Non-resectable Lung Cancer Research Articles

Prognostic factors of virus-associated pneumonia other than COVID-19 in adults

ObjectiveTo determine prognostic factors of virus-associated pneumonia other than coronavirus disease 2019. MethodsWe retrospectively studied patients suffering from virus-associated community-acquired pneumonia, and who were admitted to Saitama Cardiovascular and Respiratory Center from 2002 to 2020. Prognostic factors were analyzed by univariable and multivariable regression analysis of patient demographics, laboratory data, chest imaging, severity on admission, and initial treatment. PatientsHIV-positive patients, those with non-resected lung cancer or receiving chemotherapy, and those with COVID-19 were excluded. Included were 363 patients diagnosed by nucleic acid amplification method, paired sera, and rapid diagnostic tests. ResultsA CURB-65 score of ≥3 was significant by univariable analysis for 60-day mortality but was nonsignificant by multivariable analysis. The poor prognostic factors that were significant by multivariable analysis (p < 0.05) included immunosuppressive state due to systemic corticosteroid or immunosuppressant administration, acute kidney injury on admission, and corticosteroid administration initiated within 5 days or 5 days to 2 weeks from onset. ConclusionA CURB-65 score of ≥3, which is considered to indicate severe pneumonia, was of limited value for predicting mortality of virus-associated pneumonia. We showed patients’ underlying diseases and complications to be independent factors of poor prognosis for 60-day mortality. Timing of the initiation of corticosteroid administration remains to be elucidated.

An Essential Treatment Pattern of Lung Cancer: Magnetic Resonance-Guided Stereotactic Body Radiotherapy

<h3>Purpose/Objective(s)</h3> Stereotactic body radiation therapy (SBRT) has emerged as an important treatment for non-resectable lung cancer. MR-Linac can offer superior soft-tissue contrast, have the ability to visualize cancer physiology and daily on-table treatment adaptation. Obviously combined SBRT with MR-Linac holds the promise to improve the accuracy of radiotherapy and reduce the toxicity of organs-at-risk (OAR). However, data on treatment effect and patient acceptance is still limited. <h3>Materials/Methods</h3> Between July 2019 and October 2021,14 patients with lung cancer were treated with an MRI-Linac guided SBRT, of them, 6 in left upper lobe, 1 in left lower lobe, 2 in right upper lobe and 5 in right lower lobe. The CT simulation used a Siemens big-bore CT scanner (syngo CT VA62A) for all patients. All patients were treated with step and shoot intensity modulated radiotherapy (IMRT). The online plan was created while the patient was on the treatment table and based on the online MRI images; pre-treatment CT was deformably registered to the online MRI to obtain position error. All patients used adapt to position (ATP) workflow. The curative effect and adverse reactions in the process of treatment need to be paid close attention to, and the adverse reactions should be treated and recorded in time. <h3>Results</h3> Fourteen patients (with n=2 metastases; n=12 primary tumor) received MR-guided SBRT. Median prescribed does was 60Gy(range:54Gy-70Gy) and median planning target volume was 28.8cc (range:11.1-93.4cc). Two patients occurred grade I bone marrow suppression and two occurred grade II bone marrow suppression. One patient occurred grade I gastrointestinal toxicity. No patient occurred grade III or higher toxicity. Only one patient developed left lung recurrence and left hilar lymph node metastasis ten months after treatment, one patient was not re-examined, and others were controlled locally. <h3>Conclusion</h3> In summary, MR-guided SBRT of lung cancer is well-effective and well-accepted. The results are promising that it holds with prominent local control and mild adverse events. The influence of magnetic field on dosimetry remains to be studied. The relevant work is also conducted.

