Randomised phase 3 study of adjuvant chemotherapy with or without nadroparin in patients with completely resected non-small-cell lung cancer: the NVALT-8 study.
Br J Cancer
; 121(5): 372-377, 2019 08.
Article
in En
| MEDLINE
| ID: mdl-31337877
ABSTRACT
BACKGROUND:
Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.METHODS:
Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. The main exclusion criteria were R1/2 and wedge/segmental resection. FDG-PET was required. The primary endpoint was recurrence-free survival (RFS).RESULTS:
Among 235 registered patients, 202 were randomised (nadroparin n = 100; control n = 102). Slow accrual enabled a decrease in the number of patients needed from 600 to 202, providing 80% power to compare RFS with 94 events (α = 0.05; 2-sided). There were no differences in bleeding events between the two groups. The median RFS was 65.2 months (95% CI, 36-NA) in the nadroparin arm and 37.7 months (95% CI, 22.7-NA) in the control arm (HR 0.77 (95% CI, 0.53-1.13, P = 0.19). FDG-PET SUVmax ≥10 predicted a greater likelihood of recurrence in the first year (HR 0.48, 95% CI 0.22-0.9, P = 0.05).CONCLUSIONS:
Adjuvant nadroparin did not improve RFS in patients with resected NSCLC. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year. CLINICAL TRIAL REGISTRATION Netherlands Trial registry NTR1250/1217.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pneumonectomy
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Carcinoma, Squamous Cell
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Antineoplastic Combined Chemotherapy Protocols
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Nadroparin
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Carcinoma, Non-Small-Cell Lung
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Lung Neoplasms
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Anticoagulants
Type of study:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limits:
Aged
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
Br J Cancer
Year:
2019
Document type:
Article
Affiliation country:
Países Bajos