Clinical characteristics and treatment outcomes of patients (pts) with advanced germ cell tumor (aGCT) treated at a tertiary cancer center in Brazil.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 568-568
Author(s):  
Vitor Fiorin de Vasconcellos ◽  
Diogo Assed Bastos ◽  
Allan Andresson Lima Pereira ◽  
Bruno Rodriguez Pereira ◽  
Jamile Almeida Silva ◽  
...  
Keyword(s):  
Germ Cell ◽  
Treatment Outcomes ◽  
Performance Status ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Developed Countries ◽  
Cancer Center ◽  
High Dose ◽  
Ecog Performance Status ◽  
Poor Risk

568 Background: Reported treatment outcomes for pts with aGCT are largely based on series from developed countries. Data from less developed countries are lacking. Methods: From 2000 to 2015, a retrospective analysis identified 302 pts with aGCT treated at Instituto do Cancer do Estado de São Paulo (ICESP). Kaplan-Meier methods were used for analysis of progression-free survival (PFS) and overall survival (OS) according to the International Germ Cell Consensus Classification Group (IGCCCG). Results: Median follow-up was 46 months and median age was 28 years old. Clinical features and management are detailed in the Table. 54 pts (18%) had ECOG performance status (PS) ≥ 2 at baseline. According to the IGCCCG, 57% were good-, 18.3% intermediate-, and 24.7% poor-risk disease. Median AFP was 2.9, 243, and 3.998 and HCG was 0.4, 113 and 301 in IGCCCG good-, intermediate-, and poor-risk groups, respectively. 5-year PFS and OS were 69% and 85%, respectively, including 83% and 95.3% in good-risk, 70.9% and 83.6% in intermediate-risk and 35.1% and 62.2% in poor-risk pts. Only 3 pts (3%) received high-dose chemotherapy (HDCT) as first salvage therapy. Conclusions: Brazilian pts with advanced GCT in this cohort had similar outcomes as pts in the IGCCCG database. In comparison to contemporary series, pts with intermediate- and poor-risk GCT had slightly inferior PFS and OS, possibly due to a high percentage of pts with poor PS and less use of HDCT. [Table: see text]

scholarly journals Clinical Characteristics and Treatment Outcomes of Patients With Advanced Germ Cell Tumor Treated at a Tertiary Cancer Center in Brazil

2019 ◽  
pp. 1-8
Author(s):  
Vitor Fiorin Vasconcellos ◽  
Diogo Assed Bastos ◽  
Allan A. Lima Pereira ◽  
Gabriel Yoshiyuki Watarai ◽  
Bruno Rodriguez Pereira ◽  
...  
Keyword(s):  
Germ Cell ◽  
Treatment Outcomes ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Multivariable Analysis ◽  
Germ Cell Tumors ◽  
Cancer Center ◽  
High Dose ◽  
Poor Risk

PURPOSE Reported treatment outcomes for patients with advanced germ cell tumors (aGCT) are based mainly on series from developed nations. Data from low- and middle-income countries are underrepresented. MATERIAL AND METHODS From 2000 to 2015, a retrospective analysis identified 300 patients with aGCT treated at our institution. Kaplan-Meier methods were used for analysis of progression-free survival (PFS) and overall survival (OS) according to the International Germ Cell Consensus Classification Group (IGCCCG). RESULTS Patients’ median age was 28 years. According to the IGCCCG, 57% had good-, 18.3% intermediate-, and 24.7% poor-risk disease. Median α-fetoprotein levels were 2.9, 243, and 3,998 ng/mL, and those of human chorionic gonadotropin were 0.4, 113, and 301.5 mUI/mL in IGCCCG good-, intermediate-, and poor-risk groups, respectively. At a median 46 months of follow-up, 93 PFS events and 45 deaths had occurred and estimated 5-year PFS and OS were 69% and 85%, respectively, including 83% and 95.3% in good-risk, 70.9% and 83.6% in intermediate-risk, and 35.1% and 62.2% in poor-risk patients, respectively. In multivariable analysis, Eastern Cooperative Oncology Group performance status ≥ 2 was a significant independent prognostic factor with a hazard ratio of 2.58 (95% CI, 1.55 to 4.29; P < .001) and 6.20 (95% CI, 2.97 to 12.92; P < .001) for PFS and OS, respectively. CONCLUSION Brazilian patients with aGCT in this cohort had similar outcomes as patients in the IGCCCG database. In comparison with contemporary series, patients with intermediate- and poor-risk aGCT had slightly inferior PFS and OS, possibly due to a high percentage of patients with poor performance status and less use of high-dose chemotherapy.

