First-line Platinum-based Chemotherapy Research Articles

Clinical outcomes and treatment patterns of maintenance avelumab in locally advanced or metastatic urothelial carcinoma: a multicenter collaborative study.

The JAVELIN Bladder 100 trial demonstrated improved overall survival (OS) with maintenance avelumab in patients with locally advanced or metastatic urothelial carcinoma UC (la/mUC) who achieved disease control following first-line platinum-based chemotherapy (1L-PBC). However, real-world data on eligibility, utilization, and outcomes of maintenance avelumab therapy remain limited. This retrospective study included patients with la/mUC who received 1L-PBC. Eligibility for maintenance avelumab therapy was determined based on the best overall response to 1L-PBC, with patients who achieved stable disease or a partial or complete response considered eligible. Survival outcomes were analyzed using the Kaplan-Meier method. Multivariate Cox regression analysis was used to identify prognostic factors among patients with la/mUC who received maintenance avelumab. Of 161 prospective patients, 67.1% were eligible for maintenance avelumab therapy, and 46.3% of eligible patients received the treatment. The median progression-free survival (PFS) following avelumab initiation was 10.2months, whereas the median OS was not reached. Prognostic factors associated with PFS included the presence of liver metastases, elevated C-reactive protein (> 1.0g/dL), and administration of more than five cycles of 1L-PBC. Adverse events occurred in 60% of patients treated with avelumab, with 16% experiencing grade 3-4 adverse events. We emphasize the real-world applicability of maintenance avelumab for Japanese patients with la/mUC. Maintenance avelumab demonstrated favorable survival outcomes, consistent with clinical trial data. Identifying prognostic factors and optimizing treatment sequencing are essential strategies for improving outcomes in this patient population.

Real-world outcomes of first-line maintenance niraparib monotherapy in patients with epithelial ovarian cancer.

To assess real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) among patients with epithelial ovarian cancer (EOC) who received first-line maintenance (1LM) niraparib monotherapy. In this US-nationwide, electronic health record-derived, deidentified database study, eligible patients with EOC initiated 1LM niraparib monotherapy (1 January 2017-1 December 2022) following first-line platinum-based chemotherapy. Median rwPFS and rwTTNT were estimated with Kaplan-Meier methodology overall and in a homologous recombination-deficient (HRd) subgroup (further stratified as BRCA wild-type [BRCAwt] or BRCA-mutated [BRCAm]). Observed median rwPFS was 11.4 (95% CI, 10.1-12.7) months overall (N = 560), 18.2 (95% CI, 13.9-24.2) months for the HRd subgroup (n = 144), and 25.4 (95% CI, 15.9-not reached) and 14.2 (95% CI, 8.6-18.6) months for HRd patients with BRCAm and BRCAwt tumors, respectively. Observed median rwTTNT was 12.4 (95% CI, 11.5-13.8) months overall, 19.6 (95% CI, 14.9-23.9) months for the HRd subgroup, and 24.9 (95% CI, 16.0-not reached) and 15.1 (95% CI, 10.3-19.8) months for HRd patients with BRCAm and BRCAwt tumors, respectively. The real-world observed median rwPFS and rwTTNT were longer for patients with EOC who received 1LM niraparib monotherapy in the HRd subgroup (specifically for the BRCAm subgroup).

Exploring Prognostic Factors and Survival Outcomes in Advanced Non-Small Cell Lung Cancer Patients Undergoing First-Line Chemotherapy in Limited-Resource Settings.

Background/Objectives: Non-small cell lung cancer (NSCLC) remains a leading cause of cancer-related mortality globally, especially in limited-resource countries (LRCs) where access to advanced treatments such as targeted therapy and immunotherapy is constrained. Platinum-based chemotherapy remains a cornerstone of first-line therapy. This study aims to identify prognostic factors influencing survival outcomes and evaluate treatment response to chemotherapy in advanced NSCLC patients in LRCs. Methods: A retrospective cohort study was conducted on 200 advanced NSCLC patients treated with first-line platinum-based doublet chemotherapy at Surin Hospital Cancer Center, Thailand. Prognostic factors were assessed through univariate and multivariate Cox regression analyses. Additionally, restricted mean survival time (RMST) was calculated to compare survival outcomes between responders and non-responders. Results: Independent prognostic factors associated with improved survival included good performance status, ECOG 0-1 (HR 0.50, p = 0.012), serum albumin ≥ 3.5 mg/dL (HR 0.60, p = 0.010), and favorable response to chemotherapy (HR 0.57, p = 0.003). Responders demonstrated significantly longer RMST at 12 months (p < 0.001), 24 months (p < 0.001), and 36 months (p = 0.004) compared to non-responders. Conclusions: Identifying prognostic factors and treatment responses is important for improving outcomes in advanced NSCLC patients, particularly in limited-resource settings where access to novel therapies is restricted.

