[Show abstract][Hide abstract] ABSTRACT: Background:
The management of pT1a-b pN0 HER2-positive breast cancer is controversial and no data about the efficacy of trastuzumab in this setting are available from randomized clinical trials. The aims of this retrospective study were to assess how patients are managed in clinical practice in Italy, which clinical or biological characteristics influenced the choice of adjuvant systemic therapy and the outcome of patients.
Data of consecutive patients who underwent surgery from January 2007 to December 2012 for HER2-positive, pT1a-b pN0 M0 breast cancer were retrospectively collected from 28 Italian centres. Analysis of contingency tables and multivariate generalized logit models were used to investigate the association between the baseline clinical and biological features and the treatment strategy adopted.
Among 303 enrolled patients, 204 received adjuvant systemic therapy with trastuzumab, 65 adjuvant systemic therapy without trastuzumab and 34 did not receive adjuvant systemic therapy. At the multivariate analysis age, tumor size, proliferation index and hormone receptor status were significantly associated with the treatment choice. Five-year disease-free survival (DFS) probability was 95%, 94.3% and 69.6% for patients treated with adjuvant systemic therapy and trastuzumab, with adjuvant systemic therapy without trastuzumab and for patients who did not receive adjuvant systemic therapy, respectively (p<0.001).
The majority of patients (66%) with pT1a-b pN0 HER2-positive breast cancer enrolled in this retrospective study received adjuvant systemic therapy with trastuzumab, whereas only 11% patients did not receive any adjuvant systemic therapy. The choice of treatment type seems to be mainly influenced by tumor size, proliferation index, hormone receptor status and age. The 5-year DFS probability was significantly higher for patients receiving adjuvant systemic therapy with trastuzumab compared with patients not receiving adjuvant systemic therapy or receiving adjuvant systemic therapy without trastuzumab.
PLoS ONE 09/2015; 10(9):e0136731. DOI:10.1371/journal.pone.0136731 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Adjuvant cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) have proven highly effective in rapidly proliferating breast cancer (RPBC). It has also been seen that sequential administration of doxorubicin and CMF is superior to their alternation, especially in indolent tumors. In a phase III study, we evaluated whether adjuvant epirubicin (E) followed by CMF is superior to the inverse sequence in RPBC. Patients with node-negative or 1-3 node-positive RPBC (Thymidine Labeling Index > 3% or histological grade 3 or S-phase > 10% or Ki67 > 20%) were randomized to receive E (100 mg/m(2) i.v. d1, q21 days for 4 cycles) followed by CMF (600, 40, 600 mg/m(2) i.v. d1 and 8, q28 days for 4 cycles) (E → CMF) or CMF followed by E (CMF → E) or CMF for 6 cycles. From November 1997 to December 2004, 1066 patients were enrolled: E → CMF 440, CMF → E 438, and CMF 188. At a median follow-up of 69 months, 5-year OS was 91% (95% CI 88-94) for E → CMF and 93% (95% CI 90-95) for CMF → E, with adjusted hazard ratio of 0.88 (95% CI 0.58-1.35), and DFS was 80% in both arms, with adjusted hazard ratio of 0.99 (95% CI 0.73-1.33, Cox model). Adverse events were similar, apart from a higher rate of neutropenia in the CMF → E arm. No important differences in clinical outcome were observed between the two different sequences, making both a valid option in early breast cancer. Further molecular characterization of the tumors might help to identify subgroups achieving higher benefit from either sequence.
