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D. Behera
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OA17 - Aspects of Health Policies and Public Health (ID 397)
- Event: WCLC 2016
- Type: Oral Session
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:M. Kneussl
- Coordinates: 12/06/2016, 16:00 - 17:30, Schubert 1
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OA17.04 - Discussant for OA17.01, OA17.02, OA17.03 (ID 7092)
16:00 - 17:30 | Author(s): D. Behera
- Abstract
- Presentation
Abstract not provided
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-009 - Venous Thromboembolism (VTE) in Lung Cancer - Associations and Prognostic Role: Results of a Prospective Cohort Study from North India (ID 3758)
14:30 - 15:45 | Author(s): D. Behera
- Abstract
Background:
Venous thromboembolism (VTE) in cancer remains an under-evaluated and under-diagnosed entity. This prospective study aimed to assess VTE incidence, risk factors for its occurrence and its effect on overall survival (OS) in a cohort of lung cancer (LC) patients at diagnosis and during first-line chemotherapy.
Methods:
Over a 1-year period (July 2014-June 2015), 301 patients with histology-proven LC were screened for deep venous thrombosis (DVT) with compression ultrasonography and for pulmonary thromboembolism (PTE) with CT pulmonary angiography at diagnosis and after four cycles of chemotherapy. Patient demographics, comorbidities, presenting symptoms of VTE events, treatment details and outcomes were noted. Logistic regression and Cox proportional hazard analyses were done to determine factors associated with VTE occurrence and OS respectively.
Results:
Most patients had advanced disease (51.2% Stage IV; 31.9% stage IIIB). Overall, 16/301 patients (5.3%) had VTE [DVT alone (n=5), PTE alone (n=2) and DVT with PTE (n=9)] with incidence rate of 90 per 1000 person-years. Median duration from LC diagnosis to VTE event was 96.5 days. All DVT episodes were symptomatic. PTE events were symptomatic in 72.7% and massive (attributable hypotension) in 36.4% for which thrombolysis was done. VTE treatment was associated with minor bleeding in 3 patients but no major bleeding occured. Age, COPD [odds ratio (OR) = 5.2], ECOG PS ≥2 (OR=3.1), and number of extrathoracic metastatic sites (OR=1.9) were independent risk factors for VTE on multivariate logistic regression analysis. No association was observed with histology, EGFR mutation status, other comorbidities or baseline biochemical tests. Chemotherapy regimens, number of chemotherapy cycles and radiological responses were similar amongst patients with and without VTE. Median OS was significantly less in VTE patients [161 (95% CI = 79-243) vs. 311 (95% CI = 270-352) days; p=0.007] with death attributable to VTE in 50%. On multivariate Cox proportional hazard analysis, VTE [hazard ratio (HR) = 2.1 (95% CI = 1.1-3.8)] was independently associated with poor OS as were smoking [HR = 1.7 (95% CI = 1.1-2.7)], ECOG PS ≥ 2 [HR = 1.6 (95% CI = 1.1-2.3)] and serum albumin [continuous variable HR = 0.6 (95% CI = 0.4-0.8)].
Conclusion:
VTE occurs in approximately 5% of newly diagnosed LC patients, is associated with inherently poor prognostic factors (COPD, ECOG PS≥2, hypoalbuminemia and extent of metastasis) and with worse OS independent of other variables. Since all DVT episodes are symptomatic, compression ultrasonography remains the preferred mode for cost-effective initial evaluation of suspected VTE in developing countries.
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-030 - Optimum Duration of Vitamin B12/Folate Supplementation in NSCLC Patients on Pemetrexed Based Chemotherapy: The PEMVITASTART Randomized Trial (ID 3903)
14:30 - 15:45 | Author(s): D. Behera
- Abstract
Background:
Pemetrexed, an anti-folate drug, is the preferred chemotherapeutic agent for non-squamous NSCLC histology. Addition of vitamin B12 and folic acid (folate; 350–1000μg PO daily) supplementation to pemetrexed containing regimens reduces the incidence and severity of myelosuppression without diminishing antitumor efficacy. Folate supplementation and vitamin B12 (1000μg intramuscular every nine weeks) should be started one week before the first cycle of chemotherapy and continued for atleast three weeks beyond the last cycle. However, observational and prospective single arm studies have not shown any increase in toxicity when pemetrexed was started prior to completion of the recommended duration (one week) of supplementation.
