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

Lawrence R. Kleinberg*, Paul J. Catalano, Arlene A. Forastiere, Steven M. Keller, Edith P. Mitchel, Pramila Rani Anne, Al B Benson III

*Corresponding author for this work

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Abstract

Purpose 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 and Materials A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m2, and irinotecan, 50 mg/m2, 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/m2, and irinotecan, 65 mg/m2 day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m2, and paclitaxel, 50 mg/m2, day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m2, and paclitaxel, 175 mg/m2, 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.

Original languageEnglish (US)
Pages (from-to)738-746
Number of pages9
JournalInternational Journal of Radiation Oncology Biology Physics
Volume94
Issue number4
DOIs
StatePublished - Mar 15 2016

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irinotecan
radiology
Radiology
Cisplatin
radiation therapy
Adenocarcinoma
Radiotherapy
Endoscopy
Ultrasonography
Survival
Paclitaxel
therapy
progressions
Radiation Dosage
Neoadjuvant Therapy
cycles
strata
chemotherapy
stratification
Therapeutics

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

@article{baba32461e9049bda7a5306db572742f,
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 = "Purpose 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 and Materials A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m2, and irinotecan, 50 mg/m2, 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/m2, and irinotecan, 65 mg/m2 day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m2, and paclitaxel, 50 mg/m2, day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m2, and paclitaxel, 175 mg/m2, 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.",
author = "Kleinberg, {Lawrence R.} and Catalano, {Paul J.} and Forastiere, {Arlene A.} and Keller, {Steven M.} and Mitchel, {Edith P.} and Anne, {Pramila Rani} and {Benson III}, {Al B}",
year = "2016",
month = "3",
day = "15",
doi = "10.1016/j.ijrobp.2015.12.009",
language = "English (US)",
volume = "94",
pages = "738--746",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
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TY - JOUR

T1 - 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

T2 - Long-Term Outcome and Implications for Trial Design

AU - Kleinberg, Lawrence R.

AU - Catalano, Paul J.

AU - Forastiere, Arlene A.

AU - Keller, Steven M.

AU - Mitchel, Edith P.

AU - Anne, Pramila Rani

AU - Benson III, Al B

PY - 2016/3/15

Y1 - 2016/3/15

N2 - Purpose 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 and Materials A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m2, and irinotecan, 50 mg/m2, 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/m2, and irinotecan, 65 mg/m2 day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m2, and paclitaxel, 50 mg/m2, day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m2, and paclitaxel, 175 mg/m2, 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.

AB - Purpose 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 and Materials A total of 86 eligible patients began treatment. For arm A, preoperative chemotherapy was cisplatin, 30 mg/m2, and irinotecan, 50 mg/m2, 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/m2, and irinotecan, 65 mg/m2 day 1, 8 every 21 days for 3 cycles. Arm B therapy was cisplatin, 30 mg/m2, and paclitaxel, 50 mg/m2, day 1, 8, 15, 22, 29 with RT, followed by adjuvant cisplatin, 75 mg/m2, and paclitaxel, 175 mg/m2, 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.

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U2 - 10.1016/j.ijrobp.2015.12.009

DO - 10.1016/j.ijrobp.2015.12.009

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