A phase II study of perioperative capecitabine plus oxaliplatin for clinical SS/SE N1-3 M0 gastric cancer (OGSG1601).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 203-203
Author(s):  
Atsushi Yasuda ◽  
Jin Matsuyama ◽  
Tetsuji Terazawa ◽  
Masahiro Goto ◽  
Ryohei Kawabata ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Statistical Significance ◽  
Dose Intensity ◽  
Residual Tumor ◽  
Pathological Response ◽  
R0 Resection ◽  
Eligibility Criteria ◽  
English Edition ◽  
D2 Gastrectomy ◽  
Japanese Classification

203 Background: D2 gastrectomy followed by adjuvant S-1 is one of the standard therapy for the patients (pts) with stage III gastric cancer (GC) in Japan; however, the outcome is not satisfactory. We examined the efficacy of perioperative capecitabine and oxaliplatin (CapeOx) in pts with clinical SS/SE N1-3 M0 GC. Methods: The eligibility criteria included histopathologically confirmed clinical T3(SS)/T4a(SE) N1-3 M0 GC according to the Japanese Classification of GC (JCGC; 3rd English Edition). Three cycles of neoadjuvant CapeOx (NAC; capecitabine, 2,000 mg/m2 for 14 days; oxaliplatin, 130 mg/m2 on day 1, every 3 weeks) were administered, followed by five cycles of adjuvant CapeOx after D2 gastrectomy. The primary endpoint was the pathological response rate (pRR) according to JCGC ( ≥Grade 1b). Results: Thirty-seven pts were enrolled from April 2016 to May 2017, and fully evaluated for efficacy and toxicity. Thirty-three pts (89.2%) completed the planned three cycles of NAC and underwent gastrectomy, with an R0 resection rate of 78.4% (n = 29) and a pRR of 54.1% (n = 20, p = .058; 90% confidence interval [CI], 39.4–68.2) were demonstrated. The relative dose intensity (RDI) of capecitabine and oxaliplatin were 90.5% and 91.9%, respectively. Among 27 pts who initiated AC, 21 (63.6%) completed the treatment, and the RDI of capecitabine and oxaliplatin were 80.9% and 65.1%, respectively. Grade 3–4 toxicities during NAC included neutropenia (8%), thrombocytopenia (8%), and anorexia (8%) and during AC included neutropenia (37%), diarrhea (4%), and anorexia (4%), but no treatment-related death was reported. The overall survival (OS) rate and relapse free survival (RFS) rate at 3 years was 83.8% (95% CI, 72.7-96.5%) and 73.0% (95% CI, 60.0-88.8%), respectively. Subgroup analyses according to residual tumor after surgery (R status) showed a 3-year OS and RFS rate of 86.2% (95% CI, 74.5-99.7%) and 75.7% (95% CI, 63.0-90.8%) for R0. Conclusions: Perioperative CapeOx showed good feasibility and favorable prognosis with sufficient pathological response, although statistical significance at .058 did not reach the commonly accepted cutoff of .05. The data obtained using this novel approach warrant further investigations. Clinical trial information: 000021641.

Long-term outcomes of preoperative chemotherapy with modified DCS therapy for highly advanced gastric cancer with distant metastasis.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 193-193
Author(s):  
Atsushi Matsuki ◽  
Atsushi Nashimoto ◽  
Hiroshi Yabusaki ◽  
Masaki Aizawa
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Distant Metastasis ◽  
Response Rate ◽  
Performance Status ◽  
Pathological Response ◽  
Morbidity Rate ◽  
R0 Resection ◽  
Eligibility Criteria

