Breakthrough cancer pain: review and calls to action to improve its management.

In this paper, we review the current state of breakthrough cancer pain (BTcP) management. BTcP is a heterogeneous condition and a global problem for cancer patients. It is often managed suboptimally, which results in a negative outcome for patients, healthcare providers, and healthcare systems. Several barriers to the appropriate management of BTcP have been identified. These include, among others, an incomplete definition of BTcP, poor training of healthcare providers and patients alike, a lack of a multidisciplinary approach and the absence of specific protocols and tools. We provide some actions to help physicians and patients improve their approach to BTcP, including specific training, the design of easy-to-use tools for BTcP identification and assessment (such as checklists and pocket-sized cards), individualized treatment, and the use of multidisciplinary teams.

Active study: undetected prevalence and clinical inertia in the treatment of breakthrough cancer pain (BTcP).

AIMS: To prove if there is clinical inertia in the identification and treatment of episodes of breakthrough cancer pain (BTcP), comparing actual results from clinical practice with clinical oncologists' prior perception. DESIGN: Observational and descriptive study, using information collected by practising medical oncologists, at three moments: (a) questionnaire regarding their professional judgement of the handling of patients with BTcP in their practice, (b) cross-sectional clinical screening, to detect possible existing cases of BTcP in a representative sample of their patients, (c) retrospective self-audit of clinical case histories of patients diagnosed with BTcP to find out about how it has been handled. PARTICIPANTS AND STUDY PERIOD: A random sample on a state level of 108 specialists in medical oncology. 540 patients who suffer some type of cancer pain on the designated study date for each specialist (July-December 2016). RESULTS: The global prevalence of BTcP in the study sample covered 91.3% of the patients who were suffering some type of cancer pain. Barely 2% of the doctors surveyed suspected figures around this mark. 40.9% of the cases had not been previously detected as BTcP by their doctors. Although 90% of the patients who had previously been diagnosed with BTcP received a specific analgesic treatment for the symptoms, 42% of those patients with known BTcP were not able to control their episodes of pain. CONCLUSIONS: Clinical inertia is a serious problem in the handling of BTcP in medical oncology services, where it is the subject of a significantly low level of detection and treatment, despite the contrasting perception of specialists.

Molecular subtypes in early colorectal cancer associated with clinical features and patient prognosis

Purpose: After surgical resection, an ample prognosis variability among stages is observed. Multiple prognostic factors are individually studied and some CRC classifiers have been proposed. Not one have been implemented into clinical practice. Methods/patients: We classified 105 patients with resected CRC (stage I-III) into five molecular subtypes using BRAFV600E and RAS (KRAS; NRAS) status, and the expression of DNA mismatch repair (MMR) proteins (MLH1 and MSH2). Clinicopathological features and DFS) of distincts groups were evaluated. Results and conclusions: RAS and BRAFV600E mutations were detected in 43.8 and 11.4% of patients, respectively. 19% of tumours had lack of expression of any MMR proteins reflecting a system deficiency (dMMR). Patients with any RAS mutation had lower DFS that patients with RAS wild type (wt) (40.23 vs 45.26 months; p value = 0.035). Of a total of five molecular subtypes, three were MMR proficient (pMMR): RAS mutated (39%), BRAFV600E mutated (6.7%) and RAS/BRAFV600E wt (35.2%); and two were dMMR: BRAFV600E mutated (4.8%) and BRAFV600E wt (14.3%). Left side tumours were more frequently observed in pMMR/RAS and BRAFV600E wt subtype, and right side tumours in dMMR subtypes. Among the three pMMR subtypes, a benefit survival was observed for patients without any mutation in BRAFv600E or RAS oncogenes (median of DFS = 45.5 vs 40.98 months in RAS mutated group; p = 0.084 and vs 34.13 in BRAFv600E mutated group; p = 0.031). Molecular classification using these biomarkers can be useful to identify groups with differences in prognosis

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Molecular subtypes in early colorectal cancer associated with clinical features and patient prognosis.

