Paclitaxel, oxaliplatin, 5-fluorouracil and leucovorin combination chemotherapy in patients with recurrent or metastatic gastric cancer

2018 ◽  
Vol 104 (1) ◽  
pp. 22-29
Author(s):  
Yan-qin Lan ◽  
Ri-ping Wu ◽  
Xiao-bing Huang ◽  
Xin-li Wang ◽  
Dong-ta Zhong ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Chemotherapy ◽  
Intravenous Infusion ◽  
Median Overall Survival ◽  
Objective Response ◽  
Metastatic Gastric Cancer ◽  
Peripheral Neurotoxicity ◽  
Common Grade ◽  
Grade 3 ◽  
Safe Approach

Purpose: This study evaluated the efficacy and toxicity of combination chemotherapy with paclitaxel, oxaliplatin, 5-fluorouracil and leucovorin (POFL) in patients with recurrent or metastatic gastric cancer. Methods: One hundred and thirty-eight patients with histologically confirmed recurrent or metastatic gastric adenocarcinoma were treated with the POFL regimen: paclitaxel at a dose of 135 mg/m2 as a 3-hour intravenous infusion on day 1, oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 as an intravenous infusion over 2 hours on day 1, followed by 5-fluorouracil 2,400 mg/m2 as an infusion over a 46-hour period on 3 consecutive days, in a 2-week cycle. Results: Twelve patients could not be evaluated for response because of the absence of any measurable lesions or early discontinuation of therapy, so responses were assessed in 126 patients. The overall objective response rate was 56.3% (95% CI, 47.5%-64.9%). The median time to progression was 6.7 months (95% CI, 5.8-7.6 months), and the median overall survival was 12.6 months (95% CI, 11.3-13.9 months). The most common grade 3 and 4 toxicities were neutropenia (50.7%), peripheral neurotoxicity (16.7%) and alopecia (27.5%). Conclusions: Combination chemotherapy with POFL offers a new, active and safe approach to the treatment of recurrent or metastatic gastric cancer.

Olaparib plus paclitaxel in patients with recurrent or metastatic gastric cancer: A randomized, double-blind phase II study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4013-4013 ◽  
Author(s):  
Yung-Jue Bang ◽  
Seock-Ah Im ◽  
Keun-Wook Lee ◽  
Jae Yong Cho ◽  
Eun-Kee Song ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Parp Inhibitor ◽  
Objective Response ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Double Blind ◽  
Protein Levels ◽  
Common Grade ◽  
Atm Protein ◽  
Grade 3

4013 Background: Our multicenter study compared the efficacy of the oral PARP inhibitor olaparib plus paclitaxel (O/P) vs paclitaxel alone (P) as second-line therapy in pts with recurrent/metastatic gastric cancer (GC) (NCT01063517). As initial preclinical data suggested that responsiveness of GC cell lines to olaparib was associated with low ATM protein levels, our study was enriched for pts with low ATM tumors (ATM–) by IHC (50% randomized vs 14% screening prevalence). Methods: Eligible pts were randomized 1:1 (stratified by ATM status) to receiveolaparib 100 mg bid (tablet form) plus paclitaxel (80 mg/m2 iv on days 1, 8, 15 per 28-day cycle) or placebo plus paclitaxel until progression or investigator decision. After combination therapy, pts could take olaparib 200 mg bid monotherapy or placebo until progression. Co-primary endpoints: progression-free survival (PFS; RECIST v1.1) in all pts and ATM– pts. Secondary endpoints: overall survival (OS), objective response rate (ORR), safety. Results: 123/124 randomized pts were treated (O/P=61; P=62). Baseline characteristics were generally well balanced. Use of post-progression therapy was similar in both arms (O/P=48.4%; P=43.5%) as was median paclitaxel duration (O/P=17 wks; P=16 wks); 18 pts received monotherapy (O/P=11; P=7). More pts in the O/P than P arm had delays (79 vs 63%) and reductions (41 vs 27%) in paclitaxel dosing. The most common grade ≥3 AEs in the O/P and P arms were neutropenia (56 vs 39%) and anemia (11 vs 11%). Conclusions: Olaparib plus paclitaxel was well tolerated and led to a statistically significant improvement in OS, but not PFS, vs paclitaxel alone in both all pts and ATM– pts, with a larger benefit in ATM– pts. Clinical trial information: NCT01063517. [Table: see text]

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.

