Cisplatin, Fluorouracil in Bolus Injection, and Leucovorin in First-Line Therapy for Advanced Gastric Cancer as an Alternative to Protocols With Infusional Fluorouracil

PURPOSE Gastric cancer (GC) is the fourth most common cancer and the second leading cause of cancer death worldwide. Platinum agents and fluoropyrimidines are the main compounds used in the first-line setting for advanced GC. Given the activity of fluorouracil (FU) bolus, the PFL protocol, a chemotherapy regimen combining cisplatin, FU bolus, and leucovorin, was incorporated at the Brazilian National Cancer Institute, because this schedule does not require hospitalization or infusion pumps. This study aims to evaluate the outcomes of PFL in the first-line setting for patients with advanced GC. MATERIALS AND METHODS This was a retrospective cohort study evaluating patients with advanced GC treated in the first-line setting with cisplatin 80 mg/m2 on day 1 and FU bolus 400 mg/m2 plus leucovorin 20 mg/m2 on days 1, 8, 15, and 22 every 4 weeks, from January 2008 to December 2014. RESULTS A total of 109 patients were enrolled. The median number of cycles received per patient was four (one to 11). Complete responses were achieved in 6.4% and partial responses in 14.7%. Median progression-free survival was 6.3 months (95% CI, 5.08 to 7.58 months) and median overall survival was 8.3 months (95% CI, 6.79 to 9.87 months). Thirty-four (31.2%) patients were alive in 1 year. Grade 3 and 4 adverse events were experienced by 26.6% and 3.7% of patients, respectively, with dose reduction necessary in 9.1%. CONCLUSION PFL is active in advanced GC and could be an alternative for FU continuous infusion protocols in institutions with limited resources and/or low budget, which is the reality in many nations all over the world.

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Cisplatin and capecitabine with and without docetaxel as a first-line chemotherapy in patients with metastatic gastric carcinoma: Single clinical experience.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e15194 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e15194-e15194

Author(s):

Mekhty Narimanov ◽

Alexey Tryakin ◽

Varlam Zarkua ◽

Igor Bazin ◽

August Garin ◽

...

Keyword(s):

Gastric Carcinoma ◽

Median Overall Survival ◽

Progression Free Survival ◽

Primary Prophylaxis ◽

Median Number ◽

First Line ◽

Free Survival ◽

Grade 3 ◽

Number Of Cycles ◽

Line Chemotherapy

e15194 Background: Cisplatin and capecitabine and docetaxel are active agents for treatment of metastatic gastric carcinoma. We underwent analysis of efficacy and toxicity of douplet (CX ) and triplet (DCX) regimens which were used in our department as a first-line chemotherapy in patients with metastatic gastric carcinoma. Methods: Pts with metastatic gastric carcinoma were nonrandomly allocated to DCX regimen (docetaxel 75 mg/m2 i.v. day 1, cisplatin 75 mg/m2 i.v. day 1, capecitabine 1650 mg/m2 per os days 1-14) or CX regimen (cisplatin 75 mg/m2 i.v. day 1, capecitabine 2000 mg/m2 per os days 1-14 ). Up to 6 cycles were provided every 3 weeks. G-CSF was not routinely used for primary prophylaxis. Results: From 2008 to 2012 81 pts were included in the study (DCX – 37 pts, CX – 44 pts). Pts characteristics were similar in both groups (table 1). Median number of cycles in both groups was 5 (range, 1-6). Grade 3-4 toxicity (per cycle) in DCX and CX groups were neutropenia 24,9% and 16,1%, deep venous thrombosis – 2% and 0%, diarrhea – 6.2% and 7,4%, stomatitis – 3.8% and 2,2%, infection – 11% and 0%, anemia 14% and 13,5% pts, respectively. No toxic deaths were observed. Median progression-free survival (PFS) in DCX and CX were 7,5 months (95% CI 6,1-8,9) and 5,4 months (95% CI 5,0-6,2; p=0.0009), median overall survival (OS) 14,5 months (95% CI 10,1-18,9) and 9,3 months (95% CI 9,2-10,2; p=0.0018), respectively. Conclusions: Addition of docetaxel to the combination of cisplatin and capecitabine associates with significant improvement of PFS and OS. Higher rate of infection requires use of G-CSF in primary prophylaxis. [Table: see text]