Methods:
The current study is an open-label, randomized trial (PEMVITASTART; NCT02679443) to evaluate differences in pemetrexed-related hematological toxicity amongst patients initiated on chemotherapy following 5-7 days of vitamin B12 and folate supplementation (Delayed Arm) compared to those in whom the above supplementation is started simultaneously with (within 24 hours of) chemotherapy initiation (Immediate Arm). Eligible patients are chemo-naïve WITH cytologically/histopathologically proven non-squamous NSCLC AND locally advanced/metastatic (Stage IIIB/IV) disease (OR Stage IIIA not scheduled for upfront surgical resection) AND ECOG PS 0-2. Prior molecular targeted therapy is an exclusion but previous radiation therapy is permitted if completed atleast four weeks before enrollment. Other important exclusion criteria include hemoglobin <9 gm/dL, administration of erythropoiesis stimulating agents (ESAs) or packed RBC (PRBC) transfusions in the past four months and symptomatic untreated brain metastasis. Randomization is 1:1 into delayed and immediate arms. All enrolled patients will receive pemetrexed in standard dose of 500 mg/m2 in combination with either cisplatin (65 mg/m2) or carboplatin (AUC 5.0mg/mL/min) each drug being given on day 1 of a 3-week cycle. Primary Outcome: Incidence of any grade hematological toxicity (NCI-CTC AE v3.0); Secondary Outcomes: a) Incidence of grade 3/4 hematological toxicity b) Number of granulocyte colony stimulating factors (G-CSFs), ESAs and PRBCs administered c) Relative Dose Intensity (RDI) delivered d) Number of Inter-Cycle Delays (≥ 7 day duration). Other Pre-specified Outcomes: Changes in serum levels of folic acid and homocysteine after third/sixth cycle. Enrolled patients will be followed up till three weeks beyond completion of pemetrexed-platinum doublet chemotherapy (average 18 weeks). Radiological Responses will be assessed by RECIST v1.0. IEC approval has been obtained and patients are enrolled after giving informed consent. The single centre study was opened to accrual in July 2015 and will continue till atleast 128 patients are enrolled. Clinical trial information: NCT02679443
Results:
Not Applicable
Conclusion:
Not Applicable
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SC17 - Lung Cancer: A Global Cancer with Different Regional Challenges (ID 341)
- Event: WCLC 2016
- Type: Science Session
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:C. Vallejos, P.A. Bunn, Jr.
- Coordinates: 12/06/2016, 14:20 - 15:50, Strauss 1
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SC17.03 - Lung Cancer in India: Challenges and Perspectives (ID 6668)
14:20 - 15:50 | Author(s): D. Behera
- Abstract
- Presentation
Abstract:
Lung cancer is the commonest type of cancer in males and the leading cause of cancer death in both sexes world-wide. It is also the commonest in men in India accounting for 11.3% of all new cancers and also is the most common cause of cancer death (13.7%). In contrast to a decline trend in men in developed countries with a plateau for females, in India, the incidence continues to rise for both males and females. Data from the population based cancer registries developed under the National Cancer Registry Program of the Indian Council for Medical Research(ICMR) indicates that there is wide geographical variability in the incidence of this disease in different parts of the country. The highest age adjusted incidence rates of 45 per 100000 population are seen in the North-East region of India and are similar to areas reporting the highest incidence rates in some parts of the US and Europe. In other areas of India, especially the Western region, the age adjusted incidence rates are as low as 2 per 100000 population. The demographic profile including age, gender, stage, histology and even the molecular epidemiology (prevalence of EGFR mutations and ALK rearrangements) varies considerably in different parts of India. However, the overall incidence is much lower than that compared to many western countries. The demographic profile of lung cancer seen in India needs special mention. In the past, a single-centre large series of 1009 patients presenting to our institute from 1977-86 had shown squamous histology to the commonest (34.3%) followed by adenocarcinoma (25.9%) and small cell lung cancer (SCLC; 20.3%). Subsequent analysis of 250 patients presenting to us three decades later (2007-09), we found that the histological pattern was largely unchanged with squamous still being the commonest (34.8%) followed by adenocarcinoma (26.0%) and SCLC (18.4%). The male-female ratio as well as the current/ex-smoker to never-smoker ratio was also similar between the two cohorts. A possible reason for the lack of change in demographic profile of lung cancer was thought to be related to the fact that ‘bidi’ and NOT cigarette is the most common form of tobacco smoking in India. The ratio of bidi to cigarette smoking in India ranges from 2.5:1 to 7.0:1 in different parts of India and unlike