Combination treatment of paclitaxel, cisplatin and infusional 5-fluorouracil (PCF) as first-line chemotherapy for metastatic or recurrent gastric cancer: Prospective multicenter clinical trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15035-15035
Author(s):  
M. Jin ◽  
X. D. Zhang ◽  
Y. Q. Shu ◽  
J. Liang ◽  
J. W. Yang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Tumor Control ◽  
Time To Progression ◽  
First Line ◽  
Recurrent Gastric Cancer ◽  
Study Results ◽  
Line Chemotherapy

15035 Background: Paclitaxel has been shown to be effective in patients with advanced gastric cancer. We assess the combination of paclitaxel (Anzatax®, Mayne Pharma), infusional 5-fluorouracil and Cisplatin as first-line chemotherapy for metastatic or recurrent gastric cancer. Methods: Patients with previously untreated metastatic gastric adenocarcinomas are eligible. Fifty patients received paclitaxel (Anzatax®, Mayne Pharma) 150mg/m2 by 2-hour infusion day 1, cisplatin 15 mg/m2 daily days 1 through 5, and 5- fluorouracil by continuous infusion at a dose of 600 mg//m2 daily days 1 through 5. Cycles were repeated every 3weeks until progression. Objective tumor responses, duration of response, time to progression, and toxicity profile are the end points evaluated in this study. Results: Total 50 patients were enrolled (41 men, 9 women). The median age was 59 years (range 32 - 75). All patients had ECOG performance status (PS) 0–2 and adequate organ functions. 50 patients completed one-six cycles (mean 3 cycles). Forty-four patients were evaluable and all patients were assessable toxicity. In these 44 assessable patients, 1 CRs and 14 PRs were obtained, resulting in an overall response rate of 34%. 19 patients (43.2%) had stable disease, and 3 patients (8.9%) progressed. The tumor control rate was 77.3%. The median time to progression(TTP) was 5 months. The major (Grade 3–4) toxicities were neutropenia (22%) and anorexia (4%). There were no treatment-related deaths were recorded in all patients. The median and overall survival times are now being followed up and the results will be announced during the ASCO 2007 annual meeting. Conclusion: The combination of paclitaxel (Anzatax®, Mayne Pharma), cisplatin,and 5-FU has substantial antitumor activity in advanced gastric cancer. The toxicity of this regimen is within acceptable range, but no remarkable response rate was noted. Paclitaxel is an important new agent in the treatment of gastric cancer, and further evaluation of this agent in combination chemotherapy is warranted. No significant financial relationships to disclose.

Phase II study of trastuzumab in combination with capecitabine and oxaliplatin in patients with advanced gastric cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 83-83 ◽  
Author(s):  
Min-Hee Ryu ◽  
Baek-Yeol Ryoo ◽  
Young Soo Park ◽  
Sook Ryun Park ◽  
Jong Gwang Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Locally Advanced ◽  
Drop Out ◽  
First Line ◽  
Her2 Positive ◽  
Ecog Performance Status ◽  
Line Chemotherapy

83 Background: Trastuzumab (Herceptin) in combination with capecitabine and cisplatin has been the standard first-line chemotherapy in patients with HER2-positive advanced gastric cancer (AGC). Oxaliplatin is generally less toxic and more convenient than cisplatin, and currently replacing cisplatin for the treatment of AGC. This study aims to investigate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (HER-XELOX) in HER2-positive AGC. Methods: With Simon’s minimax two stage design (P0[response rate of historic control]=0.4, P1=0.55, two-sided alpha=0.1, beta=0.2, and 10% drop-out rate), a total of 55 patients with AGC positive for HER2 defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+and FISH+ were enrolled from Aug 2011 to Feb 2013. HER-XELOX regimen consisted of trastuzumab 8 mg/kg i.v. on day 1 in cycle 1 and then 6 mg/kg in subsequent cycles, capectabine 2000 mg/m2/day p.o. on days 1-14, and oxaliplatin 130 mg/m2i.v. on day 1, every 3 weeks. HER-XELOX was administered as a first-line chemotherapy until disease progression, unacceptable toxicity, or consent withdrawal. Results: Among the 55 patients, 37 (66%) patients were male. Median age was 57 years (range, 29-74). ECOG performance status was 0-1 in 51 (93%) patients. Fifty three (96.4%) patients had metastatic disease, and 2 (3.6%) had locally advanced unresectable disease. With complete response in 2 patients and partial response in 35 patients, confirmed overall response rate was 67.3% (95% CI, 54-80%). With a median follow-up of 13.8 months (range, 6.1-23.9) in surviving patients, median progression-free survival was 9.8 months (95% CI, 7.0-12.6). Median overall survival was 21.0 months (95% CI, 6.4-35.7). Common grade 3 or 4 toxicities with frequency > 10% included neutropenia (18.2%), anemia (10.9%), and neuropathy (10.9%). There was no febrile neutropenia. One patient died of treatment-related diarrhea and sepsis. Conclusions: HER-XELOX regimen is well tolerated and highly effective in patients with HER2-positive AGC. Clinical trial information: NCT01396707.

