How Do Elderly Poor Prognosis Patients Tolerate Palliative Concurrent Chemoradiotherapy for Locally Advanced Non–Small-Cell Lung Cancer Stage III? A Subset Analysis From a Clinical Phase III Trial

AbstractBackgroundIn a phase III trial of patients with unresectable, locally advanced, stage III non–small-cell lung cancer (NSCLC) with a poor prognosis, palliative concurrent chemoradiotherapy (CRT) provided a significantly better outcome than chemotherapy alone, except among performance status (PS) 2 patients. In the present subgroup analysis, we evaluated the effect on patients aged ≥ 70 years (42% of all included) compared with patients aged < 70 years enrolled in the trial.Patients and MethodsAll patients received 4 courses of intravenous carboplatin and oral vinorelbine. The experimental arm also received radiotherapy (42 Gy in 15 fractions). The included patients were required to have large tumors (> 8 cm), weight loss (> 10% within the previous 6 months) and/or PS 2.ResultsThe overall survival was increased among the CRT patients in both age groups, but the difference was significant only in patients aged < 70 years (median survival, 14.8 vs. 9.7 months; P = .001; age ≥ 70 years, median survival, 10.2 vs. 9.1 months; P = .09). Patients aged ≥ 70 years experienced better preserved health-related quality of life (QOL) and significantly less hematologic toxicity. The 2- and 3-year survival was significantly increased in both age groups receiving CRT.ConclusionElderly patients aged ≥ 70 years with unresectable, stage III, locally advanced, NSLCL and a poor prognosis can tolerate CRT with the doses adjusted to age and palliative intent. These results indicate that CRT can provide both survival and QOL benefits in elderly patients, except for those with PS 2 or worse. The male predominance in the ≥ 70-year-age group and the reduced chemotherapy intensity for the patients aged > 75 years might explain the lack of significant survival improvement among those patients aged ≥ 70 years

Concurrent palliative chemoradiation leads to survival and quality of life benefits in poor prognosis stage III non-small-cell lung cancer: a randomised trial by the Norwegian Lung Cancer Study Group

Background: The palliative role of chemoradiation in the treatment of patients with locally advanced, inoperable non-small-cell lung cancer stage III and negative prognostic factors remains unresolved. Methods: Patients not eligible for curative radiotherapy were randomised to receive either chemoradiation or chemotherapy alone. Four courses of intravenous carboplatin on day 1 and oral vinorelbin on days 1 and 8 were given with 3-week intervals. Patients in the chemoradiation arm also received radiotherapy with fractionation 42 Gy/15, starting at the second chemotherapy course. The primary end point was overall survival; secondary end points were health-related quality of life (HRQOL) and toxicity. Results: Enrolment was terminated due to slow accrual after 191 patients from 25 Norwegian hospitals were randomised. Median age was 67 years and 21% had PS 2. In the chemotherapy versus the chemoradiation arm, the median overall survival was 9.7 and 12.6 months, respectively (Po0.01). One-year survival was 34.0% and 53.2% (Po0.01). Following a minor decline during treatment, HRQOL remained unchanged in the chemoradiation arm. The patients in the chemotherapy arm reported gradual deterioration during the subsequent months. In the chemoradiation arm, there were more hospital admissions related to side effects (Po0.05). Conclusion: Chemoradiation was superior to chemotherapy alone with respect to survival and HRQoL at the expense of more hospital admissions due to toxicity