193 Background: Among patients (pts) with advanced gastric cancer (AGC), the poor prognosis was exhibited and many pts died even after R0 resection. The aim of this study is to evaluate the preoperative chemotherapy with docetaxel, cisplatin and S-1 (modified DCS therapy) for treatment in highly AGC with distant metastasis. Methods: A retrospective analysis was performed in 58 pts (man/woman; 49/9, median age; 64.5-years) treated with preoperative modified DCS therapy in our hospital between 2009 and 2012. Eligibility criteria included StageIV AGC with distant metastasis (H1;14, P1;18,CY1;31, LYM;25, PUL;2, OTH;2), a Performance status of 0-2 and no prior chemotherapy. The regimen consisted of docetaxel and cisplatin infusion (35mg/m2, days 1 and 15) and oral administration of S-1 (80mg/m2, days 1-14) every 4 weeks. Surgery was planned 3 to 4 weeks after the chemotherapy. Pathological response was graded according to the JGCA criteria. Almost all pts were treated with S-1 as postoperative adjuvant chemotherapy. Results: The median cycles was 2 (1-13). The incidence of grade 3/4 toxicity was neutropenia 53.4%, anemia 8.6%, anorexia 15.5%, nausea 5.2%, and diarrhea 3.4%. All of these toxicities were well tolerable and there was no TRD. According to RECIST, The overall response rate was 79.3%. Forty-tree pts underwent gastrectomy (R0/R1/R2; 27/8/8), respectively. Postoperative morbidity rate was 20.9% and there was no mortality. Over all 5 years survival rate (5YSR) was 21.4 % and that of R0 was 44.8%, on the other hand 5YSR and MST of chemotherapy alone was 0% and 14.5 month. Pathological response rate (>=1b) was 60.5% and complete response was achieved 1 pts. 5YSR of pathological responders who underwent R0 resection was 81.4% and that of non-responders who underwent even R0 resection was 22.5% (P<0.05). Conclusions: Preoperative modified DCS therapy for AGC was tolerable, and survival benefit of pathological responders with R0 surgery was promising and warrants further investigation.

A phase II study of systemic chemotherapy with docetaxel, cisplatin, and S-1 (DCS) followed by gastrectomy with D2 plus para-aortic lymph node (PAN) dissection for gastric cancer with extensive lymph node metastasis (ELM): Japan Clinical Oncology Group Study JCOG1002.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 116-116
Author(s):  
Seiji Ito ◽  
Takeshi Sano ◽  
Hiroshi Katayama ◽  
Junki Mizusawa ◽  
Daisuke Takahari ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Adverse Events ◽  
Primary Endpoint ◽  
Residual Tumor ◽  
R0 Resection ◽  
Minor Response ◽  
Term Survival ◽  
D2 Gastrectomy ◽  
Grade 3

116 Background: Gastric cancer with ELM is commonly regarded as unresectable with poor prognosis. We previously reported the safety and efficacy of cisplatin and S-1 (CS) followed by D2 gastrectomy with PAN dissection for this target (JCOG0405, Br J Surg 2014). Methods: Eligibility criteria included histologically proven gastric adenocarcinoma; bulky nodal involvement around major branched arteries to the stomach (Bulky N) and/or PAN metastases; cM0 (except PANs); negative lavage cytology; neither Borrmann type 4 nor large (8cm or more) type 3; PS 0 or 1. Patients received two or three cycles of induction chemotherapy of docetaxel (40mg/m2 day1), cisplatin (60mg/m2 day1), and S-1 (80mg/m2from day 1 to 14) every 4 weeks, and then underwent D2 gastrectomy with PAN dissection. After R0 resection, postoperative chemotherapy with S-1 was given for one year. The primary endpoint is response rate (RR) of NAC by central peer review. The planned sample size was 50 patients, provided 80% power under the hypothesis of primary endpoint as the expected RR of 80% and threshold RR of 65% with a one-sided alpha of 10%. Results: Between 07/2011 and 05/2013, 53 patients were enrolled and 1 patient was ineligible: 30 had Bulky N, 14 had PAN metastases, and 9 had both. 51of 52 patients (98.1%) completed a planned NAC. The clinical RR was 57.7% (30/52) (80%CI [47.9%-67.1%], one-sided p=0.89). The R0 resection rate was 84.6% (45/52). During DCS chemotherapy, grade 3/4 neutropenia occurred in 39.6% and grade 3/4 non-haematological adverse events in 20.8%. The incidence of grade 3/4 adverse events related to surgery was 30.6%. There was no treatment-related death. The pathological finding revealed minor response (residual tumor <1/3) was achieved in 50.0% (26/52) and major response (residual tumor <2/3) in 34.6% (18/52). The long-term survival is still under follow-up. Conclusions: Preoperative DCS revealed feasible but could not show sufficient efficacy. Preoperative CS is still being considered a standard treatment for this population. Clinical trial information: UMIN000006069.

Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 205-205
Author(s):  
Daisuke Takahari ◽  
Manabu Ohashi ◽  
Atsuo Takashima ◽  
Takuro Mizukami ◽  
Naoki Ishizuka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Complete Response ◽  
Free Survival ◽  
D2 Gastrectomy ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

205 Background:TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. 2020). This study investigated the feasibility of peri (pre and post)-operative (op) chemotherapy (chemo) with TAS-118 ± L-OHP in pts with locally advanced resectable GC. While it was reported that pre-op TAS-118 + L-OHP followed by D2 gastrectomy was well tolerated and showed promising efficay (Takahari, ASCO-GI. 2020), the recommended post-op chemo regimen, TAS-118 or TAS-118 + L-OHP, has yet to be determined. Methods:Eligible pts with GC of clinical T3-4N1-3M0 were enrolled. The protocol treatment consisted of pre-op chemo with 4 courses of TAS-118 (40-60 mg/body, orally, twice daily, 7 days) + L-OHP (85 mg/m2, intravenously, day 1) in a 2-week cycle, and gastrectomy with D2 lymphadenectomy, followed by post-op chemo with 12 courses of TAS-118 (step 1) and 8 courses of TAS-118 + L-OHP (step 2). Step 2 was started if the dose-limiting toxicity (DLT) occurred in < 6 of 10 pts in step 1. Up to 20 pts were included in the analysis of feasibility after a recommended regimen was determined. Results:Between December 2016 and February 2019, 45 pts were enrolled. The numbers of pts with cT3/4a and cN1/2/3 were 13/32 and 25/17/3, respectively. Excluding 14 pts (4 achieving pathological complete response, 4 not satisfying the criteria for post-op chemo, 3 physician judgement or pt withdrawal, 2 progressive disease, 1 adverse event [AE]), 31 pts (11/20 in step 1/2) received the post-op chemo. No DLT was observed in either step. The post-op chemo completion rate was 90.9% (95% CI, 63.6-99.5) in step 1 and 80.0% (95% CI, 59.9-92.9) in step 2. The median relative dose intensity of TAS-118 in step 1 was 83.3%, and those of TAS-118 and L-OHP in step 2 were 69.9% and 74.3%, respectively. One pt in step 2 discontinued post-op chemo due to AE. Grade ³ 3 AEs observed in ≥ 10% of pts were weight loss in both step 1 and step 2 (2 in each), and hypokalemia (n = 3) and neutropenia (n = 2) in step 2. At 1-year follow-up after the last pt was enrolled, recurrence-free survival and OS rates were 91.1% (95% CI, 78.0-96.6) and 100%, respectively at 12 months, and 69.1% (95% CI, 49.6-82.3) and 95.5% (95% CI, 71.9-99.3), respectively at 24 months. Conclusions:Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. Clinical trial information: UMIN000024688.

Phase I Trial of Capecitabine and Weekly Irinotecan in Combination With Radiotherapy for Neoadjuvant Therapy of Rectal Cancer

2005 ◽  
Vol 23 (7) ◽  
pp. 1350-1357 ◽  
Author(s):  
Ralf-Dieter Hofheinz ◽  
Bolko von Gerstenberg-Helldorf ◽  
Frederik Wenz ◽  
Ulrike Gnad ◽  
Uta Kraus-Tiefenbacher ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase I ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Residual Tumor ◽  
Advanced Rectal Cancer ◽  
R0 Resection ◽  
Phase Ii Trials ◽  
Grade 3

