Adjuvant chemotherapy in stage III gastric cancer: Preliminary results

1993 ◽  
Vol 29 ◽  
pp. S102
Author(s):  
L. Cirera ◽  
T. Cardona ◽  
E. Batiste ◽  
A. Arcusa ◽  
I. Tusquets ◽  
...  
BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yanrui Liang ◽  
Liying Zhao ◽  
Hao Chen ◽  
Tian Lin ◽  
Tao Chen ◽  
...  

Abstract Background The benefits of adjuvant chemotherapy for elderly patients with gastric cancer (GC) remain unknown because elderly patients are underrepresented in most clinical trials. This study aimed to evaluate the effectiveness and complications of adjuvant chemotherapy in patients > 65 years of age after laparoscopic D2 gastrectomy. Methods This was a single-center retrospective cohort study of elderly patients (> 65 years) with stage II/III GC who underwent curative laparoscopic D2 gastrectomy with R0 resection between 2004 and 2018. The adjuvant chemotherapy regimens included monotherapy (oral capecitabine) and doublet chemotherapy (oral capecitabine plus intravenous oxaliplatin [XELOX] or intravenous oxaliplatin, leucovorin, and 5-fluorouracil [FOLFOX]). The data were retrieved from a prospectively registered database maintained at the Department of General Surgery in Nanfang Hospital, China. The patients were divided as surgery alone and surgery plus adjuvant chemotherapy (chemo group). The overall survival (OS), disease-free survival (DFS), chemotherapy duration, and toxicity were examined. Results There were 270 patients included: 169 and 101 in the surgery and chemo groups, respectively. There were 10 (10/101) and six (6/101) patients with grade 3+ non-hematological and hematological adverse events. The 1−/3−/5-year OS rates of the surgery group were 72.9%/51.8%/48.3%, compared with 90.1%/66.4%/48.6% for the chemo group (log-rank test: P = 0.018). For stage III patients, the 1−/3−/5-year OS rates of the surgery group were 83.7%/40.7%/28.7%, compared with 89.9%/61.2%/43.6% for the chemo group (log-rank test: P = 0.015). Adjuvant chemotherapy was significantly associated with higher OS (HR = 0.568, 95%CI: 0.357–0.903, P = 0.017) and DFS (HR = 0.511, 95%CI: 0.322–0.811, P = 0.004) in stage III patients. Conclusions This study suggested that adjuvant chemotherapy significantly improves OS and DFS compared with surgery alone in elderly patients with stage III GC after D2 laparoscopic gastrectomy, with a tolerable adverse event profile.


1999 ◽  
Vol 17 (12) ◽  
pp. 3810-3815 ◽  
Author(s):  
Lluís Cirera ◽  
Anna Balil ◽  
Eduard Batiste-Alentorn ◽  
Ignasi Tusquets ◽  
Teresa Cardona ◽  
...  

PURPOSE: The efficacy of adjuvant chemotherapy in gastric cancer is controversial. We conducted a phase III, randomized, multicentric clinical trial with the goal of assessing the efficacy of the combination of mitomycin plus tegafur in prolonging the disease-free survival and overall survival of patients with resected stage III gastric cancer. PATIENTS AND METHODS: Patients with resected stage III gastric adenocarcinoma were randomly assigned, using sealed envelopes, to receive either chemotherapy or no further treatment. Chemotherapy was started within 28 days after surgery according to the following schedule: mitomycin 20 mg/m2 intravenously (bolus) at day 1 of chemotherapy; 30 days later, oral tegafur at 400 mg bid daily for 3 months. Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis and the Cox proportional hazards model. RESULTS: Between January 1988 and September 1994, 148 patients from 10 hospitals in Catalonia, Spain, were included in the study. The median follow-up period was 37 months. The tolerability of the treatment was excellent. The overall survival and disease-free survival were higher in the group of patients treated with chemotherapy (P = .04 for survival and P = .01 for disease-free survival in the log-rank test). The overall 5-year survival rate and the 5-year disease-free survival rate were, respectively, 56% and 51% in the treatment group and 36% and 31% in the control group. CONCLUSION: Our positive results are consistent with the results of recent studies; which conclude that there is a potential benefit from adjuvant chemotherapy in resected gastric cancer.


