scholarly journals External Validation of the Association of Progression-Free Survival at 6 Months (PFS6) with Overall Survival at 12 Months (OS12) in Second-Line Therapy for Advanced Urothelial Carcinoma (UC)

2012 ◽  
Vol 23 ◽  
pp. ix260 ◽  
Author(s):  
G. Sonpavde ◽  
B. Maughan ◽  
K.M. Boucher ◽  
R. Fougeray ◽  
T.K. Choueiri ◽  
...  
Keyword(s):  
Overall Survival ◽  
Urothelial Carcinoma ◽  
External Validation ◽  
Progression Free Survival ◽  
Second Line ◽  
Second Line Therapy ◽  
Free Survival ◽  
Line Therapy ◽  
Advanced Urothelial Carcinoma

PD-1 inhibitor plus chemotherapy as 2nd/subsequent line therapy had similar clinical outcome with PD-1/PD-L1 inhibitor monotherapy in advanced NSCLC.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21600-e21600
Author(s):  
Xiaoyang Zhai ◽  
Yaru Tian ◽  
Weiwei Yan ◽  
Ning An ◽  
Hui Zhu
Keyword(s):  
Overall Survival ◽  
Advanced Nsclc ◽  
Progression Free Survival ◽  
Second Line ◽  
Monotherapy Group ◽  
Second Line Therapy ◽  
Free Survival ◽  
Chemotherapy Group ◽  
Line Therapy ◽  
Nsclc Patients

e21600 Background: PD-1/PD-L1 inhibitor monotherapy has been approved as second line therapy in advanced non-small-cell lung cancer (NSCLC). The study aims to compare clinical outcome of PD-1 inhibitor plus chemotherapy with PD-1/PD-L1 inhibitor monotherapy as 2nd/subsequent line therapy in advanced NSCLC. Methods: The clinical data of NSCLC patients who received PD-1/PD-L1 inhibitor as 2nd/subsequent line therapy were retrospectively collected in our study. According to the therapy modality, patients were assigned to PD-1/PD-L1 inhibitor monotherapy group and PD-1 inhibitor plus chemotherapy group. Disease control rates (DCRs), progression free survival (PFS) and overall survival (OS) were evaluated between the 2 groups. The prognostic role of derived neutrophils-to-lymphocyte ratio (dNLR) on the outcomes was also evaluated at the same time. Results: From April 2017 to October 2019, a total of 84 patients were enrolled in the current study. Twenty-six patients were allocated to the PD-1/PD-L1 inhibitor monotherapy group and fifty-eight patients were allocated to PD-1 inhibitor plus chemotherapy group. Chemotherapy regimens were detailed as follow: liposome paclitaxel (n = 15), nab-paclitaxel(n = 12), docetaxel(n = 9), pemetrexed(n = 6), and others(n = 16). Disease control rates (DCRs) and overall survival (OS) were not significantly different between the two groups. Progression free survival (PFS) in the PD-1/PD-L1 inhibitor monotherapy was longer(median PFS: NR vs 4.4 months, p = 0.02). Univariate and multivariate analyses suggested that derived neutrophils-to-lymphocyte ratio (dNLR) was independent prognostic factor of OS and gender was independent prognostic factor of PFS. In the second-line therapy subgroup of 38 patients, OS and PFS were not significantly different in the two groups. In the subgroup of 46 patients of over 2nd line, PD-1/PD-L1 inhibitor monotherapy group had longer PFS (median PFS: NR vs 4.0 months, p = 0.01).The incidence of any grade adverse events (AEs) was no significant difference in the two groups. One patient in the PD-1 inhibitor plus chemotherapy group died of immune-related pneumonitis. Conclusions: The addition of chemotherapy to PD-1 inhibitor as 2nd/subsequent line therapy had similar clinical outcomes compared with PD-1/PD-L1 inhibitor monotherapy of advanced NSCLC patients.

scholarly journals Protocol of the EFFORT study: a prospective study of FOLFIRI plus aflibercept as second-line treatment after progression on FOLFOXIRI plus bevacizumab or during maintenance treatment in patients with unresectable/metastatic colorectal cancer

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hironaga Satake ◽  
Koji Ando ◽  
Eiji Oki ◽  
Mototsugu Shimokawa ◽  
Akitaka Makiyama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Free Survival ◽  
First Line Therapy ◽  
Line Therapy

