In the INTERLACE phase III trial of newly diagnosed locally advanced cervical cancer, which FIGO 2018 stages were eligible and what proportion of participants fell into each stage?

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INTERLACE Trial Patient Eligibility and Stage Distribution

The INTERLACE trial enrolled patients with locally advanced cervical cancer defined as FIGO 2008 stage IB1 with nodal involvement, or stage IB2, IIA, IIB, IIIB, or IVA disease, with the majority (70%) having stage IIB disease and only 11% having stage IIIB disease. 1

Eligible FIGO 2018 Stages

The trial used FIGO 2008 staging criteria for enrollment, which included: 1

  • Stage IB1 with nodal involvement (node-positive disease)
  • Stage IB2 (tumor ≥4 cm confined to cervix)
  • Stage IIA (upper two-thirds vaginal involvement)
  • Stage IIB (parametrial involvement)
  • Stage IIIB (pelvic sidewall extension or hydronephrosis)
  • Stage IVA (bladder or rectal mucosa invasion)

Notably, patients with para-aortic nodal involvement were excluded from the trial, which represents a significant limitation when comparing results to other studies and real-world populations. 2

Stage Distribution Among Participants

Of the 500 enrolled patients, the stage distribution was: 1

  • Stage IIB: 354 patients (70%) - representing the overwhelming majority
  • Stage IIIB: 56 patients (11%) - a relatively small proportion
  • Other stages (IB1 N+, IB2, IIA, IVA): 90 patients (18%) - combined

Nodal Status Distribution

The nodal involvement pattern showed: 1

  • Pelvic lymph node positive: 215 patients (43%)
  • Para-aortic lymph node positive: 0 patients (0%) - explicitly excluded from enrollment

Key Patient Selection Characteristics

The INTERLACE population had notably favorable characteristics compared to typical locally advanced cervical cancer cohorts: 2

  • Younger age than standard populations
  • Better performance status than typical advanced disease patients
  • Less advanced disease burden with predominance of stage IIB
  • No para-aortic nodal involvement - a critical exclusion that limits generalizability

This patient selection creates a more favorable prognostic group than typically seen in clinical practice, which must be considered when interpreting the trial's survival outcomes and applying results to broader populations. 2

References

2
Research

Are we making progress in curing advanced cervical cancer-again?

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2024

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