PURPOSE: After surgical resection, an ample prognosis variability among stages is observed. Multiple prognostic factors are individually studied and some CRC classifiers have been proposed. Not one have been implemented into clinical practice. METHODS/PATIENTS: We classified 105 patients with resected CRC (stage I-III) into five molecular subtypes using BRAFV600E and RAS (KRAS; NRAS) status, and the expression of DNA mismatch repair (MMR) proteins (MLH1 and MSH2). Clinicopathological features and DFS) of distincts groups were evaluated. RESULTS AND CONCLUSIONS: RAS and BRAFV600E mutations were detected in 43.8 and 11.4% of patients, respectively. 19% of tumours had lack of expression of any MMR proteins reflecting a system deficiency (dMMR). Patients with any RAS mutation had lower DFS that patients with RAS wild type (wt) (40.23 vs 45.26 months; p value = 0.035). Of a total of five molecular subtypes, three were MMR proficient (pMMR): RAS mutated (39%), BRAFV600E mutated (6.7%) and RAS/BRAFV600E wt (35.2%); and two were dMMR: BRAFV600E mutated (4.8%) and BRAFV600E wt (14.3%). Left side tumours were more frequently observed in pMMR/RAS and BRAFV600E wt subtype, and right side tumours in dMMR subtypes. Among the three pMMR subtypes, a benefit survival was observed for patients without any mutation in BRAFv600E or RAS oncogenes (median of DFS = 45.5 vs 40.98 months in RAS mutated group; p = 0.084 and vs 34.13 in BRAFv600E mutated group; p = 0.031). Molecular classification using these biomarkers can be useful to identify groups with differences in prognosis.

Oncologist's knowledge and implementation of guidelines for breakthrough cancer pain in Spain: CONOCE study

Purpose. Breakthrough cancer pain (BTcP) has been shown to be a prevalent and poor prognostic factor for oncologic patients, which remain under diagnosed and undertreated. In 2012, the Spanish Society of Medical Oncology (SEOM) published a clinical practice guideline (CPG) for the treatment of cancer pain which specifically addressed the management of BTcP. Methods. Fundación ECO designed a qualitative study using an Internet-based survey to investigate the attitudes toward, compliance with, and use of SEOM Guideline. Results. A total of 83 oncologists with a mean experience of 13 years responded. Overall, 82% were aware of different guidelines to manage BTcP. Notably, attitudes toward guidelines were highly positive and there was nearly unanimous agreement that CPG provided the best scientific evidence available (99%), on the minimum information to be gathered for the medical history (100%), on the need for a specific treatment for BTcP (100%), and fentanyl as the first-choice drug (99%). Interestingly, there were discrepancies between what oncologists agreed with and what they do in clinical practice. In fact, 87.6% declare full compliance with SEOM guideline, although adherence to registration of BTcP data in medical records ranged from 30.1 to 91.6% (mean 64.5%); therapeutic management compliance was higher ranging from 75.9 to 91.6%. Main barriers identified were time pressure together with vague statements and limited dissemination of the guidelines. Conclusion. Despite oncologist’s clinical practice is increasingly guided by GPC, it suffers from limited compliance, at least in part due to suboptimal statements. Improved dissemination and education are needed to enhance guideline implementation

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Oncologist's knowledge and implementation of guidelines for breakthrough cancer pain in Spain: CONOCE study.

