Neoadjuvant therapy for localized gastrointestinal stromal tumors (GISTs): A propensity score weighted analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e23516-e23516
Author(s):  
Kathryn E. Marqueen ◽  
Erin Moshier ◽  
Michael Buckstein ◽  
Celina Ang
Keyword(s):  
Overall Survival ◽  
Logistic Regression ◽  
Propensity Score ◽  
Survival Benefit ◽  
Postoperative Mortality ◽  
Phase Iii ◽  
R0 Resection ◽  
Treatment Groups ◽  
Significant Difference ◽  
The Impact

e23516 Background: Retrospective and single-arm prospective studies have reported clinical benefit associated with receipt of neoadjuvant imatinib for GISTs. In the absence of randomized phase III data, the impact of neoadjuvant systemic therapy (NAT) on survival, in comparison to upfront resection, remains unknown. Methods: We identified N = 14,402 patients with complete clinical, demographic, treatment and pathologic data within the National Cancer Database (2004-2016) who underwent resection of localized GIST of the stomach, esophagus, small bowel, and colorectum, with or without ≥3 months of NAT. Inverse probability of treatment weighting (IPTW) was used to adjust for covariable imbalance among treatment groups, with the propensity score estimated by logistic regression. The effect of NAT on overall survival was estimated with a weighted time-dependent Cox proportional hazards model. A weighted logistic regression was used to estimate the effect of NAT on 90-day postoperative mortality and R0 resection. Results: 759 (5.3%) patients received NAT followed by resection, compared to 13,643 (94.7%) who underwent upfront resection. Median length of NAT was 6.3 months. 53% of NAT patients were male vs. 49% of UR patients, 68% vs. 66% had primary gastric GIST, and 73% vs 49% were high risk. Patients receiving NAT had larger tumors (p < 0.001) and higher mitotic index (p = 0.003). There was a significant survival benefit associated with receipt of NAT (table). 90-day postoperative mortality rate was 3/759 (0.4%) among NAT patients vs. 307/13,643 (2.3%) UR patients. Receipt of NAT was significantly associated with lower odds of 90-day postoperative mortality (table). Of the 13,562 patients with information on margin status, the R0 resection rate was 635/716 (88.7%) for the neoadjuvant group vs. 11,823/12,846 (92%), with no significant difference between treatment groups (table). Conclusions: After adjustment for imbalance in prognostic and demographic factors, this analysis demonstrates that receipt of NAT for localized GIST is associated with a modest overall survival benefit. Although NAT patients had higher risk features, NAT was associated with a lower risk of 90-day postoperative mortality, with no difference in likelihood of achieving an R0 resection. [Table: see text]

Randomized Trial of Adjuvant Chemotherapy With Mitomycin, Fluorouracil, and Cytosine Arabinoside Followed by Oral Fluorouracil in Serosa-Negative Gastric Cancer: Japan Clinical Oncology Group 9206–1

2003 ◽  
Vol 21 (12) ◽  
pp. 2282-2287 ◽  
Author(s):  
Atsushi Nashimoto ◽  
Toshifusa Nakajima ◽  
Hiroshi Furukawa ◽  
Masatsugu Kitamura ◽  
Taira Kinoshita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Survival Benefit ◽  
Curative Resection ◽  
Cancer Recurrence ◽  
Phase Iii ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Significant Difference