P59.06 Prognostic Nutritional Index in Real-World Patients Receiving Systemic Therapy for Driver Mutation-Positive Metastatic NSCLC

The Prognostic Nutritional Index (PNI) is an indicator of nutritional and immune status. Initially a prognostic index to evaluate the risk of recurrence and predict survival in patients following surgical procedures, recent studies have indicated the PNI may also have prognostic ability in non-resected lung cancer. The PNI has been shown to be independently predictive of outcome in patients with advanced/metastatic NSCLC (mNSCLC) treated with platinum-based chemotherapy (CTx). In response, this study explored the prognostic value of the PNI among real-world driver mutation-positive patients with mNSCLC receiving palliative intent systemic therapies, including (CTx), tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICI). Alberta patients diagnosed with driver mutation-positive (KRAS, ROS1, EGFR or ALK) mNSCLC receiving a first-line palliative-intent systemic therapy were identified. Demographic, clinical, treatment and outcome data were extracted from the institutional Glans-Look Lung Cancer Research Database. PNI was calculated as: [serum albumin (g/L) + 5 × peripheral blood lymphocytes (×109/L)] using blood component values taken ≤30 days prior to systemic therapy initiation. Receiver operator characteristic (ROC) curves were constructed to identify optimal cut-off points for PNI, and patients were stratified by this factor. Kaplan-Meier analysis and Cox Proportional Hazards models were used to investigate the association between PNI and outcome. 200 patients were identified (Table 1): Kaplan-Meier survival analysis revealed that mOS was significantly different by driver mutation-type, where generally ALK-rearranged NSCLC showed superior survival times to the other driver-mutation types (Table 1; log-rank p=0.04). mPFS was greatest in those receiving TKI in the first-line setting, in comparison to CTx (13.5 vs. 6.7 months, log-rank p=0.01) Stratified by optimal cut-point, ‘high’, compared to ‘low’ PNI had significantly longer mOS (27.6 vs. 20.4 months, log-rank p=0.03), but PFS was not significantly different between high/low PNI (13.5 vs. 10.3 months, log-rank p=0.23) A Cox Proportional Hazards model, constructed for the pooled cohort and controlling for known confounders revealed that PNI failed to retain prognostic value for OS; 'good' ECOG (<2) and never-smoking history emerged as independently prognostic of prolonged OS (HR: 0.47, p=0.002 and HR: 0.53, p=0.008, respectively). Similarly, PNI was not prognostic of PFS, but rather good ECOG was prognostic of prolonged PFS (HR: 0.55, p=0.03) and CTx prognostic of reduced PFS in relation to TKI (HR: 3.4, p=0.02) Among real-world driver-mutation positive mNSCLC, ECOG serves as a more robust prognosticator of outcome than PNI. Utility of PNI as a prognostic tool appears limited in this population.

Systemic inflammation, TNM staging and survival in patients with lung cancer

Abstract Background It is recognised that systemic inflammation plays an important role in the development and progression of lung cancer. Several affordable biomarkers could be used to evaluate systemic inflammation: neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and erythrocyte sedimentation rate (ESR). These biomarkers may be linked with survival in lung cancer. Aim To assess the relation between systemic inflammation evaluated by NLR, PLR and ESR, tumour nodes metastasis (TNM) staging and negative outcome in lung cancer. Materials and methods Patients with lung cancer were classified (7th TNM lung cancer staging) into two groups: Group A (resectable stages) and Group B (nonresectable stages). Each group was divided into two subsets: survivors (As, Bs) and deceased (Ad, Bd) patients. Complete blood count (CBC) and ESR were determined. NLR and PLR were calculated. NLR, PLR and ESR values were compared between the two groups and their subsets. Results 102 consecutive patients completed the protocol. In Group A (31 patients): NLR: 2.74 (0.87–12.94), PLR: 33.95 (21.61–416.66), ESR: 35 mm/h (6–135). Subgroup As: NLR: 2.36 (0.87–8.36), PLR: 138.82 (21.61–416.66), ESR: 15 mm/h (6–110). Subgroup Ad: NLR: 2.77 (1.25–12.94), PLR: 132.57 (41.11–371.17), ESR: 62 mm/h (11–135). In Group B (71 patients): NLR: 3.51(0.76–25.60), PLR: 170.37 (3.38–651.25), ESR:40 mm/h (3–120). Subgroup Bs: NLR: 1.40 (1.32–1.73), PLR: 112.89 (91.14–140.54), ESR: 31 mm/h (9–90). Subgroup Bd: NLR: 3.59 (0.70–25.60), PLR: 183.50 (3.38–651.25), ESR: 44 mm/h (3–120). NLR and PLR values were significantly higher (p: 0.04; p: 0.05) in Group B versus Group A. No significant difference was noted for ESR values between the two groups. In patients with nonresectable stages who were deceased (subgroup Bd), NLR and PLR values were significantly higher (p: 0.01; p: 0.03) versus survivals. In patients with resectable stages who were deceased (subgroup Ad), only the ESR value was significantly higher versus survivals. Conclusions Systemic inflammation assessed by affordable biomarkers as NLR and PLR is more prominent in advanced, nonresectable lung cancer. It may be a contributor, along with TNM staging, to the poor outcome of patients with nonresectable lung cancer. Clinical implication NLR and PLR may represent a valuable additional tool in the clinical management of patients with nonresectable lung cancer.

