Abstract
BackgroundThis open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs. cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer.MethodsPatients were randomised (1:1) to S-1 plus cisplatin (study group) or cisplatin alone (control group). In each cycle, cisplatin 50 mg/m2 was administered on Day 1 in both groups. S-1 was administered orally at 80–120 mg daily on Days 1–14 of a 21-day cycle in the study group. The primary endpoint was overall survival (OS).ResultsA total of 375 patients were enrolled, of whom 364 (188, study group; 176, control group) received treatment. Median OS was 21.9 and 19.5 months in the study and control groups, respectively (log-rank P = 0.125; hazard ratio [HR] 0.84, 95% confidence interval [CI] 0.67–1.05). Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95% CI 0.48–0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs.ConclusionsS-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population.
Highlights
Cancer of the uterine cervix is one of the most common cancers among women worldwide and is prevalent in developing nations.[1]
Patient characteristics A total of 375 patients were enrolled between September 2008 and April 2011 and randomised to the study group (189) or the control group (186); of these, 364 (188 in the study group; 176 in the control group) received study treatment (Fig. 1)
Since performance status (PS) is one of the prognostic factors for cervical cancer,[14] this might be one of the reasons for the prolonged overall survival (OS) observed in our study
Summary
Cancer of the uterine cervix is one of the most common cancers among women worldwide and is prevalent in developing nations.[1]. Past presentation: An abstract titled ‘A randomised phase III trial of cisplatin with or without S-1 in patients with FIGO IVB, recurrent, or persistent cervical cancer: an Asian study’. Received: 26 December 2017 Revised: 18 June 2018 Accepted: 10 July 2018 Published online: 3 August 2018 This open-label phase III trial evaluated efficacy and safety of S-1 plus cisplatin vs cisplatin alone as first-line chemotherapy in patients with stage IVB, recurrent, or persistent cervical cancer. Median progression-free survival (PFS) was 7.3 and 4.9 months in the study and control groups, respectively (HR 0.62, 95% CI 0.48–0.80, P < 0.001). The adverse event (AE) rate increased in the study group despite the absence of any unexpected AEs. CONCLUSIONS: S-1 plus cisplatin did not show superiority over cisplatin alone in OS but significantly increased PFS in patients with stage IVB, recurrent, or persistent cervical cancer. Since the standard therapy has changed in the course of this study, further studies are warranted to confirm the clinical positioning of S-1 combined with cisplatin for this population
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