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1.
Transplantation ; 2024 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-38771067

RESUMEN

With improved medical treatments, the prognosis for many malignancies has improved, and more patients are presenting for transplant evaluation with a history of treated cancer. Solid organ transplant (SOT) recipients with a prior malignancy are at higher risk of posttransplant recurrence or de novo malignancy, and they may require a cancer surveillance program that is individualized to their specific needs. There is a dearth of literature on optimal surveillance strategies specific to SOT recipients. A working group of transplant physicians and cancer-specific specialists met to provide expert opinion recommendations on optimal cancer surveillance after transplantation for patients with a history of malignancy. Surveillance strategies provided are mainly based on general population recurrence risk data, immunosuppression effects, and limited transplant-specific data and should be considered expert opinion based on current knowledge. Prospective studies of cancer-specific surveillance models in SOT recipients should be supported to inform posttransplant management of this high-risk population.

2.
Ann Gastroenterol Surg ; 8(3): 394-400, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38707228

RESUMEN

Multidisciplinary management of rectal cancer has rapidly evolved over the last several years. This review describes recent data surrounding total neoadjuvant therapy, organ preservation, and management of lateral pelvic lymph nodes. It then presents our treatment algorithm for management of rectal cancer at The University of Texas MD Anderson Cancer Center in the context of this and other existing literature. As part of this discussion, the review describes how we tailor management based upon both patient and tumor-related factors in an effort to optimize patient outcomes.

3.
JCO Clin Cancer Inform ; 8: e2300219, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38759125

RESUMEN

PURPOSE: Dynamic operations platforms allow for cross-platform data extraction, integration, and analysis, although application of these platforms to large-scale oncology enterprises has not been described. This study presents a pipeline for automated, high-fidelity extraction, integration, and validation of cross-platform oncology data in patients undergoing treatment for rectal cancer at a single, high-volume institution. METHODS: A dynamic operations platform was used to identify patients with rectal cancer treated at MD Anderson Cancer Center between 2016 and 2022 who had magnetic resonance imaging (MRI) imaging and preoperative treatment details available in the electronic health record (EHR). Demographic, clinicopathologic, tumor mutation, radiographic, and treatment data were extracted from the EHR using a methodology adaptable to any disease site. Data accuracy was assessed by manual review. Accuracy before and after implementation of synoptic reporting was determined for MRI data. RESULTS: A total of 516 patients with localized rectal cancer were included. In the era after institutional adoption of synoptic reports, the dynamic operations platform extracted T (tumor) category data from the EHR with 95% accuracy compared with 87% before the use of synoptic reports, and N (lymph node) category with 88% compared with 58%. Correct extraction of pelvic sidewall adenopathy was 94% compared with 78%, and extramural vascular invasion accuracy was 99% compared with 89%. Neoadjuvant chemotherapy and radiation data were 99% accurate for patients who had synoptic data sources. CONCLUSION: Using dynamic operations platforms enables automated cross-platform integration of multiparameter oncology data with high fidelity in patients undergoing multimodality treatment for rectal cancer. These pipelines can be adapted to other solid tumors and, together with standardized reporting, can increase efficiency in clinical research and the translation of actionable findings toward optimizing patient outcomes.


Asunto(s)
Bases de Datos Factuales , Imagen por Resonancia Magnética , Neoplasias del Recto , Humanos , Neoplasias del Recto/terapia , Neoplasias del Recto/patología , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/diagnóstico , Femenino , Masculino , Persona de Mediana Edad , Imagen por Resonancia Magnética/métodos , Anciano , Registros Electrónicos de Salud , Adulto , Reproducibilidad de los Resultados , Estadificación de Neoplasias
4.
Colorectal Dis ; 2024 Apr 04.
Artículo en Inglés | MEDLINE | ID: mdl-38576073

