First-Line Treatment Of Cancer Research Articles

Disparities in clinical trial participation beyond first-line treatment among patients with metastatic breast or colorectal cancer.

97 Background: Disparities in clinical trial participation beyond first-line (1L) treatment of metastatic cancer have not been well studied. Using real-world data from patients diagnosed with metastatic breast cancer (mBC) or metastatic colorectal cancer (mCRC), this study evaluated 1) patterns of participation in trials by treatment line and 2) factors associated with participation in trials of second-line (2L) and subsequent lines of treatment. Methods: Patients diagnosed with mBC or mCRC between 2013 and 2021 who received at least 2L treatment were retrospectively identified from the Flatiron Health electronic health record database. Clinical trial participation was defined as receipt of “clinical study drug.” Participation in trials for treatment lines 2L to 6L were assessed, and multivariable logistic regression models were used to evaluate associations between sociodemographic and clinical factors, including age, race/ethnicity, socioeconomic status (SES), stage at diagnosis, year of metastatic diagnosis, practice type, and total lines of treatment, with participation in trials of 2L and subsequent lines of treatment. Results: Overall, participation in trials was low for patients with mBC or mCRC. For patients with mBC (n=14,590), participation in trials was similar from 2L (2.6%) to 6L (2.7%) (Table 1). Among these patients, age, race/ethnicity, and practice type were associated with participation in trials, while SES was not. For example, women age 18-49, 50-64, and 65-74 years were more likely to participate than women 75 or older (aORs: 2.88, 2.45, 1.84), and non-Hispanic Asian, non-Hispanic Black, and Hispanic women were less likely to participate than non-Hispanic white women (aORs: 0.41, 0.47, 0.61). In contrast to patients with mBC, participation in trials increased from 2.0% (2L) to 6.6% (6L) for patients with mCRC (n=7,303; Table 1). Among these patients, age, practice type, and SES were associated with participation in trials. Specifically, patients treated in academic compared to community settings (aOR: 4.25, 95% CI: 3.33, 5.42) and patients with higher SES (aOR: 2.00, 95% CI: 1.29, 3.08) were more likely to participate. For both patients with mBC (aOR: 5.00, 95% CI, 3.87, 6.46) or mCRC (aOR: 7.91, 95% CI: 5.63, 11.10), those who received more than five treatment lines compared to only two treatment lines were more likely to participate in a trial. Conclusions: These real-world findings highlight disparities in participation in clinical trials of 2L and subsequent lines of treatment by age, race/ethnicity, practice type, and SES among patients with mBC or mCRC. Further policy efforts and interventions are needed to address systematic barriers to increase participation of underrepresented groups in clinical trials.[Table: see text]

580P Efficacy and safety of dacomitinib as first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) 21L858R mutation: A multicenter, ambispective, consecutive case-series study

580P Efficacy and safety of dacomitinib as first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) 21L858R mutation: A multicenter, ambispective, consecutive case-series study

Survival benefit and biomarker of PD-1 inhibitor combination therapy in first-line of advanced biliary tract cancer: A retrospective study.

Immune checkpoint inhibitor (ICI) combination therapies have shown promise in the first-line treatment of advanced biliary tract cancer (BTC). However, the best partner remains to be validated. Moreover, progress on biomarkers predicting the efficacy of ICI in BTC is slow. This study aimed to assess the efficacy and investigate reliable predictive biomarkers of programmed cell death protein-1 (PD-1) antibody combination therapy in the first-line treatment of advanced BTC. Clinical data from patients with advanced BTC who received chemotherapy or anti-PD-1 combination therapy as first-line were collected. The primary outcome was overall survival (OS). Biomarkers, including peripheral blood inflammation scores, genetic alterations, and tumor microenvironment were investigated. Sixty-four patients were recruited and divided into four treatment groups: chemotherapy, anti-PD-1 plus chemotherapy, anti-PD-1 plus targeted therapy, and triple group (anti-PD-1 plus chemotherapy and targeted therapy). The median OS was 7.9, 11.3, 12.8, and 28.7 months, respectively. Compared to chemotherapy, mOS significantly prolonged in the triple group (p = 0.031). It showed that patients with five different peripheral blood inflammation scores had significantly prolonged mOS (p < 0.05). Genetic testing results suggested that patients with poor survival all had TP53 mutations and higher levels of KRAS and ERBB2 mutations. Low FOXP3/CD8 ratio was associated with prolonged OS (p = 0.029). With CD4-low, CD8-high, CD56-positive, CD163-high, FOXP3-high and MPO-high in TME as one factor, we calculated PLUS score according to the number of factors. The high-PLUS (>2) group showed significantly superior OS (p = 0.003). First-line anti-PD-1 combination therapy was superior to chemotherapy, and triple therapy significantly improved survival. Peripheral blood immune-inflammation score, FOXP3/CD8 ratio, and PLUS have potential as biomarkers for predicting the efficacy of first-line anti-PD-1 therapy in advanced BTC.

Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study

BackgroundThe purpose of this study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer. Patients and methodsA retrospective cohort of 11 patients with metastatic breast cancer previously treated with anthracycline and taxane (including neoadjuvant and adjuvant therapies) for advanced first-line with utidelone plus capecitabine, 32 patients treated with second-line or above, and 60 patients with vinorelbine plus cisplatin between October 2011 and August 2022 was collected. The first and second groups were treated with utidelone plus capecitabine, and the third group was treated with vinorelbine plus cisplatin. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), objective response rate (ORR), and treatment safety. ResultsBy 03/31/2023, median PFS reached 11.70 months (95 % CI 0.093–0.141) in utidelone plus capecitabine group in the advanced first-line therapy, compared to 5.60 months (95 % CI 0.025–0.079) in the second-line or above therapy [HR 0.42, (95 % CI 0.226–0.787), P = 0.0077]. In utidelone plus capecitabine, the median OS was not reached in the advanced first-line therapy, with a mean overall survival of 23.16 months (95 % CI 0.198–0.265); whereas the median OS in the second-line or above therapy was 19.50 months (95 % CI 0.083–0.307), with a mean overall survival of 16.89 months (95 % CI 0.136–0.202) [HR 0.26, (95 % CI 0.098–0.678), P = 0.0495]. The ORR for advanced first-line therapy was 27.27 % (95%CI 0.060, 0.610) compared with 15.63 % (95%CI 0.053, 0.328) for second-line or above. In advanced first-line therapy, utidelone plus capecitabine was superior to vinorelbine plus cisplatin with a median PFS of 6.12 months (95 % CI 0.051–0.072) [HR 0.49, (95 % CI 0.286–0.839), P = 0.0291]. Compared with utidelone plus capecitabine, the median OS in vinorelbine plus cisplatin advanced first-line therapy group was 35.37 months (95 % CI 0.258–0.449), and the mean overall survival was 40.79 months (95 % CI 0.315–0.501) [HR 0.54, (95 % CI 0.188–1.568), P = 0.2587]. The ORR for vinorelbine plus cisplatin was 18.33 % (95 % CI 0.095, 0.304). The most common adverse events in our study were neurological toxicity, hand-foot syndrome, hematological toxicity, gastrointestinal toxicity, and hepatic and renal function abnormalities. There were no deaths due to adverse effects during the utidelone plus capecitabine treatment period. ConclusionsIn MBC, advanced first-line therapy with utidelone plus capecitabine resulted in more favorable PFS, OS, and ORR than second-line or above therapy. In advanced first-line therapy, utidelone plus capecitabine had superior PFS, and ORR compared with vinorelbine plus cisplatin. This study concludes that utidelone plus capecitabine is a more valuable chemotherapy option in advanced first-line MBC.

A carrier-free supramolecular nano-twin-drug for overcoming irinotecan-resistance and enhancing efficacy against colorectal cancer

Irinotecan (Ir) is commonly employed as a first-line chemotherapeutic treatment for colorectal cancer (CRC). However, tremendous impediments remain to be addressed to surmount drug resistance and ameliorate adverse events. Poly-ADP-Ribose Polymerase (PARP) participates in the maintenance of genome stability and the repair of DNA damage, thus playing a critical role in chemotherapy resistance. In this work, we introduce a novel curative strategy that utilizes nanoparticles (NPs) prepared by dynamic supramolecular co-assembly of Ir and a PARP inhibitor (PARPi) niraparib (Nir) through π-π stacking and hydrogen bond interactions. The Ir and Nir self-assembled Nano-Twin-Drug of (Nir-Ir NPs) could enhance the therapeutic effect on CRC by synergistically inhibiting the DNA damage repair pathway and activating the tumor cell apoptosis process without obvious toxicity. In addition, the Nir-Ir NPs could effectively reverse irinotecan-resistance by inhibiting the expression of multiple resistance protein-1 (MRP-1). Overall, our study underscores the distinctive advantages and potential of Nir-Ir NPs as a complementary strategy to chemotherapy by simultaneously overcoming the Ir resistance and improving the anti-tumor efficacy against CRC.

