Zwicker 2013.
Study characteristics | ||
Methods | Trial acronym: MicroTEC Design: 3‐arma randomised, multicentre phase II study; use of intention‐to‐treat analyses reported Median duration of follow‐up: 2 months for the primary efficacy endpoint |
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Participants | Patients with histologically confirmed advanced‐stage malignancy for which standard curative therapies did not exist. Eligible malignancies included: adenocarcinoma of the pancreas (locally advanced or metastatic), colorectal (stage IV), non‐small‐cell lung cancer (stage III or IV), relapsed or stage IV ovarian cancer, or surgically unresectable or metastatic gastric adenocarcinoma. Median age: 68.1 (range 46.6–80.1) years in LMWH group; 67.5 (range 28.8–78.7) years in observation group Gender, n (%) males: 14 (61%) in LMWH group; 5 (46%) in observation group Metastatic disease: 52 (78.8%) overall across 3 trial arms Previous VTE: none |
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Interventions | Intervention: LMWH, enoxaparin (40 mg SC, once daily) Control: observation Treatment was given for 2 months |
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Outcomes | Primary efficacy outcome: cumulative incidence of VTE (i.e. any symptomatic proximal or distal lower extremity DVT, incidental proximal DVT, symptomatic PE, or fatal PE) at 2 months Primary safety outcome: major bleeding Secondary: toxicity and survival |
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Notes |
a2/3 trial arms with high tissue factor‐bearing microparticles (TFMP) were considered in this review. The trial arm with low TFMP without enoxaparin was excluded. Funding, quote: "the study was supported by grants from the National Institutes of Health, K23 HL84052 (JIZ) and R01 HL095084 (BF), as well as a research grant from Sanofi." Disclosure of potential conflicts of interest: 1 author had served on steering committees for Sanofi, and another had received research funds and served on advisory boards for Sanofi and Eisai Publication format: full‐text publication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "were randomized (2:1) to enoxaparin 40 mg subcutaneously once daily or observation." Comment: method of sequence generation not reported. |
Allocation concealment (selection bias) | Unclear risk | Quote: "Study coordination, randomization, and monitoring were performed by the Quality Assurance Office for Clinical Trials (QACT) at Dana Farber/Harvard Cancer Center." Comment: method of allocation concealment not clearly specified. |
Blinding (performance bias and detection bias) All outcomes | High risk | Comment: both the treating physicians and participants in the observation arms were blinded to microparticle status. However, participants in the control group were only observed; the use of placebo, blinding method, or an independent and blinded adjudication committee was not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all randomised participants were included in the analysis. 4/70 participants initially enrolled were excluded prior to randomisation. |
Selective reporting (reporting bias) | High risk | Comment: the outcome toxicity was not reported in the results section. |
COI: conflict of interest; DVT: deep vein thrombosis; ECOG: Eastern Cooperative Oncology Group; INR: international normalised ratio; IQR: interquartile range; LMWH: low‐molecular‐weight heparin; n: number of participants; PE: pulmonary embolism; RCT: randomised controlled trial; SC: subcutaneous; SD: standard deviation; UFH: unfractionated heparin; uLMWH: ultra‐low‐molecular‐weight heparin; VTE: venous thromboembolism; WHO: World Health Organization.