American Journal of Clinical Oncology-Cancer Clinical Trials最新文献

Objectives: For decades, pelvic lymph node dissection (PLND) has been a critical component of radical cystectomy in patients with bladder cancer. Although its role in curative surgery for high-risk non-muscle-invasive and muscle-invasive cases is well-established, the therapeutic advantages of extended PLND remain a topic of ongoing debate.

Methods: A comprehensive literature search of major bibliographic databases was performed from inception to November 2024. Studies comparing extended PLND (extended or super extended) with standard PLND were identified. Data for clinical outcomes was extracted and pooled estimates were calculated using a random effects model with RevMan 5.4.

Results: A total of 11 studies (2 RCTs and 9 observational) were included reporting data for 4001 patients. The pooled analysis demonstrated that extended PLND was associated with significantly better recurrence-free survival (HR=0.67, 95% CI: 0.60-0.74). Standard PLND led to significantly higher 5-year recurrence rates (RR=1.44, 95% CI: 1.28-1.62) compared with the extended approach. The pooled estimates for disease-specific survival (HR=0.86, 95% CI: 0.62-1.19), overall survival (HR=0.99, 95% CI: 0.86-1.16), and complications remained comparable.

Conclusions: Extended PLND can lead to favorable recurrence-free survival and 5-year recurrence rates. However, retrospective observational studies mainly drive the evidence, and additional RCTs are required to reach a definitive conclusion.

Objectives: For locally advanced rectal adenocarcinoma (R-ACA), a nonoperative management (NOM) approach has emerged as a guideline-supported treatment option. However, the variables associated with NOM receipt are unknown.

Methods: Utilizing the National Cancer Database, we performed a retrospective cohort study of adults with stage 1 to 3 R-ACA managed with curative intent from 2004 to 2018. The primary outcome was the proportion of patients receiving NOM versus surgery. The secondary outcome was survival among NOM patients.

Results: A total of 128,297 patients were included. In all, 115,888 (90.3%) received surgery and 12,409 (9.7%) received NOM. Receipt of NOM was associated with age above 70, Charlson-Deyo score of 0, race (Black, Asian or Pacific Islander, or other vs. White), insurance status, geographical region, treatment in a community facility, year of diagnosis (2012-2018 vs. 2004-2011), tumor grade 1 versus ≥ 2, clinical T-stage ≥ 2, and clinical N1 or N2 versus N0. In the NOM cohort, poorer overall survival was associated with age 70 and above, male sex, Charlson-Deyo score ≥ 1, insurance status, geographical region, rural urban density versus metro/urban, treatment in a community facility, year of diagnosis (2004-2011 vs. 2012-2018), clinical T4 versus T1, clinical N1 or N2 versus N0, grade 3 versus 1, treatment with a radiotherapy dose <45 Gy versus 45 to 54 Gy, and omission of chemotherapy.

Conclusions: Several demographic factors and social determinants of health were associated with receipt of NOM and overall survival. With the increasing utilization of NOM, it will be important to understand the drivers of treatment decisions and influences on access to the desired treatment approach.

Objectives: Alveolar soft part sarcoma (ASPS) is a rare sarcoma affecting the deep soft tissues of the extremities in young adults and the head/trunk in children. This population-based study investigates demographics and factors influencing survival outcomes in ASPS.

Methods: The data for this study were collected from the SEER databases from 2000 to 2020.

Results: A total of 277 cases with ASPS were extracted from the database with a median age of 25 years and slight female predilection (52.3%). ASPS has a higher incidence in black (24.2%) and Hispanic (23.1%) races. Tumor location varied by age group: the head and neck were most commonly affected in younger patients (36.2%), while the lower extremities and hip region were predominant in older patients (68.8%). In most cases, the tumor size was >4 cm. When known, and majority were distant metastases (50.7%), and lung being the most common metastatic. The 5-year CSS with distant metastases was 33.0% (95% CI: 24.7-44.0). The highest 5-year CSS was observed with surgery with adjuvant radiation 86.7% (95% CI: 78.0-96.4). Multivariate analysis revealed that male sex was associated with worse survival (hazard ratio [HR] = 2.22), while surgery with adjuvant radiation was significantly associated with improved survival (HR = 0.36).

Conclusions: This study found that the male sex and larger tumors predict poorer ASPS outcomes, while surgery with adjuvant radiation improves survival. Future prospective clinical trials should focus on genomic mutation analysis for a personalized therapeutic approach.

Objectives: To evaluate the association between the KRAS mutational load and the histologic tumor response in patients with resectable pancreatic ductal adenocarcinoma (PDAC) who received neoadjuvant treatment (NAC) with pegylated liposomal irinotecan in combination with oxaliplatin, 5-fluorouracil, and leucovorin (NALIRIFOX).

Methods: This was a multicenter, single-arm, interventional, open-label, phase 2 trial in patients 18 years or older who had histologically or cytologically confirmed PDAC and were candidates for surgery and received neoadjuvant NALIRIFOX. The primary outcome was determination of the association between the KRAS mutational load and the histologic tumor response after chemotherapy.

