Management of elderly patients with NSCLC; updated expert's opinion paper: EORTC Elderly Task Force, Lung Cancer Group and International Society for Geriatric Oncology.

Non-small-cell lung cancer (NSCLC) is a very common disease in the elderly population and its incidence in this particular population is expected to increase further, because of the ageing of the Western population. Despite this, limited data are available for the treatment of these patients and, therefore, the development of evidence-based treatment recommendations is challenging. In 2010, European Organization for Research and Treatment of Cancer (EORTC) took an initiative in collaboration with International Society of Geriatric Oncology (SIOG) and created an experts panel that provided an experts' opinion consensus paper for the management of elderly NSCLC patients. Since this publication, important new data are available and EORTC and SIOG recommended to update the 2010 recommendations. Besides recommendations for surgery, adjuvant chemotherapy and radiotherapy, treatment of locally advanced and metastatic disease, recommendations were expanded, to include data on patient preferences and geriatric assessment.

A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer.

BACKGROUND: The Breast Cancer Study Group of the Hellenic Oncology Research Group conducted a phase III trial of single-agent capecitabine versus the vinorelbine/gemcitabine doublet in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. The primary objective was to demonstrate superiority of combination treatment in terms of progression-free survival (PFS). PATIENTS AND METHODS: Women with MBC were randomly assigned to receive either capecitabine (Cap arm: 1250 mg/m(2) twice daily, on days 1-14) or vinorelbine/gemcitabine doublet (VG arm: vinorelbine 25 mg/m(2); gemcitabine 1000 mg/m(2); both drugs on days 1 and 15). RESULTS: Seventy-four women were treated on each arm and median PFS was 5.4 versus 5.2 months (P = 0.736), for VG and Cap, respectively. Median overall survival was 20.4 months for the VG arm and 22.4 months for the Cap arm (P = 0.319). Overall response rate was 28.4% in the VG arm and 24.3% in the Cap arm (P = 0.576). Both regimens were generally well tolerated. Neutropenia and fatigue were more common with VG arm and hand-foot syndrome with Cap arm. CONCLUSIONS: This trial failed to demonstrate superiority of vinorelbine/gemcitabine doublet over single-agent capecitabine in terms of PFS. Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients.

Biomarkers of clinical benefit for anti-epidermal growth factor receptor agents in patients with non-small-cell lung cancer.

Non-small-cell lung cancer (NSCLC) remains by far the major cause of cancer-related death in the Western world in both men and women. The majority of patients will be diagnosed with metastatic disease, and chemotherapy doublets remain the cornerstone of treatment for these patients. However, chemotherapy has a minimal impact on long-term survival and prognosis remains poor for these patients. Further improvement in treatment is likely to require incorporation of novel targeted therapies. Among these agents, inhibitors of the epidermal growth factor receptor (EGFR) have demonstrated significant activity in the first-, second- or third-line treatment of NSCLC. The purpose of current paper is to present the evidence for using several proposed molecular biomarkers as a tool for selection of NSCLC patients for anti-EGFR treatment. According to current data, EGFR mutation status appears to be the strongest predictor for the selection of NSCLC patients to first-line treatment with EGFR tyrosine kinase inhibitors vs chemotherapy. Use of other biomarkers remains investigational.

Efficacy and treatment tolerance in older patients with NSCLC: a meta-analysis of five phase III randomized trials conducted by the Hellenic Oncology Research Group.

BACKGROUND: Approximately 50% of newly diagnosed cases of non-small-cell lung cancer (NSCLC) are observed in patients >65 years, while 30%-40% of cases occur in patients >70 years. PATIENTS AND METHODS: The objective of the current study was to determine (i) the number of elderly (>70 years) patients with advanced/metastatic NSCLC enrolled in phase III trials of the Hellenic Oncology Research Group, (ii) the treatment-related toxicity observed in these patients compared with their younger counterparts, and (iii) the differences in terms of response rate, time to tumor progression (TTP), and overall survival (OS) between younger and older patients. RESULTS: Pooled data from five clinical trials including 1845 patients were analyzed; 1421 (77%) and 424 (23%) were <70 years and ≥70 years, respectively. No difference was observed in terms of the overall response rate and TTP. There was an OS difference between young and older patients, with higher risk for death in older patients. However, when the analysis was carried out after omitting a trial that showed a different trend, no difference was observed. Older patients experienced higher toxicity. CONCLUSIONS: This report supports the feasibility of chemotherapy treatment for older NSCLC patients. Optimization of treatment of older NSCLC patients requires the design of prospective older-specific phase III trials for these patients.

