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REVIEW: TREATMENT AND OUTCOMES

TOXview: a novel graphical presentation of cancer treatment toxicity profiles

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Pages 1138-1148 | Received 21 Dec 2018, Accepted 25 Mar 2019, Published online: 24 Apr 2019

References

  • Pinto E, Cavallin F, Saadeh LM, et al. Potential curability and perception of received information in esophageal cancer patients. Support Care Cancer. 2018;26:1807–1814.
  • Faller H, Koch U, Brähler E, et al. Satisfaction with information and unmet information needs in men and women with cancer. J Cancer Surviv. 2016;10:62–70.
  • Mendoza T. Time for better presentation and analysis of adverse events. Lancet Oncol. 2016;17:553–554.
  • Thanarajasingam G, Atherton PJ, Novotny PJ, et al. Longitudinal adverse event assessment in oncology clinical trials: the Toxicity over Time (ToxT) analysis of Alliance trials NCCTG N9741 and 979254. Lancet Oncol. 2016;17:663–670.
  • Yeh S-T. Clinical adverse events data analysis and visualization. The Pharmaceutical industry SAS users group conference proceedings; Denver, CO: GlaxoSmithKline, 2007. PO10.
  • ter Veer E, Ngai LL, van Valkenhoef G, et al. Capecitabine, 5-fluorouracil and S-1 based regimens for previously untreated advanced oesophagogastric cancer: a network meta-analysis. Sci Rep. 2017;7:3–10.
  • Siegel RL, Miller KD, Jemal A. Cancer statistics. CA Cancer J Clin. 2017;67:7–30.
  • Wagner A, Syn N, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Data Syst Rev. 2017;8:CD004064. DOI: 10.1002/14651858.CD004064.pub4
  • Al-Batran SE, Van Cutsem E, Oh SC, et al. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016;27:673–679.
  • Veer ET, Mohammad NH, Van Valkenhoef G, et al. The efficacy and safety of first-line chemotherapy in advanced esophagogastric cancer: a network meta-analysis. J Natl Cancer Inst. 2016;108:1–13.
  • Sivendran S, Latif A, McBride RB, et al. Adverse event reporting in cancer clinical trial publications. JCO. 2014;32:83–89.
  • Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.1.0 [updated March 2011]. Cochrane Collab. 2011. Available from: http://handbook.cochrane.org
  • Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw. 2010;36:1–48.
  • R Core Team. R: a language and environment for statistical computing. R Found Stat Comput. 2018. Vienna, Austria. Available online at https://www.R-project.org/.
  • Lu Y, Liu Z, Zhang J. S-1 plus oxaliplatin vs. S-1 as first-line treatment in patients with previously untreated advanced gastric cancer: a randomized phase II study. J Chemother. 2014;26:159–164.
  • Yun J, Lee J, Park SH, et al. A randomised phase II study of combination chemotherapy with epirubicin, cisplatin and capecitabine (ECX) or cisplatin and capecitabine (CX) in advanced gastric cancer. Eur J Cancer. 2010;46:885–891.
  • Van Cutsem E, Boni C, Tabernero J, et al. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015;26:149–156.
  • Thuss-Patience PC, Kretzschmar A, Repp M, et al. Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. JCO. 2005;23:494–501.
  • Tesselaar ME, Luelmo S, Polee M, et al. Randomized, phase II study comparing cisplatin and high-dose 5-fluorouracil/leucovorin with paclitaxel and high-dose 5-fluorouracil/leucovorin in patients with advanced gastric cancer and adenocarcinomas of the gastroesophageal junction. JCO. 2008;26:4567.
  • Tebbutt NC, Norman A, Cunningham D, et al. A muticentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer. Ann Oncol. 2002;13:1568–1575.
  • Sym SJ, Hong J, Park J, et al. A randomized phase II study of biweekly irinotecan monotherapy or a combination of irinotecan plus 5-fluorouracil/leucovorin (mFOLFIRI) in patients with metastatic gastric adenocarcinoma refractory to or progressive after first-line chemotherapy. Cancer Chemother Pharmacol. 2013;71:481–488.
  • Sugimoto N, Fujitani K, Imamura H, et al. Randomized phase II trial of S-1 plus irinotecan versus S-1 plus paclitaxel as first-line treatment for advanced gastric cancer (OGSG0402). Anticancer Res. 2014;34:851–857.
  • Shirao K, Boku N, Yamada Y, et al. Randomized phase iii study of 5-fluorouracil continuous infusion vs. sequential methotrexate and 5-fluorouracil therapy in far advanced gastric cancer with peritoneal metastasis (jcog0106). Jpn J Clin Oncol. 2013;43:972–980.
