title: Eastern Cooperative Oncology Group and American College of Radiology Imaging Network Randomized Phase 2 Trial of Neoadjuvant Preoperative Paclitaxel/Cisplatin/Radiation Therapy (RT) or Irinotecan/Cisplatin/RT in Esophageal Adenocarcinoma: Long-Term Outcome and Implications for Trial Design.
abstract: OBJECTIVE
  Toxicity, pathologic complete response, and long-term outcomes are reported for the neoadjuvant therapies assessed in a randomized phase 2 Eastern Cooperative Oncology Group and American College of Radiology Imaging Network trial for operable esophageal adenocarcinoma, staged as II-IVa by endoscopy/ultrasonography (EUS).
  
  
  METHODS
  A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m(2), and irinotecan, 50 mg/m(2), on day 1, 8, 22, 29 during 45 Gy radiation therapy (RT), 1.8 Gy per day over 5 weeks. Adjuvant therapy was cisplatin, 30 mg/m(2), and irinotecan, 65 mg/m(2) day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m(2), and paclitaxel, 50 mg/m(2), day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m(2), and paclitaxel, 175 mg/m(2), day 1 every 21 days for 3 cycles. Stratification included EUS stage and performance status.
  
  
  RESULTS
  In arm A, median overall survival was 35 months, and 5-, 6-, and 7-year survival rates were 46%, 39%, and 35%, respectively, whereas for arm B, they were 21 months and 27%, 27%, and 23%, respectively. Median progression- or recurrence-free survival (PFS) was 39.8 months with a 3-year PFS of 50% for arm A and 12.4 months (P=.046) with 3-year PFS of 28% for arm B. Eighty percent of the observed incidents of progression occurred within 19 months. Survival did not differ significantly by EUS and performance status strata.
  
  
  CONCLUSIONS
  Long-term survival was similar for both arms and did not appear superior to results achieved with other standard regimens.
authors.affiliation: Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, Maryland. Electronic address: kleinla@jhmi.edu.
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Kleinberg
authors.affiliation: Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, and Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Catalano
authors.affiliation: Department of Oncology, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Arlene A
authors.initials: AA
authors.lastname: Forastiere
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, NY.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Keller
authors.affiliation: Department of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.
authors.forename: Edith P
authors.initials: EP
authors.lastname: Mitchel
authors.affiliation: Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.
authors.forename: Pramila Rani
authors.initials: PR
authors.lastname: Anne
authors.affiliation: Department of Medicine-Hematology/Oncology, Lurie Cancer Center, Northwestern University, Chicago, Illinois.
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods*; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D017239:Paclitaxel / Q000008:administration & dosage; D011879:Radiotherapy Dosage; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D000077146:Irinotecan; D017239:Paclitaxel; D002945:Cisplatin; D002166:Camptothecin