PMID- 26879651 OWN - NLM STAT- MEDLINE DCOM- 20170111 LR - 20181202 IS - 1437-7772 (Electronic) IS - 1341-9625 (Linking) VI - 21 IP - 5 DP - 2016 Oct TI - Identification of adverse events that have a negative impact on quality of life in a clinical trial comparing docetaxel versus S-1 with cisplatin in lung cancer. PG - 836-842 AB - PURPOSE: In the CATS (Cisplatin And TS-1) randomized trial comparing cisplatin plus either docetaxel (DP arm) or TS-1 (SP arm) in lung cancer, efficacy was found to be equivalent but the global quality of life (QOL) score was higher in the SP arm. The purpose of the current study was to identify which of the adverse events (AEs) contributed to the deterioration of QOL. METHODS: QOL and AE data from the CATS trial were used to quantitatively analyze the relationship between deterioration of QOL score and occurrence of AEs. Subtracted values of the QOL score from post-chemotherapy to pre-chemotherapy were fully compared between patients with or without each AE (Student's t test, significance level = 0.001). Multivariate linear regression analysis was also performed. Analysis of variance was performed to identify whether grade of AE(s) might be significantly correlated with the deterioration of the QOL score (significance level of 0.05). RESULTS: As expected, gastrointestinal (GI) toxicities were associated with worsening of a variety of QOL items in both trial arms, detected by both univariate and multivariate analysis (p < 0.001 and p < 0.0001, respectively). Multivariate analysis unpredictably indicated that an increase in serum bilirubin level was the only AE that was uniquely associated with worsening of physical functioning (p = 0.0002), cognitive functioning (p < 0.0001), and financial problems (p = 0.0005) in the DP arm, although not in the SP arm. GI toxicities tended to be prolonged in the SP arm. CONCLUSION: An increase in serum bilirubin level may contribute to the worse global QOL of subjects in the DP arm in the CATS trial. The method we used here may be a unique approach to identify unpredictable AE(s) that worsen the QOL of patients treated by chemotherapy. FAU - Aotani, Eriko AU - Aotani E AUID- ORCID: 0000-0001-9843-949X AD - Global Health Research Coordinating Center, Kanagawa Academy of Science and Technology, KSP East 3F 309, 3-2-1, Sakado, Takatsu-ku, Kawasaki, Kanagawa, 213-0012, Japan. gh-aotani@newkast.or.jp. FAU - Hamano, Tetsutaro AU - Hamano T AD - Clinical Trial Coordinating Center, Kitasato Academic Research Organization, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642, Japan. FAU - Gemma, Akihiko AU - Gemma A AD - Department of Pulmonary Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. FAU - Takeuchi, Masahiro AU - Takeuchi M AD - Biostatistics and Pharmaceutical Medicine, Department of Clinical Medicine, School of Pharmacy, Kitasato University, 5-9-1, Shirokane, Minato-ku, Tokyo, 108-8641, Japan. FAU - Takebayashi, Toru AU - Takebayashi T AD - Department of Preventive Medicine and Public Health, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan. FAU - Kobayashi, Kunihiko AU - Kobayashi K AD - Department of Pulmonary Medicine, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, 350-1298, Japan. LA - eng PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20160215 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Drug Combinations) RN - 0 (Taxoids) RN - 150863-82-4 (S 1 (combination)) RN - 1548R74NSZ (Tegafur) RN - 15H5577CQD (Docetaxel) RN - 5VT6420TIG (Oxonic Acid) RN - Q20Q21Q62J (Cisplatin) RN - RFM9X3LJ49 (Bilirubin) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/*adverse effects MH - Bilirubin/blood MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Cisplatin/administration & dosage/adverse effects MH - Cognition Disorders/chemically induced MH - Docetaxel MH - Drug Combinations MH - Gastrointestinal Diseases/chemically induced MH - Humans MH - Lung Neoplasms/*drug therapy MH - Oxonic Acid/administration & dosage/adverse effects MH - *Quality of Life MH - Taxoids/*adverse effects MH - Tegafur/administration & dosage/adverse effects OTO - NOTNLM OT - Adverse events OT - Cancer chemotherapy OT - Lung cancer OT - Quality of life EDAT- 2016/02/18 06:00 MHDA- 2017/01/12 06:00 CRDT- 2016/02/17 06:00 PHST- 2015/11/18 00:00 [received] PHST- 2016/01/28 00:00 [accepted] PHST- 2016/02/18 06:00 [pubmed] PHST- 2017/01/12 06:00 [medline] PHST- 2016/02/17 06:00 [entrez] AID - 10.1007/s10147-016-0960-6 [pii] AID - 10.1007/s10147-016-0960-6 [doi] PST - ppublish SO - Int J Clin Oncol. 2016 Oct;21(5):836-842. doi: 10.1007/s10147-016-0960-6. Epub 2016 Feb 15.