Long-term Efficacy Results Research Articles

P087 LONG TERM SURGICAL RESULTS AND QUALITY OF LIFE AFTER LAPAROSCOPIC INGUINAL HERNIA REPAIR (TAPP): A PROSPECTIVE, CASE CONTROL STUDY COMPARING STANDARD HEAVYWEIGHT AND SELFGRIPPING (PROGRIP) MESH

Abstract Aim Aim of this study is to compare long term results of efficacy, recurrence and quality of life in patients submitted to TAPP for inguinal hernia repair with standard Heavyweight or Selfgripping mesh. Material and Methods A prospective case control study was conducted at single third referral center. The study included adult patients submitted to TAPP, of both sex, with primary and recurrent, unilateral and bilateral inguinal hernia. Patients received non-fixated standard heavyweight meshes (HW) or PROGRIP self gripping mesh (PG), their data were entered in EuraHS platform and the EuraHS Quality of life (QOL) questionnaire was administered before and 1 year after surgery. Primary outcome of the study is to compare long term QOL before and after surgery in HW vs PG group. Secondary outcome is perioperative morbidity and 12 months recurrence assessed with PINQ questionnaire. Results Between 2016 and 2020, 100 patients of both sexes (10 female) were enrolled, 50 in HW group and 50 in PG group. The two groups were comparable preoperatively. After 12 months no cases of CPIP were observed and there wasn’t differences in QOL reported by patients, although in both groups there was an improvement of pain, movement limitations and esthetical discomfort after surgery. None recurrence and overall only 4 cases of complications (1 hematoma and 1 seroma for each group) were registered. Conclusions Selfgripping Mesh for laparoscopic hernia repair has produced results equal to standard of care meshes in term of recurrence rate, early morbidity and postoperative quality of life of patients.

Long-term results of efficacy and safety of pulmonary vein isolation with a catheter-tissue pressure sensor and a second-generation cryoballon in patients with persistent atrial fibrillation

Long-term results of efficacy and safety of pulmonary vein isolation with a catheter-tissue pressure sensor and a second-generation cryoballon in patients with persistent atrial fibrillation

Long-Term Efficacy and Safety Results of CT-P10 and Reference Rituximab in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma: Phase III Updated Study Results with Median Follow-up of 40 Months

Long-Term Efficacy and Safety Results of CT-P10 and Reference Rituximab in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma: Phase III Updated Study Results with Median Follow-up of 40 Months

Long-term efficacy and urological toxicity of low-dose-rate brachytherapy (LDR-BT) as monotherapy in localized prostate cancer

PurposeThe purpose of this study was to evaluate the incidence of late severe (≥Grade 3) urinary toxicity and the long-term efficacy after low-dose-rate brachytherapy (LDR-BT) in patients with localized prostate cancer (PCa). Methods and MaterialsDuring the years 1999–2008, 241 patients with PCa who underwent LDR-BT with I125 and were followed up in Kuopio University Hospital were included to this analysis. The incidence of late severe (Grade 3) urinary toxicity and the long-term efficacy results were analyzed. ResultsAll D'Amico risk groups were represented, as 58.9%, 35.3%, and 5.8% of the patients were classified as low-, intermediate-, and high-risk patients, respectively. With a median followup of 11.4 years after implantation, the incidence of severe urinary toxicity increased throughout the followup period. The risk of Grade 3 urinary toxicity was highest among patients with higher Gleason scores (p = 0.016) and higher initial urine residual volumes (p = 0.017) and the cumulative incidence of severe urinary toxicity was 10.0%. The crude rate for transurethral prostatic resection was 5.8%. The relapse-free survival, the cause-specific survival, and the overall survival were 79.3%, 95.0%, and 66.4%, respectively. ConclusionsThe treatment was well tolerated as 90% of patients avoided any Grade 3 urinary toxicity. LDR-BT for localized PCa achieved high and durable efficacy. These results support the role of LDR-BT monotherapy as one of the valid primary treatment options for low-risk and favorable intermediate-risk patients.

