In this slide show we highlight some of the top news on lung cancer in 2016, including an immunotherapy approval from the FDA, and studies on depression in lung cancer patients, serious side effects to watch for when using immunotherapies, and more.
Geriatric Assessment Does Not Improve Survival in Elderly NSCLC Patients:
Allocating chemotherapy treatment based on a comprehensive geriatric assessment (CGA), a multidisciplinary approach that includes functional status, cognitive function, emotional status, comorbidities, nutritional status, polypharmacy, social and environmental situations, and assessment for geriatric syndrome, failed to improve treatment failure–free survival or overall survival in elderly patients with advanced non–small-cell lung cancer (NSCLC). The study randomized 494 patients aged 70 years or older to standard chemotherapy allocation based on performance status and age (251 patients) or a CGA group (243 patients). There was no difference between the two groups with regard to treatment failure–free survival, at 3.2 months with standard care and 3.1 months with CGA-based care, for a hazard ratio of 0.91.
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FDA Approves Crizotinib for ROS1-Rearranged Advanced NSCLC:
The US Food and Drug Administration (FDA) has announced its approval of crizotinib (Xalkori) for the treatment of patients with NSCLC and
rearrangements. The targeted treatment crizotinib was initially approved in 2011 for patients with NSCLC and
mutations. The FDA based its approval on efficacy data taken from a single-arm study of crizotinib in 50 patients with NSCLC and
rearrangements. The objective response rate according to RECIST v1.0 as evaluated by independent radiology review was 66% (95% CI, 51%–79%). Three patients had a complete response to therapy, and 33 had partial responses. The median duration of response was 17.6 months, with a median progression-free survival of 19.2 months.
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Negative Lung CT Could Lengthen Follow-Up for High-Risk Individuals:
People at high risk for lung cancer with a clean annual low-dose CT scan had a lower incidence of lung cancer and a lower risk of dying from lung cancer compared with all high-risk participants undergoing screening. Researchers analyzed data taken from the National Lung Screening Trial, which compared three annual CT scans with three annual chest radiographs for the detection of lung cancer in high-risk individuals. Of the cohort, 19,066 participants had a negative initial CT screen. These participants had significantly lower incidence of lung cancer compared with the full population of 26,231 participants (371.88 vs 661.23 per 100,000 person-years).
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Liquid Biopsy Accurately Detects Mutations in Advanced NSCLC:
Droplet digital polymerase chain reaction (ddPCR)-based plasma genotyping-referred to as liquid biopsy-exhibited perfect specificity in identifying
mutations in patients with advanced NSCLC. In fact, the test proved so reliable in the study that the Dana-Farber/Brigham and Women’s Cancer Center became the first medical facility in the country to offer it to all patients with NSCLC, either at the time of first diagnosis or time of relapse following previous treatment. In the study, which enrolled 180 patients with advanced NSCLC, the liquid biopsy showed 100% positive predictive value for detecting
exon 19 deletion, L858R, and
mutations. However, the positive predictive value for T790M mutations was only 79%. The sensitivity of plasma ddPCR was 82% for
exon 19 deletion, 74% for L858R, 77% for T790M, and 64% for
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Afatinib Improves PFS vs Gefitinib in EGFR-Mutated NSCLC:
The use of ErbB family blocker afatinib resulted in improved progression-free survival (PFS) compared with the EGFR tyrosine kinase inhibitor gefitinib in a randomized, open-label, phase II study of treatment-naive NSCLC patients with
mutations. The LUX-Lung 7 study included 319 patients randomized to either afatinib (160 patients) or gefitinib (159 patients). The median PFS was 11.0 months with afatinib vs 10.9 months with gefitinib, yielding a hazard ratio of 0.73. The authors noted that the PFS curves separated further over time, beginning at the median. The PFS rate at 24 months was 17.6% with afatinib and 7.6% with gefitinib.
