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Elderly-Specific Trials. Patients With PS 2. Please enter valid email address. Login Register. December November October September August July June May April March February January Abstract In spite of advances in molecular profiling and targeted treatments, traditional cytotoxic chemotherapy remains the standard-of-care, first-line treatment for the vast majority of patients with advanced non-small cell lung cancer.

Given the toxicity of this approach, there has historically been a reluctance to administer such therapy to those regarded as less robust, including elderly patients and patients with impaired performance status PS. Key words: non-small cell lung cancer, elderly, performance status 2. Introduction Oral, targeted therapies represent an important advance for patients with metastatic non-small cell lung cancer NSCLC , but only a minority of patients are eligible for these approaches.

It is certainly possible that in an individual patient the risks of cytotoxic chemotherapy could exceed the benefits, and treatment with chemotherapy could lead to worse survival and quality of life.

This is most likely to be the case in patients who are chemorefractory, whose cancer has progressed following multiple prior lines of chemotherapy, and in the initial treatment of less-robust patients in whom first-line chemotherapy has increased potential for morbidity and mortality.

The median age at diagnosis is 70 years. ECOG , 4 a randomized comparison of 4 platinum-based doublets in advanced NSCLC, solidified the equivalent efficacy of the majority of the current preferred first-line platinum partners: paclitaxel, docetaxel, and gemcitabine. Only pemetrexed 5 and nab -paclitaxel 6 have been added to the first-line armamentarium since then.

Determination of physiologic age, or an evaluation of life expectancy and functional reserve through a formal geriatric assessment, better correlates with chemotherapy tolerance than chronologic age. Elderly-Specific Trials Given the concerns about chemotherapy in elderly patients, the first landmark study to look specifically at an elderly patient population included a BSC arm that was compared with single-agent vinorelbine. The hazard ratio HR was 0. Proponents of the latter strategy argued that age is just a number and that there is no reason to adjust our standard-of-care approach based upon something so arbitrary.

Indeed, it is the presence of comorbid conditions that better predicts poor outcomes in NSCLC rather than age. At the initiation of this debate, it was not necessarily clear that doublets were superior to modern single agents in any patient with advanced NSCLC.

Survival was indeed better for the platinum-based doublet in the population as a whole median survival. Twenty-seven percent of the patients enrolled in this study were 70 years or older.

This was, however, still not an elderly-specific study. Mixed results were seen in randomized, elderly-specific approaches comparing non— platinum-based doublets versus single agents in the elderly.

Toxicity was increased in the doublet cohort, with more neutropenia and asthenia. However, survival was unequivocally improved in the doublet arm, with a median survival of Therefore, it is now established that for elderly patients with advanced NSCLC who wish to maximize OS, platinum-based doublet chemotherapy is the standard of care. A more recent comparison of carboplatin with either standard paclitaxel or albumin-bound paclitaxel nab -paclitaxel showed similar efficacy overall, but rather surprisingly showed dramatically improved survival for the subgroup of patients 70 years and older in the nab -paclitaxel arm median survival, It remains less clear whether the addition of bevacizumab to cytotoxic chemotherapy improves outcomes for elderly patients.

It is less clear from the data whether bevacizumab offers benefit, but it is reasonable to offer it to elderly patients who do not have contraindications to the taking bevacizumab. Patients With PS 2 While the elderly have been underrepresented in many clinical trials, patients with poor PS have typically been excluded from clinical trials. It is fair to say that there is no evidence supporting the use of cytotoxic chemotherapy in patients with PS 3 or greater.

Erlotinib has been used in patients with PS 3, and in the second- and third-line setting, erlotinib has been shown to be better than BSC in terms of progression-free survival PFS and OS in molecularly unselected patients. However, patients taking erlotinib who developed a rash did have an OS advantage relative to those receiving placebo.

Due to the generally poor outcomes of patients with poor PS treated with chemotherapy, the tendency has been to either not give chemotherapy at all or to give less toxic single-agent chemotherapy.

However, as with the group as a whole, the patients receiving doublet therapy did significantly better than those receiving single-agent paclitaxel. Fortunately, one now exists. Most important, however, the OS was also significantly better; patients taking the combination had a median OS of 9. One-year survival rates were Not surprisingly, anemia and neutropenia were more frequently observed in the combination arm.

It can therefore be concluded that for patients with PS 2 who are interested in maximizing OS and who are willing to undergo cytotoxic chemotherapy, carboplatin-based doublet therapy is indicated and is superior to single-agent therapy. Platinum-based doublet chemotherapy as first-line treatment for patients without actionable mutations is standard of care.

In addition, immune checkpoint inhibitors display a side effect profile very different from that of traditional cytotoxic chemotherapy. Therefore, with the demonstrated efficacy of these agents in advanced NSCLC, 26,27 we will once again need to sort out which patients may or may not be appropriate for treatment.

Affiliation: Tracey L. Address correspondence to: Tracey L. First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy. J Clin Oncol. Accessed June 22, Abstract Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials.

Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. Ann Oncol. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. Proc Am Soc Clin Oncol. Comparison of platinum-based chemotherapy in patients older and younger than 70 years: an analysis of Southwest Oncology Group Trials and J Thorac Oncol.

Outcomes for elderly, advanced-stage non small-cell lung cancer patients treated with bevacizumab in combination with carboplatin and paclitaxel: analysis of Eastern Cooperative Oncology Group Trial Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the Cancer and Leukemia Group B study Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group , a randomized trial.

J Natl Cancer Inst. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E a phase II trial in patients with metastatic nonsmall cell lung carcinoma. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. Age and comorbidity as independent prognostic factors in the treatment of non small-cell lung cancer: a review of National Cancer Institute of Canada Clinical Trials Group trials.

Lung Cancer. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT randomised, phase 3 trial. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial.

Isolating the role of bevacizumab in elderly patients with previously untreated nonsquamous non-small cell lung cancer: secondary analyses of the ECOG and PointBreak trials [published online January 24, ]. Am J Clin Oncol. Carboplatin and paclitaxel with vs without bevacizumab in older patients with advanced non-small cell lung cancer. Erlotinib in previously treated non-small-cell lung cancer. First-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy TOPICAL : a double-blind, placebo-controlled, phase 3 trial.

Lancet Oncol. Randomized phase III trial of single-agent pemetrexed versus carboplatin and pemetrexed in patients with advanced non-small-cell lung cancer and Eastern Cooperative Oncology Group performance status of 2.

Pembrolizumab for the treatment of non-small-cell lung cancer [published online April 19, ]. Overall survival and long-term safety of nivolumab anti-programmed death 1 antibody, BMS, ONO in patients with previously treated advanced non-small-cell lung cancer [published online April 20, ].

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Advanced (NSCLC): Implications from Recent Trials

Study record managers: refer to the Data Element Definitions if submitting registration or results information. This is a Phase III, open label, randomized study to enroll patients with advanced in a ratio at the time of registration. For the purpose of the study, treatment Arm A or Arm B will consist of up to four cycles of therapy repeated every 21 days. Primary endpoint of the study is overall survival; secondary endpoints include toxicity, response rate, and progression-free survival. The dose of carboplatin will be determined according to the formula developed by Calvert et al. Primary objective of this study is to determine and compare the overall survival produced by pemetrexed as a single-agent and by the combination of pemetrexed plus carboplatin in a patient with previously untreated, advanced non-squamous NSCLC and an ECOG Performance status of 2. Patients with at least any study treatment dose were included in safety analyses, focused on toxicity grades


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