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Outcomes of patients treated with capecitabine and temozolamide (CapTem) for advanced pancreatic neuroendocrine tumors (PNETs) and non-PNETs.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.343 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 343-343 ◽

Cited By ~ 4

Author(s):

Renata D'Alpino Peixoto ◽

Krista Noonan ◽

Hagen F. Kennecke ◽

Howard John Lim

Keyword(s):

Progression Free Survival ◽

Median Number ◽

First Line ◽

Primary Tumors ◽

Free Survival ◽

Entire Cohort ◽

First Line Therapy ◽

Poor Tolerance ◽

Well Differentiated ◽

Number Of Cycles

343 Background: Retrospective studies have demonstrated high response rates among patients with advanced PNETs treated with CapTem while responses are infrequently seen among non-PNETs. The objective of the study was to describe progression free survival (PFS) and overall survival (OS) among sequential NET patients treated with CapTem and to identify factors associated with response. Methods: Patients who initiated therapy with CapTem between 2009 and 2013 for advanced NETs and referred to one of 6 provincial cancer treatment centers were included. Patients received Cap 2000 mg/m2 day 1-14 and TMZ 200 mg/m2 on days 10-14 every 28 days. Their characteristics and outcomes were retrospectively analyzed. Results: In our cohort, 29 patients (16 male) with a median age of 59 (range 26 – 76) received palliative CapTem, 15 of them as first-line chemotherapy and 14 as subsequent lines. Primary tumors included pancreas (48.3%), small bowel (20.7%), lung (10.3%), unknown (10.3), rectum (6.9%) and appendix (3.4%). Median number of cycles was 3. For the entire cohort, median PFS and OS were 4.7 and 20.2 months, respectively. Although pancreatic NETs (PNETs) had shorter OS (18.8 months versus not reached, p=0.37), their PFS was longer than non-PNETs (4.9 versus 2.8 months, p=0.178). There was no difference in PFS between first or subsequent lines of therapy. Patients with Ki67 above 10% had a shorter PFS when compared to lower Ki67 (3.1 versus 5.5 months, p = 0.028). Three patients had to discontinue CapTem due to poor tolerance (2 intractable nauseas and 1 myocardial infarction). There were no treatment-related deaths. Conclusions: CapTem showed good activity among NETs, especially for PNETS, who derived the greatest benefit. Effectiveness was not exclusive to first-line therapy and seems better for well-differentiated tumors.

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Retrospective review of modified dose docetaxel, cisplatin, and 5-flourouracil (DCF) for the treatment of first-line metastatic gastric carcinomas.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e15175 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e15175-e15175

Author(s):

Nuriye Özdemir ◽

Sercan Aksoy ◽

Tulay Eren ◽

Huseyin Abali ◽

Omur Berna Oksuzoglu ◽

...

Keyword(s):

Gastric Cancer ◽

Retrospective Review ◽

Progression Free Survival ◽

Complete Response ◽

Metastatic Gastric Cancer ◽

Median Number ◽

Hematological Toxicity ◽

First Line ◽

Gastric Carcinomas ◽

Grade 3

e15175 Background: Docetaxel, cisplatin, and 5FU (DCF) has been shown to be an effective regimen for metastatic gastric carcinomas. However, treatment-related adverse events is quite high with original dose DCF. We evaluated the outcomes of the metastatic gastric carcinomas who treated with modified dose DCF (mDCF) in our institution. Methods: A single institution retrospective review of patients with metastatic gastric cancer treated with three weekly mDCF from 1/2006 to 1/2013 was evaluated. Over this time period a standard order-set was in place in which cisplatin 60 mg/m2, 5FU 600 mg/m2 and docetaxel 60 mg/m2 was given three weekly. Tumor response was calculated retrospectively using RECIST criteria. Results: One hundred and ninety-one patients were included the study. The median age was 55 years (23 to 76), 74% were male, and 82% were chemo-naive. Eighty percent of the patients were metastatic at the time of diagnosis. The median number of cycles administered was 6 (2-10). Hematological toxicity was mild with grade 3/4 granulocytopenia in 25% of the patients, grade 3/4 thrombocytopenia in 4% of the patients, and grade 3/4 anemia in 9% of the patients. Neutropenic infection occurred in 9 (%5) patients. Grade 3/4 nausea/vomiting was reported by 10% of the patients, and diarrhea by 7%. A total of 19 (10%) patients had dose delays or dose reductions related to toxicity. Six (3%) patients had complete response and 43 (23%) patients had partial response. Stable disease were occurred in 83 (45%) patients and 56 (23%) progressive disease. Ninety percent of the patients have died with median follow-up of 8 months. Progression-free survival was 7 months (95% CI 6 to 7.8 m) and overall survival was 10 months (95% CI 8.7 to 11.2 m). Conclusions: mDCF has mild hematological toxicity and overall excellent tolerance in first line metastatic gastric cancer patients. Response rate and the survival of these patients with a minimal toxicity are comparable with the original dose DCF.

