期刊论文详细信息
World Journal of Surgical Oncology
Total gastrectomy increases the incidence of grade III and IV toxicities in patients with gastric cancer receiving adjuvant TS-1 treatment
Jen-Shi Chen2  Yu-Shin Hung2  Wen-Chi Shen2  Hung-Chih Hsu2  Jun-Te Hsu1  Keng-Hao Liu1  Chia-Lun Chang2  Wen-Chi Chou2 
[1] Department of Surgery, Linkou Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taoyuan, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, No. 5 Fuxing Street, Guishan Township, Taoyuan County 333, Taiwan ROC
关键词: TS-1;    Safety profile;    Gastric cancer;    Compliance;    Adjuvant chemotherapy;   
Others  :  820988
DOI  :  10.1186/1477-7819-11-287
 received in 2013-04-09, accepted in 2013-10-18,  发布年份 2013
PDF
【 摘 要 】

Background

We aimed to evaluate the safety and efficacy of TS-1 adjuvant chemotherapy in Taiwanese patients with gastric cancer.

Methods

We included in this study patients with locally advanced gastric cancer who received adjuvant TS-1 or 5-fluorouracil chemotherapy after curative surgery and extended lymph node dissection between 1 June 2008 and 31 December 2012 at Chang Gung Memorial Hospital. Patient characteristics, tumor features, safety profiles and compliance with TS-1 treatment were retrospectively analyzed from medical charts.

Results

Forty patients received adjuvant chemotherapy with TS-1 and 193 with 5-fluorouracil within the study period. The 1- and 2-year overall survival rates were 90.6% and 87% in the TS-1 group and 95.4% and 86.8% in the 5-fluorouracil group (P = 0.34). The 1- and 2-year disease-free survival rates were 90.6% and 74.7% in the TS-1 group and 88% and 75.7% in the 5-fluorouracil group (P = 0.66). In the TS-1 group, tumor recurrence was more frequent in those with >15 metastatic lymph nodes than ≤15. Overall, 78.9%, 74.3%, 62.1% and 56% of patients underwent TS-1 treatment for at least 3, 6, 9 and 12 months, respectively. The most common adverse events of TS-1 were skin hyperpigmentation (55%), diarrhea (27.5%), dizziness (27.5%) and leucopenia (20%). Severe adverse events (SAEs; grade III or IV toxicity) were diarrhea (7.5%), stomatitis (7.5%), leukopenia (5%), vomiting (2.5%), anorexia (2.5%) and dizziness (2.5%). Patients who underwent total gastrectomy had a significantly greater risk of TS-1-related SAEs than patients who underwent subtotal gastrectomy (40% versus 8%, P = 0.014).

Conclusions

The incidence of SAEs during TS-1 therapy was more common in Taiwanese patients with gastric cancer who underwent total gastrectomy compared with those who underwent subtotal gastrectomy. Clinicians must be aware of and able to manage these SAEs to maximize patient compliance with adjuvant TS-1.