Differences in therapy and survival between lung cancer patients treated in hospitals with high and low patient case volume

BackgroundIn light of political discussions about minimum case volumes and certified lung cancer centers, this observational study investigates differences in therapy and survival between high vs. low patient volume hospitals (HPVH vs. LPVH). MethodsWe identified 12,374 lung cancer patients treated in HPVH (>67 patients) and LPVH in 2013 from German health insurance claims. Stratified by metastasis status (no metastases, nodal metastases, systemic metastases), we compared HPVHs and LPVHs regarding likelihood of resection and systemic therapy, type of systemic therapy, and surgical outcomes, using multivariate logistic models. Three-year survival was modeled using Cox regression. We adjusted all regression models for age, gender, comorbidity, and residence area, and included a cluster variable for the hospital. ResultsAround 24 % of patients were treated in HPVHs. Irrespective of stratum and subgroup, three-year survival was significantly better in HPVHs. In patients with systemic metastases (OR = 1.84, CI=[1.22,2.76]) and without metastases (OR = 3.28, CI=[2.13, 5.04]), resection was more likely in HPVHs. Among patients with systemic therapy, the odds of receiving pemetrexed was higher in HPVHs, in patients with nodal metastases (OR = 1.57, CI=[1.01,2.45]). In resected patients without metastases the odds ratio of receiving a thoracoscopic lobectomy was 2.28 (CI=[1.04,4.99]) in HPVHs. ConclusionOur data suggests that case volume is clinically relevant in resected and non-resected lung cancer patients, but optimal minimum case volumes may differ for subgroups.

The utility of TTF-1, napsin A, CK5 and p63 staining in the sub-classification of non-small cell carcinoma of the lung.

The potentially curative and/or palliative therapy for non-resectable lung cancer has evolved significantly over the past 2 decades. With the availability of targeted therapies, the need for precise sub-typing of non-small cell lung carcinoma (NCSLC) has become paramount. As there are few data from South Africa, we aimed to determine utility of TTF-1, napsin A, p63 and CK5 immunostaining on fine needle aspiration (FNA) cell block and formalin-fixed paraffin-embedded tissue biopsy specimens in subtyping NSCLC as adenocarcinoma and squamous cell carcinomas. All cases of NSCLC diagnosed during a 3-year period were retrospectively identified. All FNA biopsy and formalin-fixed paraffin-embedded cases that were stained with TTF-1, napsin A, CK5 and p63 were collected. A lung cancer registry was used to access and correlate clinical and radiological data. We included 271 cases with diagnoses of adenocarcinoma of the lung (n=201), squamous cell carcinoma of the lung (n=53), unspecified NSCLC (n=8) and other carcinomas (n=9). TTF-1 and napsin A had sensitivities of 99.0% and 91.9%, respectively, positive predictive values (PPVs) of 90.8% and 90.3%, respectively, and accuracies of 91.0% for adenocarcinoma of the lung. Napsin A had a higher specificity than TTF-1 (90.2% vs 62.8%). Both CK5 and P63 had high sensitivities (95.4% and 97.9%, respectively) and negative predictive values of 96.4% and 96.8%, respectively, for squamous cell carcinoma of the lung. CK5 had a higher specificity than p63 (84.4% and 61.2%, respectively), PPV (80.4% and 70.8%, respectively) and accuracy (88.8% and 79.2%, respectively) for squamous cell carcinoma. All four immunostaining methods had high sensitivities. TTF-1 and napsin A both had high PPV and diagnostic accuracy for adenocarcinoma of the lung, whereas CK5 had an equally high PPV and accuracy for squamous cell carcinoma of the lung. The specificity of napsin A for adenocarcinoma was higher than that of TTF-1. The specificity of CK5 for squamous cell carcinoma was higher than p63.