Cisplatin (CDDP) and radiation versus cetuximab (Cx) and radiation in locally advanced head and neck squamous cell cancer (SCHNC): A retrospective review.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16009-e16009 ◽  
Author(s):  
Prakash Peddi ◽  
Runhua Shi ◽  
Lori Panu ◽  
Fred Ampil ◽  
Cherie-Ann Nathan ◽  
...  
Keyword(s):  
Performance Status ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Cancer Center ◽  
Ecog Performance Status ◽  
Chi Square ◽  
Group A

e16009 Background: SCHNC is a common malignancy and approximately 60% of patients present with locally advanced disease. There is paucity of data directly comparing Cx and CDDP with concurrent radiation in locally advanced SCHNC. We retrospectively reviewed charts of patients treated with CDDP and/or Cx along with radiation in locally advanced SCHNC comparing efficacy and outcomes in an academic cancer center. Methods: Ninety-five patients with locally advanced SCHNC were treated with concurrent CDDP (100 mg/m2 day 1, 22, 43) or Cx (400mg/m2 on day -7 and 250mg/m2 weekly) at our institution between January 2006 and June 2011. Forty-four patients were treated with CDDP (group A), 24 with Cx (group B) and 27 were initially started on CDDP but were switched to Cx secondary to toxicity (group C). All patients received concurrent radiation treatments (66-70 Gy, 2.0 Gy/fraction). The selection of CDDP versus Cx was largely based on ECOG performance status (PS) and baseline renal function of the patients. Chi-square test, analysis of variance, and log-rank test was used for analysis. The three groups had similar baseline characteristics except for mean age of 61, 56 and 55 years in group A, B and C respectively; T4 tumors consisted of 44%, 75% and 41% in groups A, B and C respectively. Groups A, B and C had a combined ECOG 0 and I (PS) of 93%, 75% and 92%. Patients with ECOG III PS were excluded. Results: Oropharynx was the most common treated site (38%) followed by Larynx (35%). Complete response (CR) was seen in 77%, 17% and 67% in groups A, B and C respectively (P<0.001). Median progression free survival (PFS) was 16.6, 4.3 and 22.8 in groups A, B and C respectively (P<0.001) and median overall survival (OS) was >35, 11.6 and >32 months in groups A, B and C respectively (P<0.0001). Conclusions: Concurrent CDDP with radiation leads to better response rate PFS and OS as opposed to Cx though many patients treated with CDDP could not complete treatment due to toxicity. Randomized trial comparing the two should be considered.

Abiraterone acetate (AA) with or without cabazitaxel (CBZ) in treatment of chemotherapy naive metastatic castration-resistant prostate cancer (mCRPC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 84-84
Author(s):  
Susan F. Slovin ◽  
Karen E. Knudsen ◽  
Susan Halabi ◽  
Mark T. Fleming ◽  
Ana M. Molina ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gene Networks ◽  
Radiographic Progression ◽  
Performance Status ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Primary Objective ◽  
Castration Resistant Prostate Cancer ◽  
Ecog Performance Status ◽  
Castration Resistant

