TY - JOUR
T1 - Results of the NRG Oncology/RTOG 0848 Adjuvant Chemotherapy Question-Erlotinib+Gemcitabine for Resected Cancer of the Pancreatic Head
T2 - A Phase II Randomized Clinical Trial
AU - Abrams, Ross A.
AU - Winter, Kathryn A.
AU - Safran, Howard
AU - Goodman, Karyn A.
AU - Regine, William F.
AU - Berger, Adam C.
AU - Gillin, Michael T.
AU - Philip, Philip A.
AU - Lowy, Andrew M.
AU - Wu, Abraham
AU - Dipetrillo, Thomas A.
AU - Corn, Benjamin W.
AU - Seaward, Samantha A.
AU - Haddock, Michael G.
AU - Song, Suisui
AU - Jiang, Yixing
AU - Fisher, Barbara J.
AU - Katz, Alan W.
AU - Mehta, Sharmila
AU - Willett, Christopher G.
AU - Crane, Christopher H.
N1 - Funding Information:
A.C.B.: discloses honoraria from Castle Bioscience, and speakers’ bureau from Cardinal Health. C.H.C.: discloses honoraria and consulting or advisory roles from Trio Health and Celgene. T.A.D. discloses patents, royalties or other intellectual property with Pointsource Technologies LLC. K.A.G. discloses a consulting or advisory role with RenovoRX. M.G.H.: discloses travel, accommodations, or expenses from Medisun. Y.J.: discloses employment, and stock or other ownership of an immediate family member with ImmuCision Biotherapeutics LLC. A.M.L.: discloses a consulting or advisory role with Pfizer, Merck, and Halozyme Therapeutics, research funding from Tanabe, and Syros, expert testimony for Merck, and travel, accommodations, or expenses from Pfizer. P.A.P.: discloses honoraria from Merck, Celgene, Ipsen, Novartis, Eli Lilly, BMS, Eisai, and Biologics, a consulting or advisory role from Merck, Rafael, Roche, Ipsen, Lexicon, Eisai, Aslan, and Caris, speakers’ bureau from BMS, Celgene, Ipsen, Novartis, and Merck, research funding from Celgene, Novartis, Qed, Merck, BMS, Eisai, and Daiichi, travel, accommodations, and expenses from Merck, Celgene, Ipsen, and Lexicon. W.F.R.: discloses patents, royalties, or other intellectual properties with Xcision. The other authors declare no conflicts of interest.
Funding Information:
Supported by grants U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), U24CA180803 (IROC) from the National Cancer Institute (NCI).
Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - 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.
AB - 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.
KW - adjuvant therapy
KW - gemcitabine
KW - pancreatic cancer
UR - http://www.scopus.com/inward/record.url?scp=85079056725&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85079056725&partnerID=8YFLogxK
U2 - 10.1097/COC.0000000000000633
DO - 10.1097/COC.0000000000000633
M3 - Article
C2 - 31985516
AN - SCOPUS:85079056725
SN - 0277-3732
VL - 43
SP - 173
EP - 179
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 3
ER -