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Antibody-Drug Conjugate Shows Promise in Small-Cell Lung Cancer:
An antibody-drug conjugate, rovalpituzumab tesirine, shows promising efficacy against recurrent small-cell lung cancer (SCLC), according to early findings from a first-in-human clinical trial. The treatment combines a novel delta-like protein 3 (DLL3)-targeted antibody with a powerful anticancer agent, a pyrrolobenzodiazepine dimer toxin. The antibody component serves to deliver the anticancer agent to the tumor and into cancer cells. Presented by Charles M. Rudin, MD, PhD, at the 2016 American Society of Clinical Oncology Annual Meeting, the phase I study enrolled 74 patients with SCLC who had all failed at least standard therapy. Eleven out of 60 (18%) evaluable patients experienced tumor shrinkage, and 41 (68%) achieved clinical benefit, having at least stable disease. Nearly all the patients who responded to the treatment had elevated levels of DLL3 in their tumor.
First-Line Nivolumab Could Be Good Option in Lung Cancer:
Two parts of a phase I trial found that nivolumab could be a good first-line treatment option for patients with advanced NSCLC. In one part of the study, the immunotherapy agent yielded good safety results and durable responses as monotherapy, and in the other, nivolumab combined with platinum-based doublet chemotherapy had more toxicity but again good responses. The confirmed objective response rate was 23%; that included 4 patients with ongoing complete responses. Most of the responses (9 of 12) occurred early, by the first tumor assessment at week 11. At 24 weeks, the progression-free survival rate was 41%, and the median overall survival was 19.4 months. The safety profile was similar to that expected with single-agent therapy, though the discontinuation rate was higher with the combination therapy.
. Image courtesy of Bristol-Myers Squibb.
Pneumonitis Incidence From PD-1 Inhibitors Higher in NSCLC, RCC:
Although the overall incidence of programmed death 1 (PD-1) inhibitor–related pneumonitis is rare, the serious adverse event may occur more commonly in certain solid tumor types like NSCLC and renal cell carcinoma (RCC). Investigators conducted a systematic review and meta-analysis to compare the incidence of pneumonitis among different tumors types and treatment regimens, and identified 26 studies of PD-1 inhibitors, and included 20 studies of melanoma, NSCLC, and RCC, covering 4,496 patients in their meta-analysis. They tracked all incidence of all-grade and grade 3 or higher pneumonitis or pneumonitis-related deaths and found that patients with NSCLC had a greater incidence of both all-grade and grade 3 or higher pneumonitis compared with patients with melanoma. Patients with RCC also had a higher incidence of all-grade pneumonitis compared with patients with melanoma, but incidence of grade 3 or higher pneumonitis was not increased.
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Depression Linked With Increased Mortality in Early-Stage Lung Cancer:
Patients diagnosed with early-stage lung cancer who are also diagnosed with depression have an increased risk of mortality, according to a prospective, observational study. Researchers analyzed 1,790 patients from 5 geographic areas of the United States who were enrolled in the Cancer Care Outcomes Research and Surveillance Consortium. Patients were evaluated for depression within 3 months of a lung cancer diagnosis and again 12 months later. Thirty-eight percent (681) of patients had depression symptoms at diagnosis. Compared with patients with no history of depression, patients with early-stage disease who had depression symptoms at baseline had an increased risk of mortality.
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Selumetinib Fails to Improve Outcomes in KRAS-Mutant NSCLC:
The addition of the oral MEK inhibitor selumetinib to docetaxel failed to improve progression-free survival (PFS) and overall survival (OS) in patients with
-mutated locally advanced or metastatic NSCLC, according to a phase III trial presented at the European Society for Medical Oncology 2016 Congress. SELECT-1 included 510 patients with
-mutant NSCLC, randomized to either selumetinib plus docetaxel (254 patients) or placebo plus docetaxel (256 patients). At the time of data cutoff, 447 patients (88%) had progressed and 346 (68%) had died. In contrast to the phase II study, the PFS was no better with selumetinib (3.9 months) than without it (2.8 months). The median OS was 8.7 months with the study drug, and 7.9 months without it.
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