Carboplatin, ifosfamide, and mesna (CIM) for the treatment of gynecological carcinosarcoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16539-e16539
Author(s):  
N. Walji ◽  
A. Zachariah ◽  
C. Yap ◽  
S. A. Hussain ◽  
C. J. Poole ◽  
...  
Keyword(s):  
Complete Response ◽  
Kaplan Meier ◽  
Metastatic Setting ◽  
The Common ◽  
Group 2 ◽  
Grade 3 ◽  
Abdominal Irradiation ◽  
Toxicity Criteria ◽  
Group 1

e16539 Background: A GOG trial comparing cisplatin/ifosfamide/mesna chemotherapy versus whole abdominal irradiation for FIGO stages I-IV carcinosarcoma (CS) showed an estimated median survival (MS) of 50 months for chemotherapy but high toxicity. This study investigates the efficacy and tolerability of a novel regimen using carboplatin AUC 5, ifosfamide 3 g/m2 and mesna 1 g/m2 (CIM) in both the adjuvant and metastatic setting. Methods: Retrospective analysis of women with CS treated from May 1997-May 2007 with CIM (group 1) versus other chemotherapy regimens (group 2). Toxicity was graded according to the Common Toxicity Criteria and MS estimated using the Kaplan-Meier method. Results: Of 51 eligible women (median age 71 years) 35 (69%) had stage 3 or 4 disease. 35/51 (69%) received chemotherapy; 2 with stage 1c disease received pelvic radiotherapy (pRT) alone whilst the remaining 14 were unfit for any treatment. Median follow-up for the treated patients is 45 months. 11/35 patients (31%) received CIM as first-line chemotherapy. Other regimens included: carboplatin (n = 14); carboplatin/paclitaxel (n = 3); carboplatin/epirubicin (n = 3); carboplatin/doxorubicin (n = 2); doxorubicin/ifosfamide (n = 1); cisplatin/ifosfamide (n = 1). 20/35 (57%) received adjuvant chemotherapy (AC) of which 8 received CIM; 11/20 patients also received adjuvant pRT. MS in the CIM AC group is 54.7 months compared to 37.4 months for other regimens. 3/8 patients (37.5%) in the CIM arm developed recurrent disease compared to 9/12 (75%) for other regimens. 4/16 patients received CIM as first- or second-line palliative chemotherapy. All patients responded of whom 2 achieved clinical and radiological complete response (CR). One woman subsequently relapsed and achieved a second CR with CIM. MS for all chemotherapy-treated patients is 54.7 months (group 1) versus 20.6 months (group 2) (p = 0.07). No patients in group 1 experienced any grade 3/4 toxicity and all patients completed the prescribed treatment. There were 2 unexpected treatment-related deaths in group 2, one of whom received carboplatin/paclitaxel and the other carboplatin/epirubicin. Conclusions: CIM appears to be efficacious and well tolerated in the treatment of CS and merits further investigation in clinical trials. No significant financial relationships to disclose.

P1031The impact of the duration of atrial fibrillation persistence for arrhythmia free survival in patients undergoing catheter ablation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Furukawa ◽  
T Yamada ◽  
T Morita ◽  
S Tamaki ◽  
M Kawasaki ◽  
...  
Keyword(s):  
Catheter Ablation ◽  
Outcome Data ◽  
Free Survival ◽  
Group 4 ◽  
Kaplan Meier ◽  
Group 3 ◽  
Group 2 ◽  
Af Recurrence ◽  
Group 1

