Phase III study of individualized intraperitoneal/intravenous/oral chemotherapy compared with standard intravenous/oral chemotherapy in patients with advanced gastric cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4021-4021
Author(s):  
Yang Yang ◽  
Jia Wei ◽  
Juan Du ◽  
Lixia Yu ◽  
Hanqing Qian ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Mrna Expression ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Response Rate ◽  
Predictive Biomarkers ◽  
Oral Chemotherapy ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Gastric Cancer Patients

4021 Background: Tumor mRNA expression levels may have a promising role as potential predictive biomarkers for chemotherapy. Intraperitoneal (IP) chemotherapy provides sustained high local concentrations, and its efficacy has been shown in ovarian cancer and gastric cancer patients with peritoneal metastasis. We developed a regimen combining IP/intravenous(IV)/oral chemotherapy for the treatment of advanced gastric cancer patients with individualized chemotherapeutics according to mRNA expression. This multicenter phase III study evaluated the efficacy of individualized multi-route chemotherapy compared to standard systemic chemotherapy. Methods: Eligibility criteria included pathologically confirmed advanced gastric adenocarcinoma, and no prior chemotherapy. Patients were randomized 3:1 to an individualized arm (IN) and standard arm (ST). Randomization was stratified by center. Patients in individualized arm first underwent mRNA expression (BRCA1/TOPO1/TS) to choose sensltive chemotherapeutics from oxaliplatin/cisplatin/docetaxel/irinotecan/S-1 and then received individualized IP/IV/oral chemotherapy. The primary endpoint was overall survival (OS). Secondary endpoints were response rate, progression-free survival (PFS), and safety. Results: Between April 2013 and December 2015, 231 patients were enrolled, and 218 patients were included in the efficacy analysis. Baseline patient characteristics were balanced between the two arms. The median OS for IN and ST were 16.3 and 14.1 months, respectively (adjusted hazard ratio [aHR] 0.77, 95% confidence interval [CI] 0.61-0.98, p < 0.05). The overall response rate was 44.0% in the IN arm, and 33.9% in the ST arm (p < 0.05). Both regimens were tolerable. Conclusions: The primary analysis showed the statistical superiority of the individualized multi-route regimen. It suggested clinical efficacy of this regimen in patients with advanced gastric cancer. Clinical trial information: ChiCTR-IPR-15006201.

Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

2006 ◽  
Vol 24 (31) ◽  
pp. 4991-4997 ◽  
Author(s):  
Eric Van Cutsem ◽  
Vladimir M. Moiseyenko ◽  
Sergei Tjulandin ◽  
Alejandro Majlis ◽  
Manuel Constenla ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Risk Reduction ◽  
Cancer Patients ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Iii ◽  
First Line Therapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. Patients and Methods Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). Results In 445 randomly assigned and treated patients (DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P < .001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P = .02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (χ2 P = .01). Grade 3 to 4 treatment-related adverse events occurred in 69% (DCF) v 59% (CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy (19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). Conclusion Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer.

Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for gastric cancer with peritoneal metastasis: SP + IP PTX trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4529-4529
Author(s):  
Daisuke Kobayashi ◽  
Ryoji Fukushima ◽  
Mitsuhiko Ota ◽  
Sachio Fushida ◽  
Naoyuki Yamashita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Phase Ii ◽  
Peritoneal Metastasis ◽  
Response Rate ◽  
Phase Iii ◽  
Peritoneal Cytology ◽  
Response To Chemotherapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