Phase II study of irinotecan, 5-fluorouracil (5-FU) and leucovorin combination chemotherapy in taxane and cisplatin-based chemotherapy-refractory metastatic gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15599-e15599
Author(s):  
J. Yoon ◽  
S. Cho ◽  
W. Bae ◽  
J. Hwang ◽  
H. Shim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Phase Ii Study ◽  
Performance Status ◽  
Haematological Toxicity ◽  
Metastatic Gastric Cancer ◽  
High Dose ◽  
Ecog Performance Status ◽  
Grade 3

e15599 Background: The role of the second line chemotherapy in advanced gastric cancer was not clear, but possibility of prolongation of survival is open question. Irinotecan is promising agents in gastric cancer and this phase II study evaluated the efficacy and safety of combination chemotherapy with irinotecan, high dose of 5-fluorouracil (5-FU) and leucovorin in taxane and cisplatin based chemotherapy refractory metastatic gastric cancer. Methods: Eligible criteria were as followed; histologic confirmed adenocarcinoma of stomach, previously treated with taxane and cisplatin, age≥18, Eastern Clinical Oncology Group (ECOG) performance status of 1 or less, adequate organ function. Irinotecan (150 mg/m2) as a 30-min infusion and leucovorin (200 mg/m2) as a 15-min infusion were given on day 1, followed by 5-FU 400 mg/m2bolus infusion then 5-FU 2,400 mg/m2 as a 48-hour continuous infusion. This cycle was repeated every 2 weeks until disease progression or unacceptable toxicities. Results: Thirty-four patients were enrolled. The median age was 57 years (range 27–73 years), and the ECOG performance status of all patients was 1. All patients were evaluable for safety and survival and twenty seven patients (79.4%) were evaluable for tumor response. The overall response rate was 18.5% (95% CI: 3.9–33.1). The median progression free survival and overall survival were 4.6 (95% CI: 2.4–6.9) and 9.3 months (95% CI: 5.2–13.4), respectively. Greater than grade 3 haematological toxicities were neutropenia in nine (26.5%), febrile neutropenia in one (2.9%) and thrombocytopenia in one patient (2.9%). The major non-haematological toxicity was asthenia, but most of patients showed grade 1 or 2. Greater than grade 3 non- haematological toxicities were elevated AST/ALT in four (11.8%), hyperbilirubinemia in two (5.9%), nausea in two patients (5.9%). Conclusions: This results showed that the combination chemotherapy with irinotecan, 5-FU and leucovorin was well tolerated and active in taxane and cisplatin refractory patients. No significant financial relationships to disclose.

Docetaxel, oxaliplatin, and capecitabine (DOX) combination chemotherapy for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15065-e15065 ◽  
Author(s):  
Luigi Di Lauro ◽  
Domenico Sergi ◽  
Franca Belli ◽  
Silvia Ileana Fattoruso ◽  
Maria Grazia Arena ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Chemotherapy ◽  
Gastroesophageal Junction ◽  
Distant Metastases ◽  
Metastatic Gastric Cancer ◽  
Secondary Prophylaxis ◽  
Stage Design ◽  
Grade 3 ◽  
Ecog Ps ◽  
Disease Location