【 授权许可】

   
2013 Chou et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20140712062722623.pdf 272KB PDF download
【 参考文献 】
  • [1]Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D: Global cancer statistics. CA Canc J Clin 2011, 61(2):69-90.
  • [2]Health Registry Annual Report 2009, Republic of China. Taipei City, Taiwan, R.O.C: Bureau of Health Promotion, Department of Health, Executive Yuan; 2011.
  • [3]Wu CW, Hsiung CA, Lo SS, Hsieh MC, Chen JH, Li AF, Lui WY, Whang-Peng J: Nodal dissection for patients with gastric cancer: a randomised controlled trial. Lancet Oncol 2006, 7:309-315.
  • [4]Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ: Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol 2010, 11:439-449.
  • [5]Degiuli M, Sasako M, Ponti A, Calvo F: Survival results of a multicentre phase II study to evaluate D2 gastrectomy for gastric cancer. Br J Canc 2004, 90:1727-1732.
  • [6]Wagner AD, Unverzagt S, Grothe W, Kleber G, Grothey A, Haerting J, Fleig WE: Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev 2010, 3:CD004064.
  • [7]Wagner AD, Grothe W, Haerting J, Haerting J, Kleber G, Grothey A, Fleig WE: Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol 2006, 24:2903-2909.
  • [8]Alcobendas F, Milla A, Estape J, Curto J, Pera C: Mitomycin C as an adjuvant in resected gastric cancer. Ann Surg 1983, 198(1):13-17.
  • [9]Fielding JW, Fagg SL, Jones BG, Ellis D, Hockey MS, Minawa A, Brookes VS, Craven JL, Mason MC, Timothy A, Waterhouse JA, Wrigley PF: An interim report of a prospective, randomized, controlled study of adjuvant chemotherapy in operable gastric cancer: British Stomach Cancer Group. World J Surg 1983, 7(3):390-399.
  • [10]Nakajima T, Takahashi T, Takagi K, Kuno K, Kajitani T: Comparison of 5-fluorouracil with ftorafur in adjuvant chemotherapies with combined inductive and maintenance therapies for gastric cancer. J Clin Oncol 1984, 2(12):1366-1371.
  • [11]Krook JE, O'Connell MJ, Wieand HS, Beart RW Jr, Leigh JE, Kugler JW, Foley JF, Pfeifle DM, Twito DI: A prospective, randomized evaluation of intensive-course 5-fluorouracil plus doxorubicin as surgical adjuvant chemotherapy for resected gastric cancer. Cancer 1991, 67(10):2454-2458.
  • [12]Lise M, Nitti D, Marchet A, Sahmoud T, Buyse M, Duez N, Fiorentino M, Dos Santos JG, Labianca R, Rougier P: Final results of a phase III clinical trial of adjuvant chemotherapy with the modified fluorouracil, doxorubicin, and mitomycin regimen in resectable gastric cancer. J Clin Oncol 1995, 13(11):2757-2763.
  • [13]Macdonald JS, Fleming TR, Peterson RF, Berenberg JL, McClure S, Chapman RA, Eyre HJ, Solanki D, Cruz AB Jr, Gagliano R, Estes NC, Tangen CM, Rivkin S: Adjuvant chemotherapy with 5-FU, adriamycin, and mitomycin-C (FAM) versus surgery alone for patients with locally advanced gastric adenocarcinoma: A Southwest Oncology Group Study. Ann Surg Oncol 1995, 2(6):488-494.
  • [14]Nakajima T, Nashimoto A, Kitamura M, Kito T, Iwanaga T, Okabayashi K, Goto M: Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer: a randomised trial. Gastric Cancer Surgical Study Group. Lancet 1999, 354(9175):273-277.
  • [15]Nashimoto A, Nakajima T, Furukawa H, Kitamura M, Kinoshita T, Yamamura Y, Sasako M, Kunii Y, Motohashi H, Yamamoto S, Gastric Cancer Surgical Study Group, Japan Clinical Oncology Group: Randomized trial of adjuvant chemotherapy with mitomycin, fluorouracil, and cytosine arabinoside followed by oral fluorouracil in serosa-negative gastric cancer: Japan Clinical Oncology Group 9206–1. J Clin Oncol 2003, 21(12):2282-2287.
  • [16]Paoletti X, Oba K, Burzykowski T, Michiels S, Ohashi Y, Pignon JP, Rougier P, Sakamoto J, Sargent D, Sasako M, Van Cutsem E, Buyse M, GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group: Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis. JAMA 2010, 303(17):1729-1737.
  • [17]Sun P, Xiang JB, Chen ZY: Meta-analysis of adjuvant chemotherapy after radical surgery for advanced gastric cancer. Br J Surg 2009, 96(1):26-33.
  • [18]Nakajima T, Kinoshita T, Nashimoto A, Sairenji M, Yamaguchi T, Sakamoto J, Fujiya T, Inada T, Sasako M, Ohashi Y, National Surgical Adjuvant Study of Gastric Cancer Group: Randomized controlled trial of adjuvant uracil–tegafur versus surgery alone for serosa-negative, locally advanced gastric cancer. Br J Surg 2007, 94(12):1468-1476.
  • [19]Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K, ACTS-GC Group: Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 2007, 357(18):1810-1820.
