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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ConclusionPD-1/PD-L1 inhibitors are generally safer and better tolerated than chemotherapy for patients with NSCLC with regard to summary toxic events, detailed toxic symptoms and hematologic toxicities. However, PD-1/PD-L1 inhibitors can generate a unique spectrum of irAEs, and several of them can be severe and even life-threatening. Clinicians should be aware of the risk of these AEs, as they may have a potentially negative impact on the patients ’ quality of life and survival outcome.
Source: Journal of Cancer Research and Clinical Oncology - Category: Cancer & Oncology Source Type: research
ón ZL, Arrieta O Abstract Lung cancer (LC) has a high rate of anorexia, which negatively affects quality-of-life and prognosis; however prevalence values may vary as per diagnostic test. There is no standard for anorexia diagnosis, currently the anorexia cachexia scale (A/CS) has been proposed as a tool for diagnosing anorexia with a consensus cutoff value of ≤24, nonetheless a validated cutoff value is required. The A/CS was evaluated in advanced Non-Small Cell Lung Cancer (NSCLC) patients to establish a cutoff value. The appetite item from the QLQ-C30 questionnaire and survival served as a standard ref...
Source: Nutrition and Cancer - Category: Cancer & Oncology Authors: Tags: Nutr Cancer Source Type: research
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Source: Nutrition and Cancer - Category: Cancer & Oncology Authors: Source Type: research
ConclusionPD-1/PD-L1 inhibitors are generally safer and better tolerated than chemotherapy for patients with NSCLC with regard to summary toxic events, detailed toxic symptoms and hematologic toxicities. However, PD-1/PD-L1 inhibitors can generate a unique spectrum of irAEs, and several of them can be severe and even life-threatening. Clinicians should be aware of the risk of these AEs, as they may have a potentially negative impact on the patients ’ quality of life and survival outcome.
Source: Journal of Cancer Research and Clinical Oncology - Category: Cancer & Oncology Source Type: research
Conditions:   Anorexia;   Non-Small Cell Lung Carcinoma;   Stage III Lung Cancer AJCC v8;   Stage IIIA Lung Cancer AJCC v8;   Stage IIIB Lung Cancer AJCC v8;   Stage IIIC Lung Cancer AJCC v8;   Stage IV Lung Cancer AJCC v8;   Stage IVA Lung Cancer AJCC v8;   Stage IVB  Lung Cancer AJCC v8 Interventions:   Drug: Anamorelin Hydrochloride;   Other: Placebo Sponsors: &nbs...
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Abstract The life-threatening sides effect of the current EGFR mutant inhibitors (drugs) such as the eruption of rash which can be seen on the face, chest, back and even the trunk, diarrhea, nausea, vomiting, anorexia and stomatitis, necessitates the discovery of new potent and safe compounds as a chemo-therapeutic measure against lung cancer. Approximately about 10% of patients with Non-small cell lung cancer (NSCLC) in the US and about 35% in East Asia have tumor associated EGFR. These mutations occur within EGFR exon 18-21, which encodes a portion of the EGFR kinase domain and enables researchers to identify co...
Source: Bioinformation - Category: Bioinformatics Authors: Tags: Bioinformation Source Type: research
Conclusion The addition of cisplatin to single-agent chemotherapy does not significantly prolong overall survival, and it does not improve global health status score of quality of life in elderly patients with advanced NSCLC. PMID: 30028656 [PubMed - as supplied by publisher]
Source: Clinical Lung Cancer - Category: Cancer & Oncology Authors: Tags: J Clin Oncol Source Type: research
CONCLUSION: PD-1/PD-L1 inhibitors are generally safer and better tolerated than chemotherapy for patients with NSCLC with regard to summary toxic events, detailed toxic symptoms and hematologic toxicities. However, PD-1/PD-L1 inhibitors can generate a unique spectrum of irAEs, and several of them can be severe and even life-threatening. Clinicians should be aware of the risk of these AEs, as they may have a potentially negative impact on the patients' quality of life and survival outcome. PMID: 30019319 [PubMed - as supplied by publisher]
Source: Clinical Lung Cancer - Category: Cancer & Oncology Authors: Tags: J Cancer Res Clin Oncol Source Type: research
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
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