Abstract Background Catheter ablation (CA) for atrial fibrillation (AF) is a curable treatment option. However, AF recurrence after CA remains an important problem. Although the success rate has been improved after catheter ablation (CA) in patients with paroxysmal AF (PAF), outcome data after CA for persistent AF (PeAF) are highly variable. Previous studies showed the PeAF is one of independent predictors for AF recurrence in comparison to PAF. However, there are little information available on the prognostic significance of AF duration after CA for AF. The aim of this study is to evaluate the impact of AF duration on long-term outcomes of AF ablation in patients with PeAF compared with PAF. Methods We enrolled 778 consecutive patients, who were referred our institution between August 2015 and December 2017 for undergoing the first time CA for AF. We divided 5 groups (Group 1; PAF (n=442), Group 2; PeAF duration ≤6 months (n=198), Group 3; PeAF duration of 6 months to 2 years (n=87), Group 4; PeAF duration of 2–5 years (n=30) and Group 5; PeAF duration ≥5 years (n=21)). All patients followed up for at least 1 year. Outcome data on recurrence of AF after ablation were collected. Results There were no significant differences in baseline clinical characteristics before CA among 5 groups, except for the prevalence of congestive heart failure, left atrial diameter and left ventricular ejection fraction. During a mean follow-up period of 511±298 days, 217 patients had AF recurrence. Kaplan-Meier analysis revealed that AF recurrence was significantly higher in group 2 compared to group 1 (31% vs 20%, p=0.002) and in group 4 compared to group 3 (83% vs 30%, p<0.0001). However, AF recurrence was no significantly differences between groups 2 and 3 (31% vs 30%, p=0.76) and between groups 4 and 5 (83% vs 81%, p=0.45). Of 217 patients with AF recurrence, 154 patients had undergone multiple procedures. After last procedures, during a mean follow-up period of 546±279 days, 61 patients had AF recurrence. Kaplan-Meier analysis revealed that AF recurrence was significantly higher in group 2 compared to group 1 (10% vs 3%, P=0.0005) and in group 4 compared with group 3 (35% vs 10%, p=0.0001). However, AF recurrence was no significantly difference between groups 2 and 3 (10% vs 10%, p=0.91) and between groups 4 and 5 (47% vs 35%, p=0.47). AF Free Survival Curve Conclusion Although patients with PeAF within 2 years had significantly higher AF recurrence compared to PAF, AF ablation might still be a good contributor as the first line approach to improve outcomes in patient with PeAF within 2 years.

Comparison of intermittent versus continuous methotrexate plus 6-mp in maintenance regimen for standard risk acute lymphoblastic leukemia in children (GBTLI ALL-99)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9512-9512 ◽  
Author(s):  
S. R. Brandalise
Keyword(s):  
Maintenance Therapy ◽  
Maintenance Treatment ◽  
Risk Group ◽  
Lymphoblastic Leukemia ◽  
Treatment Schedule ◽  
Group 2 ◽  
Grade 3 ◽  
Standard Risk ◽  
Group 1

9512 Objectives: To compare by randomization the conventional use of 6-MP (50 mg/m2 daily) / MTX (25 mg/m2/wk) regimen with the intermittent use of MTX (200 mg/m2/IV 6 h infusion each 21 days)/ 6-MP (100 mg/m2/day × 10) in maintenance therapy. Methods: Newly diagnosed ALL children up to 18 yrs of age registered in the GBTLI ALL-99 Protocol. The eligibility criteria for standard-risk group were age >1 <9 years and WBC count at diagnosis <50,000/mm3 and good responders at D7/D14. Randomization was made after the late consolidation phase (week 42) prior to the maintenance treatment. Treatment Schedule: Induction: [DX(Pred), DNM, VCR, L-ASP, CICLO, Ara-C, 6-MP], Intensification: (MTX 2 g/m2 6 h inf. × 4, 6-MP) Late Consolidation: (DX, VCR, DOXO, L-ASP, CICLO, ARA-C, 6-TG) plus prolonged triple intratecal therapy, were done previously to maintenance therapy. Total treatment duration was two years. No CNS radiation was done. Toxicities were defined according to NCI-version 2001 criteria. Results: 560 pts were enrolled in the study. 22 slow responders pts (4.1%) moved to high risk group. The total number of analyzed pts was 512. Two hundred and thirty pts entered group 1 [continuous (conventional) 6MP-MTX] and 230 pts entered group 2 (Intermittent MTX/6-MP). Remission rate was 95.3%. 439 pts (87.9%) are in CCR. The mean follow up period is 2.2 years. The estimated 5 years OS rate for both groups is 88.1% ± 2.1%. The estimated 5 years EFS for both groups is 80% ± 2.9%. According to maintenance regimen, the 5 years EFS rate is 80.2% ± 4.5% and 88.3% ± 3.7% for group 1 and group 2, respectively (p=0.048). Grade 3 and 4 hepatic toxicities were 254 episodes for group 1 and 144 episodes for group 2 (p=0.019). Grade 3 CNS toxicities were 13 episodes (group 1) and 5 in group 2. Grade 4 hematological toxicities were 254 episodes for group 1 and 144 episodes for group 2 (p=0.003). Conclusions: Despite the short mean time follow-up (2.2 years) the patients with the intermittent regimen (Group 2) had better EFS rate (p = 0.048) and less hematological, CNS and hepatic toxicities, comparing with patients that received conventional maintenance treatment (group 1). No significant financial relationships to disclose.