Purpose: To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-negative gastric cancer patients (excluding patients who were T1N0), we conducted a multicenter phase III clinical trial in which 13 cancer centers in Japan participated. Patients and Methods: From January 1993 to December 1994, 252 patients were enrolled into the study and allocated randomly to adjuvant chemotherapy or surgery alone. The chemotherapy comprised intravenous mitomycin 1.33 mg/m2, fluorouracil (FU) 166.7 mg/m2, and cytarabine 13.3 mg/m2 twice weekly for the first 3 weeks after surgery, and oral FU 134 mg/m2 daily for the next 18 months for a total dose of 67 g/m2. The primary end point was relapse-free survival. Overall survival and the site of recurrence were secondary end points. Results: Ninety-eight percent of patients underwent gastrectomy with D2 or greater lymph node dissection. There were no treatment-related deaths and few serious adverse events. There was no significant difference in relapse-free and overall survival between the arms (5-year relapse-free survival 88.8% chemotherapy v 83.7% surgery alone; P = .14 and 5-year survival 91.2% chemotherapy v 86.1% surgery alone; P = .13, respectively). Nine patients (7.1%) in the chemotherapy arm and 17 patients (13.8%) in the surgery-alone arm had cancer recurrence. Conclusion: There was no statistically significant relapse-free or overall survival benefit with this adjuvant chemotherapy for patients with macroscopically serosa-negative gastric cancer after curative resection, and there was no statistical difference between the two arms relating to the types of cancer recurrence. We do not recommend adjuvant chemotherapy with this regimen for this population in clinical practice.

scholarly journals Long-term outcomes of omentum-preserving versus resecting gastrectomy for locally advanced gastric cancer with propensity score analysis

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Yusuke Sakimura ◽  
Noriyuki Inaki ◽  
Toshikatsu Tsuji ◽  
Shinichi Kadoya ◽  
Hiroyuki Bando
Keyword(s):  
Gastric Cancer ◽  
Propensity Score ◽  
Advanced Gastric Cancer ◽  
Missing Values ◽  
Propensity Score Analysis ◽  
Locally Advanced ◽  
R0 Resection ◽  
Significant Difference ◽  
First Recurrence ◽  
The Impact

Abstract Omentectomy is conducted for advanced gastric cancer (AGC) patients as radical surgery without an adequate discussion of the effect. This study was conducted to reveal the impact of omentum-preserving gastrectomy on postoperative outcomes. AGC patients with cT3 and 4 disease who underwent total or distal gastrectomy with R0 resection were identified retrospectively. They were divided into the omentum-preserved group (OPG) and the omentum-resected group (ORG) and matched with propensity score matching with multiple imputation for missing values. Three-year overall survival (OS) and 3-year relapse-free survival (RFS) were compared, and the first recurrence site and complications were analysed. The numbers of eligible patients were 94 in the OPG and 144 in the ORG, and after matching, the number was 73 in each group. No significant difference was found in the 3-year OS rate (OPG: 78.9 vs. ORG: 78.9, P = 0.54) or the 3-year RFS rate (OPG: 77.8 vs. ORG: 68.2, P = 0.24). The proportions of peritoneal carcinomatosis and peritoneal dissemination as the first recurrence site and the rate and severity of complications were similar in the two groups. Omentectomy is not required for radical gastrectomy for AGC.

An updated overall survival analysis with correction for protocol-planned crossover of the international, phase III, randomized, placebo-controlled trial of regorafenib in advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib (GRID).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 110-110 ◽  
Author(s):  
George D. Demetri ◽  
Peter Reichardt ◽  
Yoon-Koo Kang ◽  
Jean-Yves Blay ◽  
Heikki Joensuu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Failure Time ◽  
Cox Model ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
High Rate ◽  
Phase Iii ◽  
Primary Analysis ◽  
Significant Difference ◽  
The Impact

