PubMed Health⌕ Search

Biomedical subjects

R Labianca

Publications and source records attributed to R Labianca.

At least 73 records · Page 4Linked to original sources
PubMed1998

Do specialists do it better? The impact of specialization on the processes and outcomes of care for cancer patients.

OBJECTIVE: To assess the impact of specialization on processes and outcomes of care for cancer patients. DATA SOURCE: Papers published in English between 1980 and 1995 and identified through MEDLINE and Embase (MeSH terms: NEOPLASM (exploded), and PHYSICIAN PRACTICE PATTERNS (or DECISION MAKING, ATTITUDE OF HEALTH PERSONNEL, QUALITY OF HEALTH CARE, DELIVERY OF HEALTH CARE, HEALTH EDUCATION or OUTCOME ASSESSMENT HEALTH CARE), or through the reference lists of review articles. STUDY SELECTION: Studies providing information on the association between quality of care indicators for cancer patients and clinician/centre degree of specialization. A total of 47 papers concerning 46 empirical studies were considered. DATA EXTRACTION: For studies using process of care indicators, the proportion of specific procedures performed by specialists and non-specialists was abstracted. For studies using outcome indicators (e.g., mortality), the effect of specialization was quantified in terms of odds ratio (OR) expressing relative reduction in risk of death. The quality of individual studies using process or outcome indicators was assessed according to study design, avoidance of selection bias in patient identification and data analysis, degree of adjustment of the comparison between clinicians/centres with different levels of specialization. DATA SYNTHESIS: Specialized centres/clinicians fared better both when process and outcome indicators were used. While the former varied widely in different studies and their clinical relevance was often questionable, mortality was consistently lower when care was provided by specialized centres/clinicians, with the effect size being greater in smaller studies. For breast cancer, where all the studies were of sufficiently good quality, a pooled estimate of the effect of specialization was performed which showed that specialized cancer care was associated with an 18% (95% CI: 12%-23%) reduction in mortality. CONCLUSIONS: Despite the fact that care provided by specialized centres/clinicians appeared to be better both when assessed in relation to process indicators and to mortality, this evidence should be considered far from conclusive because of major methodological flaws in these studies. Relative to current efforts to promote evidence-based policy-making, this review underscores the limited capability of scientific information to provide reliable guidelines for structuring better health care systems.

Confidence Intervals↗
PubMed1998

Intensive weekly chemotherapy for locally advanced gastric cancer using 5-fluorouracil, cisplatin, epidoxorubicin, 6S-leucovorin, glutathione and filgrastim: a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD).

Local extension prevents curative resection in more than two-thirds of gastric cancer patients. Unfortunately, resectability is one of the main prognostic factors in these patients, and survival is longer when tumours are completely removed. Preoperative chemotherapy is an attractive concept for obtaining curative resection. Thirty-two locally advanced unresectable gastric cancer patients were enrolled in five Italian Group for the Study of Digestive Tract Cancer (GISCAD) centres. For 16 patients, surgical unresectability was based on computerized tomography scan evaluation of tumour size (four patients) and invasion of adjacent structures (12 patients), whereas in another 16 patients locally advanced disease was confirmed by laparotomy. They received weekly administration of cisplatin 40 mg m(-2), 5-fluorouracil 500 mg m(-2), epidoxorubicin 35 mg m(-2), 6S-stereoisomer of leucovorin 250 mg m(-2) and glutathione 1.5 g m(-2). From the day after to the day before each chemotherapy administration, filgrastim was administered by subcutaneous injection at a dose of 5 microg kg(-1). One cycle of therapy consisted of eight weekly treatments. Fifteen of 32 patients (47%) responded to chemotherapy, whereas 13 (41 %) had stable disease and four (12%) progressed on therapy. Of the 15 responding patients, 13 were completely resected after chemotherapy and two of them had a complete pathological response. Two clinically responding patients were found unresectable at operation because of peritoneal seeding. At a median follow-up from the start of treatment of 24 months (range 11-39 months), 10 of 13 resected patients are alive and eight are relapse free. Three patients died after 11, 12, and 14 months respectively. Toxicity was acceptable: side-effects consisted mainly of grade II National Cancer Institute common toxicity criteria (NCICTC) leucopenia and thrombocytopenia in ten patients. Neither treatment-related death nor surgical complications in patients undergoing surgery were observed. This weekly intensive regimen enabled resection in half of previously inoperable tumours with a moderate toxicity. It can be offered to patients with locally advanced unresectable gastric cancer to obtain curative resection.

