Real-world efficacy and safety of pembrolizumab in patients with non-small cell lung cancer: a retrospective observational study

2020 ◽  
pp. 030089162092624 ◽  
Author(s):  
François Cavaille ◽  
Mathieu Peretti ◽  
Marie Eve Garcia ◽  
Roch Giorgi ◽  
Nathalie Ausias ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clinical Trials ◽  
Performance Status ◽  
Univariate Analysis ◽  
Real Life ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
Effective Treatment Option ◽  
Multiple Tumor

Background: Pembrolizumab, a humanized immunoglobulin monoclonal antibody directed against the programmed cell death 1 receptor, demonstrated robust efficacy and a manageable safety profile across multiple tumor types in clinical trials. Aim: To investigate the efficacy and safety of first-line pembrolizumab for patients with non-small cell lung cancers (NSCLCs) in clinical practice. Methods: In this observational monocentric retrospective study, 38 patients with PD-L1 >50% were enrolled between November 2017 and November 2018. Results: The global median overall survival was 11.08 months (95% confidence interval [CI], 5.98–not reached) and the global median progression-free survival was 6 months (95% CI, 3–not reached). In the univariate analysis, clinical performance status score and the development of immune-related adverse events were the only 2 clinical factors significantly correlated with overall survival. Conclusion: The results of the present study suggest that pembrolizumab seems less effective in the real-life population than in the pivotal clinical trials in patients with NSCLC but remains an effective treatment option for patients with NSCLC. Longer follow-up is needed.

scholarly journals Effectiveness and Safety of Immune Checkpoint Inhibitors for Patients with Advanced Non Small-Cell Lung Cancer in Real-World: Review and Meta-Analysis

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1388
Author(s):  
Manlio Mencoboni ◽  
Marcello Ceppi ◽  
Marco Bruzzone ◽  
Paola Taveggia ◽  
Alessia Cavo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Group Performance ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria

Immunotherapy based on anti PD-1/PD-L1 inhibitors is the new standard of advanced non-small cell lung cancers. Pembrolizumab, nivolumab and atezolizumab are used in clinical practice. The strict eligibility criteria of clinical trials do not allow researchers to fully represent treatment effects in the patients that will ultimately use these drugs. We performed a systematic review and a meta-analysis to evaluate the effectiveness and safety of these drugs, and more generally of ICIs, as second-line therapy in NSCLC patients in real world practice. MEDLINE, PubMed, Scopus and Web of Science were searched to include original studies published between January 2015 and April 2020. A total of 32 studies was included in the meta-analysis. The overall radiological response rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and overall survival (OS) were 21%, 52%, 3.35 months and 9.98 months, respectively. The results did not change when analysis was adjusted for Eastern Cooperative Oncology Group performance status (ECOG PS) and age. A unitary increase in the percent of patients with liver and CNS metastases reduced the occurrence of DCR by 7% (p < 0.001) and the median PFS by 2% (p = 0.010), respectively. The meta-analysis showed that the efficacy and safety of immunotherapy in everyday practice is comparable to that in clinical trials.

Efficacy and safety of oral etoposide maintenance therapy following cisplatin plus etoposide in advanced small cell lung cancers (Study of the Anatolian Society of Medical Oncology).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e18546-e18546
Author(s):  
Zuhat Urakci ◽  
Muhammet Ali Kaplan ◽  
Olcun Umit Unal ◽  
Mehmet Kucukoner ◽  
Alper Sevinc ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Performance Status ◽  
Progression Free Survival ◽  
Small Cell ◽  
Oral Etoposide ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
Ecog Performance Status ◽  
Lung Cancers ◽  
Grade 3

