Neoadjuvant cisplatin-based chemotherapy in patients with ureteral obstruction secondary to muscle invasive bladder cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 523-523
Author(s):  
Marshall Strother ◽  
Alexander Kutikov ◽  
Bianca Lewis ◽  
Mengying Deng ◽  
Elizabeth A. Handorf ◽  
...  

523 Background: Neoadjuvant cisplatin-based chemotherapy (NAC) followed by cystectomy is the standard of care for muscle-invasive urothelial bladder cancer (MIBC). 15-35% of MIBC patients present with ureteral obstruction. Poor renal function increases cisplatin toxicity. It is unknown whether patients with ureteral obstruction which has been relieved (whether by nephrostomy tube or nephroureteral stent) have the same risk of toxicity as patients without ureteral obstruction. Methods: We retrospectively reviewed an institutional database of all patients undergoing NAC for MIBC with either dose dense MVAC (ddMVAC) or gemcitabine and cisplatin (GC) from January 2004 through May 2017. Patients without ureteral obstruction prior to initiation of NAC (Group A) were compared to those who had ureteral obstruction which was relieved prior to undergoing NAC (Group B). Continuous variables were compared using the Wilcoxon rank-sum test and categorical variables were compared using Fisher’s exact test. The primary outcome was premature discontinuation of NAC, which was defined as failure to complete all planned cycles. Logistic regression was used to test for differences between the groups in this outcome adjusting for age, ECOG performance status, and baseline glomerular filtration rate (GFR). Results: 160 patients in Group A and 59 patients in Group B were identified. Baseline age, Charlson Comorbidity Index, race, smoking status, and ECOG performance status were similar. Patients in Group B had lower GFR (99.2% vs 78.8% p <0.001) and were more likely to be female (21.9% vs 27.3% p <0.025) and to receive ddMVAC (65.0% vs. 83.1% p =0.012). There was no significant difference between groups in rates of premature NAC discontinuation (15.8% vs 22.0% p = 0.284) or grade ≥3 adverse events (23.4% vs 30.5% p = 0.285). Adjusted analysis showed no significant difference between the groups in frequency of premature NAC discontinuation (OR 1.96, 95% CI 0.84-4.57 p=0.12). Conclusions: We detected no difference in frequency of premature discontinuation of NAC in patients with relieved malignant ureteral obstruction relative to patients without obstruction. NAC for MIBC is likely safe in this population.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 517-517
Author(s):  
Peter Hanna ◽  
Arveen Kalapara ◽  
Subodh Regmi ◽  
Kalyana Srujana ◽  
Joseph Zabell ◽  
...  

517 Background: Radical cystectomy for muscle invasive bladder cancer is the gold standard. However, it is frequently associated with a prolonged length of hospital stay (LOS). We study the effect of ERAS protocol implementations and Alvimopan use in patients undergoing radical cystectomy and its impact on length of hospital stay (LOS). Methods: Retrospective cohort study involving consecutive patients undergoing radical cystectomy for bladder cancer at our institution from 2010 through 2018. We evaluated Alvimopan use plus an ERAS protocol post radical cystectomy versus patients who underwent ERAS protocol alone versus those who were managed prior to ERAS protocol implementation. Primary outcome of interest was LOS, controlling for age, sex, smoking status and Charleson comorbidities index. Results: 146 patients (49.32 %) received standard care (non-ERAS) (group A), 102 patients (34.45 %) underwent ERAS protocol alone (group B) and 47 patients (15.87 %) underwent ERAS protocol plus Alvimopan (group C). There was no significant difference in length of stay between group A and group B (p=0.856). However, group C experienced a shorter LOS (16.6%) compared to group A (p=0.015). Similarly, group B was not significantly associated with the days to bowel movements compared to group A (p=0.112), however, group C demonstrated a significantly shorter time (16.3%) to bowel movements compared to group A (p=0.015). On other hand, group c wasn’t significantly associated with time tolerance to regular diet (p=0.068). Limitations include retrospective nature of some of the data, non-randomized approach and confounders such as a mix of robot and open approaches to cystectomy. Conclusions: Of all ERAS protocol components, Alvimopan appeared to be the most significant contributor in accelerating GI recovery and decrease LOS in our cohort.


2015 ◽  
Vol 9 ◽  
pp. CMO.S18682 ◽  
Author(s):  
Prakash Peddi ◽  
Runhua Shi ◽  
Binu Nair ◽  
Fred Ampil ◽  
Glenn M. Mills ◽  
...  

