ABSTRACT
Patients with cancer can be immunocompromised because of their disease and/or due to anticancer therapy. In this population, severe influenza virus infections are associated with an elevated risk of morbidity and mortality. Influenza vaccination is therefore highly recommended in cancer patients, including those receiving anticancer therapy. However, vaccination coverage remains far below the recommended target for vulnerable subjects. Six specialists in oncology, hematology, immunology, and public health/vaccinology convened with the objective of developing strategies, based on evidence and clinical experience, for improving influenza vaccination coverage in cancer patients. This viewpoint provides an overview of current influenza vaccination recommendations in cancer patients, discusses barriers to vaccination coverage, and presents strategies for overcoming said barriers. New immunization issues raised by the COVID-19 pandemic are also addressed. Future directions include improving public education on influenza vaccination, providing the media with accurate information, improving knowledge among healthcare professionals, improving access to vaccines for cancer patients, co-administration of the influenza and COVID-19 vaccines, increased collaboration between oncologists and other health professionals, increased accessibility of digital vaccination registries to specialists, shared information platforms, and promoting immunization campaigns by healthcare systems with the support of scientific societies.
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BACKGROUND: The role of combination chemotherapy has not yet been established in unresectable locally advanced pancreatic cancer (LAPC) lacking dedicated randomized trials. METHODS: This phase II trial tested the efficacy of Nab-paclitaxel (NAB-P)/Gemcitabine (G) versus G alone. Patients were randomized, 1:1 to G 1000 mg/m2 on days 1, 8 and 15 every 28 days versus NAB-P 125 mg/m2 on days 1, 8 and 15 every 28 days plus G 1000 mg/m2 on days 1, 8 and 15 every 28 days. Disease progression rate after three cycles of chemotherapy was the primary end-point. Progression-free survival (PFS), overall survival (OS) and response rate were secondary end-points. FINDINGS: A total of124 patients were enrolled. The study showed a reduction of a progressive disease from 45.6% with G to 25.4% with NAB-P/G (P = 0.01) at 3 months. Noteworthy, at 6 months in the G arm, 35.6% of patients present a metastatic spread versus 20.8% in the NAB/G arm. The response rate was 5.3% in the G arm and 27% in the NAB/G arm. Median PFS was 4 months for the G arm and 7 months for the NAB-P/G arm. Median OS was 10.6 in the G arm and 12.7 months in the NAB-P/G arm. One patient died during treatment with G due to a stroke. INTERPRETATION: NAB-P/G reduced the rate of LAPC patients progressing after three cycles of chemotherapy compared with G, especially in terms of distant relapses. It positively affects PFS. To the best of our knowledge, this is the first randomized trial providing evidence that combination chemotherapy is superior to gemcitabine alone in this setting. CLINICALTRIALS. GOV IDENTIFIER: NCT02043730.
Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Pancreatic Neoplasms/drug therapy , Adenocarcinoma/pathology , Adult , Aged , Albumins/administration & dosage , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Female , Follow-Up Studies , Humans , Male , Middle Aged , Paclitaxel/administration & dosage , Pancreatic Neoplasms/pathology , Prognosis , Survival Rate , GemcitabineABSTRACT