e18546 Background: Small cell lung cancers (SCLC) constitute a mean of 15% of lung cancers and present with advanced disease at time of diagnosis in 60% of cases. Cisplatin plus etoposide schedule is the standard treatment in these patients , whereas the role of maintenance therapy is debated. We assessed the efficacy and safety of oral etoposide maintenance therapy following cisplatin plus etoposide in advanced SCLC. Methods: Demographic features, treatment response, survival rate, and toxicity rate were assessed in our patients who were followed up for advanced SCLC between 2006 and 2012, had a ECOG performance status of 0-1, and were given oral etoposide maintenance therapy (50mg/day, given 14 days of a 21-day cycle, a total of 6 cycles) following 6 courses of cisplatin (75 mg/m2, 1 day) and etoposide (100mg/m2, 3 days). Results: A total of 51 patients were studied, 46 (90.2%) of whom were male; the mean age was 59 (28-78) years at diagnosis. Forty-four (86.2%) patients had partial remission while 7 (13.7%) had complete remission. Nine (17.6%) developed neutropenic fever while grade 3-4 toxicities, neutropenia, anemia, thrombocytopenia, neuropathy, diarrhea, nausea and vomiting were present in 39.2%, 9.8%, 5.9%, 1.9%, 3.9%, 3.9%, and 1.9% respectively. Chemotherapy was postponed in fourteen (27.4%) patients due to toxicity. Six (11.7%) patients taking oral etoposide developed febrile neutropenia and 3 (5.9%) developed grade 3-4 thrombocytopenia. Chemotherapy was postponed in 5 (9.8%) patients due to toxicity while no toxic death was observed. After a median follow-up of 19 months, 32 (62.7%) patients experienced progression of disease and 29 (56.8%) died. Median progression free survival was found 11.6 months (%95 CI; 10.2-12.9 months) and median overall survival was found 15.6 (%95CI; 11.5-19.7 months) months. Conclusions: Our results were similar with the previous literature. Oral etoposide maintenance therapy following cisplatin plus etoposide therapy in advanced SCLC is effective and tolerable. Further randomized studies are needed in this topic.

NIVORAD: A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer, progressing after first or second line chemotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS9097-TPS9097 ◽  
Author(s):  
Paul Mitchell ◽  
Shankar Siva ◽  
Peey Sei Kok ◽  
Ken O'Byrne ◽  
Annie Yeung ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
New Zealand ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Stereotactic Ablative Body Radiotherapy

TPS9097 Background: Recent data has demonstrated improvements in overall survival in patients with advanced non-small cell lung cancer (NSCLC) treated with nivolumab. Radiation may augment the immune response through abscopal effects - evidence of tumour control at sites other than those irradiated. We hypothesize that the addition of stereotactic ablative body radiotherapy (SABR) to immunotherapy with nivolumab will improve progression free survival (PFS) compared with nivolumab alone. Methods: DESIGN: Open label, randomised phase II trial with 25 sites across Australia and New Zealand. ELIGIBILITY: Metastatic NSCLC progressing after 1 or 2 lines of chemotherapy with an extrapulmonary metastasis suitable for SABR. STRATIFICATION: Age, lines of chemotherapy, histology and treating institution. TREATMENT: A single dose of SABR (18-20Gy) plus nivolumab or nivolumab alone (240mg 2-weekly) given until disease progression or prohibitive adverse events. ENDPOINTS: PFS at 6 months (PFS6; primary), objective tumour response rate, adverse events, overall survival, PFS at 1 and 2 years. Tertiary correlative objectives include associations between possible prognostic/ predictive biomarkers and outcomes (including PD-L1 expression). STATISTICS:Total sample size of 120 participants allocated in a ratio of 2:1, 80 to nivolumab + SABR and 40 nivolumab alone to provide 80% power, one-sided type I error rate of 5% for PFS6 of 50% (worthy of pursuit) vs 35% (not worthy of pursuit). BIOSPECIMENS: Tumour tissue and serial bloods (4 time points) will be collected for translational research. CURRENT ENROLLMENT (as of Feb 2017): 2 out of 20 sites are open. NIVORAD is an investigator-initiated, cooperative-group trial led by the ALTG in collaboration with the NHMRC Clinical Trials Centre, University of Sydney and the Trans Tasman Radiation Oncology Group (TROG). Australian New Zealand Clinical Trials Registry: ACTRN12616000352404.

Osimertinib for patients with poor performance status and EGFR T790M mutation-positive advanced non-small-cell lung cancer (NSCLC): A phase II clinical trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21704-e21704
Author(s):  
Yuichi Ozawa ◽  
Kazuhisa Nakashima ◽  
Haruko Daga ◽  
Hisao Imai ◽  
Motohiro Tamiya ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
T790m Mutation ◽  
Egfr T790m