110 Background: The GRID study showed that regorafenib improves progression-free survival compared with placebo in patients with advanced GIST after failure of at least imatinib and sunitinib (HR 0.27; 1-sided p<0.0001; Demetri 2013). At the time of the primary analysis, no significant difference in the secondary endpoint of overall survival (OS) was observed (HR 0.77; p=0.199), but this result may have been confounded by the high rate of crossover to regorafenib (85%) of placebo patients at progression. We conducted exploratory analyses of updated OS data to assess the effect of correcting for this protocol-planned crossover. Methods: The data cut-off for this updated OS analysis was 31 January 2014 (2 years after the primary analysis). OS was corrected using two randomization-based methods: rank preserving structural failure time (RPSFT) and iterative parameter estimation (IPE); both methods are considered as best choice among all correction analytics. Hazard ratios and 95% CI were derived using the Cox model. Results: A total of 139 deaths had occurred at the time of data cut-off: 91 events (68.4% of patients) in the regorafenib group and 48 (72.7%) in the placebo group. A total of 22 patients remained on regorafenib treatment (median duration 2.1 years, range 0.9–2.4). The updated hazard ratio for OS favored regorafenib (0.85, 95% CI: 0.60 - 1.21; p=0.18). Median OS was estimated as 17.4 months in both groups, with crossover from placebo. The corrected HRs for OS are less than the uncorrected HR (Table). Conclusions: The updated analysis of OS in the GRID trial is consistent with the primary analysis. An exploratory analysis correcting for the impact of cross-over on OS suggests a survival benefit for regorafenib in GIST. Clinical trial information: NCT01271712. [Table: see text]

The impact of neoadjuvant chemoradiation versus chemotherapy on short and long-term outcomes among gastric carcinoma patients.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 78-78
Author(s):  
Basem Azab ◽  
Francisco Igor Macedo ◽  
Omar Picado ◽  
Dido Franceschi ◽  
Alan S Livingstone ◽  
...  
Keyword(s):  
Gastric Carcinoma ◽  
Data Base ◽  
Postoperative Mortality ◽  
Neoadjuvant Chemoradiation ◽  
R0 Resection ◽  
Surgical Morbidity ◽  
Cox Regression Analysis ◽  
Significant Difference ◽  
The Impact

78 Background: There is little consensus on the use of neoadjuvant chemoradiation (NCRT) versus neoadjuvant chemotherapy (NCT) in gastric carcinoma (GC) patients. We sought to compare the outcomes of these two approaches in a large national data base. Methods: National Cancer Data Base PUF (2004-2014) of GC patients who underwent NCRT/NCT followed by resection were included. Primary outcome was overall survival (OS), secondary outcomes were pathological complete response (pCR), R0 resection and postoperative mortality. Results: A total of 4204 GC patients with NCT were included, 62% of them had additional neoadjuvant radiotherapy (NRT). NCRT had higher pCR and R0 rates [551/2613 (21%), 2314/2561 (90%)] than NCT group [148/1573 (9%), 1242/1543 (80%)], p < 0.0001. Multivariate logistic regression showed similar higher odds of pCR (OR 2.8, 95% CI 1.65-4.60, p < 0.0001) and R0 (OR 1.5, 95% CI 1.14-1.99, p = 0.004) among NCRT versus NCT. There was no significant difference in length of hospital stay, 30-day readmission rate, 30- and 90-day postoperative mortality. Median, 3- and 5-year OS for NCRT versus NCT were: (20.4 months, 24% and 11%) versus (18.3 months, 19% and 6%), p < 0.001. Univariate cox regression analysis showed superior OS with NRT (HR 0.9, 95% CI 0.80-0.91, p < 0.001). After adjusting for confounding variables, pCR (HR 0.2, 95% CI 0.18-0.24, p < 0.001) and R0 (HR 0.7, 95% CI 0.61-0.75, p < 0.001) had better OS, while NRT was not. Conclusions: NRT improved pCR and R0 rates in GC without increase in surgical morbidity/mortality. The long-term OS benefit of NRT is likely secondary to higher pCR and R0 resection.

Impact of the prior chemotherapy with two different fluoropyrimidines on the efficacy of CapeIRI or FOLFIRI in metastatic colorectal cancer: An exploratory analysis of the phase III AXEPT trial.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 711-711
Author(s):  
Tae Won Kim ◽  
Kei Muro ◽  
Rui-hua Xu ◽  
Young Suk Park ◽  
Wei Wang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Progression Free Survival ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Free Survival ◽  
Prior Chemotherapy ◽  
Oral Fluoropyrimidine ◽  
Significant Difference ◽  
Phase Iii Study ◽  
The Impact

