scholarly journals Phase II feasibility study of adjuvant chemotherapy with docetaxel/cisplatin/S-1 followed by S-1 for stage III gastric cancer

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Noriyuki Hirahara ◽  
Takeshi Matsubara ◽  
Shunsuke Kaji ◽  
Tetsu Yamamoto ◽  
Ryoji Hyakudomi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Rest Period ◽  
Dose Intensity ◽  
Stage Iii ◽  
Postoperative Treatment ◽  
Hematological Toxicity ◽  
Curative Gastrectomy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Abstract Background This study aimed to evaluate the feasibility, safety, and efficacy of postoperative adjuvant chemotherapy with docetaxel/cisplatin/S-1 (DCS) following S-1 therapy in patients with stage III gastric cancer after curative gastrectomy. Methods Patients with stage III gastric cancer who underwent D2 gastrectomy were enrolled. Adjuvant chemotherapy was initiated within 8 weeks of gastrectomy. The first cycle of chemotherapy consisted of S-1 monotherapy (day 1–14), followed by a 7-day rest period. Cycles 2 and 3 consisted of the following: S-1 (day 1–14) administration, followed by a 14-day rest period, and an intravenous infusion of cisplatin and docetaxel on days 1 and 15. After two cycles, S-1 was administered for up to 1 year. Results Thirty patients were enrolled between 2014 and 2017. Febrile neutropenia of grade 3 or higher was the most common hematological toxicity with 4 patients (13.3%). Other hematological toxicities of grade 3 or higher were as follows: neutropenia in 3 (10.0%), leukopenia in 3 (10.0%), and anemia in 2 (6.7%) patients. Most frequent non-hematological toxicity of grade 3 was anorexia (n = 4, 13.3%) and general fatigue (n = 3, 10.0%); no grade 4 non-hematological toxicities were observed. Twenty-five patients (83.3%) completed two cycles of DCS treatment and 18 (60.0%) completed subsequent S-1 treatment for 1 year. The relative dose intensity of docetaxel and cisplatin was 0.86 and that of S-1 was 0.88. Conclusion The DCS regimen can be acceptable as an adjuvant chemotherapy and offers an effective postoperative treatment option for stage III gastric cancer patients. Trial registration number UMIN000012785. Date of registry 08/01/2014.

scholarly journals Phase II Feasibility Study of Adjuvant Chemotherapy With Docetaxel/Cisplatin/S-1 Followed By S-1 For Stage III Gastric Cancer

2021 ◽  
Author(s):  
Noriyuki Hirahara ◽  
Takeshi Matsubara ◽  
Shunsuke Kaji ◽  
Tetsu Yamamoto ◽  
Ryoji Hyakudomi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Rest Period ◽  
Dose Intensity ◽  
Stage Iii ◽  
Postoperative Treatment ◽  
Hematological Toxicity ◽  
Curative Gastrectomy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Abstract BackgroundTo evaluate the feasibility, safety, and efficacy of postoperative adjuvant chemotherapy with docetaxel/cisplatin/S-1 (DCS) following S-1 therapy in patients with stage III gastric cancer after curative gastrectomy.Methods Patients with stage III gastric cancer who underwent D2 gastrectomy were enrolled. Adjuvant chemotherapy was initiated within 8 weeks of gastrectomy. The first cycle of chemotherapy consisted of S-1 monotherapy (day 1–14), followed by a 7-day rest period. Cycles 2 and 3 consisted of the following: S-1 (day 1–14) administration, followed by a 14-day rest period, and an intravenous infusion of cisplatin and docetaxel on days 1 and 15. After 2 cycles, S-1 was administered for up to 1 year.Results Thirty patients were enrolled between 2013 and 2017. Febrile neutropenia of grade 3 or higher was the most common hematological toxicity with 4 patients (13.3%). Other hematological toxicities of grade 3 or higher were as follows: neutropenia in 3 (10.0%), leukopenia in 3 (10.0%), and anemia in 2 (6.7%). Most frequent non-hematological toxicity of grade 3 was anorexia (n=4, 13.3%) and general fatigue (n=3, 10.0%); no grade 4 non-hematological toxicities were observed. Twenty-five patients (83.3%) completed 2 cycles of DCS treatment and 18 (60.0%) completed subsequent S-1 treatment for 1 year. The relative dose intensity of docetaxel and cisplatin was 0.86 and that of S-1 was 0.88. Conclusion The DCS regimen can be acceptable as an adjuvant chemotherapy and offers an effective postoperative treatment option for stage III gastric cancer patients.Trial registration number: UMIN000012785 Date of registry: 08/01/2014

