In the INTRIGUE phase III trial (ClinicalTrials.gov identifier: NCT03673501), adult patients with advanced gastrointestinal stromal tumor previously treated with imatinib were randomly assigned 1:1 to ripretinib 150 mg once daily or sunitinib 50 mg once daily (4 weeks on/2 weeks off). In the primary analysis, overall survival (OS) was immature. In this study, we report the final planned analysis of OS (key secondary end point), progression-free survival (PFS) on third-line therapy (second PFS; prespecified exploratory end point), and long-term safety. Final OS analysis was prespecified to occur with approximately 200 and ≥145 events in the overall and KIT exon 11 intention-to-treat (ITT) populations, respectively. As of March 15, 2023, there were 211 and 151 OS events in the overall ITT and KIT exon 11 ITT populations, respectively. Median OS was similar between second-line ripretinib and sunitinib in both populations (overall, 35.5 v 31.5 months; KIT exon 11, 35.5 v 32.8 months). Median second PFS (on third-line therapy) for the overall ITT population was similar between the ripretinib and sunitinib arms (7.7 v 7.4 months). Safety was consistent with the primary analysis. OS from this analysis was similar between arms, and second PFS suggests that receiving ripretinib did not adversely affect the PFS of third-line therapy.

Breast cancer neoadjuvant therapy may negatively impact the immune system. As a secondary outcome of the docosahexaenoic acid (DHA) for women with breast cancer in the neoadjuvant setting (DHA-WIN trial), we sought to assess the effects of an intervention with DHA on parameters of immune function of women undergoing neoadjuvant therapy.

177Lu-prostate-specific membrane antigen-617 (177Lu-PSMA-617) has shown positive survival outcomes in metastatic castration-resistant prostate cancer. However, there are limited data in the hormone-sensitive setting. Here, in the CONSOLIDATE trial (177Lu-PSMA-617 Consolidation Therapy After Docetaxel in Patients with Synchronous High-Volume Metastatic Hormone-Sensitive Prostate Cancer), we intended to evaluate the role of 177Lu-PSMA-617 as consolidation therapy for residual disease after chemohormonal treatment in patients with synchronous high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Methods: This was an investigator-initiated randomized, parallel-group, open-label phase 2 trial. Synchronous high-volume mHSPC patients treated with androgen-deprivation therapy plus docetaxel and having residual nonprogressive disease after docetaxel completion (defined as prostate-specific antigen [PSA] > 0.2 ng/mL with PSMA-positive disease on 68Ga-PSMA-11 PET/CT) were randomized in a 1:1 ratio to the experimental arm (177Lu-PSMA-617, 7.4 GBq/cycle × 2, 6 wk apart with protocol-permitted standard of care) or control arm (protocol-permitted standard of care alone). The primary endpoint was the proportion of patients achieving a PSA level of 0.2 ng/mL or less at 6 mo from randomization. Secondary endpoints included objective radiographic response rate, radiographic progression-free survival (PFS), PSA PFS, and toxicities. Results: The trial was terminated early because of poor accrual after the coronavirus disease pandemic and a change in treatment guidelines for mHSPC. Thirty high-volume mHSPC patients were randomized between January 2021 and June 2024. The primary endpoint was achieved in 9 of 15 (60%; 95% CI, 35%-85%) patients in the experimental arm versus 2 of 15 (13%; 95% CI, 0%-30%) in the control arm (risk ratio, 4.5; 95% CI, 1.2-17.4; P = 0.008). The objective radiographic response rates were 8 of 15 (53%; 95% CI, 28%-78%) and 1 of 15 (7%; 95% CI, 0%-19%) in the experimental and control arms, respectively (P = 0.014). The estimated median radiographic PFS and PSA PFS were 18 mo (95% CI, 9-27 mo) and 15 mo (95% CI, 12-18 mo), respectively, in the experimental arm versus 9 mo (95% CI, 4-14 mo) and 9 mo (95% CI, 1-17 mo), respectively, in the control arm. No grade 3 or 4 toxicity was noted with the addition of 177Lu-PSMA-617 in the experimental arm. Conclusion: In synchronous high-volume mHSPC patients having residual disease after chemohormonal treatment, 177Lu-PSMA-617 consolidation therapy demonstrated promising efficacy and safety outcomes. Larger phase 3 trials are warranted to definitively establish its survival benefit.