Efficacy of cisplatin versus cetuximab with radiation in locally advanced head and neck cancer (LAHNC) was evaluated. A total of 96 patients with newly diagnosed LAHNC treated at our institution between 2006 and 2011 with concurrent radiation and cisplatin (group A, n = 45), cetuximab (group B, n = 24), or started with cisplatin but switched to cetuximab because of toxicity (group C, n = 27) were reviewed. Chi-square test, analysis of variance, and log-rank test were used for analysis. The three groups had similar baseline characteristics, except for median age, T stage, albumin levels, hemoglobin levels, performance status, and comorbidities. A complete response (CR) was seen in 77%, 17%, and 67% of patients ( P < 0.001), respectively. There was no significant difference in median overall survival (OS) between groups A and C. The median OS for groups A and C was not reached (>65 months), even though it was significantly longer than median OS for group B (11.6 months; P ≤ 0.001). The 2-year OS in groups A and C is significantly higher than that in group B (70% for groups A and C, 22% for group B). There is no significant difference in progression-free survival (PFS) between groups A and C. The median PFS for these groups was not reached (>62 months), and is significantly longer than that for group B (4.3 months; P ≤ 0.001). The 2-year PFS of group A (67%) and group C (76%) was significantly longer than that of group B (20%). Cisplatin with radiation appears to be more efficacious even in suboptimal dosing than cetuximab with radiation in LAHNC but the two groups were not well matched.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3590-3590
Author(s):  
Patrizia Zappasodi ◽  
Alessandro Corso ◽  
Marzia Varettoni ◽  
Catherine Klersy ◽  
Gianmatteo Pica ◽  
...  

Abstract Background: Bisphosphonates (Bi) have been proven to be effective in preventing or delaying skeletal complications in multiple myeloma (MM) with a significant improvement of the quality of life. The 2002 ASCO guidelines indicate that once initiated intravenous Bi should be continued until an evident substantial decline of performance status. Recently, osteonecrosis of the jaw (ONJ) has been reported as complication of intravenous Bi treatment, with an incidence ranging between 6 and 13% and a greater occurrence in patients (pts) receiving zoledronic acid (Zol) than in those treated with pamidronate (Pam). Aim. In this retrospective study we evaluated the incidence of ONJ and of skeletal related events (SRE) in a cohort of MM pts divided in two groups according to the schedule of administration of Bi; group A: monthly administrations until tolerated (standard), group B: monthly administrations during the first year and then every 3 months (reduced). Methods: One hundred and six MM pts (M: 63, F: 43) were included in this study: 51 pts received a standard treatment (group A) and 55 a reduced schedule (group B). Pam 90 mg i.v. was administered as a three hour infusion and Zol 4 mg i.v. as a 15 minutes infusion. SRE was defined as: pathologic fracture, radiation to bone, spinal cord compression with vertebral fracture, hypercalcemia. Results: No difference was found between the two groups concerning pts characteristics at the onset: age, sex, extension of bone disease, status of the disease (progressive or responsive). Twenty pts received only Pam, 42 only Zol and 44 pts Pam followed by Zol. The distribution of the different type of Bi was not different in the two groups. ONJ occurred in 7 pts (6.6%) with a significant difference between the two groups: 6 pts in standard schedule (11.7%) and 1 in the reduced (1.8%), p=0.01, after a median time of 22.8 months in group A, and 37.8 months in the case of group B. Four of out 7 ONJ occurred during the second year of treatment (12–24 months): that period resulted significantly related (p=0.000) to the occurrence of ONJ with respect to the others (24–38 months, 40–100 months). All ONJ occurred in pts treated with Zol alone (5 pts) or with Zol after Pam (2 pts), whereas no cases were observed in Pam alone pts (p= 0.005). The median number of infusions was 20 with comparable results in the two groups (20 in group A, 19 in group B). SRE was observed in 38 pts (35.8%): 16 pts in group A and 22 pts in group B without statistical difference (p=0.6), after a median time of 9.8 months. Conclusions: These results suggest that the reduced schedule of Bi is associated with a significant lower incidence of ONJ and, although the sample size is limited, the appearance of ONJ seems delayed with respect to the standard treatment. Moreover, the incidence of SRE is similar in the two groups. In conclusion, the reduced schedule, could be applied in order to combine the antiresorptive efficacy of Bi with a higher safety and a better compliance.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4000-4000 ◽  
Author(s):  
E. Van Cutsem ◽  
M. Nowacki ◽  
I. Lang ◽  
S. Cascinu ◽  
I. Shchepotin ◽  
...  

