s-1-(combination) and Hematologic-Diseases

Gastric cancer, as one of the increasingly common malignancies, has experienced high morbidity throughout many countries at present. Currently, chemotherapy regimen with more efficacy and safety for advanced gastric cancer (AGC) is needed. We aimed to assess the clinical efficacy and safety of S-1 combined with paclitaxel (PTX) for AGC by performing a systematic review and meta-analysis of the published studies.. All published randomized controlled trials (RCTs) of S-1 combined with PTX for AGC were searched. Studies that included patients with locally advanced or metastases' gastric cancers were included. We searched the databases included Cochrane Library of Clinical Comparative Trials, MEDLINE, Embase, American Society of Clinical Oncology meeting abstracts and China National Knowledge Internet (CNKI) from 2000 to 2018. We searched the database up to January 2018. The first endpoint was overall survival (OS). Other endpoints were progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR). Safety analyses were also performed.. A total of 7 trials (including 1407 patients, 711 patients in intervention group and 696 patients in control group) were included in the present analysis. S-1 combined with PTX significantly improved the OS [HR = 0.78, 95% CI: 0.60-0.97, P = 0.000],PFS [HR = 0.70, 95% CI: 0.55-0.85, P = 0.000], ORR [RR = 1.30, 95%CI: 1.05-1.60, P = 0.017] and DCR [RR = 1.15, 95%CI: 1.04-1.27, P = 0.008] of patients with AGC. The grade 3 or 4 haematological and non-hematologic toxicities were anemia [RR = 1.71, 95% CI: 1.04-2.79, P = 0.03], neutropenia [RR = 1.65, 95% CI: 1.32-2.06, P < 0.0001] and anorexia [RR = 1.66, 95% CI: 1.05-2.64, P = 0.03] respectively.. S-1 combined with PTX may be a good choice for patients with AGC. S-1 plus PTX experienced more efficacy and safety when compared with S-1 alone or S-1 plus other drugs.

Topics: Antineoplastic Combined Chemotherapy Protocols; Drug Combinations; Hematologic Diseases; Humans; Oxonic Acid; Paclitaxel; Stomach Neoplasms; Survival Analysis; Tegafur

In this subanalysis of a phase III trial using three categorized doses of S-1, the influence of the actual doses on safety and efficacy was evaluated.. We compared the efficacy and safety of the S-1 or gemcitabine plus S-1 combination (GS) arm between the top 10% group and the bottom 10% group according to the initial doses of S-1: ≥77.6 versus ≤65.9 mg/m2/day (n = 28 vs. 28) in the S-1 arm, and ≥65.1 versus ≤53.8 mg/m2/day (n = 27 vs. 28) in the GS arm.. Overall and progression-free survival were not significantly different between these two groups: hazard ratios of 0.818 and 0.761 with p values of 0.498 and 0.330 in the S-1 arm, and hazard ratios of 0.836 and 0.759 with p values of 0.557 and 0.323 in the GS arm, respectively. Incidences of grade 3-4 hematological toxicities were significantly higher in the top 10% group than in the bottom 10% group: 42.9 versus 14.3 and 85.2 versus 57.1%, with p values of 0.037 and 0.037 in the S-1 and the GS combination arm, respectively.. Higher actual doses of S-1 were associated with a higher incidence of hematological toxicity even in the same dose setting.

Topics: Adenocarcinoma; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Adenosquamous; Deoxycytidine; Disease-Free Survival; Drug Combinations; Female; Gemcitabine; Hematologic Diseases; Humans; Male; Middle Aged; Oxonic Acid; Pancreatic Neoplasms; Retrospective Studies; Survival Rate; Tegafur

Here, we reported an interim analysis of feasibility and safety in the first 10 cases of 30 cases in a phase II trial of intravenous and intraperitoneal paclitaxel combined with S-1 for gemcitabine-refractory pancreatic cancer with malignant ascites.. Paclitaxel was administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8 every 3 weeks, and S-1 was administered at 80 mg/m2/day for 14 consecutive days, followed by 7-day rest.. Between April 2011 and February 2012, ten patients were enrolled. A partial response was achieved in two patients (20%) and a disease control rate of 50%. The median time to progression and overall survival were 2.1 and 3.4 months, respectively. Malignant ascites was completely resolved in two patients (20%). Major grade 3/4 adverse events were myelosuppression including neutropenia (50%) and catheter-related infection (10%).. This novel combination chemotherapy was feasible and showed promising results in pancreatic cancer patients with malignant ascites (clinical trial registration number: UMIN000005306).