84 Background: Loss of retinoblastoma tumor suppressor (RB) function has been shown to lead to CRPC and is strongly associated with poor outcome. RB functions as a transcriptional repressor; as such, loss of RB causes de-repression of pro-tumorigenic gene networks, including deregulation of the androgen receptor (AR) locus, excessive AR production, and castration-resistant (ligand independent) AR activity that can bypass hormone therapy. Our hypothesis is that leveraging RB status can direct treatment decisions. The primary objective of the trial (NCT02218606) was to determine the radiographic progression free survival (rPFS) of AA/prednisone (AAP) with and without CBZ in mCRPC patients (pts) that have progressed on primary androgen deprivation therapy and no prior AR directed therapy or chemotherapy. Methods: This is a multicenter non-comparative randomized phase 2 trial. Pts were randomized 1:1 to AAP with crossover to CBZ upon AAP failure (Arm 1), or the combination of AAP + CBZ (Arm 2). Randomization was stratified by the CALGB 90401 prognostic risk groups. The primary endpoint was rPFS (time from randomization to radiographic progression or death, whichever occurs first). Arms were analyzed separately. Results: Between October 2014 and March 2019, 93 pts were accrued; 81 were randomized. Median age was 68 years and ECOG performance status was 0 or 1. Endpoints are shown in Table. Therapies were well tolerated. Conclusions: Results of AAP + CBZ (Arm 2) in chemotherapy naïve pts suggest that men may derive benefit from the earlier use of CBZ with acceptable toxicity, supporting further study of this combination in mCRPC pts. Circulating Tumor Cells are being analyzed for changes in RB/AR expression. Managed by: Prostate Cancer Clinical Trials Consortium; Funding: Sanofi US; Support: Prostate Cancer Foundation. Clinical trial information: NCT02218606. [Table: see text]

Therapeutic effect of TAS-102 (A) in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard chemotherapy by the Köhne model (Km).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 650-650 ◽  
Author(s):  
Tomohiro Nishina ◽  
Takayuki Yoshino ◽  
Nobuyuki Mizunuma ◽  
Kentaro Yamazaki ◽  
Yoshito Komatsu ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Risk Group ◽  
Performance Status ◽  
Progression Free Survival ◽  
Risk Groups ◽  
High Risk Group ◽  
Phase Iii ◽  
Tumor Site ◽  
Ecog Performance Status

650 Background: TAS-102 is a novel oral antitumor agent consisting of trifluorothymidine and thymidine phosphorylase inhibitor. In the TAS-102 phase II study, TAS-102 significantly improved overall survival (OS) compared with placebo (P) in pts with mCRC who had 2 or more prior regimens and refractory to fluoropyrimidine, irinotecan and oxaliplatin (A: 112pts; P: 57 pts; median OS, 9.0 vs 6.6 months (M); HR, 0.56; p = 0.0011) [K. Yamazaki et al. JSMO 2011 Abst 10428, Y. Kuboki et al. ECCO 2011 Abst 6005]. Km [Ann Oncol 2002; 13:308-317] suggested predictive prognosis marker and showed 4 parameters to classify pts with mCRC treated 5-FU-based first line chemotherapy into 3 risk groups (low risk group (L), intermediate risk group (IM) and high risk group (H)). We retrospectively evaluated TAS-102 phase II study by Km. Methods: Classification of pts into each risk group was done as follows: L is ECOG performance status (PS) 0-1, 1 tumor site; IM is (1) PS 0-1, >1 tumor site, ALP <300 IU/L and (2) PS >1, WBC <10×109 /L, 1 tumor site; H is (1) PS 0-1, >1 tumor site, ALP ≥300 IU/L, (2) PS >1, WBC <10×109 /L, >1 tumor site and (3) PS >1, WBC ≥10×109 /L. Progression-free survival (PFS) was assessed by an independent review committee. Results: Pts were classified as L/ IM/ H in 36/ 31/ 102 pts. The median OS for TAS-102 vs Placebo were in L (not reached vs 10.1M; hazard ratio (HR), 0.62), in IM (9.0 vs 4.9 M; HR, 0.44) and in H (7.6 vs 5.6 M; HR, 0.58). This risk stratified analysis by Km demonstrated that HR of OS and PFS was similar in each risk group (Table). Conclusions: The OS and PFS of TAS-102 were superior to that of placebo in all risk groups by Km. Further prospective TAS-102 phase III study is necessary to confirm these results. [Table: see text]

