scholarly journals Double-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590)

Cancer ◽  
2017 ◽  
Vol 123 (23) ◽  
pp. 4653-4662 ◽  
Author(s):  
Aarti K. Bhatia ◽  
Ju-Whei Lee ◽  
Harlan A. Pinto ◽  
Charlotte D. Jacobs ◽  
Paul J. Limburg ◽  
...  
Keyword(s):  
Cancer Research ◽  
Low Dose ◽  
Eastern Cooperative Oncology Group ◽  
Oncology Group ◽  
Phase 3 ◽  
Double Blind ◽  
Long Term Follow Up ◽  
Second Primaries

Comparison of chlorambucil and prednisone versus cyclophosphamide, vincristine, and prednisone as initial treatment for chronic lymphocytic leukemia: long-term follow-up of an Eastern Cooperative Oncology Group randomized clinical trial.

1991 ◽  
Vol 9 (5) ◽  
pp. 770-776 ◽  
Author(s):  
B Raphael ◽  
J W Andersen ◽  
R Silber ◽  
M Oken ◽  
D Moore ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Eastern Cooperative Oncology Group ◽  
Lymphocytic Leukemia ◽  
Prolonged Treatment ◽  
Maximal Response ◽  
Oncology Group ◽  
Duration Of Response ◽  
Long Term Follow Up

The Eastern Cooperative Oncology Group (ECOG) conducted a study in which patients with advanced chronic lymphocytic leukemia (CLL) were randomized between a regimen consisting of chlorambucil (30 mg/m2 orally day 1) and prednisone (80 mg orally days 1 to 5) (C + P) administered every 2 weeks and a more intensive regimen of cyclosphosphamide (300 mg/m2 orally days 1 to 5), vincristine (1.4 mg/m2 intravenously [IV] day 1), and prednisone (100 mg/m2 orally days 1 to 5) (CVP) given every 3 weeks. Treatment was continued for up to 18 months to maximal response. Of the 122 eligible patients, 60 received C + P, while 62 received CVP. With a median follow-up of 7 years, there were no significant differences in survival (4.8 v 3.9 years, P = .12), complete remission (CR) rate (25% v 23%; P = .83), or duration of response (2.0 v 1.9 years; P = .78) between C + P and CVP. Toxicity was modest despite the prolonged treatment. The long median survival of 4.1 years for stage III and IV patients is superior to that usually reported. This could stem from continuing treatment to maximal response rather than an increase in intensity of therapy. These results are comparable to those reported with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy by other investigators. The data suggest that intermittent C + P administered to maximal response continues to be the standard treatment approach for advanced CLL.

scholarly journals Improvements in Submental Contour Up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials

2021 ◽  
Author(s):  
Shannon Humphrey ◽  
Joel L Cohen ◽  
Ashish C Bhatia ◽  
Lawrence J Green ◽  
Jeremy B Green ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Psychological Impact ◽  
Group Versus ◽  
Phase 3 ◽  
Double Blind ◽  
Patient Reported ◽  
Long Term Follow Up

Abstract Background ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week phase 3 studies (REFINE-1 and REFINE-2). Objectives To evaluate durability of effect and long-term safety of ATX-101. Methods REFINE study patients with maintenance of ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). Primary endpoint was CR-1 response at years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored. Results 224 patients (ATX-101, n=113; placebo, n=111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group versus placebo at year 1 (86.4%, 56.8%; P<.001), year 2 (90.6%, 73.8%; P=.014), and year 3 (82.4%, 65.0%; P=.03). Most (74%) ATX-101‒treated patients satisfied at 12 weeks remained satisfied at year 3. Significant reductions from baseline in psychological impact scores were sustained through year 3 (P<.001). No new treatment-related adverse events were reported. Conclusions Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged.

Long‐Term Follow‐Up of Patients with Nodular Lymphocyte Predominant Hodgkin Lymphoma: A Report from the Spanish Lymphoma Oncology Group

2020 ◽  
Author(s):  
Beatriz Núñez García ◽  
Marta Rodríguez‐Pertierra ◽  
Silvia Sequero ◽  
Laura Gálvez Carvajal ◽  
Alberto Ruano‐Ravina ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Oncology Group ◽  
Long Term Follow Up
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