Purpose To establish the feasibility and efficacy of capecitabine in combination with weekly irinotecan (CAPIRI) with concurrent pelvic radiotherapy (RT) in patients with locally advanced rectal cancer. Patients and Methods Nineteen patients with rectal cancer clinical stage T3-4, Nx received weekly irinotecan 50 mg/m2 (days 1, 8, 15, 22, 29) and two doses of capecitabine (days 1 through 38; dose level [DL] I, 500 mg/m2 bid; DL II, 625 mg/m2 bid) according to phase I methodology. Three-dimensional conformal RT was given to a dose of 50.4 Gy (45 Gy + 5.4 Gy). Results On DL I, no dose-limiting toxicities occurred, whereas diarrhea grade 3 affected three of seven patients on DL II. Twelve patients were treated on DL I and received a median relative dose-intensity of 100% for both drugs. Grade 3 or 4 adverse events were observed in only one of these patients (asthenia grade 3). All patients underwent surgery and R0 resection was achieved in all patients. Pathologic complete remission was observed in four patients and another five patients had only microfoci of residual tumor. Conclusion Preoperative chemoradiotherapy with CAPIRI is feasible and well tolerated. The preliminary efficacy is good, and the tolerability is at least comparable with data for fluorouracil plus irinotecan chemoradiotherapy. Larger phase II trials of the CAPIRI-RT schedule clearly are warranted.

Randomized phase III trial of standard D2 versus D2 + para-aortic lymph node (PAN) dissection (D) for clinically M0 advanced gastric cancer: JCOG9501

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. LBA4015-LBA4015 ◽  
Author(s):  
M. Sasako ◽  
T. Sano ◽  
S. Yamamoto ◽  
A. Nashimoto ◽  
A. Kurita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Disease Free Survival ◽  
Operation Time ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Rank Test ◽  
R0 Resection ◽  
Eligibility Criteria ◽  
Curative Intent

LBA4015 Background: The INT-0116 study proved the efficacy of radiochemotherapy after R0 resection for gastric cancer and thus the importance of the local control and the insufficiency of D0/1 surgery. Recently D2 surgery was for the first time proven to improve the survival compared with D1 in a Taiwanese RCT (Lancet Oncol 2006). In our study, D2+PAND was compared with D2 in a RCT. Low operative mortality has been reported (Sano et al. J Clin Oncol 2004) and we now present the survival results. Methods: Eligibility criteria included; histologically proven adenocarcinoma, cT2b-T4, cM0, no macroscopic metastasis to the PAN, negative lavage cytology, adequate organ function, and age <76. Linitis plastica was excluded. Eligible pts were randomly assigned to D2 with or without PAND during surgery. All patients were followed without adjuvant therapy until recurrence. The primary endpoint was overall survival (OS) to be compared by stratified log-rank test. Assuming 256 eligible pts in each arm, the study had 75% power to detect 0.73 hazard ratio for D2+PAND to D2 in OS at 0.05 one-sided alpha. Results: Between 07/1995 and 04/2001, 523 pts were randomized (263 to D2 and 260 to D2+PAND). Baseline characteristics were well balanced between the arms. At the time of the final analysis on 23/03/06, 191 (96 and 95, in D2 and D2+PAND, respectively) had died. The 3- and 5-year OS were 76% and 69% in D2 and 76% and 70% in D2+PAND, respectively (p = 0.57, Hazard ratio was 1.03 (95% CI: 0.77–1.37)). Disease free survival did not show any difference between the groups as well. Median operation time was 63 minutes longer and median blood loss was 230 ml larger in D2+PAND than in D2. There was no difference in the incidence of major surgical complications and hospital mortality (0.8% in both arms). Conclusions: D2 or D2+PAND could be carried out safely and showed excellent survival for advanced gastric cancer treated with curative intent. PAND could not improve the survival achieved by D2. General use of PAND should be avoided. No significant financial relationships to disclose.

Phase II trial of bolus 5-FU/l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant unresectable gastric cancer (HGCSG1502).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS177-TPS177
Author(s):  
Tetsuhito Muranaka ◽  
Satoshi Yuki ◽  
Kentaro Sawada ◽  
Yasuyuki Kawamoto ◽  
Hiroshi Nakatsumi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Bolus Injection ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
Dependent Manner ◽  
Eligibility Criteria ◽  
Concentration Dependent Manner ◽  
Free Survival

