Second-line chemotherapy with paclitaxel for elderly patients with advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 108-108 ◽  
Author(s):  
Akihiro Ohba ◽  
Atsuo Takashima ◽  
Takamasa Nishiuchi ◽  
Yoshitaka Honma ◽  
Satoru Iwasa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Elderly Patients ◽  
Advanced Gastric Cancer ◽  
Progression Free Survival ◽  
The Elderly ◽  
Elderly Group ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

108 Background: Survival benefits of second-line chemotherapy such as weekly paclitaxel (wPTX) for patients with advanced gastric cancer (AGC) were shown in several phase 3 trials. However, these trials included a small proportion of elderly patients, and few elderly patients receive second-line therapy in clinical practice. The aim of this study was to compare the efficacy and safety of second-line chemotherapy with wPTX between elderly and non-elderly patients. Methods: The subjects of this retrospective study were AGC patients who received wPTX as second-line chemotherapy between January 2002 and August 2014, fulfilling the following selection criteria; 1) pathologically proven metastatic or recurrent gastric adenocarcinoma, 2) receipt of wPTX after platinum or fluoropyrimidine containing chemotherapy. Patients were divided into two groups by age: ≥ 75 years old (elderly group) and < 75 years old (non-elderly group). Response rate (RR) in patients with measurable lesions, overall survival (OS), progression-free survival (PFS), post-progression survival (PPS) and adverse events were evaluated. Hazard ratios of survival were adjusted by prognostic factors using Cox proportional hazard model. Results: A total of 272 patients, 31 elderly and 241 non-elderly, were selected in this study. RRs were 6.2% (1/16) in the elderly group and 12.7% (15/118) in the non-elderly group (p = 0.69). While PFS was similar between two groups (median 2.4 vs. 3.6 months, adjusted hazard ratio [HR] 1.18, p = 0.46), the elderly group showed shorter OS than the non-elderly group (median 5.1 vs. 6.1 months, adjusted HR 1.49, p = 0.06), associated with relatively shorter PPS (median 2.2 vs. 2.6 months, adjusted HR 1.40, p = 0.11). There were no remarkable differences in the incidences of grade 3 or higher adverse events between the two groups (hematologic 38.7 vs. 41.1%; non-hematologic 25.8 vs. 23.7%). No treatment related deaths were observed in either group. Third-line chemotherapy was administered in 19.4% of elderly group and 35.3% of non-elderly group (p = 0.11). Conclusions: It is suggested that second-line chemotherapy with wPTX for AGC may be tolerable and have some clinical benefits for elderly patients as well as for non-elderly patients.

Correlation between overall survival and other endpoints in clinical trials of second-line chemotherapy for patients with advanced gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4067-4067
Author(s):  
Kohei Shitara ◽  
Keitaro Matsuo ◽  
Kei Muro ◽  
Atsushi Ohtsu
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Rank Correlation ◽  
Progression Free Survival ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Randomized Studies ◽  
Low Correlation ◽  
Line Chemotherapy

4067 Background: The correlation between progression-free survival (PFS) or time to progression (TTP) and overall survival (OS) has been evaluated in patients with advanced gastric cancer (AGC) who received first-line chemotherapy (Shitara, K et al. Invest New Drug 2011; Shitara K and Burzykowski T, et al, ASCO 2011). However, no corresponding analysis had been done in patients who underwent second-line chemotherapy for AGC. Methods: We evaluated the potential of PFS, TTP, response rate (RR), or disease control rate (DCR) to act as surrogates for OS in phase II and III trials of second-line chemotherapy for AGC by comprehensive literature-based analysis. Correlations between each endpoint and OS were evaluated by Spearman rank correlation coefficient (ρ). Subgroup analyses by trial region or type of failure to previous chemotherapy were also conducted. Results: Fifty-six trials, including four randomized studies, were selected for analysis and covered a total of 61 treatment arms and 3,038 patients; 34 studies were conducted in Asia, 20 studies in Non-Asian countries, and two studies in both regions. Median PFS were similar in Asian and Non-Asian trials (3.0 vs. 3.3 months). In contrast, median OS tended to be longer in Asian vs. Non-Asian trials (8.0 vs. 6.0 months; p<0.01). Median PFS/TTP and OS showed a moderate correlation with ρ of 0.51 (95% CI, 0.31-0.73). Correlation tended to be higher in PFS (ρ = 0.62) than TTP (ρ = 0.29) and higher in non-Asian trials (ρ = 0.73) than Asian trials (ρ = 0.32). Correlation between PFS/TTP and OS among the trials in which eligibility required failure to previous fluorouracil and cisplatin also showed low correlation (ρ = 0.48). The RR and DCR also did not show high correlation with OS (ρ = 0.30 for RR; 95% CI 0.04-0.56; ρ = 0.53 for DCR; 95% CI 0.31-0.75). The hazard ratio (HR) of PFS and OS in each arms of the four randomized studies showed a low correlation with ρ of 0.10. Conclusions: Our results indicate that PFS/TTP, RR, and DCR did not correlate sufficiently with OS to be used as surrogate endpoints in patients with AGC who underwent second-line chemotherapy. Further research is needed based on individual patient data from ongoing randomized trials.