  • Shen L, Li J, Xu J, et al. Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, double-blind, phase III study (AVATAR study). Gastric Cancer. 2015;18:168–176.
  • Shah MA, Janjigian YY, Stoller R, et al. Randomized multicenter phase II study of modified docetaxel, cisplatin, and fluorouracil (DCF) versus DCF plus growth factor support in patients with metastatic gastric adenocarcinoma: a study of the US gastric cancer consortium. JCO. 2015;33:3874–3879.
  • Sawaki a, Yamaguchi K, Nabeya Y, et al. 5-FU/l-LV (RPMI) versus S-1 as first-line therapy in patients with advanced gastric cancer: a randomized phase III non-inferiority trial. (ISO-5FU10 Study Group trial). Eur J Cancer Suppl. 2009;7:364.
  • Yoon HH, Bendell JC, Braiteh FS, et al. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016;27:2196–2203.
  • Ryu M-H, Park YI, Chung I-J, et al. Phase III trial of s-1 plus oxaliplatin (SOX) vs s-1 plus cisplatin (SP) combination chemotherapy for first-line treatment of advanced gastric cancer (AGC): SOPP study. JCO. 2016;34:4015.
  • Ryu MH, Baba E, Lee KH, et al. Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS). Ann Oncol. 2015;26:2097–2101.
  • Roy A, Cunningham D, Hawkins R, et al. Docetaxel combined with irinotecan or 5-fluorouracil in patients with advanced oesophago-gastric cancer: a randomised phase II study. Br J Cancer. 2012;107:435–441.
  • Roth AD, Fazio N, Stupp R, et al. Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss group for clinical cancer research. JCO. 2007;25:3217–3223.
  • Roth A, Kolaric K, Zupanc D, et al. High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: a randomized study. Tumori. 1999;85:234–238.
  • Ross P, Nicolson M, Cunningham D, et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. JCO. 2002;20:1996–2004.
  • Ridwelski K, Fahlke J, Kettner E, et al. Docetaxel-cisplatin (DC) versus 5-fluorouracil-leucovorin-cisplatin (FLC) as first-line treatment for locally advanced or metastatic gastric cancer: preliminary results of a phase III study. JCO. 2008;26:4512.
  • Richards D, Kocs DM, Spira AI, et al. Results of docetaxel plus oxaliplatin (DOCOX) ± cetuximab in patients with metastatic gastric and/or gastroesophageal junction adenocarcinoma: Results of a randomised Phase 2 study. Eur J Cancer. 2013;49:2823–2831.
  • Rao S, Starling N, Cunningham D, et al. Matuzumab plus epirubicin, cisplatin and capecitabine (ECX) compared with epirubicin, cisplatin and capecitabine alone as first-line treatment in patients with advanced oesophago-gastric cancer: a randomised, multicentre open-label phase II study. Ann Oncol. 2010;21:2213–2219.
  • Pozzo C, Barone C, Szanto J, et al. Irinotecan in combination with 5-fluorouracil and folinic acid or with cisplatin in patients with advanced gastric or esophageal-gastric junction adenocarcinoma: Results of a randomized phase II study. Ann Oncol. 2004;15:1773–1781.
  • Yamada Y, Higuchi K, Nishikawa K, et al. Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer. Ann Oncol. 2015;26:141–148.
  • Park SH, Lee WK, Chung M, et al. Paclitaxel versus docetaxel for advanced gastric cancer: a randomized phase II trial in combination with infusional 5-fluorouracil. Anticancer Drugs. 2006;17:225–229.
  • Ocvirk J, Reberšek M, Skof E, et al. Randomized prospective phase II study to compare the combination chemotherapy regimen epirubicin, cisplatin, and 5-fluorouracil with epirubicin, cisplatin, and capecitabine in patients with advanced or metastatic gastric cancer. Am J Clin Oncol. 2012;35:237–241.
  • Ochenduszko S, Puskulluoglu M, Konopka K, et al. Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma: a randomized phase 3 trial. Med Oncol. 2015;32:1–8.
  • Nishikawa K, Morita S, Matsui T, et al. A randomized phase-II trial comparing sequential and concurrent paclitaxel with oral or parenteral fluorinated pyrimidines for advanced or metastatic gastric cancer. Gastric Cancer. 2012;15:363–369.