Low oxygen saturation and mortality in an adult cohort; the Tromsø Study

Published version, also available at http://dx.doi.org/10.1186/s12890-015-0003-5Background: Oxygen saturation has been shown in risk score models to predict mortality in emergency medicine. The aim of this study was to determine whether low oxygen saturation measured by a single-point measurement by pulse oximetry (SpO2) is associated with increased mortality in the general adult population. Methods: Pulse oximetry was performed in 5,152 participants in a cross-sectional survey in Tromsø, Norway, in 2001–2002 (“Tromsø 5”). Ten-year follow-up data for all-cause mortality and cause of death were obtained from the National Population and the Cause of Death Registries, respectively. Cause of death was grouped into four categories: cardiovascular disease, cancer except lung cancer, pulmonary disease, and others. SpO2 categories were assessed as predictors for all-cause mortality and death using Cox proportional-hazards regression models after correcting for age, sex, smoking history, body mass index (BMI), C-reactive protein level, self-reported diseases, respiratory symptoms, and spirometry results. Results: The mean age was 65.8 years, and 56% were women. During the follow-up, 1,046 (20.3%) participants died. The age- and sex-adjusted hazard ratios (HRs) (95% confidence intervals) for all-cause mortality were 1.99 (1.33–2.96) for SpO2 ≤ 92% and 1.36 (1.15–1.60) for SpO2 93–95%, compared with SpO2 ≥ 96%. In the multivariable Cox proportional-hazards regression models that included self-reported diseases, respiratory symptoms, smoking history, BMI, and CRP levels as the explanatory variables, SpO2 remained a significant predictor of all-cause mortality. However, after including forced expiratory volume in 1 s percent predicted (FEV1% predicted), this association was no longer significant. Mortality caused by pulmonary diseases was significantly associated with SpO2 even when FEV1% predicted was included in the model. Conclusions: Low oxygen saturation was independently associated with increased all-cause mortality and mortality caused by pulmonary diseases. When FEV1% predicted was included in the analysis, the strength of the association weakened but was still statistically significant for mortality caused by pulmonary diseases

Low FEV1, smoking history, and obesity are factors associated with oxygen saturation decrease in an adult population cohort

BACKGROUND: Worsening of pulmonary diseases is associated with a decrease in oxygen saturation (SpO(2)). Such a decrease in SpO(2) and associated factors has not been previously evaluated in a general adult population. AIM: We sought to describe SpO(2) in a sample of adults, at baseline and after 6.3 years, to determine whether factors predicting low SpO(2) in a cross-sectional study were also associated with a decrease in SpO(2) in this cohort. METHODS: As part of the Tromsø Study, 2,822 participants were examined with pulse oximetry in Tromsø 5 (2001/2002) and Tromsø 6 (2007/2008). Low SpO(2) by pulse oximetry was defined as an SpO(2) ≤95%, and SpO(2) decrease was defined as a ≥2% decrease from baseline to below 96%. RESULTS: A total of 139 (4.9%) subjects had a decrease in SpO(2). Forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value and current smoking with a history of ≥10 pack-years were the baseline characteristics most strongly associated with an SpO(2) decrease in multivariable logistic regression (odds ratio 3.55 [95% confidence interval (CI) 1.60–7.89] and 2.48 [95% CI 1.48–4.15], respectively). Male sex, age, former smoking with a history of ≥10 pack-years, body mass index ≥30 kg/m(2), and C-reactive protein ≥5 mg/L were also significantly associated with an SpO(2) decrease. A significant decrease in FEV(1) and a new diagnosis of asthma or chronic obstructive pulmonary disease during the observation period most strongly predicted a fall in SpO(2). A lower SpO(2) decrease was observed in those who quit smoking and those who lost weight, but these tendencies were not statistically significant. CONCLUSION: A decrease in SpO(2) was most strongly associated with severe airflow limitation and a history of smoking. Smoking cessation and reducing obesity seem to be important measures to target for avoiding SpO(2) decreases in the general population

Poor prognosis patients with inoperable locally advanced NSCLC and large tumors benefit from palliative chemoradiotherapy: A subset analysis from a randomized clinical phase III trial