Use of Magnetic Resonance Imaging for N-Staging in Patients with Non-Small Cell Lung Cancer. A Systematic Review

IntroductionThe aim of this study is to assess the diagnostic value of the magnetic resonance imaging (MRI) in differentiating metastasic from non-metastatic lymph nodes in NSCLC patients compared with computed tomography (CT) and fluorodeoxyglucose (FDG) - positron emission tomography (PET) or both combined. MethodsTwenty-three studies (19 studies and 4 meta-analysis) with sample size ranging between 22 and 250 patients were included in this analysis. MRI, regardless of the sequence obtained, where used for the evaluation of N-staging of NSCLC. Histopathology results and clinical or imaging follow-up were used as the reference standard. Studies were excluded if the sample size was less than 20 cases, if less than 10 lymph nodes assessment were presented or studies where standard reference was not used. Papers not reporting sufficient data were also excluded. ResultsAs compared to CT and PET, MRI demonstrated a higher sensitivity, specificity and diagnostic accuracy in the diagnosis of metastatic or non-metastatic lymph nodes in N-staging in NSCLC patients. No study considered MRI inferior than conventional techniques (CT, PET or PET/CT). Other outstanding results of this review are fewer false positives with MRI in comparison with PET, their superiority over PET/CT to detect non-resectable lung cancer, to diagnosing infiltration of adjacent structures or brain metastasis and detecting small nodules. ConclusionMRI has shown at least similar or better results in diagnostic accuracy to differentiate metastatic from non-metastatic mediastinal lymph nodes. This suggests that MRI could play a significant role in mediastinal NSCLC staging.

Use of Magnetic Resonance Imaging for N-Staging in Patients with Non-Small Cell Lung Cancer. A Systematic Review

IntroductionThe aim of this study is to assess the diagnostic value of the magnetic resonance imaging (MRI) in differentiating metastasic from non-metastatic lymph nodes in NSCLC patients compared with computed tomography (CT) and fluorodeoxyglucose (FDG) - positron emission tomography (PET) or both combined. MethodsTwenty-three studies (19 studies and 4 meta-analysis) with sample size ranging between 22 and 250 patients were included in this analysis. MRI, regardless of the sequence obtained, where used for the evaluation of N-staging of NSCLC. Histopathology results and clinical or imaging follow-up were used as the reference standard. Studies were excluded if the sample size was less than 20 cases, if less than 10 lymph nodes assessment were presented or studies where standard reference was not used. Papers not reporting sufficient data were also excluded. ResultsAs compared to CT and PET, MRI demonstrated a higher sensitivity, specificity and diagnostic accuracy in the diagnosis of metastatic or non-metastatic lymph nodes in N-staging in NSCLC patients. No study considered MRI inferior than conventional techniques (CT, PET or PET/CT). Other outstanding results of this review are fewer false positives with MRI in comparison with PET, their superiority over PET/CT to detect non-resectable lung cancer, to diagnosing infiltration of adjacent structures or brain metastasis and detecting small nodules. ConclusionMRI has shown at least similar or better results in diagnostic accuracy to differentiate metastatic from non-metastatic mediastinal lymph nodes. This suggests that MRI could play a significant role in mediastinal NSCLC staging.

Handgrip Dynamometry and Patient-Generated Subjective Global Assessment in Patients with Nonresectable Lung Cancer

ABSTRACTIntroduction: Undernutrition is frequently associated with advanced lung cancer. Accurate nutritional assessment tools are important to provide the proper nutritional therapy. Handgrip dynamometry has already been used in these patients, and the findings suggest that it is a good indicator of nutritional status. Aims: The aim of this study was to evaluate the association between nutritional status and handgrip strength (HGS) in patients with nonresectable lung cancer. Methods: Cross-sectional study involving thirty-seven subjects with nonresectable lung cancer. Nutritional status was obtained using Patient Generated Subjective Global Assessment (PG-SGA), and muscle function was evaluated by HGS using a Jamar® handgrip dynamometer on the nondominant hand. The results of both methods were compared and correlated. Results: According to PG-SGA, 73% (n = 27) of the patients were moderately undernourished, and 8% (n = 3) were severely undernourished. In total, 81% (n = 30) were undernourished. HGS was below the 50th percentile in 57% of the patients (n = 21). We found a significant association between nutritional status according to PG-SGA and HGS (P = 0.026, CI = 95%). Conclusions: Handgrip dynamometry can be a useful tool to evaluate the functional and nutritional status. It can be included in lung cancer patients evaluation, along with other nutritional assessment tools.

