Patients received four 3-week cycles of pemetrexed 500 mg/m 2 and cisplatin 75 mg/m 2 intravenously. Patients were randomised at the NVALT Data Center by Alea randomisation software, and the randomisation results were communicated via telephone or email the patients were randomised after surgery to receive chemotherapy with nadroparin subcutaneously daily for 2 weeks at the therapeutic dose followed by 14 weeks at half the therapeutic dose (for a total of 16 weeks) or chemotherapy alone. All patients provided written informed consent. The study was approved by the medical ethics committee of the University Medical Center Groningen in the Netherlands (METc nr. The exclusion criteria were wedge/segmental resection, prior chemo- or radiotherapy or contra-indication for nadroparin. This was a prospective multicentre randomised phase 3 study with patients with completely (R0) resected stage II/III NSCLC, performance scores of 0–2, adequate organ function, and INRs <1.5 who were eligible for adjuvant chemotherapy (Supplementary Fig. To compare standard uptake values from PET between different participating centres, we first initiated a PET quality control programme with phantom evaluations. We hypothesised that in patients with completely resected NSCLC with a high risk of recurrence, as defined by high FDG avidity, adding nadroparin to adjuvant chemotherapy would improve recurrence-free survival (RFS). 12 ASCO recommendations noted a lack of sufficient data and therefore stated that anticoagulation should not be used to extend the survival of patients with cancer in the absence of other indications. 9, 10, 11 However, not all studies showed a survival advantage owing to the administration of LMWH to lung cancer patients. Three major studies have indicated that the use of LMWHs may be associated with a survival benefit in cancer patients that cannot be directly linked to a reduction in venous thrombotic events (VTEs). To further improve survival, the addition of low molecular weight heparin (LMWH) may be a next step. 6, 7, 8 The effect size of adding chemotherapy is approximately 4% at 5 years. 3, 4, 5 It may identify patients who are at increased risk for recurrence and decreased survival and therefore may benefit from additional treatment.Īdjuvant chemotherapy improves overall survival (OS) in patients with completely resected NSCLC. Adding FDG-PET to CT improves not only the detection of locoregional and unexpected distant metastasis 1, 2 but also provides independent survival information based on tumour metabolic activity. The prognosis of patients with completely resected non-small cell lung cancer (NSCLC) is mainly determined by stage and performance status. Netherlands Trial registry: NTR1250/1217. In this study, a high SUVmax predicted a greater likelihood of recurrence in the first year. ConclusionsĪdjuvant nadroparin did not improve RFS in patients with resected NSCLC. 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). There were no differences in bleeding events between the two groups. 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). ResultsĪmong 235 registered patients, 202 were randomised (nadroparin: n = 100 control n = 102). The primary endpoint was recurrence-free survival (RFS). The main exclusion criteria were R1/2 and wedge/segmental resection. Multicentre phase 3 study with patients with completely resected NSCLC who were randomised after surgery to receive chemotherapy with or without nadroparin. Retrospective studies suggest that low molecular weight heparin may delay the development of metastasis in patients with resected NSCLC.
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