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.

Tumor angiogenesis genotyping and efficacy of first-line chemotherapy in metastatic gastric cancer patients.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 64-64
Author(s):  
Mario Scartozzi ◽  
Riccardo Giampieri ◽  
Cristian Loretelli ◽  
Alessandro Bittoni ◽  
Alessandra Mandolesi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Metastatic Gastric Cancer ◽  
Second Line ◽  
Tumour Angiogenesis ◽  
First Line ◽  
Altered Expression ◽  
Second Line Chemotherapy ◽  
Gastric Cancer Patients ◽  
Line Chemotherapy

64 Background: An altered expression of tumour angiogenesis-related factors has been constantly associated to a more aggressive phenotype and an increased relapse rate in several tumour types, including gastric cancer. Besides correlating with prognosis, tumour-driven angiogenesis seemed also able to influence response/resistance to chemotherapy in pre-clinical models. We examined the role of tumour angiogenesis genotyping in determining clinical outcome in metastatic gastric cancer patients receiving first-line chemotherapy. Methods: VEGF-A, VEGF-C, FLT1, KDR and FLT4 genotyping was performed on gastric tumours from 94 consecutive patients receiving platinum-based first-line chemotherapy. Results: Only theVEGF A rs25648 correlated with RR (PR = 18% among patients showing the VEGF A rs25648 CT or TT genotype vs. 44% among patients showing the VEGF A rs25648 CC genotype, p = 0.04). The VEGF A (rs2010963) and VEGF C (rs4604600 and rs7664413) correlated with mPFS and the VEGF A rs25648 and FLT4 rs307833 correlated with both mPFS and OS. Among other clinical variables tested (sex, age, ECOG performance status, gastrectomy, adjuvant chemotherapy, metastatic sites and second-line chemotherapy) only the use of second-line chemotherapy correlated with improved overall survival (10.2 months vs. 6.3 months for patients who received or did not receive second-line, p= 0.003). At multivariate the VEGF A rs25648 maintained an independent role in determining both median PFS (HR = 1.65 95% CI: 1.12-2.78, p= < 0.0001) and OS (HR = 1.58, 95% CI: 1.17-2.65, p = 0.0003). The use of second-line chemotherapy also showed an independent role in determining median OS (HR = 0.58, 95% CI: 0.38-0.87, p= 0.003). Conclusions: VEGF A rs25648 genotyping may help identifying a patients subgroup unlikely to benefit from a first-line, platinum-based combination and potentially candidate to alternative therapy choices. Our data may help designing future clinical trials with the aim to investigate the outcome of different chemotherapy regimens in different patients groups prospectively stratified according to angiogenesis profile.

Cetuximab plus docetaxel-cisplatin (DC) as first-line treatment for locally advanced or metastatic gastric cancer: Preliminary results of a phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15592-e15592
Author(s):  
J. Fahlke ◽  
K. Ridwelski ◽  
A. Florschuetz ◽  
E. Kettner ◽  
M. Leithaeuser ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Disease Progression ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Study ◽  
Published Data ◽  
First Line ◽  
Overall Response ◽  
Grade 3

e15592 Background: Based on promising published data, this multicenter, phase II study was initiated to investigate a combined treatment using DC and cetuximab in the first-line setting for patients with gastric cancer. Methods: Patients aged 18–75 years with stage III (T4, nonresectable) or stage IV gastric cancer, ECOG performance status (PS) ≤2, and life expectancy ≥3 months were recruited to receive cetuximab (400 mg/m2 on day 1 then 250 mg/m2 q1w) and DC (D 75 mg/m2 and C 75 mg/m2; both as 1-h infusions on day 1 and then q3w). Treatment was stopped in the event of disease progression, intolerable toxicity, or consent withdrawal. Tumor staging was performed after cycle 3 and then every 12 weeks. The primary endpoint was overall response rate and secondary endpoints included time to progression, overall survival and toxicity. Planned accrual was 79 patients. A per-protocol interim response analysis was planned for the initial 20 evaluable patients. Results: Preliminary data are available for 30 patients; median age 64 [range: 40–73] years; median ECOG PS 1 [range: 0–2]; adenocarcinoma 87%. Median cycles administered were 3 [range: 1–14] and the median follow-up was 1.63 months. The overall response rate was 27.3% (complete response, n=1; partial response, n=5). Stable disease was observed in 10 patients, and disease progression in 6 patients. The most relevant NCI-CTC grade 3–4 hematologic events per patient were leukopenia and neutropenia (73%), anemia (13%), and febrile neutropenia (10%). Major grade 3–4 nonhematologic toxicities were nausea (30%), vomiting (20%), diarrhea (13%), acne (13%), and fatigue (13%). Conclusions: DC and cetuximab were well tolerated and resulted in promising response rates and a predictable toxicity profile. The study is ongoing. No significant financial relationships to disclose.

