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PubMed2006

Phase II study of capecitabine and cisplatin in previously untreated advanced biliary tract cancer.

BACKGROUND: Biliary tract cancer is one of the most aggressive and chemotherapy-refractory tumors. Although only curative treatment modality is surgery, most patients are not suitable for surgery due to advanced stage of the disease at diagnosis. Thus most patients with biliary tract cancer are possible candidates for palliative chemotherapy. The standard chemotherapeutic regimen is still to be defined, however. We performed a phase II study of combination chemotherapy with capecitabine and cisplatin in these patients to evaluate efficacy and toxicity of the regimen. METHODS: Patients with previously untreated metastatic, recurrent, or inoperable biliary tract cancer were enrolled. Eligible patients were screened as following: (1) histologically confirmed, (2) age between 18 and 75 years, (3) at least one measurable lesion according to RECIST criteria, (4) ECOG performance status <or=2, (5) a life expectancy of at least 3 months, and (6) adequate laboratory values. Patients received capecitabine (2,500 mg/m2/day, days 1 to 14) and cisplatin (60 mg/m2, day 1) every 3 weeks. Response was assessed for every two cycles of chemotherapy and treatment was stopped when tumor had progressed or stable with no further response. RESULTS: Thirty-two patients were enrolled, 20 (62.5%) were male and 12 (37.5%) were female and the median age was 54 years (33-71 years). Fifteen patients (46.9%) had gallbladder cancer, 13 (40.6%) had intrahepatic cholangiocarcinoma, and 4 (12.5%) had extrahepatic biliary cancer. The most frequent metastatic sites were lymph nodes (20/32, 62.5%) and liver (28/32, 56.3%). No complete response was observed and partial response was observed in 13/32 patients. By the intent-to-treat analysis, the overall response rate was 40.6% (95% CI, 23.7-59.4) with 0 CR and 13 PRs. Stable disease was observed in 3 patients (9.4%), and 11 patients (34.4%) had progressive disease. The median time to progression was 3.5 months (95% CI, 1.3-5.8), and the median overall survival was 12.4 months (95% CI, 6.3-18.5) after the median follow-up duration of 9.5 months (4.8-26.1 months). A total of 108 cycles of chemotherapy was delivered. Grade 3 hematologic toxicities included neutropenia (5, 15.6%), anemia (1, 3.1%), and thrombocytopenia (1, 3.1%) per patient, and no grade 4 hematologic toxicities were observed. Grade 3 non-hematologic toxicities included hyperbilirubinemia (2, 6.3%), increase of alkaline phosphatase (2, 6.3%), hand-foot syndrome (2, 6.3%), anorexia, and diarrhea (1, 3.1%) per patient, respectively. There was no treatment-related death. CONCLUSION: The combination chemotherapy of capecitabine and cisplatin demonstrated a promising antitumor activity with mild toxicity profile in patients with advanced biliary tract cancer.

Adult↗

PubMed2001

A phase II study of dose-intense ifosfamide plus epirubicin with hematopoietic growth factors for the treatment of patients with advanced soft tissue sarcomas; a novel sequential schedule.

