Chemotherapy versus best supportive care for extensive small cell lung cancer.

BACKGROUND: Combination chemotherapy has been the mainstay of treatment for extensive stage small celI lung cancer (SCLC) over the last 30 years, even though it only gives a short prolongation in median survival time. The main goal for these patients should be palliation with the aim of improving their quality of life. OBJECTIVES: To determine the effectiveness of first-line chemotherapy versus placebo or best supportive care (BSC) in prolonging survival in patients with extensive SCLC at diagnosis and the effectiveness of second-line chemotherapy at relapse or progression after first-line chemotherapy compared with BSC or placebo in prolonging survival in patients with extensive SCLC; as well as to evaluate the adverse events of treatment and the quality of life of patients. SEARCH METHODS: This is the second update of the review. MEDLINE (1966 to October 2013), EMBASE (1974 to October 2013), and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 3) were searched. Experts in the field were contacted. SELECTION CRITERIA: Phase III randomised controlled trials in which any chemotherapy treatment was compared with  placebo or BSC in patients with extensive SCLC, as first-line or second-line therapy at relapse. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed study quality. We resolved disagreements by discussion. Additional information was obtained from one study author. MAIN RESULTS: Two studies of unclear risk of bias were included for first-line chemotherapy. A total of 88 men under 70 years with good performance status were randomised to receive either supportive care, placebo infusion or ifosfamide. Ifosfamide gave an extra mean survival of 78.5 days compared with supportive care or placebo infusion. Partial tumour response was greater with the active treatment. Toxicity was only seen in the chemotherapy group and quality of life was only assessed at the beginning of treatment. The quality of the evidence for overall survival and adverse effects was very low.Three studies of moderate risk of bias were included for second-line chemotherapy at relapse (one identified in the last search). A total of 932 men and women under 75 years and any performance status were randomised to receive either methotrexate-doxorubicin, topotecan, or picoplatin versus symptomatic treatment or BSC. The methotrexate-doxorubicin treatment gave a median survival of 63 days longer than in the symptomatic-treatment group for patients allocated to receive four cycles of first-line chemotherapy, and 21 days longer for patients allocated to receive eight cycles of first-line chemotherapy.Treatment with topotecan gave a median survival of 84 days longer than in the BSC group (log-rank P = 0.01). The adjusted hazard ratio (HR) for overall survival was 0.61 (95% CI 0.43 to 0.87). Treatment with picoplatin gave a median survival time of six days longer than BSC (HR 0.817, 95% CI 0.65 to 1.03, P = 0.0895). A meta-analysis of topotecan and picoplatin gave a HR of 0.73 (95% CI 0.55 to 0.96, P = 0.03; low-quality evidence).Partial or complete response in the methotrexate-doxorubicin group was 22.3%. Five patients (7%, 95% CI 2.33 to 15.67) showed a partial response with topotecan. No data were provided about tumour response in the picoplatin study. Toxicity was worst in the chemotherapy group (moderate-quality evidence). Quality of life was better in the topotecan group and was not measured in the methotrexate-doxorubicin and picoplatin studies (low-quality evidence). AUTHORS' CONCLUSIONS: Two small RCTs from the 1970s suggest that first-line chemotherapeutic treatment (based on ifosfamide) may provide a small survival benefit (less than three months) in comparison with supportive care or placebo infusion in patients with advanced SCLC. However platinum-based combination chemotherapy regimens have been shown to increase complete response rates when compared to non-platinum chemotherapy regimens with no significant difference in survival, and so these are currently the standard first-line treatment for patients with SCLC.Second-line chemotherapy at relapse or progression may prolong survival for some weeks in relation to BSC. Nevertheless, the impact of first-line chemotherapy on quality of life, older patients, women and patients with poor prognosis is unknown and the benefits of second-line chemotherapy are also unclear for older people. Globally, the evidence on which these conclusions are based is very scarce and of uncertain or low quality, which calls for well-designed, controlled trials to further evaluate the trade-offs between benefits and risks of different chemotherapeutic schedules in patients with advanced SCLC.

Chemotherapy versus best supportive care for extensive small cell lung cancer.

BACKGROUND: Combination chemotherapy has been the mainstay of treatment for extensive stage small celI lung cancer (SCLC) over the last 30 years even though it only gives a short prolongation in median survival time. The main goal for these patients should be palliation with the aim of improving their quality of life. OBJECTIVES: To evaluate the effectiveness of chemotherapy in extensive SCLC compared with best supportive care (BSC) or placebo treatment. SEARCH STRATEGY: MEDLINE (1966 to July 2008), EMBASE (1974 to week 31, 2008), and the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2008). Experts in the field were contacted. SELECTION CRITERIA: Randomised controlled trials in which any chemotherapy treatment was compared with placebo or BSC in patients with extensive SCLC, as first or second therapy at relapse. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed study quality. We resolved disagreements by discussion. Additional information was obtained from one study author. MAIN RESULTS: Two studies were included for first-line chemotherapy. A total of 65 patients were randomised to receive either placebo or ifosfamide. Ifosfamide gave an extra mean survival of 78.5 days compared with placebo. Partial tumour response was greater with the active treatment. Toxicity was only seen in the chemotherapy group.Two studies were included for second-line chemotherapy at relapse. A total of 531 patients were randomised to receive either methotrexate-doxorubicin or symptomatic treatment, or to receive oral topotecan versus BSC. The methotrexate-doxorubicin treatment gave a median survival of 63 days longer than in the symptomatic treatment group, and 21 days longer for patients allocated to receive four or eight cycles of first-line chemotherapy, respectively.Treatment with topotecan gave a median survival of 84 days longer than in the BSC group (log-rank P = 0.01). The adjusted hazard ratio for overall survival was 0.61 (95% CI, 0.43 to 0.87). Partial or complete response in the methotrexate-doxorubicin group was 22.3%. Five patients (7%, 95% CI, 2.33 to 15.67) showed a partial response with topotecan. Toxicity was worst in the chemotherapy group. Quality of life was better in the topotecan group. AUTHORS' CONCLUSIONS: Chemotherapeutic treatment prolongs survival in comparison with placebo in patients with advanced SCLC. Nevertheless, the impact of first-line chemotherapy on quality of life and in patients with poor prognosis is unknown. Well-designed, controlled trials are needed to further evaluate the risks and benefits of different chemotherapeutic schedules in patients with advanced SCLC.