BACKGROUND: Patients with advanced gastroesophageal junction cancer (GEJC) have poor survival outcomes, and GEJC-specific data from trials evaluating agents in gastric cancers (GCs) as a whole are lacking. Trifluridine/tipiracil (FTD/TPI) was approved for previously treated metastatic GC or GEJC (mGC/mGEJC) based on results of the phase 3 TAGS trial. Subgroup analyses by primary tumor type (GC or GEJC) in TAGS are reported here. METHODS: Pa tients with mGC/mGEJC treated with ≥ 2 prior chemotherapy regimens were randomized (2:1) to receive FTD/TPI or placebo, plus best supportive care. A pre-planned sub-analysis was performed to evaluate efficacy and safety outcomes by primary tumor type (GEJC or GC). RESULTS: Of 507 randomized patients, 145 (29%) had GEJC and 360 (71%) had GC as the primary disease site. Baseline characteristics were generally similar between the GEJC and GC subgroups, except that more patients in the GEJC subgroup had received ≥ 3 prior regimens (72 vs. 59% in the GC subgroup). Survival benefit with FTD/TPI was observed in both subgroups. The overall survival hazard ratio for FTD/TPI vs placebo was 0.75 (95% CI 0.50-1.11) and 0.67 (95% CI 0.52-0.87) in the GEJC and GC subgroups, respectively. Grade ≥ 3 adverse events of any cause were reported in 75 (77%) and 192 (81%) FTD/TPI-treated patients in the GEJC and GC subgroups, respectively. No new safety concerns were noted with FTD/TPI. CONCLUSION: As in patients with GC, FTD/TPI showed an efficacy benefit in patients with GEJC in the TAGS trial, along with demonstrating a manageable safety profile.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Esophagogastric Junction/pathology , Pyrrolidines/therapeutic use , Stomach Neoplasms/drug therapy , Thymine/therapeutic use , Trifluridine/therapeutic use , Adult , Aged , Aged, 80 and over , Drug Combinations , Female , Humans , Male , Middle Aged , Neoplasm Metastasis/drug therapy , Proportional Hazards Models , Stomach Neoplasms/pathology , Survival Rate , Treatment Outcome , Young AdultABSTRACT
About 75% of colorectal cancers are diagnosed as early stage, in which radical surgery is achievable. In the last decade, in Italy, the overall incidence of colorectal cancer has remained stable, while mortality gradually decreased, which is attributable to early diagnosis and improved medical, surgical and locoregional treatments. The Italian Medical Oncology Association formulated guidelines to manage early-stage colon cancer, including screening, diagnosis, treatment and follow-up, which we herein present.
Subject(s)
Colonic Neoplasms , Medical Oncology , Humans , Incidence , Italy , Neoplasm StagingABSTRACT
In cases of COVID-19 acute respiratory distress syndrome, an excessive host inflammatory response has been reported, with elevated serum interleukin-6 levels. In this multicenter retrospective cohort study we included adult patients with COVID-19, need of respiratory support, and elevated C-reactive protein who received intravenous tocilizumab in addition to standard of care. Control patients not receiving tocilizumab were matched for sex, age and respiratory support. We selected survival as the primary endpoint, along with need for invasive ventilation, thrombosis, hemorrhage, and infections as secondary endpoints at 30 days. We included 64 patients with COVID-19 in the tocilizumab group and 64 matched controls. At baseline the tocilizumab group had longer symptom duration (13 ± 5 vs. 9 ± 5 days) and received hydroxychloroquine more often than controls (100% vs. 81%). The mortality rate was similar between groups (27% with tocilizumab vs. 38%) and at multivariable analysis risk of death was not significantly influenced by tocilizumab (hazard ratio 0.61, 95% confidence interval 0.33-1.15), while being associated with the use at baseline of non invasive mechanical or invasive ventilation, and the presence of comorbidities. Among secondary outcomes, tocilizumab was associated with a lower probability of requiring invasive ventilation (hazard ratio 0.36, 95% confidence interval 0.16-0.83; P = 0.017) but not with the risk of thrombosis, bleeding, or infections. The use of intravenous tocilizumab was not associated with changes in 30-day mortality in patients with COVID-19 severe respiratory impairment. Among the secondary outcomes there was less use of invasive ventilation in the tocilizumab group.
Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Receptors, Interleukin-6/antagonists & inhibitors , Respiratory Distress Syndrome/drug therapy , Aged , Betacoronavirus/immunology , COVID-19 , Case-Control Studies , Coronavirus Infections/complications , Coronavirus Infections/immunology , Coronavirus Infections/mortality , Female , Hospital Mortality , Humans , Infusions, Intravenous , Interleukin-6/immunology , Interleukin-6/metabolism , Male , Middle Aged , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/immunology , Pneumonia, Viral/mortality , Receptors, Interleukin-6/metabolism , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/immunology , Respiratory Distress Syndrome/mortality , Retrospective Studies , SARS-CoV-2 , Severity of Illness Index , Survival Analysis , Treatment Outcome , COVID-19 Drug TreatmentABSTRACT
IMPORTANCE: Trifluridine/tipiracil (FTD/TPI) treatment has shown clinical benefit in patients with pretreated metastatic gastric cancer or gastroesophageal junction cancer (mGC/GEJC). Patients who have undergone gastrectomy constitute a significant proportion of patients with mGC/GEJC. OBJECTIVE: To assess the efficacy and safety of FTD/TPI among patients with previously treated mGC/GEJC who had or had not undergone gastrectomy. DESIGN, SETTING, AND PARTICIPANTS: This preplanned subgroup analysis of TAGS (TAS-102 Gastric Study), a phase 3, randomized, placebo-controlled, clinical trial included patients with mGC/GEJC who had received at least 2 previous chemotherapy regimens, and was conducted at 110 academic hospitals in 17 countries in Europe, Asia, and North America, with enrollment between February 24, 2016, and January 5, 2018; the data cutoff was March 31, 2018. INTERVENTIONS: Patients were randomized 2:1 to receive oral FTD/TPI 35 mg/m2 twice daily or placebo twice daily with best supportive care on days 1 through 5 and days 8 through 12 of each 28-day treatment cycle. MAIN OUTCOMES AND MEASURES: The primary end point was overall survival. This subgroup analysis was conducted to examine potential trends and was not powered for statistical significance. Efficacy and safety end points were evaluated in the subgroups. RESULTS: Of 507 randomized patients (369 [72.8%] male; mean [SD] age, 62.5 [10.5] years), 221 (43.6%) had undergone gastrectomy (147 randomized to FTD/TPI and 74 to placebo) and 286 (56.4%) had not undergone gastrectomy (190 randomized to FTD/TPI and 96 to placebo). In the gastrectomy subgroup, the overall survival hazard ratio (HR) in the FTD/TPI group vs placebo group was 0.57 (95% CI, 0.41-0.79), and the progression-free survival HR was 0.48 (95% CI, 0.35-0.65). In the no gastrectomy subgroup, the overall survival HR in the FTD/TPI group vs placebo group was 0.80 (95% CI, 0.60-1.06), and the progression-free survival HR was 0.65 (95% CI, 0.49-0.85). Among FTD/TPI-treated patients, grade 3 or higher adverse events of any cause occurred in 122 of 145 patients (84.1%) in the gastrectomy subgroup and 145 of 190 (76.3%) in the no gastrectomy subgroup: 64 (44.1%) in the gastrectomy subgroup and 50 (26.3%) in the no gastrectomy subgroup had grade 3 or higher neutropenia, 31 (21.4%) in the gastrectomy subgroup and 33 (17.4%) in the no gastrectomy subgroup had grade 3 or higher anemia, and 21 (14.5%) in the gastrectomy subgroup and 10 (5.3%) in the no gastrectomy subgroup hD grade 3 or higher leukopenia. In the gastrectomy subgroup, 94 (64.8%) had dosing modifications because of adverse events vs 101 (53.2%) in the no gastrectomy subgroup; 15 (10.3%) in the gastrectomy group and 28 (14.7%) in the no gastrectomy group discontinued treatment because of adverse events. Treatment exposure was similar between groups. CONCLUSIONS AND RELEVANCE: The FTD/TPI treatment was tolerable and provided efficacy benefits among patients with pretreated mGC/GEJC regardless of previous gastrectomy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02500043.
