Perioperative chemotherapy with oxaliplatin/5-fluorouracil/leucovorin (FOLFOX7) for locally advanced gastric cancer: Final results of a prospective multicenter phase II study (BJSA-01) with 2 years follow-up.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 4021-4021
Author(s):  
J. Ji ◽  
A. Wu ◽  
Z. Li ◽  
Y. Liu ◽  
R. Li ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Perioperative Chemotherapy ◽  
Locally Advanced Gastric Cancer ◽  
Multicenter Phase

Two-year follow-up of a phase II study on catumaxomab as part of a multimodal approach in primarily resectable gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4095-4095 ◽  
Author(s):  
Carsten Bokemeyer ◽  
Karsten Ridwelski ◽  
Djordje Atanackovic ◽  
Dirk Arnold ◽  
Ewald Woell ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Multimodal Approach ◽  
En Bloc ◽  
Locally Advanced Gastric Cancer ◽  
Number Of Patients

4095^ Background: Perioperative chemotherapy (CT) has demonstrated as survival benefit in locally advanced gastric cancer (GC) in randomized trials. However, the overall cure rate is 30-40% and a significant number of patients are not able to receive the postoperative part of their CT regimen. In Europe, the trifunctional antibody catumaxomab is approved for the treatment of malignant ascites based on a pivotal trial which also included GC patients. A new multimodal approach combining neoadjuvant CT, followed by gastrectomy and intraperitoneal (i.p.) immunotherapy with catumaxomab was assessed in a single-arm multicenter phase II study. We here report 2-year follow-up data. Methods: GC pts (T2/T3/T4, N+/–, M0) received 3 cycles of neoadjuvant fluoropyrimidin/platinum-based CT followed by ’en-bloc’ R0-gastrectomy. Catumaxomab was administered i.p. as intraoperative bolus (10 µg) followed by 4 consecutive 3-hour infusions of 10-150 µg. Primary safety endpoint was the rate of predefined postoperative complications observed during 30 days after surgery. Key efficacy endpoints included disease-free (DFS) and overall survival (OS). Results: The original study data presented at the WCGC in 2011 (Schuhmacher et al.,Ann Oncol (2011) 22(suppl. 5)) showed that the primary endpoint was met and the described application regimen is safe. At time of surgery, 27.8% of patients were stage I, 27,8% of patients were stage II, 22,3% of patients were stage III and 14,8% of patients were stage IV as assessed according to pTNM measures. At 24 months 39/54 (safety analysis set) patients were still alife,14/54 were dead, (one patient lost to follow-up), 24/37 had no progression, only 13/37 patients relapsed (for 2 patients disease status was not recorded). At the 2 year cut off DFS was 56.4% (95% CI: 41–69%), OS was 75% (95% CI: 60–85%). Conclusions: Catumaxomab as part of a multimodal therapy in primarily resectable GC is a feasible option. The 2-year follow up efficacy results show promising data for DFS and OS in a cohort of locally advanced gastric cancer pts.

A phase II study of neoadjuvant chemotherapy with a modified FOLFOX6 regimen for locally advanced gastric cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 81-81
Author(s):  
Xiang Wang ◽  
Lin Zhao ◽  
Hongfeng Liu ◽  
Chunmei Bai ◽  
Xiaoyi Li
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Postoperative Chemotherapy ◽  
Regression Rate ◽  
Locally Advanced Gastric Cancer ◽  
Laurén Classification

81 Background: The aim of this study was to evaluate the efficacy and safety of neoadjuvant chemotherapy with the mFOLFOX6 regimen in gastric cancer patients. Methods: This study was a single-arm phase II study. 73 patients with histologically confirmed locally advanced gastric cancer (T2-T4 or N+) were enrolled. The patients were administered the mFOLFOX6 regimen for 3 cycles. Surgery was scheduled 3-4 weeks after the completion of the chemotherapy. Postoperative chemotherapy began 4 weeks after surgery, and the program choice was based on the results of patients’ clinical/pathological evaluations. Perioperative efficacy, toxicity, effects of surgery, postoperative observation, and prognosis were studied. Survival analysis was performed to identify the relationship between the response and outcome and to identify factors predictive of OS. Results: 73 patients received the neoadjuvant chemotherapy, and 67 (91.8%) completed all of the preoperative cycles, with grade 3-4 toxicity arising in 33.0%. Surgery was performed in 71 (97.3%) patients, and radical resection was achieved in 67 (91.8%) patients. Postoperative chemotherapy started in 63 (88.7%) patients. The radiology response rate of chemotherapy was 45.8%. Among the patients who underwent radical surgery, pT downstaging was observed in 22 (32.8%) patients and pN downstaging was observed in 17 (25.4%) patients. All of the patients showed different levels of histological regression of the primary tumour, with a ≥ 50% regression rate of 49.2% and a pCR rate of 3.0%. Univariate analysis identified factors that were associated with OS, including local tumour infiltration, Lauren classification, pre-chemotherapy N stage, ypTNM stage, and pathologic regression rate (GHR)( ≥ 2/3/ < 2/3, ≥ 50%/ < 50%). Multivariate analysis identified both ypTNM stage and Lauren classification as independent predictors of survival. Conclusions: The mFOLFOX6 regimen was very effective and well-tolerated as a neoadjuvant chemotherapy for locally advanced gastric cancer. The ypTNM stage could serve as an independent predictor of survival. GHR ≥ 50% / < 50% could be used as a surrogate marker to guide the selection of a postoperative chemotherapy regimen. Clinical trial information: NCT02226380.

