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Comparison of Capecitabine and Tegafur/Gimeracil/Oteracil (S - 1) in the Treatment of Advanced Breast Carcinoma in the Elderly

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Comparison of Capecitabine and Tegafur/Gimeracil/Oteracil (S - 1) in the Treatment of Advanced Breast Carcinoma in the Elderly Zheng et al Tropical Journal of Pharmaceutic al Research March 201 8 ; 1 7 ( 3 ): 543 - 547 ISSN: 1596 - 5996 (print); 1596 - 9827 (electronic) © Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. Available online at http://www.tjpr. org http://dx.doi.org/10.4314/tjpr.v1 7 i 3 . 22 Original Research Article Comparison of capecitabine and tegafur/gimeracil/oteracil (S - 1) in the treatment of advanced breast carcinoma in the elderly Dong - Xing Zheng 1 *, Ji - Hai Jin 2 , Yu - Juan Liu 3 1 Oncology De partment II, 2 Breast Surgery, 3 Department of Pediatrics, Binzhou People’s Hospital, Binzhou, Shandong, 256600, PR China *For correspondence: Email: [email protected] Sent for review : 6 June 201 7 Revised accepted: 28 February 201 8 Abstract Purp ose : To analyse and compare the clinical effects and safety of capecitabine and tegafur/gimeracil/oteracil (S - 1) in the treatment of advanced breast carcinoma. Methods: Eighty - four metastatic breast cancer elderly patients for whom first or second - line tre atment had failed, were selected from among those admitted to the oncology ward of Binjiang People’s Hospital, China between January 2014 and June 2015. They were randomly divided into S - 1 group (n = 41) and capecitabine group (n = 41) and received varying doses of those drugs according to body surface area. Clinical effects, progression - free survival, and incidence of adverse reactions were compared for the two groups following treatment. Results: Disease control rate (CR) in S - 1 group was 55.6 %, much hig her than 35.1 % observed for capecitabine group (p < 0.05). The disease control rate for the S - 1 group was 93.7 %, also much higher than the 70.6 % found in capecitabine group. Survival analysis showed that the median survival times of the two groups did n ot differ significantly (p > 0.05). Furthermore, some adverse reactions such as myelosuppression and lack of strength, did not differ significantly between the two groups (p > 0.05), whereas others, including leukopenia, nausea and vomiting and hand - foot s yndrome were more serious and frequent in capecitabine group than in S - 1 group (p < 0.05). Conclusion: Monotherapy with S - 1 is more effective than that with capecitabine. Adverse reactions are minimal for both drugs. Keywords: Breast carcinoma, Capecitab ine, S - 1, Adverse reactions, Myelosuppression, Leukopenia, Hand - foot syndrome This is an Open Access article that uses a fund ing model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://c reativecommons.org/licenses/by/ 4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. Tropical Journal of Pharmaceutical Research is indexed by Science Citation Index (SciSearch), Scopus, International Pharmaceutical Abstract, Chemical Abstracts, Embase, Index Copernicus, EBSCO, African Index Medicus, JournalSeek , Journal Citation Reports/Science Edition, Directory of Open Access Journals (DOAJ), African Journal Online, Bioline International, Open - J - Gate and Pharmacy Abstracts INTRODUCTION a late stage, some with distant metastases, by the time of initial diagnosis [1,2]. Surgery and Since the 1980s, breast cancer has had the chemotherapy are the major treatment met hods highest incidence and the sixth - highest mortality for breast cancer. To extend survival as much as rate of all malignant tumours in women. In many possible, chemotherapy without surgical cases, these cancers have already progressed to treatment is more appropriate for late - stage ----------------------------------------------------- ------------------------------------------------------------------------------------------------ © 2018 The authors . This work is licensed under the Creative Commons Attribution 4.0 International License 543 Zheng et al breast cancer [3,4]. The most preferred Therapeutic regimen chemotherapeutic drugs are anthracyclines and taxanes, but their toxicity and side effects can The enrolled patient s were separated into an S - 1 severely reduce treatment effectiveness group and a capecitabine group using a random andquality of life for elderly patients most such number table, 41 patients were in each group. patients are intolerant of combined Drug doses were set according to the body chemotherapy. Many patients with advanced surface area (BSA) of each patient: 80 mg/day breast cancer have already experienced for BSA ≤ 1.25 m 2 , 100 mg/day for BSA > 1.25 treatment failure using the dr ugs mentioned m 2 but < 1.5 m 2 , and 120 mg/day for BSA ≥ above. Currently, effective, safe and easy - to - 1.5m 2 . Patients in the S - 1 group received oral S - administer therapeutic regimens that can be 1 (Shandong New Age Pharmaceutical Co., Ltd., maintained over the long term are lacking in China; State Food and Drug