Subject(s)
Colorectal Neoplasms , Stomach Neoplasms , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Colorectal Neoplasms/pathology , Drug Combinations , Gastrectomy/adverse effects , Humans , Male , Middle Aged , Pyrrolidines/adverse effects , Stomach Neoplasms/drug therapy , Stomach Neoplasms/surgery , Thymine , Trifluridine/adverse effectsABSTRACT
BACKGROUND: Trifluridine/tipiracil showed activity and was well tolerated in a phase 2 study of pretreated patients with advanced gastric cancer done in Japan. We investigated whether the treatment was efficacious compared with placebo in a global population. METHODS: TAGS was a randomised, double-blind, placebo-controlled, phase 3 trial done in 110 academic hospitals in 17 countries. Patients aged 18 years or older with histologically confirmed, non-resectable, metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) as defined by the American Joint Committee on Cancer staging classification (7th edition) who had received at least two previous chemotherapy regimens and had experienced radiological disease progression were eligible for inclusion. Patients were randomly assigned (2:1) via dynamic randomisation from a centralised interactive voice-response system to receive either oral trifluridine/tipiracil (35 mg/m2 twice daily on days 1-5 and days 8-12 every 28 days) plus best supportive care or placebo plus best supportive care. Participants were allocated to groups by study-site personnel. Randomisation was stratified by region (Japan vs rest of world), ECOG performance status (0 vs 1), and previous treatment with ramucirumab (yes vs no). Both patients and investigators were masked to treatment allocation. The primary endpoint was overall survival. Efficacy was assessed in the intention-to-treat population and safety in all patients who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov, number NCT02500043. The trial, including follow-up of all participants, has been completed. FINDINGS: Between Feb 24, 2016, and Jan 5, 2018, 507 patients were enrolled and randomly assigned, 337 to the trifluridine/tipiracil group and 170 to the placebo group. Median overall survival was 5·7 months (95% CI 4·8-6·2) in the trifluridine/tipiracil group and 3·6 months (3·1-4·1) in the placebo group (hazard ratio 0·69 [95% CI 0·56-0·85]; one-sided p=0·00029, two-sided p=0·00058). Grade 3 or worse adverse events of any cause occurred in 267 (80%) patients in the trifluridine/tipiracil group and 97 (58%) in the placebo group. The most frequent grade 3 or worse adverse events of any cause were neutropenia (n=114 [34%]) and anaemia (n=64 [19%]) in the trifluridine/tipiracil group and abdominal pain (n=15 [9%]) and general deterioration of physical health (n=15 [9%]) in the placebo group. Serious adverse events of any cause were reported in 143 (43%) patients in the trifluridine/tipiracil group and 70 (42%) in the placebo group. One treatment-related death was reported in each group (because of cardiopulmonary arrest in the trifluridine/tipiracil group and because of toxic hepatitis in the placebo group). INTERPRETATION: Trifluridine/tipiracil significantly improved overall survival compared with placebo and was well tolerated in this heavily pretreated population of patients with advanced gastric cancer. Trifluridine/tipiracil could be a new treatment option in this population who represent a high unmet medical need. FUNDING: Taiho Oncology and Taiho Pharmaceutical.
Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Agents/therapeutic use , Stomach Neoplasms/drug therapy , Trifluridine/therapeutic use , Adenocarcinoma/mortality , Adenocarcinoma/secondary , Aged , Antineoplastic Agents/adverse effects , Disease Progression , Double-Blind Method , Drug Combinations , Europe , Female , Humans , Israel , Japan , Male , Middle Aged , Neoplasm Staging , Progression-Free Survival , Pyrrolidines , Stomach Neoplasms/mortality , Stomach Neoplasms/pathology , Thymine , Time Factors , Trifluridine/adverse effects , United States , Uracil/analogs & derivativesABSTRACT
In the past 15 years, the outcome for patients with metastatic colorectal cancer has substantially improved owing to the availability of new cytotoxic and biological agents along with many significant advances in molecular selection, the use of personalised therapy and locoregional treatment, a more widespread sharing of specific professional experiences (multidisciplinary teams with oncologists, surgeons, radiotherapists, radiologists, biologists and pathologists), and the adoption of patient-centred healthcare strategies. The Italian Medical Oncology Association (AIOM) has developed evidence-based recommendations to help oncologists and all professionals involved in the management of patients with metastatic colorectal cancer in their daily clinical practice.
