No benefits to polychemotherapy after surgery in gastric cancer
MedWire News: American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL, USA: 1-5 June, 2012. Findings from the Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S) 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 a study comparing two post-surgery chemotherapy regimens (3-8 weeks) of differing intensities for patients with gastric or gastroesophageal junction adenocarcinomas.
The less intense treatment (arm B) consisted of 5-fluorouracil (5-FU) 400-600 mg/m2 (day 1, 2 q14) and folinic acid (LV) 100 mg/m2 (day 1, 2 q14), which was given for nine cycles. In total, 538 patients were randomly assigned to this arm after surgery between February 2005 and August 2009.
The more intense regimen (arm A) started with the same regimen drugs and dosages as arm B plus irinotecan (CPT-11) 180 mg/m2 (day 1 q14), which is also known as the FOLFIRI regimen, for four cycles. The patients were then given docetaxel (TXT) 75 mg/m2 (day 1 q21) and cisplatin (CDDP) 75 mg/m2 (day 1 q21) for three cycles. Overall, 562 patients were assigned to this arm of the study during the same time period as arm B.
Di Bartolomeo and colleagues followed the patients up until March 2012, with a median follow-up period of 49 months per patient (36-62 months). During this time, 558 disease relapse events occurred and 440 patients died.
Median disease free survival (DFS) was 41.3 months with no significant difference between the treatment groups, and 275 disease events were recorded in arm B and 283 in arm A.
Overall survival was also similar between the two groups with 222 deaths in arm A and 218 deaths in arm B during the follow-up period.
Toxicity was fairly consistent with the literature. Grade 3/4 leukopenia and neutropenia were significantly more common in arm A compared with arm B of the study, at 17% versus 0.8% and 46% versus 9%, respectively. Maximum hematological toxicity was also significantly more commonly in arm A compared with 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 owing 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.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Helen Albert