A multicenter, randomized trial of flat dosing versus intrapatient dose escalation of single-agent carboplatin as first-line chemotherapy for advanced ovarian cancer: an SGCTG (SCOTROC 4) and ANZGOG study on behalf of GCIG
| Autor: | Goss G, Stan B. Kaye, Pledge S, Craig M. Williams, Hani Gabra, Paul Vasey, L.-A. Lewsley, Susana Banerjee, Marcia Hall, E. Gilby, G. J. S. Rustin, Michael A. Hogg, A. hindley, Peter Harper, Emma Kipps, A. Lamont, G. skailes, James Paul |
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| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Urology Antineoplastic Agents Carcinoma Ovarian Epithelial Neutropenia Article Disease-Free Survival Drug Administration Schedule Carboplatin chemistry.chemical_compound medicine Humans Neoplasms Glandular and Epithelial Progression-free survival Aged Neoplasm Staging Dose Modification Ovarian Neoplasms business.industry Hazard ratio Induction chemotherapy Induction Chemotherapy Hematology Prognosis medicine.disease Chemotherapy regimen Surgery Treatment Outcome Oncology chemistry Area Under Curve Quality of Life Absolute neutrophil count Female business |
| Zdroj: | Annals of Oncology. 24:679-687 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mds494 |
| Popis: | Background: The aim of the study is to demonstrate that intrapatient dose escalation of carboplatin would improve the outcome in ovarian cancer compared with flat dosing. Patient and method: Patients with untreated stage IC-IV ovarian cancer received six cycles of carboplatin under the curve 6 (AUC 6) 3 weekly either with no dose modification except for toxicity (Arm A) or with dose escalations in cycles 24 based on nadir neutrophil and platelet counts (Arm 9), The primary end-point was progression-free survival (PPS). Results: Nine hundred and sixty-four patients were recruited from 71 centers, Dose oscalation was achieved in 77% of patients who had 1 cycle, The median AUCs (cycle 24) received were 6,0 Won A) and 72 Grade 3/4 non-hematological toxicity was higher in Arm 9 (31% versus 22% P=0.001), The median PFS was 12,1 months in Arm A and 9 [hazard ratio (HR) 0.00; 95% confidence interval (CI) 0.85=1.15; P = 0.03]. The median overall survival (OS) was 34.1 and 30.7 months in Arms A and B, respectively (HR 0.98; 95% CI 0.81-1.18, P = 0.82), multivariate analysis, bawling neutrophil (P < 0.441), baseline platelet counts (P < 0.001) and the difference between white blood cell (WBC) and neutrophil count (P = 0.009) had a significant adverse prognostic value. Conclusions: Intrapatient dose escalation of carboplatin based on nadir blood courts is feasible and safe, However, it provided no improvement in PPS or OS, compared with flat dosing, Baseline neutrophils over-tide nadir counts in prognostic significance, Time data may have wider implications particularly in respect of the management of chemotherapy-induced neutropenia |
| Databáze: | OpenAIRE |
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