Introduction: Poor prognosis patients with bulky stage III locally advanced non–small-cell lung cancer may not be offered concurrent chemoradiotherapy (CRT). Following a phase III trial concerning the effect of palliative CRT in inoperable poor prognosis patients, this analysis was performed to explore how tumor size influenced survival and health-related quality of life (HRQOL). Methods: A total of 188 poor prognosis patients recruited in a randomized clinical trial received four courses intravenous carboplatin day 1 and oral vinorelbine day 1 and 8, at 3-week intervals. The experimental arm (N = 94) received radiotherapy with fractionation 42 Gy/15, starting at the second chemotherapy course. This subset study compares outcomes in patients with tumors larger than 7cm (N = 108) versus tumors 7 cm or smaller (N = 76). Results: Among those with tumors larger than 7cm, the median overall survival in the chemotherapy versus CRT arm was 9.7 and 13.4 months, respectively (p = 0.001). The 1-year survival was 33% and 56%, respectively (p = 0.01). Except for a temporary decline during treatment, HRQOL was maintained in the CRT arm, regardless of tumor size. Among those who did not receive CRT, patients with tumors larger than 7cm experienced a gradual decline in the HRQOL. The CRT group had significantly more esophagitis and hospitalizations because of side effects regardless of tumor size. Conclusion: In patients with poor prognosis and inoperable locally advanced non–small-cell lung cancer, large tumor size should not be considered a negative predictive factor. Except for performance status 2, patients with tumors larger than 7 cm apparently benefit from CRT

Retrospective survival in elderly COPD patients receiving pulmonary rehabilitation; a study including maintenance rehabilitation

BACKGROUND: The aim of this study was to examine retrospective survival in elderly chronic obstructive pulmonary disease (COPD) patients receiving three different pulmonary rehabilitation (PR) programs. RESULTS: 193 patients [m / f 92 / 101, mean age 69.2 (standard deviation 8.6)] receiving PR were studied with lifetable and Cox regression analyses. Forced expiratory volume in 1 second (FEV(1)) % pred. was significantly different in the in-patient (n = 72), out-patient (n = 72), and maintenance group (n = 49) [mean 54.5 (21.8), 52.2 (17.7), and 42.9 (15.0), respectively (p = 0.004)]. PR days were 30.3 (20.4), 18.9 (10.4) and 30.0 (20.3), respectively (p < 0.001). Median survival rate was nine years in the in-patient, eight years in the out-patient and seven years in the maintenance group. Hospital stays and days were significantly increased in the maintenance group compared with the other groups (p = 0.003 and 0.010, respectively). The impact of evaluated variables on survival in the three PR groups was significant for age, FEV(1) as well as the use of long-term oxygen therapy (LTOT) (HR 1.06, for five years, p < 0.001, HR 0.98, p = 0.01, and HR 2.18, p = 0.005, respectively). CONCLUSIONS: The COPD patients in the maintenance group showed a worse survival, but after correction for gender, age and severity of obstruction, the difference was not statistically significant

Does chemotherapy improve Quality of Life in NSCLC PS 2?

Introduction Nearly 40% of patients with advanced NSCLC are in performance status (PS) 2. These patients have a shorter life expectancy than PS 0/1 patients and they are underrepresented in clinical trials. Data on how platinum-based combination chemotherapy affects Health Related Quality of Life (HRQOL) of patients with PS 2 are scarce and the treatment of this important group of patients is controversial. Methods A national multicenter phase III study on platinum based chemotherapy to 432 advanced NSCLC patients included 123 patients with PS 2. To explore the treatment impact on HRQOL, the development of HRQOL during the first nine weeks were compared between PS 2 and PS 0/1 patients. We used the EORTC QLQ-C30 and QLQ-LC13 questionnaires. Standardized area under the curve for all HRQOL items, and HRQOL responses classified as better, stable or worse, were compared between the groups. Results Whereas the demographic data at baseline were well balanced between the groups, the PS 2 patients had significantly worse function and more severe symptoms than the PS 0/1 patients. In response to combination chemotherapy, the PS 2 patients had a more profound improvement of global QOL, cognitive function, fatigue, dyspnea, sleeping problems and appetite loss in comparison to the PS 0/1 group. Conclusions PS 2 NSCLC patients seem to achieve valuable HRQOL benefits from platinum-based combination therapy. Prospective clinical studies with predefined HRQOL outcomes in PS 2 patients are needed to confirm these findings