Real-world data of osimertinib in the management of leptomeningeal metastases in EGFR mutant NSCLC: Light at the end of the tunnel?

e21197 Background: Presence of leptomeningeal metastases (LM) in NSCLC is indicative of aggressive disease and the incidence is as high as 9%-16% in the EGFR mutant subgroup. Traditionally, these patients had a dismal outcome with WBRT and intrathecal chemotherapy. Osimertinib crosses the blood brain barrier and is efficacious in the second line setting, as seen in BLOOM trial (LM ORR of 62%) and AURA program (LM ORR 55%). Osimertinib has also demonstrated CNS efficacy in the first line (FLAURA trial). This study is a retrospective review of cases with LM treated with osimertinib, and their response outcomes. Methods: 16 patients of EGFR mutant NSCLC developed LM at some point in their disease course and were treated with osimertinib. Clinical features and response outcomes were retrieved from medical record archives. Descriptive statistics were done using SPSS v23 software. LM PFS was defined as the time between 1st dose of osimertinib and date of progression in LM. LM OS was defined as the time between the first dose of osimertinib to the date of last follow up/death. ORR was defined as the percentage of cases showing CR/PR to osimertinib. Results: Median age was 61 years (range: 33-79) with 9 males and 7 females. Del19 mutations were seen in 9 patients and L858R in 7 patients. Only one patient was given WBRT prior to TKI. 6 patients with LM at diagnosis were given 1st line osimertinib. 3 (50%) progressed in LM and 3 (50%) showed partial response. Median LM PFS and median LM OS was not reached. ORR for osimertinib in the first line was 83.3%. 10 patients developed LM later in the course of the disease and median time to onset of LM was 12.47 months. Median LM PFS for osimertinib was 7.9 months (95% CI:3.2-8.3). Median LM OS was 8.2 months (95% CI: 2.6-19.8 months). ORR for osimertinib in the later line was 60%. Conclusions: This early experience reveals superior efficacy of osimertinib in LM with an excellent LM ORR in the first line setting and concordant results with second line BLOOM Study. Despite the small numbers in this study, this report becomes clinically relevant owing to the rarity of LM occurrence and paucity of available data. Efficacy of osimertinib in EGFR treatment-naive patients with LM requires further investigation and a larger prospective trial with a longer follow up may help confirm our preliminary findings.

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Selection of non-small cell lung cancer patients for intercalated chemotherapy and tyrosine kinase inhibitors

Radiology and Oncology ◽

10.1515/raon-2017-0029 ◽

2017 ◽

Vol 51 (3) ◽

pp. 241-251 ◽

Cited By ~ 2

Author(s):

Matjaz Zwitter ◽

Antonio Rossi ◽

Massimo Di Maio ◽

Maja Pohar Perme ◽

Gilberto Lopes

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Kinase Inhibitors ◽

Small Cell ◽

Second Line ◽

Small Cell Lung ◽

First Line ◽

Treatment Naïve ◽

Egfr Mutant ◽

Line Setting

AbstractBackgroundWhen treating patients with advanced non-small cell lung cancer (NSCLC) with tyrosine kinase inhibitors and chemotherapy, intercalated schedule with time separation between the two classes of drugs should avoid their mutual antagonism. In a survey of published trials, we focus on relation between eligibility criteria and effectiveness of intercalated treatment.MethodsPublished documents were identified using major medical databases, conference proceedings and references of published trials. Median progression-free survival (PFS) was taken as the basic parameter of treatment efficacy. Correlation between characteristics of patients and median PFS was assessed through the Pearson’s correlation coefficient and the coefficient of determination, separately for first-line and second-line setting.ResultsThe series includes 11 single-arm trials and 18 randomized phase II or phase III trials with a total of 2903 patients. Treatment-naive patients or those in progression after first-line treatment were included in 16 and 13 trials, respectively. In 14 trials, only patients with non-squamous histology were eligible. Proportion of patients with non-squamous carcinoma (in first-line setting), proportion of never-smokers (both in first- and second-line setting) and proportion of epidermal growth factor receptor (EGFR) mutant patients (both in first- and second-line setting) showed a moderate or strong correlation with median PFS. In six trials of intercalated treatment applied to treatment-naive EGFR-mutant patients, objective response was confirmed in 83.1% of cases and median PFS was 18.6 months.ConclusionsMost suitable candidates for intercalated treatment are treatment-naive patients with EGFR-mutant tumors, as determined from biopsy or liquid biopsy. For these patients, experience with intercalated treatment is most promising and randomized trials with comparison to the best standard treatment are warranted.

