Second-line chemotherapy in advanced biliary tract cancer: Who may benefit?

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 381-381
Author(s):  
Massimiliano Salati ◽  
Francesco Caputo ◽  
Luigi Marcheselli ◽  
Margherita Rimini ◽  
Andrea Spallanzani ◽  
...  
Keyword(s):  
High Risk ◽  
Biliary Tract Cancer ◽  
Risk Group ◽  
Daily Practice ◽  
High Risk Group ◽  
Second Line ◽  
First Line ◽  
Tract Cancer ◽  
Ecog Ps ◽  
Line Chemotherapy

381 Background: No established second-line treatment (2L) is available for patients (pts) with advanced biliary tract cancer (ABC) failing gemcitabine/platinum first-line chemotherapy (CT). However, 20-40% of pts are offered 2L CT in daily practice. We evaluated the impact of clinical and biochemical parameters on survival of ABC in order to identify factors aiding in 2L treatment selection. Methods: Medical records of consecutive ABC pts treated with 2L CT between 2005 and 2018 at the Modena Cancer Centre were reviewed. Log-rank test and multiple Cox proportional hazard regression were performed to assess the prognostic significance of covariates on OS. A prognostic score was developed from the multivariate model. Results: A total of 98 pts were identified and included in the analysis. Median (m) age was 63 years, 52% of pts were female, 75% had ECOG PS of 1-2. 72% of pts received first-line gemcitabine/platinum combination. In the 2L setting, 70% of pts received a doublet and the most common regimen was FOLFIRI (26%), followed by FOLFOX (20%) and fluoropyrimidine monotherapy (19%). Disease control rate was 39%, with 7% of objective responses. mOS and mPFS were 7.2 months and 3.5 months, respectively. At both univariate and multivariate analysis ECOG PS > 0 ( P= 0.002), peritoneum involvement ( P< 0.001), LDH > 430 UI/L ( P< 0.001), albumin < 3.5 g/dL ( P= 0.001), gamma-GT > 100 UI/L ( P= 0.001), PFS to first-line < 6 months ( P= 0.025), Na+ < 140 mEq/L ( P= 0.010), absolute lymphocyte count < 1000/uL ( P= 0.030) were significantly associated with shorter OS. By assigning to each of the 8 variables weight = 1, three different risk groups were identified: low-risk group (0-2 factors), intermediate-risk group (3-4 factors) and high-risk group (5-8 factors). mOS was 18, 9.4, and 2.9 months in the low-, intermediate-, and high-risk group, respectively ( P< 0.001). Conclusions: Our 2L study confirms the prognostic value of ECOG PS, PFS to first-line and peritoneal carcinomatosis, identifies novel biochemical prognosticators and proposes a readily-available and inexpensive score to risk stratify patients both in daily practice and clinical trials.

scholarly journals Risk-adapted treatment reduced chemotherapy exposure for clinical stage 1 pediatric testicular cancer

2020 ◽  
Author(s):  
yunlin ye ◽  
Zhuang-fei Chen ◽  
Jun Bian ◽  
Hai-tao Liang ◽  
Zi-ke Qin
Keyword(s):  
High Risk ◽  
Testicular Cancer ◽  
Decision Analysis ◽  
Relapse Rate ◽  
Risk Group ◽  
Clinical Stage ◽  
Second Line ◽  
First Line ◽  
Risk Patients ◽  
Line Chemotherapy

Abstract Background: Different from adult clinical stage I (CS1) testicular cancer, surveillance was recommended for CS1 pediatric testicular cancer. For high-risk children, greater than 50% of them suffered relapse and progress during surveillance and adjuvant chemotherapy was administrated. Risk-adapted treatment might reduce chemotherapy exposure for those children.Methods: The decision model was designed and calculated using TreeAge Pro 2011 software. Clinical utilities such as relapse rates of different groups during surveillance or after chemotherapy were collected from literatures. And a survey to urologist was performed to evaluate the toxicity of the first-line and second-line chemotherapy. Using decision analysis model, chemotherapy exposure between risk-adapted treatment and surveillance were compared based on this series of clinical utilities. One-way and two-way tests were administrated to check the feasibility.Results: In base case decision analysis of CS1 pediatric testicular cancer, risk-adapted treatment preferred lower exposure of chemotherapy than surveillance (average: 0.7965 cycle verse 1.3419 cycles). The sensitivity analysis demonstrated that when relapse rate after primary chemotherapy ≤0.10 and the relapse rate of high-risk group ≥0.40, risk-adapted treatment would expose lower chemotherapy, without association of the proportion of low-risk patients, the relapse rate of low-risk group, relapse rate after salvage chemotherapy and toxicity utility of second-line chemotherapy compared to first-line chemotherapy.Conclusions: Using decision analysis, risk-adapted treatment might decrease chemotherapy exposure for these high-risk patients and precious evaluation after orchiectomy was critical to this process. Further clinical study was needed to validate this statement.