RESUMEN

AIM: As multidisciplinary treatment strategies for colorectal cancer have improved, aggressive surgical resection has become commonplace. Multivisceral and extended resections offer curative-intent resection with significant survival benefit. However, limited data exist regarding the feasibility and oncological efficacy of performing extended resection via a minimally invasive approach. The aim of this study was to determine the perioperative and long-term outcomes following robotic extended resection for colorectal cancer. METHOD: We describe the population of patients undergoing robotic multivisceral resection for colorectal cancer at our single institution. We evaluated perioperative details and investigated short- and long-term outcomes, using the Kaplan-Meier method to analyse overall and recurrence-free survival. RESULTS: Among the 86 patients most tumours were T3 (47%) or T4 (47%) lesions in the rectum (78%). Most resections involved the anterior compartment (72%): bladder (n = 13), seminal vesicle/vas deferens (n = 27), ureter (n = 6), prostate (n = 15) and uterus/vagina/adnexa (n = 27). Three cases required conversion to open surgery; 10 patients had grade 3 complications. The median hospital stay was 4 days. Resections were R0 (>1 mm) in 78 and R1 (0 to ≤1 mm) in 8, with none being R2. The average nodal yield was 26 and 48 (55.8%) were pN0. Three-year overall survival was 88% and median progression-free survival was 19.4 months. Local recurrence was 6.1% and distant recurrence was 26.1% at 3 years. CONCLUSION: Performance of multivisceral and extended resection on the robotic platform allows patients the benefit of minimally invasive surgery while achieving oncologically sound resection of colorectal cancer.

5.
JAMA Surg ; 159(5): 563-569, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38506853

RESUMEN

Importance: Modifier 22 is a mechanism designed for surgeons to identify cases that are more complex than their Current Procedural Terminology code accounts for. However, empirical studies of the use and efficacy of modifier 22 are lacking. Objective: To assess the use of modifier 22 in common surgical procedures and the association of use with compensation. Design, Setting, and Participants: This was a cross-sectional analysis of the 2021 Physician/Supplier Procedure Summary Limited Data Set including all Part B carrier and durable medical equipment fee-for-service claims. Claims for 10 common surgical procedures were evaluated, including mastectomy, total hip arthroplasty, total knee arthroplasty, coronary artery bypass grafting, laparoscopic right colectomy, laparoscopic appendectomy, laparoscopic cholecystectomy, kidney transplant, laparoscopic total abdominal hysterectomy and bilateral salpingo-oophorectomy, and lumbar laminectomy. Data were analyzed from August to November 2023. Main Outcomes and Measures: Rate of modifier 22 use, rate of claim denial, mean charges, mean payment for accepted claims, and mean payment for all claims. Results: The sample included 625 316 surgical procedures performed in calendar year 2021. The proportion of modifier 22 coding for a procedure ranged from 5725 of 251 521 (2.3%) in total knee arthroplasty to 1566 of 18 459 (8.5%) in laparoscopic total abdominal hysterectomy and bilateral salpingo-oophorectomy. Submitted charges were 11.1% (95% CI, 9.1-13.2) to 22.8% (95% CI, 21.3-24.3) higher for claims with modifier 22, depending on the procedure. Among accepted claims, those with modifier 22 had increased payments ranging from 0.8% (95% CI, 0.7-1.0) to 4.8% (95% CI, 4.5-5.1). However, claims with modifier 22 were more likely to be denied (7.4% vs 4.0%; P < .001). As a result, overall mean payments were mixed, with 4 procedures having lower payments when modifier 22 was appended, 4 procedures having higher payments with modifier 22, and 2 procedures with no difference. The largest increase in mean payment for modifier 22 claims was for kidney transplant with an increased payment of $71.46 (95% CI, 55.32-87.60), which translates to a relative increase of 3.4% (95% CI, 2.9-4.6). Conclusions and Relevance: The findings in this study suggest that modifier 22 had little to no financial benefit when appended to claims for a diverse panel of surgical procedures. In the current system, surgeons have little reason to request modifier 22, and no mechanisms currently exist for surgeons to recoup payment for difficult operations.


