Publications database

The TALAPRO-2 trial showed improved radiographic progression-free survival and overall survival with first-line talazoparib plus enzalutamide versus placebo plus enzalutamide in patients with metastatic androgen pathway modulator-resistant prostate cancer (APMR; also referred to as castration-resistant prostate cancer) unselected for homologous recombination repair (HRR) gene alterations treated. We aimed to assess HRR gene alteration status agreement between prospective solid tumour tissue and circulating tumour DNA (ctDNA) testing, the potential complementary value of prospective and retrospective ctDNA testing, and the prognostic utility of baseline ctDNA burden, changes in ctDNA burden, and circulating tumour cell (CTC) reductions.In TALAPRO-2, a randomised, double-blind, placebo-controlled, phase 3 trial, men aged 18 years or older (≥20 years in Japan) with asymptomatic or mildly symptomatic metastatic APMR prostate cancer and no previous life-prolonging systemic therapy for APMR disease were randomly assigned (1:1) to receive once daily, oral talazoparib 0·5 mg plus enzalutamide 160 mg or placebo plus enzalutamide and stratified by HRR gene alteration status and previous treatment for androgen pathway modulator-naive/sensitive disease. [...]

CPS + EG and Neo-Bioscore are prognostic scores estimating the risk of recurrence after neoadjuvant chemotherapy for early breast cancer, but can they predict the long-term outcomes in a clinical trial? In this study, we assessed their surrogacy values at patient level and trial level for long-term outcomes, using data from 8,359 patients across nine neoadjuvant randomized trials conducted by the German Breast Group (GBG) and AGO-B study group. We found that at the patient level, both scores were significantly associated with outcomes, but at the trial level, the associations with distant disease-free survival (DDFS), invasive disease-free survival (iDFS), and overall survival (OS) were weak for both scores (R2 range = 0.03 to 0.24, with wide confidence intervals). [...]

In the DeLLphi-304 trial, at a median follow-up of <12 months, tarlatamab significantly improved overall survival (OS; P < 0.001), progression-free survival (PFS; P = 0.002), and patient-reported outcomes (PROs), and demonstrated a favorable safety profile versus chemotherapy. We report efficacy and safety outcomes after extended follow-up in patients with small-cell lung cancer (SCLC).In this phase III, open-label trial, patients with SCLC whose disease had progressed on or after platinum-based chemotherapy were randomly assigned (1 : 1) to receive either tarlatamab or chemotherapy (topotecan, lurbinectedin, or amrubicin) until disease progression, unacceptable toxicity, or death. [...]

Patients with solid rare cancers often experience impaired health-related quality of life (HRQoL), yet no validated questionnaires exist to fully capture their unique experiences. This study evaluated the relevance of items from generic and tumour-specific European Organisation for Research and Treatment of Cancer (EORTC) questionnaires across this population.A total of 397 patients across 20 solid rare cancer diagnoses, equally divided across the domains of the European Reference Network of Rare Adult Solid Tumours (EURACAN), completed the EORTC QLQ-C30, and where applicable, a tumour-specific questionnaire. [...]

Evidence supports nutritional and exercise interventions in oncology, yet their integration into routine care remains inconsistent. We evaluated a single-center, electronic patient-reported outcome‑based supportive care pathway and examined factors associated with completion of nutritional and exercise counseling.We conducted a retrospective analysis of routinely collected clinical and electronic patient-reported outcome data from outpatients at the National Center for Tumor Diseases Dresden between January and November 2024. [...]

Divarasib, a next-generation, oral KRAS G12C inhibitor, is more potent and selective in vitro than the first-generation KRAS G12C inhibitors sotorasib and adagrasib.In this phase 3, international, open-label trial, patients with previously treated KRAS G12C-mutated advanced or metastatic non-small-cell lung cancer (NSCLC) were randomly assigned to receive divarasib orally at a dose of 400 mg once daily or control treatment (sotorasib orally at a dose of 960 mg once daily or adagrasib orally at a dose of 600 mg twice daily) until the occurrence of disease progression, unacceptable adverse events, loss of clinical benefit, withdrawal of consent, death, or trial termination. The primary end point was progression-free survival as assessed by blinded independent central review. [...]

KRASG12C inhibitors such as sotorasib have expanded precision-oncology options for non-small cell lung cancer (NSCLC). However, central nervous system (CNS) disease control remains a major clinical challenge.We report the case of a female patient with extensively pretreated KRASG12C-mutated lung adenocarcinoma and metachronous progressive brain metastases. [...]

Despite curative resection and adjuvant capecitabine, about 50% of biliary tract cancer (BTC) patients have tumour recurrence or die within two years. Combination chemotherapy with cisplatin and gemcitabine (CisGem) is an established palliative chemotherapy regimen BTC, which has been evaluated in the adjuvant setting here.ACTICCA-1 is a randomized, phase III investigator-initiated trial. [...]

We previously reported the results of a multicenter phase II trial (ClinicalTrials.gov identifier: NCT04154943) of neoadjuvant cemiplimab in resectable stage II to IV cutaneous squamous cell carcinoma (CSCC), in which the pathologic complete response (pCR) rate was 51%. At the 19-month follow-up, estimated 12-month event-free survival (EFS) was 89%, with 11 EFS events. [...]

Psoriasis is a T-cell-mediated inflammatory disease amplified by metabolic stress. Acetyl-CoA carboxylase 1 (ACC1)-dependent fatty acid synthesis is required for IL-17-producing T cells. [...]