| 1. |
- Bernsdorf, Mogens, et al.
(författare)
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Effect of adding gefitinib to neoadjuvant chemotherapy in estrogen receptor negative early breast cancer in a randomized phase II trial
- 2011
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Ingår i: Breast Cancer Research and Treatment. - : Springer Science and Business Media LLC. - 1573-7217 .- 0167-6806. ; 126:2, s. 463-470
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Tidskriftsartikel (refereegranskat)abstract
- Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has shown both anti-proliferative and anti-tumoral activity in breast cancer. This study was designed to determine the effect of adding gefitinib to neoadjuvant epirubicin and cyclophosphamide (EC) on tumor response rates. Women with unilateral, primary operable, estrogen receptor negative invasive breast cancer a parts per thousand yen 2 cm were eligible for inclusion. Randomized patients were to receive four cycles of neoadjuvant EC plus 12 weeks of either gefitinib (250 mg daily) or placebo. Primary endpoint was pathologic complete response (pCR), and secondary endpoints were complete response (CR) and overall objective response (OR). 181 patients were randomized. A pCR was observed in 17% (12/71) of patients treated with gefitinib and in 12% (9/73) of patients treated with placebo (4.57% difference, 95% CI -7.19 to 6.33; P = 0.44). CR was observed in 10% of patients in both the gefitinib (7/71) and the placebo group (7/73) (0.27% difference, 95% CI -9.6 to 10.2; P = 0.96). There was no significant difference in OR (5.96%; 95% CI -9.9 to 21.9; P = 0.45) between the two groups. Post hoc subgroup analysis showed a significant difference in pCR between triple negative breast cancer (TNBC) and non-TNBC tumors (P = 0.03). More patients in the gefitinib arm had hematological toxicity (P = 0.15) and discontinued treatment (9/94 vs. 2/86) because of adverse events (AE). Tumor response rates were similar in the two groups. A significantly higher pCR rate was observed post hoc in TNBC versus non-TNBC independent of treatment. More patients in the gefitinib group discontinued treatment because of AE.
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| 2. |
- Kumler, Iben, et al.
(författare)
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Clinical outcome of percutaneous RF-ablation of non-operable patients with liver metastasis from breast cancer
- 2015
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Ingår i: Radiologia Medica. - : Springer Science and Business Media LLC. - 0033-8362 .- 1826-6983. ; 120:6, s. 536-541
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Tidskriftsartikel (refereegranskat)abstract
- Despite improved anti-neoplastic treatment the prognosis for patients with liver metastases from metastatic breast cancer remains poor. Thirty-two consecutive patients with metastatic breast cancer treated with radiofrequency ablation (RFA) at the Department of Oncology, Herlev Hospital, University of Copenhagen, from 1996 to 2010. Time to intrahepatic progression was median 11 months (range 1.6-184 months). Median survival after first RFA was 33.5 months. Survival at 1, 2 and 3 years was 87, 68 and 48 %, respectively. The local recurrence rate was 22 %. In this small, highly selected cohort we found RFA safe and efficacious with a low local recurrence rate and a median survival above that expected with systemic treatment. Our data are in line with previous studies and underscore the need for a large prospective study using optimal chemotherapy regimens and RFA/surgery to clarify whether intense treatment protocols can prolong survival for certain patient groups.
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| 3. |
- Soletormos, Gyorgy, et al.
(författare)
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Clinical Use of Cancer Biomarkers in Epithelial Ovarian Cancer Updated Guidelines From the European Group on Tumor Markers
- 2016
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Ingår i: International Journal of Gynecological Cancer. - 1048-891X .- 1525-1438. ; 26:1, s. 43-51
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Tidskriftsartikel (refereegranskat)abstract
- Objective:To present an update of the European Group on Tumor Markers guidelines for serum markers in epithelial varian cancer. Methods: Systematic literature survey from 2008 to 2013. The articles were evaluated by level of evidence and strength of recommendation. Results: Because of its low sensitivity (50-62% for early stage epithelial ovarian cancer) and limited specificity (94-98.5%), cancer antigen (CA) 125 (CA125) is not recommended as a screening test in asymptomatic women. The Risk of Malignancy Index, which includes CA125, transvaginal ultrasound, and menopausal status, is recommended for the differential diagnosis of a pelvic mass. Because human epididymis protein 4 has been reported to have superior specificity to CA125, especially in premenopausal women, it may be considered either alone or as part of the risk of ovarian malignancy algorithm, in the differential diagnosis of pelvic masses, especially in such women. CA125 should be used to monitor response to first-line chemotherapy using the previously published criteria of the Gynecological Cancer Intergroup, that is, at least a 50% reduction of a pretreatment sample of 70 kU/L or greater. The value of CA125 in posttherapy surveillance is less clear. Although a prospective randomized trial concluded that early administration of chemotherapy based on increasing CA125 levels had no effect on survival, European Group on Tumor Markers state that monitoring with CA125 in this situation should occur, especially if the patient is a candidate for secondary cytoreductive surgery. Conclusions: At present, CA125 remains the most important biomarker for epithelial ovarian cancer, excluding tumors of mucinous origin.
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| 4. |
- Soletormos, Gyorgy, et al.
(författare)
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Design of Tumor Biomarker-Monitoring Trials : A Proposal by the European Group on Tumor Markers
- 2013
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Ingår i: Clinical Chemistry. - : Oxford University Press (OUP). - 0009-9147 .- 1530-8561. ; 59:1, s. 52-59
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Tidskriftsartikel (refereegranskat)abstract
- A major application of tumor biomarkers is in serial monitoring of cancer patients, but there are no published guidelines on how to evaluate biomarkers for this purpose. The European Group on Tumor Markers has convened a multidisciplinary panel of scientists to develop guidance on the design of such monitoring trials. The panel proposes a 4-phase model for biomarker-monitoring trials analogous to that in use for the investigation of new drugs. In phase I, biomarker kinetics and correlation with tumor burden are assessed. Phase II evaluates the ability of the biomarker to identify, exclude, and/or predict a change in disease status. In phase III, the effectiveness of tumor biomarker guided intervention is assessed by measuring patient outcome in randomized trials. Phase IV consists of an audit of the long-term effects after biomarker monitoring has been included into standard patient care. Systematic well-designed evaluations of biomarkers for monitoring may provide a stronger evidence base that might enable their earlier use in evaluating responses to cancer therapy.
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