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Versus Tumor Tissue Clinical Sequencing For COLORECTAL CANCER 5 General Session, Sat, 1:45 PM-3:15 PM Utility of circulating tumor DNA (ctDNA) versus tumor tissue clinical sequencing for enrolling patients (Pts) with advanced gastrointestinal (GI) cancer to matched clinical trials: SCRUM-Japan GI-SCREEN and GOZILA Combined Analysis. Yoshiaki Nakamura, Hiroya Taniguchi, Hideaki Bando, Ken Kato, Taito Esaki, Yoshito Komatsu, Naoki Takahashi, Makoto Ueno, Yoshinori Kagawa, Tomohiro Nishina, Takeshi Kato, Yoshiyuki Yamamoto, Junji Furuse, Tadamichi Denda, Hisato Kawakami, Eiji Oki, Yu Sunakawa, Taroh Satoh, Takayuki Yoshino, Atsushi Ohtsu; National Cancer Center Hospital East, Kashiwa, Japan; Aichi Cancer Center Hospital, Nagoya, Japan; National Cancer Center Hospital, Tokyo, Japan; National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan; Hokkaido University Hospital, Sapporo, Japan; Saitama Cancer Center, Saitama, Japan; Kanagawa Cancer Center, Yokohama, Japan; Kansai Rosai Hospital, Osaka, Japan; National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan; National Hospital Organization Osaka National Hospital, Osaka, Japan; University of Tsukuba, Tsukuba, Japan; Kyorin University, Tokyo, Japan; Chiba Cancer Center, Chiba, Japan; Kindai University Faculty of Medicine, Osakasayama, Japan; Kyushu University, Fukuoka, Japan; St. Marianna University School of Medicine, Kawasaki, Japan; Osaka University, Osaka, Japan; National Cancer Center Hospital East, Chiba, Japan Background: Blood-based genomic profiling by ctDNA analysis has a promise to potentially identify actionable genomic alterations. However, utility of clinical sequencing with ctDNA com- pared with that with tumor tissue for enrolling cancer pts to matched clinical trials remains unclear. Herein we investigated the utility of ctDNA clinical sequencing by the SCRUM-Japan GI-SCREEN and GOZILA Combined Analysis. Methods: In the GI-SCREEN, tumor tissue samples of pts with advanced GI cancer were analyzed by a next generation sequencing (NGS)-based assay, Oncomine Comprehensive Assay since Feb 2015. In the GOZILA, plasma samples of pts with advanced GI cancer were analyzed by an NGS-based ctDNA assay, Guardant360 since Feb 2018. Tests were performed centrally by CLIA-certified and CAP-accredited laboratories. Pts with actionable alter- ations were enrolled to matched company-sponsored or investigator-initiated clinical trials. Results: As of Apr 2019, test results were generated in 5,029 out of 5,743 pts (88%) in GI- SCREEN and 1,089 out of 1,103 pts (99%) in GOZILA (P , 0.0001).Median turnaround time (TAT) was 35 days in GI-SCREEN and 12 days in GOZILA (P , 0.0001). There were no differences in other baseline characteristics between GI-SCREEN and GOZILA. Proportion of enrolling matched clinical trials in GOZILA was significantly higher than that in GI-SCREEN (126 pts [2.2%] in GI-SCREEN vs. 60 pts [5.4%] in GOZILA, P , 0.0001). Median time from GI-SCREEN or GOZILA enrollment to clinical trial enrollment was 5.9 and 1.0 months (mo), respectively (P , 0.0001). The objective response rate (ORR) and progression-free survival (PFS) were not significantly different (ORR: 17.5 vs. 16.7%, P = 1.00; median PFS: 2.8 vs. 2.0 mo, P = 0.24). Conclusions: Clinical sequencing with ctDNA having the advantage of the shorter TAT enrolled more pts with advanced GI cancer to matched clinical trials than those with tumor tissue, without compromising the efficacy. Clinical trial information: UMIN000029315. Research Sponsor: SCRUM-Japan. © 2020 American Society of Clinical Oncology. Visit gicasym.org and search by abstract for disclosure information. COLORECTAL CANCER 6 General Session, Sat, 8:45 AM-10:15 AM Receipt and survival outcomes by age following second-line therapy for metastatic CRC (mCRC): Analysis of 5,289 patients from the ARCAD Clinical Trials Program. Nadine Jackson McCleary, William S. Harmsen, Eric VanCutsem, Alberto F. Sobrero, Richard M. Goldberg, Josep Tabernero, Matt Seymour, Leonard B. Saltz, Bruce J. Giantonio, Arnold Dirk, Mace L. Rothenberg, Miriam Koopman, Hans-Joachim hans-joachim Schmoll, Henry C. Pitot, Paulo Marcelo Hoff, Alfredo Falcone, Aimery De Gramont, Qian Shi, Stuart M. Lichtman; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; University of Leuven, Leuven, Belgium; IRCCS Ospedale San Martino IST, Genova, Italy; West Virginia University Cancer Institute, Morgantown, WV; Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain; NIHR Clinical Research Network, Leeds UK St James’s Hospital, and University of Leeds, Leeds, United Kingdom; Memorial Sloan Kettering Cancer Center, New York, NY; University of Pennsylvania