Randomized controlled trial on the skin toxicity of panitumumab in Japanese patients with metastatic colorectal cancer: HGCSG1001 study; J-STEPP

被引：61

作者：

Kobayashi, Yoshimitsu ^{[1
]}

Komatsu, Yoshito ^{[2
]}

Yuki, Satoshi ^{[1
]}

Fukushima, Hiraku ^{[2
]}

Sasaki, Takahide ^{[1
]}

Iwanaga, Ichiro ^{[3
]}

Uebayashi, Minoru ^{[3
]}

Okuda, Hiroyuki ^{[4
]}

Kusumi, Takaya ^{[5
]}

Miyagishima, Takuto ^{[6
]}

Sogabe, Susumu ^{[7
]}

Tateyama, Miki ^{[8
]}

Hatanaka, Kazuteru ^{[9
]}

Tsuji, Yasushi ^{[10
]}

Nakamura, Michio ^{[11
]}

Konno, Jun ^{[12
]}

Yamamoto, Fumiyasu ^{[13
]}

Onodera, Manabu ^{[14
]}

Iwai, Kazuhiro ^{[15
]}

Sakata, Yuh ^{[16
]}

Abe, Riichiro ^{[17
]}

Oba, Koji ^{[18
]}

Sakamoto, Naoya ^{[1
]}

机构：

[1] Hokkaido Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Sapporo, Hokkaido, Japan

[2] Hokkaido Univ Hosp, Dept Canc Ctr, Sapporo, Hokkaido 060, Japan

[3] Japanese Red Cross Kitami Hosp, Dept Gastroenterol, Kitami, Hokkaido, Japan

[4] Keiyukai Sapporo Hosp, Dept Med Oncol, Sapporo, Hokkaido, Japan

[5] Keiyukai Sapporo Hosp, Dept Surg, Sapporo, Hokkaido, Japan

[6] Kushiro Rosai Hosp, Dept Internal Med, Kushiro, Hokkaido, Japan

[7] Kushiro Rosai Hosp, Dept Med Oncol, Kushiro, Hokkaido, Japan

[8] Tomakomai Nisshou Hosp, Dept Internal Med, Tomakomai, Japan

[9] Hakodate Municipal Hosp, Dept Gastroenterol, Hakodate, Hokkaido, Japan

[10] Tonan Hosp, Dept Med Oncol, Sapporo, Hokkaido, Japan

[11] Sapporo City Gen Hosp, Dept Gastroenterol, Sapporo, Hokkaido, Japan

[12] Hakodate Cent Gen Hosp, Dept Internal Med, Hakodate, Hokkaido, Japan

[13] Tomakomai City Hosp, Dept Gastroenterol, Tomakomai, Japan

[14] Abashiri Kosei Gen Hosp, Dept Internal Med & Gastroenterol, Abashiri, Japan

[15] Oji Gen Hosp, Dept Surg, Tomakomai, Japan

[16] Misawa City Hosp, Misawa, Japan

[17] Hokkaido Univ, Grad Sch Med, Dept Dermatol, Sapporo, Hokkaido, Japan

[18] Hokkaido Univ Hosp, Translat Res & Clin Trial Ctr, Sapporo, Hokkaido 060, Japan

来源：

FUTURE ONCOLOGY | 2015年 / 11卷 / 04期

关键词：

colorectal cancer; Japanese; panitumumab; pre-emptive; skin toxicities; GROWTH-FACTOR RECEPTOR; PHASE-III TRIAL; MONOCLONAL-ANTIBODY; OPEN-LABEL; MONOTHERAPY; FLUOROURACIL; CHEMOTHERAPY; LEUCOVORIN; MECHANISMS; IRINOTECAN;

D O I：

10.2217/fon.14.251

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Aim: We planned a randomized, open-label trial to evaluate differences between pre-emptive and reactive skin treatment for panitumumab (Pmab)-associated skin toxicities in Japanese patients with metastatic colorectal cancer. Patients & methods: Patients receiving third-line Pmab-containing regimens were randomized to pre-emptive or reactive treatment. The primary end point was the cumulative incidence of grade 2 skin toxicities during 6 weeks. Retrospectively, a dermatologist reviewed skin toxicities, in a blinded manner. Results: A total of 95 patients were enrolled (pre-emptive: 47, reactive: 48). The primary end point was achieved (21.3 and 62.5% [risk ratio: 0.34; p < 0.001], for pre-emptive and reactive treatment, respectively). A similar trend was observed in central review. Conclusion: Pre-emptive skin treatment could reduce the severity of Pmab-associated skin toxicities in Japanese metastatic colorectal cancer patients.

引用

页码：617 / 627

页数：11

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