TY - JOUR
T1 - Evaluating for Pseudoprogression in Colorectal and Pancreatic Tumors Treated with Immunotherapy
AU - Parseghian, Christine M.
AU - Patnana, Madhavi
AU - Bhosale, Priya
AU - Hess, Kenneth R.
AU - Tina Shih, Ya Chen
AU - Kim, Bumyang
AU - Kopetz, Scott
AU - Overman, Michael J.
AU - Varadhachary, Gauri R.
AU - Javle, Milind
AU - Naing, Aung
AU - Piha-Paul, Sarina
AU - Hong, David
AU - Le, Hung
AU - Subbiah, Vivek
AU - Pant, Shubham
N1 - Publisher Copyright:
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2018
Y1 - 2018
N2 - Pseudoprogression has been observed in patients with various tumor types treated with immunotherapy. However, the frequency of pseudoprogression is unknown in gastrointestinal malignancies. Metastatic colorectal cancer (mCRC) and advanced pancreatic ductal adenocarcinoma (PDAC) patients who progressed on treatment with immunotherapy beyond RECIST version 1.1 criteria were analyzed. Degree of progression, tumor markers, time to progression, overall survival, Eastern Cooperative Oncology Group Performance Status (ECOG PS), and costs were analyzed for patients treated beyond progression (TBP) and not treated beyond progression. Fifty-nine of 159 (37%) patients with mCRC or PDAC were TBP (31 mCRC, 28 PDAC). Fifty-four of 59 (92%) patients were microsatellite stable. Zero of these 59 patients with initial treatment beyond progression demonstrated subsequent radiographic tumor shrinkage at a median 42 days from first scan documenting progression. A pseudoprogression rate of 6% could be excluded with 95% confidence. Compared with baseline, median growth on the first and second scan that showed progression was 29.8% and 43%, respectively. In those not treated beyond progression, median growth at first restaging was 31.2%. The trend in change in tumor size positively correlated with the trend in tumor markers in all patients TBP. Fifteen patients (25%) experienced grade 3/4 adverse events by continuing treatment beyond progression, whereas 19 (32%) experienced deterioration in ECOG PS. Pseudoprogression was not seen in microsatellite stable patients with mCRC or PDAC treated with immunotherapy. Changes in tumor markers correlated with changes in tumor volume. This data may help inform future treatment decisions and/or trial design in patients with mCRC or advanced PDAC treated with immunotherapy.
AB - Pseudoprogression has been observed in patients with various tumor types treated with immunotherapy. However, the frequency of pseudoprogression is unknown in gastrointestinal malignancies. Metastatic colorectal cancer (mCRC) and advanced pancreatic ductal adenocarcinoma (PDAC) patients who progressed on treatment with immunotherapy beyond RECIST version 1.1 criteria were analyzed. Degree of progression, tumor markers, time to progression, overall survival, Eastern Cooperative Oncology Group Performance Status (ECOG PS), and costs were analyzed for patients treated beyond progression (TBP) and not treated beyond progression. Fifty-nine of 159 (37%) patients with mCRC or PDAC were TBP (31 mCRC, 28 PDAC). Fifty-four of 59 (92%) patients were microsatellite stable. Zero of these 59 patients with initial treatment beyond progression demonstrated subsequent radiographic tumor shrinkage at a median 42 days from first scan documenting progression. A pseudoprogression rate of 6% could be excluded with 95% confidence. Compared with baseline, median growth on the first and second scan that showed progression was 29.8% and 43%, respectively. In those not treated beyond progression, median growth at first restaging was 31.2%. The trend in change in tumor size positively correlated with the trend in tumor markers in all patients TBP. Fifteen patients (25%) experienced grade 3/4 adverse events by continuing treatment beyond progression, whereas 19 (32%) experienced deterioration in ECOG PS. Pseudoprogression was not seen in microsatellite stable patients with mCRC or PDAC treated with immunotherapy. Changes in tumor markers correlated with changes in tumor volume. This data may help inform future treatment decisions and/or trial design in patients with mCRC or advanced PDAC treated with immunotherapy.
KW - Colorectal cancer
KW - Immunotherapy
KW - Pancreatic cancer
KW - Pseudoprogression
KW - Tumor response evaluation
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U2 - 10.1097/CJI.0000000000000222
DO - 10.1097/CJI.0000000000000222
M3 - Article
C2 - 29668571
AN - SCOPUS:85048823829
SN - 1524-9557
VL - 41
SP - 284
EP - 291
JO - Journal of Immunotherapy
JF - Journal of Immunotherapy
IS - 6
ER -