Asunto(s)
Planes de Aranceles por Servicios , Procedimientos Quirúrgicos Operativos , Humanos , Estados Unidos , Estudios Transversales , Procedimientos Quirúrgicos Operativos/economía , Medicare/economía , Femenino , Current Procedural Terminology
6.
Artículo en Inglés | MEDLINE | ID: mdl-38365567

RESUMEN

BACKGROUND: A survey of medical oncologists (MOs), radiation oncologists (ROs), and surgical oncologists (SOs) who are experts in the management of patients with metastatic colorectal cancer (mCRC) was conducted to identify factors used to consider metastasis-directed therapy (MDT). MATERIALS AND METHODS: An online survey to assess clinical factors when weighing MDT in patients with mCRC was developed based on systematic review of the literature and integrated with clinical vignettes. Supporting evidence from the systematic review was included to aid in answering questions. RESULTS: Among 75 experts on mCRC invited, 47 (response rate 62.7%) chose to participate including 16 MOs, 16 ROs, and 15 SOs. Most experts would not consider MDT in patients with 3 lesions in both the liver and lung regardless of distribution or timing of metastatic disease diagnosis (6 vs. 36 months after definitive treatment). Similarly, for patients with retroperitoneal lymph node and lung and liver involvement, most experts would not offer MDT regardless of timing of metastatic disease diagnosis. In general, SOs were willing to consider MDT in patients with more advanced disease, ROs were more willing to offer treatment regardless of metastatic site location, and MOs were the least likely to consider MDT. CONCLUSIONS: Among experts caring for patients with mCRC, significant variation was noted among MOs, ROs, and SOs in the distribution and volume of metastatic disease for which MDT would be considered. This variability highlights differing opinions on management of these patients and underscores the need for well-designed prospective randomized trials to characterize the risks and potential benefits of MDT.

7.
Clin Colorectal Cancer ; 23(1): 85-94, 2024 03.
Artículo en Inglés | MEDLINE | ID: mdl-38216367

RESUMEN

BACKGROUND: The standard treatment for recurrent or persistent anal squamous cell carcinoma is surgical salvage, but disease control and survival are suboptimal. PATIENTS/METHODS: Patients treated for recurrent or persistent anal squamous cell carcinoma at our institution from 2002 to 2022 were included. Patients were classified by type of salvage treatment received: surgery alone vs. reirradiation followed by surgery and by whether they received intraoperative radiation at the time of surgery. Clinical and pathologic variables were collected and assessed for association with risk of second local recurrence and death from any cause. RESULTS: Sixty four patients were included; 55(85.9%) were treated with surgery alone and 9 (14.1%) were treated with reirradiation followed by surgery. Median (IQR) follow up from the time of salvage treatment was 40.0 (20.3-68.0) months. The 3-year cumulative incidence of second local recurrence (95% CI) after salvage surgery was 36% (24%-48%); 39% (26%-52%) for patients treated with surgery alone and 15% (0.46%-51%) for patients treated with reirradiation followed by surgery. Factors associated with increased second local recurrence after salvage surgery included a locoregional recurrence, lymphovascular space invasion and positive surgical margins. The 3-year overall survival (95% CI) after salvage surgery was 70% (59%-83%); 68% (7%-56%) after surgery alone and 89% (10.5%-70.6%) after reirradiation followed by surgery. Factors associated with worse overall survival included male sex, a larger recurrent tumor and positive surgical margins. CONCLUSIONS: Approximately 60% of patients achieved pelvic control after salvage therapy for recurrent or persistent anal squamous cell carcinoma. Although receipt of reirradiation and intraoperative radiation were not associated with improved second local recurrence or overall survival in our cohort, patients with positive surgical margins and lymphovascular space invasion on surgical pathology had higher rates of pelvic recurrence after salvage surgery and may benefit from escalated salvage therapy.