scholarly journals Risk-adapted treatment reduced chemotherapy exposure for clinical stage 1 pediatric testicular cancer

2020 ◽  
Author(s):  
yunlin ye ◽  
Zhuang-fei Chen ◽  
Jun Bian ◽  
Hai-tao Liang ◽  
Zi-ke Qin
Keyword(s):  
High Risk ◽  
Testicular Cancer ◽  
Decision Analysis ◽  
Relapse Rate ◽  
Risk Group ◽  
Clinical Stage ◽  
Second Line ◽  
First Line ◽  
Risk Patients ◽  
Line Chemotherapy

Abstract Background: Different from adult clinical stage I (CS1) testicular cancer, surveillance has been recommended for CS1 pediatric testicular cancer. However, among high-risk children, more than 50% suffer a relapse and progression during surveillance, and adjuvant chemotherapy needs to be administered. Risk-adapted treatment might reduce chemotherapy exposure among these children.Methods: A decision model was designed and calculated using TreeAge Pro 2011 software. Clinical utilities such as the relapse rates of different groups during surveillance or after chemotherapy were collected from the literature. A survey of urologists was conducted to evaluate the toxicity of first-line and second-line chemotherapy. Using the decision analysis model, chemotherapy exposure of the risk-adapted treatment and surveillance strategies were compared based on this series of clinical utilities. One-way and two-way tests were applied to check the feasibility.Results: In the base case decision analysis of CS1 pediatric testicular cancer, risk-adapted treatment resulted in a lower exposure to chemotherapy than surveillance (average: 0.7965 cycles verse 1.3419 cycles). The sensitivity analysis demonstrated that when the relapse rate after primary chemotherapy was ≤0.10 and the relapse rate of the high-risk group was ≥0.40, risk-adapted treatment would result in a lower exposure to chemotherapy, without any association with the proportion of low-risk patients, the relapse rate of the low-risk group, the relapse rate after salvage chemotherapy or the toxicity utility of second-line chemotherapy compared to first-line chemotherapy.Conclusions: Based on the decision analysis, risk-adapted treatment might decrease chemotherapy exposure for these high-risk patients, and an evaluation after orchiectomy was critical to this process. Additional clinical studies are needed to validate this statement.

scholarly journals Chemo-resistant gestational trophoblastic neoplasia: a review of cases at a tertiary cancer centre

2019 ◽  
Vol 8 (4) ◽  
pp. 1620
Author(s):  
Sharayu R. Mirji ◽  
Shilpa M. Patel ◽  
Ruchi S. Arora ◽  
Ava D. Desai ◽  
Meeta H. Mankad ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Group ◽  
Complete Response ◽  
High Risk Group ◽  
Low Risk ◽  
Gestational Trophoblastic Neoplasia ◽  
First Line ◽  
Β Hcg ◽  
Cure Rates ◽  
Line Chemotherapy

