By Helen Albert
Findings from the ITACA-S trial suggest that a more intensive postoperative chemotherapy regimen does not improve outcomes over a less-intensive regimen after radical resection in patients with gastric cancer.
Maria Di Bartolomeo (Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy) reported findings from ITACA-S (Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach) at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, USA.
The study compared two postsurgery (3-8 weeks) chemotherapy regimens in patients with gastric or gastroesophageal junction adenocarcinomas between February 2005 and August 2009.
The less-intense treatment (arm B) consisted of 5-fluorouracil (5-FU) 400-600 mg/m2 (day 1, 2, every 2 weeks) and folinic acid (LV) 100 mg/m2 (day 1, 2, every 2 weeks), which was given for nine cycles. In total, 538 patients were randomly assigned to this arm after surgery.
The more-intense regimen (arm A) started with the less-intense regimen drugs and dosages plus irinotecan (CPT-11) 180 mg/m2 (day 1, every 2 week), which is also known as the FOLFIRI regimen, for four cycles. The patients were then given docetaxel (TXT) 75 mg/m2 (day 1, every 3 weeks) and cisplatin (CDDP) 75 mg/m2 (day 1, every 3 weeks) for three cycles. Overall, 562 patients were assigned to this arm of the study.
Di Bartolomeo and colleagues followed up the patients until March 2012 for a median of 49 months (range 36-62 months).
Median disease-free survival (DFS) was 41.3 months with no significant difference between the treatment groups; 283 disease events were recorded in arm A compared with 275 in arm B.
Overall survival was also similar between the two groups, with 222 deaths in arm A and 218 in arm B over the follow-up period.
Toxicity was fairly consistent with the literature. Grade 3/4 leukopenia and neutropenia were significantly more common in arm A versus arm B of the study, at 17% versus 0.8%, and 46% versus 9%, respectively. Maximum hematologic toxicity was also significantly more common in arm A versus arm B, at 48% versus 9%. Diarrhea, vomiting, and asthenia were also more frequent in arm A, but to a lesser extent.
Notably, significantly more patients discontinued the study due to adverse events in arm A than in arm B, at 15% versus 6%.
ITACA-S is the largest western trial to compare adjuvant chemotherapy after surgery in gastric cancer patients, said Di Bartolomeo.
She added that the results show no improvements in DFS or overall survival, and greater toxicity with the more-intense versus the less-intense regimen.
"According to these results there is no indication to use a polychemotherapy regimen in an adjuvant setting for any stage of gastric cancer," concluded Di Bartolomeo.
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