Real-World Safety and Effectiveness of a Bevacizumab Biosimilar (ABP 215) in Metastatic Colorectal Cancer Patients in Canada

BackgroundABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC. Materials and MethodsRetrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site. ResultsA total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2. ConclusionThe safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study.

Pembrolizumab as a first-line treatment for advanced gastric cancer

Pembrolizumab as a first-line treatment for advanced gastric cancer

The Cost-Effectiveness of Pertuzumab for the Treatment of Metastatic HER2+ Breast Cancer in Czechia: A Semi-Markov Model Using Cost States

ObjectivesThis article estimates the cost-effectiveness of adding pertuzumab to the combination of trastuzumab and docetaxel within the first-line treatment for metastatic breast cancer with the amplification of HER2+. MethodsData from Czech clinical practice recorded in the BREAST register are used. A semi-Markov model with states derived based on the treatment phases (first-line medication, no medication, next-line medication, death) is defined to estimate costs from the healthcare payers’ perspective. The benefits are estimated as patient survival until death. The Kaplan–Meier estimates are supplemented by the Cox proportional hazard and the accelerated failure time models to control for patient characteristics. Health-related quality-of-life indicators are derived from relevant literature. ResultsBased on the used data, adding pertuzumab does not result in statistically significantly longer survival while inducing higher treatment costs (€163 360 compared with €90 112 per patient in 2018 prices). Statistically longer survival was not supported by the log-rank test (P = .97), the Cox proportional hazard model, or the accelerated failure time model using the Gompertz distribution. The incremental cost-effectiveness ratio (€87 200) substantially exceeds the willingness to pay for 1 quality-adjusted life-year (€46 500). ConclusionsThis analysis indicates that adding pertuzumab cannot be considered cost-effective in Czechia. However, the observed phenomenon may be attributed to the limited duration of patient follow-up periods at the time of the study’s execution (mean of 20-21 months). Importantly, we find that using states connected to specific treatment phases is appropriate for a retrospective analysis of patient-level clinical data.

Optimizing the first-line treatment for metastatic colorectal cancer.

Colorectal cancer represents an important oncological challenge both for its incidence, which makes it an important health problem, and for its biological complexity, which has made clinical results very difficult in terms of outcome for this category of patients. To date these diseases should not be treated as a single entity but it is necessary to distinguish colorectal cancers based on characteristics that nowadays are essential to have greater therapeutic benefits. These include the sideness of the disease, the state of microsatellites, the presence of prognostic and predictive mutations of response to treatments currently available in clinical practice, which are associated with new therapeutic targets. The greatest challenge in the future will be to circumvent the resistance mechanisms that make this disease very difficult to treat with good long-term results by studying effective combination treatments with a good toxicity profile. Once such combinations or targeted treatments are consolidated, it will be desirable to shift the best therapies to the first line treatment to make them immediately accessible to the patient. It will also be essential to refine the selection of patients who can benefit from these treatments.

Therapeutic effectiveness of anlotinib combined with etoposide in extensive-stage small-cell lung cancer: a single-arm, phase II trial

BackgroundAnlotinib plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) achieves good efficacy, but there is still room for improvement. This clinical study examined the effectiveness of anlotinib plus etoposide for maintenance therapy in ES-SCLC.MethodsThe current single-arm, prospective phase II study was performed at Jiangsu Cancer Hospital (March 2019 to March 2022). After successful primary etoposide-based therapy, anlotinib was administered at 12 mg/day on days 1 to 14 of 21-day cycles until disease progression or consent withdrawal. All patients also received etoposide at 50 mg/day on days 1 to 14 of 21-day cycles for a maximum of six cycles. Progression-free survival (PFS) constituted the primary study endpoint. Secondary endpoints were overall survival (OS), objective remission rate (ORR), disease control rate (DCR), and safety. In addition, adverse events (AEs) were assessed.ResultsTwenty-eight patients were treated. Median PFS and OS were 8.02 (95%CI 5.36–10.67) and 11.04 (95%CI 10.37–11.68) months, respectively. Totally 9 and 18 participants showed a partial response and stable disease, respectively; ORR and DCR were 32.14% and 96.43%, respectively. The commonest all-grade AEs were fatigue (n = 11, 39.28%), hypertension (n = 11, 39.28%), loss of appetite (n = 9, 32.14%), oral mucositis (n = 7, 25.00%) and proteinuria (n = 6, 21.40%). Grade 3–4 AEs included fatigue (n = 4, 14.28%), hypertension (n = 2, 7.14%), hand and foot syndrome (n = 2, 7.14%), oral mucositis (n = 1, 3.57%), hemoptysis (n = 1, 3.57%), proteinuria (n = 1, 3.57%), gingival bleeding (n = 1, 3.57%), and serum creatinine elevation (n = 1, 3.57%).ConclusionMaintenance anlotinib plus etoposide achieves promising PFS and OS in clinical ES-SCLC.Registration numberChiCTR1800019421.

