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 Journal Article
| Authors: | 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.; Willett, C. G.; Crane, C. H. |
| Article Title: | 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 |
| 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 100 mg/d. Two hundred deaths provided 90% power (1-sided α=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. © 2019 Wolters Kluwer Health, Inc. All rights reserved. |
| Keywords: | adult; cancer survival; controlled study; aged; cancer surgery; major clinical study; overall survival; erlotinib; fluorouracil; cancer combination chemotherapy; diarrhea; drug withdrawal; capecitabine; gemcitabine; adjuvant therapy; disease free survival; follow up; pancreaticoduodenectomy; multiple cycle treatment; phase 2 clinical trial; gastrointestinal symptom; randomized controlled trial; ca 19-9 antigen; continuous infusion; liver failure; adjuvant chemotherapy; pancreas adenocarcinoma; pancreatectomy; sepsis; pancreatic cancer; hepatobiliary disease; metabolic disorder; heart arrest; nutritional disorder; human; male; female; article |
| Journal Title: | American Journal of Clinical Oncology |
| Volume: | 43 |
| Issue: | 3 |
| ISSN: | 0277-3732 |
| Publisher: | Lippincott Williams & Wilkins |
| Date Published: | 2020-03-01 |
| Start Page: | 173 |
| End Page: | 179 |
| Language: | English |
| DOI: | 10.1097/coc.0000000000000633 |
| PUBMED: | 31985516 |
| PROVIDER: | scopus |
| PMCID: | PMC7280743 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2020 -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work