PATIENT REPORTED OUTCOMES (PROS) OF MULTIPLE MYELOMA (MM) PATIENTS FROM THE PANORAMA-1 STUDY WHO HAVE RECEIVED AT LEAST TWO PRIOR REGIMENS INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT.
(Abstract release date: 05/19/16)
EHA Library. G Richardson P. 06/09/16; 134857; PB1957
Paul G Richardson
Contributions
Contributions
Abstract
Abstract: PB1957
Type: Publication Only
Background
Panobinostat (PAN), in combination with bortezomib (BTZ) and dexamethasone (DEX), is approved in the EU for the treatment of adult patients with relapsed and/or refractory multiple myeloma (MM) who have received ≥2 prior regimens, including BTZ and an immunomodulatory drug, based on significant clinical benefit of PAN+BTZ+DEX PANORAMA-1.
Aims
This analysis focuses on the impact of PAN+BTZ+DEX on patient experience, including measures of symptoms, function, and health-related quality of life (HRQoL), measured by FACT/GOG-Ntx, QLQ-MY20, and EORTC-QLQ-30.
Methods
In PANORAMA-1, patients who had received between 1 and 3 previous treatment regimens were randomized 1:1 to receive up to 12 cycles of PAN or placebo (PBO), in combination with BTZ+DEX. PRO measures were administered at screening, cycle 1 day 1, and every 6 weeks thereafter until end of treatment. We present here the results at the end of 24 weeks, after completion of the first 8 cycles of the study treatment (treatment phase 1).
Results
In the approved EU population, PRO baseline data were available for 71 and 69 PAN+BTZ+DEX and PBO+BTZ+DEX treated patients, respectively, for the EORTC QLQ-C30, Global Health Status/QoL scale and for 70 patients in each treatment arm for the QLQMY20, Disease Symptoms (DS) subscale and the FACT/GOG-Ntx Neurotoxicity subscale. At Week 24, FACT-GOG-Ntx scores were similar across treatment arms, suggesting no difference in neurotoxicity symptoms (31.75 vs 33.57 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). In both treatment arms, symptoms scores were generally low on the scale of 0-100, with lower scores in the QLQ-MY20 DS subscale observed following treatment initiation and no difference between arms observed at Week 24 (23.84 vs 16.55 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). EORTC QLQ-C30 Global Health Status/QoL scores were generally stable after treatment initiation, and comparable in the 2 arms at Week 24 (53.82 vs 58.05 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively).
Conclusion
These findings support the addition of panobinostat to the well-established BTZ+DEX regimen as an efficacious treatment option with limited symptomatology and impact on patients’ HRQoL. With the increasing importance of patient-relevant humanistic benefits in determining the overall value of oncology products findings such as these are important for treatment decision making.
Session topic: E-poster
Keyword(s): Multiple myeloma, Quality of life
Type: Publication Only
Background
Panobinostat (PAN), in combination with bortezomib (BTZ) and dexamethasone (DEX), is approved in the EU for the treatment of adult patients with relapsed and/or refractory multiple myeloma (MM) who have received ≥2 prior regimens, including BTZ and an immunomodulatory drug, based on significant clinical benefit of PAN+BTZ+DEX PANORAMA-1.
Aims
This analysis focuses on the impact of PAN+BTZ+DEX on patient experience, including measures of symptoms, function, and health-related quality of life (HRQoL), measured by FACT/GOG-Ntx, QLQ-MY20, and EORTC-QLQ-30.
Methods
In PANORAMA-1, patients who had received between 1 and 3 previous treatment regimens were randomized 1:1 to receive up to 12 cycles of PAN or placebo (PBO), in combination with BTZ+DEX. PRO measures were administered at screening, cycle 1 day 1, and every 6 weeks thereafter until end of treatment. We present here the results at the end of 24 weeks, after completion of the first 8 cycles of the study treatment (treatment phase 1).
Results
In the approved EU population, PRO baseline data were available for 71 and 69 PAN+BTZ+DEX and PBO+BTZ+DEX treated patients, respectively, for the EORTC QLQ-C30, Global Health Status/QoL scale and for 70 patients in each treatment arm for the QLQMY20, Disease Symptoms (DS) subscale and the FACT/GOG-Ntx Neurotoxicity subscale. At Week 24, FACT-GOG-Ntx scores were similar across treatment arms, suggesting no difference in neurotoxicity symptoms (31.75 vs 33.57 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). In both treatment arms, symptoms scores were generally low on the scale of 0-100, with lower scores in the QLQ-MY20 DS subscale observed following treatment initiation and no difference between arms observed at Week 24 (23.84 vs 16.55 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). EORTC QLQ-C30 Global Health Status/QoL scores were generally stable after treatment initiation, and comparable in the 2 arms at Week 24 (53.82 vs 58.05 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively).
Conclusion
These findings support the addition of panobinostat to the well-established BTZ+DEX regimen as an efficacious treatment option with limited symptomatology and impact on patients’ HRQoL. With the increasing importance of patient-relevant humanistic benefits in determining the overall value of oncology products findings such as these are important for treatment decision making.