Multicenter phase II study of triplet combination chemotherapy with paclitaxel, cisplatin, and S-1 for advanced gastric cancer (OGSG 0703).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 124-124
Author(s):  
Kazumasa Fujitani ◽  
Yutaka Kimura ◽  
Hiroshi Imamura ◽  
Masahiro Gotoh ◽  
Shohei Iijima ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Phase Ii Study ◽  
Performance Status ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Statistical Hypothesis ◽  
Multicenter Phase

124 Background: Docetaxel combined with cisplatin and 5-fluorouracil is active in advanced gastric cancer, but not generally accepted because of its substantial toxicities. We conducted a multicenter phase II study of triplet combination using paclitaxel, cisplatin and S-1 (PCS) as first-line treatment for advanced gastric cancer. Methods: Patients with previously untreated, locally advanced or metastatic measurable gastric cancer, a performance status < 2, age of 20-75 years, and adequate organ functions were given intravenous paclitaxel at 70 mg/m2 and cisplatin at 30 mg/m2 on days 1 and 15, plus oral S-1 at 40 mg/m2 b.i.d. on days 1 to 21, followed by 2-week rest, repeated every 5 weeks. Treatment was continued until disease progression or unacceptable toxicity occurred, or the patient refused the therapy. Study endpoints included overall response rate (ORR) as primary, progression free survival (PFS), overall survival (OS), and toxicity. Sample size of 40 patients was determined to reject the ORR of 55% under the expectation of 75% with a power of 80% and a one-sided α of 5%. Results: A total of 52 patients were enrolled in this study, among whom 49 were assessable for efficacy and 51 assessable for toxicity. ORR was 46.9% (95% CI: 32.5-61.7%). The median PFS and median OS were 5.4 months (95% CI: 4.1-7.0) and 11.5 months (95% CI: 7.3-16.1), respectively. Frequent grade 3/4 toxicities were neutropenia (51%), leucopenia (25%), anemia (20%), hyponatremia (16%), anorexia (14%), diarrhea (8%) and fatigue (8%). There was no treatment-related death. Conclusions: Triplet combination chemotherapy with PCS demonstrated superior feasibility with promising antitumor activity, though which did not meet the statistical hypothesis, for advanced gastric cancer.

A phase II study of perioperative S-1 combined with weekly docetaxel in patients with locally advanced gastric cancer: Clinical and pharmacogenetic results.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4114-4114
Author(s):  
Sook Ryun Park ◽  
Young Woo Kim ◽  
Keun Won Ryu ◽  
Hyeong-Seok Lim ◽  
Jun Ho Lee ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Response ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Clinical Response Rate ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer

4114 Background: We conducted a phase II study to evaluate the efficacy and safety of perioperative S-1 + docetaxel (DS) in locally advanced gastric cancer (LAGC), and to investigate the association between CYP2A6 genotypes and treatment outcomes. Methods: Eligibility criteria included 18-70 yrs, PS 0-1, measurable lesion(s), and LAGC (clinical stage III-IV (M0) by Japanese staging system). Pts were given each 3 cycles of pre- and post-operative chemotherapy (S-1 40 mg/m2 bid on D1-14, docetaxel 35 mg/m2iv on D1, 8 q 3 wks), and underwent surgery (≥D2). Results: From Oct 2006 to June 2008, 44 pts entered into the study, and 43 pts were eligible. Median age=53 yrs (range, 33-69); PS 0/1=2/41; M/F=29/14; and stage IIIA/IIIB/IV (M0)=20/18/5. All 43 eligible pts completed preoperative DS and 40 pts (93%) completed postoperative DS. The most common G3/4 toxicities during pre- and post-operative DS were neutropenia (28% vs. 65%), stomatitis (19% vs. 5%), and abdominal pain (5% vs. 18%). The clinical response rate was 74.4% (95% CI, 61.4-87.4%) with 1 CR (2.3%) and 31 (72.1%) PRs. R0 resection rate was 97.7%, major pathologic response rate was 48.8% with 1 CR, and pathologic stage was 0/1/2/3/4 (%) = 2.3/44.2/20.9/20.9/11.6. With a median follow-up of 66.6 months, 3-yr PFS and 5-yr OS was 62.8% and 69.6%, respectively. Survival differed according to clinical response, clinical downstaging, and CYP2A6 genotypes (Table). Pts with two CYP2A6 variant alleles (V/V) had higher Cmax (27.7±4.6 vs. 20.3±1.2; p=0.045) and AUCinf (220.4±43.1 vs. 172.5±12.5; p=0.187) of tegafur, and lower Cmax (1.4±0.2 vs. 1.8±0.1; p=0.178) and AUCinf (8.4±1.2 vs. 9.7±0.5; p=0.308) of 5-FU than those with no or one variant allele (W/W or W/V). Conclusions: DS is active with a manageable toxicity profile in the perioperative setting in pts with LAGC. CYP2A6 genotype may be predictive of efficacy (S-1 and docetaxel was provided by JEIL Pharm. Co., Ltd. and sanofi-aventis Korea Co., Ltd., respectively). Clinical trial information: NCT00587145. [Table: see text]