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PURPOSE: Lung cancer is one of the leading causes of cancer-related death worldwide and, although targeted therapy with tyrosine kinase inhibitors has dramatically improved the rates of response and survival in advanced EGFR-mutated adenocarcinoma, the overall outcome remains unsatisfactory. Therefore, new prognostic factors, preferably simple, inexpensive, and easy to reproduce on a large scale, are needed. We performed a retrospective analysis of our database including 63 western Caucasian patients with advanced EGFR-mutated lung adenocarcinoma and receiving gefitinib, erlotinib, or afatinib as first- or second-line therapy. Several studies demonstrated a strong link between elevated neutrophil-to-lymphocyte ratio (NLR) and poor prognosis both in early and advanced stages of non-small-cell lung cancer (NSCLC). METHODS: From January 2011 to December 2015, 63 consecutive elegible patients with advanced EGFR-mutated NSCLC were included in this analysis from 5 institutions. The NLR was derived from the absolute neutrophil and the absolute lymphocyte counts of a full blood count and the cutoff value was determined according to the mean NLR level. RESULTS: Despite the small sample analyzed, we found that NLR has a prognostic role for progression-free survival (PFS) and overall survival (OS), reaching a statistically significant difference with a better PFS and OS in the lower NLR group. CONCLUSIONS: Pretreatment NLR seems to represent a reliable, simple, and easy to reproduce laboratory tool to predict outcome and response to cancer therapies in this setting of Western Caucasian patients with EGFR-mutated NSCLC.
Subject(s)
Carcinoma, Non-Small-Cell Lung/drug therapy , ErbB Receptors/genetics , Lymphocytes , Neutrophils , Afatinib , Aged , Carcinoma, Non-Small-Cell Lung/blood , Carcinoma, Non-Small-Cell Lung/pathology , Disease-Free Survival , ErbB Receptors/antagonists & inhibitors , Erlotinib Hydrochloride/administration & dosage , Female , Gefitinib , Humans , Lymphocyte Count , Male , Middle Aged , Molecular Targeted Therapy , Mutation , Neoplasm Staging , Prognosis , Protein Kinase Inhibitors/administration & dosage , Quinazolines/administration & dosageABSTRACT
Colon cancer is one of the leading tumours in the world and it is considered among the big killers, together with lung, prostate and breast cancer. In the recent years very important advances occurred in the field of treatment of this frequent disease: adjuvant chemotherapy was demonstrated to be effective, chiefly in stage III patients, and surgery was optimized in order to achieve the best results with a low morbidity. Several new target-oriented drugs are under evaluation and some of them (cetuximab and bevacizumab) have already exhibited a good activity/efficacy, mainly in combination with chemotherapy. The development of updated recommendations for the best management of these patients is crucial in order to obtain the best results, not only in clinical research but also in every-day practice. This report summarizes the most important achievements in this field and provides the readers useful suggestions for their professional practice.
Subject(s)
Carcinoma , Colonic Neoplasms , Animals , Antineoplastic Combined Chemotherapy Protocols , Carcinoma/diagnosis , Carcinoma/epidemiology , Carcinoma/etiology , Carcinoma/therapy , Colonic Neoplasms/diagnosis , Colonic Neoplasms/epidemiology , Colonic Neoplasms/etiology , Colonic Neoplasms/therapy , Humans , Incidence , Neoplasm Staging/methods , Palliative Care , Prognosis , Survival AnalysisABSTRACT
Gastric cancer is one of the most common cancers and one of the most frequent causes of cancer-related deaths. The incidence, diagnostic studies, and therapeutic options have undergone important changes in the last decades, but the prognosis for gastric cancer patients remains poor, especially in more advanced stages. Surgery is the mainstay of treatment of this disease. At least D1 resection combined to removal of a minimum of 15 lymph nodes should be recommended. In recent years, important advances have been achieved in the adjuvant setting, where survival benefits were demonstrated by perioperative chemotherapy and postoperative chemoradiotherapy. In advanced disease, patient prognosis remains very poor with median survival times rarely approaching 1 year. In this setting, palliation of symptoms, rather than cure, is the primary goal of patient management. No standard regimens have yet been established worldwide. Recent clinical trials have demonstrated major improvements, which include the development of orally administered fluoropyrimidines (capecitabine, S-1), and the addition of new drugs such as docetaxel, irinotecan, oxaliplatin. This review summarizes the most important recommendations for the management of patients with gastric cancer.
Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Stomach Neoplasms/drug therapy , Humans , Neoplasm Staging , Palliative Care , Stomach Neoplasms/pathology , Survival AnalysisABSTRACT
Rectal cancer is an important tumour from an epidemiological point of view and represents the benchmark for an optimal use of integrated treatments (surgery, radiotherapy and chemotherapy) in the oncological practice. The conventional use of total mesorectal excision and the integration with radiochemotherapy, better if preoperatively, are now able to increase survival, to decrease the occurrence of pelvic recurrence and to ameliorate the quality of life of patients. Updated recommendations for the management of these patients are here reported.
Subject(s)
Antineoplastic Agents/therapeutic use , Rectal Neoplasms/diagnosis , Rectal Neoplasms/therapy , Chemotherapy, Adjuvant , Combined Modality Therapy , Humans , Incidence , Neoplasm Recurrence, Local , Neoplasm Staging , Prognosis , Radiotherapy, Adjuvant , Rectal Neoplasms/pathology , Risk Factors , Treatment OutcomeABSTRACT
Cholangiocarcinoma is an uncommon adenocarcinoma with poor prognosis. Although the 1-year survival has increased over time, the 5-year survival has not shown any significant change (less than 5%). Cure can only be expected from surgical resection of early stage tumours but most patients initially present with advanced disease. Cancer cachexia, liver failure, and recurrent sepsis due to biliary obstruction are among the main causes of mortality. Patients' prognosis is strongly related to radical surgery and complete resection is the most effective therapy; the location within the biliary tree (proximal versus distal) has no impact on survival when a complete resection is achieved despite the fact the rate of resectability is up to 70% in case of distal cancer and 15-20% for high bile ducts tumours. Prognosis of cholangiocarcinoma remains poor even with aggressive surgical therapy because of the high incidence of local or regional recurrence and distant metastasis. Based on these data many questions need an answer: is there a role for adjuvant chemotherapy or radiotherapy? Neoadjuvant treatments provide best results? There is a standard therapy in unresectable or metastatic cholangiocarcinoma? This report tries to answer to frequently asked questions that the readers are faced with their patients every day (from diagnostic procedures to palliative treatment) and tries to suggest useful information for their professional practice.
Subject(s)
Bile Duct Neoplasms/diagnosis , Bile Duct Neoplasms/therapy , Cholangiocarcinoma/diagnosis , Cholangiocarcinoma/therapy , Bile Duct Neoplasms/epidemiology , Bile Duct Neoplasms/pathology , Bile Ducts, Intrahepatic/pathology , Cholangiocarcinoma/epidemiology , Cholangiocarcinoma/pathology , Humans , Liver Transplantation , Neoplasm Staging , Risk FactorsABSTRACT
BACKGROUND: Promising findings obtained using a weekly regimen of 5-fluorouracil (5-FU), epidoxorubicin, leucovorin (LV), and cisplatin (PELFw) to treat locally advanced and metastatic gastric cancer prompted the Italian Group for the Study of Digestive Tract Cancer (GISCAD) to investigate the efficacy of this regimen as adjuvant treatment for high-risk radically resected gastric cancer patients. METHODS: From January 1998 to January 2003, 400 gastric cancer patients at high risk for recurrence including patients with serosal invasion (stage pT3 N0) and/or lymph node metastasis (stage pT2 or pT3 N1, N2, or N3), were enrolled in a trial of adjuvant chemotherapies; 201 patients were randomly assigned to receive the PELFw regimen, consisting of eight weekly administrations of cisplatin (40 mg/m2), LV (250 mg/m2), epidoxorubicin (35 mg/m2), 5-FU (500 mg/m2), and glutathione (1.5 g/m2) with the support of filgrastim, and 196 patients were assigned to a regimen consisting of six monthly administrations of a 5-day course of 5-FU (375 mg/m2 daily) and LV (20 mg/m2 daily, 5-FU/LV). Disease-free and overall survival were estimated and compared between arms using hazard ratios (HRs) and Kaplan-Meier estimates. All statistical tests were two-sided. RESULTS: The 5-year survival rates were 52% in the PELFw arm and 50% in the 5-FU/LV arm. Compared with the 5-FU/LV regimen, the PELFw regimen did not reduce the risk of death (HR = 0.95, 95% confidence interval [CI] = 0.70 to 1.29) or relapse (HR = 0.98, 95% CI = 0.75 to 1.29). Less than 10% of patients in either arm experienced a grade 3 or 4 toxic episode. Neutropenia (occurring more often in the PELFw arm) and diarrhea and mucositis (more prevalent in the 5-FU/LV arm) were the most common serious side effects. Nevertheless, only 19 patients (9.4%) completed the treatment in the PELFw arm and 85 (43%) patients completed the treatment in the 5-FU/LV arm. CONCLUSIONS: Our study found no benefit from an intensive weekly chemotherapy in gastric cancer. The extent of toxicity experienced by the patients in the adjuvant setting suggests that, in gastric cancer, chemotherapy may be more safely administered preoperatively.