PURPOSE: The efficacy and feasibility of a novel sequential schedule of high-dose ifosfamide (HD-IFO) and full-dose epirubicin (EPI) with granulocyte colony-stimulating factor (G-CSF) was evaluated in adult patients with soft tissue sarcomas (STS). METHODS: Since November 1995, 22 chemotherapy-naive patients have been treated. HD-IFO was given as a continuous infusion at a total dose of 14-18 g/m2 per cycle, with mesna, over 6 to 8 days, q 3 weeks, twice. EPI was administered subsequently as an i.v. bolus at a total dose of 120-160 mg/m2, on days 1-2, q 2 weeks, twice. G-CSF was planned for each course of treatment as a daily subcutaneous injection for 7 days, starting 24 h after the end of the treatment. After the first four cycles, patients were evaluated for surgery and patients with locally inoperable or metastatic disease received further chemotherapy up to a maximum of eight cycles. RESULTS: The response of 19 patients could be assessed. One complete response (CR) and six partial responses (PRs) were achieved for an overall response rate of 37% (95% confidence interval, 15-59%). Noteworthy is that two of the six leiomyosarcoma patients responded to the HD-IFO treatment. The median survival period was 15 months. Most common toxicities included myelosuppression, nausea and vomiting, and stomatitis. Six patients were hospitalized for complicated nadir fever. No severe renal and CNS toxicities were seen. Transient gross hematuria occurred in six patients and affected treatment in only one case. There were no treatment-related deaths. CONCLUSIONS: By the protraction of continuous infusion of HD-IFO over 6 to 8 days, ifosfamide-induced acute renal toxicity is avoided, while G-CSF support allows the delivery of the planned dose intensity in most of the patients. Although manageable in an oncology setting, the hematologic toxicity of such a regimen remains substantial. Moreover, in terms of efficacy and median survival, this regimen showed no benefits over a conventional-dose anthracycline-ifosfamide schema. Further evaluations of this novel ifosfamide-epirubicin schedule are not warranted, even if the HD-IFO regimen could be taken forward specifically for leiomyosarcomas in a phase II trial.

Adolescent↗

PubMed1996

Phase II study of second-line treatment with high-dose cyclophosphamide in recurrent metastatic breast cancer.

A total of 78 patients with second recurrence or progression of histologically verified breast cancer were treated with single-agent cyclophosphamide given at 2.5 g/m2 by i.v. infusion every 3 weeks along with mesna support. All had previously been treated with epirubicin and cisplatin or epirubicin alone. Toxicity was predominantly hematologic: WHO grade III+IV toxicity was found in 95% of cases. The overall response rate was 26.7% (95% confidence limits, 15.8-41.4%), with 7% of patients achieving a complete response (CR) and 19.7%, a partial response (PR). The median duration of CRs and PRs was 11 and 5 moths, respectively. The response rate observed for patients previously treated with epirubicin alone was 30.5% in contrast to the 8.3% recorded for patients previously treated with cisplatin plus epirubicin. Thus, an indication of cross-resistance was absent between cyclophosphamide and epirubicin but possible between cyclophosphamide and cisplatin.

Adult↗

PubMed1996

Phase I study of ifosfamide plus high-dose epirubicin in advanced non-small-cell lung cancer.

The present phase I study was designed to determine the maximum tolerated dose (MTD) of epirubicin given in combination with ifosfamide at a dose of 3 g/m2, recycled every 4 weeks, in patients with advanced non-small-cell lung cancer (NSCLC). A total of 18 patients entered the study; they received the following four dose levels of epirubicin (i.v., day 1): 75 (6 patients), 90 (3 patients), 105 (3 patients, and 120 mg/m2 (6 patients). The MTD of epirubicin was 120 mg/m2, neutropenia being the dose-limiting toxicity. We observed 1/6, 1/3 1/3, and 2/6 partial responses (PRs) at epirubicin dose levels of 75, 90, 104, and 120 mg/m2, respectively. A phase II study of epirubicin given at a dose of 120 mg/m2, in association with conventional-dose ifosfamide in advanced NSCLC is in order.

Aged↗

PubMed1997

High-dose toremifene in advanced renal-cell carcinoma.

Toremifene (Fareston)-a novel antiestrogenic drug with a triphenylethylene structure-is effective in the treatment of postmenopausal breast cancer patients. It can be safely given even at high doses of up to 300 mg/day. The purpose of the present study was to investigate the effect and tolerability of high-dose toremifene in the treatment of patients with advanced renal-cell carcinoma (RCC). A total of 36 patients started treatment with toremifene at 300 mg/day, including 26 men and 10 women. Their mean age was 56 years (range 35-75 years). In all, 19 patients were nephrectomized. One patient was not evaluable for response because of insufficient treatment time. The response rate was 17%, including one complete response (CR, 3%) lasting for 121+ weeks and five partial responses (PRs, 14%) with a mean duration of 40+ weeks. Ten cases of no change (NC, 28%) had a mean duration of 24 weeks. There was no significant difference in the response rate when patients with lung metastases alone were compared with patients showing metastases of other sites with or without lung metastases. Total pain control was achieved in 45% of the patients who had pain at the beginning of the treatment, and partial control was attained in 20%. Ten patients (28%) developed adverse reactions, which led to discontinuation of the treatment in one case. Blood samples were taken from 16 patients on days 0, 1, 3, 7, 14, and 28 for drug analyses. The concentration of toremifene and its main metabolites measured in serum were about 1.5 times that detected after a conventional dose of 60 mg/day. It can be concluded that high-dose toremifene is an effective and safe palliative treatment in advanced RCC.