Asunto(s)
Neoplasias del Ano , Carcinoma de Células Escamosas , Humanos , Masculino , Terapia Recuperativa , Márgenes de Escisión , Carcinoma de Células Escamosas/patología , Neoplasias del Ano/terapia , Neoplasias del Ano/patología , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/terapia , Estudios Retrospectivos , Terapia Combinada , Resultado del Tratamiento
8.
JCO Oncol Pract ; 20(4): 491-502, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38252911

RESUMEN

PURPOSE: Individuals diagnosed with cancer between 15 and 39 years (adolescent and young adult [AYA]) face unique vulnerability. Detail is lacking about care delivery for these patients, especially those with ALL. We address these knowledge gaps by describing AYA ALL care delivery details at National Cancer Institute Community Oncology Research Program (NCORP) (sub)affiliates by model of care. METHODS: Participating institutions treated at least one AYA with ALL from 2012 to 2016. Study-specific criteria were used to determine the number of unique clinical facilities (CFs) per NCORP and their model of care (adult/internal medicine [IM], pediatric, mixed [both]). Surveys completed by NCORPs for each CF by model of care captured size, resources, services, and communication. RESULTS: Among 84 participating CFs (adult/IM, n=47; pediatric, n=15; mixed, n=24), 34% treated 5-10 AYAs with ALL annually; adult/IM CFs more often treated <5 (adult/IM, 60%; pediatric, 40%; mixed, 29%). Referral decisions were commonly driven by an age/diagnosis combination (58%), with frequent ALL-specific age minimums (87%) or maximums (80%). Medical, navigational, and social work services were similar across models while psychology was available at more pediatric CFs (pediatric, 80%; adult/IM, 40%; mixed, 46%-54%). More pediatric or mixed CFs reported oncologists interacting with pediatric/adult counterparts via tumor boards (pediatric, 93%; adult/IM, 26%; mixed, 96%) or initiating contact (pediatric, 100%; adult/IM, 77%; mixed 96%); more pediatric CFs reported an affiliated counterpart (pediatric, 53%; adult, 19%). Most CFs reported no AYA-specific resources (79%) or meetings (83%-98%). CONCLUSION: System-level aspects of AYA ALL care delivery have not been examined previously. At NCORPs, these characteristics differ by models of care. Additional work is ongoing to investigate the impact of these facility-level factors on guideline-concordant care in this population. Together, these findings can inform a system-level intervention for diverse practice settings.


Asunto(s)
Neoplasias , Oncólogos , Humanos , Adolescente , Adulto Joven , Niño , Neoplasias/epidemiología , Neoplasias/terapia , Neoplasias/diagnóstico , Atención a la Salud , Encuestas y Cuestionarios
9.
Mol Cancer Res ; 22(4): 337-346, 2024 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-38156967

RESUMEN

Cancer stem cells (CSC) play a critical role in metastasis, relapse, and therapy resistance in colorectal cancer. While characterization of the normal lineage of cell development in the intestine has led to the identification of many genes involved in the induction and maintenance of pluripotency, recent studies suggest significant heterogeneity in CSC populations. Moreover, while many canonical colorectal cancer CSC marker genes have been identified, the ability to use these classical markers to annotate stemness at the single-cell level is limited. In this study, we performed single-cell RNA sequencing on a cohort of 6 primary colon, 9 liver metastatic tumors, and 11 normal (nontumor) controls to identify colorectal CSCs at the single-cell level. Finding poor alignment of the 11 genes most used to identify colorectal CSC, we instead extracted a single-cell stemness signature (SCS_sig) that robustly identified "gold-standard" colorectal CSCs that expressed all marker genes. Using this SCS_sig to quantify stemness, we found that while normal epithelial cells show a bimodal distribution, indicating distinct stem and differentiated states, in tumor epithelial cells stemness is a continuum, suggesting greater plasticity in these cells. The SCS_sig score was quite variable between different tumors, reflective of the known transcriptomic heterogeneity of CRC. Notably, patients with higher SCS_sig scores had significantly shorter disease-free survival time after curative intent surgical resection, suggesting stemness is associated with relapse. IMPLICATIONS: This study reveals significant heterogeneity of expression of genes commonly used to identify colorectal CSCs, and identifies a novel stemness signature to identify these cells from scRNA-seq data.