Abstract Background FOLFOXIRI plus bevacizumab is used as a first-line therapy for patients with unresectable or metastatic colorectal cancer. However, there are no clear recommendations for second-line therapy after FOLFOXIRI plus bevacizumab combination. Here, we describe our planning for the EFFORT study to investigate whether FOLFIRI plus aflibercept has efficacy following FOLFOXIRI plus bevacizumab for mCRC. Methods EFFORT is an open-label, multicenter, single arm phase II study to evaluate whether a FOLFIRI plus aflibercept has efficacy following FOLFOXIRI plus bevacizumab for mCRC. Patients with unresectable or metastatic colorectal cancer who received FOLFOXIRI plus bevacizumab as a first-line therapy will receive aflibercept and FOLFIRI (aflibercept 4 mg/kg, irinotecan 150 mg/m2 IV over 90 min, with levofolinate 200 mg/m2 IV over 2 h, followed by fluorouracil 400 mg/m2 bolus and fluorouracil 2400 mg/m2 continuous infusion over 46 h) every 2 weeks on day 1 of each cycle. The primary endpoint is progression-free survival (PFS). To achieve 80% power to show a significant response benefit with a one-sided alpha level of 0.10, assuming a threshold progression-free survival of 3 months and an expected value of at least 5.4 months, we estimated that 32 patients are necessary. Secondary endpoints include overall survival, overall response rate, safety, and exploratory biomarker analysis for differentiating anti-VEGF drug in 2nd-line chemotherapy for unresectable or metastatic colorectal cancer. Discussion This is the first study to investigate whether FOLFIRI plus aflibercept has efficacy following FOLFOXIRI plus bevacizumab for unresectable or metastatic colorectal cancer. Switching to a different type of anti-VEGF drug in second-line therapy after FOLFOXIRI plus bevacizumab appears to be an attractive treatment strategy when considering survival benefit. It is expected that this phase II study will prove the efficacy of this strategy and that a biomarker for drug selection will be discovered. Trial registration Japan Registry of Clinical Trials jRCTs071190003. Registered April 18, 2019.

A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study.

1992 ◽  
Vol 10 (7) ◽  
pp. 1066-1073 ◽  
Author(s):  
P J Loehrer ◽  
L H Einhorn ◽  
P J Elson ◽  
E D Crawford ◽  
P Kuebler ◽  
...  
Keyword(s):  
Overall Survival ◽  
Urothelial Carcinoma ◽  
Response Rate ◽  
Combined Therapy ◽  
Single Agent ◽  
Progression Free Survival ◽  
Free Survival ◽  
Metastatic Urothelial Carcinoma ◽  
Advanced Urothelial Carcinoma ◽  
To Receive

PURPOSE A prospective randomized trial was performed to determine if the addition of methotrexate, vinblastine, and doxorubicin to cisplatin (M-VAC) imparted a response rate or a survival advantage over single-agent cisplatin in patients with advanced urothelial carcinoma. PATIENTS AND METHODS From October 1984 through May 1989, 269 patients with advanced urothelial carcinoma were entered onto this international intergroup trial and randomized to receive intravenous (IV) cisplatin (70 mg/m2) alone or with methotrexate (30 mg/m2 on days 1, 15, 22), vinblastine (3 mg/m2 on days 2, 15, 22) plus doxorubicin (30 mg/m2 on day 2). Cycles were repeated every 28 days until tumor progression or a maximum of six cycles. There were 246 fully assessable patients of whom 126 were randomized to cisplatin alone and 120 were randomized to the M-VAC regimen. RESULTS As expected, the M-VAC regimen was associated with a greater toxicity, especially leukopenia, mucositis, granulocytopenic fever, and drug-related mortality. Response rates were superior for the M-VAC regimen compared with single-agent cisplatin (39% v 12%; P less than .0001). Similarly, the progression-free survival (10.0 v 4.3 months) and overall survival (12.5 v 8.2 months) were significantly greater for the combined therapy arm. CONCLUSION Although a more toxic regimen, we found M-VAC to be superior to single-agent cisplatin with respect to response rate, duration of remission, and overall survival in patients with advanced urothelial carcinoma.