Topics: Adenocarcinoma; Aged; Alopecia; Antimetabolites, Antineoplastic; Antineoplastic Combined Chemotherapy Protocols; Ascites; Catheter-Related Infections; Deoxycytidine; Drug Administration Schedule; Drug Combinations; Drug Resistance, Neoplasm; Fatigue; Feasibility Studies; Female; Gastrointestinal Diseases; Gemcitabine; Hematologic Diseases; Humans; Infusions, Intravenous; Infusions, Parenteral; Male; Middle Aged; Oxonic Acid; Paclitaxel; Pancreatic Neoplasms; Prospective Studies; Salvage Therapy; Tegafur; Treatment Outcome

The aim of this study was to evaluate the efficacy and toxicity of a novel oral 5-fluorouracil formulation (S-1) as second-line therapy after platinum agent chemotherapy for advanced non-small cell lung cancer (NSCLC).. S-1 was administered orally at a dose of 80 mg/m(2) for 28 days, followed by 14 days of rest (1 cycle); treatment was repeated until disease progression, unacceptable toxicity, or patient refusal.. Of the 46 patients enrolled in this study, 44 were evaluable. Six patients (14%) exhibited a partial response and 28 (64%) showed stable disease. Disease-control rate was 77.3% (34/44) (95% CI, 64.9-89.7%). The overall response rate was 14% (6/44) (95% CI, 3.5-23.8%). Median progression-free survival was 4.2 months. The median survival time was 16.4 months, and the one-year survival rate 60.3%. Grade 3/4 hematological toxicities were minor. All of those adverse reactions were tolerable and reversible.. This study demonstrated the efficacy of S-1 monotherapy as second-line treatment for advanced NSCLC.

Topics: Administration, Oral; Aged; Carcinoma, Non-Small-Cell Lung; Disease Progression; Disease-Free Survival; Drug Combinations; Drug Resistance, Neoplasm; Female; Follow-Up Studies; Hematologic Diseases; Humans; Lung Neoplasms; Male; Middle Aged; Neoplasm Staging; Oxonic Acid; Platinum Compounds; Recurrence; Tegafur; Treatment Outcome

Combination chemotherapy of S-1 and cisplatin has shown promising activity against advanced gastric cancer, but the schedules and dose intensities of S-1 and cisplatin have not been consistent in several clinical trials. We investigated the efficacy and toxicity of 3-weekly S-1/cisplatin chemotherapy as first-line treatment in metastatic or relapsed gastric cancer (MRGC). Forty-six patients with MRGC were prospectively enrolled. S-1 (80 mg/m(2)/day; days 1-14) and cisplatin (60 mg/m(2); day 1) were administrated every 3 weeks. Among 46 patients who received chemotherapy, one achieved a complete response and 21 achieved a partial response, resulting in an overall response rate (RR) of 48%. Thirteen patients (28%) had stable disease and eight patients (17%) had progressive disease. After a median follow-up duration of 48.3 weeks, the median progression-free survival (PFS) and overall survival (OS) were 21.1 weeks and 68.3 weeks, respectively. Patients with good Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 had prolonged PFS and OS compared with patients with ECOG PS of 2. Common hematologic toxicities were anemia (93%), leucopenia (61%), and neutropenia (61%). However, grade 3/4 anemia, leucopenia, and neutropenia developed in only 11, 9, and 24% of patients, respectively. Grade 3/4 non-hematologic toxicities included anorexia (22%), fatigue (13%), nausea (7%), and diarrhea (7%). No treatment-related mortality occurred. Three-weekly S-1/cisplatin chemotherapy was active and well-tolerated in MRGC patients.