Background: Gestational trophoblastic neoplasia (GTN) was earlier a dreaded malignancy with high mortality rates. GTN is now considered to be one of the most curable solid tumours in women with cure rates greater than 90% even in the presence of metastases. Despite the high chemo sensitivity, treatment failure or drug resistance has been described in both groups.Methods: In this study, available records of GTN cases over 6 years were reviewed with emphasis on those who were resistant to the first line of chemotherapy. Of these, 37(34.58%) were resistant to the first line of chemotherapy. These cases were studied with respect to age, parity, antecedent pregnancy, interval from antecedent pregnancy, pretreatment β hCG, risk score and presence of metastases. The data was analyzed in order to find any risk factors associated with chemo-resistance.Results: Total number of cases of GTN was 107. Out of these 107 cases, 63 (58.88%) were low risk and 44 (41.12%) were high risk according to FIGO scoring system. Complete response was achieved with first line chemotherapy in 70 (65.42%) patients. The remaining 37 (34.57%) were resistant to first line chemotherapy. In the low risk group, 30 (47.62%) cases, and in the high-risk group, 7(15.91%) were resistant to first line of chemotherapy.Conclusions: Despite the high chemo sensitivity of GTN, resistance to first line chemotherapy may be encountered in up to 40% of cases.  It is important to identify the patients who are at risk to develop resistance, early identification of resistance and change of chemotherapy so as to minimize the exposure of these patients to ineffective chemotherapy.

scholarly journals Risk-adapted treatment reduced chemotherapy exposure for clinical stage 1 pediatric testicular cancer

2020 ◽  
Author(s):  
yunlin ye ◽  
Zhuang-fei Chen ◽  
Jun Bian ◽  
Hai-tao Liang ◽  
Zi-ke Qin
Keyword(s):  
High Risk ◽  
Testicular Cancer ◽  
Decision Analysis ◽  
Relapse Rate ◽  
Risk Group ◽  
Clinical Stage ◽  
Second Line ◽  
First Line ◽  
Risk Patients ◽  
Line Chemotherapy

Abstract Background: Different from adult clinical stage I (CS1) testicular cancer, surveillance was recommended for CS1 pediatric testicular cancer. For high-risk children, greater than 50% of them suffered relapse and progress during surveillance and adjuvant chemotherapy was administrated. Risk-adapted treatment might reduce chemotherapy exposure for those children. Methods: The decision model was designed and calculated using TreeAge Pro 2011 software. Clinical utilities such as relapse rates of different groups during surveillance or after chemotherapy were collected from literatures. And a survey to urologist was performed to evaluate the toxicity of the first-line and second-line chemotherapy. Using decision analysis model, chemotherapy exposure between risk-adapted treatment and surveillance were compared based on this series of clinical utilities. One-way and two-way tests were administrated to check the feasibility. Results: In base case decision analysis of CS1 pediatric testicular cancer, risk-adapted treatment preferred lower exposure of chemotherapy than surveillance (average: 0.7965 cycle verse 1.3419 cycles). The sensitivity analysis demonstrated that when relapse rate after primary chemotherapy ≤0.10 and the relapse rate of high-risk group ≥0.40, risk-adapted treatment would expose lower chemotherapy, without association of the proportion of low-risk patients, the relapse rate of low-risk group, relapse rate after salvage chemotherapy and toxicity utility of second-line chemotherapy compared to first-line chemotherapy. Conclusions: Using decision analysis, risk-adapted treatment might decrease chemotherapy exposure for these high-risk patients and precious evaluation after orchiectomy was critical to this process. Further clinical study was needed to validate this statement.

Prognostic factor analysis of second-line chemotherapy in advanced biliary tract cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14688-e14688 ◽  
Author(s):  
Sang-Cheol Lee ◽  
Kyoungha Kim ◽  
Hanjo Kim ◽  
Hyun Jung Kim ◽  
Se Hyung Kim ◽  
...  
Keyword(s):  
Overall Survival ◽  
Prognostic Factors ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Salvage Chemotherapy ◽  
Second Line ◽  
First Line ◽  
Factors Affecting ◽  
Tract Cancer ◽  
Line Chemotherapy

