Clinical Outcomes of Three or More Courses of First-line Chemotherapy for Metastatic Urothelial Carcinoma

2021 ◽  
Vol 1 (5) ◽  
pp. 459-461
Author(s):  
SHOHEI KAWAGUCHI ◽  
KOUJI IZUMI ◽  
RENATO NAITO ◽  
SUGURU KADOMOTO ◽  
HIROAKI IWAMOTO ◽  
...  

Background/Aim: The current standard of care for first-line treatment of locally advanced or metastatic urothelial carcinoma (UC) is platinum-based combination chemotherapy. Recently, immune checkpoint inhibitors have been reported to be effective for UC. Knowing whether immunotherapy or chemotherapy is suitable as first-line treatment is beneficial for patients. A retrospective study was conducted on the clinical outcomes of Japanese patients who received three or more courses of first-line chemotherapy for metastatic UC to assess the outcome of conventional treatments in real clinical situation. Patients and Methods: Patients who received first-line chemotherapy between August 2009 and December 2019 were included. Progression-free survival (PFS) and overall survival (OS) were assessed. Results: The median PFS and OS were 7.1 and 27.1 months, respectively, for patients with no disease progression at the end of three courses. Of 28 patients, 25 (89.3%) received second-line drug therapy and 10 (35.7%) received focal therapy for disease control. Patients with focal therapy had significantly longer OS than those without focal therapy (p=0.019, log-rank test). Conclusion: OS of metastatic UC at our Institution is relatively long, suggesting that aggressive second-line drug therapy and focal therapy may have contributed to such result.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 335-335
Author(s):  
Jennifer A Locke ◽  
Gregory Russell Pond ◽  
Guru Sonpavde ◽  
Andrea Necchi ◽  
Patrizia Giannatempo ◽  
...  

335 Background: Perioperative cisplatin based chemotherapy (PCBC) is a standard of care in the management of muscle invasive urothelial carcinoma (UC). Cisplatin based (C) therapy also represents the historical first line treatment of metastatic disease. There is however no data to guide the optimal choice of first line chemotherapy regimen – C re-treatment vs other second-line or non cisplatin regimens (NC) –in UC patients who relapse after receiving PCBC. This multicenter retrospective study compares C vs NC first line treatment on progression-free survival (PFS) for patients (pts) with advanced UC after PCBC and cystectomy. Methods: Data were collected for patients who received various first-line chemotherapies for advanced UC following previous PCBC therapy. Cox proportional hazards models were used to investigate the prognostic ability of type of peri-operative / first-line chemotherapy, visceral metastasis, ECOG status, time from prior chemotherapy (TFPC), anemia, leukocytosis and albumin on PFS. Results: Data were available for 145 pts from 12 centers. The mean age was 62 years, 113 (77.9%) were men and ECOG-PS was 0 or >0 in 74 (51.0%) and 61 (42.0%) patients. Ninety-one (62.8%) pts received C first line, the median number of cycles was 4 (range 1-17) and the median TFPC was 6.2 months (range 1-154). Median overall survival was 86 weeks (95% CI 70-106) and median PFS was 24 (95% CI 18-27) weeks. Time from perioperative chemotherapy (TFPC) (>52 weeks vs ≤52 weeks; HR 0.63 p=0.027) and ECOG-PS at first line (1+ vs 0; HR 1.73 p=0.010), were prognostic of PFS. No significant effect was noted for C vs NC first line (p=0.70); however, among patients with TFPC >52 weeks, patients with NC had worse PFS (median 4.6 months, 95% CI 1.8-12.2) than those who received C (median 8.1, 95% CI 3.2-16.3). Conclusions: There is no evidence to suggest overall superiority of C vs NC based first line chemotherapy or a second-line regimen in patients with advanced UC who received prior PCBC. However, those with TFPC >52 weeks should probably receive C first line chemotherapy given better PFS with C.


2019 ◽  
Vol 26 (2) ◽  
Author(s):  
K. Byrne ◽  
P. Hallworth ◽  
A. Abbas Tahami Monfared ◽  
A. Moshyk ◽  
J. W. Shaw

Background In the present study, we examined real-world treatment patterns for squamous cell carcinoma of the head and neck (scchn) in Canada, which are largely unknown.Methods Oncologists across Canada provided data for disease history, characteristics, and treatment patterns during May–July 2016 for 6–8 consecutive patients receiving first-line or second-line drug treatment for scchn (including locally advanced and recurrent or metastatic disease).Results Information from 16 physicians for 109 patients receiving drug treatment for scchn was provided; 1 patient was excluded from the treatment-pattern analysis. Median age in the cohort was 63 years [interquartile range (iqr): 57–68 years], and 24% were current smokers, with a mean exposure of 26.2 ± 12.7 pack–years. The most common tumour site was the oropharynx (48%). Most patients (84%) received platinum-based regimens as first-line treatment (44% received cisplatin monotherapy). Use of cetuximab-based regimens as first-line treatment was limited (17%). Of 53 patients receiving second-line treatment, 87% received a first-line platinum-based regimen. Median time between first-line treatment with a platinum-based regimen and initiation of second-line treatment was 55 days (iqr: 20–146 days). The most common second-line regimen was cetuximab monotherapy (43%); platinum-based regimens were markedly infrequent (13%).Conclusions Our analysis provides real-world insight into scchn clinical practice patterns in Canada, which could inform reimbursement decision-making. High use of platinum-based regimens in first-line drug treatment was generally reflective of treatment guidelines; cetuximab use in the second-line was higher than anticipated. Additional real-world studies are needed to understand the effect of novel therapies such as immuno-oncology agents on clinical practice and outcomes, particularly for recurrent or metastatic scchn.