An open, multicenter, phase II clinical trial to evaluate efficacy and safety of S-1 split cisplatin in patients with advanced gastric cancer (AGC): HGCSG0702—Safety analysis.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 121-121
Author(s):  
Ichiro Iwanaga ◽  
Satoshi Yuki ◽  
Hiraku Fukushima ◽  
Atsushi Ishiguro ◽  
Takenori Takahata ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Rest Period ◽  
Dose Intensity ◽  
Progression Free Survival ◽  
High Dose ◽  
Ecog Performance Status ◽  
Eligibility Criteria ◽  
Efficacy Analysis ◽  
Multicenter Phase

121 Background: From the results of SPIRITS trial, S-1 plus cisplatin has been regarded as standard first-line chemotherapy for patients with AGC in Japan. However, many facilities are forced hospitalization of hydration upon administration of high dose Cisplatin (60mg/m2). Therefore, in Hokkaido Gastrointestinal Cancer Study Group (HGCSG), to investigate the safety and efficacy, we conducted a multicenter phase II clinical trials of S-1 plus split cisplatin as a therapeutic strategy that can be administered in the outpatient. Methods: Eligibility criteria included pathologically confirmed AGC; no prior chemotherapy; Age 20 to 75, ECOG performance status (PS) of 0 to 1; adequate organ function; and written informed consent. S-1 (40-60 mg depending on patients body surface area) was given orally, twice daily for 3 consecutive weeks, and 30 mg/m2 cisplatin was given intravenously on day 1 and 15, followed by 2-week rest period, within a 5-week cycle. Primary endpoint was the response rate (RR), and secondary endpoints were progression-free survival, overall survival, safety profile, and duration of hospitalization. Results: Between Mar 2008 and Mar 2012, 40 pts were enrolled. Patients characteristics were as follows: median age 63 years (range 41-75), Male: female 30:10, PS 0:1 33:7. Median no. of cycles was 3. The most common non-hematological adverse events (AE) were anorexia (70%), nausea (60%), fatigue (60%) and diarrhea (48%) and hematological AE were anemia (88%), neutropenia (83%), leukocytopenia (68%) and thrombocytopenia (60%). The main grade 3-4 AE were neutropenia (40%), anemia (30%), anorexia (30%) and fatigue (15%). These AE were as expected. The median dose intensity of S-1 was 270mg/m2/week (relative dose intensity (RDI) 80%), and cisplatin was 10.1mg/m2/week (RDI 84%). These toxicities were tolerable and manageable. No treatment-related death was observed. Conclusions: We conclude that this S-1 plus split cisplatin regimen was well tolerated in the treatment of AGC, and most patients could be administered in the outpatient. We are planning the final efficacy analysis for February 2013.

Efficacy of TIP (paclitaxel, ifosfamide and cisplatin) as salvage chemotherapy for relapsed germ cell cancer patients stratified by the modified International Prognostic Factors Study Group (IPFSG) score: The Northern Ireland (NI) Experience.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5028-5028
Author(s):  
Adam Uprichard ◽  
Julie-Anne Scott ◽  
James Mcaleer ◽  
Judith Carser ◽  
Olabode Oladipo
Keyword(s):  
Germ Cell ◽  
Clinical Outcomes ◽  
Salvage Therapy ◽  
Primary Tumour ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
Risk Groups ◽  
Normal Serum ◽  
Published Data ◽  
High Dose

5028 Background: Salvage therapy for relapsed or refractory germ cell tumours (GCTs) after first-line treatment (1LT) failure remain controversial. The ongoing TIGER trial aims to compare conventional-dose chemotherapy (CDCT) using TIP with high-dose chemotherapy (HDCT) and to validate a modified version of the IPFSG stratification system as a secondary objective. We retrospectively analysed data from patients treated with TIP at our institution and stratified by the modified IPFSG (mIPFSG) groupings, correlating this with clinical outcomes. Methods: Data from all GCT patients who received TIP in NI between 2005 and 2014 was collected. Patients were scored using known IPFSG factors including progression-free interval (0-1), metastasis site (0-3), response to 1LT (0-2), primary tumour site (0-3), HCG (0-1), AFP (0-2), and histology (-1 to 0), and categorised into the modified strata. Descriptive and inferential statistics using SPSS compared survival measure outcomes and the favourable response rate (FRR) i.e the proportion of patients achieving either a complete response or partial response with normal serum tumour markers, according to mIPFSG group. Results: Thirty patients were identified, all of whom received 4 cycles of TIP. The median age was 37 years (range 17-57), 28 patients were non-seminoma histology with 2 patients seminoma. The cohort comprised predominantly of patients with more adverse mIPFSG features and the FRR of the group was 30%, with a median progression-free survival (PFS) of 9 months and 2-year overall survival (OS) of 50%. Clinical outcomes differed by mIPFSG score as shown below. Conclusions: Our study shows TIP efficacy comparable to published data, and to our knowledge is the first to show correlation between clinical outcomes with the regimen and the new mIPFSG model. The differences in outcomes to CDCT using TIP across risk groups in real world practice shows potential for a stratified approach to patient selection for salvage therapy, as is under investigation by the TIGER study.[Table: see text]

