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.

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 outcome of preoperative docetaxel with cisplatin plus S-1 therapy for advanced gastric cancer with extensive nodal metastasis (JCOG1002).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 141-141 ◽  
Author(s):  
Shinji Morita ◽  
Seiji Ito ◽  
Takeshi Sano ◽  
Daisuke Takahari ◽  
Hiroshi Katayama ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Response Rate ◽  
Nodal Metastasis ◽  
Clinical Response Rate ◽  
R0 Resection ◽  
Term Outcome ◽  
Term Survival ◽  
Long Term Outcome

141 Background: Neoadjuvant chemotherapy (NAC) with cisplatin plus S-1 (CS) followed by gastrectomy with D2 plus para-aortic lymph node (PAN) dissection is regarded as a standard treatment in Japan for advanced gastric cancer with bulky lymph node (BN) and/or PAN metastasis based on the results of JCOG0405. In JCOG1002, we added docetaxel to CS (DCS) to further improve the long-term outcome. However the primary endpoint, clinical response rate (RR), did not meet the expected level (Ito S, Gastric Cancer. 2017). Herein we report the long-term survival. Methods: Patients with BN and/or PAN metastasis received two or three cycles of DCS therapy (docetaxel at 40 mg/m2 and cisplatin at 60 mg/m2 on day 1, S-1 at 40 mg/m2 twice daily for 2 weeks, were administered every four weeks) followed by gastrectomy with D2 plus PAN dissection and postoperative S-1 for 1 year. Results: Between July 2011 and May 2013, 53 patients were enrolled. Clinically, 17.0% of patients had both PAN and BN metastasis, and remaining patients had either PAN (26.4%) or BN (56.6%) metastasis. The clinical response rate (RR) was 57.7 % as assessed by RECIST v1.0, and the R0 resection rate was 84.6%, which did not exceed those in JCOG0405 (64.7% and 82.3%, respectively). The pathological RR defined as residual tumor corresponding to less than one-third the size of the original tumor was 34.6% in 52 eligible patients, which was slightly higher than in JCOG0405 (28.6%). Among all eligible patients, 5-year overall survival was 54.9% (95% confidence interval 40.3–67.3%) at the date cut-off of May 2018. Among 44 eligible patients with R0 resection, 5-year progression-free survival was 47.7% (95% confidence interval 32.5–61.5%). These were similar to the results of JCOG0405 (52.8% and 50.0%). Twenty patients developed cancer recurrence. The most frequent site of recurrence was lymph nodes (50.0% of all recurrences). Conclusions: Adding docetaxel to CS in NAC for extensive lymph node metastasis did not improve not only short-term outcomes but also long-term survival. NAC with CS followed by D2 + PAN dissection and postoperative S-1 remains standard for patients with extensive nodal metastasis. Clinical trial information: UMIN000006069.

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.

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

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15567-e15567
Author(s):  
K. Fujitani ◽  
S. Tamura ◽  
Y. Kimura ◽  
T. Tsuji ◽  
J. Matsuyama ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Performance Status ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Stage Iii ◽  
R0 Resection ◽  
D2 Gastrectomy ◽  
Grade 3

e15567 Background: Although an adjuvant chemotherapy with S-1 has become the standard treatment for stage II-III gastric cancer (GC) patients (pts) after curative D2 gastrectomy in Japan, the survival benefit for stage III pts obtained by S-1 is considered to be modest. S-1 plus docetaxel has shown a good response rate of 56% with prolonged median overall survival (OS) of 14.3 months in pts with advanced GC. This phase II study evaluated the feasibility and safety of adjuvant S-1 plus docetaxel for stage III GC pts after R0 resection. Methods: Patients with curatively resected pathological stage III GC receiving D2 dissection, age 20–80 years, performance status < 1, no prior adjuvant treatment, adequate organ function, and informed consent were given S-1 (80 mg/m2/day) orally for consecutive 2 weeks plus docetaxel (40 mg/m2) intravenously on day 1, repeated every 3 weeks. The treatment was started within 45 days after gastrectomy, and repeated for 4 cycles, followed by S-1 monotherapy until 1 year after surgery. Study endpoints included feasibility of the 4 cycles of S-1 plus docetaxel as primary, and safety, progression free survival (PFS), and OS as secondary. Sample size was set to be 50, which was determined to reject the feasibility of 50% under the expectation of 75% with power of 90% and two-sided α of 5%. Results: Fifty-three pts, 42 males and 11 females with a median age of 65 years, were enrolled between 5/2007 and 8/2008. Pathological stages included IIIA in 36 pts and IIIB in 17 pts. Planned 4 cycles of treatment were delivered to 41 out of 53 pts, with the feasibility of 77.4% (95% CI 63.8–87.7%, P<0.001). Reasons for discontinuation were recurrent cancer in 1 pt, adverse events in 10, and miscellaneous in 1, respectively. 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. Conclusions: Adjuvant S-1 plus docetaxel was well-tolerated and showed good compliance. Although follow-up is ongoing on survival, this regimen could be a candidate of future phase III trial seeking for the optimal adjuvant chemotherapy for stage III GC pts after curative D2 gastrectomy. No significant financial relationships to disclose.

