Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer.

Ryu, Sang-Young; Lee, Won-Moo; Kim, Kidong; Park, Sang-Il; Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol; Cho, Chul-Koo; Nam, Byung-Ho; Lee, Eui-Don
International journal of radiation oncology, biology, physics
2011Nov ; 81 ( 4 ) :e577-81.
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Ryu, Sang-Young -
Lee, Won-Moo -
Kim, Kidong -
Park, Sang-Il -
Kim, Beob-Jong -
Kim, Moon-Hong -
Choi, Seok-Cheol -
Cho, Chul-Koo -
Nam, Byung-Ho -
Lee, Eui-Don -
ABSTRACT
PURPOSE: To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer. METHODS AND MATERIALS: In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m(2), six cycles) and triweekly (cisplatin 75 mg/m(2) every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years.

RESULTS: All patients tolerated both treatments very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03).

CONCLUSIONS: Triweekly cisplatin 75-mg/m(2) chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m(2) regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer. CI - Copyright ??2011 Elsevier Inc. All rights reserved.
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MESH
Antineoplastic Agents/*administration & dosage/adverse effects, Brachytherapy, Carcinoma, Squamous Cell/drug therapy/mortality/pathology/radiotherapy, Cisplatin/*administration & dosage/adverse effects, Combined Modality Therapy/methods, Drug Administration Schedule, Female, Humans, Medication Adherence, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Radiation-Sensitizing Agents/*administration & dosage/adverse effects, Radiotherapy Dosage, Sodium Chloride/administration & dosage, Survival Rate, Uterine Cervical Neoplasms/*drug therapy/mortality/pathology/*radiotherapy
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Triweekly cisplatin 75-mg/m 2 chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m 2 regimen.
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DOI
10.1016/j.ijrobp.2011.05.002
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ICD 03
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