Systemic immune-inflammation index to predict survival in patients with metastatic urothelial carcinoma treated with second-line vinflunine.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17019-e17019
Author(s):  
Patrik Palacka ◽  
Jana Katolicka ◽  
Tana Albertova ◽  
Katarina Rejlekova ◽  
Jana Obertova ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factor ◽  
Urothelial Carcinoma ◽  
Progression Free Survival ◽  
Second Line ◽  
Free Survival ◽  
Second Line Chemotherapy ◽  
Metastatic Urothelial Carcinoma ◽  
Immune Inflammation ◽  
Line Chemotherapy

e17019 Background: Based on our previous study, the systemic immune-inflammation index (SII) is a prognostic factor in patients with metastatic urothelial cancer (MUC) treated with platinum-based first-line chemotherapy. The objective of this retrospective analysis was to explore prognostic value of the SII at baseline of second-line chemotherapy with vinflunine in MUC population. Methods: We evaluated 70 consecutive MUC (53 bladder, 21 upper tract) patients (54 men) treated with second-line chemotherapy with vinflunine at four oncological departments since 2010. ECOG performance status (PS) ≤ 1 had 44 patients (pts.), haemoglobin < 10 g/dL was present in 25 pts. and liver involvement in 18 pts. SII was based on platelets (P), neutrophils (N) and lymphocytes (L) counts defined as PxN/L. This study population was dichotomized by median into low SII and high SII groups. Progression-free survival (PFS), overall survival (OS) and their 95% CI were estimated by Kaplan-Meier method and compared with logrank test. Results: At median follow-up of 9.0 months (1-29 months), 68 pts. experienced disease progression and 62 died. Pts. with low SII at baseline had significantly better PFS and OS opposite to those with high SII (HR = 0.61, 95% CI 0.37-1.00, p = 0.0318 for PFS, HR = 0.60, 95% CI 0.36-1.00, p = 0.0312 for OS, respectively). In addition to the prognostic factors by Bellmunt (ECOG PS ≥ 1, liver involvement, haemoglobin < 10 g/dL), we identified peritoneal metastases as a factor associated with significantly worse survival (HR = 0.28, 95% CI 0.11-0.72, p < 0.00001 for PFS, HR = 0.30, 95% CI 0.12-0.75, p < 0.00001 for OS, respectively). Conclusions: The SII at baseline of treatment with second-line vinflunine represents a prognostic factor for pts. with MUC. Based on SII, pts. could be stratified into clinical trials in future. MUC pts. with high SII might be candidates for a different treatment approach. Key Words: Metastatic Urothelial Carcinoma. Systemic Immune-Inflammation Index. Vinflunine. Progression-Free Survival. Overall Survival.

Progression-free survival in patients with cholangiocarcinoma with FGFR2 fusions or rearrangements: An exploration of response to systemic therapy.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 588-588 ◽  
Author(s):  
Kristen Bibeau ◽  
Luis Féliz ◽  
Scott Barrett ◽  
Ling Na ◽  
Christine Francis Lihou ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Progression Free Survival ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Free Survival ◽  
Prior Therapy ◽  
First Line Therapy ◽  
Line Therapy

588 Background: Most cholangiocarcinoma (CCA) patients (pts) are diagnosed with advanced disease and are ineligible for surgery. FGFR2 fusions or rearrangements are present in 10–16% of pts with intrahepatic CCA (iCCA) and are reported to be oncogenic drivers. However, little data are available on the role of FGFR2 genetic alterations in the response to systemic cancer therapy. FIGHT-202 is a phase 2 study of pemigatinib (a selective, potent, oral FGFR1–3 inhibitor) in pts with previously treated advanced/metastatic CCA (NCT02924376); primary results were reported at ESMO 2019. FIGHT-202 enrolled pts who progressed on ≥1 prior therapy, allowing the examination of the role of FGFR2 alterations on the response to prior therapy. The objective of this post hoc analysis was to evaluate progression free survival (PFS) on standard systemic therapy received prior to study enrollment among pts with CCA harboring FGFR2 fusions or rearrangements ( FGFR2+). Methods: Case report forms were reviewed to determine disease history and exposure to prior lines of systemic cancer therapies (LOSCT) in the advanced setting before receiving pemigatinib. Only pts with sufficient data on prior LOSCT were included in this analysis. Median PFS was calculated using the Kaplan-Meier method. Results: 102 pts were included in this analysis (median age 54.5, 61.8% female). Median PFS on first-line therapy was 5.5 (95% CI: 4.0, 8.0) months. Among the 38 pts (37.3%) with ≥2 prior LOSCT, median PFS on second-line therapy was 4.4 (95% CI: 3.0, 5.3) months. Conclusions: This analysis provides data about PFS on standard systemic therapies for pts with FGFR2+ CCA. Median PFS on first-line therapy was lower than historical published data, and median PFS on second-line therapy was slightly longer than previously reported, in unselected CCA populations. Limitations of this analysis include retrospective examination of investigator reported data, and that clinical trial participants may not truly reflect a general CCA patient population. The short PFS on standard therapies in pts with FGFR2+ CCA highlights the need for development of other options including targeted therapies to improve outcomes.