EORTC workshop on clinical trial methodology in older individuals with a diagnosis of solid tumors.

BACKGROUND: Due to the aging of the population, the number of older patients diagnosed with a malignant disease is increasing. A multidisciplinary approach to the senior adult cancer patient is mandatory, to assure optimal diagnosis and therapeutic management. DESIGN: European Organisation for Research and Treatment of Cancer (EORTC) has currently defined senior adult oncology as one of its priorities and has established an active Elderly Task Force (ETF). Under the auspices of the EORTC, the ETF organized a workshop on clinical trial methodology in older cancer patients and in this article, we present the conclusions of this workshop. RESULTS: Besides the 'classical' efficacy end points, quality of life, functional status and independence of the patient should be assessed in clinical trials in older patients. The participants of the workshop agreed on the use of a minimum dataset for the assessment of global health and functional status in older cancer patients. The panel also recommended that optimization of collaboration with pharmaceutical industry requires reporting of age-related data (subgroup analyses of clinical trials, age-related pooled analyses and obligatory post-marketing studies in vulnerable and frail older patients). CONCLUSION: The identification of proper clinical outcomes and the validation of geriatric screening tools are needed for conducting sound and comparable clinical trials.

Economic evaluation of docetaxel-gemcitabine versus vinorelbine-cisplatin combination as front-line treatment of patients with advanced/metastatic non-small-cell lung cancer in Greece: a cost-minimization analysis.

BACKGROUND: An economic evaluation was undertaken, alongside a randomized phase III study, to assess docetaxel-gemcitabine (DG) relative to vinorelbine-cisplatin (VC) combination as front-line treatment of patients with advanced/metastatic non-small-cell lung cancer. METHODS: No differences were found in efficacy, thus a cost-minimization analysis was carried out. Treatment cost accounts for the administration of first- and second-line chemotherapy, for concomitant medications, for laboratory and biochemical examinations, and for hospitalizations due to adverse events. Unit prices used reflect 2008 and are common among National Health Service hospitals in Greece. RESULTS: The mean total cost of therapy in the DG group [14045 euros, 95% uncertainty interval (UI) 12628 euros-15390 euros], was significantly higher than in the VC group (8143 euros, 95% UI 7314 euros-9067 euros). CONCLUSIONS: Even though the combination VC has similar effectiveness compared with DG in patients with metastatic lung cancer, it is associated with a lower overall treatment cost and hence, it is preferable from an economic perspective. However, it should be noted that although VC is associated with lower cost, it is also more toxic than DG regimen, a significant parameter that should be considered in clinical decisions.

EORTC Elderly Task Force and Lung Cancer Group and International Society for Geriatric Oncology (SIOG) experts' opinion for the treatment of non-small-cell lung cancer in an elderly population.

Non-small-cell lung cancer (NSCLC) represents a common health issue in the elderly population. Nevertheless, the paucity of large, well-conducted prospective trials makes it difficult to provide evidence-based clinical recommendations for these patients. The present paper reviews the currently available evidence regarding treatment of all stages of NSCLC in elderly patients. Surgery remains the standard for early-stage disease, though pneumonectomy is associated with higher incidence of postoperative mortality in elderly patients. Given the lack of demonstrated benefit for the use of adjuvant radiotherapy, it is also not recommended in elderly patients. Elderly patients seem to derive the same benefit from adjuvant chemotherapy as younger patients do, with no significant increase in toxicity. For locally advanced NSCLC, concurrent chemoradiotherapy may be offered to selected elderly patients as there is a higher risk for toxicity reported in the elderly population. Third-generation single-agent treatment is considered the standard of care for patients with advanced/metastatic disease. Platinum-based combination chemotherapy needs to be evaluated in prospective trials. Unfortunately, with the exception of advanced/metastatic NSCLC, prospective elderly-specific NSCLC trials are lacking and the majority of recommendations made are based on retrospective data, which might suffer from selection bias. Prospective elderly-specific trials are needed.

Chemotherapy-induced neutropenia as a prognostic factor in patients with advanced non-small cell lung cancer treated with front-line docetaxel-gemcitabine chemotherapy.