Lung cancer survival in Norway, 1997-2011: from nihilism to optimism.

We examine changes in survival and patient-, tumour- and treatment-related factors among resected and nonresected lung cancer patients, and identify subgroups with the largest and smallest survival improvements.National population-based data from the Cancer Registry of Norway, Statistics Norway and the Norwegian Patient Register were linked for lung cancer patients diagnosed during 1997-2011. The 1- and 5-year relative survival were estimated, and Cox proportional hazard regression, adjusted for selected patient characteristics, was used to assess prognostic factors for survival in lung cancer patients overall and stratified by resection status.We identified 34 157 patients with lung cancer. The proportion of histological diagnoses accompanied by molecular genetics testing increased from 0% to 26%, while those accompanied by immunohistochemistry increased from 8% to 26%. The 1-year relative survival among nonresected and resected patients increased from 21.7% to 34.2% and 75.4% to 91.5%, respectively. The improved survival remained significant after adjustment for age, sex, stage and histology. The largest improvements in survival occurred among resected and adenocarcinoma patients, while patients ≥80 years experienced the smallest increase.Lung cancer survival has increased considerably in Norway. The explanation is probably multifactorial, including improved attitude towards diagnostic work-up and treatment, and more accurate diagnostic testing that allows for improved selection for resection and improved treatment options.

Outcome of intensive care treatment for lung cancer patients

Patients with lung cancer commonly require the ICU for a variety of acute illnesses related to the underlying malignancy, treatment, or comorbid conditions. ICU admission of patients with nonresectable lung cancer has been criticized based on the high mortality rate in this population. However, recent advances in critical care may have changed this scenario. The aim of this study was to identify factors associated with hospital mortality in this group of patients.

The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

BackgroundPeople with lung cancer have substantial symptom burden and more unmet needs than the general cancer population. Physical activity (PA) has been shown to positively influence quality of life (QOL), fatigue and daily functioning in the curative treatment of people with breast and colorectal cancers and lung diseases, as well as in palliative settings. A randomised controlled trial (RCT) is needed to determine if lung cancer patients benefit from structured PA intervention. The Physical Activity in Lung Cancer (PAL) trial is designed to evaluate the impact of a 2-month PA intervention on fatigue and QOL in patients with non-resectable lung cancer. Biological mechanisms will also be studied.Methods/designA multi-centre RCT with patients randomised to usual care or a 2-month PA programme, involving supervised PA sessions including a behavioural change component and home-based PA. QOL questionnaires, disease and functional status and body composition will be assessed at baseline, 2, 4 and 6 months follow-up. The primary endpoint is comparative levels of fatigue between the 2 arms. Secondary endpoints include: QOL, functional abilities and physical function. Exploratory endpoints include: anxiety, depression, distress, dyspnoea, PA behaviour, fitness, hospitalisations, survival, cytokines and insulin-like growth factor levels.DiscussionThis study will provide high-level evidence of the effect of PA programmes on cancer-related fatigue and QOL in patients with advanced lung cancer. If positive, the study has the potential to change care for people with cancer using a simple, inexpensive intervention to improve their QOL and help them maintain independent function for as long as possible.Trial registrationAustralian New Zealand Clinical Trials Registry No. ACTRN12609000971235