Therapies for Macular Edema Associated with Central Retinal Vein Occlusion: A Report by the American Academy of Ophthalmology

To review the available evidence regarding the safety and efficacy of therapies for the treatment of macular edema (ME) associated with central retinal vein occlusion (CRVO). A literature search of the PubMed database was last conducted in March 2014 with no date restrictions but limited to articles published in English. A literature search of the Cochrane Library was also conducted in March 2014 with no date restrictions and without a language limitation. The combined searches yielded 108 citations, of which 20 were deemed clinically relevant for the Ophthalmic Technology Assessment Committee Retina/Vitreous panel to review in full text. Three additional studies were also identified for panel review. The level of evidence of these selected studies was reviewed by the panel methodologist. There were 7 citations representing 4 clinical trials that provided level I evidence supporting the use of anti-vascular endothelial growth factor (VEGF) pharmacotherapies for ME associated with CRVO, including intravitreal ranibizumab (2), aflibercept (3), and bevacizumab (2). There were 3 citations representing 2 studies with level I evidence for intravitreal corticosteroid injection with dexamethasone intravitreal implant (2 citations) or triamcinolone (1 citation), although cataract and glaucoma were observed in these studies. Level I evidence is available on the limited benefit of macular grid-pattern laser photocoagulation (1 citation). Eight other citations reviewed were rated as level II, and 4 citations were rated as level III. Long-term efficacy results (≥2 years of follow-up) are limited to intravitreal ranibizumab at this time, and few studies have evaluated combination therapy with anti-VEGF and corticosteroid versus monotherapy of either class of drug. Level I evidence indicates that intravitreal anti-VEGF pharmacotherapy is safe and effective over 2 years for ME associated with CRVO and that delay in treatment is associated with worse visual outcomes. In addition, level I evidence demonstrates short-term efficacy of intravitreal corticosteroid but also an association with a higher frequency of adverse events.

Abstract B268: A Phase I Study of CUDC-101, a multitarget inhibitor of HDACs, EGFR, and HER2, in combination with chemoradiation in patients with intermediate/high risk locally advanced squamous cell carcinoma of the head and neck.

Abstract Purpose: This study sought to establish the maximum tolerated dose (MTD) of CUDC-101 in combination with cisplatin and radiation in patients (pts) with locally advanced untreated squamous cell carcinoma of the head and neck. Patients and Methods: Pts were enrolled onto two cohorts of IV CUDC-101: 225 mg/m2 and 275 mg/m2. Pts received CUDC-101 alone 3 times a week for 1 week followed by 7 weeks of the same dose plus radiotherapy 70 Gy and cisplatin 100 mg/m2 on days 2, 23 and 44 of radiotherapy. Endpoints included safety/tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CUDC-101, and clinical activity. Results: Thirteen pts were enrolled and 12 received treatment: 4 in the 225 mg/m2 and 8 in the 275 mg/m2 cohorts; 2 pts received CUDC-101 monotherapy only.Ten pts were male and 3 were female. Mean age was 63 years. Nine pts had newly diagnosed Stage IV (A or B) disease, 3 had Stage III. Eleven pts had p16 negative disease except 1 pt who was p16 positive but with a past smoking history of >10 packs/year. Four pts had oropharynx as the primary tumor site, 2 larynx, 2 hypopharynx, 2 oral cavity, 1 tongue and 1 tonsil. Dose-limiting toxicities (DLT) included acute renal failure (ARF) in one pt treated at 275 mg/m2 leading to study discontinuation. Grade 3 CUDC-101 related adverse events were decreased appetite, leukopenia, hypertension, ARF (1 pt each). CUDC-101 PK were consistent with prior CUDC-101 single-agent PK. Tumor, skin and PBMC samples collected for PD analysis showed consistent HDAC inhibition; pEGFR staining was abrogated after therapy in the 2 pts from whom PD data are available. Data at the 12-week post-treatment disease assessment are available in 6 pts: 2 had complete response, 2 had partial response and 2 stable disease. Two pts had a post-treatment biopsy with negative pathology results. Conclusion: The results of this study showed that CUDC-101 can be combined with chemoradiation at a dose of 275 mg/m2 with ARF being the most prominent DLT. PD results showed effective HDAC target modulation. Preliminary long-term efficacy results are encouraging. Citation Information: Mol Cancer Ther 2013;12(11 Suppl):B268. Citation Format: Antonio Jimeno, Thomas Galloway, Lori Wirth, Jill Gilbert, Nabil Saba, Julie Bauman, Dimitrios Colevas, Ranee Mehra, David Raben, Cheng-Jung Lai, Robert Laliberte, Maurizio Voi, Barbara Burtness. A Phase I Study of CUDC-101, a multitarget inhibitor of HDACs, EGFR, and HER2, in combination with chemoradiation in patients with intermediate/high risk locally advanced squamous cell carcinoma of the head and neck. [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2013 Oct 19-23; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2013;12(11 Suppl):Abstract nr B268.