Keynote 057: Phase II trial of Pembrolizumab (pembro) for patients (pts) with high-risk (HR) nonmuscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 350-350 ◽  
Author(s):  
Arjun Vasant Balar ◽  
Girish S. Kulkarni ◽  
Edward M. Uchio ◽  
Joost Boormans ◽  
Loic Mourey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Complete Response ◽  
Maculopapular Rash ◽  
Median Number ◽  
Kaplan Meier ◽  
Bcg Therapy ◽  
Duration Of Response ◽  
Grade 3 ◽  
Muscle Invasive

350 Background: The PD-1 inhibitor pembro has durable antitumor activity in pts with metastatic urothelial carcinoma. Upregulation of the PD-1 pathway has been observed in BCG-resistant NMIBC, suggesting pembro may benefit. Efficacy and safety of pembro in pts with HR, BCG-unresponsive NMIBC was evaluated in the single-arm phase 2 KEYNOTE-057 study; updated results for pts with carcinoma in situ (CIS) with or without papillary tumor (cohort A) are reported. Methods: Pts with histologically confirmed HR, BCG-unresponsive CIS with or without papillary disease, who received adequate BCG therapy and were unable/unwilling to undergo radical cystectomy received pembro 200 mg Q3W for 24 mo or until recurrence, progression, or unacceptable toxicity. Pts with HR NMIBC or progressive disease during treatment were required to discontinue. Primary end point: complete response rate (CRR); key secondary end points: duration of response and safety. Results: 103 pts (median age 73 years; CIS alone 71.8%; median number of prior BCG instillations 12) have enrolled in cohort A. 3-mo CRR rate was 38.8% (95% CI 29.4%-48.9%) by central assessment. Among 40 pts who achieved CR at 3 mo, 72.5% maintained CR at last follow-up (median 14.0 mo; range 4.0-26.3) and median CR duration has not been reached (range 0+ to 14.1+ mo). 80.2% of pts had a CR duration of ≥6 mo (Kaplan-Meier method). 10 (25.0%) experienced recurrent NMIBC after CR; at the time of analysis, none progressed to muscle invasive or metastatic disease. Treatment-related adverse events (AEs) occurred in 65 (63.1%) pts; most frequent were pruritus (10.7%), fatigue (9.7%), diarrhea (8.7%), hypothyroidism (5.8%), and maculopapular rash (5.8%). Grade 3/4 treatment-related AEs occurred in 13 (12.6%) pts; 1 death was considered treatment-related (colitis in patient inadequately treated with steroids). Immune-mediated AEs occurred in 19 (18.4%) pts. Conclusions: Pembro had encouraging activity in pts with HR, BCG-unresponsive CIS with or without papillary tumors and a safety profile consistent with that of previous experience. Updated data using additional follow-up will be presented. Clinical trial. Clinical trial information: NCT02625961.

scholarly journals Preliminary Safety and Efficacy Results with an Intermittent Schedule of the PI3kδ Inhibitor ME-401 Alone or in Combination with Rituximab for B-Cell Malignancies

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2893-2893 ◽  
Author(s):  
Andrew D. Zelenetz ◽  
Jacob D. Soumerai ◽  
Deepa Jagadeesh ◽  
Nishitha Reddy ◽  
Anastasios Stathis ◽  
...  
Keyword(s):  
B Cell ◽  
Research Funding ◽  
Objective Response ◽  
Intermittent Schedule ◽  
Safety And Efficacy ◽  
Group 2 ◽  
Grade 3 ◽  
Expansion Cohort ◽  
Group 1