2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 108-108 ◽  
Author(s):  
Jin Matsuyama ◽  
Shigeyuki Tamura ◽  
Kazumasa Fujitani ◽  
Yutaka Kimura ◽  
Takeshi Tsuji ◽  
...  

108 Background: An adjuvant chemotherapy with S-1 has become the standard treatment for patients (pts) with stage II/III gastric cancer (GC) who have undergone gastrectomy with D2 dissection in Japan, but it is assumed that the survival benefit for stage III pts who received S-1 is modest. S-1 plus docetaxel has shown that the response rate and median overall survival (OS) were 56% and 14.3 months in pts with advanced GC. The aims of this phase II study were to evaluate the feasibility and safety of adjuvant S-1 plus docetaxel in pts with stage III GC with D2 surgery. Methods: Pts with pathological stage III GC who underwent gastrectomy with D2 dissection received oral S-1 (80 mg/m2/day) administration for 2 consecutive weeks and intravenous docetaxel (40 mg/m2) on day 1, repeated every 3 weeks (1 cycle). The treatment was started within 45 days after surgery, and repeated for 4 cycles, followed by S-1 administration until 1 year after surgery. The primary endpoint was feasibility of the 4 cycles administration of S-1 plus docetaxel; secondary endpoints were safety, progression-free survival (PFS), OS, and feasibility of S-1 administration until 1 year after surgery. Results: We enrolled 53 pts, 42 males and 11 females with a median age of 65 years (range, 43-78), between May 2007 and August 2008. Pathological stages included IIIA in 36 pts and IIIB in 17 pts. The feasibility of planned 4 cycles of treatment was 77.4% (95% CI 63.8-87.7%, p < 0.001) with 41 pts out of 53 pts. Grade 4 neutropenia was observed in 28% of pts with grade 3 febrile neutropenia in 9%. Non-hematological toxicities of grade 3 or more involved fatigue in 6%, anorexia in 9%, and nausea in 6%. No treatment-related deaths occurred. Reasons for discontinuation were recurrent cancer in 1 pt, adverse events in 10, and miscellaneous in 1, respectively. 3 year overall survival was 78.8% (95% CI 68.4-90.7) and 3 year disease free survival was 50.3% (95% CI 34.4-73.3). Conclusions: Adjuvant S-1 plus docetaxel therapy is feasible and has only moderate toxicity in stage III gastric cancer pts. We believe that this regimen will be a candidate for future phase III trials seeking the optimal adjuvant chemotherapy for stage III gastric cancer patients.


1995 ◽  
Vol 13 (11) ◽  
pp. 2757-2763 ◽  
Author(s):  
M Lise ◽  
D Nitti ◽  
A Marchet ◽  
T Sahmoud ◽  
M Buyse ◽  
...  

PURPOSE In a randomized clinical trial (European Organization for the Research and Treatment of Cancer [EORTC] no. 40813) on adjuvant chemotherapy in gastric cancer, results obtained after administration of the FAM2 regimen (fluorouracil [5-FU], doxorubicin, and mitomycin) were compared with results obtained after surgery alone to assess the effect of this regimen on overall survival, time to progression, and disease-free interval. PATIENTS AND METHODS Three hundred fourteen patients who had undergone curative resection for stage II or stage III (International Union Against Cancer [UICC] 1978) gastric adenocarcinoma were randomized to receive chemotherapy (treatment arm) or no further treatment (control arm). The chemotherapy schedule was repeated every 43 days for seven cycles. The log-rank test and the Cox model were used for statistical analysis. RESULTS Of 314 patients, 159 comprised the control group and 155 the FAM2 group. Nineteen FAM2 patients never received chemotherapy. The median number of cycles was five. Of the patients started on adjuvant treatment, severe hematologic and nonhematologic toxicity (grades 3 or 4, World Health Organization [WHO] scale) occurred, respectively, in 6% to 9% and in 1% to 29% of cases. The overall 5-year survival rate was 70% for stage II and 32% for stage III patients. No statistically significant difference was found between overall survival of the two treatment arms (P = .295). However, time to progression was significantly delayed in the FAM2 arm (P = .020) and disease-free survival showed borderline significance (P = .068). CONCLUSION FAM2, in view of its high toxicity, cannot be advocated as standard adjuvant treatment for gastric cancer. Large-scale clinical trials using more active, less toxic regimens are required to demonstrate whether adjuvant chemotherapy provides any real benefit.


