Few studies show what happens outside of randomized clinical trials. The purpose of the study was to describe the clinical management of metastatic gastric cancer patients resident in the Forlì area from 2000 to 2009.
Methods and study design
A total of 270 metastatic gastric cancer patients at diagnosis or relapse were considered. Data from medical records were analysed, and survival probabilities were calculated using the Kaplan-Meier method.
Results
A total of 115 patients received best supportive care, 155 at least one line of chemotherapy, 71 (45.8%) underwent second-line therapy, and 49 (31.6%) required a drug dose reduction during the first cycle of first-line therapy. Twelve (7.7%) patients died within 15 days of finishing the last chemotherapy. Median overall survival with best supportive care or chemotherapy was 3 months (95% CI, 2–4) and 11 months (95% CI, 9–12) (P <0.0001), respectively.
Conclusions
Drug dose reductions and delivery of second-line therapy were common. Chemotherapy given towards the end of life was similar to other experiences. Median overall survival was similar to randomized clinical trials.
FerlayJ., ShinH.R., BrayF., FormanD., MathersC., ParkinD.M.: Estimate of worldwide burden of cancer in 2008: Globocan 2008. Int J Cancer, 127: 2893–2917, 2010.
2.
BangY.J., Van CutsemE., FeyereislovaA., ChungH.C., ShenL., SawakiA., LordickF., OhtsuA., OmuroY., SatohT., AprileG., KulikovE., HillJ., LehleM., RüschoffJ., KangY.K., ToGA Trial Investigators: 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, 376: 687–697, 2010.
3.
KimN.K., ParkY.S., HeoD.S., SuhC., KimS.Y., ParkK.C., KangY.K., ShinD.B., KimH.T., KimH.J.: A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer, 71: 3813–3818, 1993.
4.
OhtsuA., ShimadaY., ShiraoK., BokuN., HyodoI., SaitoH., YamamichiN., MiyataY., IkedaN., YamamotoS., FukudaH., YoshidaS.: Randomized phase III trial of 5-fluorouracil alone versus plus cisplatin versus uracil and tegafur plus mitomycin C in patients with unresectable advanced astric cancer: the Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol, 21: 54–59, 2003.
5.
CunninghamD., OkinesA.F., AshleyS.: Capecitabine and oxaliplatin for advanced esophagogastric cancer. New Engl J Med, 362: 858–859, 2010.
6.
BokuN., YamamotoS., FukudaH., ShiraoK., DoiT., SawakiA., KoizumiW., SaitoH., YamaguchiK., TakiuchiH., NasuJ., OhtsuA., Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group: Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol, 10: 1063–1069, 2009.
7.
KoizumiW., NaraharaH., HaraT., TakaganeA., AkiyaT., TakagiM., MiyashitaK., NishizakiT., KobayashiO., TakiyamaW., TohY., NagaieT., TakagiS., YamamuraY., YanaokaK., OritaH., TakeuchiM.: S-1 plus cisplatin vs S-1 alone for first-line treatment of advanced gastric cancer (the SPIRITS trial): a phase III trial. Lancet Oncol, 9: 215–221, 2008.
8.
LeeS.J., EarleC.C., WeeksJ.C.: Outcomes research in oncology: history, conceptual framework, and trends in the literature. J Natl Cancer Inst, 92: 195–204, 2000.
9.
EdgeS.B., ComptonC.C.: The American Joint Committee on Cancer: the 7th edition of the AJCC Cancer Staging Manual and the future of TNM. Ann Surg Oncol, 17: 1471–1474, 2010.
10.
KrumholzH.M.: Real-world imperative of outcomes research. J Natl Cancer Inst, 92: 195–204, 2000.
CocconiG., CarliniP., GamboniA., GasperoniS., RodinòC., ZironiS., BisagniG., PorrozziS., CognettiF., Di CostanzoF., CanalettiR., RuggeriE.M., CamisaR., PucciF.; Italian Oncology Group for Clinical Research: Cisplatinum, epirubicin, leucovorin and 5 fluorouracil (PELF) is more active than 5-fluorouracil, doxorubicin and methotrexate (FAMTX) in advanced gastric carcinoma. Ann Oncol, 14: 1258–1263, 2003.
13.
CullinanS.A., MoertelC.G., WielandH.S., O'ConnellM.J., PoonM.A., KrookJ.E., MailliardJ.A., TschetterL.K.: Controlled evaluation of three drug combination regimens versus fluorouracil alone for the therapy of advanced gastric cancer. J Clin Oncol, 12: 412–416, 1994.
14.
AjaniJ.A., RodriguezW., BodokyG., MoiseyenkoV., LichinitserM., GorbunovaV., VynnychenkoI., GarinA., LangI., FalconS.: Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol, 28: 1547–1553, 2010.
15.
CatalanoV., GrazianoF., SantiniD., D'EmidioS., BaldelliA.M., RossiD., VincenziB., GiordaniP., AlessandroniP., TestaE., ToniniG., CatalanoG.: Second-line chemotherapy for patients with advanced gastric cancer: who may benefit?Br J Cancer, 99: 1402–1407, 2008.
16.
KangJ.H., LeeS.I., Lim doH., ParkK.W., OhS.Y., KwonH.C., HwangI.G., LeeS.C., NamE., ShinD.B., LeeJ., ParkJ.O., ParkY.S., LimH.Y., KangW.K., ParkS.H.: Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol, 30: 1513–1518, 2012.
17.
LinS.Z., TongH.F., YouT., YuY.J., WuW.J., ChenC., ZhangW., YeB., LiC.M., ZhenZ.Q., XuJ.R.X., ZhouJ.L.: Palliative gastrectomy and chemotherapy for stage IV gastric cancer. J Cancer Res Clin Oncol, 134; 187–192, 2008.
18.
BarchielliA., AmorosiA., BalziD., CrocettiE., NesiG.: Long-term prognosis of gastric cancer in a European country: a population-based study in Florence (Italy). 10-year survival of cases diagnosed in 1985–1987. Eur J Cancer, 37: 1674–1680, 2001.
19.
AndreisF., RizziA., RotaL., MeriggiF., MazzocchiM., ZaniboniA.: Chemotherapy use at the end of life. A retrospective single centre experience analysis. Chemotherapy use at the end of life. A retrospective single centre experience analysis. Tumori, 97: 30–34, 2011.
20.
MartoniA.A., TannenbergerS., MutriV.: Cancer chemotherapy near the end of life: the time has come to set guidelines for its appropriate use. Tumori, 93: 417–422, 2007.
21.
HartgrinkH.H., PutterH., Klein KranenbargE., BonenkampJ.J., van de VeldeC.J.; Dutch Gastric Cancer Group: Value of palliative resection in gastric cancer. Br J Surg, 89: 1438–1443, 2002.