Efficacy and Safety of Three Cycles of TIP and Sequential High Dose Chemotherapy in Patients with Testicular Non-Seminomatous Germ Cell Tumors

Background: Salvage treatment options have not been validated in relapsed or refractory germ cell tumors. Moreover, the study populations including these patients have different heterogeneities. This study aimed to evaluate the efficacy and safety of three cycles of TIP sequential high-dose chemotherapy in patients with testicular non-seminomatous germ cell tumors who relapsed or had a refractory course after first-line platinum-based chemotherapy. Methods: Data of 141 patients who underwent three cycles of TIP followed by HDCT due to relapsed/refractory gonadal NSGCTs after first-line cisplatin-based chemotherapy (BEP/EP) at Gulhane School of Medicine Hospital Medical Oncology Department between January 2017 and May 2024 were evaluated retrospectively. Patients underwent a treatment regimen consisting of two phases. Initially, they received three cycles of induction therapy using a combination known as TIP, which includes paclitaxel, ifosfomide, and cisplatin. Following this, they were given a single cycle of high-dose chemotherapy. Demographic and clinicopathological features of patients and treatment-related complications and survival outcomes were recorded. Results: Median follow-up for all patients was 35.2 (95% CI, 29.45 to 41.07) months. Complete Response (CR) or marker negative Partial Response (PR) after HDCT was achieved in 84 (59.6%) patients. Median time for PFS not reached (NR) (95% CI, NR) in the entire group. The 2-year PFS rate was 51.8%. Median time for OS not reached (95% CI, NR) and the 2-year OS rate was 72.3%. The most common myelotoxicity observed after HDCT until engraftment was grade 4 neutropenia (100%) and grade 4 thrombocytopenia (96.5%). Transplantation-related mortality occurred in 7.1% of patients. Variables that remained statistically significant in multivariable analysis and were associated with poor prognosis for overall survival were platinum refractory disease and AFP and/or beta HCG elevation. Conclusions: Significant survival can be achieved after three cycles of TIP consecutive HDCT, while treatment-related mortality was found to be low.

The prognostic impact of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio on patients with small cell lung cancer receiving first-line platinum-based chemotherapy: a systematic review and meta-analysis

BackgroundThe prognostic significance of Neutrophil-to-Lymphocyte Ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR) in Small Cell Lung Cancer (SCLC) patients receiving platinum-based chemotherapy is debated.MethodsThis study aims to elucidate their roles in survival outcomes. A systematic search across PubMed, Embase, Web of Science, and Cochrane Library identified relevant studies. The Newcastle-Ottawa Scale (NOS) evaluated study quality. Meta-analysis was conducted using random-effects and fixed-effects models, supplemented by sensitivity analysis.ResultsA total of 11 studies with 3,634 SCLC patients were included. Patients with high NLR had significantly decreased overall survival (OS) (HR = 1.39, 95% CI: 1.18–1.59, P < 0.001) and progression-free survival (PFS) (HR = 1.52, 95%CI: 1.27–1.78, P < 0.001). The OS was not statistically different between high and low PLR groups (HR = 1.13, 95%CI: 0.84–1.43, P = 0.265). Subgroup analysis revealed that OS in high NLR group was significantly lower across different strata, and OS in the high PLR group was significantly lower among patients with limited-stage SCLC (LS-SCLC) and populations with a PLR cutoff value < 160.ConclusionsHigh NLR is associated with poor OS and PFS in patients with SCLC receiving first-line platinum-based chemotherapy. PLR does not significantly impact OS, except in LS-SCLC patients and populations with a PLR cutoff value < 160. These findings require further validation from prospective studies.