4529 Background: Intraperitoneal (IP) chemotherapy is a promising treatment option for gastric cancer with peritoneal metastasis. Although a phase III study failed to show a statistically significant superiority of IP paclitaxel (PTX) combined with S-1 and intravenous PTX over S-1/cisplatin (SP), the standard of care as a first-line treatment in Japan, the sensitivity analysis suggested clinical efficacy of the IP PTX. Thus, attempts to combine IP PTX with other systemic therapies with higher efficacy have been warranted. After a dose-finding study, we sought to explore efficacy of a new regimen that combined IP PTX with SP. Methods: Gastric cancer patients with peritoneal metastasis confirmed by diagnostic imaging, laparoscopy or laparotomy were enrolled in the phase II multi-institutional prospective trial. In addition to the established SP regimen (S-1 administered orally at a dose of 80 mg/m2 bid for 21 days followed by a 14-day rest and cisplatin administered intravenously at a dose of 60 mg/m2 on day 8), IP PTX was administered on days 1, 8 and 22 at a dose of 20 mg/m2. The primary endpoint is overall survival (OS) rate at one year after treatment initiation. Secondary endpoints are progression free survival (PFS), response rate and toxicity. Results: Fifty-three patients were enrolled and fully evaluated for OS and toxicity. The median number of courses was 7 (range 1-20). The 1-year OS rate was 74% (95% CI, 60-83%). The median survival time was 19.4 months (95% CI, 16.7 months-). The 1-year PFS rate was 57% (95% CI, 42-69%). The overall response rate was 20% (95% CI, 1-72%) in 5 patients with target lesions. Cancer cells ceased to be detected by peritoneal cytology in 23 (64%) of 36 patients. Fourteen (26%) patients underwent gastrectomy after response to chemotherapy. The incidences of grade 3/4 hematological and non-hematological toxicities were 43% and 47%, respectively. The frequent grade 3/4 toxicities included neutropenia (23%), anemia (29%), diarrhea (13%) and anorexia (17%). Intraperitoneal catheter and implanted port-related complications were observed in 4 patients. There was 1 treatment-related death. Conclusions: IP PTX combined with SP is well tolerated and active in gastric cancer patients with peritoneal metastasis. Clinical trial information: UMIN000023000 .

Study to see the efficacy and toxicity profile of docetaxel-based chemotherapy in advanced stomach cancer in Bangladeshi patient population

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15687-e15687
Author(s):  
E. Hoque ◽  
S. Karim ◽  
M. Hossen ◽  
T. U. Ahmed
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Patient Population ◽  
Response Rate ◽  
Tumour Progression ◽  
Cancer Death ◽  
Toxicity Profile ◽  
Gastric Cancer Patients

e15687 Background: Gastric cancer is the second most common cause of cancer death worldwide. In Bangladesh it is one of the major causes of cancer death. Advanced gastric cancer patients have a poor prognosis of 3 to 5 months. Docetaxel has shown activity against gastric cancer as monotherapy and in combination with other agents. The purpose of this study was to investigate the efficacy and toxicity profile of docetaxel based chemotherapy in advanced stomach cancer in Bangladeshi patient population. Methods: From January 2004 to December 2006, thirty patients with advanced inoperable gastric cancer (Gastric or esophagogastric adenocarcinoma) were included in the study. Patients received no prior chemotherapy. Patients were given docetaxel 75mg/m2 I/V in 1 hour infusion and Cisplatin 75mg/m2 (d1) plus 5-fluorouracil 750mg/m2/d (days 1 to 5) I/V with adequate hydration every 3 weeks. The primary end point was time to tumour progression. Secondary end point was overall survival and toxicity profile. Results: Among the 30 evaluable patients time to tumour progression was 11.5 months. Overall response rate was 87% (26 patients). Complete response rate was 20% (6 patients), 27% (8 patients) had stable disease, 7% (2 patients) had developed progressive disease. Two-year survival rate was 21%. Grade 3 to 4 treatment related adverse events occurred in 63%. Among the toxicities there were: neutropenia (80%), stomatitis (19%), and diarrhea (15%). There was no treatment related death. Conclusions: Adding docetaxel to CF regimen significantly improved time to tumour progression and survival rate in advanced gastric cancer patients. In context with the survival benefit the toxicities of this regimen are acceptable. Docetaxel in combination with Cisplatin and 5-fluorouracil is a very safe and active in patients of Bangladesh with advanced gastric cancer. Larger studies involving higher number of patients are needed to evaluate these results in case of Bangladeshi patient population. No significant financial relationships to disclose.