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Adjuvant , Stomach Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Cisplatin/administration & dosage , Disease-Free Survival , Drug Administration Schedule , Epirubicin/administration & dosage , Female , Fluorouracil/administration & dosage , Humans , Leucovorin/administration & dosage , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Invasiveness , Stomach Neoplasms/mortality , Stomach Neoplasms/pathology , Stomach Neoplasms/surgery , Survival AnalysisABSTRACT
Gastric cancer is one of the most common cancers and one of the most frequent causes of cancer-related deaths. The incidence, diagnostic studies, and therapeutic options have undergone important changes in the last decades, but the prognosis for gastric cancer patients remains poor, especially in more advanced stages. Surgery is the mainstay of treatment of this disease, even if it is associated with a high rate of locoregional and distant recurrence. There is ongoing debate regarding the role of adjuvant treatment In advanced disease, palliation of symptoms, rather than cure, is the primary goal of patient management. Several combination therapies have been developed and have been examined in phase III trials; however, in most cases, they have failed to demonstrate a survival advantage over the reference arm. This review summarizes the most important recommendations for the management of patients with gastric cancer.
Subject(s)
Stomach Neoplasms/pathology , Stomach Neoplasms/therapy , Combined Modality Therapy , Disease Management , Humans , Neoplasm Metastasis/drug therapy , Stomach Neoplasms/etiology , Stomach Neoplasms/mortality , Treatment OutcomeABSTRACT
Colorectal cancer is one of the most frequent causes of cancer deaths. Survival for locoregional colorectal cancer is about 70% overall and 30-60% in stage III patients. Several randomized trials have shown that adjuvant chemotherapy can increase this survival rate. 5-Fluorouracil-based chemotherapy is strongly recommended in this context. There are still some questions about the setting in which patients should be treated as well as the optimal treatment. New data for different schedules and combinations are now available. Physicians have to choose between the different options now available to offer the best treatment to their patients. This Review analyses the current options for adjuvant therapy in colon and rectal cancer.
Subject(s)
Colorectal Neoplasms/therapy , Clinical Trials as Topic , Combined Modality Therapy , Humans , ImmunotherapyABSTRACT
5-Fluorouracil (5-FU) administered in several schedules since its introduction in 1957 continues to be an integral part of standard first-line therapy for colorectal cancer. Continuous intravenous (i.v.) infusion appears to yield improved response rate and overall survival, with fewer adverse effects compared with i.v. bolus dosing. However, these protracted infusions require portable infusion pumps and central venous lines, which are associated with complications (i.e. increased risk of infection and clotting and/or dislodgement of the catheter, increased risk of venous thrombosis). Colorectal carcinoma is the second cause of death for tumour after lung cancer. About 70% of cases occur over 65 years and 50% or more affects people over 70. In clinical research age was a common exclusion criteria and little information is available about the efficacy, safety and toxicity of chemotherapy in elderly patients because few studies focused on the treatment of cancer in that part of population. The goal of this article is to review the literature concerning the treatment of elderly patients with UFT, an orally administered dihydropyrimidine dehydrogenase (DPD) inhibitory fluoropyrimidine.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/drug therapy , Tegafur/therapeutic use , Uracil/therapeutic use , Administration, Oral , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Colorectal Neoplasms/mortality , Humans , Tegafur/administration & dosage , Treatment Outcome , Uracil/administration & dosageABSTRACT
