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A randomised phase II study of continuous versus stop-and-go S-1 plus oxaliplatin following disease stabilisation in first-line chemotherapy in patients with metastatic gastric cancer

European Journal of Cancer Aug 29, 2017

Park SR, et al. – Continuous versus stop–and–go chemotherapy after disease stabilisation was compared with induction chemotherapy in the first–line treatment of metastatic gastric cancer (MGC). Maintenance chemotherapy improved progression–free survival (PFS) but not the duration of disease control (DDC) and overall survival (OS) than the stop–and–go strategy. Maintenance chemotherapy exhibited a negative impact on quality of life (QOL). These findings suggested that stop–and–go strategy seemed to be an appropriate option in MGC patients following induction chemotherapy.

Methods

  • Experts randomised MGC patients who achieved disease control after 6 cycles of S-1/oxaliplatin (SOX) to receive either continuous SOX until progression (continuous arm) or to have a chemotherapy-free interval followed by SOX reintroduction at progression (stop-and-go arm).
  • Overall survival (OS) was the primary end-point.

Results

  • 247 participated in the induction phase, among the 250 patients enrolled.
  • Furthermore, 121 patients were randomised to the continuous arm (n = 59) or the stop-and-go arm (n = 62).
  • Results revealed significantly longer progression-free survival (PFS) in the continuous arm than in the stop-and-go arm (10.5 versus 7.2 months; hazard ratio [HR] 0.55, 95% CI, 0.37–0.81; P = 0.002).
  • However, duration of disease control (DDC) and OS were comparable between the two arms: median DDC, 10.5 versus 11.3 months, HR 0.92 (95% CI, 0.62–1.36; P = 0.674); median OS, 22.6 versus 22.7 months, HR 0.78 (95% CI, 0.50–1.23; P = 0.284).
  • As compared to the stop-and-go arm, adverse events including grade ≥3 fatigue (28.8% versus 8.1%; P = 0.003) and sensory neuropathy (25.4% versus 9.7%; P = 0.022) occurred more frequently in the continuous arm.
  • In addition, quality of life (QOL) including global health status, physical/role functioning and other symptom scores significantly favoured the stop-and-go arm.

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