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Combined analysis of three randomized phase III trials comparing S-1 monotherapy and S-1 combination therapy for first-line treatment of advanced gastric cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.49 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 49-49

Author(s):

Madoka Takeuchi ◽

Wataru Ichikawa ◽

Kohei Shitara ◽

Yu Sunakawa ◽

Koji Oba ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Combination Therapy ◽

Advanced Gastric Cancer ◽

Progression Free Survival ◽

Phase Iii ◽

First Line ◽

Free Survival ◽

First Line Therapy ◽

Phase Iii Trials

49 Background: S-1 is the gold standard for first line therapy of advanced gastric cancer in Asia. There have been multiple meta-analyses published researching and comparing the efficacy and safety of S-1 monotherapy versus combination1,2. However there has been no analysis using actual trial data. Methods: Actual data from three randomized Phase III trials were combined to compare the efficacy of S-1 Monotherapy and S-1 combination therapy. The START trial, comparing S-1 and combination S-1 with docetaxel, SPIRITS, comparing S-1 and combination S-1 with cisplatin and TOP-002, comparing S-1 and S-1 combination with irinotecan, were merged and combined. For this analysis, the three S-1 arms were combined (n = 642) and the different S-1 combination therapy were combined (n = 617) creating two new treatment arms. The primary efficacy outcome of overall survival, progression free survival and subset analysis of overall survival stratified by baseline characteristics were performed. Results: A total of 1248 patients, including 210 Korean patients from the START were used in the analysis. The median overall survival days for S-1 combination and monotherapy was 382 [209, 648] and 321 [177, 597] and median progression free survival days for S-1 combination and monotherapy was 153 [81, 267] and 122 [61, 204]. Both overall survival (p = 0.0088 HR = 0.85 (0.76,0.96)) and progression free survival ( p = < 0.001 HR = 0.75 (0.67,0.85)) was significantly longer in the combination therapy arm compared to the monotherapy arm. Conclusions:Although there are limitations, the analysis re-confirms that S-1 combination therapy shows to be more efficacious compared to S-1 monotherapy for advanced gastric cancer patients. It must be noted that heterogeneity of the S-1 arm was not carefully considered when combining the S-1 data for the trials. In addition, the results are limited to the Asian (Japanese and Korean) population.

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The Efficacy and Safety of Treatment Regimens Used in the First-Line Setting in Metastatic Pancreatic Cancer Patients: A Multicenter Real-Life Study

10.21203/rs.3.rs-747492/v1 ◽

2021 ◽

Author(s):

Nadiye Akdeniz ◽

Muhammet Ali Kaplan ◽

Mevlüde İnanç ◽

Doğan Uncu ◽

Yakup Ergün ◽

...

Keyword(s):