Feasibility of sequential fixed S-1 followed by paclitaxel for the treatment of advanced or recurrent gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15113-15113
Author(s):  
M. Ohashi ◽  
T. Kanda ◽  
K. Yajima ◽  
H. Honma ◽  
S. Kosugi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Treatment Time ◽  
Performance Status ◽  
Single Agent ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Recurrent Gastric Cancer ◽  
Line Chemotherapy

15113 Background: First-line chemotherapy for advanced/recurrent gastric cancer has limited efficacy, achieving a median survival time (MST) of about 7 months, while addition of second-line and subsequent chemotherapy may prolong MST to about 11.5 months. In practice, however, about half of patients failing with first-line chemotherapy are unable to receive second-line chemotherapy because of worsening of their performance status (PS), disease progression, or toxicities during protracted first-line chemotherapy. We studied the feasibility of a sequential fixed regimen devised to ensure prompt initiation of second-line chemotherapy after first-line failure. Methods: Between December 2002 and December 2006, patients with advanced or recurrent gastric cancer were enrolled who met the following requirements: 1) major organ function preserved; 2) PS 0–2; 3) presence of at least one evaluable lesion; and 4) written informed consent. The treatment regimen consisted of 3 courses of single-agent S-1 or S-1/cisplatin combination followed by weekly paclitaxel (wPTX). The endpoints of the study were entry to the second-line treatment, time to failure (TTF), and MST. Results: Of 39 patients enrolled, 37 completed first- line S-1. Twenty-eight patients (76%) then received wPTX, 2 non-wPTX chemotherapy, and 6 surgery; only 1 received no additional treatments. Second-line wPTX was followed by a third-line treatment in 23/28 patients (82%). The TTF with the sequential fixed regimen was 7 months. The MST and the 1- and 2-year survival rates in the 37 completing first-line treatment were 14.6 months, 61% and 25%, while those in the 28 switched over to wPTX were 12.5 months, 51% and 17%. Conclusions: Patients with advanced/recurrent gastric cancer treated sequentially with a fixed number of courses of S-1 followed by wPTX may have a good chance of treatment continuation. A sequential fixed regimen may further improve survival of patients with advanced/recurrent gastric cancer only with combinations of currently available drugs. No significant financial relationships to disclose.

Optimal indications for palliative chemotherapy in elderly patients with metastatic or recurrent gastric cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 207-207
Author(s):  
Hiroko Hasegawa ◽  
Kazumasa Fujitani ◽  
Aya Sugimoto ◽  
Shoichi Nakazuru ◽  
Motohiro Hirao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Elderly Patients ◽  
Primary Tumor ◽  
Multivariate Analyses ◽  
Performance Status ◽  
First Line ◽  
Recurrent Gastric Cancer ◽  
Significant Difference ◽  
Line Chemotherapy

