Miguel Pastor

Cost-Benefit Analysis of a Follow-up Program in Patients with Breast Cancer: A Randomized Prospective Study

Abstract:  Increasing the number of breast cancer patients in follow‐up involves increased costs and, with limited health care resources, there is a need to evaluate the cost‐benefit to the patient of follow‐up regimens. We present a randomized prospective study to evaluate the cost‐benefit of intensive follow‐up in the early detection of relapses in patients with breast cancer. One hundred and twenty‐one patients were randomized to standard clinical follow‐up (n = 63) or to an intensive follow‐up (n = 58) that included diagnostic laboratory tests and imaging designed to detect early relapse following curative treatment. All patients had annual mammography. The number of scheduled outpatient appointments kept were 359 in the standard clinical follow‐up and 355 in the intensive follow‐up group. After a median of 3 years of follow‐up, there were 28 relapses, 11 in standard clinical follow‐up, and 13 in the intensive follow‐up group. The overall cost of follow‐up was 24,567 euros in the standard clinical follow‐up group and 74,171 euros in the intensive follow‐up group. Performing complimentary investigations in breast cancer follow‐up is associated with higher costs without difference in early detection of relapses.

Non-hodgkin's lymphoma in older people: age is not always an adverse prognostic factor

To the Editor: Non-Hodgkin’s lymphoma (NHL) accounts for about 3% to 4% of all cancers; 1 one-third of all cases of NHL occur in patients aged 70 and older. 2 Age is considered to be an adverse prognostic factor in those patients. 3 The concept of age as an adverse prognostic factor is being reviewed. A study completed by the Non-Hodgkin’s Lymphoma Classification Project 4 concludes that age alone is not enough to determine a patient’s prognosis. We have analyzed retrospectively those patients in our center aged 65 and older diagnosed with NHL with three objectives in mind: to study the characteristics of NHL in this population, the prognostic factors that influence survival, and the influence of age in relation to other known prognostic factors. The cause-specific survival (CSS) is analyzed as a dependent variable from the moment of diagnosis until death due to NHL. Statistical analysis includes descriptive statistics and a univariate study of survival with the KaplanMeier method, with the habitual 5% ( P . 05) considered as level of significance. The 95 patients aged 65 and older constitute 22% of the total, with 47 (49%) having intermediate-grade NHL and 38 (40%) low-grade NHL. Ninety-one of 95 patients were treated (96%), with 48 evaluated as a complete response (CR) (53%) (Table 1). In the CSS analysis, age is an important prognostic factor in the global series, and the influence of age remains the same when the groups are separated according to histology. There is no significant difference in CSS between younger and older patients with performance status (PS) of 2 or greater, Ann Arbor stages I and IV, low serum albumin, the presence of B symptoms, and high and low tumor burden. The significant differences appear in groups with PS 1, Ann Arbor stages II and III, normal serum albumin, absence of B symptoms, and intermediate tumor burden. In older people, the recommendation for treatment of NHL varies and lacks consensus. Many older patients are not considered candidates to receive treatment with anthracyclines. The results of the treatment regimes without anthracyclines were inferior in response rate and survival, although the number of toxic deaths is lower with these schemes. 5,6 The major risk factor associated with toxic death is a poor PS. 7 In this NHL series, 22% of cases were older; of these, the median age was 74. This percentage is lower than that described in other studies, around 40%, 8 but the median age of those aged 70 and older is similar to those in other studies. The median survival of our patients was superior to that reported in a Dutch series; 8 the survival obtained in the Dutch study is global, whereas we have calculated the

Post-transplant lymphoproliferative disorders after solid organ and hematopoietic stem cell transplantation

Abstract Post-transplant lymphoproliferative disorders (PTLD) are a rare complication after both solid organ (SOT) and allogeneic hematopoietic stem cell transplantation (allo-HSCT). In this single center retrospective study, we compared clinical, biological, and histological features, and outcomes of PTLD after both types of transplant. We identified 82 PTLD (61 after SOT and 21 after allo-HSCT). The presence of B symptoms, Waldeyer ring, spleen, central nervous system, and liver involvement, and advanced Ann–Arbor stage were more frequent in allo-HSCT recipients. PTLD had an earlier onset in allo-HSCT than in SOT cohort (4 vs. 64 months, p < .0001). PTLD was EBV-positive in 100% of allo-HSCT, in contrast to 47% of SOT (p = .0002). Four years after PTLD diagnosis, median overall survival was 32% (95% CI, 22–48) and 10% (95% CI, 2–49) in SOT and allo-HSCT recipients, respectively (p = .002). In conclusion, the clinical presentation and the outcome of PTLD varies greatly depending on the type of transplant.

Combination or sequential single agent for the treatment of metastatic breast cancer (MBC) patients (pts). Impact of further chemotherapy (CT) in overall survival (OS) in the Alamo registry.