Asunto(s)
Neoplasias Colorrectales , Recurrencia Local de Neoplasia , Humanos , Recurrencia Local de Neoplasia/patología , Perfilación de la Expresión Génica , Neoplasias Colorrectales/patología , Recurrencia , Análisis de Secuencia de ARN , Células Madre Neoplásicas/metabolismo , Línea Celular Tumoral
10.
Eur J Cancer ; 194: 113356, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37827065

RESUMEN

BACKGROUND: Neoadjuvant immune checkpoint blockade (IO) is emerging as a therapeutic option for patients with deficient mismatch repair (dMMR) colorectal cancer (CRC) given high pathological response rates. The aim of the study was to characterise imaging and endoscopic response to IO. METHODS: A retrospective analysis of patients with localised dMMR CRC that received at least one cycle of neoadjuvant anti-PD-1 therapy was conducted. Endoscopy, imaging, and pathological outcomes were reviewed to determine response to treatment according to standardised criteria. RESULTS: Thirty-eight patients had received IO for the treatment of localised CRC (median eight cycles). Among evaluable cases (n = 31 for endoscopy and n = 34 for imaging), the best endoscopic response was complete response (CR) in 45% of cases, and the best radiographic response was CR in 23% of cases. Imaging CR rate after ≤4 cycles of IO (n = 1) was 6% compared to 44% after >4 IO cycles (n = 7). Among 28 patients with imaging and endoscopy available, a discrepancy in best response was noted in 15 (54%) cases. At a median follow-up of 28.2 months from IO start, 18 patients underwent surgical resection of which 11 (61%) had pathological CR (pCR). Despite pCR or no evidence of progression ≥6 months after completion of IO among non-operatively managed patients, 72% and 42% of patients had non-CR on imaging and endoscopy, respectively. CONCLUSIONS: Discrepancies between imaging and endoscopy are prevalent, and irregularities identified on these modalities can be identified despite pathological remission. Improved clinical response criteria are warranted.


Asunto(s)
Neoplasias Colorrectales , Inhibidores de Puntos de Control Inmunológico , Receptor de Muerte Celular Programada 1 , Humanos , Neoplasias Colorrectales/diagnóstico por imagen , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/genética , Reparación de la Incompatibilidad de ADN , Endoscopía , Inestabilidad de Microsatélites , Terapia Neoadyuvante , Receptor de Muerte Celular Programada 1/antagonistas & inhibidores , Estudios Retrospectivos , Inhibidores de Puntos de Control Inmunológico/uso terapéutico
11.
JAMA Surg ; 158(11): 1195-1202, 2023 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-37728906

RESUMEN

Importance: Circumferential resection margin (CRM) in rectal cancer surgery is a major prognostic indicator associated with local recurrence and overall survival. Facility rates of CRM positivity have recently been established as a new quality measure by the Commission on Cancer (CoC); however, the completeness of CRM status reporting is not well characterized. Objective: To describe the changes in CRM reporting and factors associated with low rates of reporting. Design, Setting, and Participants: A retrospective cohort study was conducted using data from the National Cancer Database between January 2010 and December 2019. Data were analyzed between October 1, 2021, and February 1, 2022. Data from the National Cancer Database included patients diagnosed with nonmetastatic rectal adenocarcinoma receiving surgical treatment at CoC-accredited facilities throughout the US. Exposures: Patient, tumor, and facility-level factors. Facilities were divided by surgical volume, safety-net status, and CoC facility type. Main Outcomes and Measures: Circumferential resection margin missingness rates. Results: A total of 110 571 patients (59.3% men) with rectal adenocarcinoma who underwent curative-intent surgery at 1307 CoC-accredited hospitals were included for analysis. Reporting of CRM improved over the study period, with a mean (SE) missing 12.0% (0.32%) decreased from 16.3% (0.36%). Academic facilities had a higher missingness than other facility types (14.3% vs 10.5%-12.7%; P < .001). Mean (SE) rates of missingness were similar between hospitals of varying volume (lowest quartile: 12.2% [0.93%] vs highest quartile: 12.4% [0.53%]; P = .96). Cases in which fewer than 12 lymph nodes were removed had higher rates of missingness (18.1% vs 11.4%; P < .001). Increased odds of CRM missingness were noted with T category (odds ratio [OR], 1.50; 95% CI, 1.35-1.65) and N category (OR, 2.00; 95% CI, 1.82-2.20). Black race was associated with missingness (OR, 1.13; 95% CI, 1.06-1.14). Conclusion and Relevance: Although CRM positivity reporting has improved over the last decade, the findings of this study suggest there is substantial room for improvement as it becomes a quality standard. Missingness appears to be associated with poor performance on other quality metrics and facility type. This measure appears to be ideal for targeted institution-level feedback to improve quality of care nationally.


