| zurück | ECOG 8282 | |||
Fragestellung |
verbessert eine Radiochemotherapie der Ergebnis einer alleinigen Bestrahlung bei inoperablen Pankreaskarzinomen? | |||
| Ergebnis (1) | Die zusätzliche Chemotherapie erhöht die Toxizität, verbessert aber nicht das Überleben. | |||
| - | Radio-Chemo | nur RT | ||
| Response | 9% | 6% | ||
| DFS | 5,1 M | 5,0 M | ||
| Response | 8,4 M | 7,1 M | ||
| Behandlungs-Arm A | 59,4 Gy, ED 1,8 Gy, 1000mg/qm 5-FU an Tag 2-5 als Dauerinfusion, 10 mg/qm Mitomycin an Tag 2, q29 | |||
| Behandlungs-Arm B | 59,4 Gy, ED 1,8 Gy | |||
| Patienten |
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Quelle |
1.) Cohen SJ, Dobelbower R Jr, Lipsitz S, Catalano PJ, Sischy B, Smith TJ, Haller DG; Eastern Cooperative Oncology Group: A randomized phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern Cooperative Oncology Group study E8282. IJROBP 62 (2005) 1345-50. 2.) Loehrer PJ, et al.: Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial. JCO 2011 [Epub ahead of print] | |||
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PATIENTS AND METHODSPatients with localiz14.09.2014 10:47gned to receive GEM alone (at 1,000 mg/m(2)/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m(2)/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m(2) for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed.ResultsOf 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). CONCLUSIONThis trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity. | |||
Impressum Zuletzt geändert am 16.09.2012 21:13