  • Nio Y. A randomized, comparative study of combination chemotherapies in advanced gastric cancer: 5-Fluorouracil and cisplatin (FP) versus 5-Fluorouracil, cisplatin, and 4’-Epirubicin (FPEPIR). Anticancer Res. 1992;12:1983–1988.
  • Narahara H, Iishi H, Imamura H, et al. Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002). Gastric Cancer. 2011;14:72–80.
  • Moehler M, Kanzler S, Geissler M, et al. A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2010;21:71–77.
  • Moehler M, Eimermacher A, Siebler J, et al. Randomised phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) vs 5-fluorouracil, leucovorin, and etoposide (ELF) in untreated metastatic gastric cancer. Br J Cancer. 2005;92:2122–2128.
  • Mochiki E, Ogata K, Ohno T, et al. Phase II multi-institutional prospective randomised trial comparing S-1paclitaxel with S-1cisplatin in patients with unresectable and/or recurrent advanced gastric cancer. Br J Cancer. 2012;107:31–36.
  • Lutz MP, Wilke H, Wagener DJT, et al. Weekly infusional high-dose fluorouracil (HD-FU), HD-FU plus folinic acid (HD-FU/FA), or HD-FU/FA plus biweekly cisplatin in advanced gastric cancer: Randomized phase II trial 40953 of the European organisation for research and treatment of cancer gastroi. JCO. 2007;25:2580–2585.
  • Wu D, Li X, Tong J, et al. S-1 combined with cisplatin versus cisplatin alone for the treatment of advanced gastric cancer: a pilot randomized-controlled trial. Anticancer Drugs. 2015;26:774–778.
  • Lordick F, Kang YK, Chung HC, et al. Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial. Lancet Oncol. 2013;14:490–499.
  • Loehrer PJ, Harry D, Chlebowski RT. 5-Fluorouracil vs. epirubicin vs. 5-fluorouracil plus epirubicin in advanced gastric carcinoma. Invest New Drugs. 1994;12:57–63.
  • Li Y, Qiu M, Xu J, et al. S-1 plus Cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: a pilot study. Oncotarget. 2015;6; 35107–35115.
  • Li X-D, Shen H, Jiang J-T, et al. Paclitaxel based vs oxaliplatin based regimens for advanced gastric cancer. World J Gastroenterol. 2011;17:1082–1087.
  • Lee KH, Hyun MS, Kim H-K, et al. Randomized, multicenter, phase III trial of heptaplatin 1-hour infusion and 5-fluorouracil combination chemotherapy comparing with cisplatin and 5-fluorouracil combination chemotherapy in patients with advanced gastric cancer. Cancer Res Treat. 2009;41:12.
  • Konings I, Van Der Gaast A, Van Der Wijk LJ, et al. The addition of pravastatin to chemotherapy in advanced gastric carcinoma: a randomised phase II trial. Eur J Cancer. 2010;46:3200–3204.
  • Koizumi W, Narahara H, Hara T, et al. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008;9:215–221.
  • Lee JL, Kang YK, Kang HJ, et al. A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer. Br J Cancer. 2008;99:584–590.
  • Kobayashi M, Tsuburaya A, Nishikawa K, et al. A randomized phase II trial of capecitabine plus cisplatin (XP) versus S-1 plus cisplatin (SP) as a first-line treatment for advanced gastric cancer: XP ascertainment versus SP randomized PII trial (XParTS II). JCO. 2015;33:105.
  • Kim ST, Kang JH, Lee J, et al. Simvastatin plus capecitabine-cisplatin versus placebo plus capecitabine-cisplatin in patients with previously untreated advanced gastric cancer: a double-blind randomised phase 3 study. Eur J Cancer. 2014;50:2822–2830.
  • Webb A, Cunningham D, Scarffe JH, et al. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. JCO. 1997;15:261–267.
  • Kim GM, Jeung H-C, Rha SY, et al. A randomized phase II trial of S-1-oxaliplatin versus capecitabine-oxaliplatin in advanced gastric cancer. Eur J Cancer. 2012;48:518–526.
  • Kang YK, Kang WK, Shin DB, et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009;20:666–673.
  • Jeung H-C, Rha SY, Im CK, et al. A randomized phase 2 study of docetaxel and S-1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy. Cancer. 2011;117:2050–2057.
  • Iveson T, Donehower RC, Davidenko I, et al. Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study. Lancet Oncol. 2014;15:1007–1018.
  • Ikeda R, Yoshida K, Satou Y, et al. Randomized phase II/III study of docetaxel/S-1 (DS-1) versus CDDP/5FU (FUP) in advanced or recurrent gastric cancer: updated phase II results. J Clin Oncol. 2009;27:4595.