Development of novel green and high-throughput microwell spectrophotometric assay for one-step determination of dacomitinib, a recently approved potent drug for first-line treatment of metastatic non-small cell lung cancer

Dacomitinib (DAC) is the most recent drug approved drug for the first-line treatment of patients with metastatic non-small cell lung cancer. This study describes, for the first time, the development of a novel green and high-throughput microwell spectrophotometric assay (MW-SPA) for one-step determination of DAC. The assay was based on formation of a colored charge transfer complex between DAC, as electron donor, with 2,3-dichloro-3,5-dicyano-1,4-benzoquinone, as π-electron acceptor. Ultraviolet–visible spectrophotometry was used to characterize the complex and proposing the reaction mechanism. Under refined optimum reaction conditions, it was employed as a basis for the development of the proposed MW-SPA. The assay was conducted in 96-well assay plates, and the absorbances were measured by an absorbance plate reader. Validation of the assay was performed in accordance with guidelines of the International Council on Harmonization, and all validation parameters were acceptable. The limits of detection and quantitation of the MW-SPA were 1.2 and 3.7 μg/well, respectively. The assay was applied with great distinct success for determining DAC in its bulk form and vizimpro® tablets. The greenness of the assay was ascertained by three distinct metric tools, which conclusively demonstrated the adherence of the assay to principles of green analytical chemistry approach. Moreover, the assay has high throughput capacity as it can simultaneously process large number of micro-volume samples. In conclusion, the proposed MW-SPA is valuable for the rapid and routine determination of DAC for the purposes of quality control.

Clinical relevance of sentinel lymph node biopsy in early ovarian cancer.

The first-line treatment for early ovarian cancer typically involves primary debulking surgery aimed at maximal cytoreduction, alongside adjuvant chemotherapy if clinically indicated. Nodal assessment involving pelvic and para-aortic lymph node dissection is typically performed during the primary debulking surgery. However, the survival benefit of lymphadenectomy in patients with early ovarian cancer has not been well established, and the procedure is associated with longer operation time and higher perioperative complications. With the emergence of minimally invasive surgery as a potential alternative to laparotomy for early ovarian cancer, sentinel lymph node biopsy has been evaluated in this setting. In this review, we summarized the current literature regarding sentinel lymph node biopsy in patients with early ovarian cancer, focusing on the clinical relevance of this method, including its detection rate and diagnostic accuracy. Additionally, we discuss the current status of clinical trials investigating sentinel lymph node biopsy in early ovarian cancer cases.

Facile Fabrication of Dual-Activatable Gastrointestinal-Based Nanocarriers for Safe Delivery and Controlled Release of Methotrexate.

Colon cancer is emerging as one of the most common cancers worldwide, ranking in the top three in morbidity and mortality. Oral methotrexate (MTX) has been employed as a first-line treatment for various cancers, such as colon, breast, and lung cancer. However, the complexity and particularity of the gastrointestinal microenvironment and the limitations of MTX itself, including severe adverse effects and instability, are the main obstacles to the safe delivery of MTX to colon tumor sites. Herein, an innovative oral administrated anticancer therapeutic MTX@Am7CD/SDS NPs equipped with both pH and temperature sensitivity, which could effectively prevent MTX@Am7CD/SDS NPs from being degraded in the acidic environment mimicking the stomach and small intestine, thus harboring the potential to accumulate at the site of colon lesions and further release intestinal drug under mild conditions. In cellular assays, compared with free MTX, MTX@Am7CD/SDS NPs showed a favorable tumor inhibition effect on three tumor cell lines, as well as excellent cell uptake and apoptosis-inducing effect on SW480 cells. Therefore, this work provides a feasible solution for the safe use of MTX in the treatment of colon cancer and even other intestinal diseases.

In vivo evaluation of the pharmacokinetic interactions between almonertinib and rivaroxaban, almonertinib and apixaban.