711 Background: Modified CapeIRI (irinotecan 200 mg/m2 on day 1, capecitabine 1600 mg/m2 on days 1–14 every 3 weeks) with or without bevacizumab (± BV) has shown non-inferiority of overall survival compared with FOLFIRI ± BV based on the phase III study, AXEPT, as second-line chemotherapy for patients with mCRC. In this exploratory analysis of the AXEPT trial, we evaluated the impact of the prior chemotherapy with two different fluoropyrimidine backbones (fluorouracil and leucovorin vs oral fluoropyrimidine) on the efficacy of CapeIRI and FOLFIRI. Methods: Patients were randomized to receive standard FOLFIRI ± bevacizumab or modified CapeIRI ± bevacizumab after failure to fluoropyrimidine-based chemotherapy in the AXEPT study. Prior fluoropyrimidine backbones were categorized into oral fluoropyrimidine-based (eg, capecitabine or S-1) regimen (oral 5-FU group) and fluorouracil and leucovorin-based regimen (infusional 5-FU group). Assessed endpoints included overall survival, progression-free survival, response rate, and safety. Results: Prior fluoropyrimidine backbone was available for 642 patients among all 650 randomized patients (oral 5-FU group in 291, and infusional 5-FU group in 351). Median overall survival was 17.0 and 16.7 months for FOLFIRI ± BV and CapeIRI ± BV in the prior oral 5-FU group, and 14.9 and 16.7 months for FOLFIRI ± BV and CapeIRI ± BV in the prior infusional 5-FU group. Median progression-free survival was 7.9 and 8.6 months for FOLFIRI ± BV and CapeIRI ± BV in the prior oral 5-FU group, and 6.8 and 8.3 months for FOLFIRI ± BV and CapeIRI ± BV in the prior infusional 5-FU group. Conclusions: There was no significant difference in the efficacy of CapeIRI or FOLFIRI regardless of prior fluoropyrimidine backbones. Therefore, CapeIRI ± BV could also be effective for patients after failure of oral fluoropyrimidine-based chemotherapy (eg, CapeOX ± BV). Clinical trial information: NCT01996306. [Table: see text]

Surgery Alone Versus Chemoradiotherapy Followed by Surgery for Stage I and II Esophageal Cancer: Final Analysis of Randomized Controlled Phase III Trial FFCD 9901

2014 ◽  
Vol 32 (23) ◽  
pp. 2416-2422 ◽  
Author(s):  
Christophe Mariette ◽  
Laetitia Dahan ◽  
Françoise Mornex ◽  
Emilie Maillard ◽  
Pascal-Alexandre Thomas ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Postoperative Mortality ◽  
Final Analysis ◽  
Stage I ◽  
Phase Iii ◽  
R0 Resection ◽  
Resection Rate ◽  
Phase Iii Trial ◽  
End Point

Purpose Although often investigated in locally advanced esophageal cancer (EC), the impact of neoadjuvant chemoradiotherapy (NCRT) in early stages is unknown. The aim of this multicenter randomized phase III trial was to assess whether NCRT improves outcomes for patients with stage I or II EC. Methods The primary end point was overall survival. Secondary end points were disease-free survival, postoperative morbidity, in-hospital mortality, R0 resection rate, and prognostic factor identification. From June 2000 to June 2009, 195 patients in 30 centers were randomly assigned to surgery alone (group S; n = 97) or NCRT followed by surgery (group CRT; n = 98). CRT protocol was 45 Gy in 25 fractions over 5 weeks with two courses of concomitant chemotherapy composed of fluorouracil 800 mg/m2 and cisplatin 75 mg/m2. We report the long-term results of the final analysis, after a median follow-up of 93.6 months. Results Pretreatment disease was stage I in 19.0%, IIA in 53.3%, and IIB in 27.7% of patients. For group CRT compared with group S, R0 resection rate was 93.8% versus 92.1% (P = .749), with 3-year overall survival rate of 47.5% versus 53.0% (hazard ratio [HR], 0.99; 95% CI, 0.69 to 1.40; P = .94) and postoperative mortality rate of 11.1% versus 3.4% (P = .049), respectively. Because interim analysis of the primary end point revealed an improbability of demonstrating the superiority of either treatment arm (HR, 1.09; 95% CI, 0.75 to 1.59; P = .66), the trial was stopped for anticipated futility. Conclusion Compared with surgery alone, NCRT with cisplatin plus fluorouracil does not improve R0 resection rate or survival but enhances postoperative mortality in patients with stage I or II EC.

Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor (EGFR).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7521-7521 ◽  
Author(s):  
Tetsuya Mitsudomi ◽  
Satoshi Morita ◽  
Yasushi Yatabe ◽  
Shunichi Negoro ◽  
Isamu Okamoto ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Significant Difference ◽  
The Impact ◽  
Egfr Tki ◽  
First Line Treatment ◽  
Platinum Doublet

7521 Background: WJTOG3405 met its primary endpoint of progression free survival (PFS) (9.2 months (mo.) for G vs. 6.3 mo. for CD, hazard ratio (HR) 0.489, 95% confidence interval (CI): 0.336-0.710). (Mitsudomi et al., Lancet Oncol., 2010). However, the impact on overall survival (OS) was not clear then because of relatively short follow-up period. Methods: Overall survival (OS) was re-evaluated using updated data (data cutoff, 31 July, 2011, median follow-up, 34 months) for 172 patients. Results: Eighty-two events had occurred (48%). Median survival time (MST) for G arm was 36 mo. (95% CI: 26.3 -) which was not significantly different from 39 mo. (95% CI: 31.2 -) for CD arm (HR 1.185, 95% CI 0.767-1.829). Multivariate analysis using Cox proportional hazards model revealed that none of covariates (treatment arm, smoking status, sex, age, postoperative recurrence or IIIB/IV, and mutation type) significantly affected OS. In the G arm, MST of patients with exon 19 deletion (36 mo.) was comparable to that of patients with L858R (35 mo.). In the CD arm, 78 patients (91%) received EGFR-TKI as the 2nd or later line treatment, whereas in the G arm, 52 patients (61%) received platinum doublet. Accordingly, 130 patients received both platinum doublet and EGFR-tyrosine kinase inhibitor (TKI) and 34 patients received EGFR-TKI without platinum doublet in their whole courses of therapy. MST for the former and the latter group were 36 months (95% CI: 31.2-45.7) and 45 months (95% CI: 25.6-), without significant difference. Conclusions: This update OS analysis revealed that G for advanced NSCLC with EGFR mutation offers distinct survival benefit of 3 years. There was no difference in OS whether the first-line treatment was G or CD, in accordance with the precedent studies. The reason why PFS difference was not translated into OS difference is probably due to high cross over rate to EGFR-TKI. However, it was noteworthy that 40% of patients in the G arm could be managed without platinum doublet and yet had similar outcome.

PS02.162: THREE-YEAR OVERALL SURVIVAL UPDATE FROM PHASE II STUDY OF CHEMOSELECTION WITH DCF AND SUBSEQUENT CONVERSION SURGERY FOR LOCALLY ADVANCED UNRESECTABLE ESOPHAGEAL CANCER

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 167-168
Author(s):  
Tomoya Yokota ◽  
Ken Kato ◽  
Yasuo Hamamoto ◽  
Yasuhiro Tsubosa ◽  
Hirofumi Ogawa ◽  
...  
Keyword(s):  
Overall Survival ◽  
Esophageal Cancer ◽  
Phase Ii ◽  
Locally Advanced ◽  
R0 Resection ◽  
Conversion Surgery ◽  
Significant Difference ◽  
Subsequent Conversion ◽  
The Impact

