Intensified chemotherapy and simultaneous treatment with heparin in outpatients with pancreatic cancer – the CONKO 004 pilot trialReportar como inadecuado




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BMC Cancer

, 14:204

Clinical oncology

Abstract

BackgroundAdvanced pancreatic cancer APC, beside its high mortality, causes the highest rates of venous thromboembolic events VTE. Enoxaparin, a low molecular weight heparin LMWH, is effective in prevention and treatment of VTE. Some small studies indicated that this benefit might extend to patients with cancer and probably prolong survival due to independent mechanisms. We initiated this safety investigation to get feasibility information on intensified chemotherapy combined with LMWH in outpatients with APC treated in 1 line.

MethodsThe trial was a prospective, open-label, single center investigation in outpatients with inoperable pancreatic cancer who were treated with intensified first-line chemotherapy along with concomitant application of subcutaneous LMWH. The combined chemotherapy consisted of gemcitabine 1 g-m 30 min, 5-FU 750 mg-m 24 h, folinic acid 200 mg-m 30 min, and Cisplatin 30 mg-m 90 min on day 1 and 8; q3w for the first 12 weeks GFFC followed by gemcitabine alone in patients without cancer progression. The simultaneous application of prophylactic enoxaparin started on day 1 of chemotherapy with a fixed dose of 40 mg daily. Statistical analyses were performed using R 3.01 with software package CMPRSK and SPSS software v19.0.

ResultsThe investigation was stopped after recruitment of 19 patients. At this time 15 patients had completed the required 12 weeks of treatment. Based on 71 cycles of GFFC + enoxaparin median 4-pt range: 2–4 and 108 cycles of single-agent gemcitabine + enoxaparin median 4-pt range: 0–18 the cumulative frequency of NCI-CTC toxicities grade 3-4 was below 10%. One case 5% of a symptomatic non-lethal thromboembolic event was observed while receiving LMWH treatment. No severe bleeding event as defined in the protocol has been observed. The median overall survival was 10.05 95% CI: 8.67-18.14 months.

ConclusionsThe addition of enoxaparin to GFFC chemotherapy is feasible, safe and does not appear to affect the efficacy or the toxicity profile of the chemotherapy regimen in patients with advanced pancreatic adenocarcinoma. Based on these findings we have initiated the randomized CONKO-004 trial to examine whether enoxaparin reduces the incidence of thromboembolic events or increases overall outcome.

Trial registrationClinical Trials NCT01945879.

Electronic supplementary materialThe online version of this article doi:10.1186-1471-2407-14-204 contains supplementary material, which is available to authorized users.

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Autor: Uwe Pelzer - Andreas Hilbig - Jens M Stieler - Marcus Bahra - Marianne Sinn - Bernhard Gebauer - Bernd Dörken - Hanno Ri

Fuente: https://link.springer.com/







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