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A phase I study of afatinib for patients aged 75 or older with advanced non-small cell lung cancer harboring EGFR mutations

AbstractThis phase I trial was conducted to determine the maximum tolerated dose (MTD) and recommended dose of afatinib for phase II trial in elderly patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations. The study used a standard 3  + 3 dose escalation design. Patients aged 75 years or older with advanced NSCLC harboring EGFR mutations were enrolled. The doses of afatinib, which were given once daily, were planned as follows: level 1, 20 mg/day; level 2, 30 mg/day; level 3, 40 mg/day. Dose-limiting toxicity (DLT) was def ined as grade 4 hematologic, persistent grade >  2 diarrhea for >  2 days despite concomitant medications or grade 3 non-hematologic toxicity. DLT was evaluated during day 1–28. Fifteen patients were enrolled. Patient characteristics were: male/female 3/12; median age 79 (range 75–87); PS 0/1, 2/13. Six patients have been treated at levels 1 and 3, and three patients at level 2. At level 1, one of six patients experienced grade 3 rush, grade 3 anorexia, and grade 3 infection as DLTs. At level 2, none of three patients experienced a DLT. At level 3, two patients developed grade 3 diarrhea, one of whom also experienced grade 3 anorexia. Most frequent adv erse events of any grade were diarrhea, paronychia, rush, and nausea. Most patients at level 2 and 3 required dose reduction in 3 months. MTD was defined as 40 mg/d...
Source: Medical Oncology - Category: Cancer & Oncology Source Type: research

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The cancer anorexia cachexia syndrome is a systemic metabolic disorder characterized by the catabolism of stored nutrients in skeletal muscle and adipose tissue that is particularly prevalent in nonsmall cell lung cancer (NSCLC). Loss of skeletal muscle results in functional impairments and increased mortality. The aim of the present study...
Source: Proceedings of the National Academy of Sciences - Category: Science Authors: Tags: PNAS Plus Source Type: research
Contributor : Marcus D GoncalvesSeries Type : Expression profiling by high throughput sequencingOrganism : Mus musculusThe cancer anorexia cachexia syndrome is a systemic metabolic disorder characterized by the catabolism of stored nutrients in skeletal muscle and adipose tissue that is particularly prevalent in non-small cell lung cancer (NSCLC). Loss of skeletal muscle results in functional impairments and increased mortality. The aim of the current study was to characterize the changes in systemic metabolism in a genetically engineered mouse model of NSCLC. We show that a portion of these animals develop loss of skeleta...
Source: GEO: Gene Expression Omnibus - Category: Genetics & Stem Cells Tags: Expression profiling by high throughput sequencing Mus musculus Source Type: research
Conclusions: These results indicate that 2-week treatment of tailored S-1 monotherapy with 1-week rest in elderly patients is well tolerated and demonstrates encouraging activity.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Lung Cancer Source Type: research
This study examined the efficacy and safety of anamorelin (ONO‐7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia. METHODSThis double‐blind clinical trial (ONO‐7643‐04) enrolled 174 patients with unresectable stage III/IV non–small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual‐energy x‐ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of l...
Source: Cancer - Category: Cancer & Oncology Authors: Tags: Original Article Source Type: research
Conclusions In elderly patients with previously untreated advanced NSCLC, a 2-week S-1 monotherapy treatment, tailored to both the Ccr and BSA, with a 1-week interval was well tolerated and demonstrated promising efficacy. This study was registered at the University Hospital Medical Information Network (UMIN) Center (ID: UMIN000002035), Japan.
Source: Respiratory Investigation - Category: Respiratory Medicine Source Type: research
ConclusionThe developed algorithms enable the estimation of EQ-5D-5L utilities from three cancer-specific instruments when preference-based HRQoL data are missing.
Source: The European Journal of Health Economics - Category: Health Management Source Type: research
ConclusionsS-1 as a third- or fourth-line therapy for wild-typeEGFR NSCLC showed numerically better clinical outcomes than erlotinib.Clinical trial registration no.UMIN000005308.
Source: Cancer Chemotherapy and Pharmacology - Category: Cancer & Oncology Source Type: research
CONCLUSION: Combining foretinib and erlotinib demonstrated response in unselected advanced NSCLC but also incremental toxicity. Future development will require molecular patient selection. PMID: 28706139 [PubMed - as supplied by publisher]
Source: Oncotarget - Category: Cancer & Oncology Tags: Oncotarget Source Type: research
Conclusion.Modified CBDCA plus weekly nab‐PTX demonstrated significant efficacy and acceptable toxicities in elderly patients with advanced NSCLC.
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Lung Cancer, Chinese Edition, Clinical Trial Results Source Type: research
ConclusionThe addition of bevacizumab to S-1 was tolerable, but not beneficial for patients with previously treated non-squamous NSCLC. We do not recommend further study of this regimen.
Source: Cancer Chemotherapy and Pharmacology - Category: Cancer & Oncology Source Type: research
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