BACKGROUND: Front-line docetaxel-gemcitabine (DG) combination represents an alternative to platinum-based chemotherapy in patients with advanced NSCLC. One of its more common side effects is neutropenia. The association between the grade of DG-induced neutropenia and the clinical outcome was analyzed. PATIENTS AND METHODS: Eight hundred fifty-eight patients with locally advanced/metastatic NSCLC, treated with front-line DG were retrospectively analyzed. Patients were categorized into three groups according to the presented worst neutropenia grade: absent (grade 0), mild (grades I/II) and severe (grades III/IV). RESULTS: Response rate, median time to tumor progression (TTP) and median overall survival (OS) were significantly better in patients developing any grade of neutropenia compared with those without neutropenia. The median TTPs were 3.0, 5.4 and 5.6 months for the groups with absent, mild and severe neutropenia, respectively; the median OSs were 7.9, 12.5 and 11.2 months for the same groups, respectively. Multivariate analysis revealed that both mild and severe chemotherapy-induced neutropenia were independent factors associated with a better TTP and OS survival. CONCLUSION: Although DG-induced neutropenia was emerged as an independent prognostic factor, it remains to be demonstrated in prospective studies that dose escalation of chemotherapy drugs in patients who do not develop neutropenia may improve the clinical efficacy.

Long-term clinical benefit from salvage EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer patients with EGFR wild-type tumors.

BACKGROUND: Erlotinib has been approved for the management of NSCLC patients after failure of the first or subsequent line of chemotherapy. Although the efficacy of erlotinib is clearly associated with the presence of EGFR mutations, there is a subset of patients with EGFR wild-type (EGFRwt) tumors who impressively respond. PATIENTS AND METHODS: Patients with EGFRwt NSCLC who received salvage (≥2nd line) treatment with erlotinib for a prolonged period (>6 months), were sought from the database of the Hellenic Oncology Research Group. We retrospectively analyzed the clinical, pathological and molecular characteristics of the patients with available tumor material. RESULTS: Forty-four patients that received erlotinib for >6 months (median 10.1 months) were enrolled in the study. The majority of them were male, never-smokers with adenocarcinoma histology and a good performance status. KRAS and PIK3CA mutations were detected in 21% (9/42 tested) and 13% (4/30 tested) of the patients, respectively. The ALK-EML4 translocation was found in 10% (2/20 tested); there was no patient with HER2 or BRAF mutated tumor. Twelve (54.5%) tumor specimens were considered positive for EGFR-overexpression. Eleven patients experienced a partial response (objective response rate 25%; 95% CI 12-38%) and the remaining 33 had stable disease. The median progression-free survival and overall survival were 10.1 (95% CI 8.6-11.6 months) and 24.1 (95% CI 11.2-37 months), respectively. CONCLUSIONS: Treatment with erlotinib significantly improves the clinical outcome in a subset of NSCLC patients with EGFRwt tumors. Further molecular analysis of such tumor specimens could provide a more comprehensive characterization of this particular group of patients. Nevertheless, the presence of other mutations should not prevent the treating physician from using erlotinib at later lines of salvage therapy for NSCLC patients.

Sequential administration of docetaxel followed by maintenance gefitinib, as salvage treatment in patients with advanced NSCLC: a multicenter phase II trial.

PURPOSE: To evaluate the activity and toxicity of the sequential administration of docetaxel followed by gefitinib in patients with advanced non-small cell lung cancer (NSCLC). PATIENTS AND TREATMENT: Forty-one patients pre-treated with at least one prior chemotherapy regimen (platinum- or taxane-based) for advanced/metastatic NSCLC received three cycles of docetaxel 30 mg/m2, administered as a 1-h IV infusion, on days 1, 8 and 15 of each 4-week cycle followed by gefitinib 250 mg daily po. Gefitinib treatment was continued until disease progression, development of unacceptable toxicity, or withdrawal of patients consent. RESULTS: Two (4.9%) patients achieved a partial response and 10 (24.4%) stable disease, for a disease control rate of 29.3% (95% CI: 15.3%-43.2%) while on weekly docetaxel treatment. Additionally, progressive disease (PD) was observed in 29 (70.7%). No objective responses were observed during the gefitinib maintenance therapy; however, 17 (41.5%) patients presented stable disease maintained for more than 2 months. Median time to progression was 3.0 months (range: 1-38.3 months; 95% CI: 2.4-3.6); median overall survival 6.9 months (range: 1.2-40.2 months; 95% CI: 5.34-8.52) while the 1-year survival was 28.8%. Therapy was generally well tolerated with diarrhea and rash being the most frequent toxicities. CONCLUSIONS: The sequential administration of docetaxel and gefitinib was well tolerated and moderately active against advanced pre-treated NSCLC.