4000 Background: Cetuximab in combination with irinotecan-based regimens has proven activity in previously-treated patients (pts) with mCRC. The present trial investigated the effectiveness of cetuximab in combination with standard FOLFIRI compared with FOLFIRI alone in the first-line treatment of pts with epidermal growth factor receptor (EGFR)-expressing mCRC. Methods: Pts were randomized 1:1 to receive either cetuximab (400 mg/m2 initial dose then 250 mg/m2/week [w]) plus FOLFIRI q 2 w (irinotecan 180 mg/m2, FA 400 mg/m2, 5-FU bolus 400 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 hours) (Group A) or FOLFIRI alone (Group B). The primary endpoint was progression-free survival (PFS), with secondary endpoints of overall survival (OS), response rate (RR), disease control rate and safety. 633 events were required to statistically differentiate PFS between groups with 80% power. Results: Between August 2004 and October 2005, 1,217 pts were randomized, 608 to Group A and 609 to Group B (60% male, median age 61 [19–84], ECOG performance status: 0=54%; 1=43.5%; 2=3.5%). Median PFS was significantly longer for Group A compared to Group B (8,9 months [8 - 9,5] for Group A vs. 8 months [7.6 - 9] for Group B, p=0.036). Response Rate was also significantly increased by cetuximab (46.9% vs. 38.7%, p=0.005). Treatment was generally well tolerated with neutropenia (26.7% Group A, 23.3% Group B), diarrhea (15.2% and 10.5% respectively) and skin reactions (18.7% and 0.2% respectively) being the most common grade 3/4 adverse events. Conclusions: Cetuximab in combination with FOLFIRI significantly increases response rate and significantly prolongs PFS in the first-line treatment of pts with mCRC, reducing the relative risk of progression by approximately 15%. Treatment-related side effects of cetuximab in combination with FOLFIRI were as expected, with diarrhea being moderately and skin reactions significantly more frequent as compared to FOLFIRI alone. [Table: see text]


2020 ◽  
Vol 10 (2) ◽  
Author(s):  
Sanaullah . ◽  
Mumtaz Ali ◽  
Nizamuddin . ◽  
Fazal Elahi ◽  
Amanullah . ◽  
...  

Background: Many regimes of intravesical therapy have been tried in attempt to reduce the recurrence rate of non muscle invasive bladder cancer, these generally require frequent attendance for instillation. Multiple non-comparative studies have demonstrated the favourable outcomes of the immediate treatment by instillation of mitomycin C after transurethral resection of bladder tumor (TURBT) in cases of non-muscle invasive Transitional Cell Carcinoma.Objective: To compare frequency of tumour recurrence in low risk transitional cell carcinoma of bladder between single dose Mitomycin C instillation and control group.Material and Methods: This study was conducted at urology departmentsaidu teaching hospital and Nawaz sharif kidney center swat. Study Design Quasi Experimental.Study Duration was (From: Feb 2018 to February 2019). Total 62 patients fulfilling the inclusion criteria were selected. Patient were divided between group A and B according to Non probability purposive sampling. TURBT was done in all patients. In those assigned to group A Mitomycin C 40mg was instilled through foleys catheter and clamped within 12 hrs of resection once haematuria has cleared. Mitomycin C was retained for 2 hrs and then foleys catheter was removed.Results: Mean age of patients in Group-A and in Group-B was 54.90±11.48 and 60.03±13.58 years respectively. In Group-A 1(3.2%) and in Group-B 9(29%) patients had recurrence after 3 months follow up time period. Recurrence rate of Group-B was significantly higher. i.e. (p-value=0.006).Conclusion: Results of this study showed the superiority of mitomycin C in patients with low risk non muscle invasive bladder cancer in terms of significantly lower recurrence rate as compared to that of control group. So, it can be said that single mitomycin C instillation significantly decrease recurrence in patients with low risk non muscle invasive bladder cancer.


2019 ◽  
Vol 21 (Supplement_4) ◽  
pp. iv15-iv15
Author(s):  
Igor Maleyko ◽  
Benjamin Hall ◽  
Andrew Brodbelt ◽  
David Lawson ◽  
Michael Jenkinson ◽  
...  