Abstract Background A multicenter phase II trial revealed that docetaxel plus 5-fluorouracil and cisplatin (DCF) induction chemotherapy (IC) and subsequent conversion surgery (CS) was tolerable and effective in patients with locally advanced unresectable esophageal cancer (LAUEC) (Br J Cancer 2016;115:1328–1334). Here, we report updated 3-year analyses to further characterize the impact of DCF-IC followed by CS. Methods Esophageal cancer patients with clinical T4 disease and/or unresectable supraclavicular lymph node metastasis were eligible. The treatment starts with 3 cycles of DCF-IC, followed by CS if resectable, or by concurrent radiation plus chemotherapy with 5-fluorouracil and cisplatin (CF-RT) if not resectable. This updated analysis represents 3-year overall survival (OS), 3-year progression free survival (PFS), location of relapse, and subsequent therapy. Results As of October 11, 2017, 25 patients were dead. The median follow-up period in patients surviving without death was 39.3 months (95%CI: 38.7 - 41.7months). The estimated 1-year OS was 66.7% and lower limit of 95% confidence interval was 54.6%. The estimated 3-year OS was 46.6% (95% CI; 34.2 - 63.5%). The OS for patients who underwent R0 resection (n = 19) was significantly longer than those who did not undergo R0 resection (3-year OS: 71.4% vs. 30.1%). The estimated 1-year PFS was 50.6% (95%CI: 38.1 - 67.3%) and the estimated 3-year PFS was 39.6% (95%CI: 27.7 - 56.6%). The PFS for patients who underwent R0 resection (n = 19) was significantly longer than those who did not undergo R0 resection (3-year PFS: 61.3% vs. 25%). The recurrence or progression in primary site was observed in 31% of non R0 group. There was no significant difference in the rates of distant metastasis between the two groups (non R0 group vs. R0 group; 21% vs. 16%). The subsequent therapy after protocol therapy included chemotherapy (n = 18), radiotherapy (n = 11), and surgery (n = 5). Conclusion This longer follow up of DCF-IC followed by CS strategy for patients with LAUEC revealed promising OS and PFS. Based on this phase 2 trial, JCOG1510, a prospective randomized controlled trial to compare chemoselection with DCF-IC followed by CS versus CF-RT as a standard treatment is in preparation for LAUEC. Disclosure All authors have declared no conflicts of interest.

scholarly journals The second pregnancy has no effect in the incidence of macrosomia: a cross-sectional survey in two western Chinese regions

2021 ◽  
Vol 40 (1) ◽  
Author(s):  
Li Luo ◽  
Huan Zeng ◽  
Mao Zeng ◽  
Xueqing Liu ◽  
Xianglong Xu ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Western China ◽  
Fetal Macrosomia ◽  
Multivariate Logistic Regression Model ◽  
Multivariate Logistic Regression ◽  
Cross Sectional ◽  
Second Child ◽  
Child Policy ◽  
Significant Difference ◽  
The Impact

Abstract Background After the implementation of the universal two-child policy in China, the increase in parity has led to an increase in adverse pregnancy outcomes. The impact of one and two fetuses on the incidence of fetal macrosomia has not been fully confirmed in China. This study aimed to explore the differences in the incidence of fetal macrosomia in first and second pregnancies in Western China after the implementation of the universal two-child policy. Methods A total of 1598 pregnant women from three hospitals were investigated by means of a cross-sectional study from August 2017 to January 2018. Participants were recruited by convenience and divided into first and second pregnancy groups. These groups included 1094 primiparas and 504 women giving birth to their second child. Univariate and multivariate logistic regression analyses were performed to discuss the differences in the incidence of fetal macrosomia in first and second pregnancies. Results No significant difference was found in the incidence of macrosomia in the first pregnancy group (7.2%) and the second pregnancy group (7.1%). In the second-time pregnant mothers, no significant association was found between the macrosomia of the second child (5.5%) and that of the first child (4.7%). The multivariate logistic regression model showed that mothers older than 30 years are not likely to give birth to children with macrosomia (odds ratio (OR) 0.6, 95% confidence interval (CI) 0.4,0.9). Conclusions The incidence of macrosomia in Western China is might not be affected by the birth of the second child and is not increased by low parity.

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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