Pancreatic Cancer ◽

Real Life ◽

Progression Free Survival ◽

Metastatic Pancreatic Cancer ◽

First Line ◽

Free Survival ◽

Life Study ◽

Treatment Regimens ◽

Grade 3 ◽

Line Setting

Abstract Purpose: To compare the efficacy and toxicity of three different chemotherapy regimens used as first-line treatments in the real-life management of metastatic pancreatic cancer (mPC). Methods: A total of 218 patients diagnosed with mPC at the time of initial admission were included in this multicenter study. Gemcitabine (Gem, n=71), Gemcitabine-cisplatin (Gem-Cis, n=91) and FOLFIRINOX (FFX, n=56) treatments were compared in terms of efficacy and treatment-related toxicity. Results: Overall response rate was significantly higher in the FFX group (50.0%) than in the Gem (28.2%) and Gem-Cis (27.5%) groups (p=0.010).Median progression-free survival (8.4 vs. 4.6 and 5.5 months, respectively, p<0.001) and overall survival (16.4 vs. 8.1 and 8.7 months, respectively, p=0.002) were significantly longer in theFFX group than in the Gem and Gem-Cis groups. Toxicity of any grade was noted in 46(64.8%), 56(61.5%) and 49(87.5%) patients in the Gem, Gem-Cis and FFX groups, respectively (p=0.003).Of the grade 3-4 toxicities, weakness/fatigue and mucositis were reported only in the FFX group (5.4% and 3.6%, respectively). Grade 3-4 diarrhea (10.7%, 0.0%, 2.2%, respectively) and neutropenia (25%, 4.2% and 5.5%, respectively) were more common in the FFX group than in the Gem and Gem-Cis groups. Conclusion: In conclusion, our findings indicate that FFX regimen provides a significant advantage over the other treatment regimens in terms of response rates and survival. Treatment toxicity was more frequent but manageable with the FFX regimen.FFX seems to be a preferable regimen in the first-line treatment of the younger and fit patients diagnosed with mPC.

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Assessment for markers of poor prognosis in a real-world evidence study of treatment patterns in patients with HR+/HER2- locally advanced or metastatic breast cancer in Korea and Taiwan.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e13083 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e13083-e13083

Author(s):

Diego Novick ◽

Narayan Rajan ◽

Rebecca Ming-Huei Cheng ◽

Sae Young Lee ◽

Dong Hyun Koo ◽

...

Keyword(s):

Locally Advanced ◽

Metastatic Breast ◽

Progression Free Survival ◽

Patient Characteristics ◽

First Line ◽

Free Survival ◽

Median Progression Free Survival ◽

First Line Therapy ◽

Line Therapy ◽

Grade 3

e13083 Background: To assess how patient characteristics impact treatment patterns and real-world effectiveness among patients with hormone receptor (HR+)/human epidermal growth receptor 2-negative (HER2-) locally advanced and metastatic breast cancer (ABC) in Korea and Taiwan. Methods: We conducted a retrospective chart review comprising 227 female patients aged ≥ 18 years and diagnosed HR+/HER2- ABC in Korea and Taiwan between 2015-2017. Those having at least one of the following characteristics, shown previously to negatively impact prognosis, formed the poor prognostic cohort (PPC): ECOG PS > 0, not bone-only disease, liver metastases, or negative PgR status. Anonymized data on patient characteristics, treatment pathways, progression-free survival, and grade 3 or higher adverse events (AEs) of interest was abstracted. Descriptive statistics and Kaplan Meier methods were used to assess the outcomes. Results: The mean (range) age was 57.1 (29 - 83) years. A total of 193 (85.0%) patients were PPC. Endocrine regimens were the most frequent first-line therapies used by 50.3% and 67.6% of patients in the PPC and non-PPC cohorts, respectively. Chemotherapy regimens were used by 25.9% and 17.6% as initial systemic therapy and by 60.1% and 35.3% at any time following diagnosis of ABC, for PPC and non-PPC, respectively. The median progression-free survival time, based on first-line therapy, was 8.3 (95%CI: 6.9 – 10.4) months for PPC versus 11.5 (95%CI: 5.5 – 12.0) months in non-PPC. The proportion of patients with at least 1 grade 3 or higher AEs of interest during first-line therapy was higher in the PPC cohort compared to the non-PPC cohort, 54.4% vs. 44.1% respectively. The most common AEs reported were leukopenia, asthenia/fatigue and neutropenia occurring in 27.5%, 28.0% and 20.7% of the PPC cohort and 23.5%, 2.9%, and 14.7% of the non-PPC cohort, respectively. Conclusions: The existence of one or more poor prognostic factors is associated with a higher chemotherapy use any time following diagnosis of ABC, as well as lower median progression-free survival and a higher likelihood of having an adverse event during first line therapy, compared to non-PPC cohort. These results suggest that patient poor prognostic characteristics can be drivers for therapy selection.