PURPOSE: Breakthrough cancer pain (BTcP) has been shown to be a prevalent and poor prognostic factor for oncologic patients, which remain under diagnosed and undertreated. In 2012, the Spanish Society of Medical Oncology (SEOM) published a clinical practice guideline (CPG) for the treatment of cancer pain which specifically addressed the management of BTcP. METHODS: Fundación ECO designed a qualitative study using an Internet-based survey to investigate the attitudes toward, compliance with, and use of SEOM Guideline. RESULTS: A total of 83 oncologists with a mean experience of 13 years responded. Overall, 82% were aware of different guidelines to manage BTcP. Notably, attitudes toward guidelines were highly positive and there was nearly unanimous agreement that CPG provided the best scientific evidence available (99%), on the minimum information to be gathered for the medical history (100%), on the need for a specific treatment for BTcP (100%), and fentanyl as the first-choice drug (99%). Interestingly, there were discrepancies between what oncologists agreed with and what they do in clinical practice. In fact, 87.6% declare full compliance with SEOM guideline, although adherence to registration of BTcP data in medical records ranged from 30.1 to 91.6% (mean 64.5%); therapeutic management compliance was higher ranging from 75.9 to 91.6%. Main barriers identified were time pressure together with vague statements and limited dissemination of the guidelines. CONCLUSION: Despite oncologist's clinical practice is increasingly guided by GPC, it suffers from limited compliance, at least in part due to suboptimal statements. Improved dissemination and education are needed to enhance guideline implementation.

High pKDR immunohistochemical expression is an unfavourable prognostic biomarker in patients with advanced colorectal cancer treated with chemotherapy plus bevacizumab

Purpose: To analyse the prognostic role of the immunohistochemical expression of pKDR in patients with advanced colorectal cancer treated with oxaliplatin and fluoropyrimidines combination chemotherapy with or without bevacizumab. Methods: Retrospective multicentre study, carried out at four hospitals in the Valencian Community (Spain). Patients evolution was compared based on the immunohistochemical expression of pKDR, classified using 4 categories: 0 (undetectable), 1 (mild), 2 (moderate) and 3 (high intensity). Patients were divided into two groups for the analysis: group 1 with low expression (0-1) vs. group 2 with high expression (2-3). Results: Histological samples for the pKDR analysis were available for 84 of the 112 patients selected. Seven (8.3 %) had undetectable or mild expression of pKDR (Group 1) and 77 (91.7 %) showed moderate or high expression of pKDR (Group 2). Response rate in Group 1 was 100 %compared to 54.2 % in Group 2 (p = 0.019). Progression-free survival (PFS) (15 vs. 12 months, p = 0.4) and overall survival (OS) (28 vs. 22 months, p = 0.09) were numerically but not significantly higher in patients from Group 1 vs. Group 2. Patients from Group 2 who received bevacizumab presented a significantly higher PFS (13 vs. 11, p = 0.015) and a numerically higher OS (23 vs. 17 months, p = 0.27) than those treated exclusively with chemotherapy. Conclusions: Our results suggest that the absence or low expression of pKDR is associated with a better prognostic profile in patients with advanced colorectal cancer treated with chemotherapy and bevacizumab. Patients with a high pKDR expression benefit from the combination of chemotherapy with bevacizumab (AU)

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High pKDR immunohistochemical expression is an unfavourable prognostic biomarker in patients with advanced colorectal cancer treated with chemotherapy plus bevacizumab.

PURPOSE: To analyse the prognostic role of the immunohistochemical expression of pKDR in patients with advanced colorectal cancer treated with oxaliplatin and fluoropyrimidines combination chemotherapy with or without bevacizumab. METHODS: Retrospective multicentre study, carried out at four hospitals in the Valencian Community (Spain). Patients evolution was compared based on the immunohistochemical expression of pKDR, classified using 4 categories: 0 (undetectable), 1 (mild), 2 (moderate) and 3 (high intensity). Patients were divided into two groups for the analysis: group 1 with low expression (0-1) vs. group 2 with high expression (2-3). RESULTS: Histological samples for the pKDR analysis were available for 84 of the 112 patients selected. Seven (8.3 %) had undetectable or mild expression of pKDR (Group 1) and 77 (91.7 %) showed moderate or high expression of pKDR (Group 2). Response rate in Group 1 was 100 % compared to 54.2 % in Group 2 (p = 0.019). Progression-free survival (PFS) (15 vs. 12 months, p = 0.4) and overall survival (OS) (28 vs. 22 months, p = 0.09) were numerically but not significantly higher in patients from Group 1 vs. Group 2. Patients from Group 2 who received bevacizumab presented a significantly higher PFS (13 vs. 11, p = 0.015) and a numerically higher OS (23 vs. 17 months, p = 0.27) than those treated exclusively with chemotherapy. CONCLUSIONS: Our results suggest that the absence or low expression of pKDR is associated with a better prognostic profile in patients with advanced colorectal cancer treated with chemotherapy and bevacizumab. Patients with a high pKDR expression benefit from the combination of chemotherapy with bevacizumab.