Disease Activity, Physical Function, and Radiographic Progression After Longterm Therapy with Adalimumab Plus Methotrexate: 5-Year Results of PREMIER

To evaluate the efficacy and safety of initial combination treatment with adalimumab (ADA) and methotrexate (MTX) versus monotherapy with ADA or MTX during an open-label extension of PREMIER. Patients with early rheumatoid arthritis (RA) received blinded ADA plus MTX, ADA alone, or MTX alone for 2 years in PREMIER. At Year 2, patients could enroll in an open-label extension and receive ADA monotherapy; MTX could be added at the investigator's discretion. Longterm efficacy results are presented as observed data. In the open-label period, 497 of the original 799 randomized patients had ≥ 1 dose of ADA (by original randomization: ADA plus MTX, n = 183; ADA, n = 159; MTX, n = 155). In the completers cohort [patients with available Year-5 ACR responses and modified total Sharp scores (mTSS)], the Year-5 mean change from baseline in mTSS for the ADA+MTX arm (n = 124) was 2.9, compared with 8.7 and 9.7 in the ADA (n = 115) and MTX (n = 115) arms. Comprehensive disease remission, defined as the combination of DAS28 remission, normal function (Health Assessment Questionnaire ≤ 0.5), and radiographic nonprogression (ΔmTSS ≤ 0.5), was achieved by more patients in the initial ADA+MTX arm (35%) than in the ADA (13%) or MTX (14%) arms. Initial combination treatment with ADA plus MTX, followed by open-label ADA, led to better longterm clinical, functional, and radiographic outcomes than either initial ADA or MTX monotherapy during 5 years of treatment.

Long-term efficacy results of EORTC Genito-Urinary Group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder

Long-term efficacy results of EORTC Genito-Urinary Group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder

PW01-60 - Similar short- and long-term efficacy results of aripiprazole in post-pubertal adolescents (ages 15-17) and adults with schizophrenia

IntroductionAvailable data suggest that sex hormone levels during puberty may affect symptom onset and expression, treatment responsiveness and outcomes in schizophrenia, whereas post-pubertal adolescents may have a similar clinical presentation and treatment response compared to adults with schizophrenia.ObjectivesPost-hoc analyses were conducted to assess the similarity of short- and long-term efficacy between post-pubertal adolescents and adults with schizophrenia treated with aripiprazole.MethodsBased on available European epidemiologic data, a cut-off age of 15 years was used to isolate a subgroup of mostly post-pubertal adolescents with schizophrenia in aripiprazole clinical studies. Outcome measures from this subgroup (ages 15-17; n=147) were then compared to outcomes from one adult study (n=853) on short and long-term measures of efficacy, including PANSS scores, response rates, and remission rates.ResultsComparable short and long-term treatment effects were observed on the PANSS total and subscale scores, demonstrated by overlapping 95% confidence intervals (mean change from baseline in PANSS total score (OC dataset): at week 6 in adults: -27,7; in adolescents 15-17 yr: -29,6; at week 30 in adults: -39,2; in adolescents 15-17 yr: -36). Percent of adolescents achieving response (defined as ≥ 30% decrease in PANSS total score from baseline) at 32 weeks (80,2%) on open label treatment was similar to that in adult studies at week 34 (80%) on double blind treatment (OC dataset).ConclusionsAdolescents with schizophrenia (ages 15-17, mostly post-pubertal) demonstrate a positive treatment response in short-term and long-term studies which is similar to that observed in the adult patient population.