Breast Cancer Research and Treatment 02/2011; 125(3):775-84. DOI:10.1007/s10549-010-1257-5 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this work was to carry out a cost evaluation of the home care programme for terminally ill cancer patients run by the Istituto Oncologico Romagnolo (I.O.R.) in the areas of Forlì, Cesena, Ravenna and Rimini (Romagna, Italy). To determine effective home care direct costs, we first selected 1 week of care as an observation unit. We then proceeded to assess the medical and nursing care units together with the clinical protocols administered for each patient. The Karnofsky Performance Status (KPS) was also assessed weekly. In this way, we calculated care costs for each patient and for each week as the sum of medical costs, nursing costs, treatment costs and other costs. A consecutive series of 574 patients were involved in the study from 1 April 1994 to 31 March 1995. A total of 5164 patient-weeks of care was provided, with an average cost per week of 177.6 Ecu. This weekly cost increased in the last 100 days of life (week -15 = 179.5 Ecu; week -8 = 188.3 Ecu; week -2 = 221.0 Ecu; P < 0.001). When single components were analysed in relation to total cost (treatment protocols, physician and nursing care) the increased global cost was found to be mainly attributable to the intensification in nursing care (21.8% of costs in week -15 vs 27.3% of costs in week -2). Examination of the relation between the cost of 1 week of care and KPS values clearly shows that healthcare costs increased as KPS decreased (from 152.2 Ecu with KPS > or = 60 to 292.6 Ecu with KPS < or = 20; P < 0.001). Home care costs were also seen to vary with some clinical characteristics and symptoms present when patients entered the study: asthenia, anorexia, nausea/vomiting, bedsores. Given the good results of home care for cancer patients in terms of quality of life, this method of cost accounting for home-care providers can help to monitor the rising cost of assistance and confirm the cost effectiveness of this type of care.
Supportive Care Cancer 09/1997; 5(5):396-401. DOI:10.1007/s005200050098 · 2.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Many biologic prognostic markers are available for patients with breast cancer, and considerable interest has been devoted to confirm preliminary evidence of their role as indicators of treatment response. It remains to be assessed whether such markers are predictors of response only to first-line or also to successive therapies. Proliferative activity, defined by the 3H-thymidine labeling index (TLI), was determined on the primary lesion from 76 patients at time of first diagnosis. At relapse, patients underwent chemotherapy as absolute (48 cases) or relative (28 cases) first-line treatment, and their clinical response was analyzed in relation to the TLI of the primary lesion. The objective clinical response was significantly higher for rapidly (47%; CL, 33-61%) than for slowly proliferating tumors (15%; CL, 1-29%). These findings held true also when adjusted for metastatic site, previous treatment, chemotherapy regimen administered, and hormone receptor status. However, the direct relation between cell proliferation and benefit from chemotherapy held true only when such a treatment was used as an absolute first-line approach. Cell proliferation of primary lesions represents a consistent indicator of response to chemotherapy over time. Previously administered regimens, at least hormone therapy, could alter the proliferation-related chemosensitivity profile of individual tumors.
Breast Cancer Research and Treatment 04/1997; 43(1):7-14. DOI:10.1023/A:1005780107879 · 3.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The Authors report their experiences on the treatment of 13 consecutive cases of gastro-intestinal carcinoid tumors observed over the last 11 years. The primary sites were as follows: intestine (5 cases), appendix (3 cases), colon (1 case) and peritoneum (4 cases); only 3 patients presented systemic signs. Ten patients in advanced phase were treated with a chemotherapeutic regimen containing 5-fluorouracil (5-Fu) and streptozotocin (STZ). One case was excluded from the study because of a concomitant gastric carcinoma. Of the 9 evaluable patients, two achieved partial remission (22%) with a duration of 18+ and 66 months respectively; 4 (44.5%) had stable disease for periods ranging from 7 to 40 months and 3 cases progressed. Severe toxicity (thrombocytopenia and diarrhea) occurred in 2 cases and disappeared with the suspension of therapy. The systemic signs disappeared with treatment and did not appear in 2 cases out of 3. The prospective of the employment of new drugs such as alpha-interferon and, above all, somatostatin provides hope that this uncommon disease may have an improved response rate to treatment in the future.