Heterogeneity of intermediate prognosis patients (pts) with metastatic renal cell cancer (mRCC) treated with sunitinib.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 446-446
Author(s):  
Avishay Sella ◽  
M. Dror Michaelson ◽  
Ewa M. Matczak ◽  
Ronit Simantov ◽  
Mariajose Lechuga ◽  
...  
Keyword(s):  
Risk Factors ◽  
Kinase Inhibitors ◽  
Risk Model ◽  
Cox Regression ◽  
Performance Status ◽  
Cell Cancer ◽  
Objective Response ◽  
Progression Free Survival ◽  
Cancer Center ◽  
Ecog Performance Status

446 Background: The Memorial Sloan Kettering Cancer Center risk model (MSKCC) stratifies pts with mRCC into 3 prognostic groups based on 5 risk factors. The Intermediate Prognosis (INTMP) risk group is characterized by the presence of 1 or 2 factors, equivalent to 15 possible distinct entities. This heterogeneity suggests that the efficacy of tyrosine kinase inhibitors may be less predictable in the INTMP than in the other groups. Methods: We identified 548 patients with INTMP mRCC from a pooled analysis of patients treated with sunitinib in 6 prospective phase II and III clinical trials. Statistical analysis was performed using Cox regression and Kaplan-Meier methods and Pearson chi-square tests. Results: Most INTMP pts were male (69%), with clear cell carcinoma (93%), good ECOG performance status (PS) (60.5% PS 0; 38% PS 1; 1.5% PS 2) and median age 60. There were 325 pts (56%) with 1risk factor, and the most common were <1 year from diagnosis (38%); low hemoglobin (Hg) (29%), or both (16%). Objective response rate (RR) was 35.4%, progression free survival (PFS) was 8.4 months (m) and overall survival (OS) was 20.5 m. The 325 (59.3%) pts with one risk factor fared better than the 223 (40.7%) patients with two: PFS 10.7 vs 6.5 m, HR 0.684(95% CI 0.563-0.832, p<0.001); OS 26.3 vs 14.1 m, HR 0.522 (95% CI 0.420-0.648, p<0.001). RR was similar (38.5% vs 30.9%, p=0.071). Sunitinib was more effective in pts with PS 0: PFS 9.7 vs 7.8 m, HR 0.797 (95% CI 0.654-0.972, p=0.0242); OS 24.7 vs 14.0 m, HR 0.529 (95% CI 0.426-0.657, p<0.001), RR 38.9% vs 30.1%, (p=0.036). The most common grade 3/4 adverse events (AE) were fatigue (17%), hypertension (10%), hand foot skin reaction (9%), and nausea (4%). Overall, 17% of patients discontinued due to AE, and the overall pattern of AEs did not vary among the subgroups. Conclusions: MSKCC INTMP is a heterogeneous group comprised mostly of pts with low Hg and/or < 1 year from diagnosis. PFS and OS are superior in pts with 1 vs. 2 risk factors, and PS is also an important factor in the INTMP group. Sunitinib is active and well-tolerated in INTMP pts. Clinical trial information: NCT00077974, NCT00083889, NCT00137423, NCT00267748, NCT00338884, NCT00054886.

