chemotherapy sessions (p = 0.547). The grading for the average National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) rating of rash/acne and itching improved from 2.02 ± 0.83 to 1.13 ± 0.89 and 1.52 ± 0.84 to 0.67 ± 0.90, respectively (p < 0.001). The most common reason for discontinuing the study was progression of cancer (37 %). Based on the results, the EGF ointment is effective for ERSEs, regardless of gender, age, type of tumor, and dosage of erlotinib. The EGF ointment evenly improved all kinds of symptoms of ERSEs. ClinicalTrials.gov identifier: NCT01593995
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      affiliation:
            name:Dong-A University Hospital
            address:
               name:Department of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Min Jae Park
      affiliation:
            name:Busan University Yangsan Hospital
            address:
               name:Department of Internal Medicine, Busan University Yangsan Hospital, Busan, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Myung Hee Kang
      affiliation:
            name:Gyeongsang National University Hospital
            address:
               name:Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Hoon Gu Kim
      affiliation:
            name:Gyeongsang National University Hospital
            address:
               name:Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Jeeyun Lee
      affiliation:
            name:Sungkyunkwan University School of Medicine
            address:
               name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Young Suk Park
      affiliation:
            name:Sungkyunkwan University School of Medicine
            address:
               name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Jong Mu Sun
      affiliation:
            name:Sungkyunkwan University School of Medicine
            address:
               name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Hyun Jung Kim
      affiliation:
            name:Soonchunhyang University Bucheon Hospital
            address:
               name:Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Chan Kyu Kim
      affiliation:
            name:Soonchunhyang University Bucheon Hospital
            address:
               name:Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Seong Yoon Yi
      affiliation:
            name:Inje University Ilsan Paik Hospital
            address:
               name:Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Joung-Soon Jang
      affiliation:
            name:Chung-Ang University College of Medicine
            address:
               name:Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea
               type:PostalAddress
            type:Organization
      name:Keunchil Park
      affiliation:
            name:Sungkyunkwan University School of Medicine
            address:
               name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
               type:PostalAddress
            type:Organization
            name:Sungkyunkwan University School of Medicine
            address:
               name:Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:Hyo-Jin Kim
      affiliation:
            name:Dong-A University Hospital
            address:
               name:Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea
      name:Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea
      name:Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea
      name:Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea
      name:Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea
      name:Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea
      name:Department of Dermatology, Dong-A University Hospital, Busan, Republic of Korea
      name:Department of Pulmonology, Dong-A University Hospital, Busan, Republic of Korea
      name:Department of Internal Medicine, Busan University Yangsan Hospital, Busan, Republic of Korea
      name:Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea
      name:Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Republic of Korea
      name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
      name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
      name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
      name:Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea
      name:Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea
      name:Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea
      name:Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea
      name:Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
      name:Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
      name:Department of Internal Medicine, Dong-A University Hospital, Busan, Republic of Korea
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