Clinicopathological and prognostic significance of HER2-low expression in advanced gastric cancer: a retrospective observational study.

Human epidermal growth factor receptor 2 (HER2) status is a critical biomarker in advanced gastric cancer (AGC). While the role of HER2-positive tumors in guiding targeted therapies is well-established, the clinical implications of HER2-low expression, defined as immunohistochemistry (IHC) 1+ or IHC 2+/in situ hybridization-negative (ISH-negative), remain undetermined. The aim of this study was to investigate the prognostic significance and clinicopathological features of HER2-low AGC. This retrospective analysis involved patients with AGC treated with first-line fluoropyrimidine and platinum-based chemotherapy from 2011 to 2020. Patients were categorized into HER2-zero (HER2 IHC 0), HER2-low (IHC 1+ or 2+/ISH-negative), and HER2-positive (IHC 2+/ISH-positive or 3+) groups. Among 548 patients analyzed, 33.0%, 45.1%, and 21.8% were classified as HER2-zero, HER2-low, and HER2-positive, respectively. The proportions of male patients, intestinal-type histology, esophagogastric junction/cardia involvement, metastatic disease status, ≥2 metastatic sites, liver metastasis, lymph node metastasis, and high serum carcinoembryonic antigen levels were gradually elevated in the HER2-zero, HER2-low, and HER2-positive groups. Overall survival (median) was 13.8, 13.6, and 23.0 months, respectively, with a non-significant trend favoring HER2-positive over HER2-low (adjusted hazard ratio: 0.80; P = .0672). A delayed separation of Kaplan-Meier curves for overall survival between the HER2-zero and HER2-low groups was observed, without reaching statistical significance (adjusted hazard ratio: 1.12; P = .2568). Patients with HER2-low status exhibited intermediate and specific clinicopathological features within the HER2-negative category. In terms of prognosis, HER2-low patients showed a worsening trend compared with HER2-positive patients. This evidence implies that HER2-low status represents a distinct clinical subset, bridging the gap between the HER2-zero and HER2-positive profiles.

The Prognostic Value of Systemic Immune-Inflammation Index Supporting Age-Adjusted Charlson Comorbidity Index in Non-Small Cell Lung Cancer Patients with First-Line Platinum-Based Chemotherapy.

This study aimed to examine the association between the systemic immune-inflammation index (SII) (ie, neutrophil count × platelet count/lymphocyte count), the age-adjusted Charlson comorbidity index (ACCI), and overall survival (OS) in non-small cell lung cancer (NSCLC) patients undergoing first-line platinum-based chemotherapy (PBC), with a particular emphasis on the role of SII in supporting ACCI. This retrospective study enrolled 353 cases treated between July 2013 and November 2020. Mann-Whitney U-test and Kruskal-Wallis test were employed to compare parameters between high and low SII groups. The cut-off values for SII and ACCI were determined using the X-tile software. Prognostic significance was evaluated through the utilization of Kaplan-Meier curves and Cox regression analysis. In a univariate Cox regression analysis, sex, age, TNM, lymph node, therapy, SII, and ACCI were associated with OS. After adjusting for confounders in the multivariate analysis, TNM, SII, and ACCI remained independent prognostic factors for OS. Furthermore, within the ACCI subgroups (ACCI<5 or ACCI≥5), a high SII was significantly associated with an increased risk of death. Patients with both a high ACCI and a high SII had the highest risk of death (p < 0.001), with a loss of approximately ten months of survival during the first three years after treatment. SII was proven to be valuable in predicting OS and, when complemented by ACCI, can help tailor prognostic assessment and treatment strategies in assessing the survival of NSCLC patients with first-line PBC.

Oral Metronomic Therapy: An Effective Palliative Treatment Option for Epithelial Ovarian Cancer.

