Cancer Treatment Centers of America (CTCA), headquartered in Boca Raton, Florida, is a national, for-profit network of five comprehensive cancer care and research centers and three out patient care centers that serves cancer patients throughout the United States. CTCA was originally headquartered in Schaumburg, Illinois. In January 2015, the corporate office was moved to Boca Raton, Florida, and was renamed Cancer Treatment Centers of America Global, Inc.
PURPOSE:Enfortumab vedotin (EV), a novel antibody-drug conjugate directed against Nectin-4, was explored in patients with non-small cell lung cancer (NSCLC) in cohorts 3 and 4 of the open-label, multicohort, Phase 2 EV-202 study (NCT04225117). METHODS:Patients with squamous and non-squamous NSCLC previously treated with platinum and PD-1/L1 inhibitors received EV 1.25 mg/kg intravenously on days 1, 8, and 15 of 28-day cycles. A Bayesian optimal design for Phase 2 was used, with interim analysis (IA) conducted when 20 patients were response-evaluable by investigator assessment. Primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included duration of response, disease control rate, progression-free survival (PFS), overall survival (OS), and safety. Of 40 patients, ≥ 7 and ≥ 10 responders were needed at final analysis to claim promising antitumor activity in squamous and non-squamous cohorts, respectively. RESULTS:Sixty-six patients were enrolled: 23 in squamous, 43 in the non-squamous cohort. One patient in the squamous cohort achieved a response at IA; thus, enrollment was closed. In the non-squamous cohort, 6 patients achieved partial response (ORR [95 % CI], 14.0 % [5.3-27.9 %]) at final analysis; median (95 % CI) PFS and OS were 4.1 (2.8-5.7) and 10.5 (8.1-13.1) months, respectively. Most common treatment-related adverse events (≥30 % patients) in the non-squamous cohort were rash maculopapular and peripheral sensory neuropathy (37.2 % each); pruritus (34.9 %); and alopecia (32.6 %). CONCLUSIONS:Although the predefined efficacy thresholds were not met in either cohort, the antitumor activity of EV in non-squamous NSCLC may support the option for further investigation in this population.
Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) has been well utilized in treating malignant gastric outlet obstructions (GOO) given its efficacy and lower risk profile compared to surgery. However, its efficacy and potential for use in patients with benign GOO who are poor surgical candidates is not well documented. The aim of this study was to examine the role of EUS-GJ in treatment of benign GOO in select patients. This is a single-center, open-label, retrospective descriptive study that included all consecutive patients undergoing EUS-GJ to treat benign causes of GOO. Direct antegrade and direct retrograde methods were utilized. A total of 18 patients were included, 38.9
The present pilot research examined Restore: The Journey to Self-Forgiveness—an online self-forgiveness curriculum—to evaluate its effectiveness in improving levels of self-forgiveness, related positive psychological traits/states, and mental health. Study 1 (N = 66) was a single-group and Study 2 (N = 34) was a two-group design. Pre- and postmeasures included self-forgiveness, self-blame, self-compassion, negative and positive affect, benefit finding, psychological distress, optimism, pessimism, hope, and gratitude. Results suggest that the online self-forgiveness curriculum was effective in promoting self-forgiveness, related positive psychological traits/states, and mental health. Future studies using larger, more diverse, and randomized samples should be pursued.
546 Background: TAPUR is a phase II basket study evaluating antitumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of pts with BTC with ERBB2/3 amp, oe, or mut treated with P+T are reported. Methods: Eligible pts had advanced BTC, no standard treatment (tx) options, measurable disease, ECOG Performance Status (PS) 0-2, and adequate organ function. Genomic testing was done in CLIA-certified, CAP-accredited labs. Dosing of P was 840 mg IV over 60 minutes (m), then 420 mg IV over 30-60 m Q3 weeks (wks); T was 8 mg/kg IV over 90 m, then 6 mg/kg IV over 30-60 m Q3 wks until disease progression. Primary end point was disease control (DC), defined as complete (CR) or partial (PR) response per RECIST v. 1.1, or stable disease (SD) at 16+ wks (SD16+). Simon 2-stage design tested the null DC rate of 15% vs. 35% (power = 0.85; α = 0.10). If ≥2 of 10 pts in stage 1 has DC, 18 more pts are enrolled; otherwise, cohort is closed for futility. If ≥7 of 28 pts has DC, the null DC rate is rejected. Secondary end points were progression-free survival (PFS), overall survival (OS), duration of response (DOR), duration of SD and safety. DOR is defined as time from pt’s first documented objective response (OR) to progressive disease (PD). Duration of SD is defined as time from start of tx to PD. Results: 29 pts with BTC (15 gallbladder (GB), 11 biliary duct (BD), 3 ampulla of Vater) and ERBB2/3 amp, oe, or mut were enrolled from Feb 2017 to Jan 2022. Median (med) age was 66 years (yrs) (range, 34-83 yrs). 66% of pts were female; 52% were White, 21% were Black/African American, 10% were Asian/Asian American; 83% were not Hispanic or Latino. 83% of pts had ECOG PS 0-1 and 48% had ≥3 prior systemic regimens. 1 pt was not evaluable and excluded from efficacy analysis. The table shows efficacy outcomes. 1 pt had CR (GB; ERBB2 amp; DOR: 71.1 wks), 8 pts had PR (6 GB/2 BD; 5 ERBB2 amp; 2 ERBB2 mut; 1 ERBB3 mut/ ERBB2 amp; med DOR: 30.4 wks (4.4 to 68.9 wks)) and 2 pts had SD16+. 4 pts with a KRAS mut did not achieve OR or SD16+. 4 pts had a Grade 3 drug-related adverse or serious adverse event (SAE): anemia, diarrhea, infusion related reaction (SAE), and fatigue. Conclusions: P+T demonstrated antitumor activity in pts with advanced BTC with ERBB2/3 alterations. These data, along with results previously reported by other studies, support continued study of P+T in pts with ERBB2 amplified BTC tumors. Clinical trial information: NCT02693535 . [Table: see text]
The management of primary liver cancer, comprised of hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (IHC), has evolved over time and entails a multidisciplinary approach.While surgical resection, orthotopic liver transplantation (OLT), and ablation remain the mainstay of curative therapy for carefully selected individuals, additional treatments include the use of systemic chemotherapy, immunotherapy, and liver-directed therapies, including ablation, embolization, and radiation.Determining when each of these modalities should be utilized involves a collaborative approach among several disciplines to ensure optimal patient outcomes.Recently, advances in external beam radiation technology has led to renewed interest in its utilization for primary liver cancers.The Society of Surgical Oncology (SSO) joined the American Society of Clinical Oncology (ASCO), and the American Society of Transplant Surgeons (ASTS) in the provision of a process led by the American Society of Radiation Oncology (ASTRO) to collaborate with ASTRO, to create a guideline on the utilization of external beam radiation therapy (EBRT) for primary liver cancers.Recommendations TREATMENT PRINCIPLES OF PRIMARY LIVER CANCERAll primary liver cancers should undergo a diagnostic and staging work-up based on National
