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Cited by 593

The DOI matches its Crossref record; 16 of the 16 references it cites were found in a registry or an index.

Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non-Small-Cell Lung Cancer

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Scagliotti, G. V.·2003·CancerSpectrum Knowledge Environment

Abstract

BACKGROUND: Surgery is the primary treatment for patients with stage I, II, or IIIA non-small-cell lung cancer (NSCLC). However, long-term survival of NSCLC patients after surgery alone is largely unsatisfactory, and the role of adjuvant chemotherapy in patient survival has not yet been established. METHODS: Between January 1994 and January 1999, 1209 patients with stage I, II, or IIIA NSCLC were randomly assigned to receive mitomycin C (8 mg/m2 on day 1), vindesine (3 mg/m2 on days 1 and 8), and cisplatin (100 mg/m2 on day 1) every 3 weeks for three cycles (MVP group; n = 606) or no treatment (control group; n = 603) after complete resection. Randomization was stratified by investigational center, tumor size, lymph-node involvement, and the intention to perform radiotherapy. The primary endpoint was overall survival and secondary endpoints were progression-free survival and toxicity associated with adjuvant treatment. Survival curves were analyzed using the log-rank test. All statistical tests were two-sided. RESULTS: After a median follow-up time of 64.5 months, there was no statistically significant difference between the two patient groups in overall survival (hazard ratio = 0.96, 95% confidence interval = 0.81 to 1.13; P =.589) or progression-free survival (hazard ratio = 0.89, 95% confidence interval = 0.76 to 1.03; P =.128). Only 69% of patients received the three planned cycles of MVP. Grades 3 and 4 neutropenia occurred in 16% and 12%, respectively, of patients in the MVP arm. Radiotherapy was completed by 65% of patients in the MVP arm and by 82% of patients in the control group. In the multivariable analysis, only disease stage and sex were associated with survival. CONCLUSION: This randomized trial failed to prospectively confirm a statistically significant role for adjuvant chemotherapy in completely resected NSCLC. Given the poor compliance with the MVP regimen used in this study, future studies should explore more effective treatments.

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Metadata

Authors
Scagliotti, G. V.
Venue
CancerSpectrum Knowledge Environment
Published
2003-10-01
Volume
95
Issue
19
Pages
1453-1461
ISSN
  • 0027-8874 (ISSN-L)
  • 1460-2105
OpenAlex
W2119424848
Cited by
593
References
16
FWCI
35.74
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non-Small-Cell Lung Cancer. https://app.cochat.ai/papers/10.1093/jnci/djg059
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Scagliotti, G. V. (2003). Randomized Study of Adjuvant Chemotherapy for Completely Resected Stage I, II, or IIIA Non-Small-Cell Lung Cancer. CancerSpectrum Knowledge Environment. https://doi.org/10.1093/jnci/djg059

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