Introduction The majority of the patients with advanced-stage epithelial ovarian cancer relapse within three years of standard first-line treatment. Access to novel therapies like poly ADP-ribose polymerase (PARP) inhibitors and antiangiogenic agents is limited in low- and middle-income countries. Oral metronomic therapy (OMT) may be an effective alternative treatment option in resource-limited settings. Materials and methods A retrospective study was conducted among patients with epithelial ovarian cancer who received OMT. OMT consisted of cyclophosphamide 50mg per day and tamoxifen 40mg per day which was administered continuously until unacceptable toxicity or progression was reached. OMT was given to patients with relapsed ovarian cancer and to those newly diagnosed ovarian cancer patients who were unfit for cytoreductive surgery and/or standard first-line intravenous platinum-based chemotherapy. All patients who received OMT at our center between 01-01-2017 and 31-12-2021 were included for analysis. Relevant details, as needed for the study, were collected from medical records. SPSS version 24 (IBM Corp., Armonk, NY) was used for statistical analysis. Results A total of 61 patients received OMT during the study period. The median age at diagnosis of ovarian cancer was 59 years. The median age at the start of OMT was 61 years. The majority (n= 37, 60.7%) had high-grade serous carcinoma subtype. A total of 52 patients received OMT in the relapse setting while nine received it in the first-line setting. Among relapsed ovarian cancer patients, 13 patients (21.3%) experienced platinum-sensitive relapse, 16 patients (26.2%) experienced partial platinum-sensitive relapse, and 23 patients (37.7%) experienced platinum-resistant disease. The mean duration of treatment with OMT was 7.8 months. The clinical benefit rate was 59% and the overall response rate was 22.9%. Ca-125 response was seen in 40.4% of patients. The median PFS for the overall group was 6.7 months. Median PFS was longer in patients with Ca-125 response and platinum-sensitive relapse. Only five patients (8.1%) had significant toxicity. Conclusion OMT is a safe and effective palliative treatment option for epithelial ovarian cancer, worth consideration in low- and middle-income countries.

Fuzuloparib as maintenance therapy among patients with advanced ovarian cancer after a response to first-line platinum-based chemotherapy: Results from a randomized, placebo-controlled, phase III trial

Fuzuloparib as maintenance therapy among patients with advanced ovarian cancer after a response to first-line platinum-based chemotherapy: Results from a randomized, placebo-controlled, phase III trial

The VALTIVE1 study protocol: a study for the validation of Tie2 as the first tumour vascular response biomarker for VEGF inhibitors

BackgroundAnti-angiogenic, VEGF inhibitors (VEGFi) increase progression-free survival (PFS) and, in some cases, overall survival in many solid tumours. However, their use has been compromised by a lack of informative biomarkers. We have shown that plasma Tie2 is the first tumour vascular response biomarker for VEGFi in ovarian, colorectal and gall bladder cancer: If plasma Tie2 concentrations do not change after 9 weeks of treatment with a VEGFi, the patient does not benefit, whereas a confirmed reduction of at least 10% plasma Tie2 defines a vascular response with a hazard ratio (HR) for PFS of 0.56. The aim of the VALTIVE1 study is to validate the utility of plasma Tie2 as a vascular response biomarker and to optimise the Tie2-definition of vascular response so that the subsequent randomised discontinuation VALTIVE2 study can be powered optimally.MethodsVALTIVE1 is a multi-centre, single arm, non-interventional biomarker study, with a sample size of 205 participants (176 bevacizumab-treated participants + 29 participants receiving bevacizumab and olaparib/PARPi), who are 16 years or older, have FIGO stage IIIc/IV ovarian cancer on treatment with first-line platinum-based chemotherapy and bevacizumab. Their blood plasma samples will be collected before, during, and after treatment and the concentration of Tie2 will be determined. The primary objective is to define the PFS difference between Tie2-defined vascular responders and Tie2-defined vascular non-responders in patients receiving bevacizumab for high-risk Ovarian Cancer. Secondary objectives include defining the relationship between Tie2-defined vascular progression and disease progression assessed according to RECIST 1.1 criteria and assessing the impact of PARPi on the plasma concentration of Tie2 and, therefore, the decision-making utility of Tie2 as a vascular response biomarker for bevacizumab during combined bevacizumab-PARPi maintenance.DiscussionThere is an urgent need to establish a test that tells patients and their doctors when VEGFi are working and when they stop working. The data generated from this study will be used to design a second trial aiming to prove conclusively the value of the Tie2 test.Trial registrationClinicalTrials.gov identifier: NCT04523116. Registered on 21 Aug 2020.

