scholarly journals Early tumor shrinkage and depth of response in patients with advanced gastric cancer: a retrospective analysis of a randomized phase III study of first-line S-1 plus oxaliplatin vs. S-1 plus cisplatin

2018 ◽  
Vol 22 (1) ◽  
pp. 138-146 ◽  
Author(s):  
Tomohiro Nishina ◽  
Mizutomo Azuma ◽  
Kazuhiro Nishikawa ◽  
Masahiro Gotoh ◽  
Hideaki Bando ◽  
...  
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.


Cancers ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 939 ◽  
Author(s):  
Caterina Vivaldi ◽  
Lorenzo Fornaro ◽  
Carla Cappelli ◽  
Irene Pecora ◽  
Silvia Catanese ◽  
...  

Early tumor shrinkage (ETS) and depth of response (DoR) predict favorable outcomes in metastatic colorectal cancer. We aim to evaluate their prognostic role in metastatic pancreatic cancer (PC) patients treated with first-line modified-FOLFIRINOX (FOLFOXIRI) or Gemcitabine + Nab-paclitaxel (GemNab). Hence, 138 patients were tested for ETS, defined as a ≥20% reduction in the sum of target lesions’ longest diameters (SLD) after 6–8 weeks from baseline, and DoR, i.e., the maximum percentage shrinkage in the SLD from baseline. Association of ETS and DoR with progression-free survival (PFS) and overall survival (OS) was assessed. ETS was reached in 49 patients (39.5% in the FOLFOXIRI, 29.8% in the GemNab group; p = 0.280). In the overall population, ETS was significantly associated with better PFS (8.0 vs. 4.8 months, p < 0.001) and OS (13.2 vs. 9.7 months, p = 0.001). Median DoR was −27.5% (−29.4% with FOLFOXIRI and −21.4% with GemNab, p = 0.016): DoR was significantly associated with better PFS (9.0 vs. 6.7 months, p < 0.001) and OS (14.3 vs. 11.1 months, p = 0.031). Multivariate analysis confirmed both ETS and DoR are independently associated with PFS and OS. In conclusion, our study added evidence on the role of ETS and DoR in the prediction of outcome of PC patients treated with first-line combination chemotherapy.


2013 ◽  
Vol 104 (6) ◽  
pp. 718-724 ◽  
Author(s):  
Clemens Giessen ◽  
Ruediger P. Laubender ◽  
Ludwig Fischer von Weikersthal ◽  
Andreas Schalhorn ◽  
Dominik P. Modest ◽  
...  

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3586-3586 ◽  
Author(s):  
Julian Walter Holch ◽  
Sebastian Stintzing ◽  
Swantje Held ◽  
Ludwig Fischer von Weikersthal ◽  
Thomas Decker ◽  
...  

3586 Background: Recent evidence suggests that benefit from anti-EGFR treatment is restricted to RAS wild-type left-sided colorectal cancer (LC) (Holch JW et al. Eur J Cancer 2017). However, these results are preliminary. We therefore investigated patients with RC enrolled in the FIRE-3 trial, which evaluated the efficacy of first-line FOLFIRI plus either cetuximab (cet) or bevacizumab (bev) in RAS wildtype mCRC. New metrics of tumor dynamics were used to characterize the patients. Methods: The splenic flexure was used to differentiate LC from RC. Survival analysis was done using Kaplan-Meier estimation and differences were expressed using Log-Rank test, hazard ratios (HR) and corresponding 95% confidence intervals. Central independent radiological data was used to calculate early tumor shrinkage ≥20% (ETS) and depth of response (DpR). Results: In total, 330 patients were assessable for central radiological evaluation. In patients with LC (n = 257), treatment with FOLFIRI + cet led to longer overall survival (OS) compared to FOLFIRI + bev (HR = 0.68, p = 0.016). In patients with RC (n = 68), OS was comparable between treatment arms (HR = 1.11, p = 0.715). In patients with RC and ETS < 20%, OS was inferior in patients treated with FOLFIRI + cet. In patients who reached ETS ≥20%, a comparable OS was evident between treatment arms (for further details of efficacy in patients with RC see table). Conclusions: Patients with RC do not represent a uniform population. ETS ≥20% defines a subgroup of patients where comparable treatment efficacy was observed with regard to OS, ORR and DpR by addition of cetuximab vs. bevacizumab to FOLFIRI. [Table: see text]


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 679-679 ◽  
Author(s):  
Michitaka Nagase ◽  
Kentaro Yamazaki ◽  
Hiroshi Tamagawa ◽  
Shinya Ueda ◽  
Takao Tamura ◽  
...  

679 Background: Early tumor shrinkage (ETS) has been reported as an important predictor of favorable outcomes in patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy. We investigated the impact of ETS on survival in a randomized phase III study (WJOG4407G), which directly compared mFOLFOX6+bevacizumab (Bev) with FOLFIRI+Bev as first-line treatment. Methods: The subjects of this study were patients with measurable lesions whose tumor responses at 8 weeks were evaluated. ETS was defined as 20% or more decrease in the sum of the longest diameters of target lesions (RECIST ver.1.0) at 8 weeks. Progression-free survival (PFS) and overall survival (OS) were compared between patients with ETS and without ETS in each treatment. Results: Of 402 patients enrolled in the WJOG4407G trial, 354 (mFOLFOX6+Bev/FOLFIRI+Bev 175/179) patients were evaluated for this analysis. In this population, response rate, median PFS, and median OS of mFOLFOX+Bev/FOLFIRI+Bev were 65.7/68.2%, 10.7/12.1 months (HR 0.916, 95%CI 0.725-1.157, p=0.281), and 28.9/31.9 months (HR 0.870, 95%CI 0.653-1.159, p=0.272), respectively. One hundred (57.1%)/113 (63.1%) patients in the FOLFOX+Bev/FOLFIRI+Bev groups achieved ETS. No significant difference of the ratio of the patients with ETS between both groups was observed (p=0.099). In the FOLFIRI+Bev group, both PFS and OS were significantly longer in patients with ETS than those without ETS while there were no remarkable differences in the mFOLFOX6+Bev group (see Table). Conclusions: There were substantial differences in PFS and OS between the patients with and without ETS in the FOLFIRI+Bev group, but not in the FOLFOX+Bev group. The impact of ETS on survival is suggested to be different according to chemotherapy regimens. Clinical trial information: UMIN000001396. [Table: see text]


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