Asunto(s)
Adenocarcinoma , Neoplasias del Recto , Masculino , Humanos , Femenino , Márgenes de Escisión , Estudios Retrospectivos , Recto/cirugía , Neoplasias del Recto/mortalidad , Adenocarcinoma/mortalidad
12.
Abdom Radiol (NY) ; 48(9): 2807-2813, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37393382

RESUMEN

The concept of multidisciplinary team discussion of patient's care has been a part of routine medical practice for several decades [Monson et al. in Bull Am Coll Surg 101:45-46, 2016; NHS. Improving outcomes in colorectal cancer-the manual. (Guidance on commissioning cancer services-improving outcomes). 1997.]. The idea of bringing multiple specialties and ancillary services together to help optimize patient outcomes has been implemented in several clinical arenas from burns to physical medicine and rehabilitation to oncology. In the oncology realm, multidisciplinary tumor boards (MDTs) originated as a broad-based meeting that would permit the review and discussion of cancer patients to optimize treatment strategies [Cancer Co. Optimal Resources for Cancer Care: 2020 Standards. Chicago, IL: 2019.]. Over time, as further specialization occurred and clinical treatment algorithms have become more complex, multidisciplinary tumor boards have become more disease site specific. In this article we will discuss the importance of MDTs, specifically focusing on rectal cancer MDTs including their impact on treatment planning as well as the unique interplay of clinical specialties that provide internal quality control and improvement. Additionally, we will discuss some of the potential benefits of MDTs beyond the direct impact on patient care and review some of the challenges of implementation.


Asunto(s)
Medicina , Neoplasias del Recto , Humanos , Grupo de Atención al Paciente , Neoplasias del Recto/diagnóstico por imagen , Neoplasias del Recto/terapia , Oncología Médica , Planificación de Atención al Paciente
13.
Ann Surg ; 278(4): 538-548, 2023 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-37465976

RESUMEN

OBJECTIVE: External exposures, the host, and the microbiome interact in oncology. We aimed to investigate tumoral microbiomes in young-onset rectal cancers (YORCs) for profiles potentially correlative with disease etiology and biology. BACKGROUND: YORC is rapidly increasing, with 1 in 4 new rectal cancer cases occurring under the age of 50 years. Its etiology is unknown. METHODS: YORC (<50 y old) or later-onset rectal cancer (LORC, ≥50 y old) patients underwent pretreatment biopsied of tumor and tumor-adjacent normal (TAN) tissue. After whole genome sequencing, metagenomic analysis quantified microbial communities comparing tumors versus TANs and YORCs versus LORCs, controlling for multiple testing. Response to neoadjuvant therapy (NT) was categorized as major pathological response (MPR, ≤10% residual viable tumor) versus non-MPR. RESULTS: Our 107 tumors, 75 TANs from 37 (35%) YORCs, and 70 (65%) LORCs recapitulated bacterial species were previously associated with colorectal cancers (all P <0.0001). YORC and LORC tumoral microbiome signatures were distinct. After NT, 13 patients (12.4%) achieved complete pathologic response, whereas MPR occurred in 47 patients (44%). Among YORCs, MPR was associated with Fusobacterium nucleaum , Bacteroides dorei, and Ruminococcus bromii (all P <0.001), but MPR in LORC was associated with R. bromii ( P <0.001). Network analysis of non-MPR tumors demonstrated a preponderance of oral bacteria not observed in MPR tumors. CONCLUSIONS: Microbial signatures were distinct between YORC and LORC. Failure to achieve an MPR was associated with oral bacteria in tumors. These findings urge further studies to decipher correlative versus mechanistic associations but suggest a potential for microbial modulation to augment current treatments.


