Phase II study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14037-14037
Author(s):  
J. Baek ◽  
J. Kim ◽  
Y. Chae ◽  
Y. Cho ◽  
S. Sohn ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Combination Chemotherapy ◽  
Overall Response Rate ◽  
Combination Regimen ◽  
Time To Progression ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3

14037 Background: Several studies have shown the efficacy of capecitabine and irinotecan combination chemotherapy for advanced colorectal cancer, while no results have yet been reported for advanced gastric cancer. Accordingly, the current study evaluated the efficacy and safety of a combination regimen of capecitabine plus irinotecan in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent, measurable gastric cancer received oral capecitabine 1000 mg/m2 twice daily from day 1 to 14 and intravenous irinotecan 100 mg/m2 on days 1 and 8, based on a 3-week cycle. Results: Forty-one patients were enrolled in the current study, among whom 38 were assessable for efficacy and 40 assessable for toxicity. Three complete responses and 16 partial responses were confirmed, giving an overall response rate of 46.3%. At a median follow-up of 269 days, the median time to progression and overall survival were 5.1 months and 8.6 months, respectively. Grade 3/4 neutropenia occurred in 4 patients and grade 3 febrile neutropenia was observed in 2 patients. Grade 3 diarrhea and grade 2 hand-foot syndrome occurred in 6 patients and 8 patients, respectively. Conclusions: The combination of capecitabine and irinotecan was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer. No significant financial relationships to disclose.

Phase II clinical trial of XELOX as first line treatment for patients with unresectable or metastatic gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15062-15062
Author(s):  
R. Xu ◽  
B. Han ◽  
Y. Shi ◽  
J. Xiong ◽  
Y. Li ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Objective Response ◽  
Metastatic Gastric Cancer ◽  
Line Treatment ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
First Line Treatment

15062 Background: The survival of advanced gastric cancer remains poor, while no chemotherapy regimen was recognized standard. Oxaliplatin and Capecitabine (Xeloda) have demonstrated promising antitumor efficacy in advanced colorectal cancer. The present study was conducted to further evaluate the efficacy and safety of XELOX (Oxaliplatin and Xeloda) regimen in gastric cancer. Methods: Patients with unresectable or metastatic gastric cancer were enrolled into this study. They all receive the XELOX regimens (Oxaliplatin 130mg/ m2 intravenously in 2 hours on day 1 followed by oral capecitabine 1000mg/ m2 twice daily for 14 days every 3 weeks).We evaluated the response every 2 cycles. Results: The median age of the total enrolled 45 patients was 55 years (range, 22–82 years), including 32 male and 13 female. They received a median of 5 cycles (range, 2–8 cycles) of XELOX. 21 of 45 patients (46.7%) achieved an objective response, 1 patient (2.2%) had completed response. 17 patients (37.8%) experienced stable disease. Median time to tumor progression (TTP) and median overall survival were not available yet due to the further follow-up needed. Most toxicity events were mild to moderate in XELOX regimen, with grade 3/4 neutropenia of 8.9 %, thrombocytopenia of 6.7%, anemia of 11.1%, hand-foot syndrome of 6.7 % and diarrhea of 6.7 %. Grade 3 neuropathy was 4.4%. The patients with advanced gastric cancer had a good tolerance to this chemotherapy. Conclusions: XELOX is a highly effective first-line treatment for unrsectable and metastatic gastric cancer. The response rates in this trial seems to be similar to those observed with FU/leucovorin/oxaliplatin combinations. XELOX is tolerable well in the treatment of advanced gastric cancer. No significant financial relationships to disclose.

Capecitabine As First-Line Treatment for Patients Older Than 70 Years With Metastatic Colorectal Cancer: An Oncopaz Cooperative Group Study

2005 ◽  
Vol 23 (13) ◽  
pp. 3104-3111 ◽  
Author(s):  
Jaime Feliu ◽  
Pilar Escudero ◽  
Ferrán Llosa ◽  
Matilde Bolaños ◽  
Jose-Manuel Vicent ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Elderly Patients ◽  
Combination Chemotherapy ◽  
Clinical Benefit ◽  
Overall Response Rate ◽  
Advanced Colorectal Cancer ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Clinical Benefit Response ◽  
Grade 3