Phase III study of intraperitoneal paclitaxel plus s-1/paclitaxel compared with s-1/cisplatin in gastric cancer patients with peritoneal metastasis: PHOENIX-GC trial.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 4014-4014 ◽  
Author(s):  
Hironori Ishigami ◽  
Yoshiyuki Fujiwara ◽  
Ryoji Fukushima ◽  
Atsushi Nashimoto ◽  
Hiroshi Yabusaki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Peritoneal Metastasis ◽  
Phase Iii ◽  
Phase Iii Study ◽  
Gastric Cancer Patients

Randomized, multicenter, controlled evaluation of S-1 and oxaliplatin (SOX regimen) as neoadjuvant chemotherapy for advanced gastric cancer patients (RESONANCE trial).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 90-90
Author(s):  
Tao Li ◽  
Lin Chen
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Preoperative Chemotherapy ◽  
Stage Ii ◽  
Phase Iii ◽  
D2 Lymphadenectomy ◽  
D2 Surgery ◽  
Gastric Cancer Patients

90 Background: RESONANCE trial aims to improve 3-year disease-free survival (DFS) for patients treated with neoadjuvant chemotherapy and D2 surgery with chemotherapy postoperatively. We also evaluated the postoperative complications with and without preoperative chemotherapy to reveal the safety of SOX regimen. Methods: In this phase III multicenter study, patients with American Joint Committee on Cancer(AJCC,7thed)stage II-IIII advanced gastric cancer are treated with two to four cycles of preoperative SOX chemotherapy, followed by gastrectomy with D2 lymphadenectomy, and then another four to six postoperative cycles of SOX chemotherapy. Surgical and pathological quality control is performed. The primary endpoint is 3-year DFS, secondary endpoints are 3-year OS, D2/R0 rate, and toxicity and recurrence risk. The RESONANCE trial has been registered internationally, and twenty hospitals have participated in this trial. Results: Between February 2012 and to August 2013, 128 patients were enrolled in the neoadjuvant group , 103 patients were enrolled in the adjuvant group. Seventy-four of 128 patients underwent gastrectomy with D2 lymphadenectomy after preoperative chemotherapy. In these 74 patients, 52 (70%) patients had clinical tumor response and 10 (14%) patients achieved histological response. Operative mortality was never encountered. R0 resection rate was 90.5% after neoadjuvant chemotherapy compared with 94.2% in adjuvant group (p=0.23). Postoperative complication rates in neoadjuvant and adjuvant groups were 33.8% and 37.9% respectively (p=0.58). Conclusions: Results of this study will demonstrate whether neoadjuvant chemotherapy strategy will be superior to adjuvant chemotherapy when combined with D2 surgery for AJCC stage II-III gastric cancer patients. Furthermore, it might be an important clinical evidence to verify benefit of neoadjuvant chemotherapy in advanced gastric cancer. Clinical trial information: NCT01583361.

Serum proteomic profiling of advanced gastric cancer and identification of proteomic changes following response to epirubicin, cisplatin and capecitabine chemotherapy as diagnostic and predictive biomarkers

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4537-4537
Author(s):  
H. H. Helgason ◽  
J. Y. Engwegen ◽  
A. Cats ◽  
H. Boot ◽  
M. Kuiper ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Predictive Biomarkers ◽  
Healthy Controls ◽  
Proteomic Profiling ◽  
First Line ◽  
Response To Chemotherapy ◽  
Profile Changes ◽  
Gastric Cancer Patients

