Ken Nakata1, Takamichi Komori2, Kazuhiro Saso3, Hirofumi Ota4, Yoshinori Kagawa5, Shunji Morita6, Shingo Noura7, Nobuyasu Hayashi8, Mamoru Uemura9, Chu Matsuda7, Taroh Satoh9, Tsunekazu Mizushima9, Kohei Murata6, Yuichiro Doki9, Hidetoshi Eguchi9. 1. Department of Surgery, Sakai City Medical Center, Ebaraji-cho 1-1-1, Nishi-ku, Sakai, Osaka, Japan. nakataken@msn.com. 2. Department of Gastroenterological Surgery, Hyogo Prefectural Nishinomiya Hospital, Rokutanji-cho 13-9, Nishinomiya, Hyogo, Japan. 3. Department of Surgery, Ashiya Municipal Hospital, Asahigaoka-cho 39-1, Ashiya, Hyogo, Japan. 4. Department of Gastroenterological Surgery, Ikeda City Hospital, Jounan 3-1-18, Ikeda, Osaka, Japan. 5. Department of Gastroenterological Surgery, Osaka General Medical Center, Mandaihigashi 3-1-56, Sumiyoshi-ku, Osaka, Japan. 6. Department of Surgery, Itami City Hospital, Koyaike 1-100, Itami, Hyogo, Japan. 7. Department of Surgery, Toyonaka Municipal Hospital, Shibahara-cho 4-14-1, Toyonaka, Osaka, Japan. 8. Department of Surgery, Kinan Hospital, Shinjo-cho 46-70, Tanabe, Wakayama, Japan. 9. Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 E2 Yamadaoka, Suita, Osaka, Japan.
Abstract
PURPOSE:Chemotherapy with panitumumab is expected to be well tolerated and improve survival in patients with metastatic colorectal cancer (mCRC). However, skin toxicities are its most common adverse events. The aim of this trial was to evaluate the efficacy and safety of pre-emptive antibiotic treatment with clarithromycin (CAM) to prevent panitumumabskin toxicities. METHODS: We conducted a phase lll, multicenter, open-label, randomized clinical trial on mCRC patients treated withpanitumumab. Eligible patients were randomly assigned 1:1 to pre-emptive antibiotic and control groups. In the pre-emptive group, CAM administration (200 mg twice per day) continued daily through the panitumumab treatment period. The control regimen consisted of skin care only. The primary end point was the incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period. RESULTS: Of 156 enrolled patients, 78 received pre-emptive antibiotic treatment, and 78 received reactive treatment. The number and incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period were 16 (21.3%) and 41 (54.7%) for the pre-emptive and control groups, respectively (HR, 0.32; 95% CI, 0.17-0.56). There was almost no difference in the rate of other adverse events between the two groups, but the incidence of grade ≥ 3 diarrhea in the pre-emptive group was high, at 8% vs. 1.3% in the control group. There were no treatment-related deaths. CONCLUSION:Prophylactic oral CAM together with relatively simple skin care was found to be effective in suppressing the development of grade ≥ 2 skin toxicities induced by panitumumab. CLINICAL TRIAL REGISTRATION: UMIN000011485 DATE OF REGISTRATION: Sep 1st, 2013.
RCT Entities:
PURPOSE: Chemotherapy with panitumumab is expected to be well tolerated and improve survival in patients with metastatic colorectal cancer (mCRC). However, skin toxicities are its most common adverse events. The aim of this trial was to evaluate the efficacy and safety of pre-emptive antibiotic treatment with clarithromycin (CAM) to prevent panitumumab skin toxicities. METHODS: We conducted a phase lll, multicenter, open-label, randomized clinical trial on mCRC patients treated with panitumumab. Eligible patients were randomly assigned 1:1 to pre-emptive antibiotic and control groups. In the pre-emptive group, CAM administration (200 mg twice per day) continued daily through the panitumumab treatment period. The control regimen consisted of skin care only. The primary end point was the incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period. RESULTS: Of 156 enrolled patients, 78 received pre-emptive antibiotic treatment, and 78 received reactive treatment. The number and incidence of grade ≥ 2 skin toxicities during the 6-week skin treatment period were 16 (21.3%) and 41 (54.7%) for the pre-emptive and control groups, respectively (HR, 0.32; 95% CI, 0.17-0.56). There was almost no difference in the rate of other adverse events between the two groups, but the incidence of grade ≥ 3 diarrhea in the pre-emptive group was high, at 8% vs. 1.3% in the control group. There were no treatment-related deaths. CONCLUSION: Prophylactic oral CAM together with relatively simple skin care was found to be effective in suppressing the development of grade ≥ 2 skin toxicities induced by panitumumab. CLINICAL TRIAL REGISTRATION: UMIN000011485 DATE OF REGISTRATION: Sep 1st, 2013.
Authors: Marc Peeters; Timothy Jay Price; Andrés Cervantes; Alberto F Sobrero; Michel Ducreux; Yevhen Hotko; Thierry André; Emily Chan; Florian Lordick; Cornelis J A Punt; Andrew H Strickland; Gregory Wilson; Tudor-Eliade Ciuleanu; Laslo Roman; Eric Van Cutsem; Valentina Tzekova; Simon Collins; Kelly S Oliner; Alan Rong; Jennifer Gansert Journal: J Clin Oncol Date: 2010-10-04 Impact factor: 44.544
Authors: Sebastian Stintzing; Christine Kapaun; Rüdiger Paul Laubender; Andreas Jung; Jens Neumann; Dominik Paul Modest; Clemens Giessen; Nicolas Moosmann; Andreas Wollenberg; Thomas Kirchner; Volker Heinemann Journal: Int J Cancer Date: 2012-06-26 Impact factor: 7.396
Authors: Anna Liza C Agero; Stephen W Dusza; Cristiane Benvenuto-Andrade; Klaus J Busam; Patricia Myskowski; Allan C Halpern Journal: J Am Acad Dermatol Date: 2006-10 Impact factor: 11.527
Authors: Raja Nur Firzanah Syaza Raja Sharin; Jesmine Khan; Mohamad Johari Ibahim; Mudiana Muhamad; Joanne Bowen; Wan Nor I'zzah Wan Mohamad Zain Journal: Biomed Res Int Date: 2022-06-28 Impact factor: 3.246