POF (paclitaxel plus FOLFOX) versus IP PAC (intraperitoneal paclitaxel plus FOLFOX) versus FOLFOX as a first-line treatment in advanced gastric cancer (AGC): Update from a multicenter, randomized phase II trial, FNF-004 trial.

Authors

null

Rongbo Lin

Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, China

Rongbo Lin , Yigui Chen , Jinfeng Zhu , Peicheng Lin , Wujin Chen , Wenzheng Fang , Hui Li , Jie Liu , Shen Zhao , Nan-Feng Fan

Organizations

Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, China, Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China, Department of Medical Oncology. Quanzhou First Hospital, Quanzhou, China, Department of Radiation Oncology, Fujian Cancer Hospital. Fujian Medical University Cancer Hospital, Fuzhou, China, Department of Medical Oncology, Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, China, Department of Medical Oncology, Fuzhou General Hospital, Fuzhou, China, Fujian Cancer Hospital, Fuzhou, China

Research Funding

Other Government Agency

Background: The PFS with POF was statistically significantly improved and IP PAC was trending to improve compared to FOLFOX in first-line setting in AGC were reported in 2019 ASCO-GI (abstract 6). Update and subgroup analysis were released herein. Methods: The patients with AGC were randomized to three groups. The POF or IP PAC was paclitaxel 135 mg/m2intravenously (POF) or paclitaxel 80 mg/m2 intraperitoneally (IP PAC) followed by mFOLFOX6 omitted 5-Fu bolus. Every 14 days repeated for all three regimens. Up to 9 cycles of treatment were administered, followed by S-1 until disease progression. The primary endpoint was PFS. Results: Between Nov 2015 and May 2018, 89 pts (30 POF, 29 IP PAC, 30 FOLFOX) were randomly allocated. PFS, OS and RR were seen in the table below. Either POF or IP PAC was statistically significantly better than FOLFOX in PFS. In subgroup with female, peritoneal metastasis, ascites, lymphadenopathy in peritoneal cavity, number of organs involved > 2, POF was statistically significantly better than FOLFOX in PFS. In subgroup with female, gastrium of primary tumor site, peritoneal metastasis, ascites, no lymphadenopathy out of peritoneal cavity, IP PAC was statistically significantly better than FOLFOX in PFS. Intravenously docetaxel plus S-1 still saw response after IP PAC. Conclusions: either POF or IP PAC improved survival compared to FOLFOX, especially in patients with female or peritoneum metastasis. Only POF, not IP PAC, improved response rate compared to FOLFOX. Clinical trial information: NCT02845908

POF
(n=30)
IP PAC
(n=29)
FOLFOX
(n=30)
P value (HR, 95%CI)
POF vs FOLFOXIP PAC vs FOLFOX
PFS (m, 95% CI)6.1486.2144.4050.0420.027
(3.898 -8.398)(4.191–8.237)(1.803–7.008)(0.603, 0.354-1.026)(0.510, 0.291-0.894)
OS (m, 95% CI)9.53410.8826.6410.1800.094
(8.034-11.034)(8.839 - 12.925)(4.788 - 8.494)(0.679, 0.386-1.195)(0.598, 0.332-1.077)
CR (n, %)4 (13.3%)2 (6.9%)2 (6.7%)
PR (n, %)13 (43.3%)9 (31.0%)9 (30.0%)
RR (n, %)17 (56.7%)11(37.9%)11(36.6%)0.1210.920
SD (n, %)9 (30.0%)12 (41.4%)12 (40%)
PD (n, %)4 (13.3%)6 (20.7%)7 (23.3%)

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT02845908

Citation

J Clin Oncol 37, 2019 (suppl; abstr 4035)

DOI

10.1200/JCO.2019.37.15_suppl.4035

Abstract #

4035

Poster Bd #

140

Abstract Disclosures