Asunto(s)
Microbiota , Neoplasias del Recto , Humanos , Persona de Mediana Edad , Terapia Neoadyuvante , Neoplasias del Recto/terapia , Neoplasias del Recto/patología , Biopsia
14.
N Engl J Med ; 389(4): 322-334, 2023 Jul 27.
Artículo en Inglés | MEDLINE | ID: mdl-37272534

RESUMEN

BACKGROUND: Pelvic radiation plus sensitizing chemotherapy with a fluoropyrimidine (chemoradiotherapy) before surgery is standard care for locally advanced rectal cancer in North America. Whether neoadjuvant chemotherapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) can be used in lieu of chemoradiotherapy is uncertain. METHODS: We conducted a multicenter, unblinded, noninferiority, randomized trial of neoadjuvant FOLFOX (with chemoradiotherapy given only if the primary tumor decreased in size by <20% or if FOLFOX was discontinued because of side effects) as compared with chemoradiotherapy. Adults with rectal cancer that had been clinically staged as T2 node-positive, T3 node-negative, or T3 node-positive who were candidates for sphincter-sparing surgery were eligible to participate. The primary end point was disease-free survival. Noninferiority would be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed 1.29. Secondary end points included overall survival, local recurrence (in a time-to-event analysis), complete pathological resection, complete response, and toxic effects. RESULTS: From June 2012 through December 2018, a total of 1194 patients underwent randomization and 1128 started treatment; among those who started treatment, 585 were in the FOLFOX group and 543 in the chemoradiotherapy group. At a median follow-up of 58 months, FOLFOX was noninferior to chemoradiotherapy for disease-free survival (hazard ratio for disease recurrence or death, 0.92; 90.2% confidence interval [CI], 0.74 to 1.14; P = 0.005 for noninferiority). Five-year disease-free survival was 80.8% (95% CI, 77.9 to 83.7) in the FOLFOX group and 78.6% (95% CI, 75.4 to 81.8) in the chemoradiotherapy group. The groups were similar with respect to overall survival (hazard ratio for death, 1.04; 95% CI, 0.74 to 1.44) and local recurrence (hazard ratio, 1.18; 95% CI, 0.44 to 3.16). In the FOLFOX group, 53 patients (9.1%) received preoperative chemoradiotherapy and 8 (1.4%) received postoperative chemoradiotherapy. CONCLUSIONS: In patients with locally advanced rectal cancer who were eligible for sphincter-sparing surgery, preoperative FOLFOX was noninferior to preoperative chemoradiotherapy with respect to disease-free survival. (Funded by the National Cancer Institute; PROSPECT ClinicalTrials.gov number, NCT01515787.).


Asunto(s)
Neoplasias del Recto , Adulto , Humanos , Canal Anal/cirugía , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioradioterapia/efectos adversos , Quimioradioterapia/métodos , Quimioterapia Adyuvante , Supervivencia sin Enfermedad , Fluorouracilo/administración & dosificación , Fluorouracilo/efectos adversos , Leucovorina/administración & dosificación , Leucovorina/efectos adversos , Terapia Neoadyuvante , Recurrencia Local de Neoplasia/tratamiento farmacológico , Estadificación de Neoplasias , Tratamientos Conservadores del Órgano , Oxaliplatino/administración & dosificación , Oxaliplatino/efectos adversos , Neoplasias del Recto/mortalidad , Neoplasias del Recto/patología , Neoplasias del Recto/cirugía , Cuidados Preoperatorios , Periodo Preoperatorio
16.
Clin Trials ; 20(5): 559-563, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37050880

RESUMEN

INTRODUCTION: Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning. METHODS: We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients. RESULTS: Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient. CONCLUSION: We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.