scholarly journals Vinflunine as second-line therapy for advanced urothelial carcinoma: Russian observational study

2017 ◽  
Vol 13 (3) ◽  
pp. 110-118 ◽  
Author(s):  
M. I. Volkova ◽  
V. A. Chernyaev ◽  
V. B. Matveev ◽  
B. Ya. Alekseev ◽  
K. M. Nyushko ◽  
...  
Keyword(s):  
Observational Study ◽  
Urothelial Carcinoma ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Advanced Urothelial Carcinoma

Comparative analysis of the effectiveness of second-line bevacizumab plus chemotherapy in second-line therapy in metastatic colorectal cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 619-619 ◽  
Author(s):  
Kaldigul Smagulova
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Progression Free Survival ◽  
Complete Response ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Group 2 ◽  
Group 1

619 Background: Advances in molecular biology and a wide introduction to the practice of targeted therapies have improved outcomes and significantly affect the overall survival of patients. To investigate the efficacy and safety of bevacizumab (BEV) beyond first progression combined with chemotherapy (CT) in patients with metastatic colorectal cancer. Methods: 68 patients with mCRC who received chemotherapy treatment at the Department of the Kazakh Research Institute of Oncology and Radiology. Selecting second-line chemotherapy based on oxaliplatin or irinotecan depended of an earlier first-line therapy (FOLFOX, FOLFIRI). The survival rate was calculated by Kaplan-Meier, comparison of survival curves was performed by log-rank. Results: The study included 68 patients, who were randomized from February 2009 to November 2011(to 33 [48.5%] BEV + CT and 35 [51.5%] to CT alone). Analysis of the immediate results of treatment showed that in neither case was not achieved complete response of the tumor. Partial regression in group 1 – 11 (33.3 ± 8.2)%, and group 2 - in 9 (25.7 ± 7.3)%. Stabilization is achieved in 20 (60.6 ± 8.5)% and 23 (6.7 ± 8.0)% of cases, respectively. The progression of the disease was observed in the group 1 in 2 (6.1 ± 4.1)% and 3 (8.6 ± 4.7)% of cases. Median progression-free survival (PFS) and overall survival (OS) was 11.5 months (7-16) and 12.2 months in group 1, and 9.7 months (6-13.2) (PFS), 9.1 months(OS) in group 2, respectively. The adverse event profile was consistent with previously reported data for BEV + CT. BEV-related significant adverse events included bleeding grade 3-4 (1.5 %) and venous thrombosis (2.3 %). Conclusions: Our findings demonstrate that BEV + CT continued beyond progression significantly prolong OS and PFS in second-line therapy mCRC.

A Randomized Comparison of Cisplatin Alone or in Combination With Methotrexate, Vinblastine, and Doxorubicin in Patients With Metastatic Urothelial Carcinoma

2021 ◽  
pp. 153-158
Author(s):  
Philipp Dahm ◽  
Vikram M. Narayan
Keyword(s):  
Overall Survival ◽  
Urothelial Carcinoma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Metastatic Urothelial Carcinoma ◽  
Carcinoma Of The Bladder ◽  
Advanced Urothelial Carcinoma

This chapter reviews the landmark trial in patients with advanced urothelial carcinoma of the bladder assessing how the addition of methotrexate, vinblastine, and doxorubicin to cisplatin (M-VAC) compared to cisplatin alone. The study found improved overall survival and progression-free survival in the M-VAC group, but at the expense of increased toxicity and more drug-related deaths.

Sign in / Sign up

Export Citation Format

Share Document