TPS177 Background: S-1, oral fluorouracil agent compounding tegafur, 5-chloro-2, 4-dihydropyrimidine, and potassium oxonate for gastric cancer showed non-inferiority relative to a continuous infusion of fluorouracil in JCOG9912 trial. Similarly, in ISO-5FU10 trial, S-1 revealed non-inferiority effect compared with the treatment with bolus 5-FU/l-LV treatment. It is known that there is a different mechanism of anti-cancer effect between continuous 5-FU and bolus injection of 5-FU. Continuous infusion of 5-FU and oral fluorouracil inhibit DNA synthesis, however, bolus injection of 5-FU causes dysfunction of RNA in a concentration-dependent manner. So we considered bolus 5-FU/l-LV treatment might be useful for oral fluorouracil resistant patients with gastric cancer. Methods: This is a multi-centered single-arm prospective phase II study in Japanese patients with oral fluorouracil resistant gastric cancer. The key eligibility criteria are as follows: 1) Pathologically diagnosed gastric adenocarcinoma: 2) Unresectable advanced, metastatic, or recurrent disease; 3) resistance of S-1 or capecitabine; 4) resistance or intolerance of cisplatin or oxaliplatin, paclitaxel or docetaxel, and ramucirumab; 5) 20 years of age or older; 6) ECOG PS of 0, 1 or 2. Bolus 5-FU/l-LV regimen consists of l-LV 250mg/m2/2h iv and 5-FU 600mg/m2 iv bolus given intravenously once weekly followed by 2-week rest period, within a 8-week cycle. The primary endpoint is progression free survival rate after 1cycle administration. And the secondary endpoints are response rate, disease control rate, overall survival, progression free survival, time to treatment failure, adverse events, dose intensity and QOL by EORTC QLQ-C30. This study is recruiting in Hokkaido Gastrointestinal Cancer Study Group and registered as UMIN000018882. Clinical trial information: UMIN000018882.

Feasibility and pathological response of TAS-118 + oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 351-351
Author(s):  
Daisuke Takahari ◽  
Atsuo Takashima ◽  
Takako Eguchi Nakajima ◽  
Naoki Ishizuka ◽  
Manabu Ohashi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Advanced Gastric Cancer ◽  
Preoperative Chemotherapy ◽  
Postoperative Bleeding ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Pathological Response ◽  
Complete Regression ◽  
Clinical Trial Information

351 Background: TAS-118 is a novel oral agent, containing S-1 and leucovorin. In the SOLAR study (NCT02322593), TAS-118 + oxaliplatin (OHP) significantly improved overall survival compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC). We conducted this open-label study to assess feasibility of perioperative adjuvant chemotherapy with TAS-118 + OHP in pts with locally advanced resectable GC with lymph node metastasis. (Clinical trial information: UMIN000024688). Methods: Eligible pts who had histopathologically confirmed GC with clinical T3-4N1-3M0 on image findings (14th Japanese classification of gastric carcinoma), age 20 to 79 years, were enrolled in this study. The protocol treatment consisted of preoperative 4 courses of TAS-118 (80-120 mg/body, days 1-7) + OHP (85 mg/m2, day 1) every 2 weeks, and gastrectomy with D2 lymphadenectomy, followed by postoperative 12 courses of TAS-118 alone (step1) or 8 cycles of TAS-118 + OHP (step2). The primary endpoints were tolerability of preoperative chemotherapy, gastrectomy and postoperative chemotherapy with TAS-118 plus OHP. Here, we report the feasibility of preoperative chemotherapy and gastrectomy, and pathological response. Results: Between December 2016 and April 2018, 45 pts with a median age of 61 years were enrolled. The numbers of pts with T stage (cT3/4a) and those with N stage (cN1/2/3) were 13/32 and 25/17/3, respectively. The completion rate of preoperative chemotherapy and gastrectomy was 88.9% ( 95% CI 78.0-95.5) and 95.6% (95% CI 86.7-99.2). The relative dose intensity of TAS-118 and OHP was 86.0% and 90.6%. During the 4 cycles of preoperative TAS-118 + OHP, 2 pts discontinued the treatment due to adverse event (AE). Major grade 3-4 AEs were diarrhea (17.8%) and neutropenia (8.9%). R0 resection rate was as high as 95.6%. One pts experienced grade 4 postoperative bleeding, but no treatment-related death was reported. pCR was achieved in 6/45 pts (13.3%) and other 7 pts (28.9%) showed near complete regression (<10 % residual tumor cells). Conclusions: Preoperative TAS-118 + OHP followed by D2 gastorectomy was well tolerated and showed promising efficacy. Clinical trial information: 000024688.

