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JAMA Oncology Sep 2017The data reported herein were accepted for assessment by the US Food and Drug Administration for Biologics License Application under priority review to establish the...
IMPORTANCE
The data reported herein were accepted for assessment by the US Food and Drug Administration for Biologics License Application under priority review to establish the clinical benefit of durvalumab as second-line therapy for locally advanced or metastatic urothelial carcinoma (UC), resulting in its recent US approval.
OBJECTIVE
To report a planned update of the safety and efficacy of durvalumab in patients with locally advanced/metastatic UC.
DESIGN, SETTING, AND PARTICIPANTS
This is an ongoing phase 1/2 open-label study of 191 adult patients with histologically or cytologically confirmed locally advanced/metastatic UC whose disease had progressed on, were ineligible for, or refused prior chemotherapy from 60 sites in 9 countries as reported herein.
INTERVENTION
Patients were administered durvalumab intravenous infusion, 10 mg/kg every 2 weeks, for up to 12 months or until progression, starting another anticancer therapy, or unacceptable toxic effects.
MAIN OUTCOMES AND MEASURES
Primary end points were safety and confirmed objective response rate (ORR) per blinded independent central review (Response Evaluation Criteria In Solid Tumors [RECIST], version 1.1).
RESULTS
A total of 191 patients with UC had received treatment. As of October 24, 2016 (90-day update), the median follow-up was 5.78 months (range, 0.4-25.9 months). The median age of patients was 67.0 years and most were male (136 [71.2%]) and white (123 [71.1%]). All patients had stage 4 disease, and 190 (99.5%) had prior anticancer therapy (182 [95.3%] postplatinum). The ORR was 17.8% (34 of 191; 95% CI, 12.7%-24.0%), including 7 complete responses. Responses were early (median time to response, 1.41 months), durable (median duration of response not reached), and observed regardless of programmed cell death ligand-1 (PD-L1) expression (ORR, 27.6% [n = 27; 95% CI, 19.0%-37.5%] and 5.1% [n = 4; 95% CI, 1.4%-12.5%] in patients with high and low or negative expression of PD-L1, respectively). Median progression-free survival and overall survival were 1.5 months (95% CI, 1.4-1.9 months) and 18.2 months (95% CI, 8.1 months to not estimable), respectively; the 1-year overall survival rate was 55% (95% CI, 44%-65%), as estimated by Kaplan-Meier method. Grade 3/4 treatment-related adverse events (AEs) occurred in 13 patients (6.8%); grade 3/4 immune-mediated AEs occurred in 4 patients (2.1%); and treatment-related AEs led to discontinuation of 3 patients (1.6%), 2 of whom had immune-mediated AEs that led to death (autoimmune hepatitis and pneumonitis).
CONCLUSIONS AND RELEVANCE
Durvalumab, 10 mg/kg every 2 weeks, demonstrates favorable clinical activity and an encouraging and manageable safety profile in patients with locally advanced/metastatic UC.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT01693562.
Topics: Abdominal Neoplasms; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antineoplastic Agents; B7-H1 Antigen; Carcinoma, Transitional Cell; Disease-Free Survival; Female; Follow-Up Studies; Humans; Liver Neoplasms; Male; Middle Aged; Neoplasm Staging; Response Evaluation Criteria in Solid Tumors; Retreatment; Survival Rate
PubMed: 28817753
DOI: 10.1001/jamaoncol.2017.2411 -
Medicine Dec 2017Leiomyomas arising from the anterolateral abdominal wall are uncommon, and their pathogenesis remains unknown. We present the 15th case of such a tumor, having this... (Review)
Review
RATIONALE
Leiomyomas arising from the anterolateral abdominal wall are uncommon, and their pathogenesis remains unknown. We present the 15th case of such a tumor, having this unique tumor morphology, followed by a detailed discussion on disease pathogenesis.
PATIENT CONCERNS
A 48-year-old, asymptomatic perimenopausal, multiparous Japanese woman presented with a left-sided pelvic mass. She had no history of previous surgeries or uterine leiomyomas. Although a transabdominal ultrasonogram raised suspicions of an ovarian tumor, a transvaginal ultrasonogram confirmed normal ovaries. Radiological images showed a multilocular cystic mass with enhanced solid lesions connected to the uterus. Retrospective radiological evaluation showed that the mass was largely connected to the peritoneum of the anterolateral abdominal wall.
INTERVENTIONS
Intraoperatively, the mass appeared as a dome-like protrusion from the left lower quadrant of the abdominal wall, without connection to the uterus, ovaries, or the left round ligament. No other peritoneal masses were seen. The mass was easily enucleated from the abdominal wall. Pathology confirmed that the mass was a leiomyoma with hydropic and myxoid degeneration. No striated muscle tissues were noted between the tumor and resection margin, but a thin smooth muscle layer, positive for hormone receptors, was present at the periphery, suggesting the origin of the tumor.
