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Bending the Curve Trial by Trial
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CONVERT

Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer

Phase 3N = 547NCT00433563

Population
Adults with limited-stage small-cell lung cancer, ECOG performance status 0-2, adequate pulmonary function
Design
Open-label randomised superiority trial at 73 centres in eight countries. 45 Gy in 30 twice-daily fractions of 1.5 Gy over 19 days versus 66 Gy in 33 once-daily fractions of 2 Gy over 45 days, starting on day 22 after commencing cisplatin-etoposide (four to six cycles every 3 weeks in both groups). Primary endpoint OS, modified ITT. The trial was designed to test superiority of the once-daily regimen; a 12% higher OS at 2 years with once-daily was considered clinically significant. Registered as phase NA on ClinicalTrials.gov; the paper's title calls it phase 3.
Primary endpoint
OS
Arms
  • Twice-daily chemoradiotherapy (control, n = 274): 45 Gy in 30 twice-daily fractions of 1.5 Gy over 19 days with cisplatin-etoposide
  • Once-daily chemoradiotherapy (experimental, n = 273): 66 Gy in 33 once-daily fractions of 2 Gy over 45 days with cisplatin-etoposide
People
Faivre-Finn C, CONVERT Study Team
OSHR 1.18 (95% CI 0.95–1.45)Δ median OS−5 monthsΔ 24-month OS−5 points
Show the numbers
Results reported for CONVERT
EndpointAnalysisOnce-daily chemoradiotherapyTwice-daily chemoradiotherapyEffect
OSModified intention-to-treatprimarymedian follow-up 45 monthsFaivre-Finn 2017median 25 months (21–31); 51% at 2 y (45–57%)median 30 months (24–34); 56% at 2 y (50–62%)HR 1.18 (95% CI 0.95–1.45)P=0.14The hazard ratio is for death in the once-daily group relative to the twice-daily group. Absolute difference in 2-year OS 5.3% (95% CI -3.2% to 13.7%). Four patients (one twice-daily, three once-daily) were lost to follow-up and not analysed. Grade 3-4 oesophagitis 19% in both groups (47 of 254 and 47 of 246; p=0.85); grade 4 neutropenia 49% vs 38% (p=0.05); treatment-related deaths 3 vs 8 patients.
Results reported for CONVERT
EndpointAnalysisOnce-daily chemoradiotherapyTwice-daily chemoradiotherapyEffect
OSModified intention-to-treatprimarymedian follow-up 45 monthsFaivre-Finn 2017median 25 months (21–31); 51% at 2 y (45–57%)median 30 months (24–34); 56% at 2 y (50–62%)HR 1.18 (95% CI 0.95–1.45)P=0.14The hazard ratio is for death in the once-daily group relative to the twice-daily group. Absolute difference in 2-year OS 5.3% (95% CI -3.2% to 13.7%). Four patients (one twice-daily, three once-daily) were lost to follow-up and not analysed. Grade 3-4 oesophagitis 19% in both groups (47 of 254 and 47 of 246; p=0.85); grade 4 neutropenia 49% vs 38% (p=0.05); treatment-related deaths 3 vs 8 patients.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.180.95–1.45
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0204060Months (modelled)
  • Twice-daily chemoradiotherapy (control)
  • Once-daily chemoradiotherapy (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTwice-daily chemoradiotherapyOnce-daily chemoradiotherapy
0100.0%100.0%
1964.5%59.0%
3841.6%34.9%
5627.4%21.2%
7517.7%12.5%
Primary publication: Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017;18(8):1116-1125. PubMedDOI

Appears in

Sources

  1. Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017;18(8):1116-1125.

    PubMedDOI