Abstract 5511
Background
Hyponatremia (serum sodium concentration [Na+] <135 mmol/L), is the most common electrolyte disorder in lung cancer patients (incidence 20–44%) with SIADH a frequent cause, particularly in small cell lung cancer (SCLC).
Methods
ASSERT was a prospective, observational, non-interventional study conducted from October 2015 to June 2017 in cancer patients requiring treatment for hyponatremia secondary to SIADH at 18 Italian oncology centres. Management of hyponatremia primarily included water restriction, tolvaptan and hypertonic saline, in accordance with local standard of care/guideline recommendations. The primary endpoint was change in serum [Na+] from baseline visit to end of the first month of the observational period, or earlier discontinuation.
Results
The full analysis set (FAS) included 68 adult cancer patients (lung cancer, n = 48, SCLC, n = 33). Group 1 patients received ≥1 dose of tolvaptan during the observational period; Group 2 patients did not receive tolvaptan. Overall survival (FAS) was significantly higher in Group 1 vs Group 2 (median 123 vs 56 days; p = 0.001), as was mean survival (299.4 vs 74.9 days; p = 0.001). In a linear regression analysis of the relationship between sodium levels and tolvaptan dose intensity for the lung cancer and SCLC cohorts, dose intensity correlated significantly with clinical response after 6 months of treatment in both cohorts (p = 0.005 and p = 0.023, respectively). In the lung cancer cohort, a significantly higher percentage of patients achieved serum [Na+] ≥130 mmol/L in Group 1 vs Group 2 during 6 months of follow-up (Group 1, 87.5% vs Group 2, 62.5%; p = 0.033). These results were similar to those observed in the FAS.
Conclusions
Hyponatremia secondary to SIADH is a potentially modifiable risk factor, which might be implicated in the survival of lung cancer patients. Correction of hyponatremia may be preferentially achieved with pharmacological treatment, rather than the non-pharmacological approaches routinely used in clinical practice.
Clinical trial identification
NCT102573077.
Editorial acknowledgement
Sarah Stowell PhD, CMPP of Ashley Medical Communications, funded by Otsuka Pharmaceutical Europe Ltd.
Legal entity responsible for the study
Otsuka Pharmaceutical Italy Srl.
Funding
Otsuka Pharmaceutical Italy Srl.
Disclosure
R. Berardi: Honoraria (self), Advisory / Consultancy: Otsuka Pharmaceutical. C. Ferrara: Full / Part-time employment: Otsuka Pharmaceutical Italy. M.G. Giustra: Full / Part-time employment: Otsuka Pharmaceutical Italy. R. Evans: Full / Part-time employment: Otsuka Pharmaceutical Europe. All other authors have declared no conflicts of interest.
Resources from the same session
5314 - Spirituality and religious coping for Cancer patients and providers: An ‘Almighty’ belief for palliative care
Presenter: Vibhay Pareek
Session: Poster Display session 1
Resources:
Abstract
5519 - Is there a difference of Palliative care problems and needs between cancer and non-cancer hospitalized elderly patients?
Presenter: Ioanna Chatzi
Session: Poster Display session 1
Resources:
Abstract
2505 - There is a lack of clinical research for patients with cancer in palliative care
Presenter: Marie Vinches
Session: Poster Display session 1
Resources:
Abstract
5273 - Specialist Palliative Care (SPC) in Haematological Malignancy: Establishing practices in a UK Tertiary Cancer Centre (TCC)
Presenter: Emma Kedgley
Session: Poster Display session 1
Resources:
Abstract
5864 - Evaluation of the relationship between the attachment styles and psychological resilience of cancer patients receiving chemotherapy
Presenter: Fatma Bugdayci Basal
Session: Poster Display session 1
Resources:
Abstract
770 - Gefitinib along with Methotrexate as palliative therapy in PS 3 and above in metastatic squamous cell carcinoma head and neck cancer patients
Presenter: Vidya Dusi
Session: Poster Display session 1
Resources:
Abstract
4232 - High intensity end-of-life care in pediatrics, adolescent and young adult patients with cancer using an administrative database.
Presenter: Seiko Bun
Session: Poster Display session 1
Resources:
Abstract
4845 - Embedded outpatient palliative care service within the oncology clinic: Preliminary experience in Hacettepe Oncology Hospital
Presenter: Deniz Can Guven
Session: Poster Display session 1
Resources:
Abstract
3270 - Internet-based stepped care for individuals with cancer and concurrent anxiety or depression symptoms – results from a randomized controlled trial
Presenter: Birgitta Johansson
Session: Poster Display session 1
Resources:
Abstract
5503 - Impact of Cognitive-Behavioral-Therapy (CBT) on levels of anxiety, depression and distress in cancer patients (pts)
Presenter: Daniela Tregnago
Session: Poster Display session 1
Resources:
Abstract