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Second-line systemic therapies for metastatic urothelial carcinoma: a population-based cohort analysis

Current Oncology ◽

10.3747/co.26.4070 ◽

2019 ◽

Vol 26 (2) ◽

Author(s):

E. S. Tsang ◽

C. Forbes ◽

K. N. Chi ◽

B. J. Eigl ◽

S. Parimi

Keyword(s):

Urothelial Carcinoma ◽

Systemic Therapy ◽

Topoisomerase I ◽

Cohort Analysis ◽

Retrospective Chart Review ◽

Population Based ◽

Second Line ◽

First Line ◽

Real World Data ◽

Line Setting

Introduction Patients with urothelial carcinoma (uc) have a poor prognosis after progression on first-line cisplatinbased chemotherapy. Real-world data about second-line cytotoxic therapies are limited. We sought to characterize patients with metastatic uc who receive more than 1 line of systemic therapy and to describe their treatments and outcomes.Methods Using BC Cancer’s pharmacy database, we identified patients with documented metastatic uc who had received more than 1 line of systemic therapy. A retrospective chart review was then performed to collect clinicopathologic, treatment, and outcomes data.Results The 51 included patients, of whom 42 were men (82%), had a median age of 65 years (range: 38–81 years). Sites of metastasis included lymph nodes (n = 30), bone (n = 7), lung (n = 9), and peritoneum (n = 2). Second-line chemotherapy regimens included gemcitabine–cisplatin [gc (n = 14)], paclitaxel (n = 24), docetaxel (n = 12), and an oral topoisomerase i inhibitor (n = 1). Median time to progression (ttp) and overall survival (os) were 2.0 and 6.83 months respectively. Compared with patients who received a different agent, patients who had experienced a prior response to first-line gc and who were re-challenged with second-line gc had a better median ttp (11.0 months vs. 6.0 months, p = 0.02) and survived longer (4.0 months vs. 1.0 months, p = 0.02). No differences in os between non-gc regimens were evident.Conclusions In patients with metastatic uc, overall outcomes remain poor, but compared with patients receiving other agents, the subgroup of patients re-challenged with second-line gc demonstrated improved ttp. Conventional chemotherapy regimens provide only modest benefits in the second-line setting and have largely been replaced with immunotherapy.

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Association of immune microenvironment to response in treatment-naïve non-small cell lung cancer (NSCLC) samples with follow-up second-line immunotherapy data.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.5_suppl.49 ◽

2020 ◽

Vol 38 (5_suppl) ◽

pp. 49-49

Author(s):

Marie Cumberbatch ◽

Nathan Elliott ◽

Sarah Warren ◽

Woo Ho Kim ◽

Christopher Womack ◽

...

Keyword(s):

Gene Expression ◽

Mhc Class Ii ◽

Objective Response ◽

Standard Of Care ◽

Analysis Data ◽

Second Line ◽

First Line ◽

Immune Microenvironment ◽

Treatment Naïve

49 Background: Archival specimens collected months or years prior to starting immunotherapy are often used to identify patients for second line immune checkpoint inhibitor (ICI) treatment. PD-L1 expression and the immune microenvironment in these patients may have altered over time following multiple lines of failed standard of care (SOC) treatments. Methods: Formalin fixed paraffin embedded (FFPE) tumor samples, taken during resection performed as first line surgical treatment from a cohort of NSCLC patients (n = 18), were evaluated by Nanostring using the IO360 gene expression panel, and by immunohistochemistry (IHC) for CD3, CD8, PD-L1, CD68 and CD163. The resultant immune profiles were correlated with the clinical follow-up data for radiotherapy, SOC chemotherapy, and second line immunotherapy with the aim of understanding whether immune signatures predictive of response to ICI therapy may be identified in such samples. Results: Of the 18 cases, clinical follow-up data indicated objective response to ICI therapy for 4 patients, with the mean time from initial diagnosis to ICI treatment being 2.8 years (range: 0.4 to 8.5 years). Although pathologist PD-L1 IHC scores were not predictive of response, IHC image analysis data revealed significant increases in CD3 (2.3-fold) and CD8 (2.7-fold) T cell numbers in the responder population. In addition, although CD68+ macrophage frequencies did not differ significantly between responder and non-responder populations, reduced M2-like CD163+ macrophage/monocyte numbers were evident for responders. While the Tumor Inflammation Signature was not predictive of response, several gene expression signatures were significantly associated with response including increased abundance of CD8 T cells, cytotoxic cells, cytotoxicity, MHC class II antigen presentation and Melanoma-Associated Antigens (MAGE). Conclusions: Despite these patients having received various lines of radiotherapy and SOC chemotherapy prior to receiving immunotherapy, immune profiles associated with response to second line immunotherapy were detected in surgical first line resection samples.