A phase II study of oxaliplatin with biweekly, low dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified FOLFOX-4) as first line therapy for patients with advanced or metastatic gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14052-14052
Author(s):  
H. Kim ◽  
H. Kwon ◽  
S. Y. Oh ◽  
B. G. Seo ◽  
S. G. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Continuous Infusion ◽  
Low Dose ◽  
Overall Response Rate ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3

14052 Background: To determine the activity and toxicities of low dose leucovorin (LV) plus fluorouracil (5-FU) regimen, combined with oxaliplatin every two weeks (modified FOLFOX-4), as a first-line therapy for patients with advanced or recurrent gastric cancer. Methods: Between January 2003 and March 2005, forty-five patients were enrolled in this study. Patients were treated with oxaliplatin 85 mg/m2 as a 2-hour infusion at day 1 plus LV 20 mg/m2 over 10 minutes, followed by 5-FU a 400 mg/m2 bolus and 22 hour continuous infusion of 600 mg/m2 5-FU at day 1–2. This treatment was repeated in 2 week intervals. Results: There was one patient (2.2%) demonstrated a complete response. Twenty patients (44.4%) showed a partial response. Overall response rate was 46.6%. Ten patients (22.2%) showed a stable disease and fourteen patients (31.1%) progressed during the course of the treatment. The median time to progression and overall survival time were 7.73 months (95% CI: 3.6–11.86 months) and 11.17 months (95% CI: 9.06–13.28 months) from the start of the chemotherapy, respectively. A total of 247 cycles were analyzed for toxicity. Major hematologic toxicities included grade 1–2 anemia (39.7%), neutropenia (30.4%), grade 3–4 neutropnenia (10.9%) and thrombocytopenia (9.3%).There were 12 cycles of neutropenic fever. The most common non-hematological toxicities were grade 2 nausea/vomiting (20%), grade 1–2 neuropathy (13.4%) and grade 3 diarrhea (2.2%). There was no treatment related death. Conclusions: The modified FOLFOX-4 regimen is safe and effective regimen as a first line therapy in advanced or metastatic gastric cancer. No significant financial relationships to disclose.

Second-line chemotherapy with FOLFIRI in patients with metastatic gastric cancer (MGC) not previously treated with fluoropyrimidines

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4549-4549
Author(s):  
L. Di Lauro ◽  
S. I. Fattoruso ◽  
L. Giacinti ◽  
P. Vici ◽  
D. Sergi ◽  
...  
Keyword(s):  
Distant Metastases ◽  
Metastatic Gastric Cancer ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Previously Treated ◽  
Grade 3 ◽  
Line Chemotherapy

4549 Background: No established second-line chemotherapy exists for patients (pts) with MGC failing to respond or progressing after first-line chemotherapy. This study was designed to determine the efficacy and safety of FOLFIRI combination used as second-line therapy in pts with MGC not previously treated with regimens containing fluoropyrimidines. Methods: Pts with measurable distant metastases, previously treated with a combination of epirubicin, docetaxel and cisplatin or oxaliplatin as first-line therapy, received irinotecan 180 mg/mq (150 mg/mq in pts >70 ys old) as a 1-h infusion day 1; leucovorin 100 mg/mq/day followed by bolus fluorouracil (FU) 400 mg/mq and a 22-h infusion of FU 600 mg/mq day 1–2, every 2 weeks for a maximum of 12 cycles or until disease progression, unacceptable toxicity or patients refusal. Endpoints were response rate (RR), time to progression (TTP), overall survival (OS) and safety. Results: 38 pts were enrolled: M/F 23/15; median age 66 ys (34–75); median ECOG PS 1 (0–2); number of metastatic sites 1/2/≥3: 9/18/11 pts, respectively. A total of 223 cycles was performed (median 6, range 2–12). One CR and 8 PR were observed for an overall RR of 24% (95% CI, 11–39 %). Disease remained stable in 11 pts. Median TTP was 4.0 months (95% CI, 2.9–5.1) and median OS was 6.2 months (95% CI, 4.7–7.7). Grade 3/4 neutropenia, thrombocytopenia and anemia occurred in 29%, 3% and 8% of pts, respectively. Febrile neutropenia was seen in 2 pts (5%). Other grade 3 toxicities included diarrhea in 5 pts (13%), mucositis in 2 pts (5%) and vomiting in 2 pts (5%). There were no treatment related deaths. Conclusions: FOLFIRI is an active and well tolerated second-line regimen for MGC pts not previously treated with fluoropyrimidines. No significant financial relationships to disclose.

