Ruben Mesa1, Srdan Verstovsek2, Jean-Jacques Kiladjian3, Martin Griesshammer4, Tamas Masszi5,6, Simon Durrant7, Francesco Passamonti8, Claire N Harrison9, Fabrizio Pane10, Pierre Zachee11, Huiling Zhen12, Mark M Jones12, Shreekant Parasuraman12, Jingjin Li13, Isabelle Côté13, Dany Habr13, Alessandro M Vannucchi14. 1. Mayo Clinic Cancer Center, Scottsdale, AZ, USA. 2. The University of Texas MD Anderson Cancer Center, Houston, TX, USA. 3. Hôpital Saint-Louis et Université Paris Diderot, Paris, France. 4. Johannes Wesling Clinic, Minden, Germany. 5. St. István and St. László Hospital, Budapest, Hungary. 6. Semmelweis University, Budapest, Hungary. 7. Royal Brisbane & Women's Hospital, Brisbane, Qld, Australia. 8. Ospedale di Circolo e Fondazione Macchi, Varese, Italy. 9. Guy's and St. Thomas' NHS Foundation Trust, London, UK. 10. University of Naples Federico II, Naples, Italy. 11. ZNA Stuivenberg, Antwerp, Belgium. 12. Incyte Corporation, Wilmington, DE, USA. 13. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. 14. University of Florence, Florence, Italy.
Abstract
OBJECTIVES: Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. METHODS: In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35% reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). RESULTS: Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44%) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9%). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. CONCLUSIONS:Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant.
RCT Entities:
OBJECTIVES:Polycythemia vera (PV)-related symptoms may not be adequately controlled with conventional therapy. This current analysis of the RESPONSE trial evaluated the effects of ruxolitinib compared with standard therapy on quality of life (QoL) and symptoms in patients with PV who were hydroxyurea resistant/intolerant. METHODS: In the previously reported primary analysis, ruxolitinib achieved the primary composite endpoint of hematocrit control and ≥35% reduction in spleen volume at Week 32. The current analysis evaluated patient-reported outcomes using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF), the Pruritus Symptom Impact Scale (PSIS), and the Patient Global Impression of Change (PGIC). RESULTS: Compared with standard therapy, ruxolitinib was associated with greater improvements in global health status/QoL, functional subscales, and individual symptom scores of the EORTC QLQ-C30. At Week 32, more patients in the ruxolitinib arm (44%) achieved a ≥10-point improvement in global health status/QoL vs. standard therapy (9%). Improvements in MPN-SAF symptom scores were consistent with improvements in EORTC QLQ-C30, PSIS, and PGIC scores. CONCLUSIONS:Ruxolitinib provides clinically relevant improvements in QoL and ameliorates symptom burden in patients with PV who are hydroxyurea resistant/intolerant.
Authors: Jennifer Huberty; Ryan Eckert; Krisstina Gowin; Jules Mitchell; Amylou C Dueck; Brenda F Ginos; Linda Larkey; Ruben Mesa Journal: Haematologica Date: 2017-06-08 Impact factor: 9.941
Authors: Kavitha Chinnaiya; Michelle A Lawson; Sally Thomas; Marie-Therese Haider; Jenny Down; Andrew D Chantry; David Hughes; Antony Green; Jon R Sayers; John A Snowden; Martin P Zeidler Journal: Haematologica Date: 2017-05-26 Impact factor: 9.941