Administration clinics. (SFDA) approval number: H20080803) twice daily after breakfast and supper fo r 28 days, and Drugs related to 5 - fluorouracil (5 - FU) are then stopped taking the drug for 14 days; every 6 effective in the treatment of breast cancer. Oral weeks was regarded as one cycle. Patients in admi nistration of capecitabine is recommended the capecitabine group received oral as a standard salvage treatment although capecitabine within 30 min after breakfast and adverse reactions such as hand - foot syndrome supper for 14 days, and then stopped taking the and gastrointestinal side effects restrict its clinical drug for 7 day s; every 3 weeks was regarded as application [5,6]. Some studies [7,8] have one cycle. Clinical effect was evaluated every 6 demonstrated significant eff ects achieved after a weeks. When the effect was evaluated as single treatment with S - 1 , with minimal adverse complete remission (CR), partial remission (PR), reactions. However most of the research data or stable disease (SD), treatment was continued are from Japan, and few studies have been until either tumours developed or int olerable performed in China. This study sought to adverse reactions appeared. compare the curative effects and safety of S - 1 and capecit abine in the treatment of patients with Observed features and criteria for indexing advanced breast cancer. therapeutic effect METHODS The therapeutic effect was evaluated according to RECIST 1.0. In CR all lesions disappeared Subjects and did not recur for 4 weeks. Reduction of lesion areas by m ore than 30 % and the Eighty - two elderly patients with advanced breast appearance of no new lesions for 4 weeks was cancer admitted to Binzhou People’s Hospital, considered PR. An increase in lesion area or the China, between January 2014 and June 2015, appearance of new lesions was considered were selected. All cases were con firmed as progressive disease (PD). All patients were re - advanced breast cancer, with biopsy - proven examined after two courses of treatment. Lesions invasive ductal carcinomas and distant wer e measured before and after treatment and metastases observed by Computed Tomography were compared to evaluate clinical effects. The (CT) and Magnetic Resonance Imaging (MRI). overall response rate (ORR) was the sum of The subjects were all females aged from 63 to 81 percentages of patients with CR and PR; the years (median 51 years). All patients were disease control rate (DCR) was the sum of observed to have tumour progression after one percentages of patients with CR, PR a nd SD. All or two regimens of chemotherapy. Patients were patients were followed up successfully by included if they had measurable lesions telephone and/or by outpatient services. Survival according to the response evaluation criteria in time (in months) were recorded during follow - up solid tumours (RECIST) (version 1.1) [9], and and the survival curves were drawn. were predicted to have at least a further 6months o f survival , with good bone marrow, hepatic, and Statistical analysis renal function. Those with rapid disease progression, contraindications to chemotherapy, SPSS software (ver. 12.0; SPSS Inc., USA) was organ risks, liver and kidney function deficiency, used for statistical analysis. Categorical data or uncontrolled cerebral metast asis were were compared between groups using Chi - excluded. The study was approved by the square tests. Overall survival time was analysed Medical Ethics Committee of Binzhou People’s using Kaplan - Meier plots and compar ed using Hospital (approval no. BPH20140104ZDX), and log - rank tests. Differences were considered the experiment followed the guidelines of the statistically significant if p < 0.05. Declaration of Helsinki [10]. 544 Zheng et al RESULTS Kaplan - Meier analysis indicated that the median Baseline characteristics and treatment progression - free survival (PFS) for the S - 1 group conditions and the capecitabine group was 5.5 and 4.5 months, respectively (95 % con fidence intervals: 4.7 - 6.3 and 2.4 - 5.6 months); this difference Of the 82 patients enrolled, 62 (75.6 %) had 2 undergone first - line chemotherapy and 20 (24.4 was not statistically significant (X = 0.219, p > %) had rece ived second - line chemotherapy. No 0.05; Figure 1). significant difference was found in general characteristics or previous treatment conditions between the two groups ( p > 0.05; Table 1). Clinical efficacy In S - 1 group, the median number of chemotherapy cycles was 3.5 (1 - 11 cycles); after treatment, there were no cases of CR, 13 cases of PR, 14 cases of SD, and 14 cases of PD. In the capecitabine group, the median number of chemotherapy cycles was 4 (1 - 17 cycles); after treatment, there were no cases of Figure 1: The progression - free survival (PFS) curves CR, 8 cases of PR, 11 cases of SD, and 22 of the two groups cases of PD. Adverse reactions The ORR of the S - 1 and capecitabine groups was 31.7 % (13/41) and 19.5 % (8/41), Some adverse reactions, su ch as respectively (X 2 = 3.963, p < 0.05).
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