Use of Intensive Care in Patients With Nonresectable Lung Cancer

Admission of patients with lung cancer to the ICU has been criticized. We evaluated whether ICU admission improved 3-month survival in patients with nonresectable lung cancer. Factors associated with survival were identified. A retrospective study was conducted in consecutive nonsurgical patients with lung cancer admitted to three ICUs in France between 2000 and 2007, 2005 and 2007, and 2005 and 2006. We included 103 patients with a median (interquartile range) Simplified Acute Physiology Score II of 33 (25-46) and logistic organ dysfunction (LOD) score of 3 (1-4). Invasive mechanical ventilation was required in 41 (40%) patients. Sixty-three (61%) patients had metastasis and 26 (25%) an Eastern Cooperative Oncology Group performance status (ECOG-PS) > 2. The reason for ICU admission was acute respiratory failure in 58 (56%) patients. Three-month survival rate was 37% (95% CI, 28%-46%). By multivariate analysis, variables associated with mortality were ECOG-PS > 2 (hazard ratio [HR], 2.65; 95% CI, 1.43-4.88), metastasis at admission (HR, 1.90; 95% CI, 1.08-3.33), and worse LOD score (HR, 1.19; 95% CI, 1.08-1.32). An LOD score decrease over the first 72 h was associated with survival. Survival in nonsurgical patients with lung cancer requiring ICU admission was 37% after 90 days. Our results provide additional evidence that ICU management may be appropriate in patients with nonresectable lung cancer and organ failure.

Mutation profile of EGFR gene detected by denaturing high-performance liquid chromatography in Japanese lung cancer patients

EGFR mutations in lung cancer increase sensitivity to an EGFR tyrosine kinase inhibitor, gefitinib. Mutation analysis of EGFR is essential for prediction of gefitinib response and avoidance of the coincidental severe side effects for the unresponsive population. The purpose of the present study is to apply DHPLC as a screening system of detection of EGFR mutations for large scaled population. EGFR mutations were detected by both DHPLC procedure and direct sequencing using lung cancer tissue samples obtained from 97 patients (81 surgical specimens and 16 pleural effusions of non-resectable lung cancer patients). DHPLC analysis detected EGFR mutations in 5 h as opposed to 18 h by direct sequencing for ten samples, and it costs eightfold more expensive by direct sequencing than DHPLC. In addition, DHPLC analysis was sixfold more sensitive than sequencing analysis for detection of the point mutation of exon 21, L858R. Using this system, EGFR mutations in exons 18, 19 and 21 were found in 34 of 97 patients (36%). Thirteen of the 15 patients with exon 21 mutations (87%) were female non-smokers, who were diagnosed with adenocarcinomas with the feature of BAC. Eight of the 18 patients with exon 19 mutations (44%) were 7 male and 1 female current or former smokers, and BAC feature was observed in 61% (8/18). DHPLC analysis for screening followed by sequencing analysis appears to be more sensitive and accurate, as well as easier and faster. In addition, these results suggest different mutagenesis and carcinogenesis pathways for mutations.

Exploratory Thoracotomy for Nonresectable Lung Cancer

We sought to evaluate the effect of new diagnostic modalities on patients explored surgically for inoperable lung cancer. From July 1983 to February 1992, 335 patients underwent thoracotomy for lung cancer. Thirty-three of the 35 patients with nonresectable disease had sufficient data for analysis and underwent chest radiography (CXR), CT scan, and bronchoscopy. The study was terminated when video-assisted thoracoscopy (VAT) was introduced at the institution. Causes of nonresectability included significant N2 disease not diagnosed preoperatively (n = 11), tumor invasion of contiguous mediastinal structures (n = 8), and insufficient pulmonary function (n = 4). Four patients were left with unresected disease because of thoracic metastasis. Two patients had technically unresectable disease; three patients were explored surgically because diagnoses could be obtained by no other means. One patient was found to have small cell cancer. Data analysis demonstrated that 19 of 33 thoracotomies could potentially have been avoided or resulted in resection with current techniques. Refinement of imaging criteria, a judicious surgical approach to N2 disease, and VAT may significantly reduce thoracotomies for nonresectable lung cancer.