Adult↗

PubMed1997

Feasibility trial of high-dose 7-day continuous-infusion ifosfamide given on an outpatient basis.

High-dose ifosfamide (HD-IFX) has shown significant antitumor activity in advanced sarcoma and breast carcinoma. The use of uroprotective agents and the availability of ambulatory continuous-infusion pumps has allowed dose escalation in the administration of ifosfamide (IFX) on an outpatient schedule. We report the results of a phase II trial of IFX given at high doses to heavily pretreated patients. IFX was infused at 2 g/m2 per day for a total of 7 days through a central venous access, with cycles being repeated every 21 days. Mesna was given concomitantly at equimolar doses. No hematopoietic support was used. A total of 27 heavily pretreated patients whose disease had progressed during conventional-dose chemotherapy were included (14 sarcomas, 10 breast carcinomas, and 3 bladder carcinomas). Reversible neutropenia and gastrointestinal toxicity were the most frequently encountered toxicities. Only two patients developed transient renal failure, and two others developed central nervous system toxicity. No treatment-related death was observed. Of 22 patients who were evaluable for response, 6 (27%) showed an objective response (OR), all ORs being partial responses (PRs) with a median duration of 6 months, and 12 patients had stable disease (SD; 55%) with a median duration of 3.5 months. The median overall survival (OS) was 6 months. Three patients underwent high-dose chemotherapy after showing a response to our IFX schedule. We conclude that continuous-infusion IFX given in an outpatient setting is a feasible and active regimen that produces, a manageable toxicity profile in heavily pretreated breast cancer and sarcoma patients. Early institution of this schedule in less advanced stages could improve the results obtained.

Antineoplastic Agents, Alkylating↗

PubMed1998

Activity of gemcitabine in non-small-cell lung cancer: results of the Japan gemcitabine group (A) phase II study.

PURPOSE: This phase II study was conducted to determine the response and toxicity of gemcitabine (2',2'-difluorodeoxycytidine) in chemotherapy-naive patients with non-small-cell lung cancer (NSCLC). METHODS: A group of 73 patients were entered into the study. The patients had received no previous chemotherapy and all had measurable disease. The initial starting dose of gemcitabine was 1000 mg/m2 per week x 3 followed by a week of rest, and was escalated for the next cycle to 1250 mg/m2, provided there were no signs of hematologic toxicity (WBC < 3000/microl and/or platelets < 70,000/microl) in the previous cycle. RESULTS: Among 73 eligible patients, there were 19 partial responses (PRs), with an overall response rate of 26.0% (95% confidence interval 16.5-37.6%). The response rate for stage IIIa and IIIb disease was significantly higher than that for stage IV disease [41.4% (12/29) vs 15.9% (7/44); P = 0.028]. The median duration of response in patients showing a PR was 4.6 months (1.7 10.4 months). The median number of cycles given was two per patient (range one to seven). Grade 3 anemia, leukopenia and neutropenia occurred in 15 patients (20.5%), 7 patients (9.6%) and 20 patients (27.4%), respectively. Grade 3 thrombocytopenia occurred in one patient (1.4%) which was not associated with any bleeding. There was no evidence of cumulative toxicity in the later courses of gemcitabine treatment with regard to leukopenia and thrombocytopenia. Other toxicities, including hepatic toxicity, fatigue, nausea/vomiting and fever were mild (grade 2 or less) and transient. One patient was withdrawn from the trial because of a rash. Pulmonary toxicity was experienced in two patients and one patient died of respiratory insufficiency which was thought to be drug-related. CONCLUSIONS: Gemcitabine as a single agent has proven to be an active drug for NSCLC with a favorable, generally mild side-effect profile. Further trials in combination with other agents for this disease are currently underway.

