Randomized phase II study of capecitabine with or without oxaliplatin as first-line treatment for elderly or fragile patients with metastatic colorectal cancer: a prospective, multicenter trial of the Korean Cancer Study Group CO06-01.

Hong, Yong Sang; Jung, Kyung Hae; Kim, Hwa Jung; Kim, Kyu-Pyo; Kim, Sun Young; Lee, Jae-Lyun; Shim, Byoung Yong; Zang, Dae Young; Kim, Jee Hyun; Ahn, Joong Bae; Park, Young Suk; Kim, Tae Won
American journal of clinical oncology
2013Dec ; 36 ( 6 ) :565-71.
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Hong, Yong Sang -
Jung, Kyung Hae -
Kim, Hwa Jung -
Kim, Kyu-Pyo -
Kim, Sun Young -
Lee, Jae-Lyun -
Shim, Byoung Yong -
Zang, Dae Young -
Kim, Jee Hyun -
Ahn, Joong Bae -
Park, Young Suk -
Kim, Tae Won -
ABSTRACT
BACKGROUND: To compare 2 different strategies of chemotherapy for elderly metastatic colorectal cancer patients.

METHODS: This randomized, multicenter phase II study involved 80 metastatic colorectal cancer patients aged 70 years and above (performance status [PS] 0-2) or 65 years and above (PS 2), randomly assigned to arm A (capecitabine 1250 mg/m twice daily on days 1-14) or arm B (capecitabine 1000 mg/m twice daily on days 1-14, oxaliplatin 100 mg/m on day 1 initially, 130 mg/m for subsequent cycles). Primary endpoint was response rate, and secondary endpoints were toxicity, progression-free survival, overall survival, and quality of life (QoL), which was assessed with the EORTC QLQ-C30 questionnaire.

RESULTS: Confirmed response rates were 22.5% and 35.0% (P=0.217), progression-free survival were 4.4 and 6.6 months (P=0.335), and overall survival were 14.2 and 11.0 months (P=0.106). Hematologic toxicities were frequently observed in arm B, but grade ?? toxicities were not different. Patients in arm A tended to present more favorable preservation of QoL in global health status, physical and role functioning, fatigue, and appetite loss.

CONCLUSIONS: Initial aggressive treatment strategy would not be recommended for this patient population because QoL appeared more preserved, treatments were better tolerated, and survivals did not differ in patients treated with initial capecitabine monotherapy.
elderly, fragile, metastatic colorectal cancer, chemotherapy
MESH
Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use, Asian Continental Ancestry Group, Capecitabine, Colorectal Neoplasms/*drug therapy/*pathology, Deoxycytidine/administration & dosage/adverse effects/*analogs &, Disease-Free Survival, Drug Administration Schedule, Female, Fluorouracil/administration & dosage/adverse effects/*analogs &, Humans, Male, Organoplatinum Compounds/administration & dosage/adverse effects/*therapeutic use, Prospective Studies, Quality of Life, Treatment Outcome
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Combination chemotherapy with CAPOX failed to show advantages over capecitabine monotherapy for elderly or fragile mCRC patients.
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DOI
10.1097/COC.0b013e31825d52d5
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ICD 03
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