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Use of first-line trabectedin in advanced leiomyosarcoma: a review of clinical data and future perspectives

Cancer Breaking News ◽

10.19156/cbn.2016.0002 ◽

2016 ◽

Vol 4 (1) ◽

pp. 6-10

Author(s):

Nadia Hindi ◽

Florence Duffaud ◽

Giacomo Giulio Baldi ◽

Patricia Pautier

Keyword(s):

Clinical Trials ◽

Single Agent ◽

Objective Response ◽

Progression Free Survival ◽

First Line ◽

Free Survival ◽

First Line Therapy ◽

Large Subgroup ◽

Myxoid Liposarcomas ◽

Line Setting

Leiomyosarcomas (LMS) represent a large subgroup of soft-tissue sarcoma (STS) generally considered moderately sensitive to conventional chemotherapy. Single-agent doxorubicin is the standard first-line therapy for advanced non-selected STS, although combination with ifosfamide appears to be superior in terms of objective response. Gemcitabine-based regimes, dacarbazine, trabectedin and pazopanib seem to be especially active in patients with advanced LMS, while the activity of ifosfamide in this histotype is low. Data derived from clinical trials and retrospective series show that trabectedin is especially active in L-sarcomas including non-gynecological and uterine LMS as well as liposarcomas, in particular myxoid liposarcomas. Trabectedin has also been tested in the first-line setting, alone or in combination with doxorubicin, for the treatment of LMS of uterine and non-uterine origin in a trial by the French Sarcoma Group (phase II study LMS-02) with encouraging results in terms of median progression-free survival and objective response. The toxicity profile of trabectedin appears to be comparable to, or even more manageable than, that of other chemotherapy combinations in the first-line setting. Designing new clinical trials based on specific histologic subtypes is feasible, and the results of such studies would help to optimize the management of patients with STS.

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First-line chemotherapy with irinotecan plus capecitabine for advanced colorectal cancer

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.14602 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 14602-14602

Author(s):

V. Michalaki ◽

C. Gennatas ◽

S. Gennatas ◽

J. Vasiliou ◽

V. Smyrniotis

Keyword(s):

Colorectal Cancer ◽

Colorectal Adenocarcinoma ◽

Progression Free Survival ◽

Median Number ◽

First Line ◽

Free Survival ◽

Gastrointestinal Side Effects ◽

Number Of Cycles ◽

Metastatic Sites ◽

Line Chemotherapy

14602 Background: The effective, oral fluoropyrimidine capecitabine is increasingly replacing intravenous (IV) 5-FU/LV in colorectal cancer treatment. The aim of this study was to evaluate efficacy and safety of the combination chemotherapy with irinotecan plus capecitabine (XELIRI), in patients with advanced colorectal adenocarcinoma. Methods: Patients with advanced colorectal adenocarcinoma received a first-line chemotherapy with capecitabine (1000 mg/m2 twice daily) on days 1–14 and irinotecan (240 mg/m2) on day 1 of a 21-day cycle. Results: Twenty-eight patients were evaluable for response. Baseline characteristics: 18men, 10 women; median age 65.5 years (range, 49–73); colon cancer (71%), rectal cancer (29%). Most common metastatic sites were the liver (53.5%), lymph nodes (43%), lung (21%) and bones (18%). There were 7 partial responses (25%), 8 cases of stable disease (28.5%), and 13 cases of disease progression (46.5%). The median survival was 14 months (range, 2–28.8 months) and median progression-free survival was 7 months (range, 6- 26 months). The median number of cycles received was 7 (range, 3–15 cycles). Frequently encountered therapy-related events were leukopenia and gastrointestinal side effects including diarrhea. Conclusions: First-line capecitabine/ irinotecan is an active combination for the treatment of metastatic colorectal cancer achieving high efficacy with a good safety profile. No significant financial relationships to disclose.

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Combination of docetaxel, cisplatin, and capecitabine (DCX) as a first-line chemotherapy in patients with metastatic gastric carcinoma: A phase II study.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14623 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14623-e14623

Author(s):

Mekhty Narimanov ◽

Alexey Tryakin ◽

Igor Bazin ◽

Dheepak Kanagavel ◽

Sergei Tjulandin

Keyword(s):