2022 ◽  
Author(s):  
Li-li Shen ◽  
Jun Lu ◽  
Jia Lin ◽  
Bin-bin Xu ◽  
Zhen Xue ◽  
...  

Abstract Purpose The potential additive influence of adjuvant chemotherapy (AC) on prognosis of patients with stage II/III gastric cancer (GC) who experienced complications after radical surgery is unclear.Methods The whole group was divided into a postoperative complication (PC) group and a postoperative non-complication (NPC) group, and the overall survival (OS) rate, recurrence-free survival (RFS) rate and recurrence rate were compared between the two groups of patients. Results A total of 1563 patients between January 2010 and December 2015 in our center were included in this analysis. There were 268 patients (17.14%) in the PC group and 1295 patients (82.86%) in the NPC group. The 5-year OS rate of the PC group was 55.2%, the NPC group was 63.3%; and the 5-year RFS rate of the PC group was 53.7%, the non-PC group was 58.8%. Recurrence patterns showed no significant difference between the two group (all p>0.05). Adjuvant chemotherapy (AC) significantly improved the OS and RFS rates of patients with and without PCs (both p<0.05), and it showed no significant difference between the PC group and the NPC group who received AC (both p> 0.05). Stratified analysis showed that AC only improve the OS or RFS rates of stage III patients (both p<0.05). Further stratified analysis of the time interval (TI) from operation to initiation of AC in the PC group showed that a TI after 6 weeks (≥6eeks) improved only the OS and RFS rates of stage III patients, while when a TI within 6 weeks (<6weeks), a benefit was observed in stage II and III patients (both p<0.05).Conclusion AC can abolish the negative effect of PCs on the long-term survival of patients with stage III GC; for stage II patients, the above offset effect is affected by the TI. Delaying AC initiation after 6 weeks may not improve the survival of patients experienced stage II GC with complications.


2020 ◽  
Author(s):  
Tomoyuki Matunaga ◽  
Ryo Ishiguro ◽  
Wataru Miyauchi ◽  
Yuji Shishido ◽  
Kozo Miyatani ◽  
...  

Abstract Background: This study was conducted to assess the long-term outcomes of elderly patients among propensity-score-matched gastric cancer patients after curative gastrectomy and to propose the proper management of elderly gastric cancer patients.Methods: We enrolled 626 patients with gastric cancer who underwent curative gastrectomy at our institution between January 2004 and December 2015. To minimize selection bias among 2 groups, propensity score matching was performed.Results: Patients were divided into an elderly group over 75 years old (EP group; n=186) and a non-elderly group (NEP group; n=440). After propensity score matching, patients were divided into EP group (n=186) and NEP group (n=186). Five-year overall survival was significantly lower in the EP group than in the NEP group, consistent with a subgroup analysis of each stage. However, the 5-year disease-specific survival among all enrolled patients and those with stage I and II disease did not differ significantly. Moreover, in the subgroup of stage III patients, 5-year disease-specific survival was significantly lower in the EP group (23.0%) than in the NEP group (59.4%; P=0.004). Because elderly patients with stage III disease had an extremely poor prognosis, we decided to compare the two groups with stage III. The EP group contained significantly fewer patients with D2 lymphadectomy (P=0.002) and adjuvant chemotherapy (P<0.001) than the NEP group. Multivariate analysis revealed that older age and lymphatic invasion were independent prognostic factors. C-reactive protein to albumin ratio was significantly higher in patients in the EP group than in the NEP group (P=0.046), and the prognostic nutritional index was significantly lower in EP group patients than NEP group patients (P=0.045). Conclusions: Elderly gastric cancer patients with stage III disease showed poorer disease-specific survival compared with non-elderly patients, which may be due to fewer D2 lymphadenectomies, a lack of adjuvant chemotherapy, and a poorer nutritional and inflammatory background. The safe induction of standard lymphadenectomy and adjuvant chemotherapy with perioperative aggressive nutritional support may improve the prognosis of elderly gastric cancer patients with stage III disease.