Social value of a quality-adjusted life year (QALY) in Spain: the point of view of oncologists

PURPOSE: The economic situation showed that the resources devoted to health spending are limited, making rationalisation of their consumption necessary. The relevance of pharmacoeconomic analyses is becoming crucial. The ECO Foundation, promoting the quality of oncology care, set out to analyse the consensus on the new therapeutic targets inclusion and the integration of pharmacoeconomics when evaluating their effectiveness. METHODS: Study about pharmacoeconomic estimations was performed during the first ECO-Seminar (2010). It was developed using a modified Delphi method, in four stages: (1) committee coordinator establishment, (2) expert-panel selection, (3) preparation and submission of survey (1 question) by email, and (4) analysis of the degree of consensus reached. RESULTS: Results were obtained from surveys completed by 35 experts. Regarding the tolerable annual cost for the approval of new drugs, 68.8 % of the respondents considered a cost per quality-adjusted life year (QALY) gained between 30,000 and 100,000 acceptable (34.4 % 30,000-60,000; 34.4 % 60,000-100,000), 21.9 % of the respondents found costs between 100,000-150,000/QALY and 9.3 % of the respondents found costs above 150,000/QALY acceptable. CONCLUSIONS: The costs of new drugs are higher than traditional treatments, making it a priority to identify subgroups of patients with specific molecular profiles as candidates for higher-efficiency-targeted therapies. The allocation of the available resources to the most effective interventions, to achieve the best clinical outcomes with lower costs and best subjective profile possible, allows expenditure to be rationalised. Pharmacoeconomic studies are a basic tool for obtaining better health outcomes according to the available resources, while also considering the other needs of the population (AU)

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Social value of a quality-adjusted life year (QALY) in Spain: the point of view of oncologists.

PURPOSE: The economic situation showed that the resources devoted to health spending are limited, making rationalisation of their consumption necessary. The relevance of pharmacoeconomic analyses is becoming crucial. The ECO Foundation, promoting the quality of oncology care, set out to analyse the consensus on the new therapeutic targets inclusion and the integration of pharmacoeconomics when evaluating their effectiveness. METHODS: Study about pharmacoeconomic estimations was performed during the first ECO-Seminar (2010). It was developed using a modified Delphi method, in four stages: (1) committee coordinator establishment, (2) expert-panel selection, (3) preparation and submission of survey (1 question) by email, and (4) analysis of the degree of consensus reached. RESULTS: Results were obtained from surveys completed by 35 experts. Regarding the tolerable annual cost for the approval of new drugs, 68.8 % of the respondents considered a cost per quality-adjusted life year (QALY) gained between €30,000 and 100,000 acceptable (34.4 % €30,000-60,000; 34.4 % €60,000-100,000), 21.9 % of the respondents found costs between €100,000-150,000/QALY and 9.3 % of the respondents found costs above €150,000/QALY acceptable. CONCLUSIONS: The costs of new drugs are higher than traditional treatments, making it a priority to identify subgroups of patients with specific molecular profiles as candidates for higher-efficiency-targeted therapies. The allocation of the available resources to the most effective interventions, to achieve the best clinical outcomes with lower costs and best subjective profile possible, allows expenditure to be rationalised. Pharmacoeconomic studies are a basic tool for obtaining better health outcomes according to the available resources, while also considering the other needs of the population.