Adult↗

PubMed1997

[Dose-response relationship of trans-scleral contact cyclophotocoagulation].

PURPOSE: In recent years, transscleral contact-cyclophotocoagulation has increasingly been used for the treatment of therapy-refractive glaucomas. The dose-effect correlation varies according to different authors. In this retrospective study, we tried to determine whether there is a dose-effect correlation of transscleral contact-cyclophotocoagulation. METHODS: Following diagnosis, 124 eyes of 113 patients (age range 49.9 +/- 26.5 years) were included in the study. The laser parameters used were reviewed along with the intraocular pressure (IOP) before treatment, after treatment and during the follow-up (mean 6 months). RESULTS: The IOP of 45.2% (56) of 124 eyes was < 22 mmHg. In 25.8% (32 eyes) a retreatment was necessary. No correlation between energy and decrease of IOP was found (Prs = 0.08 nonsignificant, Spearmann rank correlation). The IOP was reduced from 35.8 +/- 10.5 mmHg preoperatively to 26.3 +/- 10.5 mmHg at the end of follow-up (P approximately 0, Wilcoxon test). Therapy could be reduced by up to three antiglaucomatous drugs in therapy-refractive eyes. CONCLUSIONS: These data show that a decrease of about 10 mmHg of the IOP is possible using transscleral contact-cyclophotocoagulation. In therapy-refractive eyes, fewer drugs were needed to reach an IOP < 22 mmHg. Regardless of the diagnosis, a dose-effect correlation between the decrease of IOP and laser energy was not found.

Adult↗

PubMed2003

Prosthetic rehabilitation in traumatic upper limb amputees (an Indian perspective).

INTRODUCTION: Rehabilitation of traumatic upper limb amputees depends on a multitude of factors. This study attempts to evaluate the success of prosthetic rehabilitation in this group of patients, determine the reasons for non-compliance and find ways to increase prosthetic acceptance. MATERIALS AND METHODS: The prosthetic rehabilitation status of 71 traumatic upper-limb amputees was assessed by a questionnaire and clinical review. A Prosthetic Rehabilitation Scoring (PRS) system, based on patient satisfaction, prosthetic usage and activity level, was devised to quantify the success of rehabilitation. RESULTS: The rehabilitation was found to be equally good in above-elbow and below-elbow amputees. The delay in fitting of the prosthesis had no correlation with successful rehabilitation. Chances of successful rehabilitation decreased when the prosthesis fitting was done in older patients. The main reasons for inadequate use of the prosthesis were repeated mechanical failure and the high cost of repair and replacement. CONCLUSION: In order to achieve an optimum benefit for the patient in a developing country, the prosthesis should be durable, inexpensive and have a low cost of maintenance.

Adult↗

PubMed2026

Esketamine multi-omic biomarker evaluation in major depressive disorder (EMBER-MDD): concept, objectives and methodologies of a non-clinical investigator-initiated study.