Adult↗
PubMed1998

Schedule-selective biochemical modulation of 5-fluorouracil in advanced colorectal cancer: a multicentric phase II study.

We have recently reported high clinical activity against advanced colorectal cancer of a regimen-alternating bolus FUra, modulated by methotrexate (MTX), and continuous infusion FUra, modulated by 6-s-leucovorin (6-s-LV). Considering the low toxicity of the bolus part of this regimen and our recent in vitro finding of a strong synergism between bolus FUra and natural-beta-IFN (n-beta-IFN), this cytokine was incorporated in the bolus part of our treatment programme. Fifty-six patients with untreated, advanced, measurable colorectal cancer were treated with two biweekly cycles of FUra bolus (600 mg m(-2)), modulated by MTX (24 h earlier, 200 mg m(-2)), and n-beta-IFN (3 x 10(6) IU i.m. every 12 h, starting at the time of FUra administration for four doses), alternating with a 3-week continuous infusion of FUra (200 mg m(-2) daily), modulated by 6-s-LV (20 mg m(-2) weekly bolus). After a 1-week rest, the whole cycle (8 weeks) was repeated if indicated. A total of 5 complete and 17 partial responses were obtained (response rate, 41%; 95% confidence limits, 28-55%) in 54 assessable patients. After a median follow-up time of 36 months, five patients are still alive. Overall, the median time to treatment failure was 6.4 months. The median duration of survival was 15.0 months. There was one treatment-related death after a course of MTX --> bolus FUra/n-beta-IFN and grade III-IV toxicity occurred in 18% of the patients. As the addition of n-beta-IFN results in high toxicity, whereas the efficacy seems to be similar to that of the same regimen without the cytokine, our groups are currently randomizing the original regimen, without IFN, against standard modulated bolus FUra.

Adenocarcinoma↗
PubMed1997

Evaluation of factors influencing 5-fluorouracil-induced diarrhea in colorectal cancer patients. An Italian Group for the Study of Digestive Tract Cancer (GISCAD) study.

Diarrhea is one of the dose-limiting toxicities for administration of fluorouracil (5FU) in patients with colorectal cancer and can result in severe morbidity and mortality. No well-defined prognostic factors influencing 5FU-associated diarrhea have been identified, which means its occurrence is unforeseeable. The aim of this study was to check whether any characteristics related to patients or chemotherapy could allow the identification of subsets of patients at higher risk of developing diarrhea while receiving a regimen containing 5FU. A logistic regression analysis was performed with age, sex, site of primary tumor, presence of primary tumor, presence of colostomy, time since surgery, number of courses of chemotherapy, diarrhea in previous courses, season of treatment, and chemotherapeutic regimens used as model parameters to predict occurrence of diarrhea in 258 colorectal cancer patients receiving a 5FU-containing regimen. Presence of primary tumor (P = 0.004), previous episodes of chemotherapy-related diarrhea (P = 0.00005) and summer season (P = 0.014) were found to be significant risk factors for developing diarrhea. The other variables examined, such as age, sex, chemotherapeutic regimen, site of primary tumor, presence of colostomy, and time since surgery, were not significantly correlated to diarrhea. Chemotherapeutic regimen was the only parameter that allowed prediction of the severity of diarrhea: 5FU/6S-leucovorin/interferon caused more severe diarrhea, followed by 5FU/leucovorin weekly. Although the analysis of these clinical features does not seem to allow the definition of a well-defined subset of colorectal cancer patients at higher risk of 5FU-induced diarrhea, it can be recommended that patients with primary tumor, or who have experienced diarrhea in earlier courses of chemotherapy or are receiving treatment in summer should be carefully monitored, especially in the first cycles.

Adult↗
PubMed1997

Biological indices predictive of survival in 519 Italian terminally ill cancer patients. Italian Multicenter Study Group on Palliative Care.