Gastric Carcinoma ◽

Phase Ii ◽

Active Agent ◽

Progression Free Survival ◽

Primary Prophylaxis ◽

Similar Efficacy ◽

Median Number ◽

Free Survival ◽

Grade 3 ◽

Number Of Cycles

e14623 Background: Docetaxel is an active agent for treatment of metastatic gastric carcinoma. We launched this phase II trial to evaluate the efficacy and safety of docetaxel, cisplatin and capecitabine (DCX) combination in patients (pts) with metastatic gastric carcinoma. Methods: Pts with metastatic gastric carcinoma received docetaxel 75 mg/m2 i.v. day 1, cisplatin 75 mg/m2 i.v. day 1, capecitabine 1650 mg/m2 per os days 1-14 every 3 weeks. Up to 6 cycles were provided. G-CSF was not routinely used for primary prophylaxis. Results: From 2007 to 2011, 37 pts were included in the study, all pts were available for response. Pts characteristics and results are shown in the table. Median number of cycles delivered was 5 (range, 1-5). Grade 3-4 toxicity (per cycle) included: neutropenia – 24,9%, deep venous thrombosis – 2%, diarrhea – 6.2%, stomatitis – 3.8%, infection – 11%; anemia 14% pts. Six pts had dose reductions, 2 pts stopped chemotherapy due to toxicity. No toxic deaths were observed. Median progression-free survival (PFS) and median overall survival (OS) were 7,5 months (95% CI 6,076-8,857) and 14,5 months (95% CI 10,054-18,880), respectively. Conclusions: Compare with combination of docetaxel, cisplatin and 5-FU, evaluated in V325 study, our regimen had more favorable toxic profile with similar efficacy. Further investigation of this regimen in randomized controlled trials is warranted. [Table: see text]

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Bolus infusion of cisplatin, 5-fluorouracil, and leucovorin as alternative first-line therapy for advanced gastric cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15511 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15511-e15511

Author(s):

Rafael Correa Coelho ◽

Pedro Duarte Abreu ◽

Mariana Ribeiro Monteiro ◽

Ana Paula Stramosk ◽

Roberto Almeida Gil ◽

...

Keyword(s):

Gastric Cancer ◽

Tumor Staging ◽

Performance Status ◽

First Line ◽

First Line Therapy ◽

Chemotherapy Protocol ◽

Grade 3 ◽

Line Setting ◽

Metastatic Sites ◽

Infusion Protocol

e15511 Background: Gastric cancer (GC) is the fourth most common cancer and the second leading cause of cancer death worldwide.Classic regimens in first line setting for advanced GC combine platinum compounds and fluoropirimidines ± antracyclines or docetaxel. At Brazilian National cancer Institute (INCA), there are limitations in hospital beds and infusion pumps, so the combination between cisplatin (CDDP) + 5-Fluorouracil (5-FU) in an infusion protocol has been out of possibility. An institutional project with an adapted protocol involving CDDP + 5-FU + Leucovorin (CFL) in bolus demonstrated good results and CFL became routine at INCA for more than 10 years. Methods: Retrospective cohort study evaluating 109 patients with advanced GC treated in first line setting with CDDP 80mg/m2(D1) + 5- FU 400mg/m2 (D1,D8,D15,D22)+ Leucovorin (LV) 20mg/m2 (D1,D8,D15,D22) in 28-day cycles from January 2008 to December 2014. Results: The median age was 54 years (24y-80y), 53.6% were male, 70% white and 20% mulatto, 49.1% formal smokers and 15.5% formal drinkers. Tumor staging at initial diagnosis was: E IIA 2.7%, E IIB 2.7%, E IIIA 1.8%, E IIIB 5.5%, E IIIC 5.5% and E IV 81.8%. Performance status ≤ 2 was present in 97.3% and G3 disease in 63.6%. The most common metastatic sites were: lymph nodes 31.8%, peritoneum 24.5%, liver 21.8% and lung 2.7%. The median of cycles received per patient was 4. Complete responses were achieved in 6.4%, partial responses in 14.5% and stable disease in 14.5%. Median PFS was 6.3 months (5.08 – 7.58) and median OS was 8.3 months (6.79 – 9.87). Seventy five (68.8%) patients were alive in 1-year and 26 (23.9%) in 2-years. Dose reduction was necessary in 9.1% and the most common toxicities were: nausea 27.3%, vomiting 19.3% fatigue 13.6%, diarrhea 10.6%, mucositis 4.2% and neutropenia 4.2%. Of all adverse events, grade 3 and 4 corresponded to 11.36% and 1.51%, respectively. Three patients had neutropenia G4. Only 26 patients (23.8%) received second line treatment. Conclusions: Chemotherapy protocol in bolus combining CDDP, 5-FU and LV could be an alternative for CDDP and 5-FU infusion protocol.

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