Predictive genomic and transcriptomic analysis on endoscopic ultrasound-guided fine needle aspiration materials from primary pancreatic adenocarcinoma: a prospective multicentre study

We apply endoscopic ultrasound-guided fine needle aspiration biopsy to cytopathologically diagnose and sample nucleic acids from primary tumours regardless of the disease stage. 397 patients with proven pancreatic adenocarcinoma were included and followed up in a multicentre prospective study. DNA and mRNA were extracted from materials of primary tumours obtained by endoscopic ultrasound-guided fine needle aspiration biopsy and analysed using targeted deep sequencing and RNAseq respectively. The variant allele frequency of the KRAS mutation was used to evaluate the tumour cellularity, ranging from 15 to 20% in all cells, regardless of the tumour stage. The molecular profile of metastatic primary tumours significantly differed from other types of tumours, more frequently having TP53 mutations (p=0.0002), less frequently having RNF43 mutations, and possessing more basal-like mRNA component (p=0.001). Molecular markers associated with improved overall survival were: mutations in homologous recombination deficiency genes in patients who received first-line platinum-based chemotherapy (p=0.025) and wild-type TP53 gene in patients with locally advanced tumours who received radio-chemotherapy (p=0.01). The GemPred transcriptomic profile was associated with a significantly better overall survival in patients with locally advanced or metastatic pancreatic cancer who received a gemcitabine-based first-line treatment (p=0.019). The combination of genomic and transcriptomic analyses of primary pancreatic tumours enables us to distinguish metastatic tumours from other tumour types. Our molecular strategy may assist in predicting overall survival outcomes for platinum or gemcitabine-based chemotherapies, as well as radio-chemotherapy. Institut National Du Cancer (BCB INCa_7294), CHU of Toulouse, Inserm and Ligue Nationale Contre le Cancer (CIT program).

Olaparib as maintenance therapy in non resectable pancreatic adenocarcinoma associated with homologous recombination deficiency profile: A French retrospective multicentric AGEO real-world study

BackgroundPancreatic ductal adenocarcinoma (PDAC) has a poor prognosis. The POLO trial showed that olaparib (PARP inhibitor) improved progression-free survival (PFS) but not overall survival (OS), when used as maintenance therapy after ≥ 16 weeks of disease control with first-line platinum-based chemotherapy in patients with germline (g) BRCA 1 or 2 pathogenic variants (PV) metastatic PDAC. However, real-world data on the effectiveness of olaparib are missing. MethodsPatients with unresectable PDAC associated with somatic (s) or (g)BRCA1/2 and (g)non-BRCA-HRD PV (i.e. other homologous recombination deficiency/HRD genes) who were treated with olaparib between 2020–2023 were included. The primary objective was to describe treatment patterns. Secondary exploratory objectives included OS and PFS in patients treated with olaparib according to the POLO trial or not, OS and PFS in patients with (g)HRD PV-associated PDAC versus (s)PVs, olaparib safety profile and factors associated with olaparib poor outcomes. ResultsAmong 85 patients, 45.9 % received olaparib as defined by the POLO trial. No difference in OS and PFS was observed between patients who received olaparib according to the POLO trial versus not. Patients with (g)HRD PV-associated PDAC had better OS compared to others (22.3 versus 10.5 months, p = 0.038). Factors associated with olaparib poor outcomes included a high neutrophil-to-lymphocyte ratio and the use of olaparib outside the recommendations of the POLO trial. Few grade ≥ 3 adverse events were reported (9.4 %). ConclusionPatients with (g)HRD PV-associated PDAC had longer OS than those with (s)HRD PV. Olaparib use beyond the scope of the POLO trial was associated with poor outcomes.