Management of malignant insulinoma

AIM: Malignant insulinoma is an infrequent functional endocrine tumor of the pancreas. Adequate therapy is a demanding challenge for oncologists and endocrinologists. OBJECTIVE: To evaluate the results of multidisciplinary management of malignant insulinoma. MATERIALS AND METHODS: Retrospective review of patients with malignant insulinoma treated from 1995 to 2011. RESULTS: Seven patients with malignant insulinoma were included: four males and three females; median age was 61.8 years (range 37-78). Six tumors were sporadic and one was diagnosed in a patient with a type 1 multiple endocrine neoplasia (MEN-1). Surgery was performed in six cases and one patient was considered unresectable. Hypoglycemias persisted in all cases and somatostatin analogs, glucocorticoids and diazoxide were used. Two patients received everolimus. Other techniques were chemoembolization and internal radiation therapy with yttrium-90. Successful liver transplant was done in the patient with MEN-1. CONCLUSION: hypoglycemia management is complex and requires multiple therapies. Further evaluations will be necessary to determine the best treatment (AU)

Management of malignant insulinoma.

AIM: Malignant insulinoma is an infrequent functional endocrine tumor of the pancreas. Adequate therapy is a demanding challenge for oncologists and endocrinologists. OBJECTIVE: To evaluate the results of multidisciplinary management of malignant insulinoma. MATERIALS AND METHODS: Retrospective review of patients with malignant insulinoma treated from 1995 to 2011. RESULTS: Seven patients with malignant insulinoma were included: four males and three females; median age was 61.8 years (range 37-78). Six tumors were sporadic and one was diagnosed in a patient with a type 1 multiple endocrine neoplasia (MEN-1). Surgery was performed in six cases and one patient was considered unresectable. Hypoglycemias persisted in all cases and somatostatin analogs, glucocorticoids and diazoxide were used. Two patients received everolimus. Other techniques were chemoembolization and internal radiation therapy with yttrium-90. Successful liver transplant was done in the patient with MEN-1. CONCLUSION: Hypoglycemia management is complex and requires multiple therapies. Further evaluations will be necessary to determine the best treatment.

Toxicidad cutánea asociada a cetuximab en cáncer colorrectal metastásico / Cutaneous Toxicity Associated With Cetuximab Treatment in Metastatic Colorectal Cancer

Objetivo Evaluar la incidencia y el tipo de reacciones cutáneas secundarias al tratamiento con cetuximab y describir el protocolo terapéutico. Método Estudio retrospectivo de seguridad. Se seleccionaron los pacientes que recibieron cetuximab desde enero a diciembre de 2009. Se obtuvo la información consultando bases de datos Access y posterior revisión de historias clínicas. Se registraron los datos en una hoja de cálculo Excel. Para la gradación de la gravedad de la erupción cutánea se siguió la clasificación NCI-CTCAE. Resultados Recibieron tratamiento 43 pacientes. Presentaron erupción acneiforme 30 (69,8%): 14, grado 1 (48,3%); 13, grado 2 (44,8%), y 3, grado 3 (10,3%). La mediana de días hasta aparición de síntomas fue de 7 (4-28). Presentaron xerosis, tras una mediana de 40 (20-56) días, 10 pacientes (23,3%) y 3 (7%) manifestaron fisuras en manos y pies tras 28 (21-35) días. En dos pacientes aparecieron trastornos ungueales (como paroniquia) tras 42 (35-49) días. En cuanto a alteraciones del crecimiento del pelo: hubo dos casos de hipertricosis y un paciente experimentó un gran sobrecrecimiento de las pestañas. Se presentaron conjuntivitis importantes en cinco casos. Tuvieron lugar tres reacciones infusionales. Se aplicó a todos los pacientes un protocolo de tratamiento basado en la gravedad de la toxicidad cutánea. Conclusión El perfil de seguridad de cetuximab concuerda con el descrito en los estudios publicados. Se trata de efectos adversos cutáneos de aparición muy frecuente y de importantes consecuencias relacionadas con la efectividad de la terapia. La información al paciente y detección y tratamiento precoz de la sintomatología según un protocolo consensuado pueden favorecer el buen cumplimiento y el éxito terapéutico (AU)