Enzalutamide significantly improves overall survival (OS) of patients with metastatic hormone-sensitive prostate cancer (mHSPC). However, ∼10% of patients will die within 2 years. PCPro is a plasma lipid panel associated with decreased OS in metastatic castration-resistant prostate cancer. In this study, we assessed the association between PCPro and clinical outcomes in mHSPC by carrying out a post hoc analysis of ENZAMET, the landmark phase III trial comparing enzalutamide with nonsteroidal anti-androgen (NSAA).

Platinum-refractory advanced head and neck squamous cell carcinoma (HNSCC) has poor outcomes and limited treatment options, especially in resource-constrained settings. Triple oral metronomic chemotherapy (OMCT), involving low-dose continuous administration of chemotherapeutic agents, has shown promise in phase II studies but lacks evidence from randomized controlled trials. This study evaluated whether triple OMCT improves overall survival (OS) compared with chemotherapy of physician discretion (CPD).

The perioperative period is characterized by psychological stress and inflammatory reactions that can contribute to disease recurrence or metastatic spread. These reactions are mediated particularly by catecholamines and prostaglandins. The PROSPER trial aimed to evaluate whether a perioperative drug repurposing with a non-selective betablocker (propranolol) and a COX-2 inhibitor (etodolac) is feasible and safe in the setting of pancreatic cancer surgery.

We report the short-term results of indocyanine green (ICG)-guided laparoscopic lymphadenectomy for gastric cancer (GC). The primary outcome is 3-year disease-free survival. In this analysis, we present short-term secondary outcomes focused on the number of lymph nodes (LNs) retrieved and the diagnostic value of fluorescent status for metastatic LNs, excluding long-term outcomes. A total of 1,006 patients are included in the per-protocol analysis. The mean number of LNs retrieved in the ICG group is significantly higher than that in the non-ICG group. The negative predictive value is 93.9% for nonfluorescent stations, and the sensitivity of ICG for detecting all metastatic LN stations is 91.6%. ICG technology is safe and feasible for laparoscopic lymphadenectomy in GC and can noticeably increase the number of LNs retrieved. Further follow-up is necessary to warrant whether ICG can improve long-term survival of GC. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS)-11 trial has been registered at ClinicalTrials.gov as NCT04593615.

The EORTC QLQ-OES18 has previously demonstrated clinical validity; however, there are limited published psychometric data for patients with advanced esophageal squamous cell carcinoma (ESCC). We evaluated the measurement properties of the QLQ-OES18 in a clinical trial population of patients with advanced or metastatic ESCC.

This study aimed to evaluate the safety and tolerability of magnetic resonance (MR) imaging-guided in-bore transperineal prostate biopsies (TP-Bx).

Each year, millions of pulmonary nodules are identified incidentally or through lung cancer screening, and many involve biopsy to distinguish cancer from benign processes. Both navigational bronchoscopy and computed tomography-guided transthoracic needle biopsy are commonly used in patients undergoing biopsies of peripheral pulmonary nodules, but the relative diagnostic accuracy of these two approaches is unclear.

Despite treatment advances, most patients with metastatic hormone-sensitive prostate cancer (mHSPC) experience disease progression to castration-resistant disease within 5 years. The placebo-controlled, double-blind, phase III KEYNOTE-991 study evaluated the efficacy and safety of adding pembrolizumab to enzalutamide and androgen deprivation therapy (ADT) in participants with mHSPC.

Established first- and second-line standard-of-care treatment options (abiraterone, enzalutamide, taxane chemotherapy) are available for patients with metastatic castration-resistant prostate cancer (mCRPC), but almost all patients experience subsequent disease progression. The randomized, double-blind, phase III KEYNOTE-641 study evaluated pembrolizumab plus enzalutamide versus placebo plus enzalutamide in participants with chemotherapy-naive mCRPC.

