PMID- 33222406 OWN - NLM STAT- MEDLINE DCOM- 20210804 LR - 20210804 IS - 2045-7634 (Electronic) IS - 2045-7634 (Linking) VI - 9 IP - 24 DP - 2020 Dec TI - Disagreement between patient- and physician-reported outcomes on symptomatic adverse events as poor prognosis in patients treated with first-line cetuximab plus chemotherapy for unresectable metastatic colorectal cancer: Results of Phase II QUACK trial. PG - 9419-9430 LID - 10.1002/cam4.3564 [doi] AB - The status and prognostic value of the disagreement between physician and patient assessments of symptomatic adverse events (AEs) remain unclear for patients with metastatic colorectal cancer treated with first-line cetuximab plus chemotherapy. Paired data on patient-reported outcomes using the EORTC QLQ-C30 and physician-reported outcomes using the NCI-CTCAE for eight symptomatic AEs (fatigue, pain, insomnia, dyspnea, constipation, appetite loss, nausea/vomiting, and diarrhea) were collected from a prospective trial assessing the relationships between treatment efficacy, AEs, and quality of life. The overall agreement rates between patient and physician reporting at 4 weeks ranged from 40.2% to 76.5% for 129 patients. The level of agreement based on Cohen's kappa statistics was slight to poor for dyspnea, pain, fatigue, and insomnia, while it was moderate to fair for the remaining AEs. No clinicopathological characteristics of disagreement were found. The underreporting by physicians ranged from 12.5% (nausea/vomiting) to 56.7% (fatigue). The 2-year overall survival (OS) rate was more favorable for patients with high agreement than for those with low agreement (71.2% vs. 46.5%, p = .016), and the agreement status was an independent factor of OS (HR, 2.31; 95% CI, 1.13-4.71; p = .022). For patients who were reported as asymptomatic by the physician, the presence of patient-reported symptoms resulted in a trend toward poor prognostic outcomes for appetite loss, dyspnea, diarrhea, and constipation. These findings provide the clinical importance of the monitoring of patient-reported symptoms that can be complementary to physician-reported data to ensure more accurate clinical outcomes. 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 - Tsuji, Akihito AU - Tsuji A AD - Department of Medical Oncology, Kagawa University, Kita, Japan. FAU - Iwamoto, Shigeyoshi AU - Iwamoto S AD - Department of Surgery, Kansai Medical University Kouri Hospital, Neyagawa, 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 AUID- ORCID: 0000-0001-7629-6803 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 - Ando, Masahiko AU - Ando M AD - Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan. FAU - Sakamoto, Junichi AU - Sakamoto J AD - Tokai Central Hospital, Kakamigahara, 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 SI - JPRN/UMIN000010985 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20201121 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - 0 (Antineoplastic Agents, Immunological) RN - PQX0D8J21J (Cetuximab) SB - IM MH - Aged MH - Antineoplastic Agents, Immunological/administration & dosage/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/*adverse effects MH - Cetuximab/administration & dosage/adverse effects MH - Colorectal Neoplasms/*drug therapy/pathology/psychology MH - Female MH - Humans MH - Male MH - Neoplasm Metastasis MH - *Patient Reported Outcome Measures MH - Physicians/psychology/*statistics & numerical data MH - Prognosis MH - Prospective Studies MH - Quality of Life MH - Surveys and Questionnaires MH - Survival Rate PMC - PMC7774728 OTO - NOTNLM OT - cetuximab OT - chemotherapy OT - colorectal cancer OT - patient-reported outcome EDAT- 2020/11/23 06:00 MHDA- 2021/08/05 06:00 PMCR- 2020/11/21 CRDT- 2020/11/22 20:49 PHST- 2020/07/18 00:00 [received] PHST- 2020/10/06 00:00 [revised] PHST- 2020/10/07 00:00 [accepted] PHST- 2020/11/23 06:00 [pubmed] PHST- 2021/08/05 06:00 [medline] PHST- 2020/11/22 20:49 [entrez] PHST- 2020/11/21 00:00 [pmc-release] AID - CAM43564 [pii] AID - 10.1002/cam4.3564 [doi] PST - ppublish SO - Cancer Med. 2020 Dec;9(24):9419-9430. doi: 10.1002/cam4.3564. Epub 2020 Nov 21.