Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question - Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial

Ross A. Abrams, Kathryn A. Winter, Howard Safran, Karyn A. Goodman, William F. Regine, Adam C. Berger, Michael T. Gillin, Philip A. Philip, Andrew M. Lowy, Abraham Wu, Thomas A. DIpetrillo, Benjamin W. Corn, Samantha A. Seaward, Michael G. Haddock, Suisui Song, Yixing Jiang, Barbara J. Fisher, Alan W. Katz, Sharmila Mehta, Christopher G. WillettChristopher H. Crane

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Abstract

Purpose: NRG/RTOG 0848 was designed to determine whether adjuvant radiation with fluoropyrimidine sensitization improved survival following gemcitabine-based adjuvant chemotherapy for patients with resected pancreatic head adenocarcinoma. In step 1 of this protocol, patients were randomized to adjuvant gemcitabine versus the combination of gemcitabine and erlotinib. This manuscript reports the final analysis of these step 1 data. Methods: Eligibility within 10 weeks of curative intent pancreaticoduodenectomy with postoperative CA19-9<180. Gemcitabine arm 6 cycles of gemcitabine. Gemcitabine+erlotinib arm gemcitabine and erlotinib 100mg/d. Two hundred deaths provided 90% power (1-sided ?=0.15) to detect the hypothesized OS signal (hazard ratio=0.72) in favor of the arm 2. Results: From November 17, 2009 to February 28, 2014, 163 patients were randomized and evaluable for arm 1 and 159 for arm 2. Median age was 63 (39 to 86) years. CA19-9 ?90 in 93%. Arm 1: 32 patients (20%) grade 4 and 2 (1%) grade 5 adverse events; arm 2, 27 (17%) grade 4 and 3 (2%) grade 5. GI adverse events, arm 1: 22% grade ?3 and arm 2: 28%, (P=0.22). The median follow-up (surviving patients) was 42.5 months (min-max: <1 to 75). With 203 deaths, the median and 3-year OS (95% confidence interval) are 29.9 months (21.7, 33.4) and 39% (30, 45) for arm 1 and 28.1 months (20.7, 30.9) and 39% (31, 47) for arm 2 (log-rank P=0.62). Hazard ratio (95% confidence interval) comparing OS of arm 2 to arm 1 is 1.04 (0.79, 1.38). Conclusions: The addition of adjuvant erlotinib to gemcitabine did not provide a signal for increased OS in this trial.

Original languageEnglish (US)
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
DOIs
StateAccepted/In press - Jan 1 2020

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Keywords

  • adjuvant therapy
  • gemcitabine
  • pancreatic cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Abrams, R. A., Winter, K. A., Safran, H., Goodman, K. A., Regine, W. F., Berger, A. C., Gillin, M. T., Philip, P. A., Lowy, A. M., Wu, A., DIpetrillo, T. A., Corn, B. W., Seaward, S. A., Haddock, M. G., Song, S., Jiang, Y., Fisher, B. J., Katz, A. W., Mehta, S., ... Crane, C. H. (Accepted/In press). Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question - Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head: A Phase II Randomized Clinical Trial. American Journal of Clinical Oncology: Cancer Clinical Trials. https://doi.org/10.1097/COC.0000000000000633