Although geriatric assessment-driven intervention improves patient-centered outcomes, its influence on chemotherapy-related toxic effects remains unknown.OBJECTIVE To assess whether specific geriatric assessment-driven intervention (GAIN) can reduce chemotherapy-related toxic effects in older adults with cancer. DESIGN, SETTING, AND PARTICIPANTSA randomized clinical trial enrolled 613 participants from a National Cancer Institute-designated cancer center between 2015 and 2019. Patients were 65 years and older with a solid malignant neoplasm, were starting a new chemotherapy regimen, and completed a geriatric assessment. Patients were followed up until chemotherapy completion or 6 months after initiation, whichever occurred first. Data analysis was done by intention-to-treat principle.INTERVENTIONS Patients were randomized (2:1) to either the GAIN (intervention) or standard of care (SOC) arm. In the GAIN arm, a geriatrics-trained multidisciplinary team composed of an oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist reviewed geriatric assessment results and implemented interventions based on prespecified thresholds built into the geriatric assessment's domains. In the SOC arm, geriatric assessment results were sent to treating oncologists for consideration. MAIN OUTCOMES AND MEASURESThe primary outcome was incidence of grade 3 or higher chemotherapy-related toxic effects (graded using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0). Secondary outcomes included advance directive completion, emergency department visits, unplanned hospitalizations, average length of stay, unplanned hospital readmissions, chemotherapy dose modifications, and early discontinuation. Overall survival analysis was performed up to 12 months after chemotherapy initiation. RESULTS Among the 605 eligible participants for analysis, median (range) age was 71 (65-91) years, 357 (59.0%) were women, and 432 (71.4%) had stage IV disease. Cancer types included gastrointestinal (202 [33.4%]), breast (136 [22.5%]), lung (97 [16.0%]), genitourinary (91 [15.0%]), gynecologic (54 [8.9%]), and other (25 [4.1%]). Incidence of grade 3 or higher chemotherapy-related toxic effects was 50.5% (95% CI, 45.6% to 55.4%) in the GAIN arm and 60.6% (95% CI, 53.9% to 67.3%) in the SOC arm, resulting in a significant 10.1% reduction (95% CI, −1.5 to −18.2%; P = .02). A significant absolute increase in advance directive completion of 28.4% with GAIN vs 13.3% with SOC (P < .001) was observed. No significant differences were observed in emergency department visits, unplanned hospitalizations, average length of stay, unplanned readmissions, chemotherapy dose modifications or discontinuations, or overall survival. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, integration of multidisciplinary GAIN significantly reduced grade 3 or higher chemotherapy-related toxic effects in older adults with cancer. Implementation of GAIN into oncology clinical practice should be con...
12010 Background: Geriatric assessment (GA) can predict chemotherapy (chemo) toxicity in older adults (age ≥65) with cancer. However, evidence regarding the effect of GA-driven intervention (GAIN) on the incidence of chemo toxicity has been limited. Therefore, we conducted a randomized controlled trial evaluating the impact of GAIN vs. standard of care (SOC) on chemo toxicity in older adults with cancer. Methods: Patients (pts) age ≥65, diagnosed with a solid malignancy, and starting a new chemo regimen at City of Hope were eligible (NCT02517034). In a 2:1 ratio, 600 pts were randomly assigned to either GAIN (n = 398) or SOC (n = 202) arms. All pts completed a baseline GA prior to chemo. In the GAIN arm, a multidisciplinary team led by a geriatric oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist, reviewed GA results and implemented interventions based on predefined triggers built into the GA’s various domains. In the SOC arm, GA results were sent to treating oncologists to use at their discretion. Pts were followed until either end of chemo or 6 months after start of chemo, whichever occurred first. The primary endpoint was incidence of grade 3-5 chemo-related toxicity (NCI CTCAE v.4.0). Secondary endpoints included advance directive (AD) completion, emergency room (ER) visits, hospitalizations, and average length of stay (ALOS). Chi-square and Fisher’s exact tests were used to compare the categorical outcomes, and Kruskal-Wallis test was used to compare the ALOS between arms. Results: Pt characteristics were balanced between arms. Median age was 71 (range 65-91). Cancer types included: 33% gastrointestinal, 23% breast, 16% lung, 15% genitourinary, and 13% other. Most (71%) had stage IV disease. The incidence of grade 3-5 chemo-related toxicity was 50.5% (95% CI: 45.6-55.4%) in the GAIN arm and 60.4% (95% CI: 53.7-67.1%) in the SOC arm (p = 0.02). Compared to SOC, the GAIN arm had a reduction of 9.9% (95% CI: 1.6-18.2%) in chemo-related toxicity. At the end of study, AD completion increased 24.1% in the GAIN arm vs. 10.4% in the SOC arm (p < 0.001). No significant differences in ER visits (27.4% vs. 30.7%), hospitalizations (22.1% vs. 19.3%), or ALOS (median 4.8 vs. 5.0 days) were observed between the GAIN and SOC arms, respectively. Conclusions: Integration of multidisciplinary GA-driven interventions reduced grade 3-5 chemo-related toxicity and improved AD completion in older adults with cancer. GA-driven interventions should be included as a part of cancer care for all older adults. Clinical trial information: NCT02517034 .
