Quality of Life Analyses from the Randomized, Open-Label, Phase III PointBreak Study of Pemetrexed-Carboplatin-Bevacizumab followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab followed by Maintenance Bevacizumab in Patients with Stage IIIB or IV Nonsquamous Non–Small-Cell Lung Cancer
| Autor: | Jyoti D. Patel, Jian Chen, Jingyi Liu, Edward B. Garon, Robert C. Hermann, Katherine B. Winfree, Mark A. Socinski, Susan C. Guba, Mark R. Olsen, Ramaswamy Govindan, Craig H. Reynolds, Philip Bonomi, David R. Spigel |
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| Rok vydání: | 2015 |
| Předmět: |
Oncology
Male Pulmonary and Respiratory Medicine medicine.medical_specialty Guanine Lung Neoplasms Bevacizumab Paclitaxel Functional assessment of cancer therapy Gynecologic oncology Pemetrexed Antibodies Monoclonal Humanized Drug Administration Schedule law.invention Carboplatin chemistry.chemical_compound Quality of life Randomized controlled trial Glutamates law Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Humans Lung cancer Neoplasm Staging business.industry Nonsquamous non–small-cell lung cancer medicine.disease Surgery Treatment Outcome chemistry Quality of Life Female business Progressive disease medicine.drug |
| Zdroj: | Journal of Thoracic Oncology. 10(2):353-359 |
| ISSN: | 1556-0864 |
| DOI: | 10.1097/jto.0000000000000277 |
| Popis: | IntroductionTreatment 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.MethodsChemonaive 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).ResultsMean 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).ConclusionsRandomized 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. |
| Databáze: | OpenAIRE |
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