Lung cancer : journal of the International Association for the Study of Lung Cancer
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Randomized Controlled Trial
A phase II randomized trial of adjuvant chemotherapy with S-1 versus S-1 plus cisplatin for completely resected pathological stage II/IIIA non-small cell lung cancer.
Platinum-based combination chemotherapy is the standard postoperative adjuvant treatment for pathological stage II/III non-small cell lung cancer (NSCLC). Oral S-1 therapy has good efficacy and relatively low toxicity for the treatment of advanced NSCLC. We investigated whether long-term S-1 monotherapy is also useful as an adjuvant therapy after surgery in patients with NSCLC. ⋯ Long-term adjuvant chemotherapy with S-1 was a feasible and promising treatment for patients with completely resected NSCLC, regardless of cisplatin addition. S-1 monotherapy should be investigated further, based on its low toxicity and practical convenience.
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Multicenter Study
Phase II trial of gefitinib plus pemetrexed after relapse using first-line gefitinib in patients with non-small cell lung cancer harboring EGFR gene mutations.
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (i.e., EGFR-TKIs) improve the survival of lung cancer patients harboring EGFR mutations. Despite the initial efficacy of EGFR-TKIs, the disease progression caused by acquired resistance to these inhibitors is inevitable. T790M mutations represent a major resistance mechanism to EGFR-TKIs but can be overcome using osimertinib. The IMPRESS trial revealed that the continuation of EGFR-TKI beyond progressive disease (PD) concurrent with platinum-doublet chemotherapy was not beneficial. However, various clinical trials have suggested that EGFR-TKI beyond PD plus single-agent chemotherapy may be a possible treatment strategy. ⋯ Gefitinib plus pemetrexed treatment following relapse using gefitinib in patients with Non-small cell lung cancer harboring EGFR mutations demonstrated preferable PFS with mild toxicity. This combination therapy may be considered for platinum-unfit patients without T790M with disease progression using first-line gefitinib. (This clinical trial was registered in UMIN-CTGR as UMIN000010709).
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De novo T790 M mutation in EGFR has been reported in various studies. However, its genetic characteristics and association with EGFR tyrosine kinase inhibitors (TKIs) treatment response remain poorly studied. ⋯ The molecular characteristics of de novo T790 M carriers differ distinctly from acquired T790 M carriers. The RAF of EGFR T790 M mutation may serve as a predictive biomarker for treatment response to EGFR-TKIs. Osimertinib is potentially an effective drug for the treatment of NSCLC with de novo T790 M.
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Nivolumab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, has been shown to yield a durable response and significant prolongation of the survival in some patients with non-small-cell lung cancer (NSCLC). However, identification of patients who are likely to respond to nivolumab remains difficult at present. ⋯ A rapid increase of the LMR was significantly associated with the effects of nivolumab monotherapy in our study cohort. Therefore, early change of the LMR may be used as a novel effective surrogate marker to decide on continuation of anti-PD-1 therapy.
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The cost-effectiveness of low-dose computed tomography (LDCT) screening for lung cancer is uncertain. This study estimated the health gains, costs (net health system, and including 'unrelated') and cost-effectiveness of biennial LDCT screening among 55-74 years olds with a smoking history of at least 30 pack years, and (if a former smoker) having quit within last 15 years, in New Zealand. ⋯ We estimated 0.037 QALYs gained (95% uncertainty interval (UI) 0.024-0.053) per eligible participant, at a cost of US$3606 ($2689-4681). The overall incremental cost effectiveness ratio (ICER) was US$104,000 per QALY gained (95% UI US$59,000-US$175,000). The cost-effectiveness varied moderately by socio-demographics, with the 'best' ICER being US$52,000 for 70-74 year old Māori females and the 'worst' ICER being US$142,000 for 55-59 year old non-Māori females. The ICER varied little by current smoking status, due to higher competing mortality risk limiting QALY gains for current smokers. The two scenarios that lowered the ICER the most were increasing the screening uptake to 100% (ICER = US$50,000 per QALY), and improving the sensitivity (from 93.8%-98%) and specificity (from 73.4%-95%) of the screening test (ICER = US$42,000 per QALY). Based on a threshold of GDP per capita per QALY gained (i.e. US$30,000), LDCT screening for lung cancer is unlikely to be cost-effective in New Zealand for any sociodemographic group.