Most Read Articles
22 May 2017
Chronic obstructive pulmonary disease (COPD) is currently the 10th commonest cause of death in Singapore, with a disease burden of 5.9 percent according to a 2015 population-based survey (EPIC-Asia survey) in Singapore. Pearl Toh spoke with Dr Augustine Tee, chief and senior consultant of the Department of Respiratory and Critical Care Medicine at Changi General Hospital (CGH) in Singapore, on how COPD is often underdetected in the primary care population as symptoms are not specific and diagnosis requires a combination of clinical risk factors, symptoms and spirometry testing.
15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
04 Aug 2017
Chronic obstructive pulmonary disease (COPD) is the fourth cause of global mortality, with experts predicting a potential future rise in the prevalence rates of COPD. 
11 May 2016

In conjunction with World Asthma Day which falls on 3rd May 2016, MIMS Doctor speaks to a renowned respiratory medicine specialist, Dato' Dr. Hj Abdul Razak Abdul Muttalif, regarding the chronic airway disease.

Nivolumab better maintains quality of life and symptom control vs docetaxel in advanced NSCLC

Pearl Toh
21 Dec 2016

Nivolumab better preserved health-related quality of life and symptom control than docetaxel in patients with previously treated advanced nonsquamous non-small cell lung cancer (NSCLC), according to additional data from the CHECKMATE 057* trial presented at the recent European Society for Medical Oncology Asia 2016 Congress (ESMO Asia 2016) held in Singapore.

The open-label phase III CHECKMATE 057 study has previously demonstrated a better overall survival (OS), the primary endpoint, at 1 year with the anti-PD-1 monoclonal antibody nivolumab, which also showed a favourable safety profile, compared with docetaxel in NSCLC patients who had progressed despite previous treatment with platinum-based chemotherapy.

Being presented were the data from additional endpoints on patient reported outcomes (PROs) based on the EuroQoL-5 dimensions (EQ-5D) tool, which is a generic measure of health status; and lung cancer symptom scale (LCSS), a lung cancer-specific measure of symptom burden which includes the average symptom burden index (ASBI) and the 3-item global index (3-IGI). [ESMO Asia 2016, abstract 442O]

“Compared with the baseline [score] for EQ-5D, there was predominantly a maintenance of the general health status for the group of patients who received nivolumab compared with the slight deterioration for patients who had received docetaxel,” said Dr Martin Reck of Lung Clinic Grosshansdorf at Airway Research Center North in Grosshansdorf, Germany.

Although there were no differences within or between treatment arms using the index-based scoring of EQ-5D (EQ-5D utility index), Kaplan-Meier analysis of data from the visual analogue scale (EQ-5D VAS) indicated that the time to deterioration in general health status separated from 4 months onwards in favour of nivolumab (hazard ratio [HR], 0.76, 95 percent confidence interval [CI], 0.59–0.98).

In addition, analyses of mean changes from baseline in symptom burden as measured by the LCSS ASBI and 3-IGI revealed a reduction in symptom burden and improvement in quality of life favouring nivolumab over docetaxel, which emerged at the first common assessment at week 12 and persisted throughout the entire assessment period up to week 54. The differences in ASBI were significant at weeks 12, 24, 30, and 42, whereas for the 3-IGI at weeks 24 and 30.

The time to deterioration for ASBI was also longer with nivolumab than with docetaxel (HR, 0.65, 95 percent CI, 0.49–0.85) based on Kaplan-Meier analysis, with separation of the curves between treatment arms occurring as early as 2 months after initiating treatment. 

“Symptom improvement observed with the LCSS occurred earlier than global health status improvement seen with the EQ-5D VAS,” noted Reck, saying both measures indicated benefit prior to separation of the OS curves.

He also pointed out that the updated 2-year OS rate continued to be better with nivolumab than with docetaxel (median OS, 12.2 vs 9.5 months; HR, 0.75, 95 percent CI, 0.63–0.91), consistent with previous finding from the 1-year survival data.

The updated tolerability data after 2 years also indicated better tolerability for nivolumab, with a lower rate of grade 3–4 adverse events (11 percent vs 54 percent) and a lower number of adverse events of any grade which led to treatment discontinuation (6 percent vs 15 percent) compared with docetaxel.

“In addition to this clear signal of objective efficacy, now we have also seen supportive data for the symptomatic efficacy ... a trend towards a better maintenance in the general health status ... a better impact on symptom burden ... and a better control of symptom burden [based on the EQ-5D VAS and the LCSS],” said Reck.

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Most Read Articles
22 May 2017
Chronic obstructive pulmonary disease (COPD) is currently the 10th commonest cause of death in Singapore, with a disease burden of 5.9 percent according to a 2015 population-based survey (EPIC-Asia survey) in Singapore. Pearl Toh spoke with Dr Augustine Tee, chief and senior consultant of the Department of Respiratory and Critical Care Medicine at Changi General Hospital (CGH) in Singapore, on how COPD is often underdetected in the primary care population as symptoms are not specific and diagnosis requires a combination of clinical risk factors, symptoms and spirometry testing.
15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
04 Aug 2017
Chronic obstructive pulmonary disease (COPD) is the fourth cause of global mortality, with experts predicting a potential future rise in the prevalence rates of COPD. 
11 May 2016

In conjunction with World Asthma Day which falls on 3rd May 2016, MIMS Doctor speaks to a renowned respiratory medicine specialist, Dato' Dr. Hj Abdul Razak Abdul Muttalif, regarding the chronic airway disease.