The knowledge of prognostic factors capable of subdividing cancer patients into groups having homogenous survival times is useful even in very advanced stages of illness. This prospective multicenter study assessed these prognostic factors in 530 terminal patients with solid tumors who were undergoing only palliative care. Thirteen hematological and urinary parameters were assessed on admission and every 28 days thereafter. In 519 assessable patients with a median survival of 32 days, six biological parameters demonstrated a statistically significant predictive prognosis. A poor prognosis was predicted by high total white blood count (WBC) (P < 0.0001), high neutrophil percentage (P < 0.0001), low lymphocyte percentage (P < 0.0001), low serum albumin level (P = 0.0015), low pseudocholinesterase level (P < 0.0001), and high proteinuria (P = 0.0064). Multiple regression analysis showed that only WBC, lymphocyte percentage and pseudocholinesterase level were independent predictors of survival. The individualization of biological parameters having an independent prognostic capacity is a useful step in the attempt to identify subsets of patients with a homogeneous prognosis. The biological factors needed are easily detected by means of a simple blood test and do not require invasive operations on patients who are already debilitated.

Aged↗
PubMed1997

Gastrointestinal Tract Cancer Liaison Office: an attempt to organise clinical research in Europe.

The Gastrointestinal Tract Cancer Liaison Office (GITCLO) was developed in an attempt to organise the increasing body of clinical research in gastrointestinal tumours in Europe. This paper represents an analysis, by tumour localisation, of the trials collected for the second edition of the GITCLO booklet. The list of cooperative groups, chairmen and study coordinators is given with their respective telephone and telefax numbers. A total of 84 trials were collected, conducted by 46 co-operative groups in 14 countries. For each organ and stage of disease, a summary of concepts investigated is given with the references of the study co-ordinator. Obviously, too many questions are raised at the same time. In colorectal cancer, for example, a total of 41 trials exploring 22 concepts are currently open for patients' registration. We hope that the present attempt to clarify the situation of clinical research in the field of gastrointestinal cancers in Europe will speed up therapeutic progress in the best interest of the patients.

Colorectal Neoplasms↗
PubMed1997

High-versus low-dose levo-leucovorin as a modulator of 5-fluorouracil in advanced colorectal cancer: a 'GISCAD' phase III study. Italian Group for the Study of Digestive Tract Cancer.

BACKGROUND: Although leucovorin (LV) + 5-fluorouracil (5-FU) is considered the treatment of choice for advanced colorectal cancer in most countries, the optimal schedule of this combination has not yet been established. Low-dose LV appears to be as active as high-dose LV in the daily-times-five regimen, but no randomized study of the levorotatory stereoisomer (6S-LV) given at two different dose levels has been published. PATIENTS AND METHODS: Between November 1991 and June 1994, 422 patients (all with measurable disease previously untreated with chemotherapy) were randomized to 6S-LV (100 mg/sqm/i.v.) + 5-FU (370 mg sqm/15 min i.v. infusion), both administered for 5 days every 28 days (arm A), or to 6S-LV (10 mg/sqm/i.v./5-FU (doses as above), also given for 5 days every 28 days (arm B). The primary endpoint of the study was the comparison of response rates (WHO criteria): the secondary endpoint was the assessment of survival and tolerability. No evaluation of the quality of life or the symptomatic effect of treatment was planned. RESULTS: The response rate was 9.3% in arm A (95% CI: 5.4-13.1), with 2 CR and 18 PR, and 10.7% in arm B (95% CI: 6.5-14.9), with 3 CR + 19 PR, without any significant difference (P = 0.78). The median time to progression was eight months in both groups and overall survival was 11 months, with no difference between treatments. Toxicity mainly consisted of gastrointestinal side effects (mucositis and diarrhoea), which were rarely severe (grade 3-4: 5%-10% of patients) and similar in the two groups. CONCLUSIONS: In this large-scale multicentre trial, the low and high doses of 6S-LV appeared to be equivalent in terms of the biochemical modulation of 5-FU in advanced colorectal cancer although, for several reasons (including the timing and the strict criteria of response evaluation, the high number of patients with unfavourable prognostic factors, the multi-institutional nature of the study, the dose and modality of 5-FU administration), the response rate was lower than that reported in some of the other published studies. Given the considerable difference in economic cost between the two dosages, the use of high-dose 6S-LV in the daily-times-five regimen is not recommended in clinical practice.

Adult↗
PubMed1997

Intensive weekly chemotherapy for advanced gastric cancer using fluorouracil, cisplatin, epi-doxorubicin, 6S-leucovorin, glutathione, and filgrastim: a report from the Italian Group for the Study of Digestive Tract Cancer.