e15065 Background: So far, the prognosis of advanced gastric cancer is dismal. Combination chemotherapy of docetaxel (D), cisplatin (C) and fluorouracil (F) showed activity in metastatic gastric cancer, but this regimen was complicated by a high incidence of myelotoxicity. We performed a multicenter phase II trial substituting C with oxaliplatin (O) and F with capecitabine (X) in chemotherapy-naive patients (pts) with gastric or GEJ adenocarcinoma. Methods: Pts with measurable distant metastases received D 60 mg/mq iv, O 100 mg/mq iv on day 1 and X 500 mg/mq orally twice daily continuously, with cycles repeated every 3 weeks for a maximum of 8. G-CSF was used only as secondary prophylaxis. The primary endpoint was overall response rate (RR) according to RECIST. Toxicity was reported according to NCI-CTC v 3.0. Optimal Simon's two-stage design was employed with 6/15 responses required in the first stage to allow continuation to 46 pts. Results: 46 pts were enrolled: M/F 28/18; median age 66 years (32-75); median ECOG PS 1 (0-2); primary tumor resected/ unresected 16/30; disease location was gastric in 34 and GEJ in 12 pts; sites of disease were liver in 27, nodes in 25, peritoneum in 20, lung in 8 and bone in 5 pts. At the time of analysis all pts were evaluable for response and toxicity. In 46 pts, 3 CR and 21 PR were observed, for an overall RR of 52.1% (95% CI, 37.7%-66.5%). Responses were obtained in 15/27 pts (55%) with liver metastases. Disease remained stable in 14 pts (30.5 %). Median TTP was 6.8 months and median OS was 12.6 months. Grade 3/4 neutropenia, thrombocytopenia and anemia occurred in 41%, 4% and 9% of the pts, respectively. Febrile neutropenia was observed in 2 pts (4%). Other grade 3 toxicities included mucositis in 2 pts (4%), vomiting in 3 pts (6.5%) and diarrhea in 2 pt (4%). There were no severe neurotoxicity, nor treatment-related deaths. Conclusions: The DOX combination is an active and well tolerated novel chemotherapy regimen for treating metastatic gastric or GEJ adenocarcinoma and deserves further evaluation in randomized trials and, hopefully, in neoadjuvant setting.

Phase II study of paclitaxel, cisplatin, and 5-FU combination chemotherapy in patients with advanced gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15052-15052
Author(s):  
S. Cho ◽  
H. Shim ◽  
S. Lee ◽  
J. Ahn ◽  
D. Yang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Bone Marrow ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Combination Chemotherapy ◽  
Phase Ii Study ◽  
Objective Response ◽  
Dose Intensity ◽  
Bone Marrow Suppression ◽  
Grade 3

15052 Background: Taxane has been used widely in advanced gastric cancer, but toxicities are problematic. To avoid the bone marrow suppression, docetaxel could be replaced paclitaxel to reduce bone marrow suppression and to improve the efficacy, we planned to augmentation of the dose intensity. This phase II study evaluated the efficacy and safety of combination chemotherapy with paclitaxel, cisplatin, and 5-fluorouracil (5-FU) in advanced gastric cancer. Methods: Patients with histologically confirmed gastric adenocarcinoma, ECOG PS = 2, at least one measurable lesion and adequate organ functions were eligible. Paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) were given as a 1-h intravenous infusion on day 1, followed by 5-FU (750 mg/m2) as a 24-h continuous infusion for 5 days. This cycle was repeated every 3 weeks. Results: Forty-five eligible patients (median age 56 years) were treated in this way. Of the 41 patients in whom efficacy was evaluable, an objective response rate (ORR) was seen in 20 (48.8%), a complete response in two, and a partial response in 18 patients. The median time to progression was 6.9 months (95% CI, 5.86–7.94), and the median overall survival was 13.1 months (95% CI, 8.83–17.37). The main hematological toxicity was neutropenia and greater than grade 3 neutropenia was observed in 67 cycles (25%). Febrile neutropenia developed in three patients (7.3%). The major non-hematological toxicities were asthenia and peripheral neuropathy, but grade 3 or 4 toxicity was not seen. Conclusions: The combination chemotherapy with paclitaxel, cisplatin, and 5-FU is a promising regimen, and was well tolerated in patients with advanced gastric cancer. No significant financial relationships to disclose.

