Annals of Oncology Advance Access originally published online on May 26, 2005
Annals of Oncology 2005 16(8):1326-1333; doi:10.1093/annonc/mdi252
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© 2005 European Society for Medical Oncology
Adjuvant chemoradiation using 5-fluorouracil/folinic acid/cisplatin with or without paclitaxel and radiation in patients with completely resected high-risk gastric cancer: two cooperative phase II studies of the AIO/ARO/ACO
1 Department of Hematology/Oncology, 3 Department of Radiation Oncology, University of Tuebingen, Tuebingen; 2 Division of Medical Oncology, British Columbia Cancer Agency–Vancover Cancer Centre, Vancover, Canada; 4 Department of Radiation Oncology, University of Duesseldorf, Duesseldorf; 5 Department of Medical Oncology/Hematology, Kliniken Essen Mitte, Essen; 6 Department of Internal Medicine, Westdeutsches Tumorzentrum Essen, 45122 Essen; 7 Department of Hematology/Oncology, Katharinenhospital Stuttgart, Stuttgart; 8 Department of Surgery, Oberschwabenklinik, Ravensburg; 9 Department of Hematology/Oncology, University of Hamburg, Hamburg, Germany
* Correspondence to: Prof. C. Bokemeyer, M.D., Department of Hematology/Oncology, University Hospital Hamburg Eppendorf, Martinistr. 52, 20 246 Hamburg, Germany. Tel: +49-40-42 803-2960; Fax: +49-40-42 803-8054; Email: c.bokemeyer{at}uke.uni-hamburg.de
Background: The current two studies evaluate the feasibility, toxicity and efficacy of an adjuvant combined modality treatment strategy containing a three to four-drug chemotherapy regimen plus 5-fluorouracil (FU)-based radiochemotherapy.
Patients and methods: Between December 2000 and October 2003, a total of 86 patients were included in both studies. Patients with completely resected gastric adenocarcinoma including a D1 or D2 lymph node dissection (LND) were eligible. Treatment consisted of two cycles of folinic acid 500 mg/m2, 5-FU 2000 mg/m2 continuous infusion over 24 h once weekly for 6 consecutive weeks, paclitaxel 175 mg/m2 in weeks 1 and 4 and cisplatin 50 mg/m2 in weeks 2 and 5 (FLPP; n=41) or two cycles of the same 5-FU/folinic acid schedule but with cisplatin 50 mg/m2 only in weeks 1, 3 and 5 (FLP; n=45). Radiation with 45 Gy plus concomitantly applied 5-FU 225 mg/m2/24 h was scheduled in between the two cycles.
Results: Patients characteristics were: D1/D2 LND FLP group 53%/42%; FLPP group 27%/68%; stage distribution: UICC stages III/IV(M0) FLP group 63% and FLPP group 66%. Median follow-up was 10 months (3–25) for FLP and 18 months (2–51) for FLPP patients. CTC grade 3/4 toxicities during the first cycle/chemoradiation/second cycle of FLP: granulocytopenia 3%/0/27%, anorexia 6%/10%/8%; diarrhea 8%/0/4%, nausea 3%/0/4%; FLPP: granulocytopenia 0/0/37%, anorexia 5%/11%/6%; diarrhea 5%/0/3, nausea 3%/8%/0%; early death in one patient due to Pneumocystis carinii pneumonia. Projected 2-year progression-free survival was 64% (95% CI 56% to 68%) for the FLP and 61% (95% CI 42% to 78%) for the FLPP group.
Conclusions: Both chemoradiation regimens appear feasible with an acceptable toxicity profile indicating that cisplatin can be added to 5-FU/FA and that even a four-drug regimen can be investigated further in prospective clinical trials in completely resected gastric cancer patients. Treatment should be given in experienced centres in order to avoid unnecessary toxicity.
Key words: gastric cancer, adjuvant chemoradiation, feasibility, toxicity