  • [20]Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzén F, Noh SH, CLASSIC Trial Investigators: Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet 2012, 379(9813):315-321.
  • [21]Japanese Gastric Cancer Association: Japanese classification of gastric carcinoma – 2nd English edition. Gastric Canc 1998, 1(1):10-24.
  • [22]Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y: Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol 2011, 29(33):4387-4393.
  • [23]Greene FL, Page DL, Fleming ID, Fritz AG, Balch CM, Haller DG, Morrow M: AJCC Cancer Staging Manual. New York: Springer; 2002.
  • [24]The Gastric (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group: Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis. JAMA 2010, 303(17):1729-1737.
  • [25]Wolmark N, Rockette H, Fisher B, Wickerham DL, Redmond C, Fisher ER, Jones J, Mamounas EP, Ore L, Petrelli NJ: The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from national surgical adjuvant breast and bowel project protocol C-03. J Clin Oncol 1993, 11(10):1879-1887.
  • [26]Hirata K, Horikoshi N, Aiba K, Okazaki M, Denno R, Sasaki K, Nakano Y, Ishizuka H, Yamada Y, Uno S, Taguchi T, Shirasaka T: Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Canc Res 1999, 5(8):2000-2005.
  • [27]Taguchi T, Inuyama Y, Kanamaru R, Hasegawa K, Akazawa S, Niitani H, Furue H, Kurihara M, Ota K, Suga S, Ariyoshi Y, Takai S, Shimoyama T, Toge T, Takashima S, Sugimachi K, Hara Y, Fujita H, Kimura K, Saito T, Tsukagoshi S, Nakao I: Phase I study of S-1. S-1 study group. Gan To Kagaku Ryoho 1997, 24(15):2253-2264.
  • [28]Chu QS, Hammond LA, Schwartz G, Ochoa L, Rha SY, Denis L, Molpus K, Roedig B, Letrent SP, Damle B, DeCillis AP, Rowinsky EK: Phase I and pharmacokinetic study of the oral fluoropyrimidine S-1 on a once-daily-for-28-day schedule in patients with advanced malignancies. Clin Canc Res 2004, 10(15):4913-4921.
  • [29]Hoff PM, Saad ED, Ajani JA, Lassere Y, Wenske C, Medgyesy D, Dwivedy S, Russo M, Pazdur R: Phase I study with pharmacokinetics of S-1 on an oral daily schedule for 28 days in patients with solid tumors. Clin Canc Res 2003, 9(1):134-142.
  • [30]Cohen SJ, Leichman CG, Yeslow G, Beard M, Proefrock A, Roedig B, Damle B, Letrent SP, DeCillis AP, Meropol NJ: Phase I and pharmacokinetic study of once daily oral administration of S-1 in patients with advanced cancer. Clin Canc Res 2002, 8(7):2116-2122.
  • [31]van Groeningen CJ, Peters GJ, Schornagel JH, Gall H, Noordhuis P, de Vries MJ, Turner SL, Swart MS, Pinedo HM, Hanauske AR, Giaccone G: Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 2000, 18(14):2772-2779.
  • [32]Ajani JA, Faust J, Ikeda K, Yao JC, Anbe H, Carr KL, Houghton M, Urrea P: Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma. J Clin Oncol 2005, 23(28):6957-6965.
  • [33]Ruddy K, Mayer E, Partridge A: Patient adherence and persistence with oral anticancer treatment. CA Canc J Clin 2009, 59(1):56-66.
  • [34]Tsujimoto H, Horiguchi H, Hiraki S, Yaguchi Y, Takahata R, Kumano I, Yoshida K, Matsumoto Y, Ono S, Yamamoto J, Hase K: Tolerability of adjuvant chemotherapy with S-1 after curative resection in patients with stage II/III gastric cancer. Oncol Lett 2012, 4(5):1135-1139.
  • [35]Aoyama T, Yoshikawa T, Shirai J, Hayashi T, Yamada T, Tsuchida K, Hasegawa S, Cho H, Yukawa N, Oshima T, Rino Y, Masuda M, Tsuburaya A: Body weight loss after surgery is an independent risk factor for continuation of S-1 adjuvant chemotherapy for gastric cancer. Ann Surg Oncoldoi:10.1245/s10434-012-2776-6
  • [36]Aoyama T, Yoshikawa T, Hayashi T, Kuwabara H, Mikayama Y, Ogata T, Cho H, Tsuburaya A: Risk factors for 6-month continuation of S-1 adjuvant chemotherapy for gastric cancer. Gastric Cancdoi:10.1007/s10120-012-0158-1
  • [37]Jeong JH, Ryu MH, Ryoo BY, Lee SS, Park I, Lee SH, Kim KC, Yook JH, Oh ST, Kim BS, Kang YK: Safety and feasibility of adjuvant chemotherapy with S-1 in Korean patients with curatively resected advanced gastric cancer. Canc Chemother Pharmacol 2012, 70(4):523-529.
  • [38]Chen JS, Chao Y, Hsieh RK, Cheng AL, Chen PM, Chiou TJ, Chao TY, Yeh KH, Chen LT, Whang-Peng J: A phase II and pharmacokinetic study of first line S-1 for advanced gastric cancer in Taiwan. Canc Chemother Pharmacol 2011, 67(6):1281-1289.
  • [39]Kinoshita T, Nashimoto A, Yamamura Y, Okamura T, Sasako M, Sakamoto J, Kojima H, Hiratsuka M, Arai K, Sairenji M, Fukushima N, Kimura H, Nakajima T: Feasibility study of adjuvant chemotherapy with S-1 (TS-1: tegafur, gimeracil, oteracil potassium) for gastric cancer. Gastric Canc 2004, 7(2):104-109.
  文献评价指标  
  下载次数:3次 浏览次数:6次