Single-agent gemcitabine: an active and better tolerated alternative to standard cisplatin-based chemotherapy in locally advanced or metastatic non-small cell lung cancer

Lung Cancer ◽  
1999 ◽  
Vol 26 (2) ◽  
pp. 85-94 ◽  
Author(s):  
W TENBOKKELHUININK ◽  
B BERGMAN ◽  
A CHEMAISSANI ◽  
W DORNOFF ◽  
P DRINGS ◽  
...  
2011 ◽  
Vol 29 (31) ◽  
pp. 4129-4136 ◽  
Author(s):  
Purvish M. Parikh ◽  
Ashok Vaid ◽  
Suresh H. Advani ◽  
Raghunadharao Digumarti ◽  
Jayaprakash Madhavan ◽  
...  

Purpose To investigate the activity and safety of oral talactoferrin (TLF) in patients with stages IIIB to IV non–small-cell lung cancer (NSCLC) for whom one or two prior lines of systemic anticancer therapy had failed. Patients and Methods Patients (n = 100) were randomly assigned to receive either oral TLF (1.5 g in 15 mL phosphate-based buffer) or placebo (15 mL phosphate-based buffer) twice per day in addition to supportive care. Oral TLF or placebo was administered for a maximum of three 14-week cycles with dosing for 12 consecutive weeks followed by 2 weeks off. The primary objective was overall survival (OS) in the intent-to-treat (ITT) patient population. Secondary objectives included progression-free survival (PFS), disease control rate (DCR), and safety. Results TLF was associated with improvement in OS in the ITT patient population, meeting the protocol-specified level of significance of a one-tailed P = .05. Compared with the placebo group, median OS increased by 65% in the TLF group (3.7 to 6.1 months; hazard ratio, 0.68; 90% CI, 0.47 to 0.98; P = .04 with one-tailed log-rank test). Supportive trends were also observed for PFS and DCR. TLF was well tolerated and, generally, there were fewer adverse events (AEs) and grade ≥ 3 AEs reported in the TLF arm. AEs were consistent with those expected in late-stage NSCLC. Conclusion TLF demonstrated an apparent improvement in OS in patients with stages IIIB to IV NSCLC for whom one or two prior lines of systemic anticancer therapy had failed and was well tolerated. These results should be confirmed in a global phase III trial.


Author(s):  
Élia Cipriano ◽  
◽  
Helena Magalhães ◽  
Fernanda Estevinho ◽  
◽  
...  

Background: In non -small cell lung cancer (NSCLC) elderly patients with advanced disease and without driver mutations, questions remain if they benefit from doublet chemotherapy (ChT) or single -agent ChT. Methods: A retrospective study characterizing elderly NSCLC patients with advanced disease. The primary endpoint was overall survival (OS) after doublet ChT and single -agent ChT, calculated using Kaplan -Meier method and Log Rank test. Results: Forty -six patients with locally advanced or metastatic disease were treated with ChT (22 with platinum- -based doublet ChT and 24 with single -agent ChT). With a median follow -up of 26.6 months (mo.), the median OS was 8.4 mo. in doublet ChT and 7.0 mo. in single‑agent ChT, p=0.441. Conclusions: There were no statistically significant differences in survival between platinum -based doublet and monotherapy ChT in our studied population.


2020 ◽  
Vol 8 (2) ◽  
pp. e001620
Author(s):  
Afaf Abed ◽  
Leslie Calapre ◽  
Johnny Lo ◽  
Suzana Correia ◽  
Samantha Bowyer ◽  
...  

BackgroundWe aimed to assess the impact of genomic human leukocyte antigen (HLA)-I/II homozygosity on the survival benefit of patients with unresectable locally advanced, metastatic non-small lung cancer treated by single-agent programmed cell death protein-1/programmed death ligand 1 (PD1/PDL1) inhibitors.MethodsWe collected blood from 170 patients with advanced lung cancer treated with immunotherapy at two major oncology centers in Western Australia. Genomic DNA was extracted from white blood cells and used for HLA-I/II high-resolution typing. HLA-I/II homozygosity was tested for association with survival outcomes. Univariable and multivariable Cox regression models were constructed to determine whether HLA homozygosity was an independent prognostic factor affecting Overall Survival (OS) and Progression Free Survival (PFS). We also investigated the association between individual HLA-A and -B supertypes with OS.ResultsHomozygosity at HLA-I loci, but not HLA-II, was significantly associated with shorter OS (HR=2.17, 95% CI 1.13 to 4.17, p=0.02) in both univariable and multivariable analysis. The effect of HLA-I homozygosity in OS was particularly relevant for patients with tumors expressing PDL1 ≥50% (HR=3.93, 95% CI 1.30 to 11.85, p<0.001). The adverse effect of HLA-I homozygosity on PFS was only apparent after controlling for interactions between PDL1 status and HLA-I genotype (HR=2.21, 95% CI 1.04 to 4.70, p=0.038). The presence of HLA-A02 supertype was the only HLA-I supertype to be associated with improved OS (HR=0.56, 95% CI 0.34 to 0.93, p=0.023).ConclusionOur results suggest that homozygosity at ≥1 HLA-I loci is associated with short OS and PFS in patients with advanced non-small cell lung cancer with PDL1 ≥50% treated with single-agent immunotherapy. Carriers of HLA-A02 supertype reported better survival outcomes in this cohort of patients.


2012 ◽  
Vol 6 ◽  
pp. CMO.S6248 ◽  
Author(s):  
Michel Velez ◽  
Belisario A. Arango ◽  
Cesar A. Perez ◽  
Edgardo S. Santos

Lung cancer incidence continues to rise and is the number one cause of cancer death in both men and women worldwide with projected 221,130 new cases and 156,940 deaths in the United States in 2011. 1 Non-small cell lung cancer (NSCLC) represents more than 85% of the cases with most patients having either locally advanced or metastatic disease at the time of initial diagnosis, and approximately 60%–70% of them have an adenocarcinoma histologic subtype. In the last three years, we have seen several advances in the management of NSCLC, with several factors playing an important role in the treatment decision making process. Maintenance therapy has been added to the algorithm of NSCLC management and Pemetrexed has been studied as single agent or in combination in this setting with recent studies showing safety and improved progression free survival (PFS) and/or overall survival (OS), still the disease for the most part has a dismal outcome. More research work needs to be done to identify which patients truly benefit from these approaches, and to whom we should offer maintenance or switch maintenance vs. close observation.


2002 ◽  
Vol 29 (3 Suppl 12) ◽  
pp. 10-16 ◽  
Author(s):  
Angela Davies ◽  
David R. Gandara ◽  
Primo Lara ◽  
Zelanna Goldberg ◽  
Peter Roberts ◽  
...  

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