Abramson Cancer Center, Philadelphia, MA; Instituto CUF de Oncologia, Lisbon, Portugal; Pfizer Inc., New York, NY; University Medical Center Utrecht, Utrecht, Netherlands; Martin Luther University, Halle, Germany; Instituto do Cancer do Estado de Sao~ Paulo, Sao~ Paulo, Brazil; Azienda Ospedaliera Universitaria Pisana, Pisa, Italy; Franco-British Institute, Levallois-Perret, France Background: Rates and survival outcomes for second-line therapy for mCRC for OA vs. YA are poorly understood. Methods: Pts with available subsequent treatment data after progression from 10 1st line trials were included. Associations between key clinical/disease characteristics, time to initial progression (TTiP) and rate of receipt of second-line therapy were evaluated. Time to progression (TTP) and overall survival (OS) were compared between OA and YA who were enrolled on second-line trials by Cox regression, adjusting for age, sex, ECOG PS, number of metastatic sites, presence of metastasis in lung/liver/peritoneum. Results: OA comprised 16.4% of first-line trials. OA and ECOG PS .0 were less likely to receive second-line therapy than YA. Odds of receiving second-line therapy decreased by 11% for each additional decade of life in multivariate analysis (p=0.0117). OA enrolled in second-line trials experience similar mTTP and mOS as YA (5.1 vs. 5.2mos; 11.6 vs 12.4mos, respectively). Conclusions: OA are less likely to receive 2nd line therapy for mCRC. We did not observe a statistical difference in survival outcomes for OA vs. YA following second-line therapy. Further study is needed to examine unmeasured factors, including comor- bidity and functional status given observed inferior outcomes among adults with ECOG PS .0, and consideration given to inclusion of geriatric assessment to select OA likely to benefit from 2nd line therapy for mCRC. Research Sponsor: NIH/NCI Gastrointestinal SPORE Dana-Farber/Harvard Cancer Center. TTiP¥ TTP OS N= 5289 N=7921 N=8280 OR HR HR (95% CI) P-value (95% CI) P-value (95% CI) P-value Age at enrollment – mean (SD) 59.8 (10.7) 1.11 (1.02, 1.21) 0.012 Age per 0.97 (0.94,0.99) 0.005 0.99 (0.97,1.02) 0.618 decade ECOG 0 2566 (90.4) Referent PS – no. (%) 1 1815 (85.8) 1.55 (1.30,1.84) 1.22 (1.16,1.28) 1.51 (1.43, 1.59) .1 115(69.7) 4.07 (2.85, 5.82) ,0.0001 1.59 (1.38,1.83) ,0.001 3.54 (3.13,4.02) ,0.0001 Metastasis Lung 1562 (87.4) 1.03 (0.86,1.23) 0.761 1.10 (1.04,1.18) 0.003 1.08 (1.01,1.16) 0.02 Liver 3421 (88.0) 0.90 (0.75, 1.09) 0.291 1.36 (1.28,1.45) ,0.001 1.62 (1.52,1.74) ,0.001 Peritoneum 407 (88.1) 0.92 (0.68, 1.24) 0.571 1.27 (1.03,1.57) 0.025 1.42 (1.14,1.75) 0.001 ¥Odds of no subsequent therapy among subset of first-line mCRC pts. © 2020 American Society of Clinical Oncology. Visit gicasym.org and search by abstract for disclosure information. COLORECTAL CANCER 7 Oral Abstract Session, Sat, 10:45 AM-12:15 PM A randomized phase III trial comparing primary tumor resection plus chemotherapy with chemotherapy alone in incurable stage IV colorectal cancer: JCOG1007 study (iPACS). Yukihide Kanemitsu, Kohei Shitara, Junki Mizusawa, Tetsuya Hamaguchi, Dai Shida, Koji Komori, Satoshi Ikeda, Hitoshi Ojima, Seiji Hasegawa, Akio Shiomi, Jun Watanabe, Yasumasa Takii, Takashi Yamaguchi, Kenji Katsumata, Masaaki Ito, Jyunji Okuda, Ryoji Hyakudomi, Yasuhiro Shimada, Hiroshi Katayama, Haruhiko Fukuda; Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan; National Cancer Center Hospital East, Chiba, Japan; Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan; Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan; Aichi Cancer Center Hospital, Aichi, Japan; Hiroshima Prefectural Hospital, Hiroshima, Japan; Gunma Prefectural Cancer Center, Gunma, Japan; Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan; Division of Colon and Rectal Surgery, Shizuoka Cancer Center Hospital, Shizuoka, Japan; Yokosuka Kyosai Hospital, Yokosuka, Japan; Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan; Department of Surgery, Kyoto Medical Center, Kyoto, Japan; Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University, Tokyo, Japan; Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan; Department of General and Gastroenterological Surgery, Osaka Medical College Hospital, Osaka, Japan; Shimane University Faculty of Medicine, Shimane, Japan; Clinical Oncology Division, Kochi Health Sciences Center, Kochi, Japan Background: It is still controversial whether primary tumor resection (PTR) before chemotherapy (CTX) improves overall survival (OS) of colorectal cancer (CRC) patients (pts) with synchronous unresectable metastases. There are several retrospective analyses suggesting better outcomes in
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