Adjuvant chemotherapy for colon cancer.

Surgery remains the only curative therapy for colon cancer. However, several studies during the last years have proved that systemic chemotherapy in the adjuvant setting definitely improves the curative rate for those patients with localized colon cancer. The combination of 5-fluorouracil (5-FU) and leukovorin (LV) remained the reference treatment for over a decade. However, oxaliplatin-based chemotherapy has emerged as the new standard of care in adjuvant treatment of stage III colon cancer. The role of adjuvant therapy in stage II cancers remains controversial and its routine use is recommended only in high risk patients. This review focuses on the efficacy, safety and toxicity of several drugs used in the adjuvant treatment of colon cancer and on clinical issues, such as the timing for initiation of chemotherapy, its duration and treatment of special patient subgroups, such as stage II or elderly patients.

The inflammatory bowel disease questionnaire: a review of its national validation studies.

Health-related quality of life (HRQoL) is an important measure of illness perception on the part of the patient. The Inflammatory Bowel Disease Questionnaire (IBDQ) is a widely used questionnaire for HRQoL assessment in patients with inflammatory bowel diseases (IBDs). This questionnaire has been adapted and validated into several languages and cultural milieus. The aim of this study is to review the methods used by several adaptation studies for assessing the validity and reliability of the adapted IBDQ. A search was made of the Medline database for relevant articles since 1989. Standard validation criteria were used for including studies for further evaluation. The following aspects of the validation procedure were examined: translation, construct validity, reliability, sensitivity to change, and used statistical methods. Nine validation studies of the IBDQ, in England and in non English-speaking countries (Holland, Spain, Korea, Sweden, Greece, and China) were selected. All studies concluded that the adapted instrument was valid and reliable. Only few modifications were proposed. Two studies recommended the split of the four dimensions of the original questionnaire in five. Assessing HRQoL in patients with IBD is an ever-increasing practice, especially in clinical trials. IBDQ was proven to be valid and reliable in several cultural and linguistic milieus when appropriate validation procedures were applied.

ZD1839, a novel, oral epidermal growth factor receptor-tyrosine kinase inhibitor, as salvage treatment in patients with advanced non-small cell lung cancer. Experience from a single center participating in a compassionate use program.

OBJECTIVE: We evaluated the efficacy and tolerability of the orally active, selective epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) ZD1839 in patients with pretreated advanced non-small cell lung cancer (NSCLC) participating in a compassionate use program. PATIENTS AND METHODS: Thirty-one patients with advanced, unresectable and progressive NSCLC, previously treated with one or two chemotherapy regimens, received ZD1839 250 mg orally once daily. Patients who had received only one prior chemotherapy regimen had to be considered unsuitable for second-line chemotherapy. RESULTS: The disease control rate was 32% (95% CI: 15.8-48.7) (1/31 patients had a partial response and 9/31 patients had stable disease) and the median overall survival 23 weeks (range 4-40). Symptom improvement was reported by 39% of patients overall and by 83% of patients who achieved disease control. The median time to symptom improvement was 3 weeks (range 2-4). Adverse events were generally mild (grade I or II) and reversible and consisted mostly of skin rash, diarrhea and fatigue. CONCLUSIONS: ZD1839 demonstrated clinically meaningful antitumor activity with significant improvement in symptoms in this heavily pretreated group of patients with advanced NSCLC. Furthermore, ZD1839 showed a favorable toxicity profile, with the majority of adverse events being mild and reversible.

Docetaxel versus docetaxel/cisplatin in patients with advanced non-small-cell lung cancer: preliminary analysis of a multicenter, randomized phase III study.