e21704 Background: Osimertinib has been shown to be effective against epidermal growth factor receptor ( EGFR) T790M-positive non-small cell lung cancer (NSCLC), but so far all clinical trials have targeted performance status (PS) 0 to 1 cases. The efficacy and safety of osimertinib in EGFR T790M-positive NSCLC patients with poor PS remain elusive. Methods: We conducted an open-label, multi-center, single-arm phase II study to evaluate the efficacy and safety of osimertinib in patients with EGFR T790M mutation-positive NSCLC who had Eastern Cooperative Oncology Group PS scores of 2 to 4. Patients received 80 mg of osimertinib once daily. The primary endpoint was progression-free survival (PFS). The planned sample size was 18 patients to achieve power of at least 80% with one-sided alpha of 0.05 and expected and threshold PFS as 8.2 months and 3.0 months. Results: Eighteen patients (4 men and 14 women) were enrolled between June 2017 and November 2018. The median age was 77 years (range: 55–85 years). Ten, six, and two patients had PS scores of 2, 3, and 4, respectively. All patients had adenocarcinoma with common EGFR mutations and were previously treated with first- or second-generation EGFR- tyrosine kinase inhibitors, and 10 patients (56%) had central nervous system (CNS) metastasis. The overall median PFS was 7.0 months (90% confidence interval: 5.5-8.9 months). The overall response rate (ORR) was 53%, the median time to first response was 1.5 months, the median duration of response was 6.7 months, and the median overall survival (OS) was 12.7 months. Moreover, improved PS scores were observed in 13 patients (72%) including six with PS 2, six with PS 3, and one with PS 4. Osimertinib also showed an ORR of 60% in the patients with CNS metastasis, and the median PFS and OS were 6.5 months and 22.0 months, respectively. Although anemia, rash, and anorexia were frequently reported, the incidence of grade 3 adverse events was low, and no grade 4 or 5 events were observed. Interstitial lung disease (ILD) was observed in three patients (two with grade 2, one with grade 1). All three patients discontinued osimertinib treatment and recovered from ILD. Conclusions: Osimertinib therapy could be a promising treatment option for patients with EGFR T790M mutation-positive advanced NSCLC who have poor PS. Clinical trial information: UMIN000027655.

Docetaxel compared with vinorelbine in elderly patients with advanced non-small cell lung cancer (NSCLC): A randomized phase II Hellenic Oncology Research Group trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7615-7615 ◽  
Author(s):  
A. Karampeazis ◽  
L. Vamvakas ◽  
A. Agelidou ◽  
V. Chandrinos ◽  
X. Tsiafaki ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Elderly Patients ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Statistical Difference ◽  
Median Overall Survival ◽  
Performance Status ◽  
Small Cell ◽  
Small Cell Lung

7615 Background: To compare docetaxel versus vinorelbine as front-line treatment of elderly patients with advanced non-small-cell lung cancer (NSCLC). Methods: Chemotherapy-naive patients >65 years, with stage histologically or cytologically documented IIIB/IV NSCLC and performance status (PS) 0–3 were randomly assigned to receive docetaxel 38 mg/m2 (days 1 and 8) or vinorelbine 25 mg/m2 (days 1 and 8) every 21 days. Treatment was continued for a maximum of six cycles and was interrupted in case of disease progression or unacceptable toxicity. Results: A total of 112 patients with median age of 76 years (range, 66–87) were enrolled onto the study. PS 2–3 had 39 (35%) patients. The two treatment groups were well balanced. There was no statistical difference between the 2 arms in median overall survival (6.27 months vs 3.97 months; p=0.129), in median time to progression (2.2 months vs 2 months; p=0.863.) and in overall response rate (5.3% vs 11.3%; p=0.247). Docetaxel conferred a statistically significant survival benefit compared to vinorelbine only in patients with PS 0–1 (11.4 months vs 4.3 months; p=0.009). Among patients treated with docetaxel there was a significant difference in median overall survival for patients with PS 0–1 compared with patients with PS 2–3 (11.4 months vs 2.5 months; p=0.004) while there was no statistical difference in the vinorelbine arm (4.3 months vs 2.8 months; p=0.970).The most common grade 3 and 4 toxicity was neutropenia (3.4% for docetaxel; 27.8% for vinorelbine; p=0.0001). Other toxicities were mild, well tolerated and similar for both groups with the exception of asthenia grade 2 (8.6% for docetaxel; 24.1% for vinorelbine; p=0.026). Conclusions: Docetaxel improves survival compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer and good performance status without increasing toxicity. No significant financial relationships to disclose.

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