# ANITA (Adjuvant Navelbine International Trialist Association)

Source: https://onco.cc/trials/anita/  
OnCo record `anita` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Confirmed that chemotherapy after lung cancer surgery adds about two years to median survival, with the benefit lasting at least seven years.

## Summary

ANITA randomised 840 patients with completely resected stage IB to IIIA non-small-cell lung cancer from 101 centres in 14 countries to observation (433) or to vinorelbine 30 mg/m2 with cisplatin 100 mg/m2 (407). Postoperative radiotherapy was not mandated and followed each centre's policy. Thirty-six percent had stage IB disease, 24 percent stage II and 39 percent stage IIIA.

After a median 76 months, median survival was 65.7 months with chemotherapy against 43.7 months with observation, and the adjusted hazard ratio for death was 0.80 (95 percent confidence interval 0.66 to 0.96, p=0.017). Five-year overall survival improved by 8.6 percent and the gain was maintained at seven years (8.4 percent).

Tolerance was the limiting factor: neutropenia in 92 percent, febrile neutropenia in 9 percent and seven toxic deaths (2 percent), with compliance far better for cisplatin (median dose intensity 89 percent) than for vinorelbine (59 percent). A retrospective subgroup suggested postoperative radiotherapy helped N2 patients, a hypothesis Lung ART later tested and refuted.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: ANITA trial
- Registry id: ISRCTN95053737
- Phase: 3
- Setting: Completely resected stage IB to IIIA non-small-cell lung cancer: vinorelbine 30 mg/m2 with cisplatin 100 mg/m2 versus observation, with overall survival as the primary endpoint
- Sponsor: Adjuvant Navelbine International Trialist Association
- Enrolled: 840
- Result: Median survival 65.7 against 43.7 months (hazard ratio 0.80); five-year overall survival improved by 8.6 percent.
- Outcomes: Overall survival (median): Vinorelbine and cisplatin 65.7 months vs Observation 43.7 months, HR 0.8
- Replication: Consistent with IALT and JBR.10; pooled in the LACE analysis.

## Sources

- ANITA (Lancet Oncology 2006): https://doi.org/10.1016/S1470-2045(06)70804-X
- ISRCTN95053737: https://www.isrctn.com/ISRCTN95053737

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Vinorelbine](https://onco.cc/drugs/vinorelbine/)
- trials: [IALT (International Adjuvant Lung Cancer Trial)](https://onco.cc/trials/ialt/), [JBR.10 (NCIC CTG)](https://onco.cc/trials/jbr-10/), [LACE (Lung Adjuvant Cisplatin Evaluation) pooled analysis](https://onco.cc/trials/lace-pooled-analysis/), [Lung ART](https://onco.cc/trials/lung-art/)

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