  • Icli F, Celik I, Aykan F, et al. A randomized Phase III trial of etoposide, epirubicin, and cisplatin versus 5-fluorouracil, epirubicin, and cisplatin in the treatment of patients with advanced gastric carcinoma. Turkish Oncology Group. Cancer. 1998;83:2475–2480.
  • Hwang IG, Ji JH, Kang JH, et al. A multi-center, open-label, randomized phase III trial of first-line chemotherapy with capecitabine monotherapy versus capecitabine plus oxaliplatin in elderly patients with advanced gastric cancer. J Geriatr Oncol. 2017;8:170–175.
  • Huang D, Ba Y, Xiong J, et al. A multicentre randomised trial comparing weekly paclitaxel + S-1 with weekly paclitaxel + 5-fluorouracil for patients with advanced gastric cancer. Eur J Cancer. 2013;49:2995–3002.
  • Hecht JR, Bang YJ, Qin SK, et al. Lapatinib in combination with capecitabine plus oxaliplatin in human epidermal growth factor receptor 2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma: TRIO-013/LOGiC - A randomized phase III trial. JCO. 2016;34:443–451.
  • Ohtsu A, Shah MA, Van Cutsem E, et al. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. JCO. 2011;29:3968–3976.
  • Wang J, Xu R, Li J, et al. Randomized multicenter phase III study of a modified docetaxel and cisplatin plus fluorouracil regimen compared with cisplatin and fluorouracil as first-line therapy for advanced or locally recurrent gastric cancer. Gastric Cancer. 2016;19:234–244.
  • Guimbaud R, Louvet C, Ries P, et al. Prospective, randomized, multicenter, phase III study of fluorouracil, leucovorin, and irinotecan versus epirubicin, cisplatin, and capecitabine in advanced gastric adenocarcinoma: a French intergroup (Fédération Francophone de Cancérologie Digestive. JCO. 2014;32:3520–3526.
  • Fujitani K, Yang H-K, Mizusawa J, et al. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial. Lancet Oncol. 2016;17:309–318.
  • Eatock MM, Tebbutt NC, Bampton CL, et al. Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer. Ann Oncol. 2013;24:710–718.
  • Du F, Zheng Z, Shi S, et al. S-1 and cisplatin with or without nimotuzumab for patients with untreated unresectable or metastatic gastric cancer. Medicine. 2015;94:e958.
  • Dank M, Zaluski J, Barone C, et al. Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction. Ann Oncol. 2008;19:1450–1457.
  • Dai X, Zhang X, Wang C, et al. Paclitaxel/oxaliplatin/fluorouracil (TOF) regimen versus S-1/oxaliplatin (SOX) regimen for metastatic gastric cancer patients. Oncotarget. 2017;8:30495–30501.
  • Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358:36–46.
  • Coombes RC, Chilvers CE, Amadori D, et al. Randomised trial of epirubicin versus fluorouracil in advanced gastric cancer. An International Collaborative Cancer Group (ICCG) study. Ann Oncol Off J Eur Soc Med Oncol. 1994;5:33–36.
  • Colucci G, Giotta F, Maiello E, et al. Efficacy of the association of folinic acid and 5-fluorouracil alone versus folinic acid and 5-fluorouracil plus 4-epidoxorubicin in the treatment of advanced gastric carcinoma. Am J Clin Oncol Cancer Clin Trials. 1995;18:519–524.
  • Cocconi G, Carlini P, Gamboni A, et al. Cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) is more active than 5-fluorouracil* Doxorubicin and methotrexate (FAMTX) in advanced gastric carcinoma. Ann Oncol. 2003;14:1258–1263.
  • Waddell T, Chau I, Cunningham D, et al. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial. Lancet Oncol. 2013;14:481–489.
  • Cocconi G, Bella M, Zironi S, et al. Fluorouracil, doxorubicin, and mitomycin combination versus PELF chemotherapy in advanced gastric cancer: a prospective randomized trial of the Italian Oncology Group for Clinical Research. JCO. 1994;12:2687–2693.
  • Bouché O, Raoul JL, Bonnetain F, et al. Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Fédération Francophone de Cancérologie. JCO. 2004;22:4319–4328.
  • Boku N, Yamamoto S, Fukuda H, et al. Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol. 2009;10:1063–1069.
  • Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376:687–697.
  • Bando H, Yamada Y, Tanabe S, et al. Efficacy and safety of S-1 and oxaliplatin combination therapy in elderly patients with advanced gastric cancer. Gastric Cancer. 2016;19:919–926.
