Effect of first-line pembrolizumab treatment in individuals with advanced non-small cell lung cancer and poor performance status.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18796-e18796
Author(s):  
Rajwanth Veluswamy ◽  
Jiayi Ji ◽  
Liangyuan Hu ◽  
Xiaoliang Wang ◽  
Cardinale B. Smith ◽  
...  

e18796 Background: There is limited evidence supporting the optimal use of immune checkpoint inhibitors (ICIs) in NSCLC patients with poor performance status (PS), as clinical trials exclude these patients. In this study, we use real-world oncology data to determine the impact of first line pembrolizumab vs. no treatment in high PD(L)-1 expressing cancers in individuals with advanced NSCLC and ECOG PS ≥2. Methods: We performed a retrospective cohort study of patients with advanced NSCLC with ECOG PS ≥2 between 09/01/2014 and 02/18/2020, using the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. Patients were included if they were PD(L)-1 high (≥50%) and had clinical and treatment information recorded within 90 days of diagnosis. Real-world overall survival (rwOS) was defined as time from diagnosis to death (censored at last EHR activity). Median rwOS was estimated using weighted Kaplan-Meier methods. A marginal Cox structural model with inverse probability of treatment weighting was used to adjust for selection bias and estimate the effectiveness of pembrolizumab. The inverse probability weights were estimated using an ensemble machine learning technique, Super Learner, based on age, gender, race, practice type and smoking history. Adjusted hazard ratios (aHR) were estimated using weighted Cox proportional hazards models. Stratified analysis was conducted by ECOG PS (2 vs >2). Results: 217 (16%) individuals with advanced NSCLC and high PD(L)-1 expression received no treatment, compared to 546 (39%) individuals who received 1L pembrolizumab. The no-treatment group had a lower proportion of ECOG 2 compared to the pembrolizumab group (Table). Median rwOS in the no-treatment group was 2.4 months, compared to 7.1 months in the pembrolizumab group (p<0.001). In unadjusted survival analyses in the entire cohort and in cohorts stratified by ECOG status, treatment with pembrolizumab was associated with a significantly lower risk of death (hazard ratio [HR]: 0.38, 95% Confidence Interval [CI]: 0.31-0.45). In adjusted analyses, individuals treated with pembrolizumab had improved survival (HR: 0.40, 95% CI: 0.35-0.45). Conclusions: Our analysis of real-world clinical oncology data demonstrated that 1L treatment with pembrolizumab was associated with significantly improved rwOS among individuals with ECOG ≥ 2. [Table: see text]

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12515-e12515
Author(s):  
Margaret Lee ◽  
Sheau Wen Lok ◽  
Natalie Heather Turner ◽  
Daphne Day ◽  
Sally Greenberg ◽  
...  

e12515 Background: The management and outcomes of HER2 positive MBC have dramatically evolved with the introduction of HER2-targeted therapies. However, limited data regarding the uptake, impact and safety of these treatments in the real-world context, prompted us to initiate a comprehensive registry across multiple settings in Australia. Methods: We examined the multisite electronic registry TABITHA (Treatment of Advanced Breast Cancer in the HER2 positive Australian Patient) to capture clinical data of consecutive patients diagnosed with HER2 positive MBC between Jan 2016-Jan 2017. Patient demographics, use and outcomes of treatment were explored. Results: An initial cohort of 74 patients was identified, 28 (38%) with de novo metastatic and 46 (62%) with relapsed disease. The median age at presentation with MBC was 57 years (range 27-83), with main metastatic sites being bone (n = 41, 55%), major organs (n = 40, 54%), locoregional (N = 26, 35%) and central nervous system (n = 13, 18%). In total, 64 (86%) patients had received first-line HER2 therapy, including trastuzumab plus pertuzumab (n = 48, 75%), trastuzumab alone (n = 10, 16%) and trastuzumab-emtansine (n = 6, 9%). Ten patients had not received any HER2 therapy, of which 8 received best supportive care alone, 1 received endocrine therapy, and 1 received anti-resorptive therapy. The median age of non-HER2 treated patients was 61 (range 44-81) and 40% were ECOG 2+ compared to 25% of patients receiving HER2 therapy (p = NS). First-line HER2 therapy had been discontinued in 20/63 (32%) patients, due to progressive disease (n = 18, 90%) or toxicity (n = 2, 10%). Median time to progression was 12.7+ months (range 2.0-81.9+). Conclusions: Whilst trials of HER2 directed therapies have demonstrated a substantial impact on survival outcomes for MBC with modest toxicity, a proportion of HER2 positive patients in routine care may not receive these agents. Poor performance status contributes to non-HER2 therapy use, however data collection is ongoing and other potential drivers will be further examined. Where HER2 directed therapies are used, the preliminary data indicates good activity with the majority of patients still currently on treatment.