2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 262-262
Author(s):  
Shinji Urakami ◽  
Junji Yonese ◽  
Yasuhisa Fujii ◽  
Shinya Yamamoto ◽  
Takeshi Yuasa ◽  
...  

262 Background: We had previously reported the phase I/II study of a combination regimen of gemcitabine, etoposide, and cisplatin (GEP) in second-line treatment for patients with advanced UC. This study sought to examine the combination chemotherapy of GEP as first-line treatment for advanced urothelial carcinoma (UC) to assess efficacy, feasibility, prognostic factors, and the impact of postchemotherapy surgery on outcomes. Methods: Forty-two patients were treated with GEP as first-line treatment for metastatic or unresectable locally advanced UC. GEP was recycled every 4 weeks. Etoposide and cisplatin were given on days 1 through 3 at doses of 60 mg/m2 and 20 mg/m2, respectively, and gemcitabine was given on days 1, 8, and 15 at a dose of 800 mg/m2. Results: The median patient age was 64 years. Twenty-three male patients and 19 female patients were included. The primary cancer site is urinary bladder in 21 patients, and upper urinary tract in 21 patients. Nineteen had visceral/bone metastases, 16 had disease restricted to lymph nodes, and the remaining 7 had unresectable disease at primary site. The median number of GEP courses was 4. Thirty of 42 assessable patients (71.4%) demonstrated objective responses. At a median follow-up of 14.6 months, the median overall survival time (OS) was 16.2 months. Twenty-four of 30 responders underwent postchemotherapy surgeries. Median OS in the patients with postchemotherapy surgery was 25.4 months. In the multivariable analysis, anemia and visceral/bone metastasis were significant pretreatment prognostic factors for OS. In addition, being male and anemic were independent poor prognostic factors in patients with postchemotherapy surgery. Grade 3-4 neutropenia, anemia and thrombocytopenia occurred in 84%, 73% and 57%. There were no treatment-related deaths. Conclusions: GEP as first-line chemotherapy in combined-multimodality treatment is active and moderately tolerable for advanced UC. Postchemotherapy surgery may yield favorable outcomes in patients who achieved objective responses. Anemia and visceral/bone metastasis were independent pretreatment predictors for OS.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16151-e16151
Author(s):  
J. M. Cervera ◽  
I. Garcia-Carbonero ◽  
R. Girones ◽  
M. Beltran ◽  
V. Calderero ◽  
...  

e16151 Background: IV NVB plus hydrocortisone (HC) compared with HC alone resulted in improved clinical benefit, progression-free survival (PFS) and PSA response rate in HRPC. The oral formulation of NVB avoids the side effects associated with the IV injection, may reduce administration and toxicity-related costs and is easy to administer. Due to these advantages, single agent oral NVB treatment could be considered as an optimal option for patients (p) with HRPC previously treated with a taxane or as first-line treatment when a taxane is not indicated. We retrospectively evaluated efficacy and toxicity or oral NVB administered as single agent as first or second-line chemotherapy of metastatic HRPC. Methods: Retrospectively data was collected from p with metastatic HRPC treated with oral NVB 80 mg/m2 days 1 and 8, with a prior test of myelosensitivity at 60 mg/m2 for the first cycle, plus prednisone 10 mg/day. Patients had received a taxane as first-line treatment or had a documented contraindication to receiving docetaxel. 1 cycle was equivalent to a 3-week period. Results: Data on 55 p treated in 11 Spanish centres were included for assessment. Median age was 72.5 years (range 54–86). ECOG PS 0, 17%; 1, 66%; 2, 17%. Median PSA 75 ng/mL. Prior taxane chemotherapy, 87%. Median number of cycles was 4 (range 1–6). 53.8% of p could escalate oral NVB to 80 mg/m2. 221 cycles were performed, 4.1% were delayed and 3.2% had a dose reduction. Grade 3–4 events were infrequent and mainly haematological: neutropenia (5.5% of p), anemia (3.6%), pain (3.6%), infection (1.8%), asthenia (1.8%), respiratory (1.8%). No febrile neutropenia was reported. 49 p were evaluable for PSA response rate; complete plus partial response was observed in 20.4% (95% CI: 10.2% - 34.3%) and PSA stable was reported in 40.8%. 29 p were evaluable for measurable disease; among them, 20.7% presented partial response and 44.8% stable disease. Median follow-up was 4.3 months. Survival status: 49 p (89.1%) are alive and 6 p (10.9%) died. Conclusions: Oral NVB is a safe and active regimen in previous chemotherapy treated HRPC. For those p who can not receive a taxane as first-line therapy, oral NVB can also be considered as an effective first-line treatment. No significant financial relationships to disclose.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15144-e15144
Author(s):  
Jose Manuel Cervera Grau ◽  
Miguel Beltran ◽  
Iciar Garcia Carbonero ◽  
Regina Girones ◽  
Aranzazu Gonzalez del Alba ◽  
...  

