Real-world effectiveness of drugs newly approved in Japan on survival in patients with advanced gastric cancer.

Authors

null

Toru Kadono

Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan;

Toru Kadono , Satoru Iwasa , Hidekazu Hirano , Hirokazu Shoji , Natsuko Okita Okita , Atsuo Takashima , Ken Kato

Organizations

Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan; , Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan;

Research Funding

No funding received
None.

Background: Ramucirumab (RAM), nivolumab (NIVO), and trifluridine/tipiracil (FTD/TPI) were approved for advanced gastric cancer (AGC) between 2010 and 2020 in Japan. However, the impact of these newly approved drugs on survival in the real-world clinical setting is not clear. Methods: This retrospective study investigated the effectiveness of RAM, NIVO, and FTD/TPI in patients with performance status (PS) 0 to 2 who received doublet or triplet chemotherapy including platinum agents in first-line (1L) for advanced gastric adenocarcinoma at our hospital between 2010 and 2020. Patients were divided into two groups before or after 2017 to compare the effectiveness. Results: From a total of 825 patients, 533 were assigned to the pre-2017 group and 292 to the post-2017 group. Baseline characteristics of the pre- and post-2017 groups were, respectively, as follows: median age, 64 (range, 20-83) and 65 (25-85) years; PS 0, 206 (39%) and 89 (31%), and PS 1-2, 327 (61%) and 202 (69%); peritoneal metastasis, 334 (63%) and 189 (65%); liver metastasis, 157 (30%) and 68 (23%); and HER2 positive, 82 (15%) and 57 (20%). There was no difference in the proportion of fluoropyrimidine and platinum agents between the two groups. For the pre- and post-2017 groups, 1L chemotherapy comprised fluoropyrimidine plus platinum agents (FP) for 71% and 68% of patients, FP plus taxanes for 15% and 1%, FP plus trastuzumab for 11% and 15%, and FP plus immune checkpoint inhibitors (ICIs) for 1% and 10%, respectively. Taxanes and irinotecan were used significantly more often in any treatment line in the pre-2017 group (taxanes, 74% vs. 64%, p<0.01; irinotecan, 32% vs. 7%, p<0.01), whereas RAM, ICIs, and FTD/TPI were used significantly more often in any line in the post-2017 group (RAM, 50% vs. 17%, p<0.01; ICIs, 48% vs. 9%, p<0.01; FTD/TPI, 6% vs. 0%, p<0.01). Overall survival was significantly longer in the post-2017 group than in the pre-2017 group (median, 16.9 months vs. 13.8 months, HR 0.74, p<0.01). Progression-free survival did not differ between the pre- and post-2017 groups in relation to 1L (median, 6.0 vs. 5.9 months, p=0.74); second-line treatment (median, 3.0 months [95%CI, 2.6-3.3] vs. 3.1 months [95%CI, 2.3-3.6]; HR 0.96 [95%CI, 0.82-1.14], p=0.57); third-line treatment (median, 2.1 months [95%CI, 1.8-2.5] vs. 1.8 months [95%CI, 1.4-2.1]; HR 1.03 [95%CI, 0.82-1.29], p=0.80); or fourth-line treatment (median, 1.9 months [95%CI, 1.7-2.5] vs. 1.8 months [95%CI, 1.5-2.8]; HR 0.85 [95%CI, 0.57-1.25], p=0.39). Rates of second-, third-, and fourth-line treatment in the pre- and post-2017 groups were 83% and 79% (p=0.23), 45% and 56% (p<0.01), 16% and 22% (p=0.07), respectively. Conclusions: Newly approved drugs in salvage-line treatment of AGC may have contributed to prolonged survival.

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Abstract Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr 322)

DOI

10.1200/JCO.2023.41.4_suppl.322

Abstract #

322

Poster Bd #

D3

Abstract Disclosures