Decision aids (DAs) may increase engagement in decision-making by addressing barriers that disproportionately impact socioeconomically disadvantaged patients. The impact of a breast cancer surgery DA on increasing patient engagement in decision-making was tested in clinics serving a high proportion of socioeconomically disadvantaged patients.

Ovarian cancer is among the most lethal malignancies in women. The advent of PARP inhibitors (PARPi) has improved outcomes. However, treatment-related toxicity remains a critical challenge, impacting patient quality of life and treatment adherence.

This study aimed to develop and validate a computed tomography (CT)-based intratumoral and peritumoral radiomics nomogram to improve the stratification of postoperative recurrence risk in patients with localized clear cell renal cell carcinoma (ccRCC).

After the global approval of atezolizumab plus bevacizumab and chemotherapy as first-line metastatic nonsquamous non-small-cell lung cancer (nsqNSCLC) treatment, the IMpower151 ( NCT04194203 ) trial was conducted in China to address regional differences. Chemotherapy-naive patients with metastatic nsqNSCLC (N = 305) were randomized 1:1 to receive either atezolizumab, bevacizumab, carboplatin and paclitaxel or pemetrexed (ABCPem/Pac; n = 152) or placebo plus bevacizumab, carboplatin and pemetrexed or paclitaxel (BCPem/Pac; n = 153). The primary endpoint was investigator-assessed progression-free survival (INV-PFS); secondary endpoints included subgroup analyses of INV-PFS, independent review facility-assessed PFS, overall survival, and investigator-assessed objective response rate and duration of response per RECIST v.1.1. Most patients (97%) received pemetrexed, and 53% had EGFR+ tumors. Median INV-PFS for ABCPem/Pac versus BCPem/Pac was 9.5 versus 7.1 months (stratified hazard ratio: 0.84; 95% confidence interval: 0.65, 1.09; P = 0.184). INV-PFS across subgroups and independent review facility-assessed PFS were consistent with INV-PFS in the intention-to-treat population. Median overall survival was 20.7 versus 18.7 months in the ABCPem/Pac versus BCPem/Pac arms, respectively (stratified hazard ratio: 0.93; 95% confidence interval: 0.67, 1.28). Confirmed objective response rate with ABCPem/Pac versus BCPem/Pac was 48% versus 50%, respectively; median duration of response was 11.3 versus 8.3 months. Adverse events of special interest for atezolizumab were observed in 68% (grades 3 and 4: 11%) and 71% (grades 3 and 4: 7%) of patients receiving ABCPem/Pac and BCPem/Pac, respectively. The most common adverse events of special interest for atezolizumab in the ABCPem/Pac and BCPem/Pac arms were hepatitis (driven by laboratory abnormalities; mostly low grade), hypothyroidism and rash. Overall, IMpower151 did not meet its primary endpoint (INV-PFS) in metastatic nsqNSCLC. ABCPem/Pac was generally well tolerated, with no new safety signals. Trial registration number: ClinicalTrials.gov, NCT02366143.

FAST-Forward showed that 26 Gray (Gy) in 5 fractions (Fr) over one week adjuvant radiotherapy to breast or chest wall was as safe and effective as a three-week schedule (40 Gy/15Fr) for early breast cancer. The nodal sub-study investigated whether a one-week schedule is safe for adjuvant axillary radiotherapy.

To prospectively evaluate safety and efficacy of dose-intensified multifraction SBRT using a simultaneous-integrated boost concept for vertebral oligometastases.

We aimed to evaluate the efficacy of two different radiotherapy strategies in elderly patients with locally advanced nasopharyngeal carcinoma (NPC) using geriatric assessment.

More than 30% of patients with pancreatic cancer are unresectable because of the local extension with a median overall survival (OS) of <1 year. Combination of fluorouracil (FU), oxaliplatin, and irinotecan (FOLFIRINOX) is superior to gemcitabine in the treatment of metastatic pancreatic cancer, but standard of care remains gemcitabine in locally advanced pancreatic cancer (LAPC).