Efficacy and safety of S-1 and oxaliplatin combination therapy in elderly patients with advanced gastric cancer

BackgroundA randomized phase III study of Japanese patients with advanced gastric cancer, the G-SOX trial, revealed that S-1 and oxaliplatin (SOX) combination therapy was noninferior to S-1 and cisplatin (CS) combination therapy. However, it is unclear whether the efficacy and safety in elderly patients were different between the two regimens.MethodsA total of 685 patients registered in the G-SOX trial were classified as elderly (70 years or older) or not elderly (younger than 70 years), and 663 patients (SOX therapy, elderly 113 of 333 patients, 34 %; CS therapy, elderly 99 of 330 patients, 30 %) and 673 patients (SOX therapy, elderly 114 of 338 patients, 34 %; CS therapy, elderly 101 of 335 patients, 30 %) were analyzed for efficacy and safety, respectively. Treatment delivery of SOX was also compared between elderly and nonelderly groups.ResultsNo differences in efficacy were identified between the elderly and nonelderly groups for either regimen. In the elderly groups, SOX therapy showed better trends in progression-free survival (hazard ratio 0.805, 95 % confidence interval 0.588–1.102) and overall survival (hazard ratio 0.857, 95 % confidence interval 0.629–1.167) compared with CS therapy, although there were no significant differences. Grade 3 or worse adverse events were less frequent in the elderly group receiving SOX than in the elderly group receiving CS except for the low incidence of sensory neuropathy (5.3 % vs 0 %), neutropenia (25.4 % vs 42.6 %), anemia (21.1 % vs 42.6 %), febrile neutropenia (1.8 % vs 10.9 %), increased creatinine level (0.9 % vs 3.0 %), and hyponatremia (7.9 % vs 18.8 %).ConclusionsSOX is an effective and feasible therapy in both nonelderly and elderly patients with advanced gastric cancer. In elderly patients, SOX demonstrated favorable efficacy and safety compared with CS.

[1]  K Nishikawa,et al.  Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer. , 2015, Annals of oncology : official journal of the European Society for Medical Oncology.

[2]  Jacques Ferlay,et al.  GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 11 [Internet] , 2013 .

[3]  H. Wildiers,et al.  Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendations†. , 2015, Annals of oncology : official journal of the European Society for Medical Oncology.

[4]  Hiroshi Nishimoto,et al.  Cancer incidence and incidence rates in Japan in 2008: a study of 25 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project. , 2012, Japanese journal of clinical oncology.

[5]  C. Bokemeyer,et al.  Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  C. Mathers,et al.  GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer , 2013 .

[7]  Murielle Mauer,et al.  End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--Alliance for Clinical Trials in Oncology--International Society Of Geriatric Oncology position article. , 2013, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[8]  Ken Kato,et al.  Impact of adding cisplatin to S-1 in elderly patients with advanced gastric cancer , 2013, Journal of Cancer Research and Clinical Oncology.

[9]  L. Rubenstein,et al.  Impacts of Geriatric Evaluation and Management Programs on Defined Outcomes: Overview of the Evidence , 1991, Journal of the American Geriatrics Society.

[10]  N. Boku,et al.  Comparison of safety and efficacy of S-1 monotherapy and S-1 plus cisplatin therapy in elderly patients with advanced gastric cancer , 2013, International Journal of Clinical Oncology.

[11]  H. Cohen,et al.  Use of comprehensive geriatric assessment in older cancer patients: recommendations from the task force on CGA of the International Society of Geriatric Oncology (SIOG). , 2005, Critical reviews in oncology/hematology.

[12]  Masahiro Takeuchi,et al.  S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. , 2008, The Lancet. Oncology.