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TDM-1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: A meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e13010 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e13010-e13010

Author(s):

Claudia Omarini ◽

Federico Piacentini ◽

Isabella Sperduti ◽

Krisida Cerma ◽

Monica Barbolini ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Real World ◽

Meta Analysis ◽

Metastatic Breast ◽

Second Line ◽

First Line ◽

Her2 Positive ◽

Real World Data ◽

Line Setting

e13010 Background: Based on the results reported in Emilia trial population, current guidelines consider TDM-1 the standard second-line therapy for HER2 positive metastatic breast cancer (MBC) patients. Despite that, there are no prospective studies supporting the efficacy of TDM-1 following trastuzumab (T) + pertuzumab (P) and taxane first-line treatment. Currently, only real-world data have investigated this sequence with controversial results Methods: We performed a meta-analysis of the available real world data to determine the efficacy of TDM-1 after first-line TP in HER2 positive MBC patients. We used a random-effect model to find differences in the rate of 1-year progression free survival (PFS) between TP pre-treated population and the phase III Emilia trial (T pre-treated population). Results: Seven studies were eligible, in three of them data were from sub-group population analysis. The meta-analysis showed a combined 1-years PFS risk difference for TDM-1 efficacy after TP in second or more lines of -0.122, with lower and upper limits of -0.253 and 0.010, respectively (p=0.07) , with low heterogeneity among studies (I2 < 0.0001, p =0.836). Considering the four studies on TDM-1 in second-line setting, 1-years PFS risk was -0.034 (95% CI -0.207 – 0,139; p=0.701) (I2 < 0.0001, p =0.91). Conclusions: Results from the meta-analysis show that the efficacy of TDM-1 after TP double-block seems to be similar to the previously reported in Emilia trial. In the second line setting, available data are not mature enough to confirm TDM-1 efficacy in TP pre-treated population. Currently, TP pretreated patients should receive TDM-1 as indicated in the guidelines.

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Analysis of Adverse Events of Dasatinib and Nilotinib in Chronic Phase Chronic Myeloid Leukemia Patients Treated Outside Clinical Trials

Blood ◽

10.1182/blood.v128.22.1902.1902 ◽

2016 ◽

Vol 128 (22) ◽

pp. 1902-1902

Author(s):

Koung Jin Suh ◽

Ji Yun Lee ◽

Dong-Yeop Shin ◽

Youngil Koh ◽

Soo-Mee Bang ◽

...

Keyword(s):

Adverse Events ◽

Chronic Phase ◽

Drug Discontinuation ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Day Range ◽