4537 Background: Gastric cancer is the fourth most commonly diagnosed cancer and is the second leading cause of cancer death worldwide. Prognosis is highly dependent on stage at diagnosis making early diagnosis mandatory. By using SELDI - TOF mass spectrometry we compared serum protein profiles of gastric cancer patients with healthy controls and those of gastric cancer patients responding to first-line ECC chemotherapy with those with no response or early progressive disease. Methods: Serum from patients with advanced gastric cancer (GC) was obtained, according to a predefined schedule, prior to start of first-line epirubicin (50 mg/m2 day 1), cisplatin (60 mg/m2 day 1) and capecitabine (1,000 mg/m2 d1–14) chemotherapy (ECC) and serially before each treatment cycle every 3 weeks and analyzed by standardized SELDI-TOF MS/MS. Serum proteomic profiles of GC patients were compared with those of matched healthy controls and proteomic profile changes in responding and non-responding patients were analyzed. Results: In total 82 patients (mean age 57 years) were treated with mean 5 ECC cycles resulting in a response rate of 35%, mean time to progression of 7.1 months and mean overall survival of 12.4 months (95% CI: 10.7 - 14.1). By comparing GC patients and healthy controls we identified 18 m/z values that significantly (p < 0.00001) differentiated between the two groups (m/z 2.7 - 66.6 kDa). Comparison of responding and non-responding patients identified 2 proteins, m/z 3109 and 7559 Da, potentially predicting response (p < 0.001). Serial analysis of proteins changing differently during chemotherapy according to response will be performed. Conclusions: We identified 18 m/z values/proteins that highly (p < 1.0 E-05) discriminated between gastric cancer patients and healthy controls serving as candidate biomarkers of gastric cancer and 2 m/z values that significantly predicted response to chemotherapy. No significant financial relationships to disclose.

Randomized, Open-Label, Phase III Study Comparing Irinotecan With Paclitaxel in Patients With Advanced Gastric Cancer Without Severe Peritoneal Metastasis After Failure of Prior Combination Chemotherapy Using Fluoropyrimidine Plus Platinum: WJOG 4007 Trial

2013 ◽  
Vol 31 (35) ◽  
pp. 4438-4444 ◽  
Author(s):  
Shuichi Hironaka ◽  
Shinya Ueda ◽  
Hirofumi Yasui ◽  
Tomohiro Nishina ◽  
Masahiro Tsuda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Phase Iii ◽  
Significant Difference ◽  
Paclitaxel Group ◽  
Phase Iii Study ◽  
Third Line ◽  
Line Chemotherapy

Purpose This phase III study compared treatment with weekly paclitaxel and biweekly irinotecan in patients with advanced gastric cancer refractory to treatment with fluoropyrimidine plus platinum. Patients and Methods Patients were randomly assigned to receive either paclitaxel (80 mg/m2 on days 1, 8, and 15, every 4 weeks) or irinotecan (150 mg/m2 on days 1 and 15, every 4 weeks). Primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), response rate, adverse events, and proportion of patients who received third-line chemotherapy. Results Of 223 patients, 219 were eligible for analysis. Median OS was 9.5 months in 108 patients allocated to the paclitaxel group and 8.4 months in 111 patients allocated to the irinotecan group (hazard ratio [HR], 1.13; 95% CI, 0.86 to 1.49; P = .38). Median PFS was 3.6 months in the paclitaxel group and 2.3 months in the irinotecan group (HR, 1.14; 95% CI, 0.88 to 1.49; P = .33). Response rate was 20.9% in the paclitaxel group and 13.6% in the irinotecan group (P = .24). Common grade 3 to 4 adverse events were neutropenia (paclitaxel group, 28.7%; irinotecan group, 39.1%), anemia (21.3%; 30.0%), and anorexia (7.4%; 17.3%). Treatment-related deaths occurred in two patients (1.8%) in the irinotecan group. Third-line chemotherapy was administered in 97 patients (89.8%) after paclitaxel treatment and in 80 patients (72.1%) after irinotecan treatment (P = .001). Conclusion No statistically significant difference was observed between paclitaxel and irinotecan for OS. Both are reasonable second-line treatment options for advanced gastric cancer.

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