Four versus six cycles of platinum-based chemotherapy for advanced Urothelial carcinoma in the era of immune checkpoint inhibitors: A retrospective cohort study (FOCUS, KCSG-GU23-08)

IntroductionThis study aimed to assess the survival outcomes of four versus six cycles of first-line platinum-based chemotherapy (PBCT) in the era of immune checkpoint inhibitor (ICI) for patients with advanced urothelial carcinoma (UC). Patients and MethodsPatients with histologically confirmed advanced UC were allocated to either the 4-cycle PBCT (C4) or 6-cycle PBCT (C6) groups and retrospectively analyzed. After the planned cycles, active surveillance was conducted every 6–8 weeks, followed by second-line treatments, including ICIs, upon progression. The primary endpoint was overall survival (OS). ResultsOf the 161 patients initiated with PBCT between September 2016 and February 2023, 27 were deemed ineligible, leaving 134 patients for analysis (C4, n = 58; C6, n = 77). Baseline characteristics, including cisplatin eligibility, were similar between the groups. With a median follow-up of 23.7 months (95 % confidence interval (CI), 20.3–27.1), no significant difference was observed in OS between the C6 and C4 groups (18.7 months vs. 17.0 months; hazard ratio (HR) 1.27, P = 0.343). In multivariate analysis adjusted for sex, initial presentation, metastatic lesion, and ECOG PS, no significant difference was observed between the C6 and C4 groups (HR 1.29, 95 % CI, 0.78–2.14, P = 0.315). ConclusionsThis study showed that four cycles of PBCT do not differ from six cycles regarding OS.

Efficacy and Safety of First-Line Platinum-Based Doublet Chemotherapy in Advanced Primary Pulmonary Salivary Gland Tumors (PSGTs)

Primary pulmonary salivary gland tumors (PSGT) constitute a rare subtype of non-small cell lung cancer (NSCLC). Currently, no established treatment guidelines exist for advanced PSGT. The efficacy of platinum-based chemotherapy for PSGT within the context of NSCLC remains uncertain. Therefore, we retrospectively collected 37 PSGT patients who underwent first-line platinum-based chemotherapy from 2010 to 2023. Survival analysis, employing the Kaplan–Meier method, and group comparisons via the log rank test were conducted. Our results show that first-line platinum-based chemotherapy demonstrates favorable efficacy and manageable safety in advanced PSGT, with the combination of Paclitaxel + Platinum emerging as a preferred option.

Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer.

In the phase 3 EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 study, cemiplimab significantly improved overall survival (OS) versus chemotherapy for patients with recurrent or metastatic cervical cancer who progressed after first-line platinum-based chemotherapy. We present a post hoc subgroup analysis of patients enrolled in Japan. Patients were enrolled regardless of programmed cell death-ligand 1 status and randomized 1:1 to cemiplimab 350 mg intravenously every 3 weeks or investigator's choice single-agent chemotherapy for up to 96 weeks. Primary endpoint was OS. Key secondary endpoints were progression-free survival (PFS) and objective response rate (ORR). Overall, 608 patients were randomized, of whom 56 (9.2%) were in Japan (cemiplimab, n = 29; chemotherapy, n = 27). The median (range) duration of follow-up was 13.6 (6.0-25.3) versus 18.2 (6.0-38.2) months for patients in Japan and for the overall population, respectively. Median OS (95% confidence interval [CI]) was 8.4 (7.0-not evaluable) and 9.4 (5.4-14.9) months for cemiplimab versus chemotherapy (hazard ratio [HR]: 0.86; 95% CI: 0.43-1.68). Median PFS (95% CI) was 4.0 (1.4-8.2) versus 3.7 (1.8-4.2) months with cemiplimab and chemotherapy (HR: 0.90; 95% CI: 0.50-1.61), respectively. ORR was 17.2% for cemiplimab and 7.4% for chemotherapy (odds ratio, 2.47; 95% CI, 0.44-13.99). Incidence of treatment-emergent adverse events at any grade was 79.3% for cemiplimab and 100% for chemotherapy. Grade ≥3 adverse events were 37.9% versus 66.7% with cemiplimab and chemotherapy, respectively. While acknowledging limitations inherent to a small subgroup analysis, the HR of 0.86 observed in Japanese patients suggests an emerging survival benefit despite a 4.6-month shorter median duration of follow-up versus the overall study population.