Abstract Background: ME-401, a potent and selective oral PI3kδ inhibitor, achieved a high rate of early and durable responses in patients with follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) when administered once daily in 28-day cycles on a continuous schedule (CS) in a dose escalation Phase 1b study (Soumerai et al, ASCO 2018:#7519). The most common adverse events (AEs) were the delayed onset (beyond Cycle 2) of grade 3 diarrhea and rash, which were reversible with drug interruption and/or corticosteroids. These delayed AEs were thought to be due to pathway inhibition in regulatory T cells (Treg) leading to a disruption in immune homeostasis. We hypothesized that an intermittent schedule (IS) beyond Cycle 2 might mitigate or reduce the incidence of significant delayed AEs. The IS tested was selected based on the kinetics of Treg repopulation, and consists of ME-401 administered on days 1-7 of a 28-day cycle. We report preliminary results of this strategy. Methods: Group 1 included 31 patients with relapsed FL (n = 22) or CLL/SLL (n = 9) who received ME-401 on a CS at doses ≥60 mg per day. 11/29 patients (38%) who received >2 cycles of therapy had developed delayed grade 3 AEs on CS and could be re-challenged with either the CS or IS (from December 2017 onward) following recovery from toxicity. The other 18/29 patients (62%) had not developed a grade 3 AEs of interest on CS and, beginning in December 2017, were switched to IS after a median of 26 weeks (range, 8-49) of daily dosing. Group 2 included 15 patients with relapsed FL (n = 9), diffuse large B-cell lymphoma (n = 4), marginal zone lymphoma (MZL, n = 1), and CLL (n = 1) who received rituximab 375 mg/m2 x 8 doses over 6 months and ME-401 at 60 mg daily x 2 cycles then switched to the IS. Group 3 includes 30 patients with relapsed FL/CLL/SLL enrolling in an expansion cohort of ME-401 alone at 60 mg daily x 2 cycles then switching to IS. Results: Group 1: Of the 11 patients who developed a delayed grade 3 AE on CS, 6 were never re-challenged, 2 were re-challenged with CS with recurrence of their AE, and 3 were re-challenged with IS without recurrence of their AE. Of the 18 patients switched to the IS, and with a median follow-up of 5.2 months (range, 2.3-6.6) on IS, 3 developed grade 3 diarrhea on IS, 2 in the first cycle and 1 in the second cycle after the switch to IS, of whom 2 have been re-treated with IS for 1+ and 5+ months without recurrence of the AE. One patient was not evaluable for response due to discontinuation on Day 28 for personal reasons and 27/30 (90%) evaluable patients achieved an objective response. With a median follow-up of 9.4 months (range, 2.2-17.5) from enrollment, only 2/27 (7%) responders had disease progression (PD) on CS and were discontinued. Of the 18 patients who were switched to IS, only 1 SLL patient with a partial response (PR) achieved on CS developed PD on IS and was successfully rescued with switch back to CS. Another CLL patient in PR on CS had 10% increase in SPD from nadir in Cycle 5 on the IS and was switched back to CS. Group 2: 10/15 patients have completed 2 cycles of daily dosing at the time of analysis and were systematically switched to IS. With a median follow-up of 3.4 months (range, 1.5-5.7) on IS, only 1/10 patients developed delayed grade 3 diarrhea in the first cycle after switch to IS. 7/10 patients (70%) with FL/MZL achieved an objective response and no PD was reported with a median follow-up of 5.2 months (range, 3.1-7.5) from enrollment. Conclusions: Preliminary data suggest that switching to an intermittent schedule consisting of ME-401 administered on days 1-7 of a 28-day cycle following 2 cycles of continuous daily dosing was associated with a low rate of delayed grade 3 AEs and was associated with preservation of response in the vast majority of patients. All delayed grade 3 AEs of interest on IS occurred within 1-2 cycles of switching from CS to IS, suggesting that these might have represented a delayed effect of daily dosing. IS may also be a suitable re-treatment strategy in patients with delayed AEs on CS. Safety and efficacy data for the expansion cohort of 30 patients treated with ME-401 at 60 mg for 2 cycles then switched to IS will be presented at the meeting. A randomized study comparing CS and IS in FL is planned. Disclosures Zelenetz: Abbvie: Research Funding; Celgene: Consultancy; AstraZeneca: Consultancy; Novartis/Sandoz: Consultancy; Amgen: Consultancy; Gilead: Consultancy, Research Funding; Genentech/Roche: Consultancy, Research Funding. Reddy:MEI Pharma: Research Funding. Stathis:Oncology Therapeutic Development: Research Funding. Ghalie:MEI Pharma: Employment, Equity Ownership; Viracta Therapeutics: Membership on an entity's Board of Directors or advisory committees. Pagel:Pharmacyclics, an AbbVie Company: Consultancy; Gilead: Consultancy.

