【国際学会】賀川義規医師がASCO-GI 2022で発表しました
2022.01.23
Abstract ID: 79 Pre‐emptive oral clarithromycin to reduce the skin toxicity of panitumumab treatment for metastatic colorectal cancer.
Yoshinori Kagawa, Takamichi Komori, Ken Nakata, Kazuhiro Saso, Hirofumi Ota, Shunji Morita, Shingo Noura, Nobuyasu Hayashi, Mamoru Uemura, Chu Matsuda, Taroh Satoh, Tsunekazu Mizushima, Kohei Murata, Yuichiro Doki, Hidetoshi Eguchi, Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO); Department of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan; Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Hyogo, Japan; Department of Surgery, Sakai City Medical Center, Osaka, Japan; Ashiya Municipal Hospital, Ashiya, Hyogo, Japan; Department of Surgery, Ikeda City Hospital, Ikeda, Japan; Itami City Hospital, Itami, Osaka, Japan; Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan; Kinan Hospital, Tanabe, Wakayama, Japan; Osaka University, Suita, Osaka, Japan; Osaka International Cancer Institute, Osaka, Japan; Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Osaka, Japan; Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan; Kanasi Rosai Hospital, Amagasaki, Hygo, Japan; Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Suita City, Osaka, Japan; Osaka University Graduate School of Medicine, Suita, Osaka, Japan
Background: 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 pani- tumumab. 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.
Conclusions: 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.
Methods: We conducted a phase lll, multicenter, open-label, randomized clinical trial on mCRC patients treated with pani- tumumab. 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.
Conclusions: 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.