scholarly journals Risk of Death, Relapse or Progression, and Loss of Life Expectancy at Different Progression-Free Survival Milestones in Primary Central Nervous System Lymphoma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1699-1699
Author(s):  
Jorne Lionel Biccler ◽  
Kerry J Savage ◽  
Peter de Nully Brown ◽  
Judit Jørgensen ◽  
Thomas Stauffer Larsen ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Performance Status ◽  
Central Nervous System Lymphoma ◽  
Progression Free Survival ◽  
High Dose ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Risk Of Death ◽  
Background Population

Abstract Primary Central Nervous System Lymphoma (PCNSL) is a rare aggressive non-Hodgkin lymphoma involving exclusively the central nervous system (CNS). The majority of PCNSLs are diffuse large B-cell lymphomas (DLBCL), but treatment and prognosis differ from systemic DLBCL due to differences in biology and the difficulty of delivering effective therapies with high penetration across the blood-brain barrier (BBB). While PCNSL often responds to initial therapy, relapses are common even after achieving a complete remission. The aims of this study were to estimate the risk of death or relapse and the loss of life expectancy in PCNSL after primary treatment with high-dose methotrexate (HD-MTX) containing regimens. Outcomes were assessed at baseline and for patients reaching pre-defined milestones of progression-free survival (PFS). Data on PCNSL patients were extracted from the nationwide Danish lymphoma register. The inclusion criteria were I) histologically-proven DLBCL morphology, II) involvement restricted to parenchymal or leptomeningeal CNS involvement without ocular involvement, III) treatment protocols containing HD-MTX, and IV) diagnosis between 2000-2017. PFS was defined as the time from diagnosis until death, relapse/progression, or end-of-treatment response assessment for patients with stable or progressive disease at the response assessment. The five-year PFS event probability risk was estimated for all patients and conditional on patients reaching different PFS milestones. The five-year restricted loss of lifetime (5y-RLEL) was defined as the numeric difference in the number of days patients and individuals from a background population are expected to live in the following five year period. This was estimated for all patients and for subsets of patients free of PFS events after one (PFS1), two (PFS2), or three (PFS3) years. Additionally, the results were stratified according to gender, ECOG performance status 0-1/> 1, elevated LDH status, treatment with/without rituximab, and age at diagnosis ≤60/>60 years. The survival of an age- and gender-matched general population was calculated by using life tables from the Human Mortality Database. In total 253 patients were included in the analyses; 60% were male, median age at diagnosis was 66 (range 27 - 85), 46% had an ECOG performance status > 1, and 33% had elevated LDH levels. Consolidation therapy (radiotherapy and/or high-dose therapy with autologous stem cell transplantation) was used in 23% of patients and 36% received rituximab in first line. The median follow-up was 6.9 years (range 0.7 - 17.7), the 5-year overall survival was 35% (95% CI 29-42), and the five-year PFS was 28% (95% CI 22-34). Patients reaching PFS1 had a 51% (95% CI 41-61) probability of a PFS event in the following five years (Figure 1A). After the PFS1 milestone, the five-year probability of a PFS event did not change substantially (Figure 1A) and the event probability remained high even after three years of PFS. On average, the PCNSL patients lost 2.2 living years (95% CI 1.9 - 2.4) in the five years after first pathologic diagnosis of PCNSL (Figure 1B). At PFS1, the 5y-RLEL decreased to 1.0 years (95% CI 0.7 - 1.3) (Figure 1B). The achievement of later PFS milestones only led to minor additional decreases in 5y-RLEL (PFS3: 0.7 years [95% CI 0.3 - 1.1]) (Figure 1B). The 5y-RLEL estimates were substantially larger for patients with an ECOG performance status > 1 vs patients with an ECOG performance status ≤ 1 (Figure 1B). Outcome differences between risk factor defined subgroups decreased after PFS1 and later PFS milestones (Figure 1B). The outlook of PCNSL patients treated with HD-MTX-based therapy improves significantly given a progression-free survival of one year, after which baseline adverse risk factors lose prognostic impact over time. However, in contrast to systemic DLBCL, survival does not normalize to the background population even after several years without PFS event. By the time of the ASH, updated results that include patients from the population-based lymphoma database in British Columbia (Canada) will be presented. Disclosures No relevant conflicts of interest to declare.

