NEW YORK (Reuters Health) Jan 10 - Adding radiotherapy to capecitabine-cisplatin chemotherapy after complete resection of gastric cancer did not significantly improve disease-free survival for most patients in the ARTIST trial.
The randomized study, by Dr. Won Ki Kang from Sungkyunkwan University School of Medicine in Seoul, Korea and colleagues, involved 458 patients.
The researchers reported online December 19 in the Journal of Clinical Oncology that 75.4% of patients in the chemotherapy-only arm and 81.7% in the chemoradiotherapy arm completed treatment as planned.
After a median follow-up of 53.2 months, there were 55 recurrence events in the chemoradiation group and 72 in the chemotherapy group. The estimated three-year disease-free survival rates were 78.2% with radiation and 74.2% without it (P=0.0862).
For the 396 patients with positive lymph nodes, however, three-year disease-free survival was significantly higher with chemoradiotherapy (77.5% vs 72.3%; P=0.0365).
"Because these findings were from a subgroup analysis, the data should be interpreted with caution," the researchers warn. They say they're planning "a subsequent phase III trial (ARTIST-II) to compare chemotherapy versus chemotherapy with radiotherapy in patients with D2 lymph node dissection and pathologic lymph node-positive disease... to confirm the benefit of adjuvant chemoradiotherapy."
Rates of locoregional recurrence and distant metastases did not differ significantly between the treatment arms.
Grade 3 or 4 vomiting, stomatitis, hand-foot syndrome, and diarrhea occurred in up to 12% of patients in both study arms. Grade 4 neutropenia affected 5.7% of patients in the chemotherapy arm and 4.8% in the chemoradiotherapy arm.
There were two treatment-related deaths, one from neutropenic septic shock during chemotherapy and one from non-neutropenic pneumonia in the chemoradiotherapy group.
"The postoperative capecitabine-cisplatin regimen was well tolerated, and the safety data presented here are comparable to those observed in a previous study of the capecitabine-cisplatin regimen in patients with advanced gastric cancer," the investigators conclude. "Patients in the ARTIST trial will continue to be observed for recurrence and survival."
SOURCE: http://bit.ly/zwBazO
J Clin Oncol 2011.
The randomized study, by Dr. Won Ki Kang from Sungkyunkwan University School of Medicine in Seoul, Korea and colleagues, involved 458 patients.
The researchers reported online December 19 in the Journal of Clinical Oncology that 75.4% of patients in the chemotherapy-only arm and 81.7% in the chemoradiotherapy arm completed treatment as planned.
After a median follow-up of 53.2 months, there were 55 recurrence events in the chemoradiation group and 72 in the chemotherapy group. The estimated three-year disease-free survival rates were 78.2% with radiation and 74.2% without it (P=0.0862).
For the 396 patients with positive lymph nodes, however, three-year disease-free survival was significantly higher with chemoradiotherapy (77.5% vs 72.3%; P=0.0365).
"Because these findings were from a subgroup analysis, the data should be interpreted with caution," the researchers warn. They say they're planning "a subsequent phase III trial (ARTIST-II) to compare chemotherapy versus chemotherapy with radiotherapy in patients with D2 lymph node dissection and pathologic lymph node-positive disease... to confirm the benefit of adjuvant chemoradiotherapy."
Rates of locoregional recurrence and distant metastases did not differ significantly between the treatment arms.
Grade 3 or 4 vomiting, stomatitis, hand-foot syndrome, and diarrhea occurred in up to 12% of patients in both study arms. Grade 4 neutropenia affected 5.7% of patients in the chemotherapy arm and 4.8% in the chemoradiotherapy arm.
There were two treatment-related deaths, one from neutropenic septic shock during chemotherapy and one from non-neutropenic pneumonia in the chemoradiotherapy group.
"The postoperative capecitabine-cisplatin regimen was well tolerated, and the safety data presented here are comparable to those observed in a previous study of the capecitabine-cisplatin regimen in patients with advanced gastric cancer," the investigators conclude. "Patients in the ARTIST trial will continue to be observed for recurrence and survival."
SOURCE: http://bit.ly/zwBazO
J Clin Oncol 2011.
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