e14688 Background: There is no evidence that second-line chemotherapy in advanced biliary tract cancer (BTC) will result in substantial prolongation of survival. The purpose of this study was to evaluate prognostic factors for the survival of patients with advanced biliary tract cancer who was refractory BTC for first-line chemotherapy. Methods: We reviewed 89 patients retrospecitively with advanced biliary tract cancer who had enrolled in two clinical trials at three branches of Soonchunhyang university hospital. They received palliative chemotherapy with 2 regimens (biweekly GEMOX and modified FOLFOX-6). GEMOX is consist of gemcitabine 1,000 mg/m2 intravenously on day 1 and oxaliplatin 85 mg/m2 intravenously on day 2 every 2 weeks and mFOLFOX-6 is that oxaliplatin 85mg/m2 and folinic acid 400 mg/m2 on day 1 follwed by a 5-FU bolus 400 mg/m2 and 46-h infusion 2400 mg/m2 every 2 weeks. To evaluate the clinicopathologic factors that affected overall survival, univariate and multivariate analyses were performed on the baseline factors. Results: 89 patients were enrolled from Sep 2006 to Aug 2010. Medain age was 62.14 years (range 35-81). Univariate analysis revealed 4 prognostic factors affecting overall survival after first-line chemotherapy. Performance status of 0-1 vs >2 (p=0.014), salvage chemotherapy (p=0.021), locoregional disease vs disseminated disease (p=0.046) and responder of first-line chemotherapy (p=0.025) was revealed. Multivariate analysis found 2 prognostic factors affecting overall survival. They were salvage chemotherapy and initial responder. Conclusions: This results suggest that 2nd-line chemotherapy is needed for patients with good performance and responder of initial chemotherapy.

Prognostic models in advanced gastric cancer in first and second line chemotherapy treatment in Spanish population.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15603-e15603
Author(s):  
Jorge Hernando-Cubero ◽  
Natalia Alvarez-Garcia ◽  
Roberto A. Pazo Cid ◽  
Javier Martinez Trufero ◽  
Maria Alvarez ◽  
...  
Keyword(s):  
Risk Factors ◽  
Gastric Cancer ◽  
Prognostic Factors ◽  
Risk Group ◽  
High Risk Group ◽  
Second Line ◽  
Chemotherapy Treatment ◽  
First Line ◽  
Moderate Risk ◽  
Line Chemotherapy

e15603 Background: No globally accepted prognostic score has been developed in advanced gastric cancer (AGC). The purpose of this study is to explore baseline host or tumor related prognostic factors in spanish AGC patients in first and second line chemotherapy treatment. In addition we compare our scores with previously published scores in asian and european population. Methods: A total of 166 patients with AGC treated in our institution between 2012 and 2016 were screened. 119 received first line chemotherapy (CT) and 47 of them also received second line CT and were included in the analysis. Prognostic factors were evaluated using the Cox proportional hazard model. We use as comparators four first line and three second line scores published in literature. Results: The overal survival (OS) in first line and second line patients were 9 and 5 months. To construct first line CT score we selected four risk factors: ECOG≥2, Her2 negative, Irinotecan based CT and albumin < 3,6mg/dl. OS were 23 months in low risk group, who had zero or one risk points, 15 months for patients in the moderate risk group, who had two or three risk points, and 5 months for patients in the high risk group, who had all four risk points. In the second line CT score we included four risk factors: ECOG ≥2, albumin < 3.6mg/dl, Hb < 11.5mg/dl and CA19.9 reduction less than 30% after 2 CT cycles. OS were 30 months in low risk group, who had zero or one risk points, 16 months for patients in the moderate risk group, who had two or three risk points, and 3 months for patients in the high risk group, who had all four risk points. Conclusions: In the present study, we propose two new prognostic scores for patients with AGC developed in the same cohort and including HER2 status. This prognostic model could help clinicians choose and applicable treatment based on the stimated prognosis. [Table: see text]

Outcomes of continuously infused 5-fluorouracil, doxorubicin, and mitomycin-C (iFAM) as salvage regimen in patients with biliary tract cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 282-282 ◽  
Author(s):  
K. Lim ◽  
S. Han ◽  
D. Oh ◽  
S. Im ◽  
T. Kim ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Mitomycin C ◽  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Salvage Chemotherapy ◽  
First Line ◽  
Salvage Regimen ◽  
Tract Cancer ◽  
Ecog Ps ◽  
Line Chemotherapy