Long-Term Efficacy Results of EORTC Genito-Urinary Group Randomized Phase 3 Study 30911 Comparing Intravesical Instillations of Epirubicin, Bacillus Calmette-Guérin, and Bacillus Calmette-Guérin plus Isoniazid in Patients with Intermediate- and High-Risk Stage Ta T1 Urothelial Carcinoma of the Bladder

BackgroundIntravesical chemotherapy and bacillus Calmette-Guérin (BCG) reduce the recurrence rate in patients with stage Ta T1 urothelial bladder cancer; however, the benefit of BCG relative to chemotherapy for long-term end points is controversial, especially in intermediate-risk patients. ObjectiveThe aim of the study was to compare the long-term efficacy of BCG and epirubicin. Design, setting, and participantsFrom January 1992 to February 1997, 957 patients with intermediate- or high-risk stage Ta T1 urothelial bladder cancer were randomized after transurethral resection to one of three treatment groups in the European Organization for Research and Treatment of Cancer Genito-Urinary Group phase 3 trial 30911. InterventionPatients received six weekly instillations of epirubicin, BCG, or BCG plus isoniazid (INH) followed by three weekly maintenance instillations at months 3, 6, 12, 18, 24, 30, and 36. MeasurementsEnd points were time to recurrence, progression, distant metastases, overall survival, and disease-specific survival. Results and limitationsWith 837 eligible patients and a median follow-up of 9.2 yr, time to first recurrence (p<0.001), distant metastases (p=0.046), overall survival (p=0.023), and disease-specific survival (p=0.026) were significantly longer in the two BCG arms combined as compared with epirubicin; however, there was no difference for progression. Three hundred twenty-three patients with stage T1 or grade 3 tumors were high risk, and the remaining 497 patients were intermediate risk. The observed treatment benefit was at least as large, if not larger, in the intermediate-risk patients compared with the high-risk patients. ConclusionsIn patients with intermediate- and high-risk stage Ta and T1 urothelial bladder cancer, intravesical BCG with or without INH is superior to intravesical epirubicin not only for time to first recurrence but also for time to distant metastases, overall survival, and disease-specific survival. The benefit of BCG is not limited to just high-risk patients; intermediate-risk patients also benefit from BCG. Trial registrationThis study was registered with the US National Cancer Institute clinical trials database [protocol ID: EORTC-30911]. http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=77075&version=HealthProfessional&protocolsearchid=6540260.

REPLACE-2: long-term efficacy results

REPLACE-2: long-term efficacy results

37 Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer (AOC): long-term efficacy results

37 Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer (AOC): long-term efficacy results

Prostate Cancer: Emerging Concepts: Part II

To review important topics related to prostate cancer that have arisen since this subject was last covered in Annals in 1993. The review consists of two parts. Part II describes neoadjuvant hormonal therapy, new local treatment options (including three-dimensional conformal radiation therapy, brachytherapy, and cryosurgery), antiandrogen therapy management of erectile dysfunction, funding and legislation for research, and areas for future research, especially in genetics investigations. Randomized studies identified through a MEDLINE search (1992 to 1996); large, single-institutional conferences and consortiums; and studies presented at regional, national, and international symposia. Qualitative and quantitative data are reported. Part II describes results of completed randomized trials that used neoadjuvant hormonal therapy. Studies have shown that nearly 50% more patients with cT2 disease will have pathologically confined (pT2) prostate cancer as a result of preoperative neoadjuvant hormonal therapy. Time to development of progressive disease and disease-free survival are improved in patients receiving neoadjuvant hormonal therapy before radiation therapy, but the long-term overall effects on survival of neoadjuvant therapy before surgery or radiation are unknown. Other methods for treating localized prostate cancer (three-dimensional conformal radiation therapy, brachytherapy, and cryotherapy) are gaining popularity, despite the lack of long-term efficacy results. Advances in the understanding of the optimal use of antiandrogens and managing treatment-induced erectile dysfunction continue to benefit patients with prostate cancer. Prostate cancer is being detected with increasing frequency, and many patients are receiving such treatments as radical prostatectomy and radiation therapy. Although refinements in prostate-specific antigen (PSA)-based testing have contributed substantially to the increased rate of detection of prostate cancer, the incidence of disease was increasing dramatically even before PSA detection was possible. Despite earlier detection, the optimal therapy for the early form of the disease is still enigmatic. Further studies and longer follow-up of patients who participated in completed studies are needed to better define the outcomes and importance of prostate cancer therapies. More research is needed to help elucidate the reasons for the increased incidence of the disease; such efforts should help define strategies to ultimately prevent prostate cancer.