Objectives Rathke cleft cysts (RCCs) are rare, benign lesions formed from remnants of Rathke pouch during embryologic development. However, following marsupialization, maintaining tract patency remains a challenge. Several techniques for decreasing stenosis have been described, including free mucosal grafting, silastic spacing, and using steroid‐eluting stents. Nasoseptal flaps (NSFs) have a reliable vascular supply and are widely utilized in skull base reconstruction. We present a novel technique to maintain patency of the marsupialized RCC cavity by lining it with an NSF to promote long‐term drainage and re‐epithelialization of the RCC cavity. Methods Retrospective chart review of all patients who underwent surgery for symptomatic RCCs. These patients underwent endoscopic endonasal surgery between February 3, 2016, and June 12, 2018, with marsupialization followed by circumferential NSF lining. Primary outcomes include symptomatic control, surgical complications, and RCC cavity patency. Results Seven patients underwent RCC marsupialization with no intraoperative cerebrospinal fluid leak, followed by circumferential lining of the marsupialized cavity with an NSF. In each case, no cyst re‐accumulation or recurrent symptoms were noted, and the NSF lining provided long‐term patency of the tract in all cases to a mean of 6.7 ± 10.1 months of follow‐up, including one patient with sustained patency at 29 months follow‐up. Conclusion Utilization of the NSF to “stent open” the RCC cavity following marsupialization is a safe and effective means to prevent restenosis. Advantages include sustained patency of RCC cavity for complete drainage and a dependable vascular supply. Level of Evidence 4 Laryngoscope, 129:2258–2261, 2019
Objective Inverted papilloma (IP) is the most common benign neoplasm of the nasal cavity with known risk of recurrence. There is no standardized approach to definitive treatment for attachment sites. This systematic review aims to determine whether surgeon choice of technique differs by anatomic attachment site and whether different surgical techniques contribute to reduced rates of recurrence. Data Sources PubMed and Ovid Medline. Review Methods A systematic review was conducted for studies reporting on IP. Those that included IP recurrence rates and primary tumor attachment site were reviewed. Results Of 122 published studies, 14 met eligibility criteria, representing 585 patients and a recurrence rate of 5.8%. The maxillary sinus (50.9%) was the most common primary attachment site, and the sphenoid sinus was associated with the highest rate of recurrence (10.4%). The most utilized technique included debulking the tumor, removing mucosa over the attachment site, and drilling the underlying bone. The most common Krouse stage represented was T3 (53.3%). No single technique predicted a propensity for recurrence, but certain techniques are favored depending on IP attachment site. Finally, frozen sections to obtain evidence of clear margins intraoperatively significantly reduced rates of recurrence (3.4% vs 7.3%, P = .045). Conclusion Based on the current literature, the most common technique to address site of attachment involves resecting mucosa and drilling the tumor base. Choice of technique appears to differ for various sites of attachment. Use of intraoperative frozen section analysis appears to be associated with decreased recurrence overall. Level of Evidence 3.
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