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J. Jassem
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MO06 - NSCLC - Chemotherapy I (ID 108)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:R. Perez-Soler, P.M. Ellis
- Coordinates: 10/28/2013, 16:15 - 17:45, Parkside Ballroom A, Level 1
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MO06.06 - Oral vinorelbine (NVBo) and cisplatin (P) or pemetrexed (Pem) and P as first-line chemotherapy for non squamous (NS) metastatic or locally advanced non small cell lung cancer (M or LA NSCLC): Final results of a prospective randomised phase II trial (NAVoTrial 1) (ID 276)
16:15 - 17:45 | Author(s): J. Jassem
- Abstract
- Presentation
Background
NVBo and P are an established regimen in advanced NSCLC. The approval of Pem and P in NS NSCLC recognises histology as treatment driver even if the higher chemosensitivity of NS NSCLC is recognised and reported with other chemotherapies (Ardizzoni. JNCI 2007). NVBo + P also showed better survival in NS NSCLC than in Squamous NSCLC (Tan. Ann.Oncol. 2009). The current randomised (2:1) phase II trial assessed disease control (DCR) (SD + PR + CR) of NVBo/CDDP or PEM/CDDP in NS NSCLC.Methods
Stage IIIB/IV untreated/relapsed NS NSCLC pts were randomised to receive q3w NVBo 80 mg/m² D1D8 (60 at Cycle 1) + P 80 mg/m² D1 (Arm A) or Pem 500 mg/m² + P 75 mg/m² D1 (Arm B). After 4 cycles of combination, non PD pts received single agent NVBo (Arm A) or PEM (Arm B) as maintenance until progression or toxicity. Pts were randomised on a 2/1 basis and stratified according to Stage (IIIB - IV - relapse), non SCC confirmed by histology or cytology, gender, smoking status and centre.Results
From 11/09 to 02/11, 153 patients were enrolled in 31 centers and randomised to Arm A (102 pts) or Arm B (51 pts). DCR after combination and maintenance was 75.0% (95% CI, 65.3 to 83.1) in Arm A and 76.5% (95% CI, 62.5 to 87.2) in Arm B. Median PFS was 4.2 (95% CI, 3.6 to 4.7) and 4.3 months (95% CI, 3.8 to 5.6) in Arm A and Arm B, respectively. Median OS was 10.2 months (95% CI, 7.8 to 11.9) and 10.8 months (95% CI, 7.0 to16.4) in Arm A and Arm B, respectively. During the combination period Grade 3/4 neutropenia was 44.0% in Arm A and 18.3% in Arm B but febrile neutropenia was 2% in both arms; grade 3/4 thrombopenia was 0% and 6% in Arm A and Arm B, respectively.Conclusion
Both doublets reported good efficacy and acceptable tolerability. The maintenance allowed continuation of effective treatment with either oral vinorelbine or pemetrexed as single agent, with an acceptable safety with both agents. These results are sufficiently compelling to consider whether a phase III randomised non inferiority study with oral vinorelbine maintenance after induction vinorelbine/cddp could be as effective as pemetrexed maintenance. An oral maintenance may be a definite advantage over intravenous maintenance.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.
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O07 - Supportive and Surgical Care (ID 136)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Surgery
- Presentations: 1
- Moderators:M. Culligan, K.A. Mooney
- Coordinates: 10/28/2013, 10:30 - 12:00, Bayside Gallery A, Level 1
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O07.03 - Quantifying the humanistic burden of caregiving for patients with lung cancer in Europe (ID 1981)
10:30 - 12:00 | Author(s): J. Jassem
- Abstract
- Presentation
Background
Lung cancer, the leading cause of cancer-related death, is associated with poor survival, painful, life-threatening disease attributes, and greater associated economic burden compared with other cancers. The disease also presents multiple challenges for the caregivers of patients with lung cancer, including increased distress, significant impact on social and health-related quality of life (HRQoL), and costs associated with loss of income and time spent on patient care. Little information exists on the extent of this caregiver burden. The current study aims to investigate the HRQoL and the comorbidity burden of caregivers of patients with lung cancer in several European (EU) countries.Methods
Data were provided from the 2010 and 2011 EU National Health and Wellness Survey (NHWS), an annual, stratified, random, cross-sectional, self-administered Internet-based survey of healthcare attitudes and behaviors among adults in France, Germany, Italy, Spain, and the United Kingdom (n=114,962). Respondents who reported providing care for a patient with lung cancer ("caregivers") were compared with respondents not providing care ("non-caregivers") on measures of HRQoL and self-reports of diagnosis with conditions known to be caused or exacerbated by psychological stress. HRQoL was assessed using the 12-Item Short Form Survey (SF)-12v2, which included Mental (MCS) and Physical (PCS) Component Summary scores; mental and physical functioning subscales; and SF-6D health state utilities (with higher scores indicating better health status and minimally important differences [MIDs] of 3 points in PCS/MCS scores, and 0.03 points in health utilities).The self-reported diagnoses of interest included depression, anxiety, insomnia, headache, migraine, and gastrointestinal (GI) illnesses (ie, gastroesophageal reflux disease, heartburn, and/or irritable bowel syndrome). Regression models were used to predict health outcomes as a function of caregiving vs non-caregiving, controlling for demographics (age, gender, education, income, marital status, employment, body mass index category), health risk behaviors (exercise, smoking), and the Charlson Comorbidity Index (reflecting mortality risk).Results
No significant differences between caregivers (n=107) and non-caregivers (n=103,868) on sociodemographic and health characteristics were observed. Caregivers and non-caregivers were on average 44.1 and 46.3 years old, respectively, and employed (55.1% and 57.4%, respectively), suggesting care given by children rather than by spouse/partner. Adjusting for covariates, caregivers reported significantly worse HRQoL than non-caregivers, including PCS (-1.91 points, P=.017), MCS (-3.52 points, P <.001, exceeding MID), health utilities (-0.049 points, P <.001, exceeding MID), and all subscales, except vitality (-1.83 to -4.87, all P <.03). In addition, caregivers had about twice the odds of non-caregivers of diagnosis with depression (OR=1.885, P =.018), insomnia (OR=2.190, P =.002), headache (OR=1.997, P =.008), and GI problems (OR=1.970, P =.002).Conclusion
Adjusting for confounders, caregivers for patients with lung cancer reported significantly lower mental and physical health status, lower health utilities, and higher depression, insomnia, headache, and GI problems than non-caregivers. In addition to confirming and extending knowledge of the caregiver burden of lung cancer in EU, this study highlights a need for increased personalized support for caregivers. Research on other aspects of caregiver burden, such as healthcare resource utilization and work productivity, will help refine estimation of the financial impact of lung cancer on society.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.
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PL03 - Presidential Symposium Including Top Rated Abstracts (ID 85)
- Event: WCLC 2013
- Type: Plenary Session
- Track:
- Presentations: 1
- Moderators:M. Boyer, K. Fong
- Coordinates: 10/29/2013, 08:15 - 09:45, Plenary Hall, Ground Level
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PL03.06 - DISCUSSANT (ID 3886)
08:15 - 09:45 | Author(s): J. Jassem
- Abstract
Abstract not provided