Comparison of S-1 and cisplatin combination versus S-1 adjuvant chemotherapy for advanced gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14652-e14652
Author(s):  
Hyo Song Kim ◽  
Hei-Cheul Jeung ◽  
Minkyu Jung ◽  
Hye Ryun Kim ◽  
Ji Yeong Ahn ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Therapeutic Option ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Hematologic Toxicity ◽  
Combination Regimen ◽  
Grade 3 ◽  
Gastric Cancer Patients

e14652 Background: Adjuvant chemotherapy demonstrated the efficacy for stage II-III gastric cancer patients in the ACT-GC and CLASSIC trial. However, in the subgroup analysis, stage III patients receiving S-1 monotherapy didn’t report survival benefit unlike the capecitabine/oxaliplatin combination regimen in CLASSIC trial. With the assumption that doublet adjuvant chemotherapy may be more effective for advanced stages of patients, we compared the efficacy of S-1/cisplatin (SP) and S-1 adjuvant chemotherapy. Methods: After curative D2 resection, 274 patients were treated with S-1 monotherapy (98 patients, 80 mg/m2 for 4 weeks, every 6 weeks) or S-1 plus cisplatin (176 patients, S-1 80 mg/m2 day 1-14 and cisplatin 60 mg/m2 day 1, every 3 weeks). Treatment was continued for 12 months in S-1 arm and 6 months in SP arm or until unacceptable toxic effects or disease progression. Results: A total of 65 (66.3%) patients in SP and 118 (67%) in S-1 group completed all the treatment. The relative dose intensity of S-1 was 82% for S-1 and 88% for SP group, respectively. During the early times after the operation, more patients in SP group completed adjuvant treatment. More patients in SP discontinued treatment during the 1st cycle (12.5% S-1 vs 8.5 % SP group) and this trend was consisted thereafter. The progression free survival (PFS) was not reached for both groups. For the stage III patients, 2 year PFS was better for SP group (89%) than S-1 group (80.8%). Among the 23 recurrence, S-1 group (19.8%) demonstrated more frequent recurrence than SP group (12%). In terms of tolerance, hematologic toxicities was more frequent in SP group, therefore, 21% of SP group and 3.4% of S-1 monotherapy had grade 3-4 neutropenia. However, for the non-hematologic toxicity, grade 3-4 anorexia was similar and grade 3-4 stomatitis was more common in S-1 group (2.8% vs 7%) Conclusions: S-1 plus cisplatin adjuvant chemotherapy is effective and tolerable. For the high risk patients, considering favorable compliance and slightly better efficacy, combination treatment may be a good therapeutic option. Further studies for optimal drugs and schedule are warranted.

Phase II feasibility study of adjuvant S-1 plus docetaxel for stage III gastric cancer patients after curative D2 gastrectomy (OGSG 0604).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 108-108 ◽  
Author(s):  
Jin Matsuyama ◽  
Shigeyuki Tamura ◽  
Kazumasa Fujitani ◽  
Yutaka Kimura ◽  
Takeshi Tsuji ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Phase Ii ◽  
Stage Iii ◽  
Free Survival ◽  
D2 Dissection ◽  
Grade 3 ◽  
Gastric Cancer Patients

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.

Irinotecan plus S-1 (IRIS) versus S-1 alone as first line treatment for advanced gastric cancer: Preliminary results of a randomized phase III study (GC0301/TOP-002)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4525-4525 ◽  
Author(s):  
K. Chin ◽  
H. Iishi ◽  
H. Imamura ◽  
O. Kobayashi ◽  
H. Imamoto ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Cancer Survival ◽  
Single Agent ◽  
Rest Period ◽  
Phase Iii ◽  
Best Response ◽  
Independent Review ◽  
Grade 3 ◽  
Gastric Cancer Patients

4525 Background: Irinotecan has single agent activity and combination activity with S-1 reportedly in phase I/II studies with advanced gastric cancer patients (pts). S-1, oral fluoropyrimidine, also has activity on gastric cancer. A multicenter, randomized phase III trial comparing IRIS to S-1 alone in advanced gastric cancer was conducted. Methods: Pts with previously untreated gastric cancer were randomized to Arm A (oral S-1 80 mg/m2/day from day 1 to 28 followed by a 14-day rest period), or Arm B (oral S-1 80 mg/m2/day from day 1 to 21 and intravenous irinotecan 80 mg/m2 on days 1 and 15 followed by a 14-day rest). Treatment was continued unless disease progression was observed. Inclusion criteria: PS (ECOG) of 0 to 2; adequate major organ functions. Primary endpoint was overall survival. Results: From June 2004 to November 2005, 326 pts were randomized to arm A (162 pts) and arm B (164 pts). Pts characteristics (arm A vs. arm B) were as follows: median age: 63 vs. 63 years, PS 0–1: 97% vs. 97%, and distribution of subtype of intestinal/diffuse/others: 44%/55%/1% vs. 41%/58%/1%. Among 187 RECIST-evaluable pts (93 vs 94) reviewed by independent review panel, best response rates were 26.9% for arm A and 41.5% for arm B(p=0.035). Among 319 toxicity-evaluable patients (161 vs 158), grade 3 or 4 toxicities for arm A vs arm B (% of pts) were as follows: neutropenia 9.3% vs 26.6%, diarrhea 5.6% vs 15.8%, anorexia 9.9% vs 15.8%, nausea 3.7% vs 7.0%, vomiting 0.6% vs 2.5%. Conclusions: IRIS is effective, and well tolerated in pts with advanced gastric cancer. Survival analysis is underway. No significant financial relationships to disclose.