scholarly journals Low-Dose Radiotherapy Versus Moderate-Dose Radiotherapy for the Treatment of Indolent Orbital Adnexal Lymphomas

2021 ◽  
Vol 11 ◽  
Author(s):  
Jonathan Baron ◽  
Christopher M. Wright ◽  
Daniel Y. Lee ◽  
Maribel Carpenter ◽  
Shwetha H. Manjunath ◽  
...  
Keyword(s):  
Low Dose ◽  
Response Rates ◽  
Complete Response ◽  
Moderate Dose ◽  
Exact Test ◽  
Overall Response ◽  
Low Dose Radiotherapy ◽  
Kaplan Meier ◽  
Grade 3

PurposeRadiation therapy (RT) with doses ranging from 24 Gray (Gy) to 40 Gy is a proven treatment modality for indolent orbital adnexal lymphoma (IOAL), but recently the use of low dose RT (LDRT, defined as 2 Gy x 2 fractions) has become a notable alternative. However, limited data exists comparing outcomes following LDRT to moderate-dose RT (MDRT, RT dose 4 – 36 Gy). We present a single institution retrospective analysis comparing outcomes of patients with IOALs following LDRT or MDRT.MethodsA total of 36 patients treated with 38 consecutive courses of RT were identified; LDRT was delivered for 14 courses and MDRT for 24 courses. Overall response rates (ORR) were recorded according to Deauville or RECIST criteria with a response characterized as a complete response (CR) or partial response. Local control (LC), orbital control (OC), and overall survival (OS) rates were estimated with the Kaplan-Meier method. RT toxicity was graded per CTCAEv5 and compared with the Fisher’s exact test.ResultsMedian follow-up time was 29 months (m) (range, 4-129m), and median MDRT dose used was 24 Gy (range 21-36 Gy). Overall response rates (ORR) were 100% (CR 50%) and 87.5% (CR 58.3%) following LDRT and MDRT, respectively. OS at 2 years was 100% and 95% for the LDRT and MDRT groups, respectively (p=0.36). LC rates at 2 years was 100% for both LDRT and MDRT groups and at 4 years was 100% and 89% for the LDRT and MDRT groups, respectively (p=0.56). The 4-year OC rate (including both ipsilateral and contralateral relapses) was 80% and 85% for the LDRT and MDRT groups, respectively (p=0.79). No patient required treatment with RT to a previously irradiated orbit. Acute toxicities were reported following 6 LDRT courses compared to 20 MDRT courses (p=.014). No Grade 3 or higher acute toxicities occurred in either group. Late toxicities were reported following 2 LDRT courses compared to 10 MDRT courses (p=0.147).ConclusionsLDRT produced similar ORR, LC, OC, and OS rates compared to MDRT with fewer acute and minimal late toxicities reported. Future multi-center studies with larger patient numbers are warranted to show significant associations.

P1962Impact of Dual Antiplatelet Therapy duration on clinical outcome after stent implantation for coronary bifurcation lesions: results from the Euro Bifurcation Club - P2BiTO - registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Di Serafino ◽  
H Gamra ◽  
P Cirillo ◽  
M Zimarino ◽  
I J Amat-Santos ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Clinical Outcome ◽  
Dual Antiplatelet Therapy ◽  
Coronary Bifurcation ◽  
Kaplan Meier ◽  
Bifurcation Lesions ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Duration of Dual Antiplatelet Therapy (DAPT) following Acute Coronary Syndromes (ACS) or Stable Coronary Artery Disease (SCAD) treated with coronary stenting is still debated. Although current guidelines consider several “clinical” criteria to decide for short DAPT (<6 months), standard DAPT (12 months) and prolonged DAPT (>12 months), the relationship between DAPT duration, treatment of bifurcations and its impact on clinical outcome has been poorly investigated in real world registries. Purpose We evaluated the impact of DAPT duration on clinical outcomes in consecutive all-comers patients treated with stenting of coronary artery bifurcation lesions included in the Euro Bifurcation Club -P2BiTO - registry. Methods Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centres between January 2012 and December 2014 were collected. The primary endpoint of the study was the cumulative occurrence of Major Adverse Cardiac Events (MACCE), defined as a composite of overall-death death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke during the follow-up; the secondary endpoints were the single occurrence of any of the above mentioned events. Results Data on DAPT duration was available for 3992 patients (79%). Patients were divided into 3 groups: Group 1) DAPT <6-months (n=720); Group 2) DAPT >6-months but <12-month (n=1602); Group 3) DAPT >12-months (n=1670). Follow up was completed in 3935 (98%) patients with a median of 20 months (C.I.=12–28). At 24 months after the index procedure, MACCE occurred more frequently in the DAPT <6-month group (Group 1) as compared with both Group 2 and 3 (respectively, 102 (14%) versus 154 (10%) and 164 (10%), HR: 0.72 (0.64–0.82), p<0.001). This difference remains after adjustment for clinical and angiographic characteristics (HR: 0.66 (0.58–0.77), p<0.001). On the contrary, no significant difference was found between Group 2 and Group 3 patients. At the Kaplan-Meier analysis (Figure 1), freedom from MACCE survival was significantly lower in patients receiving DAPT for less than 6 months (Log-Rank: 29.5, p<0.001). Figure 1. Kaplan-Meier curves Conclusions In the P2BiTO registry, short DAPT duration of less than 6 months was associated with a significantly higher risk of MACCE compared to longer DAPT in a real-world registry of patients treated for coronary artery bifurcation stenosis.

