Meeting
2020 Gastrointestinal Cancers Symposium
Analysis of early tumor shrinkage (ETS) and depth of response (DpR) in metastatic colorectal cancer (mCRC) patients (pts) treated with second-line FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev): Results from a randomized phase II WJOG6210G trial.
Authors
Naoki Izawa
St. Marianna University School of Medicine, Kawasaki, Japan
Naoki Izawa , Kohei Shitara , Toshiki Masuishi , Tadamichi Denda , Kentaro Yamazaki , Toshikazu Moriwaki , Hiroyuki Okuda , Chihiro Kondoh , Tomohiro Nishina , Akitaka Makiyama , Hideo Baba , Hironori Yamaguchi , Masato Nakamura , Akihito Tsuji , Taito Esaki , Yoshinori Miyata , Masahito Kotaka , Takeharu Yamanaka , Takako Eguchi Nakajima , Kei Muro
Organizations
St. Marianna University School of Medicine, Kawasaki, Japan, National Cancer Center Hospital East, Kashiwa, Japan, Aichi Cancer Center Hospital, Nagoya, Japan, Chiba Cancer Center Hospital, Chiba, Japan, Shizuoka Cancer Center, Shimonagakubo, Japan, University of Tsukuba, Tsukuba, Japan, Keiyukai Sapporo Hospital, Sapporo, Japan, Toranomon Hospital, Tokyo, Japan, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan, Japan Community Healthcare Organization Kyushu Hospital, Kita-Kyushu, Japan, Kumamoto University, Kumamoto, Japan, Jichi Medical University, Shimotsuke, Japan, Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan, Kagawa University, Kagawa, Japan, National Kyushu Cancer Center, Fukuoka, Japan, Saku Central Hospital Advanced Care Center, Saku, Japan, Sano Hospital, Kobe, Japan, Yokohama City University School of Medicine, Yokohama, Japan, St Marianna University School of Medicine, Kawasaki, Japan
Research Funding
Other Government Agency
Japan Agency for Medical Research and Development
Background: The WJOG 6210G trial demonstrated a similar efficacy between Pani and Bev arms at 2nd-line setting in pts with KRAS exon2 wild-type mCRC (Shitara K, et al, Cancer Sci 2016). The exploratory analyses of clinical trials evaluating 1st-line chemotherapy for mCRC have shown significant associations of ETS and DpR with prognosis; however, there is few data in 2nd-line treatment. We investigated whether ETS and DpR are associated with clinical outcomes in mCRC pts treated with 2nd-line treatment using the data of WJOG 6210G trial. Methods: ETS was defined as tumor reduction of 20% at week 8 compared to baseline in the sum of longest diameters of target lesions according to the RECIST criteria. DpR was defined as the percentage of maximum tumor shrinkage of target lesions. Fisher’s exact test and t-test were used to compare ETS and DpR between Pani and Bev arms. A Cox regression model was used to evaluate associations between ETS and progression-free survival (PFS), and overall survival (OS). The association of DpR with PFS and OS was analyzed using Spearman’s rank correlation coefficient. Results: Eighty-seven pts were evaluable for ETS and DpR (Pani, n = 41; Bev, n = 46) among 121 pts enrolled in the WJOG6210G. Pts in the Pani arm had a higher ETS rate (39.0 % vs. 8.7 %, p< 0.001) and greater DpR [median: 23.7 % (range: -49.0 to 100) vs. 0 % (range: -40.7 to 61.5), p< 0.001] than pts in the Bev arm. Pts with ETS achieved longer PFS [median: 10.5 vs. 5.4 m, HR: 0.40 (95% CI: 0.20-0.80), p = 0.009] and OS [median: 22.3 vs. 14.5 m, HR: 0.49 (95% CI: 0.23-0.98), p = 0.044] than pts without ETS in the Pani arm. Similarly, the Bev arm pts with ETS had longer PFS [median: 17.1 vs. 5.6 m, HR: 0.078 (95% CI: 0.004-0.38), p = 0.0002] and OS [median: 30.9 vs. 13.2 m, HR: 0.35 (95% CI: 0.083-0.99), p = 0.048]. There were moderately linear correlations of DpR with PFS and OS in both Pani (PFS: r = 0.75, p< 0.001; OS: r = 0.60, p< 0.001) and Bev arms (PFS: r = 0.68, p< 0.001; OS: r = 0.44, p = 0.002). Conclusions: ETS and DpR were significantly associated with PFS and OS in mCRC pts treated with 2nd-line FOLFIRI in combination with Pani or Bev. Clinical trial information: UMIN000031621.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session C: Anal and Colorectal Cancer
Track
Colorectal Cancer,Anal Cancer
Sub Track
Tumor Biology, Biomarkers, and Pathology
Clinical Trial Registration Number
UMIN000031621
Citation
J Clin Oncol 38, 2020 (suppl 4; abstr 201)
Abstract #
201
Poster Bd #
K1
Abstract Disclosures
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