cigarette making, there has been no change in the process of bidi manufacturing which is primarily a cottage industry. The other important aspect related to its association of quantified tobacco smoke exposure. The smoking index (SI; number of combined bidis and cigarettes smoked per day multiplied by number of years smoked) has been developed for this purpose. Patients can be categorized as either never-smokers (SI=0), light to moderate smokers (SI=1-300) and heavy smokers (SI≥301). In a cohort of 520 non-small cell lung cancer (NSCLC) patients, we observed that age, gender, histological type and stage differed significantly between the three groups. Never-smokers had significantly more females (52%), were younger (mean age 54.5 years), lesser squamous histology (28%), more advanced stage (IIIB/IV; 92%), more metastatic disease (67.4%) and more extra-thoracic metastases (42%) while group of heavy smokers had more males (98%), were older (mean age 61.2 years), more squamous histology (58%), lesser advanced stage (81%), lesser metastatic disease (39%) and lesser extra-thoracic metastases (17%). We have identified another risk factor in women to be the exposure to Biomass fuel. Majority of patients (approximately 83% of NSCLC histology at our centre) present with advanced stage(IIIB/IV) at the time of diagnosis and are managed non-surgically. Misdiagnosis as tuberculosis and empirical treatment with anti-tubercular drugs prior to referral to higher centre is one of the important causes for delayed diagnosis of this disease in India. Developing and under-developing countries are often constrained with regards to availability of health care and other resources necessary for appropriate management of the health related requirements of their population and this holds true for lung cancer as well. Some of the challenges in resource constrained settings include: · Large population with high population density · Illiteracy and poor health awareness · Sub-optimal economic and infrastructure inputs for health care · Suboptimal ratios of doctor and nurses for population · Overburdened hospitals and health care facilities · Huge burden of TB that hinders differentiation by the primary physician with lung cancer Important issues in resource constrained settings include choosing the platinum agent as well as the non-platinum agent. Decision on dose intensity may also be influenced by similar factors (efficacy, tolerance, toxicity profile and packaging strengths of marketed drugs). A list of some of the important factors influencing decision are shown below.
Dr. D. Behera Senior Professor & Head, Dept. of Pulmonary Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh - 160012 (INDIA) Email: [email protected] Select References and suggested reading 1. Behera D, Balamugesh T. Lung cancer in India. Indian J Chest Dis Allied Sci 2004; 46 : 269-81 2. Behera D. Managing lung cancer in developing countries: difficulties and solutions. Indian J Chest Dis Allied Sci 2006; 48: 243-4 3. Jindal SK, Behera D. Clinical spectrum of primary lung cancer: review of Chandigarh experience of 10 years. Lung India 1990; 8: 94-98 4. Singh N, Aggarwal AN, Gupta D, Behera D, Jindal SK. Unchanging clinico-epidemiological profile of lung cancer in North India over three decades. Cancer Epidemiol 2010; 34: 101-4. 5. Behera D, Balamugesh T. Indoor air pollution as a risk factor for lung cancer in women. J Assoc Physicians India 2005; 53: 190-2. 6. Singh N, Aggarwal AN, Gupta D, Behera D, Jindal SK. Quantified smoking status and non-small cell lung cancer stage at presentation: analysis of a North Indian cohort and a systematic review of literature. J Thorac Dis 2012; 4: 474-84. 7. Singh N, Behera D. Lung cancer epidemiology and clinical profile in North India: Similarities and differences with other geographical regions of India. Indian J Cancer 2013; 50: 291 8. Singh N, Aggarwal AN, Behera D. Management of advanced lung cancer in resource constrained settings : a perspective from India. Expert Rev Anticancer Ther 2012: 12: 1479–95. 9. Maturu VN, Singh N, Bal A, Gupta N, Das A, Behera D. Relationship of epidermal growth factor receptor activating mutations with histologic subtyping according to International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society 2011 adenocarcinoma classification and their impact on overall survival. Lung India 2016; 33: 257-66. 10. Bal A, Singh N, Agarwal P, Das A, Behera D. ALK gene rearranged lung adenocarcinomas: molecular genetics and morphology in cohort of patients from North India. APMIS 2016 Aug 8; DOI: 10.1111/apm.12581 [Epub ahead of print]Characteristic Relative importance Disease related Age ++ Gender + Histology +++ Molecular profile of tumor ++ Stage + Performance Status +++ Unrelated to disease Co-morbid illnesses + Socio-economic background/financial constraints +++ Medical reimbursement/insurance issues +++ Wishes of patient/family members ++ Frequency of hospital visits ++
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
