Impact of early tumor shrinkage on quality of life in patients treated with first-line cetuximab plus chemotherapy for unresectable metastatic colorectal cancer: results of Phase II QUACK trial
Akira Ooki,
Satoshi Morita,
Akihito Tsuji,
Shigeyoshi Iwamoto,
Hiroki Hara,
Hiroaki Tanioka,
Hironaga Satake,
Masato Kataoka,
Masahito Kotaka,
Yoshinori Kagawa,
Masato Nakamura,
Tatsushi Shingai,
Masashi Ishikawa,
Yasuhiro Miyake,
Takeshi Suto,
Yojiro Hashiguchi,
Taichi Yabuno,
Masahiko Ando,
Junichi Sakamoto,
Kensei Yamaguchi
Affiliations
Akira Ooki
Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Satoshi Morita
Department of Biomedical Statistics and Bioinformatics, Kyoto University
Akihito Tsuji
Department of Medical Oncology, Kagawa University
Shigeyoshi Iwamoto
Department of Surgery, Kansai Medical University Kouri Hospital
Hiroki Hara
Department of Gastroenterology, Saitama Cancer Center
Hiroaki Tanioka
Department of Clinical Oncology, Kawasaki Medical School
Hironaga Satake
Cancer Treatment Center, Kansai Medical University Hospital
Masato Kataoka
Department of Surgery, National Hospital Organization Nagoya Medical Center
Masahito Kotaka
Gastrointestinal Cancer Center, Sano Hospital
Yoshinori Kagawa
Department of Surgery, Kansai Rosai Hospital
Masato Nakamura
Aizawa Comprehensive Cancer Center, Aizawa Hospital
Tatsushi Shingai
Department of Surgery, Osaka Saiseikai Senri Hospital
Masashi Ishikawa
Department of Surgery, Shikoku Central Hospital
Yasuhiro Miyake
Department of Surgery, Osaka Minato Central Hospital
Takeshi Suto
Department of Surgery, Yamagata Prefectural Central Hospital
Yojiro Hashiguchi
Department of Surgery, Teikyo University School of Medicine
Taichi Yabuno
Department of Surgery, Yokohama Municipal Citizen’s Hospital
Masahiko Ando
Department of Advanced Medicine, Nagoya University Hospital
Junichi Sakamoto
Tokai Central Hospital
Kensei Yamaguchi
Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Abstract Purpose Although early tumor shrinkage (ETS) is a predictor of improved overall survival (OS), the association between ETS and health-related quality of life (HRQOL) remains unclear for patients with metastatic colorectal cancer (mCRC) treated with first-line cetuximab plus chemotherapy. Methods The data were collected from a prospective trial that assessed HRQOL using the EORTC QLQ-C30. The impact of ETS on HRQOL was estimated using a linear mixed-effects model for repeated measures. Results ETS was achieved in 82 (64.1%) of 128 mCRC patients treated with first-line cetuximab plus chemotherapy, and these patients had a significantly longer OS than those without ETS (HR, 0.38; 95% CI, 0.20–0.72; P = .002). Asymptomatic patients with ETS had a favorable OS, while symptomatic patients without ETS had a worse OS (2-year OS rates, 77.8% vs. 42.5%). Symptomatic patients with ETS had similar outcomes as asymptomatic patients without ETS (2-year OS rates, 64.1% vs. 67.0%). For symptomatic patients, ETS was associated with improved HRQOL scores between baseline and 8 weeks: the mean changes for patients with and without ETS were 5.86 and -4.94 for global health status (GHS)/QOL, 26.73 and 3.79 for physical functioning, and 13.58 and -3.10 for social functioning, respectively. The improved HRQOL was comparable to that of asymptomatic patients without ETS. For asymptomatic patients, ETS showed a decreased deterioration in HRQOL. Conclusion Our findings highlight the importance of ETS for HRQOL and prognostic estimates, and assessing ETS may provide clinically useful information for physicians and patients to make more informed decisions.
