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Bending the Curve Trial by Trial
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ANITA

Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial

N = 840

Population
Patients with completely resected stage IB-IIIA non-small-cell lung cancer: stage IB 301 (36%), stage II 203 (24%), stage IIIA 325 (39%).
Design
Randomised controlled trial in 101 centres in 14 countries: observation (433) or vinorelbine 30 mg/m2 plus cisplatin 100 mg/m2 (407). Postoperative radiotherapy was not mandatory. Primary endpoint overall survival; analysis by intention to treat. 367 patients in the chemotherapy group and 431 in the control group received their assigned treatment. Registered as ISRCTN95053737. Median follow-up 76 months (range 43-116).
Primary endpoint
OS
Arms
  • Observation (control, n = 433): Observation after complete resection
  • Vinorelbine plus cisplatin (experimental, n = 407): Vinorelbine 30 mg/m2 plus cisplatin 100 mg/m2
People
Douillard JY
OSHR 0.80 (95% CI 0.66–0.96)Δ median OS+22 months
Show the numbers
Results reported for ANITA
EndpointAnalysisVinorelbine plus cisplatinObservationEffect
OSprimarymedian follow-up 76 monthsDouillard 2006median 65.7 months (47.9–88.5)median 43.7 months (35.7–52.3)HR 0.80 (95% CI 0.66–0.96)P=0.017The abstract gives the hazard ratio as the adjusted risk for death. Overall survival at 5 years with chemotherapy was improved by 8.6% and at 7 years by 8.4% (absolute differences as published).
Toxic death rateChemotherapy group (denominator not stated in the abstract)primaryDouillard 20062%—Seven toxic deaths were recorded; the abstract gives the percentage as 2% and does not state the denominator (367 patients received chemotherapy).
Results reported for ANITA
EndpointAnalysisVinorelbine plus cisplatinObservationEffect
OSprimarymedian follow-up 76 monthsDouillard 2006median 65.7 months (47.9–88.5)median 43.7 months (35.7–52.3)HR 0.80 (95% CI 0.66–0.96)P=0.017The abstract gives the hazard ratio as the adjusted risk for death. Overall survival at 5 years with chemotherapy was improved by 8.6% and at 7 years by 8.4% (absolute differences as published).
Toxic death rateChemotherapy group (denominator not stated in the abstract)primaryDouillard 20062%—Seven toxic deaths were recorded; the abstract gives the percentage as 2% and does not state the denominator (367 patients received chemotherapy).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.80.66–0.96
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%050100150Months (modelled)
  • Vinorelbine plus cisplatin (experimental)
  • Observation (control)

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

Data table (modelled values)
MonthsVinorelbine plus cisplatinObservation
0100.0%100.0%
4164.9%52.2%
8242.1%27.2%
12327.3%14.2%
16417.7%7.4%
Primary publication: Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzáles-Larriba JL, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7(9):719-27. PubMedDOI

Appears in

Sources

  1. Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzáles-Larriba JL, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006;7(9):719-27.

    PubMedDOI