207 Background: Gastric cancer is the second causes of cancer-related deaths in the world and its incidence of advanced gastric cancer (AGC) in the elderly is increasing as a result of increased life expectancy. However, elderly patients have been underrepresented in many kinds of chemotherapy clinical trials. Therefore it is difficult to evaluate the efficacy and safety of chemotherapy for elderly patients and select the appropriate patients aged 70 years or older who are likely to benefit from the chemotherapy. Methods: There were 265 patients with primary unresectable or recurrent gastric cancer treated at our institution between April 2007 and March 2014. Of all, 90 patients aged 70 years or older were retrospectively identified. We evaluated the efficacy of the chemotherapy and prognostic significance of clinico-pathologic factors to identify the optimal indications for chemotherapy. Univariate and multivariate analyses were perfomed on the base-line characteristics such as patient’s performance status (PS), gender, chemotherapy regimens, history of gastrectomy, presense of co-morbidity, serum LDH level, serum C reactive protein, and nutritional status, at the initiation of the first-line chemotherapy. Results: The median overall survival time (OS) was 343 days and the median TTF on first-line chemotherapy was 111 days. The toxicity was mild and tolerable. There were no significant difference in overall survival between patients receiving monotherapy and combination therapy. On multivariate analyses, PS 1 or 2 (hazard ratio (HR), 1.883; 95% confidence interval (CI), 1.047–3.390), presence of primary tumor (HR, 1.916; 95% CI, 1.063–3.448) at the initiation of the first- line chemotherapy were identified as significant independent poor prognostic factors for overall survival. Especially in patients aged 75 years or older, only PS was an independent prognostic factor for OS (HR, 3.703; 95% CI, 1.314–9.900). Conclusions: Analysis of our results shows that patients aged 70 years or older with good performance status and absence of primary tumor might achieve clinical benefit from chemotherapy.

Phase II trial of biweekly reduced-dose combination chemotherapy of oxaliplatin/5-fluorouracil/folic acid (Modified FOLFOX) as first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15544-e15544
Author(s):  
H. Kim ◽  
B. Lee ◽  
T. Kim ◽  
S. Nam ◽  
B. Kim
Keyword(s):  
Gastric Cancer ◽  
Folic Acid ◽  
Elderly Patients ◽  
Advanced Gastric Cancer ◽  
Combination Chemotherapy ◽  
First Line ◽  
Reduced Dose ◽  
Recurrent Gastric Cancer ◽  
Dose Combination ◽  
Line Chemotherapy

e15544 Background: Although combination chemotherapy as ECF (epirubicin, cisplatin, and 5-FU) and DCF (docetaxel, cisplatin, and 5-FU) are effective advanced gastric cancer, but it is too toxic to apply for elderly patients with increased comorbidity. Combination of oxaliplatin and 5-FU has proven to be a effective and tolerable regimen in advanced gastric cancer, and we investigated the efficacy and safety of reduced-dose combination chemotherapy of oxaliplatin/5-FU/folic acid as first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. Methods: Elderly patients (≥60 years) with measurable, metastatic or recurrent gastric cancer were enrolled. Patients received oxaliplatin 75mg/m2 (2-hour intravenous infusion on D1), 5-FU 1000mg/m2 (12-hour continuous infusion on D1,2), and folic acid 20mg/m2 (15-minute infusion on D1,2) every 2 weeks. Results: Total 37 patients were enrolled between April 2004 and August 2008. Median age was 67 years old (range, 60 to 80 years), and 22 patients (59.5%) had increased Charlson comorbidity index score (CCI ≥1). Of 36 evaluable patients, 2 patients achieved complete response (CR), and 12 patients partial response (PR) with representing overall response rate of 44.4% (95% CI 27.7- 60.2). Stable disease (SD) was observed in 12 patients (33.3%), and progressive disease in 8 patients (22.3%). The median time to progression was 4.6 months, and median overall survival was 9.2 months. Relative dose intensity was 97.4% in both oxaliplatin and 5-FU. Grade 3 or 4 hematologic toxicities included neutropenia in one patients (2.7%), and anemia in three patients (8.1%). Peripheral neuropathy occurred (grade 2) was only observed in three patients (8.1%). Conclusions: The reduced-dose combination chemotherapy of oxaliplatin/5-FU/folic acid was effective and tolerable in elderly patients with metastatic or recurrent gastric cancer as first-line treatment. No significant financial relationships to disclose.