The purpose of this study was to compare the efficacy and safety profile of docetaxel versus the combination of docetaxel/cisplatin as frontline treatment of patients with advanced or metastatic non-small-cell lung cancer (NSCLC) in a multicenter, randomized, prospective phase III trial. Patients with unresectable stage IIIB or metastatic stage IV NSCLC who had previously undergone no chemotherapy were allocated to receive either docetaxel (100 mg/m2 in a 1-hour intravenous infusion; group A) or the combination of docetaxel (100 mg/m2 day 1) and cisplatin (80 mg/m2 day 2) after adequate hydration (group B). Appropriate premedication was given before docetaxel infusion. All patients in group B received granulocyte colony-stimulating factor (150 microg/m2 subcutaneously) support from days 3 to 9 after treatment. Response and toxicity were assessed by World Health Organization criteria. From March 1999 to November 2001, 302 patients were randomly assigned to receive docetaxel (group A, n = 146) or docetaxel/cisplatin (group B, n = 156). The overall response rate was significantly higher in the combination arm (18% vs. 36%; P < 0.001). However, the 2 groups did not differ in median duration of response, time to progression (TTP), median overall survival (OS), or 1-year survival rate. Drug combination was associated with higher toxicity than single-agent therapy. Both regimens had comparable activity in terms of TTP and OS in chemotherapy-naive patients with advanced NSCLC; however, single-agent therapy had a more favorable toxicity profile.

Instruments for quality of life assessment in patients with gastrointestinal cancer.

Health-related quality of life (HRQoL) is a multi-dimensional concept, encompassing all aspects of patient health and used widely as an outcome measure in clinical trials. In this review, the current status of HRQoL assessment in clinical studies of gastrointestinal cancer is examined and the various instruments proposed for this purpose are considered and compared. The cancer-specific questionnaires, among them the Spitzer Quality of Life Index, the Rotterdam Symptom Check List, the Functional Living Index-Cancer, the Functional Assessment of Cancer Therapy General (FACT-G) and the Quality of Life Questionnaire of the European Organization for Research and Treatment in Cancer (EORTC), provide essential information about particular concerns of cancer patients and are most sensitive in detecting changes over time. The domain-specific questionnaires, among them the Multidimensional Fatigue Inventory, the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale and the Anorectal Sphincter-Conservative Treatment Questionnaire, are designed to assess one specific domain of quality of life. The core-module cancer-specific questionnaires combine a core questionnaire for use in any type of cancer with a module questionnaire which assesses specific issues in cancer patient subgroups. Such core-module instruments have been evaluated for colorectal, pancreatic, hepatobiliary, oesophageal and gastric cancer. The most valid and standardized instruments for HRQoL assessment in cancer patients are the EORTC and the FACT questionnaires, which are widely used in Europe and around the world. Data provided by these specific instruments complement clinical outcomes and may help to evaluate the costs and benefits of different treatment options, thus being essential to further improvement of treatment and care of cancer patients.

Instruments for quality of life assessment in patients with inflammatory bowel disease.

BACKGROUND: Health-Related Quality of Life is an important measure of illness perception on the part of the patient. In this review, the current status of the Health-Related Quality of Life assessment in studies concerning inflammatory bowel disease is examined and the various instruments proposed for this purpose are considered and compared. METHODS: A search was made of the Medline database, for relevant articles since 1980. Standard criteria were used for including studies for further evaluation. RESULTS: All studies on measuring Health-Related Quality of Life in inflammatory bowel disease patients conclude that the instruments used were valid and reliable assessment tools. Valid instruments that have been proposed for the assessment of health-related quality of life are: the Inflammatory Bowel Disease Questionnaire, the Rating Form of Inflammatory Bowel Disease Patient Concerns, an Inflammatory Bowel Disease-specific questionnaire developed in Cleveland, the Ulcerative colitis and Crohn's disease Health Status Scales and a Disease-specific questionnaire developed in the University of Padova. CONCLUSIONS: Assessing health-related quality of life in inflammatory bowel disease patients is an ever-expanding practice, especially in clinical trials. The instruments that, currently, satisfy most demands for simplicity and validity are the Inflammatory Bowel Disease Questionnaire, reflecting primarily disease activity, and the Rating Form of Inflammatory Bowel Disease Patient Concerns which corresponds more to the psychological and social aspects of inflammatory bowel disease from the patient's point of view.

Autonomic imbalance during the day in patients with inflammatory bowel disease in remission. Evidence from spectral analysis of heart rate variability over 24 hours.