[Show abstract][Hide abstract] ABSTRACT: By analyzing c-myc specific fragments from white blood cell DNAs of 98 gastric cancer patients and 46 control subjects, we observed 6 unexpected patterns due to presence of a variant c-myc gene in addition to the normal gene. Restriction enzyme mapping indicated that the variant c-myc gene was the result of a 5' deletion including the first exon and part of the first intron. The deleted region, non-coding for the functional c-myc protein, contains sequences involved in the regulation of transcription. We therefore analyzed the c-myc mRNAs from a subject carrying the truncated gene and from a subject homozygous for the normal gene in Northern blotting experiments: the mRNAs were indistinguishable, both qualitatively and quantitatively. Family analysis demonstrated that the truncated gene is inherited in a Mendelian fashion. Population studies showed that the allele, both in patients and in control subjects, reaches a polymorphic frequency (2.1% for the whole sample) and that it is not associated with a risk of cancer.
Human Genetics 10/1991; 87(5):579-82. DOI:10.1007/BF00209016 · 4.82 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Les auteurs rapportent les résultats de 8 606 gastroscopies réalisées dans une région à haut risque de cancer gastrique.
Ils analysent les données relatives aux lésions bénignes et malignes. Par comparaison avec d’autres études de la littérature,
la gastrite chronique atrophique (GAC) et les polypes (surtout observés chez la femme), ainsi que les ulcères gastriques bénins,
ont été observés avec une fréquence particulièrement élevée.
Comme on peut s’y attendre le nombre de tumeurs gastriques est également élevé: 890 (10,3 %). Le nombre de cancers gastriques
superficiels (CS) (60 cas) est élevé en valeur absolue, mais rapporté à sa fréquence, il rejoint les taux observés dans les
programmes de dépistage (6,7 %).
Les auteurs suggèrent qu’en vue d’un accroissement du diagnostic de lésions au stade précoce, les facteurs de risque devraient
être déterminés afin d’identifier des sous-groupes de population soumis à des investigations programmées.
L’analyse des résultats de la présente étude montre l’importance du sexe, de l’áge, des pathologies considérées comme prénéoplasiques
(polypes, gastrite chronique atrophique et ulcère gastrique) et confirment la faible spécificité de la Symptomatologie.
The authors report the data concerning 8 606 gastroscopic examinations in a high-risk area for gastric cancer.
They analyze the data collected on the benign findings as well as the neoplastic pathologies. In comparison with other case
studies in the literature, Chronic Atrophic Gastritis (CAG) and polyps (above all in females), and benign gastric ulcers were
found to occur with particular frequency.
As was supposed, the number of gastric tumors also turned out to be high: 890 (10.3 %). The number of early gastric cancers
(EGC) (60 cases), high in absolute terms, is in line with the values reported in other case studies not deriving from screening
The authors suggest that in order to increase the percentage of early diagnoses, the risk factors must be determined in order
to identify those subgroups of the population to be submitted to aimed investigations.
From the analysis of the data in the present study, the importance of sex, age, and pathologies considered preneoplastic (polyps,
Chronic Atrophic Gastritis, and gastric ulcer) emerged, while the scarce specificity of the symptomatology was confirmed.
Los autores comentan los resultados de 8.606 gastroscopias practicadas en una región de riesgo elevado para el cancer gástrico.
Analizan los datos relativos a las lesiones benignas y a las malignas. En comparación con otros estudios de la literatura,
la gastritis crónica trófica (GAC) y los pólipos (en especial en mujeres), asi como las úlcéras gàstricas benignas, aparecieron
con una frecuencia particularmente elevada.
Como es de esperar el núméro de tumores gástricos es asimismo elevado: 890 (10.3 %). El núméro de carcinomas superficiales
(CS) (60 casos) es elevado en valor absoluto, pero alcanza los niveles observados en programas de detección precoz (6.7 %)
si nos referimos a su frecuencia.
Los autores sugieren la determinación previa de factores de riesgo, con el fin de identificar subgrupos de riesgo elevado,
los cuales, al ser sometidos a investigaciones programadas permitiran un incremento del numéro de lesiones diagnosticadas
en estadio precoz. El análisis de los resultados de éste estudio muestra la importancia del sexo, edad y patologias consideradas
como preneoplásicas (pólipos, gastritis crónica atrófica, y úlcera gástrica), y confirman la pobre especificidad de la sintomatología.