PURPOSE: A multiinstitutional trial was performed to confirm the clinical activity, in terms of response rate and toxicity (primary objectives) and duration of responses and survival (secondary objectives), of an intensive weekly regimen in advanced gastric cancer. PATIENTS AND METHODS: Patients with measurable unresectable and/or metastatic gastric carcinoma received 1-day per week administration of cisplatin (CDDP) 40 mg/m2, fluorouracil (5FU) 500 mg/m2, epi-doxorubicin (epi-ADR) 35 mg/m2, 6S-stereoisomer of leucovorin 250 mg/m2, and glutathione 1.5 g/m2. On the other days, filgrastim was administered by subcutaneous injection at a dose of 5 mg/kg. One cycle of therapy consisted of eight 1-week treatments. Patients who showed a response or stable disease received a further 6 weeks of therapy. RESULTS: Of 105 enrolled patients, 11 had locally advanced unresectable disease only; 33 had primary nonresected and metastatic disease; 48 had metastatic disease and primary tumor resected; 10 had locoregional recurrence and metastatic disease; and three had locoregional recurrence only. After one cycle, 18 complete responses (CRs) and 47 partial responses (PRs) were achieved, for an overall response rate of 62% (95% confidence interval [CI], 53% to 71%). Twenty patients had stable disease and 20 progressed on therapy. The median survival duration of all 105 patients was 11 months, with 1- and 2-year survival rates of 42% and 5%, respectively. World Health Organization (WHO) grade III to IV toxicity, in terms of anemia, neutropenia, thrombocytopenia, and mucositis, was experienced by 40 patients (38%). There were no treatment-related deaths. CONCLUSION: These data support the results of the pilot study and confirmed the high activity of the regimen, with acceptable toxicity. This schedule deserves evaluation in the adjuvant setting.

Adult↗
PubMed1997

Treatment of colorectal cancer. Current guidelines and future prospects for drug therapy.

Colorectal carcinoma is one of the most common cancers in Western countries (yearly incidence rate of 1:3000), and represents, after lung cancer, the second leading cause of deaths due to cancer. During the past decades, knowledge about this carcinoma has considerably increased, but little progress has been made in improvement in patient survival. At least 40% of patients with colorectal cancer will have metastases sometime during the course of their illness. In colon cancer, the first therapeutic approach is surgery, but the important role of adjuvant chemotherapy in these patients, in terms of disease-free survival and overall survival benefit, is now well established. Until today, standard therapy was represented by fluorouracil plus levamisole and/or calcium folinate (folinic acid). Other strategies are represented by monoclonal antibodies (mAb), which improve survival, (with a decrease in mortality by 32%), and by portal vein fluorouracil, alone or in combination with systemic therapy. In rectal cancer, the best results have been obtained with a combination of radiotherapy and chemotherapy. In advanced colorectal cancer, a standard treatment has not yet been established. This disease is usually considered as poorly chemosensitive and for more than 30 years fluorouracil has been the standard drug. Tumour response rates (partial+complete) for patients treated with bolus intravenous fluorouracil are 10 to 15%, with a median survival about 1 year. Many attempts have been made to improve these results. Biochemical modulation of fluorouracil is one of the most interesting strategies developed in the last few years in an attempt to increase the therapeutic index of this compound. Another way has been to administer fluorouracil by continuous infusion. Further innovative compounds such as irinotecan and raltitrexed are now being evaluated in clinical trials. Preliminary data from phase II and III studies have provided encouraging results on the use of these new drugs. In metastatic disease confined to the liver, the possibility of locoregional therapy through implantable pumps should be taken into consideration.

Chemotherapy, Adjuvant↗
PubMed1996

Cisplatin-associated anaemia in patients with solid tumours. A retrospective evaluation and considerations relative to erythropoietin administration.

We have reviewed the incidence of cisplatin-induced anaemia in patients affected with solid tumours treated with at least three courses of first-line cisplatin-containing regimens. In our experience, a low percentage (5%) of patients required transfusions of red blood cells. We think it is of the utmost importance to adopt uniform criteria in monitoring and treatment of patients at risk of developing cisplatin anaemia and to identify subsets of patients to eventually treat with erythropoietin.

Anemia↗
PubMed1996

Modulated 5-fluorouracil (5-FU) regimens in advanced colorectal cancer: a critical review of comparative studies.