BACKGROUND: The objective of the current study was to determine the influence of media information on the opinions and feelings of patients with cancer and to measure the factors that affected the decision-making process and physician-patient communication. METHODS: The study consisted of a sequence of 2 nationwide surveys across the same dynamic target population of 2600 unselected patients with cancer who attended 1 of 13 centers throughout Italy. The authors measured the changes in patients' opinions and attitudes at the peak of a media campaign promoting the Di Bella therapy, an unproven cancer treatment method, and after the publicized demonstration of its ineffectiveness. An identical 10-item questionnaire was used. RESULTS: Opinions and feelings changed in the two surveys according to the way the media described the efficacy of the treatment, but physician-patient communication and the decision-making process remained unchanged. Multivariate analysis confirmed the enormous influence of the media on patient opinions (odds ratio [OR], 4.67; P < 0.0001), feelings of hope (OR, 3.63; P < 0.0001), and confusion (OR, 0.51; P < 0.0001), but not on physician-patient communication or the decision-making process. Educational level influenced almost all of the studied factors, and communication and decision-making also were influenced by the patients' gender and place of residence. There was no significant correlation with patient age. CONCLUSIONS: The media play a powerful role in affecting patients' opinions and feelings; the physician-patient communication and the decision-making process are not subject to media influence but are related primarily to level of education. The power of the media should be directed toward improving the spread of scientific knowledge to encourage behavioral changes, particularly among individuals with lower levels of education.
Subject(s)
Mass Media , Neoplasms/therapy , Patient Participation , Physician-Patient Relations , Treatment Outcome , Cross-Sectional Studies , Decision Making , Female , Health Care Surveys , Health Knowledge, Attitudes, Practice , Humans , Italy , Male , Medical Informatics , Multivariate Analysis , Neoplasms/prevention & control , Neoplasms/psychology , Odds Ratio , Patient Satisfaction , Probability , Surveys and QuestionnairesABSTRACT
GOALS: The aim of this prospective study was to assess the quality of pain management hospitalized cancer patients. PATIENTS AND METHODS: In a quantitative and qualitative evaluation from six oncology centers in Italy, all consecutive cancer patients complaining of pain and hospitalized during the same 2 weeks were requested to fill in a McGill pain questionnaire (MPQ), a present pain intensity scale (PPI), and a hospital anxiety and depression acale (HADS), and to answer a questionnaire focused (QF) on the quality of medical and nursing care. The healthcare provider's antalgic prescriptions were assessed by an index of pain management (IPM). MAIN RESULTS: Of 120 patients with pain admitted to oncology divisions (65 men and 52 women; mean age 57 years, range 21-79 years), 117 completed the questionnaires. The quantitative evaluation (PPI) showed a significant pain reduction between admission and discharge pain levels-from 2.65 to 1.50 ( p<0.001). While a significant reduction of anxiety (HADS) was also found-from 10.24 to 9.11 ( p<0.001)-depression did not improve (9.83 and 9.72). The most relevant information from qualitative evaluation (QF) was: in 37.6% of patients, pain level was higher overnight; 47% waited for spontaneous decrease of pain intensity before asking for nurse or physician intervention; 69% asked for nurse help when pain level was really high. The health care response to patients' pain was not completely satisfactory, since analgesic prescription was adequate in 56.52% but inadequate in 43.47%. CONCLUSIONS: Pain control in hospitalized cancer patients is not completely satisfactory. The physician's attitude is to underestimate and undertreat pain, while nurses are not adequately trained for timely intervention despite published guidelines for pain management. The findings of this study support the concern of inadequate knowledge and inappropriate attitudes regarding pain management, even in cancer patients hospitalized in medical oncology divisions.
Subject(s)
Inpatients , Neoplasms/complications , Pain Management , Pain/nursing , Adult , Aged , Female , Humans , Italy , Male , Middle Aged , Pain/etiology , Pain Measurement , Prospective Studies , Surveys and QuestionnairesABSTRACT
Tumors of the small intestine are rare and usually occur in association with genetic disease and chronic intestinal inflammation. We report three cases of small bowel adenocarcinoma in patients affected by celiac disease who received a safe chemotherapy regimen (FOLFOX IV or LV5FU2) after tumor resection.