Phase II trial report of preoperative chemotherapy (CX) with S-1 plus cisplatin for stage IV gastric cancer (StIV GC).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 107-107 ◽  
Author(s):  
S. Satoh ◽  
H. Okabe ◽  
S. Teramukai ◽  
S. Hasegawa ◽  
N. Ozaki ◽  
...  
Keyword(s):  
Phase Ii ◽  
Surgical Complication ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Helical Ct ◽  
R0 Resection ◽  
Eligibility Criteria ◽  
Stage Iv Gastric Cancer ◽  
Japanese Classification ◽  
One Year

107 Background: Prognosis of StIV GC is poor. S-1 plus cisplatin now becomes one of the Japanese standards for unresectable or recurrent GC. We conducted a multicenter phase II study of preoperative S-1 plus cisplatin for StIV GC (KYUH-UHA-GC03-01, NCT00088816 ). In ASCO 2010, we reported early outcomes, indicating that this regimen is feasible and safe. We will report here the results concerning prognosis and recurrence. Methods: Eligibility criteria included histologically proven StIV GC according to Japanese classification. Helical CT and staging laparoscopy were mandatory. Patients (pts) received oral S-1 (80-120 mg/body/day, day 1-21) and intravenous cisplatin (60 mg/m2 on day 8) every 5 weeks for 2 courses. After CX, operation was performed. S-1 (80-120 mg/body/day, day 1-14) was administered every 3 weeks for one year postoperatively. The primary endpoint was 2-year overall survival (OS), and the secondary endpoints were progression free survival (PFS), response, pathologic response, R0 resection, surgical complication, the first recurrence sites and toxicities. Sample size was set at 50. Results: 51 pts were enrolled and all pts were observed more than 2 years after registration. The median age was 63 (range 35-79). PreOp CX was accomplished in 44 cases. Response was 50% (95% CI: 27.2-72.8). 44 (86.3%) pts underwent surgery and R0 resection was done in 26 pts (51%). Adjuvant chemotherarpy was accomplished in 11 cases. Recurrences were observed 14 cases (53.8%). Most frequent recurrence site was peritoneum. 2-Y OS and PFS were 43.1% [96% CI: 29.4-56.1] and 33.3% [20.9-46.2], respectively. R0 in GC with single StIV factor (n = 24) was 79.2% and that in GC with multiple StIV factors (n = 27) was 25.9%, respectively. All pts with only Cy+ (n = 12) showed complete eradication of cancer cell by S-1/CDDP. Pts with only Cy+ showed significantly better prognosis than other pts. Conclusions: As compared to Japanese national StIV control (OS: 20.8%), this induction CX showed promising survival. Especially, pts with only Cy+ was popular and showed significantly better prognosis by S1/CDDP induction CX. No significant financial relationships to disclose.

Predictive factors for long-term survival after conversion surgery for unresectable gastric cancer: A retrospective analysis.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 205-205
Author(s):  
Tamotsu Sagawa ◽  
Kyoko Hamaguchi ◽  
Akira Sakurada ◽  
Fumito Tamura ◽  
Tsuyoshi Hayashi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Residual Tumor ◽  
R0 Resection ◽  
Conversion Surgery ◽  
Tumor Depth ◽  
Term Survival ◽  
Long Term Survival ◽  
Line Therapy ◽  
Unresectable Gastric Cancer

