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Sökning: onr:"swepub:oai:DiVA.org:uu-102518" > CA 19-9 tumour-mark...

  • Hess, Viviane (författare)

CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial

  • Artikel/kapitelEngelska2008

Förlag, utgivningsår, omfång ...

  • 2008
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-102518
  • urn:nbn:se:uu:diva-102518urn
  • https://doi.org/10.1016/S1470-2045(08)70001-9DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:116608450URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • restricted
  • BACKGROUND: Several studies in patients undergoing chemotherapy for advanced pancreatic carcinoma have linked a decrease in the concentration of the tumour marker carbohydrate antigen (CA) 19-9 to lengthened survival. The aim of this study was to test the hypotheses that an early decrease in baseline serum CA 19-9 concentration (on day 42, after two cycles of chemotherapy) by at least 50% is associated with lengthened survival, and that a decrease in CA 19-9 concentration of at least 50% from the baseline concentration to the lowest value measured at any time during treatment (nadir) is of prognostic significance, enabling its use as a surrogate endpoint for survival. METHODS: CA 19-9 serum concentration was measured at baseline and every 3 weeks thereafter in patients with histologically proven advanced pancreatic carcinoma enrolled in a randomised trial of gemcitabine versus gemcitabine plus capecitabine. Patients were excluded if baseline serum CA 19-9 concentration was below the upper limit of normal (ULN) in the laboratory or if this measurement was missing. Comparisons of survival between patients with and without a CA 19-9 response were corrected for the guarantee-time bias by the landmark method. The trial on which this study is based is registered on the clinical trials site of the US National Cancer Institute website http://www.clinicaltrials.gov/ct/show/NCT00030732. FINDINGS: 247 of 319 randomised patients were assessable for analysis of baseline serum CA 19-9 concentration, and, of these, 175 patients were assessable for tumour-marker response to treatment. Median overall survival for patients with a baseline CA 19-9 concentration equal to or above the median value (ie, 59xULN) was 5.8 months (95% CI 5.1-7.0), which was significantly shorter than that for patients with baseline concentrations below the median value (10.3 months [95% CI 8.6-12.8], p<0.0001). An early decrease in CA 19-9 concentration of at least 50% after two cycles of chemotherapy was not associated with a longer overall survival compared with patients who did not have a decrease of at least 50% (median 10.1 months [9.2-12.7] vs 8.6 months [6.9-11.2], p=0.53; hazard ratio for death 1.11 [0.81-1.52]). Furthermore, a decrease in CA 19-9 concentration of at least 50% reached at the CA 19-9 nadir concentration was not associated with a longer overall survival compared with those patients who did not have a decrease of at least 50% (median 7.8 months [6.5.10.1] vs 6.7 months [5.5-9.8], p=0.74; 0.95 [0.69-1.31]) after adjusting for the guarantee-time bias. INTERPRETATION: Pretreatment serum CA 19-9 concentration is an independent prognostic factor for survival, but a decrease in concentration during chemotherapy is not significantly associated with lengthened survival compared with those who did not have a corresponding decrease. Our data suggest that CA 19-9 response during chemotherapy is not a valid surrogate endpoint for survival in clinical trials.

Ämnesord och genrebeteckningar

  • MEDICINE
  • MEDICIN

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Glimelius, BengtUppsala universitet,Institutionen för onkologi, radiologi och klinisk immunologi (författare)
  • Grawe, Philipp (författare)
  • Dietrich, Daniel (författare)
  • Bodoky, György (författare)
  • Ruhstaller, Thomas (författare)
  • Bajetta, Emilio (författare)
  • Saletti, Piercarlo (författare)
  • Figer, Arie (författare)
  • Scheithauer, Werner (författare)
  • Herrmann, Richard (författare)
  • Bodoky, G (författare)
  • Ruhstaller, T (författare)
  • Saletti, P (författare)
  • Grawe, P (författare)
  • Hess, V (författare)
  • Bajetta, E (författare)
  • Glimelius, BKarolinska Institutet (författare)
  • Herrmann, R (författare)
  • Scheithauer, W (författare)
  • Figer, A (författare)
  • Dietrich, D (författare)
  • Uppsala universitetInstitutionen för onkologi, radiologi och klinisk immunologi (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet Oncology9:2, s. 132-81470-20451474-5488

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