De Gramont Schedule is a Very Low Toxic and Effective Regimen in Low Performance Status Patients Affected by Metastatic Gastric Cancer: Preliminary Report

2002 ◽  
Vol 88 (4) ◽  
pp. A21-A24 ◽  
Author(s):  
Antonio Rea ◽  
Gennaro Gadaleta Caldarola ◽  
Claudia Sandomenico ◽  
Mauro Colangelo ◽  
Aldo Filice ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Preliminary Report ◽  
Median Overall Survival ◽  
Performance Status ◽  
Metastatic Gastric Cancer ◽  
Hard Choice ◽  
Major Response ◽  
Low Performance ◽  
Grade 3

Summary Treatment of patients affected by metastatic gastric cancer with low performance status (PS) is a very hard choice. It is mandatory to define a very well-tolerated schedule to be employed in these subgroup of patients. Patients and Methods From June 1999 to December 2001, 21 patients (pts) affected by metastatic gastric cancer with low performance status (≥2 ECOG) were treated with bimonthly “de Gramont” schedule. Treatment was planned to perform 6 courses of chemotherapy for each patient plus other 2-4 if a response had been documented. Results A total of 161 courses of de Gramont schedule was administered to the 21 pts enrolled. We observed 8 PD (38%), 8 SD (38%), 5 objective responses (24% – 2 MR, 3 PR). Duration of objective responses (OR) was 5 months, 3 months for 3 PRs and 2 and 1 months for two MRs respectively. At time of observation (June 2002) median overall survival (OS) was 14 months, median survival from the starting de Gramont schedule was 8 months. Toxicity was very mild: grade 3 leukopenia in 1 pt, grade 1-2 anemia and piastrinopenia in 3 pts, grade 1-2 nausea vomiting in 5 pts, grade 1 diarrhea in 4 pts, grade 3 mucositis in 2 pts. No other side effect was renowned. PS ameliorated in 12 (57%) pts, even if a major response was not noted. Conclusions de Gramont schedule can be safely and effectively employed in metastatic gastric cancer pts with very low performance status.

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.

scholarly journals Efficacy of Regional Chemotherapy Approach in Peritoneal Metastatic Gastric Cancer

2021 ◽  
Vol 10 (22) ◽  
pp. 5322
Author(s):  
Kornelia Aigner ◽  
Yogesh Kumar Vashist ◽  
Emir Selak ◽  
Sabine Gailhofer ◽  
Karl Reinhard Aigner
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Median Overall Survival ◽  
Metastatic Gastric Cancer ◽  
Regional Chemotherapy ◽  
Intraarterial Infusion ◽  
Flow Perfusion ◽  
Advanced Stages ◽  
Grade 3 ◽  
Upper Abdominal

Peritoneal spread is frequent in gastric cancer (GC) and a palliative condition. After failure to systemic chemotherapy (sCTx) remaining therapeutic options are very limited. We evaluated the feasibility and efficacy of locoregional chemotherapy (RegCTx) in peritoneal metastatic GC. In total, 38 (23 male and 15 female) patients with peritoneal metastatic GC after failure of previous sCTx and unresectable disease were enrolled in this study. Using the hypoxic abdominal stop-flow perfusion, upper abdominal perfusion and intraarterial infusion technique in total 114 cycles with Cisplatin, Adriamycin and Mitomycin C were applied. No significant procedure related toxicity was noticed- especially no Grade 3 or 4 toxicity occurred. With the RegCTx approach a median overall survival of 17.4 months was achieved. Patients who had undergone previously resection of the GC the median overall survival was even better with 23.5 months. RegCTx is a promising, safe and efficient approach in diffuse metastatic GC. The evaluation of RegCTx in the setting of multimodal treatment approach at less advanced stages is also warranted.

scholarly journals Clinical Study of Sintilimab as Second-Line or Above Therapy in Patients With Advanced or Metastatic Gastric Cancer: A Retrospective Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Caiyun Nie ◽  
Huifang Lv ◽  
Yingjun Liu ◽  
Beibei Chen ◽  
Weifeng Xu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Therapeutic Strategy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Second Line ◽  
Free Survival ◽  
Grade 3 ◽  
Systemic Therapies