Treatment resistance (TR) in major depressive disorder (MDD) affects a substantial minority of patients and is hard to recognize early, delaying intensified care. The Esketamine multi-omic biomarker evaluation in MDD (EMBER-MDD) is a non-interventional, investigator-initiated, in-vitro study within the EU Psych-STRATA programme, analyzing biospecimens collected in the randomized INTENSIFY study and the mirror OBS-TR cohort after participants complete treatment. EMBER-MDD aims to discover individual-omic and integrated multi-omic (hypothesis-free) biomarkers and signatures associated with TR risk, and molecular correlates of clinical response to esketamine nasal spray versus treatment as usual (TAU). Biomaterials will derive from approximately 420 adults with MDD (estimated n = 210 esketamine; n = 210 TAU) and include whole blood, RNA-stabilized whole blood, plasma and serum, sampled at baseline and, when feasible, during and after treatment (up to ~ 5,040 aliquots stored at - 80 °C). Genomics will use baseline DNA genotyping on Illumina Infinium GSA v3.0+MD arrays; epigenomics will profile genome-wide DNA methylation across time points using MethylationEPIC v2.0; transcriptomics will employ mRNA-seq (NovaSeq X/ X Plus); and proteomics/ metabolomics will be generated using high-throughput Olink and/ or Biocrates platforms. Each layer will undergo state-of-the-art preprocessing and analyses (e.g., GWAS/ PRS, EWAS, differential expression, WGCNA, pathway and network analyses), followed by integrative strategies including QTL mapping (meQTL/ eQTL/ pQTL/ mQTL) and intermediate-fusion machine learning with nested cross-validation, explainable AI (SHAP/ LIME) and treatment-effect modelling. All outputs are research-only and will not support individual efficacy, tolerability, or clinical decision-making. The study will deliver robust biosignatures and mechanistic hypotheses to guide future validation and inform stratified, molecularly guided intervention strategies in subsequent prospective trials. Trial registration number: 2023-506617-21-00 and 2025-178-f-S.

Humans↗

PubMed1999

Primitive reflexes in a case-control study of patients with advanced human immunodeficiency virus type 1.

This study estimated the frequency of nine primitive reflexes (PR) and assessed their possible clinical value in a group of patients with acquired immunodeficiency syndrome. We studied 78 patients with human inmunodeficiency type 1 (HIV-1) infection in WHO clinical stage 3 or 4 and 81 matched seronegative controls. All participants were examined using a standardized neurological examination and the Mini-Mental State Examination. Cognitive impairment and PR was found in 36% of patients but in none of the controls (P<0.0001; logistic regression odds ratio: 14.7). Overall, PR were 2-36 times more frequent in patients with HIV-1 infection. This association was stronger for the glabellar, snout, Rossolimo, and digital signs. At least two PR were observed in 92% of patients vs. 8% of controls (P<0.0001; 95% confidence interval: 68%-100%; logistic regression odds ratio: 10.8). These data support the association of PR with cognitive decline in patients with advanced HIV-1 infection without overt neurological disease. Larger follow-up studies with multivariate techniques are needed to identify which PRs are useful as indicators of HIV-1-associated cognitive/motor complex and minor neurocognitive disorders.

Acquired Immunodeficiency Syndrome↗

PubMed1999

The psychophysics of perceptual memory.

Psychophysical studies of short-term memory for attributes or dimensions of the visual stimulus known to be important in early visual processing--spatial frequency, orientation, contrast, motion--identify an early perceptual memory system. The proposed system, which may be part of the Schacter-Tulving perceptual representation system (PRS), is located early in the visual processing stream, prior to the structural description system responsible for shape priming but beyond primary visual cortex (V1), and consists of a series of parallel special-purpose perceptual mechanisms with independent but limited processing resources, where each mechanism is devoted to the analysis of a single stimulus dimension and is coupled to a memory store. The experimental evidence for this hypothesis is reviewed.

Evoked Potentials↗

PubMed2002

Quality assurance for detection of estrogen and progesterone receptors by immunohistochemistry in Austrian pathology laboratories.

Steroid hormone receptors are important prognostic and predictive factors in breast carcinomas. Thus their determination is of essential importance. The aims of this study were to assess the quality of the immunohistochemical assays, and to assess the interlaboratory and interobserver variability performed by different laboratories in Austria. Ten unstained slides for interlaboratory variability evaluation and ten immunohistochemically prestained slides for interobserver variability evaluation from breast carcinomas known to show different degrees of steroid hormone receptor expressions were sent to 32 surgical pathology laboratories in Austria (participation rate 97%). The participants were requested to perform their in-house immunohistochemistry (IHC) technique for estrogen receptors (ERs) and progesterone receptors (PRs) on the unstained slides. All slides were evaluated by estimating percentage and intensity of stained nuclei semiquantitatively. From these data the Reiner, Remmele and the Allred scores were calculated. A less than 10% cut-off level was chosen as threshold for positive cases. Regarding the series of prestained slides, both sensitivity and specificity were very high (>96.88%); false-positive and -negative rates were low (<3.31%). Interobserver variability showed moderate multirater kappa values concerning the ER (Reiner score: kappa=0.57) and PR scores (Reiner score: kappa=0.53). The agreement among observers was better for negative cases than positive cases. In-house slides representing interlaboratory variability showed fair to moderate kappa values concerning the ER and PR scores (kappa for ER Reiner score=0.41; PR=0.32). In this slide series, sensitivity and specificity were high (>82.2%) and false-positive or -negative rates were low in ER cases (<3.03) and moderately low in PR cases (17.46%). These results demonstrate that variability is higher when participants use their own staining method. In more detailed analysis, the automated IHC techniques showed an advantage over manual techniques concerning interlaboratory variability. There exists no difference in reproducibility with respect to scoring systems for steroid hormone receptor estimation.