Efficacy and prognostic factor analysis in second-line chemotherapy for elderly patients with metastatic gastric cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 143-143
Author(s):  
Ayaka Shoji ◽  
Hiroko Hasegawa ◽  
Seiya Kato ◽  
Ryosuke Kiyota ◽  
Kazuma Shinkai ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Elderly Patients ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
The Other ◽  
Second Line ◽  
Eligibility Criteria ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

143 Background: Recently, the proportion of elderly patients (pts) with advanced gastric cancer has increased in Japan. Survival benefits of second-line chemotherapy (CTX) such as weekly paclitaxel (PTX)±Ramucirumab (RAM) or irinotecan (CPT) were shown in several phase 3 trials for metastatic gastric cancer (mGC). However, efficacy and prognostic factors in the second line CTX for elderly pts are not well studied. Methods: We retrospectively reviewed for mGC pts aged ≥ 70 years who underwent PTX+RAM, PTX or CPT as second-line CTX. Eligibility criteria were as follows: PS 0-2, refractory to an S-1containing CTX. Response rate (RR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were evaluated. Univariate and multivariate analyses were performed to determine prognostic factors of survival. Results: There were 250 pts with mGC treated at our institution between April 2007 and March 2017. Of all, total of 85 pts were eligible. Median age was 75 years (71-85). The RR was 28.0% in the PTX+RAM group (n=28), 17.2% in the PTX group (n=29) and 18.5% in the CPT group (n=28). Median PFS was 5.1 months(M) and MST was 12.2 M in the PTX+RAM group, compared with 4.1 M and 9.7 M in the PTX group, or 3.3M and 9.8M in the CPT group. The ORR, PFS and OS were better in the PTX+RAM group though differences between groups were not statistically significant. Grade 3 or higher non-hematological AEs such as fatigue or diarrhea were more frequent in the CPT group on the other hand, hematological AEs were more frequent in the PTX+RAM group. On multivariate analysis, PS (HR,3.13; 95%CI, 1.60-5.77), LDH (HR,3.19; 95%CI, 1.80-5.57), and CEA (HR,2.35; 95%CI, 1.30-4.16) were found to be significant prognostic factors for elderly pts with mGC who underwent second-line CTX. Conclusions: PTX+RAM therapy seemed to be more effective than the other regimens. Furthermore, this analysis for prognostic factors may help clinicians to better select elderly pts who may benefit from a second-line CTX.

Paclitaxel combined with ramucirumab as the second-line chemotherapy for elderly patients with advanced gastric cancer.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e16088-e16088
Author(s):  
Tetsuya Kusumoto ◽  
Hideo Uehara ◽  
Kenkichi Hashimoto ◽  
Yoshihiko Fujinaka ◽  
Keiji Yoshinaga ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Elderly Patients ◽  
Advanced Gastric Cancer ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

scholarly journals Results of the use of ramucirumab in combination with irinotecan and fluoropyrimidines in the second-line chemotherapy for disseminated gastric cancer

2019 ◽  
pp. 100-109
Author(s):  
N. S. Besova ◽  
T. A. Titova ◽  
D. L. Stroyakovsky ◽  
E. V. Perminova ◽  
S. G. Bagrova ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Median Duration ◽  
Progression Free Survival ◽  
Angiogenesis Inhibitors ◽  
Median Number ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Venous Thromboembolic Events ◽  
Line Chemotherapy

Background: Several studies show that the combination chemotherapy with ramucirumab allows to improve the treatment results of advanced gastric cancer (GC). Irinotecan with fluoropyrimidines is own of the second line chemotherapy options for these patients. As angiogenesis inhibitors can enhance the efficacy of chemotherapy, we investigated the combination of irinotecan and fluoropyrimidines with ramucirumab in metastatic GC.Methods: Eligible patients had advanced morphologically verified GC and disease progression during or within 4 months following first-line therapy. They received FOLFIRI plus ramucirumab (8 mg/kg on day 1) or XELIRI in combination with ramucirumab (8 mg/kg on days 1 and 8). The primary end point was progression-free survival (PFS). Secondary end-points were disease control rate (DCR) and safety.Results: Between September 2015 and April 2019, 39 patients (pts) were enrolled and 38 were evaluated for efficacy and toxicity. Median number of cycles was 9 (2-20). Seven patients achieved a partial response (PR) for an overall response rate of 17.9%. A total of 29 (74.4%) patients had stable disease (SD) for a DCR of 92.3%. With a median follow up 7,5 months, median PFS was 7.58 months (95% CI 6.6-8.5) and the median OS has not yet been reached. Median duration of PR response was 8,7 months (4,11-10,94+) and median duration of SD was 4,14 months (1,84-11,99+). The main treatment-related grade 3 or 4 adverse events were neutropenia (7/38; 18.4%), anemia (1/38; 2.6%) and diarrhea (2/38; 4.3%).The most frequent adverse events of special interest (AESIs) any grade were hypertension (16/38; 42.1%), bleeding/hemorrhage (10/38; 26.3%), proteinuria (6/38; 15.7%) and venous thromboembolic events (10/38; 26,3%). Gastrointestinal perforation developed in two patients (2/38; 5.3%). No treatment-related deaths occurred.Conclusion: In our research ramucirumab with irinotecan and fluoropyrimidines demonstrate the high activity and a manageable safety profile in patients with pre-treated metastatic GC

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