scholarly journals Prospective Observational Study of Imatinib Therapy in Japanese Patients with Advanced Gastrointestinal Stromal Tumors: Long-term Follow-up and Second Malignancy

2012 ◽  
Vol 42 (7) ◽  
pp. 578-585 ◽  
Author(s):  
Tatsuo Kanda ◽  
Takashi Ishikawa ◽  
Seiichi Hirota ◽  
Kazuhito Yajima ◽  
Shin-ichi Kosugi ◽  
...  
Keyword(s):  
Observational Study ◽  
Gastrointestinal Stromal Tumors ◽  
Prospective Observational Study ◽  
Japanese Patients ◽  
Imatinib Therapy ◽  
Long Term Results ◽  
Second Malignancies ◽  
Stromal Tumors

Abstract Objective Limited data are available concerning long-term results of imatinib therapy in patients with advanced gastrointestinal stromal tumors. We aimed to clarify the long-term outcomes of imatinib therapy in Japanese patients with advanced gastrointestinal stromal tumors. Methods A prospective, observational study of imatinib therapy for unresectable and metastatic gastrointestinal stromal tumors was conducted in our institution. Imatinib was initiated at a dose of 400 mg daily and continued until disease progression. Safety, efficacy and long-term tolerability and survival were evaluated in an intent-to-treat population. The median follow-up period in this study was 68 months. Results Seventy patients were enrolled between December 2001 and December 2009. Treatment-related Grade 3/4 adverse events occurred in 49 patients (70.0%). Although 14 patients required adverse effect management with hospitalization, only 5 patients (7.1%) withdrew from the treatment owing to imatinib intolerance. The tumor response and clinical benefit rates were 61.4 and 85.7%, respectively. Thirty-seven patients (52.9%) maintained the treatment at 400 mg daily imatinib, whereas 33 patients (47.1%) had their dose reduced to 300 mg daily or less. The overall survival rate at 5 years was 60.9% and the median survival time was 70 months. The median progression-free survival time of all the 70 enrolled patients was 30 months. Seven patients (10.0%) suffered from second malignancies, including three patients with genitourinary carcinomas. Conclusions Despite the need for dose reduction, the long-term results of imatinib therapy for advanced gastrointestinal stromal tumors were good in Japanese patients. Physicians should pay attention to the occurrence of second malignancies during imatinib therapy for gastrointestinal stromal tumor patients.

scholarly journals Correlation of Long-term Results of Imatinib in Advanced Gastrointestinal Stromal Tumors With Next-Generation Sequencing Results

JAMA Oncology ◽  
2017 ◽  
Vol 3 (7) ◽  
pp. 944 ◽  
Author(s):  
Michael C. Heinrich ◽  
Cathryn Rankin ◽  
Charles D. Blanke ◽  
George D. Demetri ◽  
Ernest C. Borden ◽  
...  
Keyword(s):  
Next Generation Sequencing ◽  
Gastrointestinal Stromal Tumors ◽  
Long Term Results ◽  
Next Generation ◽  
Stromal Tumors ◽  
Generation Sequencing

scholarly journals Long-term Safety and Dosing of OnabotulinumtoxinA: A Prospective, Observational Study

2019 ◽  
Vol 46 (6) ◽  
pp. 742-752 ◽  
Author(s):  
Theodore Wein ◽  
Mandar Jog ◽  
Meetu Bhogal ◽  
Sonja Dhani ◽  
Robert Miller ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Observational Study ◽  
Therapeutic Indication ◽  
Prospective Observational Study ◽  
Muscular Weakness ◽  
Canadian Study ◽  
Safety Population ◽  
Risk Balance

