Comparison of early tumor shrinkage between oxaliplatin plus S-1 and cisplatin plus S-1 in first-line chemotherapy with advanced gastric cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 75-75
Author(s):  
Hiroki Osumi ◽  
Daisuke Takahari ◽  
Eiji Shinozaki ◽  
Keisho Chin ◽  
Mariko Ogura ◽  
...  

75 Background: Early tumor shrinkage (ETS) is regarded as predictive marker in metastatic colorectal cancer. In the phase III study comparing oxaliplatin plus S-1 (SOX) to cisplatin plus S-1 (SP) in patients with advanced gastric cancer (AGC), although response rates were almost same between two groups, ETS wasn’t evaluated. Therefore, in AGC, it is controversial whether ETS is predictive or not and which is more suitable regimen, especially as neo adjuvant chemotherapy (NAC). The aim of this study is to compare ETS in SOX with SP and to evaluate the relationship between ETS and clinical outcomes in AGC. Methods: We retrospectively enrolled consecutive 469 patients (SOX 128, SP 341) with histopathologically confirmed HER2 negative AGC treated as 1st-line chemotherapy or NAC in our institution between January 2010 and June 2016. ETS was defined relative change in the sum of the longest diameters of target regions at week 8 (±4) compared to baseline. (Cut-off: 20%). Tumor response was assessed computed tomography using the RECIST 1.1. Patients with peritoneal metastasis and/or bone metastasis without target region were excluded in this study. Results: 192 patients (SOX 60, SP 132) were included in this study. Median tumor shrinkage between SOX and SP were 30% (min-35%, max77%) and 21% (min-89%, max73%), respectively ( p= .16). The ratio of ETS between SOX and SP was 53.3% and 50.7%, respectively ( p= .75). ETS > 20% was associated with longer OS and PFS when compared with ETS≦20% in SOX group. (ETS > 20% vs≦20%: OS 15.3 vs 10.1 months, HR 0.47 p= .03 PFS 7.6 vs 4.2 months, HR 0.58 p= .09) On the other hand, ETS > 20% was associated with significantly longer PFS only when compared with ETS≦20% in SP group and significant independent predictive factor. (ETS > 20% vs≦20%: OS 15.7 vs 10.9 months, HR 0.79 p= .29 PFS 7.7 vs 4.0 months, HR 0.57 p= .01) In multivariate analysis, ETS remained significant independent predictive factor for PFS in SP group (HR 0.53, p= .006). Conclusions: The ratio of ETS was similar between SOX and SP. ETS may be an early-on-treatment predictor in AGC.

2015 ◽  
Vol 26 ◽  
pp. vii104
Author(s):  
Naotoshi Sugimoto ◽  
Tetsuhiro Yoshinami ◽  
Sachiko Yamamoto ◽  
Toshinari Yagi ◽  
Fumio Imamura

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 237-237
Author(s):  
Yasuhiro Kaga ◽  
Yu Sunakawa ◽  
Yutaro Kubota ◽  
Teppei Tagawa ◽  
Taikan Yamamoto ◽  
...  

237 Background: Results from the phase III PRODIGE 4/ACCORD 11 trial provided one of current standard regimens for advanced pancreatic cancer (PC), consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX), which has superior response rate (RR) and survival benefit even with severe toxicity (Thierry C, et al. N Engl J Med 2011;364:1817-1825). There are several reports on the correlation between early tumor shrinkage (ETS) or depth of response (DpR) and survival in chemotherapies for colorectal cancer; however, few studies have investigated it in PC. We therefore analyzed retrospectively whether the ETS will predict outcomes in pts with PC treated with FOLFIRINOX therapy. Methods: Advanced PC pts with ECOG PS of 0 or 1, who received FOLFIRINOX as 1st- or 2nd-line treatment between November 2012 and July 2015 in 3 institutes of Showa University were included in this analysis. ETS was defined as a reduction ≥ 20% of target lesions’ diameters measured at 8 weeks from treatment start. We evaluated the association of ETS with progression-free survival (PFS) and overall survival (OS) but also addressed the correlation between outcomes and DpR, which was percentage of maximal tumor shrinkage observed at the nadir diameter compared with baseline. Results: Fifty-nine PC pts with median age of 63 (range 34-76) years and males of 68% were enrolled: 80% of pts had metastatic disease. In the population, RR, median PFS, and OS were 28%, 5.4 months, and 10.7 months, respectively. Among 46 (78%) evaluable pts for the ETS, 12 (26%) pts experienced ETS. The PFS was significantly longer in pts with ETS compared to pts with no ETS (9.0 vs. 4.2 months, HR 0.43, 95%CI 0.17-0.96, log-rank P= 0.045). Moreover, pts with ETS had a better OS although no statistical significance (HR 0.53, log-rank P= 0.25). Median DpR was 11.1% (from -75.7 to 100), and the correlation of DpR with clinical outcome was observed (P= 0.024 for PFS, P= 0.22 for OS). Conclusions: This retrospective analysis suggests that the early response to FOLFIRINOX treatment may predict better outcomes in pts with advanced PC. The ETS may serve as a novel predictor of prolonged survival time in PC pts treated with FOLFIRINOX.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15540-e15540
Author(s):  
Tetsuya Kusumoto ◽  
Akinori Egashira ◽  
Hideto Sonoda ◽  
Kenkichi Hashimoto ◽  
Hideo Uehara ◽  
...  

e15540 Background: Second-line chemotherapy can now be considered as a proven treatment option for metastatic or locally advanced gastric cancer (AGC). Two global randomized phase III trials (REGARD and RAINBOW) showed that survival benefit was significantly observed in patients treated with ramucirumab (RAM) alone and in combination with weekly doses of PTX, compared with placebo, respectively. The purpose of the study is to evaluate the efficacy and safety of weekly dose of PTX combined with RAM practically as the second-line treatment in Japanese patients with AGC refractory to an S-1-containing chemotherapy regimen. Methods: We conducted a retrospective review of the data of 18 patients with AGC who received more than 2 cycles of PTX/RAM combined chemotherapy as the second-line regimen following S-1-based treatment. The objective response rate (ORR), adverse events, progression-free survival (PFS) and overall survival (OS) were analyzed and compared with PTX monotherapy group. Results: Median number of courses were 5 for the PTX/RAM group and the discontinuation of treatment except for disease progression was found in 2 cases (33.3%). The rates of hematological toxicities of higher than grade 3 were 33.3% in the PTX/RAM group, which were higher than those found in the PTX groups. The tumor responses of the PTX/RAM group were 22% for the ORR and 78% for the DCR, compared with 21% and 48% in the PTX group, respectively. The dose intensities of PTX were 72.4% in the former group. The survival data showed that the MST after second-line exposure was 290 days and the median PFS was 131 days in the PTX/RAM group, compared with 159 days and 90 days in the PTX group, which were not significantly different. Conclusions: PTX/RAM might be one of the best regimens for Japanese patients with AGC as the second-line treatment following S-1-containing chemotherapy.


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