Objective To evaluate the impact and type of side-effects in patients treated with cetuximab and provide a description of the general measures and treatment. Methods Retrospective safety study. We included all patients that received cetuximab from January to December 2009. All information was obtained from the Pharmacy and Oncology Department's Access databases and reviewed the patient's medical history. All data was registered in an Excel workbook. Skin toxicity was graded by the current National Cancer Institute-Common Toxicity Criteria (NCI-CTC).Results During the study period 43 patients received treatment with cetuximab. Acneiform eruption was present in 30 of the cases (69.8%): 14 patients with grade 1 (48.3%), 13 with grade 2 (44.8%) and 3 with grade 3 (10.3%). These adverse effects appeared in a median of seven (4–28) days. In a median of 40 (20–56) days, ten patients (23.3%) presented xerosis, and three (7%) suffered painful fissures in hands and feet after a median of 28 (21–35) days. Paronychia was present in two patients after a median of 42 (35–49) days. Finally, an alteration in hair growth was observed in two patients with overgrowth of facial hair and one patient with overgrowth of the eyelashes. Five patients presented important conjunctivitis. Three infusion reactions occurred. A grade-based treatment algorithm was used for all patients that presented cutaneous toxicity. Conclusions A considerable number of patients treated with cetuximab develop dermatological side-effects which left untreated could represent a threat to the efficacy of the therapy. Therefore effective management is mandatory, patient education and immediate treatment based on a grade-based algorithm to alleviate symptoms is necessary, so that patient compliance is guaranteed (AU)

[Cutaneous toxicity associated with cetuximab treatment in metastatic colorectal cancer]. / Toxicidad cutánea asociada a cetuximab en cáncer colorrectal metastásico.

OBJECTIVE: To evaluate the impact and type of side-effects in patients treated with cetuximab and provide a description of the general measures and treatment. METHODS: Retrospective safety study. We included all patients that received cetuximab from January to December 2009. All information was obtained from the Pharmacy and Oncology Department's Access databases and reviewed the patient's medical history. All data was registered in an Excel workbook. Skin toxicity was graded by the current National Cancer Institute-Common Toxicity Criteria (NCI-CTC). RESULTS: During the study period 43 patients received treatment with cetuximab. Acneiform eruption was present in 30 of the cases (69.8%): 14 patients with grade 1 (48.3%), 13 with grade 2 (44.8%) and 3 with grade 3 (10.3%). These adverse effects appeared in a median of seven (4-28) days. In a median of 40 (20-56) days, ten patients (23.3%) presented xerosis, and three (7%) suffered painful fissures in hands and feet after a median of 28 (21-35) days. Paronychia was present in two patients after a median of 42 (35-49) days. Finally, an alteration in hair growth was observed in two patients with overgrowth of facial hair and one patient with overgrowth of the eyelashes. Five patients presented important conjunctivitis. Three infusion reactions occurred. A grade-based treatment algorithm was used for all patients that presented cutaneous toxicity. CONCLUSIONS: A considerable number of patients treated with cetuximab develop dermatological side-effects which left untreated could represent a threat to the efficacy of the therapy. Therefore effective management is mandatory, patient education and immediate treatment based on a grade-based algorithm to alleviate symptoms is necessary, so that patient compliance is guaranteed.

Professional survey on knowledge and clinical patterns of pain management in Spanish medical oncology

Cancer pain is still not treated adequately. The barriers impeding its appropriate treatment include lack of knowledge, erroneous beliefs and inappropriate attitudes with regard to pain, which are sustained by some or all of those involved in the problem. The present study shows the results of an exploratory survey using a large sample of specialists in clinical oncology. Its main objective is to evaluate daily analgesic practices and compliance with clinical guidelines in order to identify areas that should be improved in this particular therapeutic field. Information collection from the responders was in the form of a self-administered written questionnaire, structured in three thematic areas: clinical patterns and resources used in pain treatment in clinical practice, pain and pain-relief therapy, and theoretical knowledge and decision-making in clinical practice. The study identified those skills that most need improvement in the treatment of pain (scientific and technical knowledge and clinical decision-making capacity of professionals) in order to reduce the unjustified variability in current clinical practice (AU)

[Pharmacoeconomics and cost of cancer drugs]. / Farmacoeconomía y los costes de los medicamentos contra el cáncer.

