David R Spigel1, Jyoti D Patel, Craig H Reynolds, Edward B Garon, Robert C Hermann, Ramaswamy Govindan, Mark R Olsen, Katherine B Winfree, Jian Chen, Jingyi Liu, Susan C Guba, Mark A Socinski, Philip Bonomi. 1. *Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN; †Feinberg School of Medicine, Northwestern University, Chicago, IL; ‡Ocala Oncology, Ocala, FL and US Oncology Research, Inc., Houston, TX; §David Geffen School of Medicine at UCLA/Translational Research in Oncology-US, Los Angeles, CA; ║Northwest Georgia Oncology Centers, Marietta, GA; ¶Washington University School of Medicine, St. Louis, MO; #Tulsa Cancer Institute, Tulsa, OK; **Eli Lilly and Company, Indianapolis, IN; ††University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA; and ‡‡Rush University Medical Center, Chicago, IL.
Abstract
INTRODUCTION: Treatment impact on quality of life (QoL) informs treatment management decisions in advanced nonsquamous non-small-cell lung cancer (NS NSCLC). QoL outcomes from the phase III PointBreak trial are reported. METHODS:Chemonaive patients (n = 939) with stage IIIB/IV nonsquamous non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status 0 to 1 were randomized (1:1) topemetrexed-carboplatin-bevacizumab (pemetrexed arm) or paclitaxel-carboplatin-bevacizumab (paclitaxel arm). Patients without progressive disease receivedmaintenance pemetrexed-bevacizumab (pemetrexed arm) or bevacizumab (paclitaxel arm). QoL was assessed using Functional Assessment of Cancer Therapy (FACT)-General (FACT-G), FACT-Lung (FACT-L), and FACT/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) instruments. Subscale scores, total scores, and trial outcome indices were analyzed using linear mixed-effects models. Post hoc analyses examined the association between baseline FACT scores and overall survival (OS). RESULTS: Mean score differences in change from baseline significantly favored the pemetrexed arm for the neurotoxicity subscale score, FACT-Ntx total scores, and FACT-Ntx trial outcome index. They occurred at cycle 2 (p < 0.001) and persisted through induction cycles 2 to 4 and six maintenance cycles. Investigator-assessed, qualitative, drug-related differences in grade 2 (1.6% versus 10.6%) and grade 3 (0.0% versus 4.1%) sensory neuropathy and grade 3/4 fatigue (10.9% versus 5.0%, p = 0.0012) were observed between the pemetrexed and paclitaxel arms. Baseline FACT-G, FACT-L, and FACT-Ntx scores were significant prognostic factors for OS (p < 0.001). CONCLUSIONS: Randomized patients reported similar changes in QoL, except for less change from baseline in neurotoxicity on the pemetrexed arm; investigators reported greater neurotoxicity on the paclitaxel arm and greater fatigue on the pemetrexed arm. Higher baseline FACT scores were favorable prognostic factors for OS.
RCT Entities:
INTRODUCTION: Treatment impact on quality of life (QoL) informs treatment management decisions in advanced nonsquamous non-small-cell lung cancer (NS NSCLC). QoL outcomes from the phase III PointBreak trial are reported. METHODS: Chemonaive patients (n = 939) with stage IIIB/IV nonsquamous non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status 0 to 1 were randomized (1:1) to pemetrexed-carboplatin-bevacizumab (pemetrexed arm) or paclitaxel-carboplatin-bevacizumab (paclitaxel arm). Patients without progressive disease received maintenance pemetrexed-bevacizumab (pemetrexed arm) or bevacizumab (paclitaxel arm). QoL was assessed using Functional Assessment of Cancer Therapy (FACT)-General (FACT-G), FACT-Lung (FACT-L), and FACT/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) instruments. Subscale scores, total scores, and trial outcome indices were analyzed using linear mixed-effects models. Post hoc analyses examined the association between baseline FACT scores and overall survival (OS). RESULTS: Mean score differences in change from baseline significantly favored the pemetrexed arm for the neurotoxicity subscale score, FACT-Ntx total scores, and FACT-Ntx trial outcome index. They occurred at cycle 2 (p < 0.001) and persisted through induction cycles 2 to 4 and six maintenance cycles. Investigator-assessed, qualitative, drug-related differences in grade 2 (1.6% versus 10.6%) and grade 3 (0.0% versus 4.1%) sensory neuropathy and grade 3/4 fatigue (10.9% versus 5.0%, p = 0.0012) were observed between the pemetrexed and paclitaxel arms. Baseline FACT-G, FACT-L, and FACT-Ntx scores were significant prognostic factors for OS (p < 0.001). CONCLUSIONS: Randomized patients reported similar changes in QoL, except for less change from baseline in neurotoxicity on the pemetrexed arm; investigators reported greater neurotoxicity on the paclitaxel arm and greater fatigue on the pemetrexed arm. Higher baseline FACT scores were favorable prognostic factors for OS.
Authors: Veronica B Ajewole; James E Cox; Joshua T Swan; Soumya G Chikermane; Beverly Lamoth; Tomona Iso; Laura O Okolo; Christen L Ford; Amy M Schneider; Eleanor C Hobaugh; Kelty R Baker Journal: Support Care Cancer Date: 2019-07-29 Impact factor: 3.603
Authors: Kuan Liao; Tianxiao Wang; Jake Coomber-Moore; David C Wong; Fabio Gomes; Corinne Faivre-Finn; Matthew Sperrin; Janelle Yorke; Sabine N van der Veer Journal: BMC Cancer Date: 2022-10-19 Impact factor: 4.638
Authors: Jonathan A Ledermann; Philipp Harter; Charlie Gourley; Michael Friedlander; Ignace Vergote; Gordon Rustin; Clare Scott; Werner Meier; Ronnie Shapira-Frommer; Tamar Safra; Daniela Matei; Anitra Fielding; Bryan Bennett; David Parry; Stuart Spencer; Helen Mann; Ursula Matulonis Journal: Br J Cancer Date: 2016-11-08 Impact factor: 7.640
Authors: Mark S Walker; William Wong; Arliene Ravelo; Paul J E Miller; Lee S Schwartzberg Journal: Health Qual Life Outcomes Date: 2017-08-14 Impact factor: 3.186
Authors: Mark de Mol; Sabine Visser; Joachim G J V Aerts; Paul Lodder; Jolanda de Vries; Brenda L den Oudsten Journal: BMC Cancer Date: 2018-11-26 Impact factor: 4.430