Grade 3 ◽

Line Setting

Abstract Background Patients with chronic myeloid leukemia (CML) encounter lifelong treatment. Incidence and severity of adverse events (AEs) of tyrosine kinase inhibitors (TKIs) are therefore one of the most important factors when making treatment decisions; yet studies focusing on AEs in "real life" setting and their impact on drug discontinuation and treatment outcomes are lacking. Methods We retrospectively analyzed the rates and severity of AEs in 201 patients with chronic phase CML treated with nilotinib or dasatinib used as both first- and second-line therapy in two Korean tertiary care centers. AEs were graded according to Common Terminology Criteria for Adverse Events version 4.03. Event-free survival (EFS) was defined as the time from the start of the treatment to the earliest date of any of following event: treatment discontinuation due to AEs, loss of complete hematologic response (CHR), loss of major cytogenetic response (MCyR), loss of major molecular response (MMR), progression to accelerated phase (AP) or blastic phase (BP), discontinuation due to treatment failure as assessed by the clinician, and death from any cause on therapy. Progression-free survival (PFS) was defined as the time from the start of the treatment to the earliest date of any of following event: loss of CHR, MCyR, MMR, progression to AP or BP, discontinuation due to treatment failure as assessed by the clinician, and death from any cause on therapy. Results There were 135 men (67%) and 66 women (33%). One-hundred and twenty (60%) received nilotinib (first line, n = 68; second line, n = 52) and 81 (40%) patients received dasatinib (first line, n = 37; second line, n = 44). For the majority of patients who received second line treatment with nilotinib and dasatinib, reason for imatinib discontinuation was resistance (81% in nilotinib group and 80% in dasatinib group). The median starting dose of nilotinib was 600mg/day (range 600 - 800mg/day) and dasatinib 100mg/day (range 100-140mg/day). During the median follow-up of 36.9 months (8.0 - 114.1) for nilotinib group and 37.2 months (2.2 - 95.0) for dasatinib group, 88.3% (106/120) of patients in nilotinib group and 86.4% (70/81) in dasatinib group experienced AEs. Dasatinib group had significantly higher grade 3-4 AEs compared to nilotinib group (21.7% vs. 54.3%, p < 0.001); however, rate of grade 3-4 non-hematological AEs were similar in both groups (13% vs. 14%, p = 0.960). Dasatinib group had more frequent dose reduction, interruption, and drug discontinuation (p < 0.001, p = 0.004, and p = 0.006, respectively). At the time of analysis, 58 out of 201 (29%) discontinued treatment because of AEs (n = 47, 23%), resistance (n = 9, 5%), or other reasons (n = 2, 1%). Eighty one percent (47 out of 58) of drug discontinuation was due to AEs, and half of AE leading to drug discontinuation was grade 2. Treatment discontinuation occurred more rapidly in the first line setting than in the second line setting (duration of treatment, 2.9 months vs. 15.6 months, p = 0.015). Pleural effusion occurred in 35% (n = 28) in dasatinib group, and led to dasatinib discontinuation in 14 patients (Grade 2, n = 11; Grade 3, n = 3). One patient stopped dasatinib due to pulmonary artery hypertension. In nilotinib group, stroke, acute coronary syndrome and peripheral artery occlusive disease (PAOD) occurred in 5% (n = 6); only PAOD led to nilotinib discontinuation. Dasatinib group had significantly shorter duration of EFS than nilotinib group (median EFS not reached [NR] vs. 48.7 months, p = 0.040 for first line treatment; NR vs. 50.5 months, p = 0.036 for second line treatment). However, PFS did not show statistically significant differences (p = 0.505 for first line and p = 0.179 for second line). Conclusion AE was the main cause of nilotinib and dasatinib discontinuation in CML patients. Persistent grade 2 AEs, especially pleural effusion, were hard to manage and this translated into early discontinuation of drug especially in the first line setting and significantly shorter EFS in dasatinib treated patients compared to nilotinib treated patients. Large, prospective population based studies with long term follow-up are warranted to confirm our finding. Disclosures No relevant conflicts of interest to declare.

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Patient profiles as an aim to optimize selection in the second line setting: the role of aflibercept

Clinical & Translational Oncology ◽

10.1007/s12094-021-02568-y ◽

2021 ◽

Author(s):

B. González Astorga ◽

F. Salvà Ballabrera ◽

E. Aranda Aguilar ◽

E. Élez Fernández ◽

P. García-Alfonso ◽

...

Keyword(s):

Colorectal Cancer ◽

Therapeutic Option ◽

Scientific Evidence ◽

Treatment Options ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Effective Therapeutic Option ◽

Line Setting ◽

First Line Treatment

AbstractColorectal cancer is the second leading cause of cancer-related death worldwide. For metastatic colorectal cancer (mCRC) patients, it is recommended, as first-line treatment, chemotherapy (CT) based on doublet cytotoxic combinations of fluorouracil, leucovorin, and irinotecan (FOLFIRI) and fluorouracil, leucovorin, and oxaliplatin (FOLFOX). In addition to CT, biological (targeted agents) are indicated in the first-line treatment, unless contraindicated. In this context, most of mCRC patients are likely to progress and to change from first line to second line treatment when they develop resistance to first-line treatment options. It is in this second line setting where Aflibercept offers an alternative and effective therapeutic option, thought its specific mechanism of action for different patient’s profile: RAS mutant, RAS wild-type (wt), BRAF mutant, potentially resectable and elderly patients. In this paper, a panel of experienced oncologists specialized in the management of mCRC experts have reviewed and selected scientific evidence focused on Aflibercept as an alternative treatment.