205 Background: Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. However, the association between clinical factors and long-term prognosis after conversion surgery for unresectable gastric cancer has not been investigated. Methods: We retrospective reviewed 36 gastric cancer patients who underwent conversion surgery at our institute between 2005 and 2015. Clinicopathologic characteristics and patient outcomes were analyzed, with particular focus on the potential to predict long-term survival. Results: The number of incurable factors was one in 31 patients and two in 5, including metastases to non-regional lymph node in 22, peritoneum in 10, liver in 6, and lung in 3. The regimen of chemotherapy was Docetaxel/CDDP/S-1 in 23 patients, Docetaxel/CDDP/S-1+Trastuzmab in 7, S-1/CDDP in 2, Docetaxel/S-1 in 1, CPT/CDDP in 1, and S-1 monotherapy in 1. Complete resection with no residual tumor (R0) was achieved in 25 of 36 patients, microscopic residual tumor status (R1) in 10, and macroscopic residual tumor (R2) in 1. The 3-year overall survival (OS) rate among the 36 patients who underwent conversion surgery was 60.3 % (median survival time, 1200 days). The 3-year OS rate among patients who underwent R0 resection was 70.8 % (median survival time, 1503 days). Patients who underwent R0 resection had significantly longer OS times than those who underwent R1 and R2 resection ( p=0.0124). We selected 16 variables in addition to residual tumor for Kaplan–Meier analysis. According to the log rank test, the following four variables were significantly associated with a better OS: clinical response to 1st line therapy (CR or PR vs. SD or PD)( p=0.0283), pathological response grade (1b-3 vs. 0-1a) ( p=0.0304), pathological tumor depth (CR or T1~T3 vs. T4) ( p=0.0261), and pathological nodal stage (N0〜2 vs. N3) ( p=0.0086). Conclusions: Our data indicates that clinical response to 1st line therapy in preoperative characteristics, R0 resection, pathological response grade, pathological tumor depth, pathological nodal stage in postoperative characteristics are predictive factors that can be expected to long-term survival.

A retrospective study of surgical treatment for gastric cancer in our institute as a clinical hospital in Japan

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15125-15125
Author(s):  
T. Kishimoto ◽  
H. Imamura ◽  
K. Yamamoto ◽  
Y. Miyazaki ◽  
H. Furukawa
Keyword(s):  
Gastric Cancer ◽  
Retrospective Study ◽  
Surgical Treatment ◽  
Surgical Complications ◽  
Safe Procedure ◽  
Clinical Hospital ◽  
D2 Gastrectomy ◽  
Randomized Controlled ◽  
Japanese Classification

15125 Background: Two European randomized controlled trials comparing D1 and D2 gastrectomy revealed a high operative mortality in the D2 group. Based on these reports, D1 gastrectomy is a standard treatment for western patients. In contrast, D2 gastrectomy is considered a standard and safe procedure in Japan. Moreover, the operative morbidity/mortality and the incidence of the major surgical complications were not different between D2and extended para-aortic lymphadenectomy in a prospective randomized controlled trial in Japan. We report a retrospective study of surgical treatment for gastric cancer in our institute as a clinical hospital in Japan. Methods: Patients who underwent gastrectomy between January 1998 and November 2006 in our institute were analyzed. Survival according to the staging by Japanese Classification of Gastric Cancer, the level of the dissection of lymph nodes, and all complications were studied. Results: A total 1342 patients underwent gastrectomy between January 1998 and November 2006 in our institute. The male/female ratio was 2.2 and the mean age was 64.7±11.4 years(range,27–94 years). The 5-year survival according to the staging by Japanese Classification of Gastric Cancer was 98.4%, 84.7%, 77.2%, 46.1%, 40.2% and 33.4% in the stage IA, IB, II, IIIA, IIIB, and IV, respectively. D0, D1, D2, and D3 or D4 gastrectomy was performed in 48, 200, 610, and 27 patients, respectively. Complications were identified in 295 patients(22%) involving 2 patients with treatment death(0.01%) and anastomotic leak, surgical site infection, pancreatic fistula, ileus, anastomotic stenosis, abdominal abcess, liver dysfunction, postoperative bleeding, pneumonia , DIC , peritonitis, and others were identified in 66, 51, 42, 28, 26, 23, 21, 14, 13, 4, 3, and 4 patients, respectively. We analyzed the D0/D1 and D2/D3/D4 dissection subgroups about complications. There was no significant difference in the incidence of complications between the two groups (p=0.093). Conclusions: Our data suggested that gastrectomy with D2 dissection has been a safe treatment with a good prognosis in our institute. D2 gastrectomy is considered a safe treatmemt without increasing surgical complications. No significant financial relationships to disclose.

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