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) 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 353-359 |
| Number of pages | 7 |
| Journal | Journal of Thoracic Oncology |
| Volume | 10 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 6 2015 |
Funding
This study was sponsored by Eli Lilly and Company and Genentech/Roche. Disclosure: D.R.S. has received consulting fees or honorarium and support from Eli Lilly for travel to meetings for this study. C.R. receives consulting fees or honorarium from Eli Lilly and has received support from Eli Lilly for travel to a meeting for this study. He has received ongoing payment for lectures including service on speakers bureaus from Eli Lilly. He has been a member of the speakers bureaus for and has performed advisory board work with Eli Lilly and Genentech. His employing organization receives grant funding from Eli Lilly. E.B.G. has received support from Eli Lilly for travel to an investigator meeting. His employing organization receives grant funding from Eli Lilly for a clinical trial. His employing organization has received payment for consultancy from Boehringer Ingelheim and has an ongoing relationship with Pfizer, AstraZeneca, Novartis Genentech, and Puma Biotechnology. He has also received funding from the National Institutes of Health for research on which this article is based. R.C.H.'s employing organization receives payment of direct expenses incurred in conduct of the clinical trial per the sponsor agreement. He receives payment from Genentech/Roche for lectures related to a different product than in this study. R.G. is a consultant for and receives funding from Pfizer, Genentech/Roche, Bristol-Myers Squibb, Merck, Boehringer Ingelheim, Abbott Oncology, Covidien, and Mallinckrodt. K.B.W. and J.C. are employees of Eli Lilly with stock/stock options. J.L. is an employee of Eli Lilly. S.C.G. is an employee of Eli Lilly with stock/stock options, and the company has paid for travel, accommodations, and meeting expenses. M.A.S. is an consultant for and receives funding from Celgene and Teva. He receives grant funding from Genentech, GlaxoSmithKline, Merrimack, and Signa. P.B.'s employing organization has received grant funding from Eli Lilly. For the remaining authors, no conflicts of interests were declared.
Keywords
- Bevacizumab
- Functional assessment of cancer therapy
- Nonsquamous non-small-cell lung cancer
- Paclitaxel
- Pemetrexed
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