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Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.4500 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 4500-4500

Author(s):

Brian I. Rini ◽

Elizabeth R. Plimack ◽

Viktor Stus ◽

Tom Waddell ◽

Rustem Gafanov ◽

...

Keyword(s):

Interim Analysis ◽

Final Analysis ◽

Similar Proportion ◽

First Line ◽

Cell Renal Cell Carcinoma ◽

Superior Efficacy ◽

Treatment Naïve ◽

To Receive ◽

Safety Signals

4500 Background: In the first interim analysis of the randomized, multicenter, open-label, phase 3 KEYNOTE-426 study (NCT02853331), treatment with pembro + axi significantly improved OS, PFS, and ORR vs sunitinib monotherapy in treatment-naive advanced ccRCC. Extended follow-up (median, 30.6 mo) continued to demonstrate the superior efficacy of pembro + axi vs sunitinib monotherapy in this patient population. Here, we present the results of the prespecified final analysis with 42.8-mo median follow-up. Methods: Treatment-naive patients (pts) with advanced ccRCC, KPS ≥70%, and measurable disease (RECIST v1.1) were randomly assigned 1:1 to receive pembro 200 mg IV Q3W for up to 35 doses + axi 5 mg orally BID or sunitinib 50 mg orally QD on a 4-wk on/2-wk off schedule until progression, intolerable toxicity, or withdrawal. Randomization was stratified by IMDC risk (favorable vs intermediate vs poor) and geographic region (North America vs Western Europe vs Rest of World). Dual primary endpoints were OS and PFS. Secondary endpoints were ORR, DOR, and safety. The protocol-specified final analysis was based on a target of 404 OS events. No formal hypothesis testing was performed because all efficacy endpoints were met previously at the first interim analysis; nominal P values are reported. Results: Overall, 861 pts were randomly assigned to receive pembro + axi (n=432) or sunitinib (n=429). Median duration of follow-up, defined as time from randomization to the database cutoff date, was 42.8 mo (range, 35.6-50.6). At data cutoff, 418 pts had died: 193 (44.7%) of 432 pts in the pembro + axi arm vs 225 (52.4%) of 429 pts in the sunitinib arm. Compared with sunitinib, pembro + axi improved OS (median: 45.7 vs 40.1 mo; HR, 0.73 [95% CI, 0.60-0.88]; P<0.001) and PFS (median: 15.7 vs 11.1 mo; HR, 0.68 [95% CI, 0.58-0.80]; P<0.0001). The 42-mo OS rate was 57.5% with pembro + axi vs 48.5% with sunitinib; the 42-mo PFS rate was 25.1% with pembro + axi vs 10.6% with sunitinib. For pembro + axi vs sunitinib, ORR was 60.4% vs 39.6% ( P<0.0001); CR rate was 10.0% vs 3.5%; median DOR was 23.6 mo (range 1.4+ to 43.4+) vs 15.3 mo (range, 2.3-42.8+). Subsequent anticancer therapy was administered to 47.2% of pts in pembro + axi arm vs 65.5% of pts in sunitinib arm. Although a similar proportion of pts in each arm received VEGF/VEGFR inhibitors, only 10.2% of pts in the pembro + axi arm received subsequent treatment with a PD-1/L1 inhibitor compared to 48.7% of pts in the sunitinib arm. No new safety signals were observed. Conclusions: With a median follow-up of 42.8 mo, this is the longest follow-up of an anti-PD–1/L1 immunotherapy combined with a VEGF/VEGFR inhibitor for first-line RCC. These results show that pembro + axi continues to demonstrate superior efficacy over sunitinib with respect to OS, PFS, and ORR, with no new safety signals. Clinical trial information: NCT02853331.

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Sequential Treatment of Metastatic Adenocarcinoma of the Pancreatic Duct with Liver Metastasis Following the NAPOLI-1 Study Protocol with nal-Irinotecan plus 5-FU in the Second Line

Case Reports in Oncology ◽

10.1159/000504471 ◽

2020 ◽

Vol 13 (1) ◽

pp. 79-84

Author(s):

Dilara Akhoundova Sanoyan ◽

Cäcilia S. Reiner ◽

Panagiota Papageorgiou ◽

Alexander R. Siebenhüner

Keyword(s):

Systemic Treatment ◽

Sequential Treatment ◽

Phase Iii ◽

Ductal Adenocarcinoma ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Curative Surgery ◽