282 Background: In advanced biliary tract cancer, after failure of first-line chemotherapy, salvage chemotherapy has not yet been established and the prognostic factors in salvage setting have not been widely known. The purpose of this study was to evaluate the efficacy and safety of iFAM as salvage chemotherapy in biliary tract cancer and to reveal the prognostic factors. Methods: Eligibility included: 1) age 18-75, 2) histologically confirmed biliary tract cancer, 3) previously treated with palliative first-line chemotherapy, 4) ECOG PS 0-2, 5) adequate organ function. iFAM consisted of 5-FU 800 mg/m2 over 12 hour on days 1-5, doxorubicin 30 mg/m2 on day 1, and mitomycin-C 8 mg/m2 on day 1, every 4 weeks. Results: Between February 2003 and August 2009, 50 patients (pts) were enrolled. The median age was 57.3 yrs (range: 26.0-71.5 yrs), and there were 33 men (66%). 32 pts (64%) had ECOG PS 0-1 and 18 pts (36%) had PS 2. Biliary tract cancers were extrahepatic cholangiocarcinoma (30%), intrahepatic cholangiocarcinoma (30%) and gallbladder cancer (40%). Previous chemotherapy mainly consisted of gemcitabine-based and 5-FU-based regimens. Median cycles of iFAM were 2 (range: 1-6). Best responses to iFAM were PR in 2 (4%) pts and SD in 9 (18%), that is response rate was 4% and disease control rate was 22% (95% CI: 7.35-28.65). The median PFS and OS were 2.2 (95% CI: 2.0–2.4) months and 5.0 (95% CI: 3.3–6.7) months, respectively. Grade 3/4 hematologic toxicities were neutropenia (10%), anemia (2%), and thrombocytopenia (8%). Frequent nonhematologic toxicities were alopecia (34%), stomatitis (28%), vomiting (24%), and diarrhea (12%), which were grade 1/2. ECOG PS (0-1 vs 2) was significant prognostic factor for both PFS (p=0.029) and OS (p=0.025). Poor response to previous chemotherapy (p=0.031) were poor prognostic factors for OS. Conclusions: iFAM is an effective and safe treatment option in refractory biliary tract cancer and can be considered as salvage regimen, especially for patients with good PS and good response to previous chemotherapy. No significant financial relationships to disclose.

An exploratory study of fruquintinib as second-line treatment for patients with advanced or metastatic biliary tract cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS4657-TPS4657
Author(s):  
Qiu Li ◽  
Pengfei Zhang
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Tract Cancer ◽  
Number Of Patients ◽  
Line Chemotherapy

TPS4657 Background: Biliary tract cancer (BTC) is a relatively uncommon but highly fatal malignancy and most patients with BTC are diagnosed at advanced stages. Currently, no standard second-line treatment has been established following recurrence from the first-line treatment. VEGF is highly expressed in more than 50% of BTC, which indicates anti-angiogenesis might be a potentially effective method to improve the outcome in BTC. Fruquintinib is a novel small molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3 and is currently being evaluated in clinical trials for multiple cancers including lung cancer, gastric cancer and colorectal cancer, and showed strong anti-tumor activity. However, the effect and safety of fruquintinib has not been investigated in the setting of second-line treatment for BTC. Methods: The study is a multicenter, single-arm, phase 2 trial of fruquintinib (5 mg, po, for 3 weeks, followed by 1 week off, 4 weeks for a cycle) for patients with advanced or metastatic BTC who have failed to first-line chemotherapy. The primary endpoint is progression-free survival (PFS) with the null hypotheses of 8 weeks, and the median PFS≥15 weeks as evidence of the study drug activity (α=0.05, 80% power, one-sided). The number of patients required to complete the study is 27. Allowing for 20% expulsion rate, the study needs 33 patients. The secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), safety and quality of life (QoL). Meanwhile, the study also set an exploratory objective to evaluate the mutation status of related genes in plasma (cfDNA) and tumor tissue and explore the interplay between mutation patterns with efficacy. Major eligibility requirements: Age ≥18 years; Histologically or cytologically confirmed diagnosis of advanced or metastatic biliary tract adenocarcinoma; First-line chemotherapy failed (tumor progression or intolerable adverse events); No less than 3 months of expected survival; ECOG PS≤1; At least one measurable lesion according to RECIST 1.1 criteria; Adequate organ function. Eligible patients with advanced or metastatic BTC refractory to first-line chemotherapy will be enrolled at 7 medical centers in China. The study is open and actively enrolling at time of submission. Clinical trial information: NCT04156958 .

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