1424P Maintenance capecitabine plus ramucirumab after first-line platinum-based chemotherapy in advanced oesophagogastric adenocarcinoma (OGA): Final analysis from the PLATFORM trial

1424P Maintenance capecitabine plus ramucirumab after first-line platinum-based chemotherapy in advanced oesophagogastric adenocarcinoma (OGA): Final analysis from the PLATFORM trial

1977P Efficacy of talazoparib and avelumab as a maintenance treatment in patients with advanced/metastatic urothelial carcinoma (mUC) whose disease did not progress after a first-line platinum-based chemotherapy (PBCT): The GETUG-TALASUR trial

1977P Efficacy of talazoparib and avelumab as a maintenance treatment in patients with advanced/metastatic urothelial carcinoma (mUC) whose disease did not progress after a first-line platinum-based chemotherapy (PBCT): The GETUG-TALASUR trial

1318P Four-year outcomes from GEMSTONE-302 study: First-line sugemalimab plus platinum-based chemotherapy in metastatic non-small cell lung cancer (NSCLC)

1318P Four-year outcomes from GEMSTONE-302 study: First-line sugemalimab plus platinum-based chemotherapy in metastatic non-small cell lung cancer (NSCLC)

Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial

The phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial met its primary endpoint. Niraparib first-line maintenance significantly prolonged progression-free survival (PFS) among patients with newly diagnosed advanced ovarian cancer (aOC) that responded to first-line platinum-based chemotherapy, regardless of homologous recombination deficiency (HRD) status. Final overall survival (OS) results are reported. Patients were randomized 2:1 to niraparib or placebo, stratified by response to first-line treatment, receipt of neoadjuvant chemotherapy, and tumor HRD status. After reaching 60% target maturity, OS was evaluated via a stratified log-rank test using randomization stratification factors and summarized using Kaplan-Meier methodology. OS testing was hierarchical (overall population first, then the homologous recombination-deficient [HRd] population). Other secondary outcomes and long-term safety were assessed; an updated, ad hoc analysis of investigator-assessed PFS was also conducted (cutoff date, 08Apr2024). Median follow-up was 73.9 months. In the overall population, the OS hazard ratio (HR) was 1.01 (95% CI, 0.84-1.23; P= 0.8834) for niraparib (n= 487) versus placebo (n;= 246). In the HRd (n= 373) and homologous recombination-proficient (n= 249) populations, the OS HRs were 0.95 (95% CI, 0.71-1.29) and 0.93 (95% CI 0.69-1.26), respectively. Subsequent poly(ADP-ribose) polymerase inhibitor therapy was received by 11.7% and 15.8% of niraparib patients and 37.8% and 48.4% of placebo patients in the overall and HRd populations, respectively. The 5-year PFS rate numerically favored niraparib in the overall (niraparib, 22%; placebo, 12%) and HRd populations (niraparib, 35%; placebo, 16%). Myelodysplastic syndromes/acute myeloid leukemia incidence was <2.5% (niraparib, 2.3%; placebo, 1.6%). No new safety signals were observed. In patients with newly diagnosed aOC at high risk of recurrence, there was no difference in OS between treatment arms. In the HRd population, patients alive at 5 years were twice as likely to be progression free with niraparib treatment than placebo. Long-term safety remained consistent with the established niraparib safety profile.

A case of pagetoid spread of urothelial carcinoma with notable reduction achieved through enfortumab vedotin, resulting in complete surgical resection.

Secondary extramammary Paget's disease is a rare condition associated with the contiguous extension of tumor cells from the underlying adnexal structures, genitourinary, or gastrointestinal tracts. We report the case of an 80-year-old female with a 7-year history of urothelial carcinoma who presented with erythema of the labia majora. The diagnosis was pagetoid spread of urothelial carcinoma. The patient declined surgical resection of the lesion. She underwent nine cycles of first-line platinum-based chemotherapy and received one course of pembrolizumab for metastatic urothelial carcinoma. As the lesion progressively enlarged, third-line therapy with enfortumab vedotin was initiated, which resulted in significant tumor reduction. This allowed for a successful surgical complete resection of the tumor. Enfortumab vedotin was highly effective and demonstrated dramatic efficacy for controlling extramammary Paget's disease secondary to urothelial carcinoma.