To Receive

Pancreatic ductal adenocarcinoma (PDAC) is typically diagnosed at an advanced or metastatic stage, when curative surgery is not recommended. Therefore, the prognosis is poor for this dismal disease, with only 1–2% of the patients reaching the 5-year survival follow-up. Current advances in systemic treatment with gemcitabine regimens, specifically polychemotherapy with gemcitabine plus nab-paclitaxel or other multidrug regimens such as FOLFIRINOX in the first line, have improved disease control over time. This higher efficacy of systemic treatment enables metastatic PDAC patients to receive second-line treatment more often nowadays. Currently, there is only one regimen for second-line treatment approved by the EMA, FDA, and Swissmedic, based on the phase III NAPOLI-1 study. In this case report, we present an outstanding response to sequential treatment with gemcitabine plus nab-paclitaxel followed by second-line treatment with nal-irinotecan plus 5-fluorouracil.

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Afatinib versus gefitinib or erlotinib in first-line setting for Malaysia patients with EGFR mutant advanced lung adenocarcinoma

Annals of Oncology ◽

10.1093/annonc/mdz437.013 ◽

2019 ◽

Vol 30 ◽

pp. ix164 ◽

Cited By ~ 1

Author(s):

C.S. Chai ◽

C.K. Liam ◽

O. Po Lin ◽

Y.K. Pang ◽

G.F. Ho ◽

...

Keyword(s):

Lung Adenocarcinoma ◽

First Line ◽

Egfr Mutant ◽

Line Setting

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Characteristics, treatment patterns, and economic burden of patients with metastatic cervical cancer receiving systemic anticancer therapy.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.51 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 51-51

Author(s):

Xiaoyun Pan ◽

Lincy S. Lal ◽

John White ◽

Seyed Hamidreza Mahmoudpour ◽

Christian Valencia

Keyword(s):

Cervical Cancer ◽

Economic Burden ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Duration Of Treatment ◽

Second Line Therapy ◽

Treatment Regimens ◽

Line Therapy

51 Background: In 2021, 14,480 patients are estimated to be diagnosed with cervical cancer in the US; 16% of patients are expected to have metastatic disease for whom the 5-year survival rate is 17.6% per SEER estimates. Patients with metastatic cervical cancer (mCC) are treated mainly with systemic therapy. This study aims to describe the clinical characteristics, demographics, treatment patterns, and economic burden of patients with mCC receiving systemic therapy. Methods: Eligible women had been diagnosed with cervical cancer, as evidenced by >2 outpatient or >1 inpatient claim in the Optum Research Database from January 2014 through January 2020. Patients were included if they had metastasis within 6 months before or after cervical cancer diagnosis, with evidence of systemic treatment on or after the latter of a claim date for cervical cancer disease or metastatic disease. The index date was the first-line treatment initiation date. Patients were required to have ≥6 months of pre-index continuous enrollment. The top 3 treatment regimens and median treatment duration by line of therapy were described. All-cause per-patient-per-month (PPPM) costs (2019 US dollars), including plan and patient paid amounts, were reported for full follow-up period from first-line and second-line therapy initiation. Results: The study sample consisted of 778 patients (mean age, 59 years; commercial, 58%; Medicare Advantage, 42%). The mean (median) follow-up period was 14 (9) months. Top baseline comorbidities were diseases of the urinary system (71%) and diseases of the female genital organs (70%), and the median Charlson comorbidity index was 7. In the first line, 80% of patients received platinum-based therapy and 23% received bevacizumab (bev). Of 778 patients, only 294 (38%) received second-line therapy, with 34% receiving bev. Top first-line treatment regimens were carboplatin + paclitaxel (27%), cisplatin (21%), and bev + carboplatin + paclitaxel (10%); the median (95% CI) duration of treatment was 3.4 (3.1-3.7) months. Top second-line treatment regimens were bev + carboplatin + paclitaxel (13%), carboplatin + paclitaxel (11%), and pembrolizumab (6%); the median duration of treatment was 3.8 (3.1-4.2) months. Mean all-cause total PPPM costs were $19,519 from first-line and $22,660 second-line therapy initiation (table). Conclusions: This study indicates that real-world mCC patients have short treatment durations and significant economic burden with first-line and second-line therapy. Novel therapies associated with greater clinical benefits in patients with mCC may provide economic benefit.[Table: see text]

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