LESSONS
Benign leiomyomas of the anterolateral abdominal wall likely originate from Müllerian-like smooth muscle remnants in this region. They should be considered in the differential diagnosis of solid and cystic masses and be distinguished from uterine and ovarian masses on imaging to avoid unnecessary organ resection.
Topics: Abdominal Neoplasms; Abdominal Wall; Diagnosis, Differential; Female; Humans; Leiomyoma; Middle Aged
PubMed: 29310403
DOI: 10.1097/MD.0000000000008971 -
Ultrasound in Obstetrics & Gynecology :... Dec 2010To analyze the safety, adequacy and accuracy of tru-cut biopsy and to evaluate factors potentially affecting adequacy.
OBJECTIVE
To analyze the safety, adequacy and accuracy of tru-cut biopsy and to evaluate factors potentially affecting adequacy.
METHODS
We analyzed retrospectively a group of patients who had undergone tru-cut biopsy for either primary suboptimally operable tumors, recurrence or suspected non-genital or secondary tumor. Tru-cut biopsy was performed either transvaginally or transabdominally, using an automatic biopsy gun with disposable needle and needle guide attached to the probe. The adequacy, i.e. obtaining a sample sufficient for identification of the origin of the tumor and performance of immunohistochemistry; accuracy, i.e. agreement between biopsy and final postoperative histology; and safety, as determined by complication rate, were assessed. Variables potentially influencing adequacy were analyzed using the orthogonal projections to latent structure method.
RESULTS
A total of 195 biopsies were performed on 190 patients. An adequate sample was obtained in 178 (91.3%) biopsies. The final histology was not in agreement with the result from tru-cut biopsy in two out of 118 patients who underwent subsequent surgery (accuracy 98.3%). There were complications in two cases out of the 195 biopsies performed (1.0%). Ascites, elevated CA 125, primary suboptimal operable tumor, serous epithelial ovarian cancer histology, carcinomatosis and vaginal approach were significant positive predictors for the achievement of an adequate sample, while recurrence as an indication, non-serous and non-ovarian histotypes and transabdominal approach were negative predictors.
CONCLUSION
Ultrasound-guided tru-cut biopsy is an efficient, minimally invasive, accurate and safe diagnostic method in the management of advanced, recurrent or atypical abdominal and pelvic tumors of probable non-genital origin, where unnecessary laparotomy or laparoscopy can be avoided. The adequacy of tru-cut biopsy is mainly influenced by indication group, histology, site of biopsy and approach. Our analysis can help in counseling the patient before the procedure and helps to explain the possible causes of failure of the procedure.
Topics: Abdominal Neoplasms; Adult; Aged; Aged, 80 and over; Biopsy; Female; Gynecology; Humans; Immunohistochemistry; Middle Aged; Pelvic Neoplasms; Retrospective Studies; Ultrasonography, Interventional; Young Adult
PubMed: 20737454
DOI: 10.1002/uog.8803 -
Fertility and Sterility Oct 2008To report a case of clear cell carcinoma in abdominal wall endometriosis after cesarean section. (Review)
Review
OBJECTIVE
To report a case of clear cell carcinoma in abdominal wall endometriosis after cesarean section.
DESIGN
Case report.
SETTING
A French oncology center.
PATIENT(S)
A 38-year-old woman who developed a 10-cm mass in the abdominal wall muscles, 13 years after a cesarean section.
INTERVENTION(S)
Abdominal wall resection and chemotherapy.
MAIN OUTCOME MEASURE(S)
Clinical outcome.
RESULT(S)
The diagnosis of clear cell carcinoma in abdominal wall endometriosis was confirmed, and wide surgical excision with abdominal wall reconstruction was performed after three courses of chemotherapy.
CONCLUSION(S)
The malignant transformation of abdominal wall endometrioma has not been clearly elucidated, owing to its rarity. However, the eventuality should always be considered, and the prognosis improved through wide surgical excision.
Topics: Abdominal Neoplasms; Abdominal Wall; Adult; Cell Transformation, Neoplastic; Endometriosis; Female; Humans; Sarcoma, Clear Cell
PubMed: 18082734
DOI: 10.1016/j.fertnstert.2007.08.080 -
Anesthesiology Jan 2015
Topics: Abdominal Neoplasms; Erythrocyte Transfusion; Female; Humans; Male
PubMed: 25405396
DOI: 10.1097/ALN.0000000000000518 -
Asian Pacific Journal of Cancer... 2014To investigate the differential features of CT images in children with neuroblastomas (N) and ganglioneuroblastomas (G).
OBJECTIVE
To investigate the differential features of CT images in children with neuroblastomas (N) and ganglioneuroblastomas (G).
