SUMMARY: In this trial, neoadjuvant chemoradiation followed by surgery was compared with surgery alone, in patients with esophageal or GE junction tumors. Three hundred and sixty six (366) patients were randomized and chemoradiotherapy consisted of weekly PARAPLATIN® (Carboplatin) and TAXOL® (Paclitaxel) for 5 weeks with concurrent radiotherapy followed by surgery. Complete resection was feasible in 92% of the patients receiving chemoradiation compared to 69% in the surgery alone group (P<0.001). Overall survival was 49 months in the chemoradiation/surgery group compared to 24 months in the surgery alone group (HR=0.65, P<0.003). This benefit was seen regardless of histology and postoperative complications were similar in both treatment groups. This study has conclusively established that chemoradiation followed by surgery is superior to surgery alone, in patients with esophageal and GE junction tumors. van Hagen P, Hulshof MCCM, van Lanschot JJB, et al. for the CROSS Group. N Engl J Med 2012; 366:2074-2084
Month: August 2012
Prevention of Pegfilgrastim-Induced Bone Pain A Phase III Double-Blind Placebo-Controlled Randomized Clinical Trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base
SUMMARY:Bone pain related to NEULASTA® (Pegfilgrastim) has been reported to 25%-60% of patients in various clinical trials. In this randomized placebo controlled clinical trial, 510 patients were randomly assigned to receive either Naproxen 500 mg PO BID or placebo, for 5-8 days following NEULASTA®. Naproxen reduced the proportion of pain, patients reported, by 10% (71% vs 61%, P=0.02) and severe pain was reduced by 8% (27% vs 19%, P=0.05). Naproxen also reduced the overall pain incidence (P=0.02) and duration of pain (P=0.009). The authors concluded that Naproxen 500mg PO BID is effective in modestly reducing the incidence and severity of NEULASTA® induced bone pain. The adverse effects of Naproxen, has to be taken into consideration before prescribing this agent for bone pain. Kirshner JJ, Heckler CE, Janelsins MC, et al. J Clin Oncol 2012;30:1974-1979.