TY - JOUR
T1 - Feasibility of sequential adjuvant chemotherapy with a 3-month oxaliplatin-based regimen followed by 3 months of capecitabine in patients with stage III and high-risk stage II colorectal cancer
T2 - JSWOG-C2 study
AU - Tsuruta, Atsushi
AU - Yamashita, Kazuki
AU - Tanioka, Hiroaki
AU - Tsuji, Akihito
AU - Inukai, Michio
AU - Yamakawa, Toshiki
AU - Yamatsuji, Tomoki
AU - Yoshimitsu, Masanori
AU - Toyota, Kazuhiro
AU - Yamano, Taketoshi
AU - Nagasaka, Takeshi
AU - Okajima, Masazumi
N1 - Funding Information:
We thank Frederick H Hausheer, MD, FACP, BioNumerik Pharmacoceutical, Inc. for his granting permission to use PNQ-oxaliplatin. We also thank Dr Hideo Okumura,Dr Yasuo Oka, and Dr Yuji Yamamoto for collecting data and for their great support. We thank the patients who participated in this study and their families and physicians. This study was presented at the ESMO 17th World Congress on Gastrointestinal Cancer 2015 (July 1-4, Barcelona, Spain) as a poster presentation (P-246). The poster?s abstract was published in "Poster Abstracts" in Annals of Oncology 26 (Supplement 4), iv1-iv100, 2015. This paper is the first to publish as an original article.
Publisher Copyright:
© 2016 Tsuruta et al.
PY - 2016/11/23
Y1 - 2016/11/23
N2 - Background: Six months of oxaliplatin-based chemotherapy is the standard adjuvant chemotherapy for completely resected stage III colorectal cancer (CRC). Also, patients with stage II CRC who are considered to be at high risk of disease recurrence often receive the same adjuvant chemotherapy treatment. We prospectively investigated the extent and degree of neuropathy suffered by stage III and high-risk stage II resectable CRC patients who underwent sequential approach involving 3 months of an oxaliplatin-based regimen followed by 3 months of capecitabine. Patients and methods: Patients with completely resected stage III and high-risk stage II CRC aged ≥20 years were eligible. Patients were treated with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) for 3 months followed by capecitabine (2,500 mg/m2 on days 1-14 every 3 weeks) for 3 months. Primary end points were frequency and the grade of oxaliplatin-induced neurotoxicity as evaluated using the physician-based Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) grading and the patient-based scale, self-reported Patient Neurotoxicity Questionnaire. Results: Ninety-one patients were enrolled and 86 patients assessed. Eighty-four percent of patients completed the planned oxaliplatin-based therapy for 3 months, and 63% of patients completed all treatments for the full 6 months. Overall incidences of grade 3 or 4 peripheral sensory or motor neuropathy according to the CTCAE were 3.5% and 1.2%, respectively. Regarding the peripheral sensory neuropathy, the proportion of Patient Neurotoxicity Questionnaire (grade C-E) and CTCAE (grade 2-4) at months 1.5/3/6 were 11.3/22.1/29.4% and 5.3/4.4/11.3%, respectively (Spearman correlation coefficient: 0.47). Conclusion: A sequential approach to adjuvant chemotherapy with 3 months of an oxaliplatin-based regimen followed by 3 months of capecitabine was tolerated by patients and associated with a low incidence of neuropathy.
AB - Background: Six months of oxaliplatin-based chemotherapy is the standard adjuvant chemotherapy for completely resected stage III colorectal cancer (CRC). Also, patients with stage II CRC who are considered to be at high risk of disease recurrence often receive the same adjuvant chemotherapy treatment. We prospectively investigated the extent and degree of neuropathy suffered by stage III and high-risk stage II resectable CRC patients who underwent sequential approach involving 3 months of an oxaliplatin-based regimen followed by 3 months of capecitabine. Patients and methods: Patients with completely resected stage III and high-risk stage II CRC aged ≥20 years were eligible. Patients were treated with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) for 3 months followed by capecitabine (2,500 mg/m2 on days 1-14 every 3 weeks) for 3 months. Primary end points were frequency and the grade of oxaliplatin-induced neurotoxicity as evaluated using the physician-based Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) grading and the patient-based scale, self-reported Patient Neurotoxicity Questionnaire. Results: Ninety-one patients were enrolled and 86 patients assessed. Eighty-four percent of patients completed the planned oxaliplatin-based therapy for 3 months, and 63% of patients completed all treatments for the full 6 months. Overall incidences of grade 3 or 4 peripheral sensory or motor neuropathy according to the CTCAE were 3.5% and 1.2%, respectively. Regarding the peripheral sensory neuropathy, the proportion of Patient Neurotoxicity Questionnaire (grade C-E) and CTCAE (grade 2-4) at months 1.5/3/6 were 11.3/22.1/29.4% and 5.3/4.4/11.3%, respectively (Spearman correlation coefficient: 0.47). Conclusion: A sequential approach to adjuvant chemotherapy with 3 months of an oxaliplatin-based regimen followed by 3 months of capecitabine was tolerated by patients and associated with a low incidence of neuropathy.
KW - Adjuvant chemotherapy
KW - Oxaliplatin
KW - Patient neurotoxicity questionnaire
KW - Peripheral neurotoxicity
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U2 - 10.2147/DDDT.S112322
DO - 10.2147/DDDT.S112322
M3 - Article
C2 - 27920498
AN - SCOPUS:85003749556
SN - 1177-8881
VL - 10
SP - 3827
EP - 3835
JO - Drug Design, Development and Therapy
JF - Drug Design, Development and Therapy
ER -