CTRC-AACR San Antonio Breast Cancer Symposium: 2008 Abstracts Abstract #2121 Introduction: Combinations can improve OS in MBC; however sequential single agent is sometimes preferred. In a recent report, pts receiving paclitaxel monotherapy in first line had a significantly worse OS if they were not receiving post study CT (PSC); no difference was seen in pts receiving paclitaxel+gemcitabine (Llombart, EBCC 2008). In this trial only 58% of pts received PSC. Purpose: To assess, outside the context of a clinical trial, the amount of MBC pts receiving CT beyond first line, as well as the impact of combination use and further CT lines in their OS. Methods: Alamo 1-2 is a breast cancer patient registry run by the GEICAM. 15482 pts diagnosed from 1990-1997 in 54 sites were included in the database. 4668 pts were stage IV; 778 (16.7%) metastatic at diagnosis and 3890 (83.3%) have had a recurrence. Results: 3045 (65%) pts received CT in first line, 83% were combinations (with anthracyclines 42%, CMF 16%, taxane+anthracyclines 9.4% or +other agents 8%) and 16% were monotherapy. Among other variables studied, only previous treatment (in early stage) was influencing the choice of a combination (pts without previous CT received more combinations than pts receiving CMF, than pts receiving anthracyclines). Median survival for pts receiving single agent was significantly shorter compared to pts receiving combination, 16.2 and 21.85 months (m) respectively, HR=1.37 (IC 95%: 1.21-1.55; p 65, negative hormonal receptor status, hepatic disease, Grade 3 and ≥ 3 disease sites. Half of the pts never received further CT after first line treatment. Only age and number of disease sites were influencing this decision in the Cox multivariate model. Median survival was 24.9 m in pts receiving further CT and 14.5 m in the ones not receiving it. In pts not receiving further CT, median OS was significantly shorter if they were treated with single agent in first line in comparison to those receiving previous combination: HR= 1.59 (IC 95%: 1.33-1.89; p< 0,00001). This difference was not significant in pts receiving further CT: HR= 1.15 (IC 95%: 0.97-1.37; p=0.101). Conclusion: Our data show that only half of the MBC pts receive further CT after first line; they have longer survival. We found significant evidence that further CT is impacting the OS in pts treated with single agent in first line, but not in those receiving previous combination. Those facts should be taken into consideration when selecting single agent or a combination in first line. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 2121.

Small cell lung cancer in the elderly: factors influencing treatment decision and effect on survival

The prognostic relevance of age is not well defined. The aim of the study was to review the characteristics of elderly patients (pts) with small cell lung cancer (SCLC) diagnosed and treated at a single institution over an 11-year period. Prognostic factors for survival were investigated.Between Nov/1981 and Jan/1993, out of 405 SCLC pts diagnosed, 152 were aged 65 years or older (median 70). One hundred and four pts aged 65–86 were treated with chemotherapy with or without surgery or radiotherapy. Distribution, univariate and multivariate analysis of prognostic factors were performed.Comorbidity, early death in treated pts, neutrophilia, hypoalbuminemia and poor performance status (ECOG, PS = 2-3) were more frequent in older pts (p < 0.05). Elderly pts underwent lesser extensive staging and received less than optimal treatment (p < 0.05). Factors that influenced the decision to treat with chemotherapy for elderly pts were: age, disease stage (VALG) and PS (0-1-3). Two-year survival of treated pts according to age was [8.2%/< 70 and 3.2%/≥ 70 (Wilcoxon, p > 0.05)] and [6.2%/65-69 and 3.2%/≥70 (Wilcoxon, p < 0.05)]. Univariate analysis in older population showed a significative statistical prognostic importance (p < 0.05) for: disease extent, hyperglycemia, hyponatremia, hypoalbuminemia, bilirubin, AST, ALT, LDH and paraneoplastic syndrome. Multiple regression analysis showed independent prognostic value for LDH, hyponatremia, hyperglycemia, disease extent and number of cycles of chemotherapy.Age and PS influenced the decision to treat with chemotherapy. In the older population, early deaths were more frequent than in younger pts. However only pts aged 70 years or older showed a worse outcome. The last suggests that specific therapeutic regimens are needed for SCLC in this population of pts. Various prognostic parameters should be considered in the management of elderly pts: PS, hypoalbuminemia and neutrophilia.ResumenEl valor pronóstico de la edad en el carcinoma pulmonar de célula pequeña (CPCP) no está bien definido. El objetivo del estudio fue revisar las características de los pacientes (pts) ancianos con CPCP diagnosticados y tratados en una Única institución durante un período de 11 años. Se investigaron factores pronósticos para supervivencia en este grupo.Entre noviembre de 1981 y enero de 1993 se diagnosticaron 405 casos de CPCP, de los cuales 152 tenían 65 años o más (mediana: 70 años). Un total de 104 pts con edades entre 65 y 86 años recibieron quimioterapia con o sin radioterapia o cirugía. Se realizó un análisis descriptivo, univariante y multivariante de factores pronóstico.Comorbilidad, muerte precoz con pts tratados, neutrofilia, hipoalbuminemia y un pobre estado funcional (ECOG = 2-3) fueron más frecuentes en pts ancianos (p < 0,05).El estudio de extensión y el nÚmero de tratamientos óptimos fueron menores en ancianos (p < 0,05). Influyeron en la decisión de tratar este grupo con quimioterapia: la edad, extensión de enfermedad (VALG) y estado funcional (ECOG = 0-1-3). La supervivencia a 2 años segÚn la edad fue: [8,2%/< 70 y 3,2%/≥ 70 (Wilcoxon, p < 0,05)] y [6,2%/65-69 y 3,2%/ ≥ 70 (Wilcoxon, p < 0,05)]. El análisis univariante en la población anciana demostró valor pronóstico (p < 0,05) para: extensión de enfermedad, hiperglucemia, hiponatremia, hipoalbuminemia, bilirrubina, AST, ALD, LDH y síndrome paraneoplásico. La regresión mÚltiple demostró valor independiente para LDH, hiponatremia, hiperglucemia, extensión de enfermedad y nÚmero completo de ciclos de quimioterapiaEdad y estado funcional influyeron en la decisión de tratar con quimioterapia.El nÚmero de muertes precoces fue mayor en ancianos, aunque la evolución fue peor sólo en mayores de 70 años, lo cual sugiere la necesidad de regímenes terapéuticos específicos para este grupo de edad afecto de CPCP, en cuyo manejo deberemos tener en cuenta parámetros como el estado funcional hipoalbuminemia y neutrofilia.