Several modifications to the administration schedule of 5-fluorouracil (5-FU) alone or in combination with other agents have been investigated in advanced colorectal cancer. Biochemical modulation of 5-FU with leucovorin (LV) increases response rate compared with 5-FU alone, but without improvement of overall survival. The best treatment schedule and optimal dose of LV remain unclear, although low doses seem equally as effective as high doses, with the advantage of reduced cost. Methotrexate can increase the activity of 5-FU to a similar degree as LV and a recent meta-analysis showed a slight improvement in survival. The combination of 5-FU + interferon has been disappointing, with phase III trials showing similar activity to 5-FU + LV, but with high toxicity. Other modulators (e.g. hydroxyurea, N-phosphonacetyl-L-aspartate, dipyridamole) show promising but sometimes conflicting results. Standardisation of assessment criteria should be considered when comparing these data to the activity of new drugs such as 'Tomudex' (raltitrexed, previously known as ZD1694), CPT-11 and oxaliplatin.

Antimetabolites, Antineoplastic↗
PubMed1996

Factors influencing response rates for advanced colorectal cancer chemotherapy.

BACKGROUND: The activity of various chemotherapy regimens used in the treatment of advanced colorectal cancer is assessed by different groups of investigators and in various trials by what appear to be common criteria. However, there may be substantial inter-trial variation in the interpretation and application of these criteria which contributes to differences in response rates reported for the same regimen. MATERIALS AND METHODS: This paper reviews the most prominent studies in this field and examines the factors which may influence the assessment of activity in clinical trials such as patient selection, the definition and application of response criteria, the methods of assessment of time to progression and duration of response, factors related to the therapeutic regimen and statistical methods. Each factor is critically discussed. RESULTS: The analysis confirms that there is a large variability among the different studies and that an inter-trial comparison is often impossible, with subsequent difficulties for clinicians in determining the true impact of therapies. DISCUSSION: After briefly commenting on the various issues, this review makes recommendations about how to achieve consistency among trials, for instance by using standard criteria, by extending the use of randomization even in phase II trials and by evaluating high quality, well conducted clinical trials in a meta-analysis, thereby making possible comparison across trials. The conclusions, although specific to colorectal cancer, are also applicable to other advanced malignancies.

Antineoplastic Agents↗
PubMed1996

Sequential methotrexate and 5-fluorouracil as second-line chemotherapy for advanced colorectal cancer patients pretreated with 5-fluorouracil and leucovorin: a GISCAD study.

The biochemical modulation of 5-fluorouracil (5-FU) by means of methotrexate (MTX) and 6-S leucovorin (LV) seems mainly directed at two different intracellular targets, supporting the hypothesis of possible non-cross resistance between these two methods of 5-FU potentiation. Thirty-one patients, all previously treated with 5-FU and LV for advanced colorectal cancer (ACC), were treated with MTX = 200 mg/m2 iv day 1 and 5-FU 600 mg/m2 day 2 with 6-S LV 10 mg/m2 po q 6 h X 6 starting 24 h after MTX, repeated every 2 weeks. Of 30 evaluable patients, 2 Partial Remissions (PR) were achieved (Response Rate = 6.6%; 95% Confidence Interval 0%-14%). Eight patients had disease stabilization (SD). The overall median survival was 5 months (range 1-11). No WHO grade III-IV toxicities were reported. Despite the good tolerability, this combination of MTX, 5-FU and LV rescue has minimal activity in ACC after the failure of 5FU+LV-based chemotherapy.

Adult↗
PubMed1995

Epirubicin, cisplatin, and continuous infusion 5-fluorouracil is an active and safe regimen for patients with advanced gastric cancer. An Italian Group for the Study of Digestive Tract Cancer (GISCAD) report.

BACKGROUND: A Phase II confirmatory multicenter trial was performed to evaluate a combination of epirubicin, cisplatin, and continuous infusion 5-fluorouracil (ECF) in treating patients with advanced gastric cancer. METHODS: Fifty-three patients with locally advanced (n = 7) or metastatic (n = 46) gastric cancer received a dose of epirubicin (50 mg/m2) and cisplatin (60 mg/m2) intravenously every 21 days for eight cycles with 5-fluorouracil (200 mg/m2/day) by intravenous continuous infusion for 21 consecutive weeks, administered through a central line using an external pump. RESULTS: Eight complete responses and 22 partial responses (response rate = 56%, 95% confidence interval +/- 13) were achieved. Twelve patients had stable disease. The median duration of response was 10 months (range, 3-21 months), and the median survival for all the patients was 9+ months (range, 2-28 months). Overall toxicity, which was primarily hematologic, was mild with only three patients requiring hospitalization for neutropenic fever. No death due to toxicity occurred. CONCLUSIONS: This study found that the ECF regimen is substantially active in treating patients with advanced gastric cancer and has a favorable pattern of toxicity. This schedule clearly deserves randomized comparative trials for palliation of metastatic disease and for adjuvant purposes.