2019 ◽  
Vol 26 (1) ◽  
pp. 216-219 ◽  
Author(s):  
Lindsay Hunter ◽  
Justin Moser ◽  
Caleb Sturge ◽  
Gonzalo Barraza ◽  
Sarah Colonna

Background Plasmacytoid urothelial carcinoma (PUC) is a rare but aggressive variant of transitional cell carcinoma. In patients with unresectable disease, cisplatin-based combination chemotherapy is the most commonly used treatment. However, many patients are cisplatin-ineligible due to poor performance status or other comorbidities. We report a case of a cisplatin-ineligible patient with metastatic PUC who was treated with pembrolizumab. Case report A 71-year-old man with 30 pack-year smoking history and schizoaffective disorder was found to have multiple right-sided lung nodules after presenting with atypical chest pain. Staging CT showed bilateral adrenal masses and a large soft tissue mass in the right iliac fossa. Tissue pathology and immunohistochemical staining was consistent with PUC. As the patient was cisplatin-ineligible due to poor performance status and multiple medical comorbidities, the decision was made to treat with pembrolizumab. Repeat CT chest and abdomen showed partial response at three months and stable disease at six months. Discussion The KEYNOTE-052 study found that first-line pembrolizumab in cisplatin-ineligible patients with urothelial cancer resulted in complete or partial response in 24% of patients with few adverse effects. However, it is unclear if patients with plasmacytoid variant were included. To our knowledge, this is the first case report of a patient with metastatic PUC not only treated with pembrolizumab but shown to have clinical response. Conclusion Given our patient’s clinical response, pembrolizumab is a promising first-line agent for treating cisplatin-ineligible patients with metastatic PUC. Further evaluation is warranted to confirm the benefit of treating this patient population with pembrolizumab.


Author(s):  
Alvin J. X. Lee ◽  
Karin Purshouse

AbstractThe SARS-Cov-2 pandemic in 2020 has caused oncology teams around the world to adapt their practice in the aim of protecting patients. Early evidence from China indicated that patients with cancer, and particularly those who had recently received chemotherapy or surgery, were at increased risk of adverse outcomes following SARS-Cov-2 infection. Many registries of cancer patients infected with SARS-Cov-2 emerged during the first wave. We collate the evidence from these national and international studies and focus on the risk factors for patients with solid cancers and the contribution of systemic anti-cancer treatments (SACT—chemotherapy, immunotherapy, targeted and hormone therapy) to outcomes following SARS-Cov-2 infection. Patients with cancer infected with SARS-Cov-2 have a higher probability of death compared with patients without cancer. Common risk factors for mortality following COVID-19 include age, male sex, smoking history, number of comorbidities and poor performance status. Oncological features that may predict for worse outcomes include tumour stage, disease trajectory and lung cancer. Most studies did not identify an association between SACT and adverse outcomes. Recent data suggest that the timing of receipt of SACT may be associated with risk of mortality. Ongoing recruitment to these registries will enable us to provide evidence-based care.


2020 ◽  
Vol 11 (12) ◽  
pp. 3618-3621
Author(s):  
Ryoko Inaba‐Higashiyama ◽  
Tatsuya Yoshida ◽  
Hitomi Jo ◽  
Masayuki Shirasawa ◽  
Noriko Motoi ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19629-19629
Author(s):  
K. Shitara ◽  
M. Munakata ◽  
O. Muto ◽  
M. Kasai ◽  
Y. Sakata

19629 Background: The prognosis of advanced gastrointestinal cancer patients, especially those with poor PS, is generally dismal. Needless to say, such patients are ineligible for participation in clinical studies. However, there are many patients with poor PS who wish to receive chemotherapy. Methods: From June 2000 to October 2006, a total of 508 patients with advanced cancer, including 304 gastrointestinal cancer patients, were treated by chemotherapy in our hospital. Of these, 110 gastrointestinal cancer patients (gastric=35, colorectal=30, pancreatic=26, biliary tract=11, esophageal=8) had poor PS (ECOG PS 3 = 68 patients, PS 4 = 42 patients). In 103 patients with at least one measurable lesion, a partial response according to RECIST criteria was obtained in 13 patients (12.6%). In 60 patients with ascites (47 patients), pleural effusion (25 patients), or both (12 patients), 11 of the patients (18.3%) achieved decreased fluid accumulation. A decline in tumor markers (>25%) was observed in 28 patients. Improvement in PS was seen in 13 patients (11.8%). As a result, 35 patients (31.8 %, including 9 patients with PS 4) achieved a tumor response, a decrease in accumulated fluid, or a decline in tumor markers, which resulted in a survival benefit compared to the other 75 patients without effect (6.4 months vs. 2.3 months, p<0.001). Alleviation of some symptoms was observed in 28 out of 98 symptomatic patients (30.4%). A better response and/or a decline in tumor markers significantly correlated with alleviation of symptoms (p<0.001). No treatment related death was seen. Conclusions: With regard to response rate, chemotherapy was rarely effective for patients with advanced gastrointestinal cancer with poor PS. However, more than a few patients gained a certain survival benefit and alleviation of symptoms. Thus, chemotherapy may be warranted in cases of patients with advanced gastrointestinal cancer who wish to receive chemotherapy despite the low possibility of response. No significant financial relationships to disclose.


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