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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ConclusionSecond-line cytotoxic drug chemotherapy after first-line EGFR –TKI treatment among elderly patients with NSCLC harboring sensitiveEGFR mutations was effective and safe and showed equivalent outcomes to first-line cytotoxic drug chemotherapy.
Source: Cancer Chemotherapy and Pharmacology - Category: Cancer & Oncology Source Type: research
Conclusion The recommended phase II dose of birabresib in patients with select solid tumors is 80 mg once daily with continuous dosing. Birabresib has dose-proportional exposure and a favorable safety profile, with clinical activity observed in NMC. Future studies of birabresib must consider intermittent scheduling to possibly mitigate the toxicities of chronic dosing. PMID: 29733771 [PubMed - as supplied by publisher]
Source: Clinical Prostate Cancer - Category: Cancer & Oncology Authors: Tags: J Clin Oncol Source Type: research
AbstractPurposeThis phase II study was performed to evaluate the efficacy and safety of cisplatin/pemetrexed combined with 15  mg/kg of bevacizumab followed by pemetrexed/bevacizumab maintenance therapy as first-line chemotherapy in advanced non-squamous non-small cell lung cancer (NSCLC) limited to epidermal growth factor receptor (EGFR)-wild type.Patients and methodsFifty patients with advanced or metastaticEGFR-wild type NSCLC aged  
Source: Cancer Chemotherapy and Pharmacology - Category: Cancer & Oncology Source Type: research
Conclusion: Paclitaxel combined with avastin decreased MPE volume and increased survival rate of NSCLC patients via inhibiting vascular endothelial growth factor expression.
Source: Revista da Associacao Medica Brasileira - Category: General Medicine Source Type: research
Conclusions Combination PEM and RT shows promising efficacy but relatively severe RT-related toxicities. Therefore, this treatment should be prescribed to elderly patients with caution.Trial registration UMIN 000005036.
Source: Investigational New Drugs - Category: Drugs & Pharmacology Source Type: research
Abstract  Adjuvant cisplatin-vinorelbine chemotherapy has been shown to be effective in patients with completely resected non-small cell lung cancer (NSCLC) in several Phase III trials, but not yet in the Japanese population. Pharmacists are expected to assist patients with completion of adjuvant chemotherapy. The aim of this retrospective study was to evaluate the compliance with and safety of adjuvant cisplatin-vinorelbine chemotherapy in Japanese patients and to evaluate the contribution of pharmacists to completion of treatment. Thirty-four patients with NSCLC who received adjuvant cisplatin-vinorelbine chem...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - Category: Drugs & Pharmacology Authors: Tags: Yakugaku Zasshi Source Type: research
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
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