Asunto(s)
Oncología Médica , Neoplasias de la Próstata , Humanos , Masculino , Atención a la Salud , Ensayos Clínicos como Asunto
18.
Ann Surg Oncol ; 30(6): 3560-3568, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36943527

RESUMEN

BACKGROUND: The use of the robotic approach is increasing for colorectal cancer operations, but the added cost of the platform has the potential to introduce challenges in its dissemination. We hypothesized that adoption of the robot is introducing new disparities in access to minimally invasive surgery (MIS) for colorectal cancer, especially across patient insurance groups. METHODS: This cross-sectional study analyzed surgical cases of stage I-III colorectal cancer from the National Cancer Database (NCDB) between 2010 and 2019. The primary outcome was surgical approach (robotic, laparoscopic, or the composite "MIS"). The predictor was a patient's primary payor. Potential confounders included sociodemographics, tumor characteristics, and the facility. Hierarchical multivariable models were generated, and sensitivity analyses were performed. RESULTS: For colorectal cancer operations, the MIS approach increased from 39% in 2010 to 73% in 2019, driven predominantly by an increase in the robotic approach from 2 to 24%. For laparoscopy, the size of the disparity between patients with Private insurance and Medicaid shrank from 11% (2010) to 4% (2019), whereas this disparity increased for the robotic approach from 1% (2010) to 5% (2019). On adjusted analysis, patients with Medicaid (odds ratio [OR] 0.86 [CI 0.79-0.95]) and the Uninsured (OR 0.67 [CI 0.56-0.79]) had lower odds of receiving a robotic operation than those with Private insurance in 2019. This disparity remained consistent across five sensitivity analyses. CONCLUSIONS: As the field of colorectal cancer surgery shifts away from laparoscopy and toward robotics, new inequities across patient insurance are emerging. Proactive efforts are needed to ensure all patients benefit from a minimally invasive approach.


Asunto(s)
Neoplasias Colorrectales , Seguro , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Estados Unidos , Humanos , Estudios Transversales , Neoplasias Colorrectales/cirugía , Estudios Retrospectivos
19.
Cancers (Basel) ; 15(6)2023 Mar 10.
Artículo en Inglés | MEDLINE | ID: mdl-36980587

RESUMEN

The identification of transcriptomic and protein biomarkers prognosticating recurrence risk after chemoradiation of localized squamous cell carcinoma of the anus (SCCA) has been limited by a lack of available fresh tissue at initial presentation. We analyzed archival FFPE SCCA specimens from pretreatment biopsies prior to chemoradiation for protein and RNA biomarkers from patients with localized SCCA who recurred (N = 23) and who did not recur (N = 25). Tumor cells and the tumor microenvironment (TME) were analyzed separately to identify biomarkers with significantly different expression between the recurrent and non-recurrent groups. Recurrent patients had higher mean protein expression of FoxP3, MAPK-activation markers (BRAF, p38-MAPK) and PI3K/Akt activation (phospho-Akt) within the tumor regions. The TME was characterized by the higher protein expression of immune checkpoint biomarkers such as PD-1, OX40L and LAG3. For patients with recurrent SCCA, the higher mean protein expression of fibronectin was observed in the tumor and TME compartments. No significant differences in RNA expression were observed. The higher baseline expression of immune checkpoint biomarkers, together with markers of MAPK and PI3K/Akt signaling, are associated with recurrence following chemoradiation for patients with localized SCCA. These data provide a rationale towards the application of immune-based therapeutic strategies to improve curative-intent outcomes beyond conventional therapies for patients with SCCA.

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