Results: Twenty patients were included in the study. Before initiating NAC, 11 patients were KRAS+, 6 were KRAS-, and 3 were not evaluable for KRAS mutation status. Eight of the 11 (72.7%) patients changed from KRAS+ at baseline to KRAS- after treatment, and none of the 6 (0.0%) patients changed from KRAS- at baseline to KRAS+ after treatment. A good histopathologic response after NAC was observed in 3 (15%) of the 20 patients, with a greater proportion of good responses among patients who were KRAS- (3 out of 16 [18.8%]) than among those who were KRAS+ (0 out of 1 [0.0%]) after NAC, although the differences were not statistically significant (P=0.633).

Conclusions: Our results indicate that patients with potentially resectable PDAC tend to have detectable KRAS in the blood if the disease is locally more advanced and that most patients who are treated with neoadjuvant NALIRIFOX are negative for KRAS at the end of therapy.

Objectives: In this study, we report conditional survival rate for gynecologic malignancies using Surveillance, Epidemiology, and End Results (SEER) database for patients who have received treatment with radiation therapy.

Methods: Utilizing the SEER 22 database and SEER*Stat 8.4.3, regional gynecologic malignancies (cervix uteri, corpus uteri, vagina, vulva) treated with external beam radiation therapy (EBRT), brachytherapy, or both, were identified between 2000 and 2020. 5-year CS was calculated annually for each type of cancer treated with different types of therapies up to 5 years post diagnosis. The timeframes for percentages of survived patients are 12 to 72, 24 to 84, 36 to 96, 48 to 108, and 60 to 120 months, which gives the percentage of patients surviving up to 5 years at 1 to 5 years from when patients received diagnosis.

Results: There were 59,441 patients who received radiation in the initial cohort. This was further subdivided into 24,073 (40%) patients who received EBRT only, 18,528 (31%) who received brachytherapy only, and 16,840 (28%) who received combined EBRT and brachytherapy. 5-year CS was calculated each year after initial diagnosis up to 5 years after. For all types of cancers that were analyzed, the 5-year CS increased as the year after diagnosis increased.

Conclusions: CS is an effective method to prognosticate patients over time. In our cohort of patients with gynecologic malignancies treated with radiation, the overall trends for 5-year CS were similar across any treatment modality. These findings may help elucidate statistics for survivorship care and may help develop evidence-based policies.

Objectives: We report on the biomarker analyses focusing on neutrophil-to-lymphocyte ratios (NLR) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with combined cetuximab and nivolumab.

Methods: Data were obtained from a phase II trial (NCT03370276). Peripheral blood NLR was obtained at baseline (B-NLR) and on-treatment (OT-NLR; 1 mo from treatment initiation). Tumor NLR (T-NLR) was determined by staining of immune cells in primary tumors. Patients were stratified into high (≥median) or low NLR (

Results: While B-NLR did not correlate with survival or responses, low OT-NLR was associated with superior overall survival (OS; P<0.0001), progression-free survival (PFS; P=0.0002), and overall response (P<0.001) compared with high OT-NLR. Multivariable analysis further demonstrated that low OT-NLR was associated with superior OS (HR 0.32, 95% CI, 0.17-0.61) and PFS (HR 0.45, 95% CI, 0.25-0.81). Compared with patients with high OT-NLR, a higher proportion of patients with low OT-NLR had OS≥24 months (P=0.0001). Low OT-NLR was associated with higher baseline PD-L1 combined positive scores (P=0.037). Low pretreatment T-NLR was associated with superior OS and PFS in multivariable analysis and correlated with superior overall response (P=0.011).

Conclusions: Low OT-NLR and pretreatment T-NLR correlated with superior treatment outcomes in patients with R/M HNSCC treated with cetuximab and nivolumab. Further evaluation of T-NLR to improve patient selection and peripheral blood OT-NLR as a dynamic biomarker contributing to clinical benefit assessment given cetuximab and nivolumab is warranted.

Esophageal squamous cell carcinoma (ESCC) is a major global health burden with limited treatment options. Combining immunotherapy with antiangiogenic agents has shown promise. Camrelizumab, a PD-1 inhibitor, and apatinib, a VEGFR-2 inhibitor, offer synergistic effects, improving outcomes in patients with advanced or metastatic ESCC. A literature search was conducted across PubMed, Cochrane, Embase, Scopus, and clinicaltrials.gov from inception till May 2025. Nine studies evaluating the safety and efficacy of camrelizumab plus apatinib were included. Analysis was conducted on R Studio v4.5.0. Pooled estimates were reported as proportions and 95% CI using a random effect model. Statistical heterogeneity was assessed using I². Subgroup analysis was based on treatment exposure. The pooled 1-year overall survival (OS) rate was 71%, with treatment-naive patients exhibiting a statistically higher 1-year OS of 95% compared with 55% in pretreated patients. One-year progression-free survival was 25%. The overall response rate was significantly higher in the treatment-naive group than in the previously treated group (87% vs. 28%). Previously treated patients showed a modest complete response rate (CRR) of 1%, while treatment-naive patients showed a significantly higher CRR of 22%. Partial response rate was significantly higher in the treatment-naive subgroup (64% vs. 26%). Hemangioma was the significant adverse event in the treatment-naive subgroup (47% vs. 12%). Rates of leukopenia, neutropenia, anemia, and thrombocytopenia were comparable between the 2 subgroups. Camrelizumab plus apatinib has shown promising efficacy with improved OS, PFS, and response rates. Large-scale trials are warranted to validate these findings and optimize treatment strategies.