Abstract Aim Current standard of care for glioblastoma is maximum safe resection followed by radio chemotherapy with Temozolomide. Older patients are less likely to receive the full treatment. The aim was to determine treatment and outcomes in glioblastoma patients >65 years. Methods Single centre retrospective study from 2001–2016. Eligible patients had: (i) diagnosis of glioblastoma (ii) undergone biopsy or resection with radiotherapy ± adjuvant chemotherapy. Age at diagnosis, type of surgery, performance status, complications, adjuvant therapy and median survival (MS) were recorded. Patients were assigned to group A (age <65), B (age 65–69 years) or C (age >/= 70 years). Results 637 patients met the eligibility criteria and 403 had complete records for analysis. Age distribution of the cohort was 17.9 – 91.6 years. In the group A (n=259), those who had undergone resection had significantly longer MS compared to biopsy: 17.2 vs 13.2 months (P<0.05 CI: 444.043 – 561.957). 70 patients developed complications. In the group B (n=79), those who had undergone resection had significantly longer MS compared to biopsy: 12.3 vs 5.1 months (P<0.05 CI: 194.354 – 335.646). 17 patients developed complications. In the group C (n=64), analysis did not show statistically significant difference (P=0.066 CI: 220.476 – 321.524). Clinically, patients who had resection had longer MS (10.5 months vs 3.5 months). Furthermore, there was no significant difference in the rate of complications between resection and biopsy (Fisher’s exact test, P=0.755). Conclusion i) Patients >65 should be treated as per the Stupp protocol ii) In patients >70 surgical resection should be considered.:


2021 ◽  
pp. 205141582097799
Author(s):  
Edward JM Hart ◽  
Liam E Kavanagh ◽  
Alexandra M Guy ◽  
Bronagh Lindsey ◽  
Jo Walters ◽  
...  

Objective: Robot-assisted radical cystectomy (RARC) is considered the gold-standard for patients who fail Bacillus Calmette–Guérin (BCG) treatment for high-grade non-muscle-invasive bladder cancer. We reviewed our histopathological outcomes to assess whether we are proceeding to cystectomy at an appropriate time. Methods: A retrospective analysis of the RARC database (2015–2020) was performed to identify patients who received intravesical BCG before cystectomy. Data regarding demographics, number of BCG instillations and staging were collected. Histopathological stage at cystectomy was compared between patients who received an induction course of BCG only (group A), and those who had continued maintenance doses (group B). Results: A total of 73 patients (57 males and 16 females) met the final inclusion criteria, with 24 patients in group A and 49 patients in group B. At cystectomy, 19 patients had ⩾T2 disease (group A: 7; group B: 12). There was no significant difference between groups ( p=0.78). Pelvic lymph node dissection was performed in 68 patients, with six patients found to have lymph node metastases. Conclusion: RARC plays a key role in managing BCG failure, considering the number of patients with muscle-invasive disease at final staging. However, prolonged BCG treatment was not associated with more advanced disease in our case series. Thus, persistence with intravesical treatment warrants consideration for selected patients. Level of evidence: Level 4.


2014 ◽  
Vol 2014 ◽  
pp. 1-7
Author(s):  
Mohamed Shehata ◽  
Bassem AbdElhalim ◽  
Hany Hanna ◽  
Mervat Nabih

Objective. Tachyarrhythmias, after coronary artery bypass graft (CABG) surgery, develop in 11%–40% of patients. Surgery technique (on-pump or off-pump) might affect incidence of post-CABG tachyarrhythmias. Methods. The study included 60 patients undergoing CABG (≥2 grafts) with left ventricle ejection fraction (LV EF) >40%. Patients were divided into two groups equally: group A (on-pump) and group B (off-pump). Patients were subjected to electrocardiographic monitoring (7 days postoperatively), transthoracic echocardiography, with recording of surgical details and complications. Results. Data collected between December 2012 and May 2013 showed no significant difference between two groups regarding incidence of postoperative tachyarrhythmias with statistically significant higher incidence of supraventricular tachycardia in group B (P<0.05) and a trend towards higher incidence of atrial fibrillation in group A. Patients who developed postoperative tachyarrhythmias in group A showed higher prevalence of family history of coronary artery disease and higher incidence of postoperative chest infections (P<0.05), while those in group B showed higher mean LV EF (pre- and postoperatively) (P<0.05). Data were statistically described in terms of mean ± standard deviation. Comparison of numerical and categorical variables was done using Student’s t- and Chi-square tests, respectively. Conclusion. Adopting off-pump CABG technique is not associated with less incidence of post-operative tachyarrhythmias, as compared to on-pump technique.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6581-6581
Author(s):  
N. Khattry ◽  
L. Kumar ◽  
R. Kumar ◽  
C. Patel ◽  
V. Raina ◽  
...  

