Roldano Fossati

Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group

PURPOSE Several recent trials have shown a significant overall survival (OS) benefit from postoperative cisplatin-based chemotherapy in patients with non-small-cell lung cancer (NSCLC). The aim of the Lung Adjuvant Cisplatin Evaluation was to identify treatment options associated with a higher benefit or groups of patients who particularly benefit from postoperative chemotherapy. PATIENTS AND METHODS Individual patient data were collected and pooled from the five largest trials (4,584 patients) of cisplatin-based chemotherapy in completely resected patients that were conducted after the 1995 NSCLC meta-analysis. The interactions between patient subgroups or treatment types and chemotherapy effect on OS were analyzed using hazard ratios (HRs) and log-rank tests stratified by trial. RESULTS With a median follow-up time of 5.2 years, the overall HR of death was 0.89 (95% CI, 0.82 to 0.96; P = .005), corresponding to a 5-year absolute benefit of 5.4% from chemotherapy. There was no heterogeneity of chemotherapy effect among trials. The benefit varied with stage (test for trend, P = .04; HR for stage IA = 1.40; 95% CI, 0.95 to 2.06; HR for stage IB = 0.93; 95% CI, 0.78 to 1.10; HR for stage II = 0.83; 95% CI, 0.73 to 0.95; and HR for stage III = 0.83; 95% CI, 0.72 to 0.94). The effect of chemotherapy did not vary significantly (test for interaction, P = .11) with the associated drugs, including vinorelbine (HR = 0.80; 95% CI, 0.70 to 0.91), etoposide or vinca alkaloid (HR = 0.92; 95% CI, 0.80 to 1.07), or other (HR = 0.97; 95% CI, 0.84 to 1.13). Chemotherapy effect was higher in patients with better performance status. There was no interaction between chemotherapy effect and sex, age, histology, type of surgery, planned radiotherapy, or planned total dose of cisplatin. CONCLUSION Postoperative cisplatin-based chemotherapy significantly improves survival in patients with NSCLC.

Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma

OBJECTIVE The purpose of this study was to explore in greater depth the outcomes of the Italian randomized trial investigating the role of pelvic lymphadenectomy in clinical early stage endometrial cancer. In the attempt to identify the patients with poorer prognosis, the impact of age and body mass index were also thoroughly investigated by cancer-specific survival (CSS) analyses. STUDY DESIGN Survival outcomes of trial patients were analyzed in relation to age (≤65 years and >65 years) in the 2 arms (lymphadenectomy and no lymphadenectomy) and in the whole population of the trial. RESULTS Univariate and multivariable analyses of CSS and overall survival (OS) of patients showed that age >65 years is a strong independent poor prognostic factor (5-y OS 92.1% and 78.4% in ≤65 years and >65 years patients, respectively, P < .0001; 5-y CSS 93.8% and 83.5% in ≤65 years and >65 years patients, respectively, P = .003). Among women ≤65 years, node negative patients had 94.4% 5-y OS and 96.3% 5-y CSS vs 74.3% 5-y OS and 74.3% 5-y CSS for node positive patients (P = .009 and P = .002, respectively), while among women >65 y, node negative patients had 75.7% 5-y OS and 83.6% 5-y CSS vs 74.1% 5-y OS and 83.3% 5-y CSS for node positive patients (P = .55 and P = .58, respectively). Univariate and multivariable survival analyses in the whole trial population showed that older age, and higher tumor grade and stage were significantly associated to a worse prognosis. CONCLUSION Older women faced an intrinsic poorer survival whether or not they underwent lymphadenectomy, and, unexpectedly, irrespective of the presence of nodal metastasis. Only in older patients was obesity (body mass index >30) significantly associated with scarce prognosis.

Follow-up for patients with colorectal cancer after curative-intent primary treatment.

The introduction of effective anesthetics in the midnineteenth century permitted the rapid development of surgery, which remains the primary form of therapy for colorectal cancer. Some patients were rendered grossly disease-free by surgery, creating a population at risk for recurrence for the first time in history. A few decades later, surgical salvage of relapse was attempted and, in a few instances, patients were cured. This provided a rationale for trying to diagnose recurrence early, while resection was still feasible. It was known at that time that individuals with one cancer were unusually likely to develop another, particularly in the same tissue as the index lesion. This provided further justification for patient follow-up, but posttreatment surveillance strategies evolved unevenly and largely without clinical trials to demonstrate effectiveness. Efforts to diagnose and treat recurrent colorectal cancer reached a peak with planned “second-look” laparotomy for patients with various intra-abdominal cancers judged to be at high risk for local-regional relapse. 1 Over half of these patients had node-positive colorectal cancer and nearly 50% of them had relapse documented at exploration. Most importantly, some patients were rendered tumor-free at operation, and a few of these were long-term disease-free survivors. The very high morbidity and mortality rates (to say nothing of the costs) associated with this strategy soon became apparent, but the introduction of modern diagnostic tools such as computed tomography (CT) and carcino-embryonic antigen (CEA) measurement now permit clinicians to select patients for salvage attempts much more precisely. Many of the wealthier nations of the world are now able to provide access to modern medicine to all or most of their citizens, with concomitant increases in the duration and quality of life. A by-product of the increase in the average life span has been a large increase in the total number of people afflicted with colorectal cancer, as the incidence of the disease increases with age. Costs of care also have risen dramatically, and therein lies one of the conundrums of modern clinical practice: how to use costly resources wisely. In an attempt to rationalize care, the concept of the randomized trial was introduced in the mid-twentieth century. The results of one million randomized trials have been published since then, 2 but very few have dealt with follow-up of patients with colorectal carcinoma. This poses an important problem because there are many patients at risk and the costs of diagnosis (and treatment, if needed) are high. 3 The American Cancer Society predicts that, in the

Association between Helicobacter pylori infection and vulvar lichen sclerosus: a clinical comparative study

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