The EORTC QLQ-LC13: A modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials: Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. Department of Pulmonary Medicine, Renstromska Hospital, P.O. Box 17301, S-402 64 Goteborg. Eur J Cancer Part A Gen Top 1994;30:635–642

The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials composed of two basic elements: (1) a core quality of life questionnaire, the EORTC QLQ-C30, covering general aspects of health-related quality of life, and (2) additional disease- or treatment-specific questionnaire modules. Two international field studies were carried out to evaluate the practicality, reliability and validity of the core questionnaire, supplemented by a 13-item lung cancer-specific questionnaire module, the EORTC QLQ-LC13. In this paper, the results of an evaluation of the QLQ-LC13 are reported. The lung cancer questionnaire module comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). It was administered to patients with non-resectable lung cancer recruited from 17 countries. In total, 883 and 735 patients, respectively, completed the questionnaire prior to and once during treatment. The symptom measures discriminated clearly between patients differing in performance status. All item scores changed significantly in the expected direction (i.e. lung cancer symptoms decreased and treatment toxicities increased) during treatment. With one exception (problems with a sore mouth), the change of toxicity measures over time was related specifically to either chemo- or radiotherapy. However, the single item on neuropathy did not measure adequately the full range of symptoms. The hypothesised scale structure of the questionnaire was partially supported by the data. The multi-item dyspnoea scale met the minimal standards for reliability (Cronbach alpha coefficient > 0.70), while the pain items did not form a scale with reliability estimates acceptable for group comparisons. In conclusion, the results form international field testing lend support to the EORTC QLQ-LC13 as a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. In a few areas, however, the questionnaire module could benefit from further refinements. In addition, its performance over a longer period of time still needs to be investigated.

The EORTC QLQ-LC13: a modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials

The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials composed of two basic elements: (1) a core quality of life questionnaire, the EORTC QLQ-C30, covering general aspects of health-related quality of life, and (2) additional disease- or treatment-specific questionnaire modules. Two international field studies were carried out to evaluate the practicality, reliability and validity of the core questionnaire, supplemented by a 13-item lung cancer-specific questionnaire module, the EORTC QLQ-LC13. In this paper, the results of an evaluation of the QLQ-LC13 are reported. The lung cancer questionnaire module comprises both multi-item and single-item measures of lung cancer-associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). It was administered to patients with non-resectable lung cancer recruited from 17 countries. In total, 883 and 735 patients, respectively, completed the questionnaire prior to and once during treatment. The symptom measures discriminated clearly between patients differing in performance status. All item scores changed significantly in the expected direction (i.e. lung cancer symptoms decreased and treatment toxicities increased) during treatment. With one exception (problems with a sore mouth), the change of toxicity measures over time was related specifically to either chemoor radiotherapy. However, the single item on neuropathy did not measure adequately the full range of symptoms. The hypothesised scale structure of the questionnaire was partially supported by the data. The multi-item dyspnoea scale met the minimal standards for reliability (Cronbach α coefficient >0.70), while the pain items did not form a scale with reliability estimates acceptable for group comparisons. In conclusion, the results from international field testing lend support to the EORTC QLQ-LC13 as a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer patients participating in clinical trials, when combined with the EORTC core quality of life questionnaire. In a few areas, however, the questionnaire module could benefit from further refinements. In addition, its performance over a longer period of time still needs to be investigated.

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.

Decreases in serum cholesterol levels in advanced lung cancer.

Serum lipid concentrations, including triglycerides, free fatty acids, phospholipids, low-density lipoproteins, total cholesterol, high-density lipoprotein (HDL) cholesterol and lipoprotein fractions, were investigated in 43 male patients with advanced nonresectable lung cancer and 37 age- and sex-matched healthy male controls. The cancer patients as a group demonstrated significantly lower total cholesterol and HDL cholesterol as compared with the healthy controls. There were no significant differences between the various fractions of lipoproteins in the two patient groups. These results suggest hypocholesterolemia including decreased serum HDL cholesterol in advanced lung cancer patients.

Does Radiation Increase Survival in Nonresectable Lung Cancer?

Letters15 March 1992Does Radiation Increase Survival in Nonresectable Lung Cancer?George G. Spellman Jr, MDGeorge G. Spellman Jr, MDSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-116-6-524_2 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptTo the Editors: Although Dr. Ihde (1) awaits the end of the beginning in efforts to treat unresectable lung cancer, many clinicians and patients await the beginning of the beginning. Medical research has provided little information on the "no treatment" alternative for patients who are deciding whether to have traditional thoracic radiation, making informed consent difficult.A retrospective chart review of 16 patients with unresectable carcinoma of the lung, who died in the past 4 years after having declined cancer therapy, revealed 1-, 2-, and 5-year survival rates of 50%, 31%, and 13%, respectively. These data support Johnson and colleagues'...