2014 ◽  
pp. 111-119
Author(s):  
Quang Bo Nguyen ◽  
Manh Ha Le ◽  
Nhu Hiep Pham ◽  
Loc Le

Purpose: To review some characteristics of patients and evaluate preliminary results of adjuvant chemotherapy for patients with resected gastric cancer. Objectives and Methods:The study was conducted on 30 patients with gastric cancer (male/female = 20/10) treated by adjuvant chemotherapy after gastrectomy at the Digestive Surgical Depatment at Hue Central Hospital from January. 2011 to May. 2012. We noted their clinical and paraclinical signs and studied the preliminary results of adjuvant chemotherapy after gastrectomy for gastric cancer. Results: The male/female = 2/1, The common group of age is 41-60, accounting for 63,33%. The primary tumor were found mostly at antrum and pylorus (66,67%).The postoperative mortality and morbidity common rates were 0% and 3,33%. Almost patients treated by adjuvant chemotherapy from 4-8 weeks after gastrectomy (73,33%). Fatigue is the most common toxicity of chemotherapy with 33,33% and alopecia was 26,67%. The follow-up time is about 11 months (rank 6-15 months). The life time expectancy of all 30 patients by stages disease: Stage II: 100%, stage III: 94,17% and stage IV: 16,67%. Conclusion: We review general characteristics of patients, and evaluate the results of surgery, quality of life after surgery combine with supportive care. Number of patients with total points within the 8-10 points by Spitzer index from 70% to 80% after the second re-examination. Most of chemotherapy toxicity is tolerable. However, this study needs to be carry out in the longer time, with larger number of patients. Key words: gastric cancer, chemotherapy


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4142-TPS4142
Author(s):  
Minkyu Jung ◽  
Seok Yun Kang ◽  
Bong-Seog Kim ◽  
Ki Hyang Kim ◽  
Kyung Hee Lee ◽  
...  

TPS4142 Background: Complete surgical resections remains the only chance for cure in patients with gastric cancer, but approximately from 40% to 80% of patients still have recurrences and most patients ultimately die from their disease. The recent adjuvant trials in gastric cancer showed significantly improved survival in patients with adjuvant chemotherapy than those with surgery alone. However, further studies need for the effect of adjuvant chemotherapy following D2 dissected gastric cancer patients, especially in advanced gastric cancer. S-1 is an oral anticancer drug, a prodrug of fluorouracil, very effective in gastric cancer. Docetaxel is the first drug that showed survival benefits when added to the two drugs in advanced gastric cancer patients. And docetaxel is also synergistic anti-cancer effect with S-1 in advanced gastric cancer. Base on this background, the aim of this study is to detect a significant increase in 3 –year disease free survival (DFS) of adjuvant chemotherapy with docetaxel and S-1(DS) relative to those with S-1 and cisplatin (SP) in patients with stage III gastric cancer Methods: This study is an open-label, phase 3, randomized controlled trial, multicenter in South Korea. Patients with stage III (AJCC 7th edition) gastric cancer who had had curative D2 gastrectomy is randomly assigned to receive adjuvant chemotherapy of eight 3-week cycles of intravenous docetaxel (35 mg/m2 on day 1 and 8 of each cycle) plus oral S-1 (35 mg/m2 twice daily on days 1 to 14 of each cycle) for 6 months (DS) or chemotherapy of eight 3-week cycles of oral S1 plus intravenous cisplatin (60 mg/m2). After satisfying the screening criteria, patients have been randomized to the SD or SP arm in a 1:1 ratio. The randomization is stratified by institution and stage of disease (IIIA vs. IIIB vs. IIIC). The each stratum has been randomized by using the method of randomly permuted block. The primary endpoint is 3 year DFS, will analyze by intention to treat. A total of 290 patients will be enrolled, 67 patients have been treated to day, with continuing accrual. The trial is registered at ClinicalTrials.gov (NCT01283217).


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