6581 Background: Standard induction regimen for the management of acute myeloid leukemia (AML) includes 45 mg/m2 of daunorubicin (DNR) × 3 days and 100 mg/m2 of ara-c × 7 days. Recent studies suggest that higher doses of DNR may have better outcome. Randomized studies to objectively authenticate these observations to the best of our knowledge are not available. This study was undertaken as a preliminary trial to compare the induction remission rates and toxicity of 60 mg/m2 of DNR with standard dose of 45 mg/m2. Methods: Sixty newly diagnosed AML patients, except AML—M3, from January 2003—May 2005 were randomized to either 45mg/m2 (group A ) or 60 mg/m2 (group B) of DNR for three days. The dose of ara-c was 100mg/m2 for 7 days in both groups. All denovo AML patients with 0–2 performance status (ECOG) were included in the study. Results: Fifty six patients were evaluable, 30 in group A and 26 in group B. The baseline demographic and clinical characteristics were comparable. Twenty (67%) patients in group A and 23 (88%) in group B (p=0.05) achieved complete remission (CR). Fifteen (50%) patients in group A and 22 (84.6%) in group B (p=0.006) achieved remission after single course of induction chemotherapy. Nine patients (30%) in group A and 3 (11.5%) in group B died due to uncontrolled sepsis (p=0.09). Five patients, all belonging to Group A, had persistent disease at the time of death. Though there was no significant difference with respect to major organ toxicities in both the groups, duration of grade 4 thrombocytopenia and duration of admission were significantly greater in group A (P=0.02 and P=0.005 respectively). Conclusions: This study indicates that daunorubicin in the dose of 60 mg/m2 is superior to 45mg/m2 as a remission induction therapy for AML patients with good performance status. Further follow up is required to ascertain whether higher remission rate leads to higher disease free and over all survival. No significant financial relationships to disclose.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16012-e16012 ◽  
Author(s):  
J. H. Hoffman-Censits ◽  
Y. Wong ◽  
T. Li ◽  
S. Boorjian ◽  
V. N. Giri ◽  
...  

e16012 Background: Despite radical cystectomy (RC), subjects with MIUBC remain at risk of recurrence and optimal timing of chemotherapy remains unclear. Historically, we offered adjuvant (ADJ) CG to patients (pts) with T≥3 or node positive tumors. Since Dec 2005, neoadjuvant (NEO) CG treatment has been our preferred approach for pts with ≥T2 tumors. We compare our results with NEO and ADJ CG, including pathologic response after NEO CG. Methods: We reviewed records of patients who underwent RC for MIUBC and received at least 2 cycles of perioperative CG between Jan 2002 and Dec 2008at FCCC. We used Fisher's exact and Wilcoxon tests, as well as Generalized Estimating Equations (GEE), to compare baseline patient characteristics, dose intensity, completion, and complication rates in the ADJ and NEO groups. Results: Results of 22 ADJ and 17 NEO patients are shown below. Characteristics of age, gender, race, preop T stage and ECOG performance status (PS) ≤1 were similar. There was no significant difference in preoperative T stage between groups (p=0.2). The delivery of full doses (C 70mg/m2,G 1000 mg/m2) of GC were similar in the NEO vs the ADJ group. The delay between RC and chemotherapy may be shorter in the patients treated preoperatively, and trended toward significance (p=0.06). Reasons for dose modifications and delays are also shown in the Table . Of pts treated with NEO CG, 10/17 (55.7%) were ≤pT1 with 9 of those 10 pts also pN0 (52.9% of 17 pts) . 5/17 (29.4%) had positive lymph nodes at RC. Conclusions: CG for MIUBC is well tolerated in the NEO setting, with dose intensity comparable to that delivered adjuvantly. NEO pathologic downstaging with CG appears comparable to historical results with MVAC, and should be confirmed in larger, prospective studies. [Table: see text] No significant financial relationships to disclose.


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