scholarly journals Phase II Study of Neoadjuvant Chemotherapy With S-1 Plus Oxaliplatin for Gastric Cancer Clinical T4 or N2-3

2021 ◽  
Author(s):  
AKIKO SERIZAWA ◽  
Hidekazu Kuramochi ◽  
Kiyoaki Taniguchi ◽  
Masaho Ota ◽  
Satoshi Katagiri ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Survival Rates ◽  
Pathological Response ◽  
R0 Resection ◽  
Resection Rate ◽  
Grade 3 ◽  
One Year

Abstract Background: In Japan, the standard treatment for stage II or III gastric cancer is D2 gastrectomy followed by administration of S-1 for one year. However, patients with stage III disease have unsatisfactory survival rates. The purpose of this study was to evaluate the efficacy and safety of neoadjuvant chemotherapy consisting of S-1 and oxaliplatin for advanced gastric cancer.Methods: Patients with cT4 or cN2–3 gastric cancer were scheduled to receive two courses of chemotherapy (130 mg/m2 oxaliplatin on Day 1, 80 mg/m2 S-1 per day twice daily for 14 days) followed by surgery. The primary endpoint was the R0 resection rate. The secondary endpoints were rates of completion of protocol treatment, pathological response, and adverse events; and 3-year overall survival, 5-year overall survival, and 5-year recurrence-free survival.Results: Between May 2016 and March 2019, 30 patients were enrolled in the study, all of whom completed the protocol treatment. The R0 resection rate (primary endpoint) was 93.3% (95% confidence interval: 77.9–99.2). The pathological response rate was 63.3%. Grade 3–4 toxicities included anemia (3.3%), anorexia (6.7%), and fatigue (3.3%). Relative dose intensities were 91.2% and 94.2% for S-1 and oxaliplatin, respectively.Conclusions: Neoadjuvant S-1 and oxaliplatin is highly effective, achieving an acceptable R0 resection rate with relatively few severe toxicities and good compliance. Trial registration information:Registry name: A prospective intervention study on the availability of preoperative SOX therapy for T4 or N2-3 gastric cancerTrial ID: UMIN: UMIN000024656URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028365

scholarly journals FLOT Neoadjuvant Chemotherapy Followed by Laparoscopic D2 Gastrectomy in the Treatment of Locally Resectable Advanced Gastric Cancer

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Shun Zhang ◽  
Dongyi Yan ◽  
Qi Sun ◽  
Tao Du ◽  
Dongliang Cao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Postoperative Complications ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Laparoscopic Gastrectomy ◽  
R0 Resection ◽  
D2 Gastrectomy ◽  
Grade 3 ◽  
Pathologic Complete Remission ◽  
Gastric Cancer Patients

Background. The prognosis of patients with advanced gastric cancer remains unsatisfactory, highlighting the need for improved therapeutic strategies. We analyzed 23 resectable advanced gastric cancer patients who received FLOT followed by laparoscopic gastrectomy with D2 lymphadenectomy to evaluate the efficacy and safety. Methods. Patients aged 18–75 years with gastric adenocarcinoma (stage cT3–4 and/or N + M0) underwent neoadjuvant FLOT therapy (four preoperative and four postoperative 2-week cycles) at Shanghai East Hospital. Laparoscopic gastrectomy was scheduled 3-4 weeks after completion of the last cycle of preoperative chemotherapy. The type of surgical procedure was determined by the location and extent of the primary tumor. Results. 23 patients were reviewed in the study. 20 patients (81.2%) received four courses of FOLT therapy, while 3 patients (18.8%) received three courses of treatment. There were 3 (13.0%) complete responses, 13 (56.5%) partial responses, 4 (26.1%) of stable disease, and 1 (4.3%) of progressive disease. The clinical efficacy response rate was 69.6%. The R0 resection rate was 91.3%. Only one patient exhibited grade III postoperative complications. The pathologic complete remission was 13%. The common grade 3/4 adverse events from chemotherapy were leucopenia (17.4%), neutropenia (30.4%), anemia (13%), anorexia (13%), and nausea (17.4%). Postoperative complications occurred in 5 patients (26.1%). There was no treatment-related mortality or reoperation. The most reason for not completing chemotherapy was the patient’s request. Conclusions. These findings suggest that FLOT neoadjuvant chemotherapy, followed by laparoscopic D2 gastrectomy, is effective and safe in advanced, resectable advanced gastric cancer.