Clinical impact of diverting ileostomy on the dose intensity of adjuvant chemotherapy for colorectal cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 867-867
Author(s):  
Shusuke Yagi ◽  
Eiji Shinozaki ◽  
Keisho Chin ◽  
Mitsukuni Suenaga ◽  
Daisuke Takahari ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Dose Intensity ◽  
Clinical Impact ◽  
Stage Ii ◽  
Stage Iii ◽  
Diverting Ileostomy ◽  
Grade 3

867 Background: CAPOX as adjuvant chemotherapy is a standard care option for stage III and high risk stage II colorectal cancer(CRC). And then chemotherapy induced diarrhea (CID) is known as one of the dose-limiting toxicities for CAPOX. Although diverting ileostomy is useful for preventing serious complications of high risk anastomosis, it is well recognized that high ileostomy output is hard to manage. Furthermore, the effect of diverting ileostomy on CID of adjuvant chemotherapy is unclear. In this study, we addressed the clinical impact of diverting ileostomy on the dose intensity of adjuvant chemotherapy for CRC. Methods: Patients who diagnosed with stage III colon cancer and stage II or III rectal cancer after curative surgery and received CAPOX as adjuvant chemotherapy during 2011- 2014 were reviewed retrospectively. We investigated the relationship between diverting ileostomy and dose intensity, toxicities and disease-free survival (DFS). Results: 112 patients (median age 60 years, 52% male, 69% colon cancer, 63% stage III, median follow-up 47 months) were enrolled in this study. Of 112 patients, 100 patients were received chemotherapy without ileostomy (non-ileostomy group: NIG) and 12 patients were received chemotherapy with ileostomy (ileostomy group: IG). 112 Patients received 870 chemotherapy cycles. All treatment related grade 3/4 adverse events were documented in 39% of patients in NIG and 33% of patients in IG (P = 0.77). Grade 3/4 of CID occurred in 8% of patients in NIG and 8% of patients in IG (P = 1). Grade 3/4 of neutropenia were recognized in 21% of patients in NIG and 17% of patients in IG (P = 1). Average relative dose intensity (RDI) in NIG were 75.7% and 85.8% for capecitabine and oxaliplatin, respectively. Average RDI of capecitabine and oxaliplatin in IG were 76.1% and 82.7%, respectively. Significant difference of RDI of capecitabine and oxaliplatin were not shown in comparison between NIG and IG (P = 0.93, P = 0.63). The 3-year DFS rate was 85.0% in NIG and 75.0% in IG. The HR for DFS for NIG compared to IG was 1.709 (95% CI, 0.49 to 5.95; P = 0.40). Conclusions: The presence of diverting ileostomy does not affect RDI of CAPOX as adjuvant chemotherapy.

scholarly journals Postoperative Adjuvant Chemotherapy Cancel Out the Negative Survival Impact on Stage II/III Gastric Cancer Patients With Postoperative Complications

2022 ◽  
Author(s):  
Li-li Shen ◽  
Jun Lu ◽  
Jia Lin ◽  
Bin-bin Xu ◽  
Zhen Xue ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Ii ◽  
Stage Iii ◽  
Time Interval ◽  
Term Survival ◽  
Significant Difference ◽  
Negative Effect ◽  
Gastric Cancer Patients ◽  
Stratified Analysis

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.

scholarly journals Appraisal of Long-time Outcomes After Curative Surgery in Elderly Patients with Gastric Cancer: A Propensity Score Matching Analysis

2020 ◽  
Author(s):  
Tomoyuki Matunaga ◽  
Ryo Ishiguro ◽  
Wataru Miyauchi ◽  
Yuji Shishido ◽  
Kozo Miyatani ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Propensity Score ◽  
Elderly Patients ◽  
Propensity Score Matching ◽  
Cancer Patients ◽  
Stage Iii ◽  
Disease Specific Survival ◽  
Gastric Cancer Patients ◽  
Disease Specific

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.

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