BackgroundThe present study was conducted to analyze the clinical efficacy and safety of sintilimab as second-line or above therapy for patients with advanced or metastatic gastric cancer.MethodsPatients with advanced or metastatic gastric cancer that progressed after prior systemic therapies and treated with sintilimab from March 2019 to July 2020 were retrospectively analyzed in this study. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.ResultsFifty-two patients with advanced or metastatic gastric cancer received sintilimab monotherapy or combination therapy after they failed from prior systemic therapies. Eight patients achieved partial response (PR), 26 patients had stable disease (SD), and 18 patients had progressive disease (PD). The ORR and DCR were 15.4% (8/52) and 65.4% (34/52), respectively. Median PFS was 2.5 months (95% CI = 2.0–3.0), and median OS was 5.8 months (95% CI = 4.9–6.7). The ORR and DCR were 30.0% (6/20) and 80.0% (16/20), respectively, in intestinal subtype, which were superior than in non-intestinal subtype (ORR: 6.3%, DCR: 56.3%). Patients with intestinal subtype obtained longer PFS (4.0 vs. 1.9) and OS (9.0 vs. 4.1) than those with non-intestinal subtype. The incidence of grade 3–4 adverse events was 44.2%.ConclusionsSintilimab monotherapy or combination therapy provides a feasible therapeutic strategy for patients with advanced or metastatic gastric cancer who failed from prior systemic therapies. The efficacy of sintilimab in intestinal subtype was superior than that in non-intestinal subtype.

Randomized, single-centered, phase II clinical trial of nimotuzumab plus cisplatin and S-1 as first-line therapy in patients with advanced gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14668-e14668 ◽  
Author(s):  
Jin-Wan Wang ◽  
Yihebali Chi ◽  
Zhao-xu Zheng ◽  
Tao Qu ◽  
Ai-Ping Zhou ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Performance Status ◽  
Objective Response ◽  
Survival Rates ◽  
Skin Toxicity ◽  
Metastatic Gastric Cancer ◽  
Open Label ◽  
First Line Therapy ◽  
Grade 3

e14668 Background: Nimotuzumab, a humanized IgG1 anti-EGFR monoclonal antibody, has demonstrated efficacy associated with an absence of severe skin toxicity in many phase I/II cancer trials. Methods: This is a single-center, parallel assignment and open-label study randomized to receive a infusion Cisplatin (30mg/m2/d, on day 1 and 2) and oral S-1 (80mg/m2/d, twice daily on day 1-14) every 3 weeks, either alone or together with Nimotuzumab (200 mg as a infusion on day 1, 8 and 15) (CS or NCS) as 1st line in patients with advanced or metastatic gastric cancer. The observation points were ORR, TTP, PFS, 1-year survival rates and safety. Results: 62 patients, 43 men and 19 women, median age 57 years (22-76 years), on good performance status (ECOG PS 0-2, one prior regimen) were treated with NCS (n = 31) or CS (n = 31). Up to 2012-01-16, 57 patients (NCS 30 cases compared with CS 27 cases) have undergone efficacy assessment. The objective response rate (ORR: PR 15) was 50% (15/30) in NCS group compared with (ORR: pCR 2+ PR 15) 63.0% (17/27) in CS group. Disease control rate was 96.7% and 96.3%, respectively. Until the same day, 36 patients have achieved progression in both groups (NCS 15: CS 11), median TTP was 5 months in NCS group compared with 3 months in CS group, and average TTP was 4.9 months and 4 months, respectively. The incidence of adverse events was similar between both groups. Adverse events included grade 3/4 hypo-hemoglobin 13.33%/7.41%, grade 3/4 thrombocytopenia 3.33%/0 and grade 3/4 neutropenia 3.33%/0. One patient experienced grade 3/4 digestive side effects 3.33%/0. Conclusions: The results have demonstrated benefit in TTP improvement. Further investigation is ongoing.

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