Cancer is a disease of high incidence, which determines that the health systems will be forced to allocation a significant amount of resources. In an era of evidence-based medicine and increasing cost pressures, it is important to understand the relative clinical and economic impact of the many drug treatment strategies available for cancer patients. Currently, resources that may be spent in pharmacoeconomics expenditure are limited so it is necessary to rationalize their consumption and priorize in the allocation of these resources to the options with higher economic advantages. Pharmacoeconomic studies will permit us to know what is the efficiency of different therapeutic alternatives so they will help to determine the therapeutic options that we should use in routine medical practice.

Estudio de utilizacion de pemetrexed en el cancer de pulmon no microcitico / Study of use of pemetrexed in non-small cell lung cancer

Objetivo Estudiar la efectividad y la seguridad del pemetrexed en el cancer de pulmon no microcitico. Metodo Estudio retrospectivo (marzo 2006¨Cmayo 2008) de utilizacion de pemetrexed. Se obtuvo la informacion de bases de datos Access de los Servicios de Farmacia y Oncologia, del registro de visitas a consultas externas y de la historia clinica. Los datos se analizaron con SPSS v12.0. Las variables cuantitativas se expresaron con la mediana (minimo-maximo). Resultados Fueron 44 pacientes (61,7 años [39¨C77]) la mayoria hombres (86%), fumadores/exfumadores (80%), histologia epidermoide/escamosa (46%) o adenocarcinoma (36%), con buen estado funcional (86%) y estadio iii o superior al inicio del tratamiento con pemetrexed (93%). El tratamiento previo con taxanos y este junto con la neutropenia previa fueron los criterios de cambio a pemetrexed en el 34,4 y el 22,7% de los pacientes, respectivamente. Ningun paciente presento respuesta completa o parcial; el 18,2% mostro enfermedad estable y el 81,8% progresion de la enfermedad, siendo los principales motivos de retirada del pemetrexed la progresion de la enfermedad (54,5%) y el empeoramiento clinico (15,9%). La mediana de supervivencia desde el inicio de la quimioterapia fue de 22,2 meses (16¨C28,4) y desde el inicio con pemetrexed fue de 7,8 meses (4,4¨C11,2), siendo esta significativamente mayor en las mujeres y de aquellos con valor 0-1 en la escala Eastern Cooperative Oncology Group. Los efectos adversos mas frecuentes fueron astenia y neurotoxicidad. Conclusion Pemetrexed se ha utilizado en todos los casos como segunda linea o superior con buen perfil de seguridad. En ningun caso se alcano respuesta completa o parcial, pero la supervivencia desde el inicio de pemetrexed iguala o supera a la de otros estudios (AU)

Objective To study the effectiveness and safety of pemetrexed in non-small cell lung cancer. Method Retrospective study (March 2006¨CMay 2008) of pemetrexed use. Information was obtained from the Access database belonging to the Pharmacy and Oncology Departments, the registry of external consultations and clinical histories. Data were analysed using SPSS software version 12.0. Quantitative variables are expressed as the median (minimum-maximum).Results The study included 44 patients (61.7 [39¨C77] years old), mostly male (86%), smokers or former smokers (80%) with predominantly epidermoid/squamous disease (46%) or adenocarcinoma, in a good functional state (86%) and in stage ¡ÝIII upon beginning pemetrexed treatment (93%). Prior treatment with taxanes and taxane treatment along with a prior history of neutropoenia were the criteria for changing to pemetrexed in 34.4% and 22.7% of the patients, respectively. None of the patients presented a complete or partial response: 18.2% showed disease stability and 81.8% showed disease progression. The main reasons for discontinuing pemetrexed were progression of the disease (54.5%) and worsening of symptoms (15.9%). Median survival after beginning chemotherapy was 22.2 months (ranging from 16¨C28.4) and 7.8 months (4.4¨C11.2) after beginning pemetrexed treatment. These last figures were significantly higher in women and those with an ECOG of 0 to 1. The most common adverse effects were weakness and neurotoxicity. Conclusion In each of the cases, pemetrexed was used as a second-line treatment or higher with a good safety profile. A complete or partial response was not reached in any of the cases, but survival after beginning pemetrexed was equal to or longer than that achieved in other studies (AU)