MATERIALS AND METHODS
Clinical data of 12 children in group G and 15 in group N undergoing CT examination and definitely diagnosed by pathology were retrospectively analyzed. The focal conditions were observed and compared in the two groups, including location, size, boundaries, morphology, enhanced degree and mode, abdominal vascular involvement, presence or absence of spanning the midline, infiltration of peripheral organs, angiography manifestations in tumors or surroundings, presence or absence of calcification and vascular tumor emboli as well as metastases of distal organs and lymph nodes.
RESULTS
In group N, the incidence of tumors in the adrenal area was conspicuously higher than in group G (P<0.05), while that of tumors with regular morphology and clear boundaries was significantly lower than in group G (P<0.01); Angiography manifestation rate and incidences of vascular embedding, lymph node metastasis, infiltration and organic metastasis in group N were all markedly higher than in group G (P<0.05). There was no statistical significance between the two groups in terms of focal size, presence or absence of calcification and spanning the midline, and enhanced degree and mode, as well as vascular tumor emboli (P>0.05).
CONCLUSIONS
Mostly located in adrenal areas and with vascular embedding as a primary manifestation, the neuroblastoma extremely readily metastases to lymph nodes and other organs as well as infiltrating local tissues, with dilation on angiography frequent in or around the tumors. With vascular displacement as a primary manifestation, ganglioneuroblastoma has a regular morphology and clear boundaries.
Topics: Abdominal Neoplasms; Child; Child, Preschool; Cohort Studies; Diagnosis, Differential; Female; Ganglioneuroblastoma; Humans; Infant; Lymph Nodes; Male; Neoplasm Staging; Neuroblastoma; Retrospective Studies; Tomography, X-Ray Computed; Tumor Burden
PubMed: 25556501
DOI: 10.7314/apjcp.2014.15.23.10509 -
Journal of Cancer Research and... Jan 2023Sister Mary Joseph's nodule is an umbilical nodule found in patients with metastatic abdominal cancers. It is quite rare finding and needs a high index of suspicion for...
Sister Mary Joseph's nodule is an umbilical nodule found in patients with metastatic abdominal cancers. It is quite rare finding and needs a high index of suspicion for diagnosis. Detection of Sister Mary Joseph's nodule should warrant widespread search for abdominal carcinoma and it universally carries quite poor clinical prognosis. Here, we describe the case of a 28-year-old patient who presented with Sister Mary Joseph's Nodule and was found to have metastatic signet ring cell gastric carcinoma on investigation. A brief discussion about this rare condition is also presented.
Topics: Humans; Adult; Sister Mary Joseph's Nodule; Umbilicus; Abdominal Neoplasms; Carcinoma, Signet Ring Cell; Stomach Neoplasms
PubMed: 38384087
DOI: 10.4103/jcrt.jcrt_928_22 -
Sao Paulo Medical Journal = Revista... 2018Malignant transformation of endometriosis in the abdominal wall is a rare and still poorly understood event. Less than 30 cases have been reported in the worldwide...
BACKGROUND
Malignant transformation of endometriosis in the abdominal wall is a rare and still poorly understood event. Less than 30 cases have been reported in the worldwide literature. Most cases of solid tumors are report in a previous abdominal scar with malignant transformation of a focus of endometriosis. Presence of lymph node metastases in nearby chains is frequent and is associated with poor prognosis.
CASE REPORT
We report a case of a 42-year-old woman with a history of abdominal surgery (Pfannenstiel) to resect abdominal wall endometriosis. Physical examination revealed a solid mass of approximately 10 cm x 6 cm in the anterior wall of the abdomen. Computed tomography (CT) of the abdomen and pelvis showed a heterogeneous, predominantly hypoattenuating expansive formation measuring 10.6 cm x 4.7 cm x 8.3 cm. The patient underwent exploratory incisional laparotomy, block resection of the abdominal mass and lymphadenectomy of the external and inguinal iliac chains. The abdominal wall was reconstructed using a semi-absorbable tissue-separating screen to reconstitute the defect caused by resection of the tumor. Histological evaluation revealed infiltration by malignant epithelioid neoplasia, thus confirming the immunohistochemical profile of adenocarcinoma with clear cell components. Lymphadenectomy showed metastatic involvement of an external iliac chain lymph node.
CONCLUSION
Resection of the mass along with the abdominal wall, with wall margins, is the most effective treatment. Reconstruction is a challenge for surgeons. The patient has been followed up postoperatively for eight months, without any evidence of disease to date.
Topics: Abdominal Neoplasms; Abdominal Wall; Adenocarcinoma, Clear Cell; Adult; Cell Transformation, Neoplastic; Endometriosis; Female; Humans; Lymph Node Excision; Lymphatic Metastasis; Neoadjuvant Therapy; Tomography, X-Ray Computed
PubMed: 29116312
DOI: 10.1590/1516-3180.2017.0103300417 -
Annals of Surgery Feb 1994The aims of this study were to analyze the natural history of patients with pseudomyxoma peritonei (PMP), evaluate clinical and pathologic variables as prognostic...