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.

A phase II study of irinotecan, oxaliplatin, 5-fluorouracil, leucovorin (FOLFOXIRI) as a first-line chemotherapy in metastatic gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4076-4076
Author(s):  
J. Lee ◽  
W. Kang ◽  
S. Lee ◽  
J. Kwon ◽  
H. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Phase Ii Study ◽  
Objective Response ◽  
Metastatic Gastric Cancer ◽  
Efficacy And Safety ◽  
First Line ◽  
Grade 3

4076 Background: Previous phase II study showed a high efficacy and safety of FOLFOXIRI (irinotecan, oxaliplatin, 5-fluorouracil, leucovorin) combination chemotherapy in metastatic colorectal cancer. This non-randomized open label phase II study evaluated the efficacy and safety of FOLFOXIRI in metastatic or recurrent gastric cancer patients. Methods: Patients with: histologically proven, bidimensionally measurable, metastatic gastric adenocarcinoma, age 18 - 70 years, with a performance status 0 - 2, no prior chemotherapy or at least 12 months after adjuvant therapy, life expectancy > 3 months, signed written informed consent were eligible. Treatment consisted of irinotecan 150 mg/m2 day 1, oxaliplatin 85 mg/m2 day 1, leucovorin 100 mg/m2 day and 5-fluorouracil 2000 mg/m2 as a 48-h continuous infusion starting on day 1, repeated every 2 weeks until unacceptable toxicity, patients’ refusal, or up to 12 cycles. The planned sample size was 48 and the primary endpoint was response rate. Results: From August 2004 to August 2005, 48 patients were prospectively enrolled. The median age was 54 years (24 - 69) and male:female ratio was 1.3:1. In total, 379 cycles were administered with a median of 9 cycles per patient (range, 1–12) and 45/48 patients were evaluable for treatment response. Three patients were not assessable for response due patients’ refusal for further chemotherapy following the first cycle. By per-protocol analysis, the objective response rate was 73.3 % (95% CI, 60.8–85.8) with 2 CRs and 31 PRs. Four patients (9%) had stable disease and 8 patients (18%) had progressive disease. The estimated median survival of all patients was 14.0 months (95% CI, 11.8 - 16.2 ) and the estimated median time-to-progression was 8.9 months (95% CI, 6.7–11.0). In total of 379 cycles administered, most common grade 3/4 toxicities were neutropenia (11% of all cycles) and emesis (12%). Grade 2 peripheral neuropathy occurred in 5 patients. One (2%) patient had severe tumor bleeding and 5 (10%) patients experienced grade 3 diarrhea. Conclusions: FOLFOXIRI combination chemotherapy showed a very promising preliminary anti-tumor activity and was generally well tolerated as a first-line treatment for patients with metastatic gastric cancer. No significant financial relationships to disclose.

A prospective study of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 129-129
Author(s):  
Ikuo Takahashi ◽  
Mototugu Shimokawa ◽  
Yasunori Emi ◽  
Hiroaki Tanioka ◽  
Takeshi Shiraishi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Practice ◽  
Prospective Study ◽  
Response Rate ◽  
Objective Response ◽  
The Elderly ◽  
Metastatic Gastric Cancer ◽  
Tolerability Profile ◽  
First Line ◽  
Grade 3

