SUMMARY: It is estimated that in 2014, over 18,000 new cases of esophageal carcinoma will be diagnosed in the U.S. and over 15,000 will die of the disease. There has been a rise in the incidence of esophageal cancer in recent decades. Even though stage 0, I, and II and most stage III esophageal cancers are potentially resectable, a significant number of these patients have associated comorbid conditions that may preclude them from undergoing surgical intervention. In this group of patients, as well as those with inoperable esophageal cancer, cisplatin based chemoradiation treatment has been associated with improved survival. Cisplatin however is associated with significant toxicities. The rationale for substituting ELOXATIN® for Cisplatin is based on its lower emetogenicity, lack of nephrotoxicity and lack of need for IV hydration. Prior phase II trials have demonstrated that ELOXATIN® (Oxaliplatin) based chemotherapy given alone or in combination with radiation therapy improved response rates with acceptable toxicities, in patients with advanced esophageal cancer. Based on this information, the authors conducted an open labeled, multicenter study to assess the efficacy and safety of the FOLFOX chemotherapy regimen (Fluorouracil plus Leucovorin and Oxaliplatin) compared to Fluorouracil and Cisplatin, when administered as a part of chemoradiotherapy treatment, in patients with locally advanced esophageal cancer. Patients with stage I—IVA esophageal carcinoma (adenocarcinoma, squamous-cell, or adenosquamous) who were not candidates for surgical intervention were randomly assigned to receive FOLFOX chemotherapy (N=131) or Cisplatin and Fluorouracil (N=128), with concurrent radiation. FOLFOX chemotherapy consisted of 6 cycles of ELOXATIN® 85 mg/m2 IV, Leucovorin 200 mg/m2 IV, Fluorouracil 400 mg/m2 IV bolus given on day 1, and infusional Fluorouracil 1600 mg/m2 given over 46 hours, every 2 weeks, with the first 3 cycles given concurrently with radiation therapy. Chemotherapy with Cisplatin and Fluorouracil consisted of 4 cycles of Cisplatin 75 mg/m2 IV given on day 1 and infusional Fluorouracil 1000 mg/m2 per day, given for 4 days, with the first 2 cycles given concurrently with radiation therapy at 4 week intervals and the remaining 2 cycles given 3 weeks apart after completion of radiation therapy. Both treatment groups received 50Gy radiotherapy, in 25 fractions, at five fractions per week. The primary endpoint was Progression Free Survival (PFS). At a median follow up of 25.3 months, the median PFS was 9.7 months in the FOLFOX group and 9.4 months in the Cisplatin group and this was not statistically significant (P=0.64), suggesting that FOLFOX in combination with radiation may be an alternative to Cisplatin and Fluorouracil. FOLFOX chemotherapy may alleviate Cisplatin related toxicities such as nausea and vomiting, nephrotoxicity and the need for IV hydration, making this a much more tolerable regimen in advanced esophageal carcinoma. Conroy T, Galais M, Raoul J, et al. Lancet Oncol, 2014;15: 305-314
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