Background: Almonertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), is commonly used as a first-line treatment for non-small cell lung cancer (NSCLC) patients with EGFR T790M mutations. Rivaroxaban and apixaban are a selective, direct factor Xa inhibitor used to treat venous thromboembolism (VTE), which is a frequent complication of NSCLC. Rivaroxaban and apixaban are substrates of CYP3A4, P-gp and BCRP, whereas almonertinib is an inhibitor of P-gp and BCRP. Rivaroxaban or apixaban are often prescribed together with almonertinib in NSCLC patients, but clear information on pharmacokinetic drug interaction is lacking. Therefore, this study aimed to unravel the extent of interactions between almonertinib-rivaroxaban and almonertinib apixaban in rats, and whether the pharmacokinetic interaction can be mitigated by rivaroxaban and apixaban dose adjustment. Methods: Rats were divided into ten groups (n = 6) that received rivaroxaban (2mg/kg) (group 1), apixaban (0.5mg/kg) (group 2), almonertinib (15mg/kg) (group 3, group 4), almonertinib with rivaroxaban (2mg/kg) (group 5), almonertinib with rivaroxaban (1mg/kg) (group 6), almonertinib with apixaban (0.5mg/kg) (group 7), almonertinib with apixaban (0.25mg/kg) (group 8), rivaroxaban (2mg/kg) with almonertinib (group 9), apixaban (0.5mg/kg) with almonertinib (group 10). The concentrations of drugs were determined by an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). The levels of messenger RNA were determined using quantitative real-time polymerase chain reaction (qRT-PCR). Results and Discussion: The results indicate that almonertinib increased the Cmax and AUC0-t of 2mg/kg rivaroxaban by 3.30 and 3.60-fold, 1mg/kg rivaroxaban by 1.28 and 1.90-fold. Almonertinib increased the Cmax and AUC0-t of 0.5mg/kg apixaban by 2.69 and 2.87-fold, 0.25mg/kg apixaban by 2.19 and 2.06-fold. In addition, rivaroxaban also increased systemic exposure to almonertinib. The results of qRT-PCR showed that almonertinib reduced the expression of Cyp3a1 in liver and intestine, and Abcb1a, Abcg2 in intestine and kidney. The pharmacokinetic results suggest that it is important to take special care of the interactions of these drugs in clinical applications.

The involvement of hepatic cytochrome P450s in the cytotoxicity of lapatinib.

Lapatinib, an oral tyrosine kinase inhibitor used as a first-line treatment for HER2-positive breast cancer, has been reported to be associated with hepatotoxicity; however, the underlying mechanisms remain unclear. In this study, we report that lapatinib causes cytotoxicity in multiple types of hepatic cells, including primary human hepatocytes, HepaRG cells, and HepG2 cells. A 24-h treatment with lapatinib induced cell cycle disturbances, apoptosis, and DNA damage, and decreased the protein levels of topoisomerase in HepG2 cells. We investigated the role of cytochrome P450 (CYP)-mediated metabolism in lapatinib-induced cytotoxicity using our previously established HepG2 cell lines, which express each of 14 CYPs (1A1, 1A2, 1B1, 2A6, 2B6, 2C8, 2C9, 2C18, 2C19, 2D6, 2E1, 3A4, 3A5, and 3A7). We demonstrate that lapatinib is metabolized by CYP1A1, 3A4, 3A5, and 3A7. Among these, lapatinib-induced cytotoxicity and DNA damage were attenuated in cells overexpressing CYP3A5 or 3A7. Additionally, we measured the production of three primary metabolites of lapatinib (O-dealkylated lapatinib, N-dealkylated lapatinib, and N-hydroxy lapatinib) in CYP1A1-, 3A4-, 3A5-, and 3A7-overexpressing HepG2 cells. We compared the cytotoxicity of lapatinib and its 3 metabolites in primary human hepatocytes, HepaRG cells, and HepG2 cells and demonstrated that N-dealkylated lapatinib is more toxic than the parent drug and the other metabolites. Taken together, our results indicate that lapatinib-induced cytotoxicity involves multiple mechanisms, such as apoptosis and DNA damage; that N-dealkylated lapatinib is a toxic metabolite contributing to the toxic effect of lapatinib; and that CYP3A5- and 3A7-mediated metabolism plays a role in attenuating the cytotoxicity of lapatinib.

Tislelizumab plus chemotherapy vs. pembrolizumab plus chemotherapy for the first-line treatment of advanced non-small cell lung cancer: systematic review and indirect comparison of randomized trials.