Adult↗
PubMed1995

Prognostic factors in resectable gastric cancer: results of EORTC study no. 40813 on FAM adjuvant chemotherapy.

BACKGROUND: The high incidence of locoregional recurrences and distant metastases after curative surgery for gastric cancer calls for improved locoregional control and systemic adjuvant treatment. METHODS: In a randomized clinical trial on adjuvant FAM2 chemotherapy, quality of surgery was evaluated by comparing surgical and pathology data. Univariate and multivariate analysis was made to evaluate the effect of prognostic factors on survival and time of recurrence in relation to patients, tumor, and therapy. RESULTS: Of 314 patients randomized from 28 European institutions, 159 comprised the control and 155 the FAM2 group. After a median follow-up of 80 months, no statistically significant difference was found between survivals. However, for recurrence time, treated patients had a significant advantage over controls (p = 0.02). At univariate analysis, statistically significant differences in survival and time to progression emerged for T, N, disease stage and "adequacy" of surgery. The multivariate analysis retained preoperative Hb level, T, N, and "adequacy" of surgery for time of survival; and T, N, "adequacy" of surgery and adjuvant chemotherapy for recurrence time. CONCLUSIONS: Disease stage is the most important prognostic factor. "Adequate" surgery has an important effect. Adjuvant FAM2 delayed time of recurrence, but did not influence overall survival.

Adenocarcinoma↗
PubMed1995

Oral etoposide as second-line chemotherapy for colorectal cancer: a GISCAD study. Gruppo Italiano Studio Carcinomi Apparato Digerente.

Twenty-one patients with advanced colorectal cancer, all previously pretreated with a fluoropyrimidine-based regimen, received oral etoposide: 100 mg/die for 21 consecutive days, every three weeks. No objective response was achieved; 6 pts had a short-lasting stabilization of their disease. Toxicity was substantial and mainly represented by myelosuppression and alopecia. Protracted administration of etoposide is inactive as second-line treatment of colorectal cancer.

Administration, Oral↗
PubMed1995

Final results of a phase III clinical trial of adjuvant chemotherapy with the modified fluorouracil, doxorubicin, and mitomycin regimen in resectable gastric cancer.

PURPOSE: In a randomized clinical trial (European Organization for the Research and Treatment of Cancer [EORTC] no. 40813) on adjuvant chemotherapy in gastric cancer, results obtained after administration of the FAM2 regimen (fluorouracil [5-FU], doxorubicin, and mitomycin) were compared with results obtained after surgery alone to assess the effect of this regimen on overall survival, time to progression, and disease-free interval. PATIENTS AND METHODS: Three hundred fourteen patients who had undergone curative resection for stage II or stage III (International Union Against Cancer [UICC] 1978) gastric adenocarcinoma were randomized to receive chemotherapy (treatment arm) or no further treatment (control arm). The chemotherapy schedule was repeated every 43 days for seven cycles. The log-rank test and the Cox model were used for statistical analysis. RESULTS: Of 314 patients, 159 comprised the control group and 155 the FAM2 group. Nineteen FAM2 patients never received chemotherapy. The median number of cycles was five. Of the patients started on adjuvant treatment, severe hematologic and nonhematologic toxicity (grades 3 or 4, World Health Organization [WHO] scale) occurred, respectively, in 6% to 9% and in 1% to 29% of cases. The overall 5-year survival rate was 70% for stage II and 32% for stage III patients. No statistically significant difference was found between overall survival of the two treatment arms (P = .295). However, time to progression was significantly delayed in the FAM2 arm (P = .020) and disease-free survival showed borderline significance (P = .068). CONCLUSION: FAM2, in view of its high toxicity, cannot be advocated as standard adjuvant treatment for gastric cancer. Large-scale clinical trials using more active, less toxic regimens are required to demonstrate whether adjuvant chemotherapy provides any real benefit.

Adenocarcinoma↗