Topics: Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Disease-Free Survival; Drug Administration Schedule; Drug Combinations; Fatigue; Follow-Up Studies; Gastrointestinal Diseases; Hematologic Diseases; Humans; Kaplan-Meier Estimate; Middle Aged; Oxonic Acid; Proportional Hazards Models; Prospective Studies; Stomach Neoplasms; Tegafur; Treatment Outcome

S-1 granulated powder has recently been released to the market as an additional format to that of the capsule. Patients who previously found it difficult to swallow the capsules are now able to take S-1 in powder form. This study evaluated the feasibility of S-1 granulated powder as adjuvant chemotherapy for advanced head and neck cancer. S-1 was orally administered for 2  weeks, followed by 1  week of rest (one course) for 12  months (16 courses). Twenty-four stage III and IV head and neck cancer patients were enrolled in this study. In total, 10 (47.6%) of the patients follow the planned schedule and dose. Severe adverse events were observed in 22 patients (91.7%), whereas no grade 4 adverse events were observed. S-1 granulated powder should be presented as an additional option for the treatment of head and neck cancer, especially for patients experiencing difficulty in swallowing oral medications.

Topics: Administration, Oral; Adult; Aged; Antimetabolites, Antineoplastic; Carcinoma, Squamous Cell; Chemotherapy, Adjuvant; Drug Combinations; Fatigue; Feasibility Studies; Female; Follow-Up Studies; Head and Neck Neoplasms; Hematologic Diseases; Humans; Male; Middle Aged; Nausea; Neoplasm Staging; Oxonic Acid; Prognosis; Tegafur; Vomiting

The aim of this study was to analyze the risk factors for grade 3 to 4 hematological toxicity after primary chemotherapy (Tegafur, gimeracil, oteracil potassium (S-1)/irinotecan hydrochloride (CPT-11)) in 87 (56 male, 31 female; median age 66.1 years) patients with unresectable or recurrent colonic cancer between April 2005 and May 2009, and to prepare a risk classes (low-risk, intermediate-risk or high-risk groups). The rate of grade 3 to 4 hematological toxicity was 16.1%. At multivariate analysis, risk factors for grade 3 to 4 hematological toxicity were baseline WBC, Cr, female (p<0.05). The toxicity index (TI) consisted of risk factors and regression coefficient. We were stratified patients into three groups according to TI that was calculated for each patient. The group with high value was found to include patients with grade 3 to 4 hematological toxicity with a significantly higher frequency than the group with low value (4.2% vs 57.1%, p=0.004). This risk classes could be useful to identify patients at high risk for chemotherapy-induced grade 3 to 4 hematological toxicity.

Topics: Aged; Antimetabolites, Antineoplastic; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Colonic Neoplasms; Drug Combinations; Female; Hematologic Diseases; Humans; Irinotecan; Male; Neoplasm Recurrence, Local; Oxonic Acid; Risk Factors; Tegafur

S-1 is an oral 5-fluorouracil (5-FU) anticancer agent and has shown promising effects in the treatment of a wide range of carcinomas, including head and neck cancer. In addition to being used as adjuvant chemotherapy, S-1 is a promising agent for palliative treatment. Its ease of administration makes it an ideal drug to treat patients in the outpatient setting while maintaining adequate quality of life. However, the clinical role of S-1 in patients with recurrent/metastatic head and neck cancer is still uncertain. We retrospectively reviewed 16 patients with recurrent/metastatic head and neck cancer who received S-1 monotherapy. Thirteen patients with squamous cell carcinoma (SCC) and 3 patients with non-SCC who had recurrent/metastatic disease received S-1 monotherapy as outpatients. One patient with nasopharyngeal undifferentiated carcinoma and 1 patient with maxillary adenosquamous carcinoma showed complete response (CR), while all SCC patients showed stable disease (SD) or progressive disease (PD). Median time to progression (TTP) was 12 weeks. Five patients showed grade 3 and 4 adverse reactions, all hematological. Except for one episode of grade 4 leucopenia which required hospitalization and granulocyte colony-stimulating factor (GCSF) treatment, all adverse events resolved with dose reduction or dose omission. S-1 was safely administered in outpatients and showed some efficacy in the treatment of recurrent/metastatic head and neck cancer in patients who had received previous chemotherapy. S-1 could be used as palliative treatment in patients with recurrent/metastatic head and neck cancer.

Topics: Administration, Oral; Aged; Antimetabolites, Antineoplastic; Carcinoma, Adenosquamous; Carcinoma, Squamous Cell; Drug Combinations; Female; Head and Neck Neoplasms; Hematologic Diseases; Humans; Male; Middle Aged; Neoplasm Recurrence, Local; Oxonic Acid; Palliative Care; Retrospective Studies; Tegafur; Treatment Outcome