PMID- 31665356
OWN - NLM
STAT- MEDLINE
DCOM- 20200515
LR  - 20200515
IS  - 1465-3621 (Electronic)
IS  - 0368-2811 (Linking)
VI  - 50
IP  - 2
DP  - 2020 Feb 17
TI  - Clinical impact of baseline renal function on safety and early discontinuation of 
      adjuvant capecitabine plus oxaliplatin in elderly patients with resected colon 
      cancer: a multicenter post-marketing surveillance study.
PG  - 122-128
LID - 10.1093/jjco/hyz149 [doi]
AB  - BACKGROUND: Adjuvant capecitabine and oxaliplatin (CAPOX) is a standard treatment 
      for resected colon cancer; however, in patients with moderate renal impairment, 
      the incidence of CAPOX-related adverse events (AEs) and the rate of early 
      discontinuation are higher than in patients with no or mild renal impairment. The 
      aim of this retrospective study was to assess the impact of baseline renal 
      function on the safety and discontinuation of adjuvant CAPOX therapy started with 
      the standard dose of capecitabine in elderly patients with colon cancer. METHODS: 
      Data from patients aged >/=65 years old who received CAPOX at the standard starting 
      dose as adjuvant therapy for stage II/III colon cancer were collected and 
      analyzed retrospectively. Patients were divided into two groups based on their 
      renal function: CLcr-H (patients with a creatinine clearance [CLcr] >/=50 ml/min) 
      and CLcr-L (CLcr <50 ml/min), and AEs and discontinuations were assessed. 
      RESULTS: Overall, 189 patients were assessed (CLcr-H group = 137 and CLcr-L 
      group = 52). No patients experienced grade 4 AEs. The incidence of grade 3 
      CAPOX-related AEs was higher in the CLcr-L group (42.3%) than in the CLcr-H group 
      (31.3%). The proportion of patients who discontinued treatment within four cycles 
      due to AEs was also higher in the CLcr-L group (21.1%) than in the CLcr-H group 
      (2.9%). Multivariate analysis identified that CLcr <50 ml/min was the only 
      significant risk factor for CAPOX therapy discontinuation due to AEs 
      (P = 0.0008). CONCLUSIONS: This study demonstrates that the tolerability of 
      adjuvant CAPOX therapy was decreased in elderly patients with impaired renal 
      function. CLINICAL TRIAL REGISTRATION: University Hospital Medical Information 
      Network Clinical Trials Registry number UMIN000016446.
CI  - (c) The Author(s) 2019. Published by Oxford University Press. All rights reserved. 
      For permissions, please e-mail: journals.permissions@oup.com.
FAU - Yamazaki, Kentaro
AU  - Yamazaki K
AD  - Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, 
      Shizuoka, Japan.
FAU - Matsumoto, Shigemi
AU  - Matsumoto S
AD  - Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, 
      Kyoto, Japan.
FAU - Imamura, Chiyo K
AU  - Imamura CK
AD  - Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
FAU - Yamagiwa, Chiemi
AU  - Yamagiwa C
AD  - Real World Data Science Department, Chugai Pharmaceutical Co., Ltd., Tokyo, 
      Japan.
FAU - Shimizu, Ayaka
AU  - Shimizu A
AD  - Real World Data Science Department, Chugai Pharmaceutical Co., Ltd., Tokyo, 
      Japan.
FAU - Yoshino, Takayuki
AU  - Yoshino T
AD  - Department of Gastroenterology and Gastrointestinal Oncology, National Cancer 
      Center Hospital East, Kashiwa, Chiba, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Jpn J Clin Oncol
JT  - Japanese journal of clinical oncology
JID - 0313225
RN  - 04ZR38536J (Oxaliplatin)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - AYI8EX34EU (Creatinine)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/*adverse 
      effects
MH  - Capecitabine/administration & dosage/adverse effects
MH  - Chemotherapy, Adjuvant
MH  - Colonic Neoplasms/blood/*drug therapy/pathology/surgery
MH  - Creatinine/blood
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Kidney/*drug effects/physiology
MH  - Male
MH  - Oxaliplatin/administration & dosage/adverse effects
MH  - Product Surveillance, Postmarketing
MH  - Retrospective Studies
MH  - Risk Factors
OTO - NOTNLM
OT  - capecitabine
OT  - creatinine
OT  - drug tolerance
OT  - oxaliplatin
OT  - safety
EDAT- 2019/10/31 06:00
MHDA- 2020/05/16 06:00
CRDT- 2019/10/31 06:00
PHST- 2019/05/13 00:00 [received]
PHST- 2019/08/27 00:00 [accepted]
PHST- 2019/10/31 06:00 [pubmed]
PHST- 2020/05/16 06:00 [medline]
PHST- 2019/10/31 06:00 [entrez]
AID - 5607884 [pii]
AID - 10.1093/jjco/hyz149 [doi]
PST - ppublish
SO  - Jpn J Clin Oncol. 2020 Feb 17;50(2):122-128. doi: 10.1093/jjco/hyz149.