129 Background: Capecitabine plus cisplatin (XP) is one of the standard therapies for metastatic gastric cancer (mGC). However there is no clinical practice date in Japan, and results from the ToGA and AVAGAST study suggested dose of cisplatin should be lower in Japanese. This study was designed to evaluate the efficacy and safety of mXP in the clinical practice in Japanese mGC patients (pts) including the elderly. Methods: The study design was multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated mGC; presence of measurable lesions; age 20 years; ECOG performance status (PS) 0–2; and adequate organ function. Pts received mXP (cisplatin 60 mg/m2 d1 plus capecitabine 1,000 mg/m2 bid d1-14) q3w. This schedule was repeated until unacceptable toxicity or disease progression occurred. The primary endpoint was RECIST-confirmed objective response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and expected value of 50%, with one-sided alpha of 0.05 and beta of approximately 0.2. Results: Of the 42 pts (male/female, 34/8; median age, 63.5 years (range 50-81); PS 0/1/2, 34/8/0) enrolled from Nov 2011 to Oct 2013. One patient did not fulfill the eligibility criteria. Forty one pts were assessed for response; CR 2 pts, PR 16 pts, SD 14 pts, PD 8 pts, and NE 1 pts. The confirmed ORR was 43.9% (90% CI; 31.2-56.7%, 95% CI; 28.7-59.1%). Median PFS and mOS were 4.5 months (95% CI; 3.9 – 6.5M) and 11.4 months (95% CI; 7.7 – not reached). The most common grade 3/4 adverse events were anorexia 24.4%, neutropenia 36.6%, fatigue 9.8%, hand-foot syndrome 7.3%. Grade 3/4 peripheral neuropathy did not occur. Conclusions: First-line chemotherapy for HER2-negative patient of mXP showed a promising response rate and an acceptable tolerability profile in the clinical practice in Japanese mGC pts including the elderly. Clinical trial information: UMIN:000006668.

Liposomal irinotecan plus fluorouracil/leucovorin versus FOLFIRINOX as the second-line chemotherapy for patients with metastatic pancreatic cancer: Multicenter study of the Korean Cancer Study Group (KCSG).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4624-4624
Author(s):  
Hongjae Chon ◽  
Hyung Soon Park ◽  
Beodeul Kang ◽  
Hyeon-Su Im ◽  
Choong-kun Lee ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Liver Metastasis ◽  
Overall Response Rate ◽  
Response Rate ◽  
Metastatic Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Liposomal Irinotecan ◽  
Grade 3

4624 Background: There is no clear consensus on the second-line treatment for patients with metastatic pancreatic cancer (mPC). The aim of this study was to compare the efficacy and tolerability between liposomal irinotecan (nal-IRI) plus fluorouralcil/leucovorin (FL) and FOLFIRINOX (oxaliplatin/irinotecan/leucovorin/fluorouracil) in patients who failed to first-line gemcitabine-based therapy. Methods: In this retrospective study, 378 mPC patients who received nal-IRI/FL (n = 104) or FOLFIRINOX (n = 274) as the second-line treatment across 11 institutions from January 2015 to August 2019 were analyzed. The primary end point was progression free survival (PFS), and secondary end points were overall survival (OS), overall response rate, and tolerability. Results: There were no significant differences between the two groups in terms of baseline characteristics, except first-line regimen (previous gemcitabine/nab-paclitaxel, nal-IRI/FL, 85.6% vs. FOLFIRINOX, 51.5%; previous gemcitabine monotherapy, 5.8% vs. 24.5%). The median follow-up time was 6.0 months. The median PFS (nal-IRI/FL, 3.7 months vs. FOLFIRINOX, 5.0 months) and OS (nal-IRI/FL, 7.7 months vs. FOLFRINOX, 9.7 months) were comparable between two groups (P = 0.40 and 0.13, respectively). The overall response rate was not significantly different between two groups (nal-IRI/FL, 14% vs. FOLFRINOX, 16%; P = 0.644). In multivariate analysis, poor ECOG status, presence of liver metastasis, high NLR, and high CA19-9 were independent prognostic factors for PFS and OS, but chemotherapy regimen (nal-IRI/FL vs. FOLFRINOX) was not. In a subgroup analysis of patients with liver metastasis, FOLFIRINOX exerted significant PFS (median: 2.1 months vs. 4.1 months for nal-IRI/FL vs. FOLFIRINOX, respectively; P = 0.02) and OS (median: 6.7 months vs. 8.4 months for nal-IRI/FL vs. FOLFIRINOX, respectively; P = 0.04) benefit compared with nal-IRI/FL. Grade 3 neutropenia or higher were more frequently observed in FOLFIRINOX (47.2%) than nal-IRI/FL (35%) (P = 0.033). Grade 3 peripheral neuropathy was also common in FOLFIRIONX (5.9%) group compared with nal-IRI/FL (1.0%) (P = 0.049). Conclusions: In second-line setting for mPC after progression on gemcitabine-based therapy, both nal-IRI/FL and FOLFIRINOX regimen showed comparable efficacy and acceptable safety outcomes. FOLFIRINOX regimen might be preferentially considered in patients with liver metastasis.

Sign in / Sign up

Export Citation Format

Share Document