[Relationship between quality of life and various models of home care in terminal oncology patients from a health area of Madrid]. / Relación de la calidad de vida con diferentes modelos de atención domiciliaria en enfermos oncológicos terminales de un área sanitaria de Madrid.

BACKGROUND: This study assesses the effectiveness of the palliative home care for the purpose of ascertaining whether terminal cancer patients treated by Homecare Support Teams have a better quality of life than those treated by Primary Care Teams. METHODS: A quasi-experimental prospective study conducted in Madrid Healthcare District 4 on patients referred from the hospital to Homecare Support Teams or to Primary Care Teams. The main study variable was the quality of life gauged using the Rotterdam Symptom Check List and the Hospital Anxiety and Depression Scale. Statistical differences were evaluated by MANOVA, repeated measures ANOVA and Friedman test. RESULTS: A total of 165 patients were treated by Homecare Support Teams and 56 by Primary Care Teams. The patients treated by the Homecare Support Teams showed better point scores on the overall scale (mean difference: 9.5; CI 95%; 2.3-16.67) and pain scale Symptom Check List during the first week of the study. The effect size was greater on the Homecare Support Team group. The prescription of drugs and the place of death were different between both groups. CONCLUSIONS: At the start of the study, the patients treated by Homecare Support Teams showed a better perception of the health condition than those treated by the Primary Care Teams. However, the great number of patients lost along the study makes it necessary be cautious when considering these results.

Reliability and concurrent validity of the Palliative Outcome Scale, the Rotterdam Symptom Checklist, and the Brief Pain Inventory.

BACKGROUND: Some domains of the questionnaires used to measure symptoms and quality of life (QOL) in patients with advanced cancer seem to measure similar dimensions or constructs, so it would be useful for clinicians to demonstrate the interchangeability of equivalent domains of the questionnaires in measuring the same constructs. OBJECTIVE: This study investigated the reliability and concurrent validity of the Palliative Outcome Scale (POS), the Rotterdam Symptom Checklist (RSCL), and the Brief Pain Inventory (BPI), used to measure symptom control in patients with advanced cancer. DESIGN: This was an evaluative study. SETTING/SUBJECTS: Subjects were patients with advanced cancer attended by Spanish primary care physicians. MEASUREMENTS: Secondary analysis was performed of 117 outpatients who completed the POS, BPI, and RSCL at two different times, with an interval of 7 to 10 days. Bland and Altman analyses and plot, repeatability coefficient, as well as Spearman correlations were carried out. RESULTS: There were 117 included patients. Mean age was 69.4 (11.5) years, gender was 60% male, 37.6% completed only elementary school, diagnoses were mainly digestive and lung cancer, with a low functional rate and presence of oncologic pain. First and second questionnaire rounds showed significant correlations and agreement. Agreement was shown between pain intensity of BPI and pain and physical scales of RSCL, and between physical symptoms of RSCL and of POS, with significant correlations in equivalent dimensions. CONCLUSION: BPI, POS, and RSCL have shown adequate reliability and moderate concurrent validity among them.

Clinical effectiveness of online training in palliative care of primary care physicians.

BACKGROUND: Primary care physicians (PCPs) have a major responsibility in the management of palliative patients. Online palliative care (PC) education has not been shown to have a clinical impact on patients that is equal or different to traditional training. OBJECTIVE: This study tested the clinical effectiveness of online PC education of physicians through impact on symptom control, quality of life (QOL), caregiver satisfaction, and knowledge-attitude of physicians at 18 months of the intervention. METHODS: We conducted a randomized clinical trial. Subjects were 169 physicians randomly assigned to receive the online model or traditional training. Consecutive patients with advanced cancer requiring PC were included. Physicians and patients completed the Palliative Care Outcome Scale (POS), and patients the Brief Pain Inventory (BPI) and the Rotterdam Symptom Checklist (RSCL) twice, 7 to 10 days apart. Caregivers completed the SERVQUAL. Physicians' level of knowledge-attitude was measured at 18 months. RESULTS: Sixty-seven physicians enrolled 117 patients. The intervention group had reduced scores for pain, symptoms, and family anxiety. The global RSCL scale showed a difference between groups. There was no significant difference in the questionnaires used. Caregiver satisfaction was comparable between groups. Physicians in the intervention group significantly increased their knowledge without any differences in attitude. Online training was completed by 86.6% in the intervention group, whereas 13.4% in the control group accessed traditional training. CONCLUSIONS: Participation in an online PC education program by PCPs improved patient scores for some symptoms and family anxiety on the POS and also showed improved global QOL. Significant differences were found in physicians' knowledge at short and long term.