Purpose To determine the tolerability of capecitabine in elderly patients with advanced colorectal cancer (CRC). Patients and Methods Fifty-one patients with advanced CRC who were ≥ 70 years and considered ineligible for combination chemotherapy received oral capecitabine 1,250 mg/m2 twice daily on days 1 to 14 every 3 weeks. Patients with a creatinine clearance of 30 to 50 mL/min received a dose of 950 mg/m2 twice daily. Results A total of 248 cycles of capecitabine were administered (median, five cycles; range, one to eight cycles). The overall response rate was 24% (95% CI, 15% to 41%), including two complete responses (CR; 4%) and 10 partial responses (PR; 20%). Disease control (CR + PR + stable disease) was achieved in 67% of patients. The median times to disease progression and overall survival were 7 months (95% CI, 6.4 to 9.5 months) and 11 months (95% CI, 8.6 to 13.3 months), respectively. Of the 35 patients evaluated for clinical benefit response, 14 (40%; 95% CI, 24% to 58%) showed clinical benefit. Capecitabine was well tolerated. Treatment-related grade 3 and 4 adverse events were observed in only six patients (12%), and the most common events were diarrhea, hand-foot syndrome, and thrombocytopenia. One patient (2%) had an episode of angina, but no treatment-related deaths were reported. Conclusion Our findings suggest that capecitabine is effective and well tolerated in elderly patients with advanced CRC who are considered ineligible for combination chemotherapy.

Phase II study of mFOLFOX-4 followed by mFOLFIRI in advanced gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15546-e15546
Author(s):  
H. Kwon ◽  
S. Lee ◽  
S. Oh ◽  
S. Kim ◽  
H. Kim
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Second Line ◽  
Time To Progression ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3 ◽  
Gastric Cancer Patients

e15546 Background: FOLFOX followed by FOLFIRI regimen has been commonly used in colorectal cancer. This combination has also been evaluated in a number of phase II studies in the first- and second-line treatment setting of advanced gastric cancer. We have evaluated the efficacy and toxicity of modified FOLFOX-4 followed by modified FOLFIRI regimens in advanced gastric cancer patients. Methods: Previously untreated patients with advanced or recurrent gastric cancer were enrolled. As first-line therapy, patients received modified FOLFOX-4, bolus ldLV 50mg followed by a 5-FU bolus 400mg/m2 and 22-hour infusion 600mg/m2 on day 1 and 2, with oxaliplatin 85mg/m2 on day 1 every 14 days. At progression, patients received modified FOLFIRI, bolus ldLV 50mg followed by a 5-FU bolus 400mg/m2 and 22-hour infusion 600mg/m2 on day 1 and 2, with irinotecan 150mg/m2 on day 1 every 14 days as second-line therapy. Results: Fifty-six patients were enrolled in first-line mFOLFOX-4. Of these, 32 (57.1%) patients received sequential mFOLFIRI as second-line chemotherapy. In first- line therapy, mFOLFOX-4 achieved 41.4% (95% CI, 28–54%) partial response and 32.1% (95% CI, 20–45%) stable disease. The median time to progression was 4.2 months (95% CI, 2.8–5.5 months). In second-line therapy, mFOLFIRI achieved 18.8% (95% CI, 4–33%) partial response and 31.3% (95% CI, 14–48%) stable disease. The median time to progression was 3.1 months (95% CI, 1.4–4.7 months). Median survival was 12.8 months (95% CI, 9.5–16.0 months) in overall 56 patients, and median survival of sequential chemotherapy was 13.2 months (95% CI, 9.4–16.9 months) in 32 patients. In first-line mFOLFOX-4, NCI-CTC grade 3/4 hematological toxicities were neutropenia and thrombocytopenia in 28 (7.6%), 1 (0.3%) of the cycles, respectively and neutropenic fever was observed in 7 cycles (1.9%). Grade 1/2 sensory neuropathy was observed in three patients (5.6%). In second-line mFOLFIRI, NCI-CTC grade 3/4 hematological toxicity was neutropenia in 20 (19.8%) of the cycles, and neutropenic fever was observed in 5 cycles (4.6%). Grade 3 diarrhea was observed in one patient (3.1%). Conclusions: As sequential chemotherapy, the mFOLFOX-4 followed by mFOLFIRI regimen is both feasible and safe for advanced gastric cancer patients. No significant financial relationships to disclose.

Multicenter phase II study of docetaxel plus oxaliplatin combination chemotherapy in patients with advanced gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15026-15026
Author(s):  
J. Kim ◽  
H. Song ◽  
Y. Do ◽  
K. Lee ◽  
M. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Median Overall Survival ◽  
Combination Regimen ◽  
Intention To Treat ◽  
Patient Refusal ◽  
Grade 3 ◽  
Treat Analysis ◽  
Unacceptable Toxicity