Impact of early FDG-PET directed intervention on preoperative therapy for locally advanced gastric cancer: A Cooperative Group random assignment phase II study (Alliance A021302) Impac.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4135-TPS4135
Author(s):  
Manish A. Shah ◽  
Qian Shi ◽  
Vivian E. Strong ◽  
Jon Strasser ◽  
David H. Ilson ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Fdg Pet ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Operative Therapy ◽  
Salvage Chemotherapy ◽  
Cooperative Group ◽  
Locally Advanced Gastric Cancer

TPS4135 Background: Gastric cancer is a prevalent and morbid illness for which new treatment strategies are needed. Peri-operative therapy is a standard approach that is associated with only a 15% improvement in overall survival. Early FDG-PET scanning, performed prior to cycle 2, can distinguish patients (pts) responding to chemotherapy from those who are not. FDG-PET non-responding pts have poorer survival. This study addresses the question of salvage therapy in pts who are PET non-responders. Specifically, does salvage chemotherapy with docetaxel /irinotecan improve pt survival in FDG-PET-nonresponding pts with locally advanced gastric cancer. Methods: This is a multicenter, cooperative group, NCI supported, randomized phase II study of salvage chemotherapy + surgery versus surgery and post-operative chemoradiotherapy in pts who are FDG-PET non-responders (defined as a decrease in SUVmaxof the primary tumor of less than 35%). A total of 176 pts with locally advanced, resectable gastric cancer who were FDG-PET non-responders to cycle 1 of platinum/capecitabine based chemotherapy will be randomized in a 1:1 manner to receive either (Arm A) surgery followed by fluoropyrimidine-sensitized radiotherapy (4500 cGy), or (Arm B) salvage chemotherapy with docetaxel / irinotecan (DI) for 2 cycles followed by standard resection and 3 cycles DI post-operatively. DI is administered as D 30 mg/m2, I 50 mg/m2 given on D1, D8 of a 21 day cycle. 416 pts will be screened to yield 162 non-responders (81 FDG-PET non-responders per treatment group). With expected 120 events, the study will have 80% power to detect a hazard ratio of 0.625 for improved survival at the one-sided significant level of 0.15. Pts will be required to provide tissue at the time of resection, as well as whole blood prior to resection for correlative studies associated with platinum sensitivity, FDG avidity, and prognostic markers. This study is available through all cooperative groups (SWOG, ACRIN/ECOG, Alliance, and NRG) and the National Clinical Trials Network. Enrollment began in November 2015. Support: U10CA180821, U10CA180882; Clinical Trial Information: NCT02485834 .

Updated results of a randomized phase II trial for neoadjuvant versus adjuvant docetaxel/cisplatin chemotherapy in patients with locally advanced gastric cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 111-111
Author(s):  
Young Woo Kim ◽  
Keun Won Ryu ◽  
Il Ju Choi ◽  
Myeong-Cherl Kook ◽  
Young Iee Park ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Phase Iii ◽  
Cancer Center ◽  
Locally Advanced Gastric Cancer ◽  
Randomized Phase Ii

111 Background: Recent phase III trials proved the role of adjuvant chemotherapy in patients with gastric cancer after D2 resection, but the optimal treatment sequence remains to be determined. Here we report long-term follow up results for the randomized phase II trial comparing between neoadjuvant and adjuvant docetaxel/cisplatin (DC) chemotherapy in patients with locally advanced gastric cancer (LAGC). Methods: Patients with LAGC (stage IIIA-IV) were stratified by Japanese staging system and randomized to either neoadjuvant or adjuvant weekly DC chemotherapy in the National Cancer Center of Korea from 2003 to 2005. FDG-PET/CT screening was employed to exclude patients with metastasis. Patients randomized to neoadjuvant arm received 3 cycles of DC regimen (docetaxel 36 mg/m2 and cisplatin 40 mg/m2 on days 1 and 8 every 3 weeks), followed by surgery (D2 dissection). In adjuvant arm, patients underwent surgery, followed by 3 cycles of the same DC chemotherapy regimen. Results: Neoadjuvant arm (n=43) demonstrated higher R0 resection rate than adjuvant arm (n=44) [81% v 73%], but the difference was not statistically significant. At a median follow-up for suriving patients of 7.2 years, there were no significant differences in OS and PFS between the two arms [Log rank P=0.93 and P=0.89, respectively]. Conclusions: The timing of perioperative DC chemotherapy does not affect the overall survival of patients with LAGC.

Sign in / Sign up

Export Citation Format

Share Document