Session topic: E-poster
Keyword(s): Multiple myeloma, Quality of life
Abstract: PB1957
Type: Publication Only
Background
Panobinostat (PAN), in combination with bortezomib (BTZ) and dexamethasone (DEX), is approved in the EU for the treatment of adult patients with relapsed and/or refractory multiple myeloma (MM) who have received ≥2 prior regimens, including BTZ and an immunomodulatory drug, based on significant clinical benefit of PAN+BTZ+DEX PANORAMA-1.
Aims
This analysis focuses on the impact of PAN+BTZ+DEX on patient experience, including measures of symptoms, function, and health-related quality of life (HRQoL), measured by FACT/GOG-Ntx, QLQ-MY20, and EORTC-QLQ-30.
Methods
In PANORAMA-1, patients who had received between 1 and 3 previous treatment regimens were randomized 1:1 to receive up to 12 cycles of PAN or placebo (PBO), in combination with BTZ+DEX. PRO measures were administered at screening, cycle 1 day 1, and every 6 weeks thereafter until end of treatment. We present here the results at the end of 24 weeks, after completion of the first 8 cycles of the study treatment (treatment phase 1).
Results
In the approved EU population, PRO baseline data were available for 71 and 69 PAN+BTZ+DEX and PBO+BTZ+DEX treated patients, respectively, for the EORTC QLQ-C30, Global Health Status/QoL scale and for 70 patients in each treatment arm for the QLQMY20, Disease Symptoms (DS) subscale and the FACT/GOG-Ntx Neurotoxicity subscale. At Week 24, FACT-GOG-Ntx scores were similar across treatment arms, suggesting no difference in neurotoxicity symptoms (31.75 vs 33.57 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). In both treatment arms, symptoms scores were generally low on the scale of 0-100, with lower scores in the QLQ-MY20 DS subscale observed following treatment initiation and no difference between arms observed at Week 24 (23.84 vs 16.55 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). EORTC QLQ-C30 Global Health Status/QoL scores were generally stable after treatment initiation, and comparable in the 2 arms at Week 24 (53.82 vs 58.05 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively).
Conclusion
These findings support the addition of panobinostat to the well-established BTZ+DEX regimen as an efficacious treatment option with limited symptomatology and impact on patients’ HRQoL. With the increasing importance of patient-relevant humanistic benefits in determining the overall value of oncology products findings such as these are important for treatment decision making.
Session topic: E-poster
Keyword(s): Multiple myeloma, Quality of life
Type: Publication Only
Background
Panobinostat (PAN), in combination with bortezomib (BTZ) and dexamethasone (DEX), is approved in the EU for the treatment of adult patients with relapsed and/or refractory multiple myeloma (MM) who have received ≥2 prior regimens, including BTZ and an immunomodulatory drug, based on significant clinical benefit of PAN+BTZ+DEX PANORAMA-1.
Aims
This analysis focuses on the impact of PAN+BTZ+DEX on patient experience, including measures of symptoms, function, and health-related quality of life (HRQoL), measured by FACT/GOG-Ntx, QLQ-MY20, and EORTC-QLQ-30.
Methods
In PANORAMA-1, patients who had received between 1 and 3 previous treatment regimens were randomized 1:1 to receive up to 12 cycles of PAN or placebo (PBO), in combination with BTZ+DEX. PRO measures were administered at screening, cycle 1 day 1, and every 6 weeks thereafter until end of treatment. We present here the results at the end of 24 weeks, after completion of the first 8 cycles of the study treatment (treatment phase 1).
Results
In the approved EU population, PRO baseline data were available for 71 and 69 PAN+BTZ+DEX and PBO+BTZ+DEX treated patients, respectively, for the EORTC QLQ-C30, Global Health Status/QoL scale and for 70 patients in each treatment arm for the QLQMY20, Disease Symptoms (DS) subscale and the FACT/GOG-Ntx Neurotoxicity subscale. At Week 24, FACT-GOG-Ntx scores were similar across treatment arms, suggesting no difference in neurotoxicity symptoms (31.75 vs 33.57 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). In both treatment arms, symptoms scores were generally low on the scale of 0-100, with lower scores in the QLQ-MY20 DS subscale observed following treatment initiation and no difference between arms observed at Week 24 (23.84 vs 16.55 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively). EORTC QLQ-C30 Global Health Status/QoL scores were generally stable after treatment initiation, and comparable in the 2 arms at Week 24 (53.82 vs 58.05 for PAN+BTZ+DEX vs PBO+BTZ+DEX treated patients, respectively).
Conclusion
These findings support the addition of panobinostat to the well-established BTZ+DEX regimen as an efficacious treatment option with limited symptomatology and impact on patients’ HRQoL. With the increasing importance of patient-relevant humanistic benefits in determining the overall value of oncology products findings such as these are important for treatment decision making.
Session topic: E-poster
Keyword(s): Multiple myeloma, Quality of life
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