A prospective Phase II study to examine the relationship between quality of life and adverse events of first-line chemotherapy plus cetuximab in patients with KRAS wild-type unresectable metastatic colorectal cancer: QUACK trial

被引：11

作者：

Iwamoto, Shigeyoshi ^{[1
]}

Ooki, Akira ^{[2
,3
]}

Morita, Satoshi ^{[4
]}

Hara, Hiroki ^{[2
]}

Tanioka, Hiroaki ^{[5
]}

Satake, Hironaga ^{[6
]}

Kataoka, Masato ^{[7
]}

Kotaka, Masahito ^{[8
]}

Kagawa, Yoshinori ^{[9
]}

Nakamura, Masato ^{[10
]}

Shingai, Tatsushi ^{[11
]}

Ishikawa, Masashi ^{[12
]}

Miyake, Yasuhiro ^{[13
]}

Sudo, Takeshi ^{[14
]}

Hashiguchi, Yojiro ^{[15
]}

Yabuno, Taichi ^{[16
]}

Sakamoto, Junichi ^{[17
]}

Tsuji, Akihito ^{[18
]}

Ando, Masahiko ^{[19
]}

Yamaguchi, Kensei ^{[2
,3
]}

机构：

[1] Aichi Med Univ, Canc Ctr, Nagakute, Aichi, Japan

[2] Saitama Canc Ctr, Dept Gastroenterol, Saitama, Japan

[3] Japanese Fdn Canc Res, Dept Gastroenterol Chemotherapy, Canc Inst Hosp, Tokyo, Japan

[4] Kyoto Univ, Dept Biomed Stat & Bioinformat, Kyoto, Japan

[5] Okayama Rosai Hosp, Dept Med Oncol, Okayama, Japan

[6] Kobe City Med Ctr Gen Hosp, Dept Med Oncol, Kobe, Hyogo, Japan

[7] Natl Hosp Org Nagoya Med Ctr, Dept Surg, Nagoya, Aichi, Japan

[8] Sano Hosp, Gastrointestinal Canc Ctr, Kobe, Hyogo, Japan

[9] Kansai Rosai Hosp, Dept Surg, Amagasaki, Hyogo, Japan

[10] Aizawa Hosp, Comprehens Canc Ctr, Matsumoto, Nagano, Japan

[11] Osaka Saiseikai Senri Hosp, Dept Surg, Suita, Osaka, Japan

[12] Shikoku Cent Hosp, Dept Surg, Shikokuchuo, Japan

[13] Osaka Minato Cent Hosp, Dept Surg, Osaka, Japan

[14] Yamagata Prefectural Cent Hosp, Dept Surg, Yamagata, Japan

[15] Teikyo Univ, Dept Surg, Sch Med, Tokyo, Japan

[16] Yokohama Municipal Citizens Hosp, Dept Surg, Yokohama, Kanagawa, Japan

[17] Tokai Cent Hosp, Kakamigahara, Japan

[18] Kagawa Univ, Dept Med Oncol, Takamatsu, Kagawa, Japan

[19] Nagoya Univ, Ctr Adv Med & Clin Res, Nagoya, Aichi, Japan

来源：

CANCER MEDICINE | 2018年 / 7卷 / 09期

关键词：

adverse event; Cetuximab; chemotherapy; colorectal cancer; Quality of Life; CLINICAL-PRACTICE GUIDELINES; SKIN TOXICITY; TUMOR KRAS; OPEN-LABEL; FLUOROURACIL; METAANALYSIS; PANITUMUMAB; LEUCOVORIN; BEVACIZUMAB; OXALIPLATIN;

D O I：

10.1002/cam4.1623

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A prospective trial has not been performed to investigate associations between quality of life (QOL), adverse events (AEs), and overall survival (OS) in the first-line treatment with cetuximab plus standard chemotherapy for advanced/metastatic colorectal cancer (mCRC). Associations between patient outcome and health-related QOL (HRQOL) together with skin toxicity-related QOL were prospectively evaluated using EORTC QLQ-C30 and DLQI questionnaires. One hundred and forty mCRC patients were analyzed in this study, and 87.8% received pre-emptive skin treatment. Skin toxicity had no clinical impact on HRQOL or skin-related QOL during the first 8 weeks and throughout the study period. An early skin reaction with a grade >= 2 at 8 weeks was significantly associated with a favorable OS compared with a grade of <= 1 (HR, 0.50; 95% CI, 0.24-0.95; P = .035) and was confirmed to be an independent predictor of OS (HR, 0.48; 95% CI, 0.21-0.97; P = .040). Patients symptomatic at baseline who responded to treatment had improved HRQOL compared to nonresponding patients. Severe mucositis/stomatitis had a statistically significant and clinically meaningful negative impact on HRQOL (mean changes from baseline throughout the study period in global health status were -12.64 for a grade of >= 2 vs -0.35 for a grade of 0 or 1 (P = .005)). In conclusion, severe early skin reactions predict favorable OS for patients treated with cetuximab plus chemotherapy without impairing QOL,. In addition, mucositis/stomatitis was the most substantial AE compromising both QOL and treatment compliance.

引用

页码：4217 / 4227

页数：11