  • Al-Batran S-E, Pauligk C, Homann N, et al. The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: a randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+). Eur J Cancer. 2013;49:835–842.
  • Al-Batran S-E, Hartmann JT, Probst S, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26:1435–1442.
  • Komatsu Y, Takahashi Y, Kimura Y, et al. Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301). Anticancer Drugs. 2011;22:576–583.
  • Wang X, Wang ML, Zhou LY, et al. Randomized phase II study comparing paclitaxel with S-1 vs. S-1 as first-line treatment in patients with advanced gastric cancer. Clin Transl Oncol. 2013;15:836–842.
  • Yoshino S, Nishikawa K, Morita S, et al. Randomised phase III study of S-1 alone versus S-1 plus lentinan for unresectable or recurrent gastric cancer (JFMC36-0701). Eur J Cancer. 2016;65:164–171.
  • Vanhoefer U, Rougier P, Wilke H, et al. Final results of a randomized phase III trial of sequential high-dose methotrexate, fluorouracil, and doxorubicin versus etoposide, leucovorin, and fluorouracil versus infusional fluorouracil and cisplatin in advanced gastric cancer: atrial of the Europe. JCO. 2000;18:2648–2657.
  • Hironaka S, Sugimoto N, Yamaguchi K, et al. S-1 plus leucovorin versus S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin in patients with advanced gastric cancer: a randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016;17:99–108.
  • Hall PS, Lord SR, Collinson M, et al. A randomised phase II trial and feasibility study of palliative chemotherapy in frail or elderly patients with advanced gastroesophageal cancer (321GO). Br J Cancer. 2017;116:472–478.
  • Kondo K, Sakamoto J, Nakazato H, et al. A phase III randomized study comparing doxifluridine and 5-fluorouracil as supportive chemotherapy in advanced and recurrent gastric cancer. Oncol Rep. 2000;7:485–490.
  • Ajani JA, Abramov M, Bondarenko I, et al. A phase III trial comparing oral S-1/cisplatin and intravenous 5-fluorouracil/cisplatin in patients with untreated diffuse gastric cancer. Ann Oncol. 2017;28:2142–2148.
  • Al-Batran S-E, Schuler MH, Zvirbule Z, et al. FAST: an international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without IMAB362, a first-in-class anti-CLDN18.2 antibody, as first-line therapy in patients with advanced CLDN18.2+ gastric and gast. JCO. 2016;34:LBA4001–LBA4001.
  • Ohtsu A, Shimada Y, Shirao K, et al. Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: the Japan clinical oncology group study (JCOG9205). JCO. 2003;21:54–59.
  • Jin M, Lu H, Li J, et al. Ramdomized 3-armed phase III study of S-1 monotherapy versus S-1/CDDP (SP) versus 5-FU/CDDP (FP) in patients (pts) with advanced gastric cancer (AGC): SC-101 study. JCO. 2008;26:4533.
  • Koizumi W, Yamaguchi K, Hosaka H, et al. Erratum: randomised phase II study of S-1/cisplatin plus TSU-68 vs S-1/cisplatin in patients with advanced gastric cancer (British Journal of Cancer (2013) 109 (2079-2086). Br J Cancer. 2014;111:2382.
  • Ajani JA, Rodriguez W, Bodoky G, et al. Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. JCO. 2010;28:1547–1553.
  • Ajani J. A, Fodor MB, Tjulandin S. a, et al. Phase II multi-institutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinoma. JCO. 2005;23:5660–5667.
  • Van Cutsem E, Moiseyenko VM, Tjulandin S, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 study group. JCO. 2006;24:4991–4997.
  • Park SH, Nam E, Park J, et al. Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer. Ann Oncol. 2007;19:729–733.
  • Zhang ZD, Kong Y, Yang W, et al. Clinical evaluation of cetuximab combined with an S-1 and oxaliplatin regimen for Chinese patients with advanced gastric cancer. World J Surg Oncol. 2014;12:1–6.
  • Sivendran S, Galsky MD. Adverse event reporting in oncology clinical trials - lost in translation? Expert Opin Drug Saf. 2016;15:893–896.
  • Zhang S, Chen Q, Wang Q. The use of and adherence to CTCAE v3.0 in cancer clinical trial publications. Oncotarget. 2016;7:65577–65588.
  • Schoen MW, Basch E, Hudson LL, et al. Software for administering the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events: usability study. JMIR Hum Factors. 2018;5:e10070.