scholarly journals Positive lymph node ratio is an index in predicting prognosis for remnant gastric cancer with insufficient retrieved lymph node in R0 resection

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Honghu Wang ◽  
Hao Qi ◽  
Xiaofang Liu ◽  
Ziming Gao ◽  
Iko Hidasa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Lymph Nodes ◽  
Lymph Node Ratio ◽  
Prognostic Index ◽  
Staging System ◽  
R0 Resection ◽  
Remnant Gastric Cancer ◽  
Curative Intent ◽  
Node Ratio

AbstractThe staging system of remnant gastric cancer (RGC) has not yet been established, with the current staging being based on the guidelines for primary gastric cancer. Often, surgeries for RGC fail to achieve the > 15 lymph nodes needed for TNM staging. Compared with the pN staging system, lymph node ratio (NR) may be more accurate for RGC staging and prognosis prediction. We retrospectively analyzed the data of 208 patients who underwent R0 gastrectomy with curative intent and who have ≤ 15 retrieved lymph nodes (RLNs) for RGC between 2000 and 2014. The patients were divided into four groups on the basis of the NR cutoffs: rN0: 0; rN1: > 0 and ≤ 1/6; rN2: > 1/6 and ≤ 1/2; and rN3: > 1/2. The 5-year overall survival (OS) rates for rN0, rN1, rN2, and rN3 were 84.3%, 64.7%, 31.5%, and 12.7%, respectively. Multivariable analyses revealed that tumor size (p = 0.005), lymphovascular invasion (p = 0.023), and NR (p < 0.001), but not pN stage (p = 0.682), were independent factors for OS. When the RLN count is ≤ 15, the NR is superior to pN as an important and independent prognostic index of RGC, thus predicting the prognosis of RGC patients more accurately.

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.

scholarly journals Neoadjuvant Chemotherapy Compared With Surgery Alone for Locally Advanced Cancer of the Stomach and Cardia: European Organisation for Research and Treatment of Cancer Randomized Trial 40954

2010 ◽  
Vol 28 (35) ◽  
pp. 5210-5218 ◽  
Author(s):  
Christoph Schuhmacher ◽  
Stephan Gretschel ◽  
Florian Lordick ◽  
Peter Reichardt ◽  
Werner Hohenberger ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Neoadjuvant Chemotherapy ◽  
Preoperative Chemotherapy ◽  
Survival Benefit ◽  
Locally Advanced ◽  
Postoperative Chemotherapy ◽  
Phase Iii ◽  
R0 Resection ◽  
Resection Rate

PurposePatients with locally advanced gastric cancer benefit from combined pre- and postoperative chemotherapy, although fewer than 50% could receive postoperative chemotherapy. We examined the value of purely preoperative chemotherapy in a phase III trial with strict preoperative staging and surgical resection guidelines.Patients and MethodsPatients with locally advanced adenocarcinoma of the stomach or esophagogastric junction (AEG II and III) were randomly assigned to preoperative chemotherapy followed by surgery or to surgery alone. To detect with 80% power an improvement in median survival from 17 months with surgery alone to 24 months with neoadjuvant, 282 events were required.ResultsThis trial was stopped for poor accrual after 144 patients were randomly assigned (72:72); 52.8% patients had tumors located in the proximal third of the stomach, including AEG type II and III. The International Union Against Cancer R0 resection rate was 81.9% after neoadjuvant chemotherapy as compared with 66.7% with surgery alone (P = .036). The surgery-only group had more lymph node metastases than the neoadjuvant group (76.5% v 61.4%; P = .018). Postoperative complications were more frequent in the neoadjuvant arm (27.1% v 16.2%; P = .09). After a median follow-up of 4.4 years and 67 deaths, a survival benefit could not be shown (hazard ratio, 0.84; 95% CI, 0.52 to 1.35; P = .466).ConclusionThis trial showed a significantly increased R0 resection rate but failed to demonstrate a survival benefit. Possible explanations are low statistical power, a high rate of proximal gastric cancer including AEG and/or a better outcome than expected after radical surgery alone due to the high quality of surgery with resections of regional lymph nodes outside the perigastic area (celiac trunc, hepatic ligament, lymph node at a. lienalis; D2).

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