15026 Background: The present study was conducted to evaluate the efficacy and safety of a combination regimen of docetaxel plus oxaliplatin in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent, measurable gastric cancer received intravenous docetaxel 65 mg/m2 plus oxaliplatin (Oxalpla®, Yuhan.Co. Seoul, Korea) 120 mg/m2 on days 1 in a 3-week cycle. Treatment was continued until disease progression, patient refusal, or an unacceptable toxicity up to 9 cycles. Results: Forty-two patients were enrolled in the current study. Of these, 39 were assessable for efficacy and 41 assessable for toxicity. Seventeen partial responses were confirmed, giving an overall response rate of 40.5% (95% CI: 26.0% to 54.1%, intention-to-treat analysis). At a median follow-up of 160.5 days, the median time to progression was 6.1 months, whereas median overall survival was not reached yet. Grade 3/4 neutropenia occurred in 10 patients, plus febrile neutropenia was observed in 3 patients. Most common non-hamatologic toxicity was nausea (grade 1/2 56.9%). There were two treatment-related deaths. Conclusions: Docetaxel and oxaliplatin combination was found to be well-tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer. No significant financial relationships to disclose.

Clinical observation of nab-paclitaxel plus S-1 as first-line chemotherapy for advanced gastric cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15554-e15554
Author(s):  
Yi Hu ◽  
Danyang Sun
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Advanced Gastric Cancer ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Standard Treatment ◽  
Therapeutic Option ◽  
First Line ◽  
Grade 3 ◽  
Line Setting

e15554 Background: Gastric cancer is the third leading cause of death in the world with poor prognosis. Until recently, no standard treatment was available for patients with advanced gastric cancer in the first-line setting. Nab-paclitaxel and S-1 were both proved to have antitumor activity in many solid tumors including gastric cancer. We aimed to evaluate the efficacy and tolerance of nab-paclitaxel in combination with S-1. Methods: Patients with unresectable or recurrent gastric cancer received combination therapy of nab-paclitaxel plus S-1 every 3 weeks as one cycle. Nab-paclitaxel was administered at total dose of 260mg/ m2 on day 1 and 5 or on day 1 and 8. S-1 was given orally twice a day for 14 days, the doses were assigned according to body surface area. S-1 alone was administered as maintenance therapy after 6 to 8 cycles of combination therapy until disease progression. Results: Among the 33 patients enrolled, 28 patients (84.8%) had KPS 90, one third of patients were recurrent after gastrectomy. They received an average of 5.7 cycles of combination treatment. The median PFS was 6.6 months (95%CI, 5.557-7.716 months). The overall response rate was 51.5%, with one CR, 16 PR, 16 SD, and no PD. The median overall survival time was not obtained at the time of analysis. In safety profile, the highest incidence rate of grade 3 and grade 4 adverse events was neutropenia (12.1%). Conclusions: The combination of nab-paclitaxel plus S-1 was well tolerated and presented antitumor efficacy which may be a new therapeutic option for patients with advanced gastric cancer.

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.

Paclitaxel, 5-fluorouracil, and leucovorin combination chemotherapy as first-line treatment in patients with advanced gastric cancer

2019 ◽  
Vol 30 (3) ◽  
pp. 302-307 ◽  
Author(s):  
Wan-Cai Que ◽  
Yan-Fang Huang ◽  
Xiao-Yan Lin ◽  
Yan-Qin Lan ◽  
Xin-Yan Gao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Combination Chemotherapy ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

scholarly journals Second-Line Irinotecan, Leucovorin, and 5-Fluorouracil for Gastric Cancer Patients after Failed Docetaxel and S-1

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Joo Young Jung ◽  
Min-Hee Ryu ◽  
Baek-Yeol Ryoo ◽  
Boram Han ◽  
Ji Woong Cho ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Response Rate ◽  
Response Rate ◽  
Antitumour Activity ◽  
Metastatic Gastric Cancer ◽  
Second Line ◽  
First Line ◽  
Previously Treated ◽  
Grade 3 ◽  
Gastric Cancer Patients

Background.This retrospective study aimed to assess the efficacy and toxicities of second-line chemotherapy with irinotecan, leucovorin, and 5-fluorouracil (5-FU) in metastatic gastric cancer (MGC) patients previously treated with docetaxel and S-1 with or without oxaliplatin (DS/DOS).Patients and Methods.We reviewed the data of patients who had previously been treated with first-line DS/DOS and received biweekly irinotecan-based chemotherapy (FOLFIRI/IFL) between October 2004 and November 2011.Results.A total of 209 cycles were administered to 35 patients, with a median of 4 (range, 1–22) cycles each. The overall response rate in 29 response-assessable patients was 17.2%, including 2 complete and 3 partial responses. The median progression-free and overall survivals were 3.81 (95% confidence interval [CI], 1.82–5.80) months and 6.24 (95% CI, 1.44–11.04) months, respectively. The major grade 3/4 toxicity was neutropenia (8.6%).Conclusion.FOLFIRI/IFL chemotherapy showed modest antitumour activity and tolerable toxicities in DS/DOS-treated MGC patients.

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