OBJECTIVE
The aims of this study were to analyze the natural history of patients with pseudomyxoma peritonei (PMP), evaluate clinical and pathologic variables as prognostic indicators, and review the authors' experience with different treatments.
SUMMARY BACKGROUND DATA
PMP is an unusual form of intra-abdominal neoplasm that presents with large amounts of extracellular mucin. Diffuse peritoneal spread occurs in most patients with PMP, and distant metastasis is infrequent. Debulking surgery, radiation therapy (radioisotope and external beam), and chemotherapy (both intraperitoneal and systemic) have all been advocated for optional patient management, but the variability of patients studied, the small patient numbers, and the prolonged course of this disease make the evaluation of results difficult.
METHODS
Fifty-six patients were treated for PMP at the Mayo Clinic between 1957 and 1983. The data were collected retrospectively. Univariate (log-rank test) and multivariate (Cox regression model) analyses were performed for disease recurrence and patient survival.
RESULTS
Most patients with PMP had carcinomas of the appendix (52%) or ovary (34%). All gross tumor could be removed only in the 34% of patients with limited disease. Although tumor progression occurred in 76% of patients, the 1-, 5-, and 10-year survival rates were 98%, 53%, and 32%, respectively. Adverse predictors of patient survival included weight loss (p = 0.001), abdominal distention (p = 0.004), use of systemic chemotherapy (p = 0.005), diffuse disease (p = 0.038), and invasion of other organs (p = 0.04). Intraperitoneal chemotherapy (p = 0.009) and radioisotopes (p = 0.0043) both were effective in prolonging the recurrence time of symptomatic PMP.
CONCLUSIONS
Although PMP is an indolent disease, aggressive surgical debulking followed by intraperitoneal radioisotopes and/or chemotherapy should be considered because of the diffuse peritoneal involvement.
Topics: Adolescent; Adult; Aged; Combined Modality Therapy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Multivariate Analysis; Neoplasm Recurrence, Local; Peritoneal Neoplasms; Ploidies; Prognosis; Pseudomyxoma Peritonei; Reoperation; Retrospective Studies; Survival Rate
PubMed: 8129481
DOI: 10.1097/00000658-199402000-00002 -
Journal of Applied Clinical Medical... Jun 2024We evaluate the performance of a deformable image registration (DIR) software package in registering abdominal magnetic resonance images (MRIs) and then develop a...
PURPOSE
We evaluate the performance of a deformable image registration (DIR) software package in registering abdominal magnetic resonance images (MRIs) and then develop a mechanical modeling method to mitigate detected DIR uncertainties.
MATERIALS AND METHODS
Three evaluation metrics, namely mean displacement to agreement (MDA), DICE similarity coefficient (DSC), and standard deviation of Jacobian determinants (STD-JD), are used to assess the multi-modality (MM), contour-consistency (CC), and image-intensity (II)-based DIR algorithms in the MIM software package, as well as an in-house developed, contour matching-based finite element method (CM-FEM). Furthermore, we develop a hybrid FEM registration technique to modify the displacement vector field of each MIM registration. The MIM and FEM registrations were evaluated on MRIs obtained from 10 abdominal cancer patients. One-tailed Wilcoxon-Mann-Whitney (WMW) tests were conducted to compare the MIM registrations with their FEM modifications.
RESULTS
For the registrations performed with the MIM-CC, MIM-MM, MIM-II, and CM-FEM algorithms, their average MDAs are 0.62 ± 0.27, 2.39 ± 1.30, 3.07 ± 2.42, 1.04 ± 0.72 mm, and average DSCs are 0.94 ± 0.03, 0.80 ± 0.12, 0.77 ± 0.15, 0.90 ± 0.11, respectively. The p-values of the WMW tests between the MIM registrations and their FEM modifications are less than 0.0084 for STD-JDs and greater than 0.87 for MDA and DSC.
CONCLUSIONS
Among the three MIM DIR algorithms, MIM-CC shows the smallest errors in terms of MDA and DSC but exhibits significant Jacobian uncertainties in the interior regions of abdominal organs. The hybrid FEM technique effectively mitigates the Jacobian uncertainties in these regions.
Topics: Humans; Magnetic Resonance Imaging; Algorithms; Image Processing, Computer-Assisted; Radiotherapy, Image-Guided; Radiotherapy Planning, Computer-Assisted; Radiotherapy Dosage; Radiotherapy, Intensity-Modulated; Software; Uncertainty; Abdominal Neoplasms
PubMed: 38634799
DOI: 10.1002/acm2.14358