ABSTRACT:Background:Although therapeutic treatments are intended to help alleviate symptoms associated with disease, safety must be carefully considered and monitored to confirm continued positive benefit/risk balance. The objective of MOBILITY was to study the long-term safety of onabotulinumtoxinA for treatment of various therapeutic indications.Methods:A prospective, multicenter, observational, Phase IV Canadian study in patients treated with onabotulinumtoxinA for a therapeutic indication. Dosing was determined by the participating physician. Adverse events (AEs) were recorded throughout the study.Results:Patients (n= 1372) with adult focal spasticity, blepharospasm, cerebral palsy, cervical dystonia, hemifacial spasm, hyperhidrosis, or “other” diagnoses were enrolled into the safety cohort. Eighty-three patients (6%) reported 209 AEs; 44 AEs in 24 patients (2%) were considered treatment-related AEs. Seventy-two serious AEs were reported by 38 patients (3%); 10 serious AEs in 5 patients (0.4%) were considered treatment related. Most commonly reported treatment-related AEs were muscular weakness (n= 7/44) and dysphagia (n= 6/44).Conclusions:In patients with follow-up for up to six treatments with onabotulinumtoxinA, treatment-related AEs were reported in <2% of the safety population over the course of nearly 5 years. Our findings from MOBILITY provide further evidence that onabotulinumtoxinA treatment is safe for long-term use across a variety of therapeutic indications.

W1723 Long-Term Follow-up of Patients With Gastric Gastrointestinal Stromal Tumors (GISTs) 5 CM or Less After Surgical or Endoscopic Resection

2010 ◽  
Vol 138 (5) ◽  
pp. S-727
Author(s):  
Mi-Young Kim ◽  
Kee Don Choi ◽  
Jeong Hoon Lee ◽  
Hye-won Park ◽  
Do Hoon Kim ◽  
...  
Keyword(s):  
Endoscopic Resection ◽  
Gastrointestinal Stromal Tumors ◽  
Stromal Tumors ◽  
Long Term Follow Up

Long-Term Results of the HD2000 Trial Comparing ABVD Versus BEACOPP Versus COPP-EBV-CAD in Untreated Patients With Advanced Hodgkin Lymphoma: A Study by Fondazione Italiana Linfomi

2016 ◽  
Vol 34 (11) ◽  
pp. 1175-1181 ◽  
Author(s):  
Francesco Merli ◽  
Stefano Luminari ◽  
Paolo G. Gobbi ◽  
Nicola Cascavilla ◽  
Caterina Mammi ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Cumulative Risk ◽  
Progression Free Survival ◽  
Long Term Results ◽  
Entire Group ◽  
Second Malignancies ◽  
Free Survival ◽  
Post Hoc

Purpose The randomized HD2000 trial compared six cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine), four escalated plus two standard cycles of BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone), and six cycles of COPP-EBV-CAD (cyclophosphamide, lomustine, vindesine, melphalan, prednisone, epidoxorubicin, vincristine, procarbazine, vinblastine, and bleomycin; CEC) in patients with advanced-stage Hodgkin lymphoma. After a median follow-up of 42 months, patients who received BEACOPP were reported to have experienced better progression-free survival (PFS) but not better overall survival (OS) results than those receiving ABVD. We here report a post hoc analysis of this trial after a median follow-up of 10 years. Patients and Methods Three hundred seven patients were enrolled, 295 of whom were evaluable. At the time of our analysis, the median follow-up for the entire group was 120 months (range, 4 to 169 months). Results The 10-year PFS results for the ABVD, BEACOPP, and CEC arms were 69%, 75%, and 76%, respectively; corresponding OS results were 85%, 84%, and 86%. Overall, 13 second malignancies were reported: one in the ABVD arm and six each in the BEACOPP and CEC arms. The cumulative risk of developing second malignancies at 10 years was 0.9%, 6.6%, and 6% with ABVD, BEACOPP, and CEC, respectively; the risk with either BEACOPP or CEC was significantly higher than that reported with ABVD (P = .027 and .02, respectively). Conclusion With these mature results, we confirm that patients with advanced Hodgkin lymphoma have similar OS results when treated with ABVD, BEACOPP, or CEC. However, with longer follow-up, we were not able to confirm the superiority of BEACOPP over ABVD in terms of PFS, mainly because of higher mortality rates resulting from second malignancies observed after treatment with BEACOPP and CEC.

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