ANITA: Phase III adjuvant vinorelbine (N) and cisplatin (P) versus observation in completely resected (stage I-III) non small cell lung cancer (NSCLC) patients (pts)

Reviewer: James M. Metz, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: July 11, 2005

Presenter: R. Rosell
Presenter's Affiliation: Catalan Institute of Oncology, Badalona, Spain
Type of Session: Plenary

Recent studies have shown a significant improvement in overall survival with the addition of adjuvant chemotherapy after surgical resection of lung cancer. The ANITA study was designed to evaluate the survival impact of adjuvant NP compared to observation alone in patients with completely resected lung cancer.  This study has been presented previously and these are considered the final results of this study

Materials and Methods

  • All patients had completely resected stage I (T2N0 only), stage II, and stage III NSCLC
  • Patients were randomized to 4 cycles of adjuvant NP (N 30mg/m2/wk for 16 weeks and P 100 mg/m2 day 1 every 4 weeks) versus observation
  • Patients could receive postoperative radiation therapy which was determined by the treating institution
  • The main study endpoint was overall survival


  • 840 pts randomized from 101 centers in 14 countries
  • Median age 59 years, 86% were male, and squamous cell carcinoma in 59%
  • Stage distribution was I (35%), II (30%), and IIIa (35%)
  • Patients were well balanced between the control and treatment arms
  • Lobectomy was performed in 58% and pneumonectomy in 37%
  • Median follow-up is > 70 months
  • Median survival 65.8 months for NP versus 43.7 months for observation (p=0.013)
  • Median survival for N1 disease was 65 months versus 31 months in favor of NP
  • Median survival for N2 disease was 33 versus 20 months in favor of NP
  • Patients with N2 disease who received postoperative radiation therapy had better survival than patients who received NP only
  • 5 yr survival for N2 was a follows: 16% surgery only vs 21% in XRT only vs 34% chemo only vs 47% for chemo/XRT
  • There was no benefit to postoperative radiation therapy for patients with N0 or N1 diseases
  • Toxicity of the NP was as expected and manageable.  There was a 1% rate of death caused from the chemotherapy

Author's Conclusions

  • NP significantly improves survival in patients with completely resected stage II and IIIa patients with NSCLC
  • There is no benefit with the addition of NP in patients with stage Ib NSCLC
  • Toxicity of NP was manageable
  • Future studies should investigate the role of radiation in addition to chemotherapy in patients with N2 disease

Clinical/Scientific Implications

This study adds to the growing body of scientific literature that supports the use of chemotherapy in patients that have undergone a complete resection of their NSCLC.  This study also questions the use of chemotherapy in patients with Ib (T2N0) NSCLC as no benefit is seen in survival, which is consistent with the recent JBR-10 study recently published in the New England Journal of Medicine.  As has been seen in other disease sites, as the systemic control of disease improves, local therapy with radiation gains importance.    Radiation has previously been criticized as detrimental in the postoperative setting because there was toxicity and no survival benefit.  As has been confirmed in numerous studies, this study shows there is no benefit to postoperative XRT in patients with N0 or N1 disease that has been completely resected.  However, this study does show a potential benefit in patients with N2 disease.  Previous studies have shown improved local control with the addition of XRT, but no survival advantage.  However, as has been show previously with breast cancer, until there is a significant systemic impact with chemotherapy, there is not a large impact of radiation.  Based on the results of this subgroup analysis, the authors have suggested future trials investigate the role of radiation in patients with N2 disease. 

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