First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9000-9000
Author(s):  
Martin Reck ◽  
Tudor-Eliade Ciuleanu ◽  
Manuel Cobo ◽  
Michael Schenker ◽  
Bogdan Zurawski ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Performance Status ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Expression Level ◽  
First Line ◽  
Ecog Performance Status ◽  
Grade 3

9000 Background: In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles). Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Here we report data with 2 years’ minimum follow-up from this study. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles; n = 361) or chemo alone (4 cycles; n = 358). Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. The primary endpoint was OS. Secondary endpoints included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels. Safety was exploratory. Results: At a minimum follow-up of 24.4 months for OS (database lock: Feb 18, 2021), pts treated with NIVO + IPI + chemo continued to derive OS benefit vs chemo, with a median OS of 15.8 months vs 11.0 months, respectively (HR, 0.72 [95% CI, 0.61–0.86]); 2-year OS rates were 38% vs 26%. Median PFS with NIVO + IPI + chemo vs chemo was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56–0.79]); 8% and 37% of pts who had disease progression received subsequent immunotherapy, respectively. ORR was 38% with NIVO + IPI + chemo vs 25% with chemo. Similar clinical benefit with NIVO + IPI + chemo vs chemo was observed in all randomized pts and across the majority of subgroups, including by PD-L1 expression level (Table) or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of pts in the NIVO + IPI + chemo arm vs 88% and 38% in the chemo arm, respectively. Conclusion: With 2 years’ minimum follow-up, first-line NIVO + IPI + chemo demonstrated durable survival and benefit versus chemo in pts with advanced NSCLC; no new safety signals were identified. Clinical trial information: NCT03215706. [Table: see text]

Initial experience of TAS-102 chemotherapy in Australian patients with chemorefractory metastatic colorectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 71-71
Author(s):  
Azim Jalali ◽  
Hui-Li Wong ◽  
Rachel Wong ◽  
Margaret Lee ◽  
Lucy Gately ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Febrile Neutropenia ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Performance Status ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Performance Status ◽  
Number Of Patients

71 Background: For patients with refractory metastatic colorectal cancer (mCRC) treatment with Trifluridine/Tipiracil, also known as TAS-102, improves overall survival. In Australia, TAS-102 was initially made available locally through patients self-funding, later via an industry sponsored Medicine Access Program (MAP) and then via the Pharmaceutical Benefits Scheme (PBS). This study aims to investigate the efficacy and safety of TAS-102 in real world Australian population. Methods: A retrospective analysis of prospectively collected data from the Treatment of Recurrent and Advanced Colorectal Cancer (TRACC) registry was undertaken. The characteristics and outcomes of patients receiving TAS-102 were assessed and compared to all TRACC patients and those enrolled in the registration study (RECOURSE). Results: Across 13 sites, 107 patients were treated with TAS-102 (non-PBS n = 27, PBS n = 80), The median number of patients per site was 7 (range: 1-17). The median age was 60 years (range: 31-83), compared to 67 for all TRACC patients and 63 for RECOURSE. Comparing registry TAS-102 and RECOURSE patients, 75% vs 100% were ECOG performance status 0-1, 74% vs 79% had initiated treatment more than 18 months from diagnosis of metastatic disease and 39% vs 49% were RAS wild type. Median time on treatment was 10.4 weeks (range: 1.7-32). Median clinician assessed progression-free survival was 3.3 compared to RECIST defined PFS of 2 months in RECOURSE study, while median overall survival was the same at 7.1 months. Two patients (2.3%) had febrile neutropenia and there were no treatment-related deaths in the real-world series, where TAS102 dose at treatment initiation was at clinician discretion. In the RECOURSE study there was a 4% febrile neutropenia rate and one treatment-related death. Conclusions: TRACC registry patients treated with TAS102 were younger than both TRACC patients overall and those from the RECOURSE trial. Less strict application of RECIST criteria and less frequent imaging may have contributed to an apparently longer PFS. However overall survival outcomes achieved with TAS102 in real world patients were comparable to findings from this pivotal trial with an acceptable rate of major adverse events.

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