Austria↗

PubMed2004

Correlation between the DNA global methylation status and progesterone receptor expression in normal endometrium, endometrioid adenocarcinoma and precursors.

Endometrial carcinomas are the most common malignancy of the female genital tract and the third most common cancer in women. Progesterone and oestrogen receptors (PRs, ERs) are the most widely documented prognostic and predictive factors in endometrioid adenocarcinoma. Besides the hormonal pathway involved in the progression of preneoplastic and neoplastic lesions, alterations of the DNA methylation status have been shown to be an early signal of tumorigenesis. In this study, we show that in normal endometrium, during the proliferative phase, DNA methylation and PR expression are high, with a significant decline towards the end of the secretory phase and a gradual increase in non-atypical and atypical endometrial hyperplasia; they reach their highest level in grade I, then decrease significantly in grade-II and grade-III endometrioid adenocarcinomas. During each stage, a significant positive correlation is observed between DNA methylation and PR (P<0.0001). The strong parallelism between DNA methylation and PR expression precludes establishing a precise determination regarding the timing of these events, clearly involved in the genesis of endometrioid adenocarcinoma.

Carcinoma, Endometrioid↗

PubMed1997

PRS1 is a key member of the gene family encoding phosphoribosylpyrophosphate synthetase in Saccharomyces cerevisiae.

In Saccharomyces cerevisiae the metabolite phosphoribosyl-pyrophosphate (PRPP) is required for purine, pyrimidine, tryptophan and histidine biosynthesis. Enzymes that can synthesize PRPP can be encoded by at least four genes. We have studied 5-phospho-ribosyl-1(alpha)-pyrophosphate synthetases (PRS) genetically and biochemically. Each of the four genes, all of which are transcribed, has been disrupted in haploid yeast strains of each mating type and although all disruptants are able to grow on complete medium, differences in growth rate and enzyme activity suggest that disruption of PRS1 or PRS3 has a significant effect on cell metabolism, whereas disruption of PRS2 or PRS4 has little measurable effect. Using Western blot analysis with antisera raised against peptides derived from the non-homology region (NHR) and the N-terminal half of the PRS1 gene product it has been shown that the NHR is not removed by protein splicing. However, the fact that disruption of this gene causes the most dramatic decrease in cell growth rate and enzyme activity suggests that Prs1p may have a key structural or regulatory role in the production of PRPP in the cell.

Amino Acid Sequence↗

PubMed2001

Differences in the progesterone receptor contents between familial breast cancers and sporadic breast cancers stratified by patient age.

In the present study, we investigated the estrogen (ER) and progesterone receptor (PR) contents of familial breast cancers (FBCs) and compared the findings with those of sporadic breast cancers., stratified by the patients' age. To evaluate the hormone receptor contents of Japanese FBCs, we collected a consecutive series of 250 FBCs and 2,533 sporadic breast cancers (SBCs). These patients were divided into the three groups stratified by the patients' age at initial surgery (group I, under 40 years old; group II, 40-60 years old; group III, over 60 years old). The clinicopathological features of FBCs and SBCs, including ERs and PRs, were analyzed for each group. In all age groups, the PR contents of FBCs were significantly lower than those of SBCs, particularly for group III. In FBCs, the PR content was significantly lower in group III than in groups I or II. In addition, there was a nonsignificant trend towards a high frequency of ER-positive, PR-negative tumors in FBC patients aged 60 years and over. These data indicate that the loss of ER function and/or loss of binding capacity of PR to progesterone was associated with some late-onset FBCS.