Optimal indications for second-line chemotherapy in advanced gastric cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 105-105
Author(s):  
Hiroko Hasegawa ◽  
Kazumasa Fujitani ◽  
Shoichi Nakazuru ◽  
Motohiro Hirao ◽  
Eiji Mita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Clinicopathological Variables ◽  
Line Chemotherapy

105 Background: It remains uncertain whether every patient with advanced gastric cancer (AGC) who progresses after first-line chemotherapy should receive second-line chemotherapy. We conducted the present study to identify the optimal indications for second-line chemotherapy. Methods: In this retrospective study, 101 patients were included in univariate and multivariate analyses to identify clinicopathological variables independently associated with longer survival post progression (SPP), defined as the time from recognition of disease progression on first-line chemotherapy to death from any cause or last follow-up. Results: Median SPP of all patients was 340 days. On multivariate analysis, both performance status (PS) 2 (hazard ratio (HR), 14.234; 95% confidence interval (CI), 2.766–73.258), serum albumin (Alb) level < 3.5 g/dl (HR, 2.088; 95% CI, 1.047–4.060) at initiation of second-line chemotherapy, and time to progression (TTP) < 170 days on first-line chemotherapy (HR, 2.497; 95% CI, 1.227–5.083) were identified as independent prognostic factors for shorter SPP. Median SPP was 496, 375, and 232 days in patients with 0, 1, and 2 of these 3 negative prognostic factors, respectively (p = 0.0002). Conclusions: The present study suggests that second-line chemotherapy would be less beneficial in patients with 2 or more of the following 3 negative prognostic factors: PS 2, Alb < 3.5 g/dl at initiation of second-line chemotherapy, and TTP < 170 days on first-line chemotherapy.

Randomized phase II trial of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) for advanced gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4580-4580
Author(s):  
D. Shin ◽  
S. Lee ◽  
S. Park ◽  
J. Park ◽  
E. Cho ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Objective Response ◽  
Comparable Efficacy ◽  
First Line ◽  
Number Of Patients ◽  
Control Response ◽  
Line Chemotherapy

4580 Background: Irinotecan, in combination with 5-fluorouracil (FU) or cisplatin, clearly demonstrated efficacy against gastric cancer. We compared the combination of irinotecan, leucovorin and FU (ILF) with cisplatin plus ILF (PILF) as first-line chemotherapy in patients with advanced gastric cancer (AGC). Methods: Patients with chemotherapy-naïve, histologically-confirmed, metastatic gastric adenocarcinoma were randomized to receive irinotecan 150 mg/m2 on day 1, leucovorin 20 mg/m2 and a 22-h infusion of FU 1,000 mg/m2 on days 1 and 2 (ILF), or ILF plus cisplatin 30 mg/m2 on day 2 (PILF). Treatment was repeated every 2 weeks until disease progression, unacceptable toxicity, or patients’ refusal. Primary endpoint was response rate which assessed every 4 cycles of chemotherapy. With a single-stage phase II design, the required number of patients was at least 35 per each arm. Results: Of 91 patients registered, 46 patients were treated with ILF and 44 with PILF. For both arms, 635 chemotherapy cycles were delivered (median, 6 for ILF and 8 for PILF; p=0.46). Both ILF and PILF were generally well tolerated. However, PILF was associated with, although statistically insignificant, substantially more grade 3 or 4 toxicities than ILF (46% and 38%, respectively). In the ILF and PILF arm, 11% and 25% of patients, respectively, discontinued treatment because of toxicity. Treatment duration was similar for both arms (4.3 for ILF v 5.6 months for PILF; p=0.13). Four patients died during treatment: one in the ILF arm and 3 in the PILF arm. The objective response rate was 37% for both arms. Disease control (response plus stable disease) was achieved in 59% and 73% (p=0.02) of patients treated with ILF and PILF. There were no significant differences in therapeutic efficacy between ILF and PILF with respect to progression-free (4.8 v 6.2 months; p=0.60) and overall (10.9 v 10.4 months; p=0.93) survival. Conclusions: Both ILF and PILF appear to be active as first-line chemotherapy for AGC, with acceptable safety profiles. Given the comparable efficacy results, ILF could be a reasonable standard chemotherapy for untreated AGC patients. No significant financial relationships to disclose.

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