PMID- 31962002 OWN - NLM STAT- MEDLINE DCOM- 20210423 LR - 20210423 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 9 IP - 5 DP - 2020 Mar TI - Patient-reported symptom burden as a prognostic factor in treatment with first-line cetuximab plus chemotherapy for unresectable metastatic colorectal cancer: Results of Phase II QUACK trial. PG - 1779-1789 LID - 10.1002/cam4.2826 [doi] AB - BACKGROUND: It remains unclear whether patients' self-perceptions of symptoms at baseline clinically impact the prognostic relevance, treatment efficacy, or toxicity profiles in metastatic colorectal cancer (mCRC) patients treated with the first-line cetuximab and standard chemotherapy. METHODS: The data were collected from a prospective trial that assessed the relationships between quality of life (QOL), treatment efficacy, and adverse events (AEs). RESULTS: The analysis of 137 mCRC patients revealed a significant association between the presence of baseline tumor-related symptoms and a lower overall survival (OS) compared to the absence of symptoms (HR, 2.49; 95% CI, 1.37-4.62; P = .003). The asymptomatic responders had favorable outcomes compared to the symptomatic nonresponders (2-year OS rates: 83.6% and 35.9%, respectively), while the symptomatic responders had similar outcomes to the asymptomatic nonresponders. The median postprogression survival differed significantly: 10.2 months for the symptomatic patients and 15.9 months for the asymptomatic patients (HR, 2.29; 95% CI, 1.25-4.29, P = .008). The objective response rates and patient toxicity profiles were similar irrespective of the severity of baseline symptoms. CONCLUSION: Baseline symptoms were associated with worse OS but not with impaired treatment efficacy or more frequent AEs in mCRC patients treated with cetuximab in addition to chemotherapy. CI - (c) 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Ooki, Akira AU - Ooki A AUID- ORCID: 0000-0001-7618-5775 AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. FAU - Morita, Satoshi AU - Morita S AD - Department of Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan. FAU - Iwamoto, Shigeyoshi AU - Iwamoto S AD - Cancer Center, Aichi Medical University, Nagakute, Japan. FAU - Hara, Hiroki AU - Hara H AD - Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan. FAU - Tanioka, Hiroaki AU - Tanioka H AD - Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan. FAU - Satake, Hironaga AU - Satake H AD - Cancer Treatment Center, Kansai Medical University Hospital, Osaka, Japan. FAU - Kataoka, Masato AU - Kataoka M AD - Department of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan. FAU - Kotaka, Masahito AU - Kotaka M AD - Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan. FAU - Kagawa, Yoshinori AU - Kagawa Y AD - Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan. FAU - Nakamura, Masato AU - Nakamura M AD - Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan. FAU - Shingai, Tatsushi AU - Shingai T AD - Department of Surgery, Osaka Saiseikai Senri Hospital, Suita, Japan. FAU - Ishikawa, Masashi AU - Ishikawa M AD - Department of Surgery, Shikoku Central Hospital, Shikokuchuo, Japan. FAU - Miyake, Yasuhiro AU - Miyake Y AD - Department of Surgery, Osaka Minato Central Hospital, Osaka, Japan. FAU - Suto, Takeshi AU - Suto T AD - Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan. FAU - Hashiguchi, Yojiro AU - Hashiguchi Y AD - Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan. FAU - Yabuno, Taichi AU - Yabuno T AD - Department of Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan. FAU - Sakamoto, Junichi AU - Sakamoto J AD - Tokai Central Hospital, Kakamigahara, Japan. FAU - Tsuji, Akihito AU - Tsuji A AD - Department of Medical Oncology, Kagawa University, Kita, Japan. FAU - Ando, Masahiko AU - Ando M AD - Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan. FAU - Yamaguchi, Kensei AU - Yamaguchi K AD - Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20200121 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - PQX0D8J21J (Cetuximab) SB - IM MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Cetuximab/*administration & dosage/adverse effects MH - Colorectal Neoplasms/complications/diagnosis/*drug therapy MH - Drug-Related Side Effects and Adverse Reactions/*diagnosis/etiology MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - *Patient Reported Outcome Measures MH - Prognosis MH - Progression-Free Survival MH - Prospective Studies MH - *Quality of Life MH - Response Evaluation Criteria in Solid Tumors MH - Self Report/statistics & numerical data MH - Severity of Illness Index PMC - PMC7050093 OTO - NOTNLM OT - cetuximab OT - chemotherapy OT - colorectal cancer OT - quality of life OT - symptom EDAT- 2020/01/22 06:00 MHDA- 2021/04/24 06:00 PMCR- 2020/01/21 CRDT- 2020/01/22 06:00 PHST- 2019/09/20 00:00 [received] PHST- 2019/12/13 00:00 [revised] PHST- 2019/12/22 00:00 [accepted] PHST- 2020/01/22 06:00 [pubmed] PHST- 2021/04/24 06:00 [medline] PHST- 2020/01/22 06:00 [entrez] PHST- 2020/01/21 00:00 [pmc-release] AID - CAM42826 [pii] AID - 10.1002/cam4.2826 [doi] PST - ppublish SO - Cancer Med. 2020 Mar;9(5):1779-1789. doi: 10.1002/cam4.2826. Epub 2020 Jan 21.