Objective: To identify prognostic factors predicting recurrence in vulvar cancer patients undergoing surgery.

Methods: We retrospectively evaluated data from consecutive patients with vulvar cancer treated between 2002 and 2024 in 2 Italian centers. Basic descriptive statistics and multivariable analysis were used to create predictive models for patient outcomes. Five-year disease-free survival (DFS) and overall survival (OS) were analyzed using a Cox proportional hazards model.

Results: The study included 283 patients diagnosed with vulvar cancer (239 with squamous cell carcinoma). The most frequent stages were stage I (50.9%) and stage III (30.4%). After a median follow-up of 27 months, 91 (32.2%) recurrences were observed, of which 20% were local, 6% were regional, and 6% were distant. The five-year DFS and OS were 46% and 60%, respectively. Multivariate analysis identified the presence of positive lymph nodes (hazard ratio [HR]: 3.54, 95% confidence interval [CI]: 1.04-12.08), age (HR: 1.02, 95% CI: 1-1.04), FIGO stage II (HR: 3.12, 95% CI: 1.24-7.87), and FIGO stage IV (HR: 3.85, 95% CI: 1.19-12.43) as factors associated with worse DFS. Positive nodes (HR: 2.64, 95% CI: 1.2-5.8) and tumor diameter >4 cm (HR: 1.89, 95% CI: 1.05-3.42) were associated with OS. FIGO stage >I was predictive of regional and distant recurrences, but no factor was found to correlate with local recurrence.

Conclusions: FIGO stage >I was predictive of regional and distant recurrences, while no factors influencing local recurrence were identified. Positive nodes, age, and FIGO stage >I correlated with DFS, whereas tumor diameter >4 cm and positive nodes influenced OS.

Objectives: Among patients that underwent palliative RT (pRT) at a single institution, we evaluated whether differences exist across race and ethnicity in location of pRT consultation and delivery of pRT.

Methods: This retrospective study included cancer patients aged 18 years or older who received pRT between 10/2021 and 10/2022. Logistic regression models were used to examine univariable (UVA) and multivariable (MVA) associations between race and pRT consult in the inpatient (vs. outpatient) setting. A subset analysis of quality metrics for pRT delivery was limited to patients who had outpatient consults for pain.

Results: Four hundred forty patients underwent 548 pRT consults (104 inpatient and 444 outpatient) followed by a course of pRT. Most patients were male (58.2%), White non-Hispanic (WNH) (72.6%), and English-speaking (92.9%). On MVA adjusting for histology, language, and insurance type, consults for Black/African American (BAA) patients had 2.92 higher odds of being performed in the inpatient setting compared with consults for WNH patients (95% CI: 1.28-6.70, P =0.011), although the global P -value was P =0.217. Among 290 outpatient consults for painful lesions, no differences in time to pRT start (global P =0.84), number of prescribed fractions of RT (global P =0.94), or new prescriptions for opioids (global P =0.69) were noted by race and ethnicity.

Conclusions: In this study, BAA race was associated with the location of pRT consultation, but no discernible differences were noted regarding the outpatient delivery of pRT for pain. These findings support the importance of inpatient pRT programs to ensure equitable access. More research is needed to understand barriers to outpatient consult.

Objectives: Breast cancer accounted for over 1/3 of new US cancer diagnoses in 2024, remains the most commonly diagnosed cancer globally, and is the leading cause of cancer-related mortality among women. We evaluated breast cancer patient experience at a National Cancer Institute-designated cancer center to assess potential barriers to optimal care.

Methods: Over a 10-month period (4/1/24 to 1/31/25), eligible breast cancer patients identified in clinic visits and who self-reported diagnoses were surveyed about their experience. Each survey included a "Likelihood to Recommend" (LTR) question, scored on a 5-point Likert scale, as a proxy for satisfaction. We examined surveys from 2 service lines: medical practice (clinic visits) and outpatient oncology (radiation/infusion). We extracted demographic data from the electronic medical record. Underrepresented minorities (URMs) were defined as African American, Native American, and/or Hispanic patients. Fisher's exact test assessed differences by race and ethnicity ( P <0.05).

Results: Of 15,153 patients (76.5% White, 9.9% Black, 7.6% Native American, and 94.3% non-Hispanic), 2,066 patients (13.6% response rate) completed the surveys. Response rates were significantly higher among White/non-Hispanic patients compared with URMs ( P =0.0001). For outpatient oncology, patient experiences did not significantly differ by race or ethnicity. For medical practice, a trend toward significance was observed by ethnicity ( P =0.07), but not by race.

Conclusions: Our retrospective cohort study found significantly lower survey response rates among URMs, which could indicate barriers to sharing patient experiences. These findings establish a baseline for comparison and support future implementation of targeted navigation programs to improve patient experience and care delivery.