Cervical cancer: neoadjuvant cisplatin-gemcitabine fails phase 2 trial

  • da Costa SCS & al.
  • J Clin Oncol
  • 26 Aug 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Neoadjuvant chemotherapy (NACT) followed by standard chemoradiation therapy (CRT) was associated with lower complete response rate and survival in patients with locally advanced cervical cancer vs standard CRT.

Why this matters

  • 40% of patients relapse after standard CRT.
  • Phase 3 studies INTERLACE and OUTBACK are evaluating a different NACT regimen and adjuvant chemotherapy, respectively.

Study design

  • Phase 2 CIRCE study of 107 patients with locally advanced cervical cancer, randomly assigned to NACT (cisplatin+gemcitabine), followed by standard CRT (cisplatin+pelvic radiotherapy) or standard CRT alone.
  • Funding: None disclosed.

Key results

  • 87.8% of patients had squamous cell carcinoma.
  • Median follow-up was 31.7 months.
  • NACT was associated with significantly worse survival vs CRT alone:
    • 3-year PFS rate (40.9% vs 60.4%; P=.030).
    • 3-year OS rate (60.7% vs 86.8%; P=.007).
    • Median PFS (25 months vs not reached; HR, 1.84; P=.033).
    • Median OS (48.7 months vs not reached; HR, 2.79; P=.006).
  • Complete response rates were significantly lower with NACT (56.3% vs 80.3%; P=.008).
  • The most common early toxicities were myelosuppression, gastrointestinal symptoms, and dysuria.
    • Patients in the NACT group experienced higher rates of hypomagnesemia (27.2% vs 7.6%; P=.030) and neuropathy (25.4% vs 1.9%; P=.002).
  • Late toxicities were similar between the 2 groups.

Limitations

  • 2-dimensional brachytherapy was used in most patients.

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