Pembrolizumab (PEM) and tislelizumab (TIS), in combination with chemotherapy, have demonstrated significant clinical benefits in first-line treatment of advanced non-small cell lung cancer (NSCLC). However, no head-to-head clinical trial has yet compared these two treatments. We conducted a literature search of randomized trials, in which TIS plus chemotherapy or PEM plus chemotherapy were studied for the first-line treatment of NSCLC. Randomized design and the endpoint of progression-free survival (PFS) were the inclusion criteria for our analysis. Adjusted indirect comparison between TIS and PEM was performed by application of the IPDfromKM-Shiny method. This method is based on the reconstruction of individual patient data from Kaplan-Meier curves. Outcomes in terms of PFS were expressed as hazard ratio (HR) with 95% and 90% confidence interval (CI). Data were extracted from 5 randomized trials involving nearly 2,000 participants. In comparing PEM plus chemotherapy (n=748) or TIS plus chemotherapy (n=462) vs. chemotherapy alone (n=782), the Shiny method found a significant advantage in terms of PFS (HR =0.5856, 95% CI: 0.4986-0.6876 for TIS; HR =0.5573, 95% CI: 0.4969-0.6251 for PEM), thus confirming the results of the original trials. The indirect comparison of PEM plus chemotherapy vs. TIS plus chemotherapy showed a substantial equivalence between these two regimens (HR =0.952; 95% CI: 0.775-1.168; 90% CI: 0.801-1.130) suggesting an acceptable degree of equivalence according to regulatory criteria. Medians were 8.89 months for PEM combination, 7.97 months for TIS combination, and 5.69 for the controls. The PFS of TIS combined with chemotherapy was similar to that of PEM combined with chemotherapy. Based on the HR with 90% CI, these two agents met an equivalence criterion for PEM vs. TIS ranging from -19.9% to +13.0%.

1443P Patient-reported outcomes (PROs) with cemiplimab plus chemotherapy (CEMI + CHEMO) for first-line treatment of advanced non-small cell lung cancer (aNSCLC): PD-L1 level subgroups in EMPOWER-Lung 3

1443P Patient-reported outcomes (PROs) with cemiplimab plus chemotherapy (CEMI + CHEMO) for first-line treatment of advanced non-small cell lung cancer (aNSCLC): PD-L1 level subgroups in EMPOWER-Lung 3

763P Penpulimab + anlotinib plus chemo-less therapy in first-line treatment for persistent, recurrent, or metastatic cervical cancer: A single-arm, phase II study (ALTN-AK105-II-06)

763P Penpulimab + anlotinib plus chemo-less therapy in first-line treatment for persistent, recurrent, or metastatic cervical cancer: A single-arm, phase II study (ALTN-AK105-II-06)

Real-world data on efficacy and safety of pembrolizumab in the first-line treatment of metastatic lung cancer in patients with PD-L1 expression >0% - a single center experience.

With the advent of immunotherapy, there has been a significant improvement in the outcomes of non-small cell lung cancer treatment. Several clinical trials have confirmed the efficacy and safety of pembrolizumab, but research with real-world data is needed to confirm the findings from clinical trials. In this retrospective study, data on the treatment of lung cancer with pembrolizumab were analyzed in 78 patients who started pembrolizumab therapy as first-line treatment for metastatic disease at University Hospital Centre Osijek, from May 15, 2018, until December 31, 2021. November 30, 2022, was set as the last date of data monitoring. Patients who had received less than 3 cycles of pembrolizumab were excluded from the study. The main objectives of the study were OS (overall survival) and PFS (progression-free survival). The differences in the incidence and type of adverse events between the two groups of patients were also compared. Kaplan-Meier analysis of the survival determined that the median OS was 20 months and PFS was 13 months. Although OS and PFS are longer in patients with PD-L1 (programmed death-ligand 1) ≥ 50%, the differences are not statistically significant. The most commonly reported adverse events related to pembrolizumab treatment were gastrointestinal adverse events. No significant differences were found in the frequency of occurrence of certain adverse events between the two groups of patients. This study demonstrates that real-world data for pembrolizumab treatment of non-small cell lung cancer confirm the efficacy and safety indicated by clinical trials. Nevertheless, it is necessary to assess the patient's general condition more objectively before starting the treatment.

1542P Updated results of a phase II clinical trial: Paclitaxel and carboplatin plus PD-1 blockades combined with anlotinib as first-line treatment for advanced oesophageal cancer

1542P Updated results of a phase II clinical trial: Paclitaxel and carboplatin plus PD-1 blockades combined with anlotinib as first-line treatment for advanced oesophageal cancer