e15144 Background: IV NVB plus hydrocortisone (HC) compared with HC alone resulted in improved clinical benefit, progression-free survival (PFS) and PSA response rate in HRPC. The oral formulation of NVB avoids the side effects associated with the IV injection, may reduce administration and toxicity-related costs and is easy to administer. Due to these advantages, single agent NVBO treatment could be considered as an optimal option for patients (p) with HRPC previously treated with a taxane or as first-line treatment when a taxane is not indicated. We retrospectively evaluated efficacy and toxicity or NVBO administered as single agent as first or second-line chemotherapy of metastatic HRPC. Methods: Retrospectively data was collected from p with metastatic HRPC treated with NVBO 80 mg/m2 on days 1 and 8, with a prior test of myelosensitivity at 60 mg/m2 for the 1st cycle (cy), plus prednisone 10 mg/day. Patients had received either a taxane as 1st-line treatment or had a documented contraindication to receiving docetaxel. 1 cy was equivalent to a 3-week period. Results: Data on 67 p treated in 13 Spanish centres were included. Median age 73 years (range 54-86). ECOG PS 0, 16.4%; 1, 56.7%; 2, 11.9%. Median PSA 88.9 ng/mL. Prior chemotherapy, 58.2%. Median number of cy was 4 (range 1-6). 56.9% of p could escalate NVBO to 80 mg/m2. 265 cy were performed, 9.1% were delayed and 2.3% had a dose reduction. Grade 3-4 events were infrequent and mainly hematological: neutropenia (6% of p), anemia (4.5%), pain (3%), infection (1.5%), asthenia (3%), respiratory (1.5%), cystitis (1.5%), rectal bleeding (1.5%), febrile syndrome (1.5%), renal (1.5%). No febrile neutropenia was reported. PSA response rate 16.1%, PSA stable was reported in 41.9%. 39 p were evaluable for measurable disease; among them, PR 17.9%, SD 48.7%. Median follow-up, 7.1 months. Median overall survival, 11 months [95% CI: 7.3-14.7]. Median PFS, 2.9 months [95% CI: 2.2-3.6]. Conclusions: NVBO is a safe and active regimen in previous chemotherapy treated HRPC. For those p who cannot receive a taxane as first-line therapy, NVBO can also be considered as an effective first-line treatment.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19001-e19001 ◽  
Author(s):  
David L Veenstra ◽  
Preeti S. Bajaj ◽  
Josh John Carlson ◽  
Hans-Peter Goertz

e19001 Background: A recent phase III clinical trial, EURTAC, demonstrated that first-line treatment with erlotinib significantly improved progression-free survival (PFS) compared with standard chemotherapy in advanced non-small cell lung cancer (NSCLC) patients whose tumors harbored epidermal growth factor receptor (EGFR) mutations (Rosell 2012). We sought to estimate the cost-utility of treatment with erlotinib in this patient population from the US payer perspective. Methods: We developed a Markov model with three health states: PFS, progression, and death. Patients received treatment until progression, unacceptable toxicity or death; patients randomized to chemotherapy received a maximum of 4 treatment cycles. Transition probabilities were extrapolated from the trial. Median PFS was 9.7 months in patients receiving erlotinib and 5.2 months in patients receiving chemotherapy (p<0.0001). Cost and utility data were obtained from the literature. Probabilistic sensitivity analysis (PSA) was performed to assess uncertainty. We evaluated two scenarios: 1) first-line erlotinib vs. first-line chemotherapy, and 2) first-line erlotinib and mixed second-line treatments vs. first-line chemotherapy and second-line erlotinib. Results: First-line treatment with erlotinib vs. chemotherapy resulted in an increase of 0.60 life-years or 0.44 quality-adjusted life-years (QALYs). Mean total costs were $59,300 in the erlotinib arm and $17,800 in the chemotherapy arm, yielding an incremental cost-effectiveness ratio (ICER) of $98,338 with a 53% probability of being cost-effective at a willingness to pay (WTP) of $100,000/QALY. In the second scenario, the ICER was $50,002/QALY, with a 66% probability of being cost-effective. The main cost drivers in the model were the time spent in the PFS health state and drug costs. Conclusions: Treatment with erlotinib in first-line EGFR-positive NSCLC results in increased costs but also substantial increases in QALYs, demonstrating that this personalized approached to treatment may be cost-effective.


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