[Study of use of pemetrexed in non-small cell lung cancer]. / Estudio de utilización de pemetrexed en el cáncer de pulmón no microcítico.

OBJECTIVE: To study the effectiveness and safety of pemetrexed in non-small cell lung cancer. METHOD: Retrospective study (March 2006-May 2008) of pemetrexed use. Information was obtained from the Access database belonging to the Pharmacy and Oncology Departments, the registry of external consultations and clinical histories. Data were analysed using SPSS software version 12.0. Quantitative variables are expressed as the median (minimum-maximum). RESULTS: The study included 44 patients (61.7 [39-77] years old), mostly male (86%), smokers or former smokers (80%) with predominantly epidermoid/squamous disease (46%) or adenocarcinoma, in a good functional state (86%) and in stage > or =III upon beginning pemetrexed treatment (93%). Prior treatment with taxanes and taxane treatment along with a prior history of neutropoenia were the criteria for changing to pemetrexed in 34.4% and 22.7% of the patients, respectively. None of the patients presented a complete or partial response: 18.2% showed disease stability and 81.8% showed disease progression. The main reasons for discontinuing pemetrexed were progression of the disease (54.5%) and worsening of symptoms (15.9%). Median survival after beginning chemotherapy was 22.2 months (ranging from 16-28.4) and 7.8 months (4.4-11.2) after beginning pemetrexed treatment. These last figures were significantly higher in women and those with an ECOG of 0 to 1. The most common adverse effects were weakness and neurotoxicity. CONCLUSION: In each of the cases, pemetrexed was used as a second-line treatment or higher with a good safety profile. A complete or partial response was not reached in any of the cases, but survival after beginning pemetrexed was equal to or longer than that achieved in other studies.

Farmacoeconomía y los costes de los medicamentos contra el cáncer / Pharmacoeconomics and cost of cancer drugs

El cáncer es una enfermedad de elevada incidencia, lo que condiciona que los sistemas de salud se vean obligados a destinarle un importante volumen de recursos. En la era de la medicina basada en la evidencia, y de las presiones de un gasto sanitario en aumento, es necesario comprender el impacto clínico y económico de las diferentes estrategias disponibles para los pacientes oncológicos. En la actualidad, los recursos que pueden ser destinados al gasto farmacéutico son limitados, por lo que es necesario racionalizar su consumo y priorizar en la asignación de estos recursos a las opciones que presenten mayores ventajas económicas. Los estudios de farmacoeconomía nos van a permitir conocer cuál es la eficiencia de las diferentes alternativas terapéuticas disponibles y, por lo tanto, nos ayudarán a determinar qué opciones terapéuticas deberían emplearse de forma rutinaria (AU)

Cancer is a disease of high incidence, which determines that the health systems will be forced to allocation a significant amount of resources. In an era of evidence-based medicine and increasing cost pressures, it is important to understand the relative clinical and economic impact of the many drug treatment strategies available for cancer patients. Currently, resources that may be spent in pharmacoeconomics expenditure are limited so it is necessary to rationalize their consumption and priorize in the allocation of these resources to the options with higher economic advantages. Pharmacoeconomic studies will permit us to know what is the efficiency of different therapeutic alternatives so they will help to determine the therapeutic options that we should use in routine medical practice (AU)