Adult↗

PubMed1999

Oral UFT (uracil plus futrafur) for neoadjuvant chemotherapy of gastric cancer.

BACKGROUND: Neoadjuvant chemotherapy has become one of the topics of interest in chemotherapy of gastric cancer; the present study assessed the clinical benefits of neoadjuvant chemotherapy with oral uracil and futrafur (UFT) for gastric cancer.METHODS: Between 1991 and 1997, 82 patients with gastric cancer (36 with early and 46 with advanced cancers) received UFT at 300-600 mg/day orally for 1-6 weeks before surgery. Objective responses, histological effects, and postsurgical survival rates were assessed.RESULTS: In 69 of the 82 patients, the objective responses of the primary lesions were assessed by endoscopy or upper gastrointestinal series examination, and 2 complete responses (CR)s, 25 partial responses (PRs), and 42 no changes (NCs) were seen (39.1% response). Histological effects were evaluated in 82 patients, and 2 grade 3, 11 grade 2, 11 grade 1b, 27 grade 1a, and 31 grade 0 effects were seen. A longer period of UFT administration was associated with a CR or PR. However, the objective responses did not correlate with the histological effects. All the patients underwent gastrectomy, and during the median follow-up period of 41 months, 3-year survival rates were 97.1% for pTNM stage 1, 75% for stage 2, 86.7% for stage 3, and 41.6% for stage 4. The survival rates of stage 3 and stage 4 patients were higher than those of the historical controls in our department. However, CR or PR did not correlate with the improvement in survival. Side effects before surgery were not serious; they included slight myelotoxicity, liver dysfunction, and anorexia; however, 3 patients (3.7%) had suture insufficiency, 3 patients (3.7%) had methicillin-resistant Staphylococcus aureus (MRSA) enteritis, and 7 patients (8.5%) had liver dysfunction.CONCLUSIONS: Preoperative chemotherapy for gastric cancer with oral UFT was safe and resulted in a good local response (macro- and microscopically) which may indicate the possibility of improved survival with neoadjuvant chemotherapy with UFT. Furthermore, preoperative chemotherapy with oral UFT is easy and patients can receive this treatment on an outpatient basis.

Journal Article↗

PubMed2002

Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer.

BACKGROUND: To increase the options for agents for gastric cancer chemotherapy, we performed a phase II clinical trial on the use of a 3-h infusion of paclitaxel to confirm its efficacy and the feasibility of its use in patients with advanced gastric cancer. METHODS: Thirty-two (32) patients with measurable metastatic gastric cancer were enrolled in this study. Seventeen patients (53%) had received prior chemotherapy for metastatic disease, 4 patients (13%) had adjuvant chemotherapy alone, and 11 patients (34%) were chemotherapy-naive. Paclitaxel was intravenously infused for 3 h, at a dose of 210 mg/m(2), once every 3 weeks. To prevent hypersensitivity reactions, standard premedication was administered to all patients. RESULTS: Nine (28%; 9/32 ) objective partial responses (PRs) were observed (95% confidence interval [CI], 14%-47%), and the remaining 23 patients showed stable (12 patients; 37.5%) and progressive disease (11 patients; 34.4%). The median time to response was 20 days (range, 14-38 days). The median response duration was 87 days (range, 50-103 days). The median survival of all patients was 234 days (range, 13-646+ days). The major adverse reactions were myelosuppression (grade 3/4 leukopenia and neutropenia were observed in 59% and 88% of the patients, respectively), alopecia, and peripheral neuropathy. Peripheral neuropathy was observed in 19 patients, however, most of the patients recovered after the completion of treatment. CONCLUSION: A 3-h infusion of paclitaxel is an effective therapy for advanced gastric cancer and is clinically well tolerated by the patients.

Adenocarcinoma↗