Combined treatment image guided-intensity modulated radiotherapy (IG-IMRT) plus high-dose rate brachytherapy (HDR) and hormonotherapy (HT) as treatment for high-risk prostate cancer: Five-year result of a phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15571-15571
Author(s):  
B. Guix ◽  
J. Bartrina ◽  
I. Henriquez ◽  
R. Serrate ◽  
P. Palombo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Dose Rate ◽  
Late Effects ◽  
High Dose Rate ◽  
High Dose ◽  
Group 2 ◽  
Grade 3 ◽  
Group 1

15571 Background: To report early and late toxicity and preliminary biochemical outcome in 345 patients with high-risk (Gleason >=7; PSA>20 or T2c-T3) clinically localized prostate cancer treated with combined high-dose-rate brachytherapy and IMRT (IMRT-HDR) to the prostate and seminal vesicles with 24–36 months of hormononal treatment (goserelin+bicalutamide) (HT). Methods: Between 12/1999 and 10/2003, 345 patients with PSA>20, Gleason score>6 and/or T2c-T3 N0 M0 prostate cancer were treated with IG-IMRT followed by HDR implant to the prostate and HT. Patients were randomly assigned to receive HT for 24 (group 1, 172 patients) or 36 months (group 2, 173 patients). Acute and late toxicities were scored by the EORTC/RTOG morbidity grading scales. Special attention to local, regional or distant recurrence, survival, late effects, PSA and testosterone levels and quality of life was done. PSA failure was defined as nadir +2.0 ng/ml. Results: All patients completed treatment. One patient included in the group 1 and none of the group 2 experienced grade 3 rectal toxicity (rectal ulcer). Seven patients in each group (4.0%) developed acute Grade 2 urinary symptoms, and none experienced urinary retention. No patient (0%) developed Grade 4 rectal complications or grade 3 or 4 urinary complications. With a median follow-up of 44 months, the 5-year actuarial PSA relapse-free survival rates for the whole group of patients was 95.7 %. No statistical differences between group 1 and 2 patients were found. Conclusions: High-dose IG-IMRT+HDR and HT was a safe and effective method of escalating the dose to the prostate without increasing the risk of late effects. Acute and late rectal and urinary complications were significantly low, compared with what has been observed with high-dose conventional, 3D-conformal or IMRT-only. Short-term PSA control rates seem to be at least comparable to those achieved with 3D-EBRT or IMRT. Both treatment regimes were very effective. Longer follow-up is needed to know if better PSA control rate are achieved with longer HT. No significant financial relationships to disclose.

scholarly journals Osteochondral Autograft Transportation vs Arthroscopic Fragment Resectionfor Large Capitellar Osteochondritis Dissecans in Adolescent Athletes - A Minimum of 5-year Follow-up

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0036
Author(s):  
Yusuke Ueda ◽  
Hiroyuki Sugaya ◽  
Norimasa Takahashi ◽  
Keisuke Matsuki ◽  
Hiroshige Hamada ◽  
...  
Keyword(s):  
Radial Head ◽  
Functional Outcomes ◽  
Dash Score ◽  
Functional Scores ◽  
The Mean ◽  
Group 2 ◽  
Grade 3 ◽  
Osteochondral Grafting ◽  
Group 1