BACKGROUND: Autonomic function in inflammatory bowel disease has not yet been studied by means of analysis of 24-hour heart rate variability. AIM: To measure heart rate variability in inflammatory bowel disease patients in remission. PATIENTS AND METHODS: Study population comprised 27 patients with inflammatory bowel disease in remission and 28 healthy, sex- and age-matched controls. Two frequency ranges were analysed: low frequency (0.06-0.15 Hz) and high frequency (0.15-0.40 Hz). RESULTS: Mean values of low frequency and low frequency/high frequency ratio were lower in patients than in controls (p < 0.001). High frequency in patients tended to be higher than in controls (p = 0.09). The only factor that had a marginal effect on heart rate variability indexes was age. In high frequency, there was a significant time effect (p = 0.001) for both groups. There was also a significant time effect in low frequency/high frequency ratio in both groups (p < 0.001). During daytime, the mean values in low frequency/high frequency ratio were lower in patients than in controls (p < 0.001). CONCLUSIONS: There is a shift in the autonomic balance in patients with inflammatory bowel disease in remission towards a condition of relative parasympathetic predominance, which, in the first place, reflects a sympathetic pullback. This imbalance has a circadian rhythm and it is more pronounced during the day.

Epidermal growth factor receptor tyrosine kinase inhibitors in the treatment of NSCLC.

Improvements in our understanding of the molecular biology of cancer have shifted management of lung cancer toward molecular-guided, individualized treatment. Development of epidermal growth factor receptor tyrosine kinase inhibitors, erlotinib and gefitinib, represent the best example of this approach. Erlotinib was tested as second/third line treatment in unselected population of patients and demonstrated a statistically significant prolongation of overall survival, while gefitinib was shown to be non-inferior to docetaxel as second line treatment. The discovery of EGFR activating mutations facilitated the selection of patients most likely to benefit from erlotinib/gefitinib. These drugs in patients with EGFR activating mutations offer an increased progression free survival and significantly higher response rates compared to chemotherapy. The purpose of this paper is to present the relevant clinical data, describe the predictive markers available for TKIs treatment in NSCLC, and describe the mechanisms associated with resistance to treatment with these agents.

Economic evaluation of pemetrexed versus erlotinib as second-line treatment of patients with advanced/metastatic non-small cell lung cancer in Greece: a cost minimization analysis.

OBJECTIVES: An economic evaluation was conducted in conjunction with a prospective, multicenter, randomized trial, to compare pemetrexed with erlotinib in pretreated patients with metastatic non-small cell lung cancer (NSCLC) in Greece. METHODS: The effectiveness of treatments examined was comparable; thus, cost minimization analysis was conducted to evaluate which option is less costly. Patient-level resource utilization data were combined with unit cost data, which were aggregated to compute the total treatment cost for each patient. The analysis was conducted with respect to the individual incurring the cost. Due to the limited life-expectancy of the patients, discounting was unnecessary. Since data were right censored, the Bang and Tsiatis method was employed to identify unbiased estimators of the mean cost per treatment arm, while other methods were employed for sensitivity analysis. To analyze uncertainty and to construct uncertainty intervals (UI), stochastic analysis was performed based on 5000 bootstrap replications. RESULTS: The one-year survival rate was 28.3% in the pemetrexed arm and 31.7% in the erlotinib arm, while the corresponding median survival over the follow-up period was 7.1 and 6.7 months, respectively (P = 0.765). Total cost in the pemetrexed arm was €10508 (95% UI: €9552-€11488), while in the erlotinib arm the cost was €9563 (95% UI: €8499-€10711); thus, no statistically significant difference was found between the comparators (P = 0.206). Results remained constant for all sensitivity analyses. CONCLUSIONS: There is no survival or cost difference between erlotinib and pemetrexed; thus, these therapies are equivalent. Further studies are needed to determine whether other parameters, such as quality of life, differ among treatment options.

Are we treating enough elderly patients with early stage non-small cell lung cancer?

Despite the fact that non-small-cell lung cancer (NSCLC) is very common in the older population, these patients are frequently underrepresented in clinical trials evaluating new anti-cancer agents, and thus it is difficult to reach evidence-based recommendations for this special population. The purpose of the present paper is to present the currently available evidence regarding treatment of early-stages of NSCLC in older patients. Although, age is still considered as a negative factor influencing treatment decisions and curative cancer-directed surgery is often omitted in the older population several studies support that surgical resection is feasible in the older patient and that age per se is not a contraindication for various surgical procedures. Pneumonectomy is associated with a higher mortality in the older population and this issue should be taken into account when deciding whether a patient is suitable for pneumonectomy. Older patients should be considered for adjuvant chemotherapy after surgical resection although little information is available regarding the real benefit and tolerability of these regimens for patients over 75 years of age. Given the lack of demonstrated benefit for the use of adjuvant RT it is also not recommended in older population.