Objectives: Small capitellar osteochondritis dissecans (OCD) lesions have shown excellent functional and radiographic outcomes after arthroscopic (AS) fragment resection in previous studies. However, surgical options for unstable large capitellar OCD lesions in skeletally immature athletes remains controversial. Before 2007, we exclusively performed AS fragment resection for all inviable lesions regardless of lesion size. However, we initiated to perform osteochondral grafting for selected larger lesions in the year of 2007. The purpose of this study is to investigate functional outcomes and radiographic changes after osteochondral grafting and AS fragment resection for unstable large capitellar OCD lesions(>1/2 radial head diameter) in skeletally immature athletes with a minimum of 5-years follow-up. Methods: Group 1 consisted of 19 elbows in 19 patients (19 males; 16 baseball, 2 badminton and 1 gymnastics) that underwent osteochondral grafting for capitellar OCD (mean age, 14; range, 13-15), and the mean follow-up was 8 years (range; 5-11). Group 2 consisted of 21 elbows in 19 patients (17 males and 2 females; 16 baseball, 2 gymnastics and1 handball) that underwent AS fragment resection (mean age, 14. range, 13-15), and the mean follow-up was 8 years (range, 5-10). Preoperatively, the mean transverse diameter of lesions was 13 mm (range, 11-14) in Group 1 and 13 mm (range, 10-16) in Group 2. Superior migration of the radial head (>2-mm side-to-side difference) was seen in four elbows in Group 1 and one elbow in Group 2. Radial head enlargement with more than 20% of the contralateral side was seen in seven elbows in Group 1 and one elbow in Group 2. Functional scores (JOA score, DASH score and patient satisfaction), range of motion (ROM), and radiographic findings including Kellgren-Lawrence osteoarthritis (OA) grade were evaluated and compared between the groups. Results: All patients returned to sports activity. Functional scores at the final follow-up were not different between Group 1 and 2: JOA score, 90 (range, 68-100) vs 91 (range, 82-100); DASH score, 1 (range, 0-7) vs 3 (range, 0-14); Patient satisfaction, 84 (range, 50-100) vs 81 (range, 50-100). Flexion ROM at the final follow-up did not show significant improvement in both groups compared to preoperative values, though there was a significant difference at the final follow-up between the groups: Group 1, 133º (range, 115-150º); Group 2, 133º (range, 120-145º). Extension ROM showed significant improvement in both groups (P<.001 for both): Group 1, -18º (range, -35-0º) to -8º (range, -22-10º); Group 2, -17º (range, -50-0º) to 0º (range, -10-20º). Group 2 had significantly better extension than Group 1 at the final follow-up (P =.003). OA change progressed in 12 elbows (63%) in Group 1 and in 9 elbows (47%) in Group 2. There were four grade 3 OA elbows in Group 1, which preoperatively had superior migration and enlargement of the radial head. No elbows showed severe OA change in Group 2. Conclusion: Functional outcomes and radiological findings after both osteochondral grafting and AS fragment resection for unstable large capitellar OCD lesions in adolescent athletes were satisfactory with a mean follow-up of 8 years. However, grade 3 OA were seen after osteochondral grafting in four elbows with preoperativesuperior migration of the radial head. Osteochondral grafting should be performed before radiographical changes become severe.

scholarly journals Analysis of long-term oncological results of clinical versus pathological responses after neoadjuvant treatment in locally advanced rectal cancer

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Mariana F. Coraglio ◽  
Martin A. Eleta ◽  
Mirta R. Kujaruk ◽  
Javier H. Oviedo ◽  
Enrique L. Roca ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Anal Verge ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Distant Recurrence ◽  
Watch And Wait ◽  
Oncological Results ◽  
Group 2 ◽  
Group 1

Abstract Background Nonoperative management after neoadjuvant treatment in low rectal cancer enables organ preservation and avoids surgical morbidity. Our aim is to compare oncological outcomes in patients with clinical complete response in watch and wait strategy with those who received neoadjuvant therapy followed by surgery with a pathological complete response. Methods Patients with non-metastatic rectal cancer after neoadjuvant treatment with clinical complete response in watch and wait approach (group 1, n = 26) and complete pathological responders (ypT0N0) after chemoradiotherapy and surgery (group 2, n = 22), between January 2011 and October 2018, were included retrospectively, and all of them evaluated and followed in a multidisciplinary team. A comparative analysis of local and distant recurrence rates and disease-free and overall survival between both groups was carried out. Statistical analysis was performed using log-rank test, Cox proportional hazards regression model, and Kaplan-Meier curves. Results No differences were found between patient’s demographic characteristics in both groups. Group 1: distance from the anal verge mean 5 cm (r = 1–12), 10 (38%) stage III, and 7 (27%) circumferential resection margin involved. The median follow-up of 47 months (r = 6, a 108). Group 2: distance from the anal verge mean 7 cm (r = 2–12), 16 (72%) stage III, and 13 (59%) circumferential resection margin involved. The median follow-up 49.5 months (r = 3, a 112). Local recurrence: 2 patients in group 1 (8.3%) and 1 in group 2 (4.8%) (p = 0.6235). Distant recurrence: 1 patient in group 1 (3.8%) and 3 in group 2 (19.2%) (p = 0.2237). Disease-free survival: 87.9% in group 1, 80% in group 2 (p = 0.7546). Overall survival: 86% in group 1 and 85% in group 2 (p = 0.5367). Conclusion Oncological results in operated patients with pathological complete response were similar to those in patients under a watch and wait strategy mediating a systematic and personalized evaluation. Surgery can safely be deferred in clinical complete responders.

Dose escalation of five-fraction SABR for prostate cancer: Biochemical outcome and toxicity comparison of two prospective trials.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 224-224
Author(s):  
Hima Bindu Musunuru ◽  
Harvey Charles Quon ◽  
Liying Zhang ◽  
Patrick Cheung ◽  
Colin I Tang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Intensity Modulated Radiotherapy ◽  
Psa Bounce ◽  
Stereotactic Ablative Body Radiotherapy ◽  
Gi Toxicity ◽  
Psa Nadir ◽  
Group 2 ◽  
Grade 3 ◽  
Group 1

224 Background: To compare the biochemical outcomes and toxicities of two different 5 fraction stereotactic ablative body radiotherapy (SABR) schedules for the treatment of localized prostate cancer. Methods: Two sequential phase I/II studies of 5-fraction SABR for the treatment of low and intermediate risk (LR and IR) prostate cancer have been conducted. In the first trial, 84 LR patients(pts) received 35 Gy in 5 fractions, once per week over 29 days (Group 1). In the second trial, 30 pts (18 LR, 11 IR) received 40 Gy in 5 fractions, once per week over 29 days (Group 2). Treatment was delivered to the prostate with intensity modulated radiotherapy using daily image guidance and a 4mm (Group 1) or 5 mm (Group 2) CTV-PTV margin. PSA nadir and bRFS(nadir+2 definition) were compared between the two groups. Acute (CTCv3.0), late (RTOG) and cumulative toxicity for late grade ≥ 2 GU/GI toxicities were also compared. Results: Median follow up was 74 (IQR 67-81) and 36 (IQR 32-39) months. Median PSA nadir was 0.4 ng/ml and 0.3 ng/ml. Time to PSA nadir was 54 and 32.5 months. 44.0% in group 1 and 30% in Group 2 experienced benign PSA bounce. There were 3 and 0 PSA failures in Groups 1 and 2. 2-, 4- and 6-year bRFS was 100%, 98.7% and 95.9% and 100%, 100% and not reached in groups 1 and 2, respectively (p=0.91). The only acute grade 3 toxicity was noticed in Group 1 (1 pt, GU). Late grade 4 GI toxicity was noted in Group 1 (1 pt, GI, fistula). Up to 4 years of follow-up, Group 2 pts have had a greater percentage of grade 2+ cumulative GU (5.0% vs 24.2%) and GI (7.6% vs 26.2%) toxicities. Conclusions: Pts receiving a dose escalated SABR had slightly lower PSA nadir and similar bRFS - longer follow up is needed to better estimate biochemical outcomes in Group 2. There seemed to be a greater risk of grade 2 toxicities in the higher dose cohort but grade 3+ toxicities were not increased. Quality of life analyses will be presented separately. Clinical trial information: NCT01578902 , NCT01146340 .[Table: see text]

Sign in / Sign up

Export Citation Format

Share Document